Response to Defendants’ Motion for Summary Judgment

Grange v. Mylan

Description: This brief was filed in Utah federal court in response to a summary judgment motion filed by the defendants in a fentanyl pain patch case. The response generally addresses issues relating to manufacturing, design and marketing defects in terms of negligence and strict product liability. It discusses the use of circumstantial evidence to prove a product defect. And it addresses the issue of spoliation. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF UTAH, CENTRAL DIVISION
RONALD GRANGE, JR,Individually and in his capacity as the Personal Representative of the Estate of Ronald T. Grange Sr., deceased, and APRIL GRANGE HOLMES, the heirs at law,

Plaintiffs,

vs.

MYLAN LABORATORIES, INC n/k/a MYLAN, INC.; MYLAN TECHOLOGIES, INC.; MYLAN PHARMACEUTICALS, INC. and ENTITY DOES I THROUGH V,

Defendants.

Case No. 1:07-CV-107 TCJudge Tena Campbell

PLAINTIFFS’ MEMORANDUM IN OPPOSITION TO

DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Table of Contents

 

Table of Authorities………………………………………………………………………………iii

Introduction……………………………………………………………………………………….vi

Statement of Material Facts in Genuine Dispute…………………………………………………ix

Response to the Mylan Defendants’ Statement of Undisputed Facts…………………………….xi

The Plaintiffs’ Statement of Undisputed Facts…………………………………………………xviii

  1. The Mylan Fentanyl Patch…………………………………………………………xviii
  1. Ronald Grange’s Chronic Pain, Fentanyl Prescription, and Death………………….xix
  1. The Medical Examiner Certifies “Fentanyl Toxicity” as Grange’s Cause of Death

…………………………………………………………………………………..xxi

  1. The Mylan Defendants Knew of Patients’ Elevated Levels Prior to Grange’s Death

…………………………………………………………………………………xxiii

  1. The Mylan Defendants’ Failure to Provide Adequate Warnings for Their Patches

………………………………………………………………………………….xxv

Argument & Authorities…………………………………………………………………………..1

  1. The plaintiffs have produced ample evidence that Grange died of fentanyl toxicity…1
  1. A jury could reasonably find that Grange’s patch had a manufacturing defect.………3
  1. The plaintiffs can rely on circumstantial evidence to prove malfunction.………..4
  1. Circumstantial evidence of product malfunction is overwhelming in this case.….7
  1. Dr. Berner opines that, contrary to the Mylan Defendants’ contention, the

Mylan patch can and did malfunction…………………………………………….10

  1. No fentanyl patches were improperly discarded, but—even if they were—

dismissal of this action is not an appropriate sanction.………………………………13

  1. The plaintiffs did not discard the fentanyl patch at issue.………………………..13
  1. No fentanyl patches were improperly discarded.…………………………………14

Table of Contents (cont’d)

  1. No spoliation sanction is proper because, even if inappropriately discarded, the unused patches are not critical evidence.…………………………………………15
  1. The Mylan Defendants inadequately warned Grange’s physician.………………….18
  1. The Mylan Defendants’ fentanyl-patch warnings were inadequate.…………….18
  1. Dr. Stanley would not have prescribed fentanyl for Grange had the Mylan Defendants adequately warned him.……………………………………………..20
  1. The defendants breached their duty of care when designing their fentanyl-patch.….23
  1. Utah permits negligent-design claims.……………………………………………23
  1. Sufficient evidence exists of the Mylan Defendants’ negligent design.…………24

Conclusion……………………………………………………………………………………….28

Certificate of Service…………………………………………………………………………….28

Table of Authorities

 

Decisions

 

Artiglio v. Super. Ct., 22 Cal. App. 4th 1388 (Cal. Ct. App. 1994)………………………………23

 

Barnish v. KWI Bldg. Co., 980 A.2d 535 (Pa. 2009)………………………………………………9

 

Bishop v. Gentec, 48 P.3d 218 (Utah 2002)……………………………………………………….5

 

Bozicevich v. Kenilworth Mercantile Co., 199 P. 406 (Utah 1921)……………………………….2

 

Burlington N. & Santa Fe Ry. v. Grant, 505 F.3d 1013 (10th Cir. 2007)……………………….16

 

Burns v. Cannondale Bicycle Co., 876 P.2d 415 (Utah Ct. App. 1994)……………………2, 6, 14

 

Carlin v. Super. Ct., 13 Cal. 4th 1104 (1996)……………………………………………………23

 

DeWitt v. Eveready Battery Co., 565 S.E.2d 140 (N.C. 2002)……………………………………5

 

Doyle v. White Metal Rolling & Stamping Corp., 618 N.E.2d 909 (Ill. 1993)……………………5

 

Drysdale v. Ford, 947 P.2d 678 (Utah 1997)……………………………………………………18

 

Egbert v. Nissan Motor Co., 228 P.3d 737 (Utah 2010)…………………………………………..6

 

Egbert v. Nissan N. Am., Inc., 167 P.3d 1058 (Utah 2007)…………………………………….4,5

 

Flury v. Daimler Chrysler Corp., 427 F.3d 939 (11th Cir. 2005)……………………………….17

 

Gen. Motors Corp. v. Hopkins, 548 S.W.2d 344 (Tex. 1977)…………………………………….5

 

Griffin v. Prudential Ins. Co., 133 P.2d 333 (Utah 1943)…………………………………………1

 

Gower v. Savage Arms, Inc., No. 99-cv-1572, 2002 U.S. Dist. LEXIS 11261

(E.D. Pa. June 12, 2002) (unpublished)……………………………………………………4

 

Gudmundson v. Del Ozone, 2010 UT 33 (Utah 2010)…………………………………………….5

 

Grundberg v. The Upjohn Co., 813 P.2d 89 (Utah 1991)………………………………………..23

 

Harker v. Black & Decker, No. 93-3273, 1994 U.S. App. LEXIS 7439

(6th Cir. Apr. 11, 1994) (unpublished)……………………………………………………4

 

Harsco Corp. v. Renner, 475 F.3d 1179 (10th Cir. 2007)……………………………………….23

Table of Authorities (cont’d)

 

Henderson v. Sunbeam Corp., 46 F.3d 1151 (10th Cir. 1995)……………………………………5

 

Holloway v. Gen. Motors Corp., 271 N.W.2d 777 (Mich. 1978)…………………………………5

 

House v. Armour of Am., 929 P.2d 340 (Utah 1996)…………………………………………….18

 

Jordan F. Miller Corp. v. Mid-Continent Aircraft Serv., No. 97-5089,

1998 U.S. App. LEXIS 2739 (10th Cir. Feb. 20, 1998) (unpublished)………………….16

 

King v. Searle Pharms., 832 P.2d 858 (Utah 1992)……………………………………………….6

 

Lake-Allen v. Johnson & Johnson, L.P., No. 2:08-cv-930,

2009 U.S. Dist. LEXIS 64860 (D. Utah July 27, 2009) (unpublished)………………….23

 

Lamb v. B & B Amusements Corp., 869 P.2d 926 (Utah 1993)…………………………………..1

 

Martin v. Unit Rig & Equip. Co., 715 F.2d 1434 (10th Cir. 1983)………………………………..5

 

Mays v. Ciba-Geigy Corp., 661 P.2d 348 (Kan. 1983)……………………………………………8

 

Moraca v. Ford Motor Co., 332 A.2d 599 (N.J. 1975)……………………………………………5

 

Nash v. Gen. Elec. Co., 410 N.E.2d 792 (Ohio Ct. App. 1979)…………………………………..4

 

North v. Ford Motor Co., 505 F. Supp. 2d 1113 (D. Utah 2007)………………………………..17

 

Orth v. Emerson Elec. Co., 980 F.2d 632 (10th Cir. 1992)………………………………………5

 

Parsons v. Ford Motor Co., 85 S.W.3d 323 (Tex. Ct. App. 2002)……………………………….4

 

Pehle v. Farm Bureau Life Ins. Co., 397 F.3d 897 (10th Cir. 2005)………………………………5

 

Rasbury v. Bainum, 387 P.2d 239 (Utah 1963)………………………………………………….17

 

Rogers v. Johnson & Johnson Prods., Inc., 565 A.2d 751 (Pa. 1989)……………………………5

 

Rowe v. Albertson’s Inc., 178 F. App’x 859 (10th Cir. 2006) (unpublished)……………………16

 

Slisze v. Stanley-Bostitch, 979 P.2d 317 (Utah 1999)………………………………………..24, 25

 

Soule v. Gen. Motors Corp., 8 Cal. 4th 548 (1994)……………………………………………….5

 

Stewart v. Ford Motor Co., 553 F.2d 130 (D.C. Cir. 1977)……………………………………4, 8

 

Table of Authorities (cont’d)

 

Taylor v. Cooper Tire & Rubber Co., 130 F.3d 1395 (10th Cir. 1997)…………………….5, 6, 10

 

Turner v. Pub. Serv. Co., 563 F.3d 1136 (10th Cir. 2009)…………………………………..16, 17

 

Union Ins. Co. v. RCA Corp., 724 P.2d 80 (Colo. Ct. App. 1986)………………………………..7

 

Utah Local Gov’t Trust v. Wheeler Mach. Co., 199 P.3d 949 (Utah 2008)……………………..24

 

Warren v. Liberty Mut. Fire Ins. Co., 555 F.3d 1141 (10th Cir. 2009)…………………………..1

Webb v. Univ. of Utah, 125 P.3d 906 (Utah 2005)………………………………………………24

 

Weir v. Fed. Ins. Co., 811 F.2d 1387 (10th Cir. 1987)……………………………………5, 7, 8, 9

Whitlock v. Old Am. Ins. Co., 442 P.2d 26 (Utah 1968)…………………………………………..2

Williams v. Am. Med. Sys., 548 S.E.2d 371 (Ga. Ct. App. 2001)…………………………………5

Statutes

Utah Code § 78B-6-703(2)………………………………………………………………………..4

 

Other Authorities

Michael H. Graham, Federal Practice & Procedure § 7003 (interim ed. 2006)…………………16

W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 103 (5th ed. 1984))…..………1

Model Utah Jury Instruction 1002……………………………………………………….1, 4, 6, 24

Model Utah Jury Instruction 1008……………………………………………………………….18

Model Utah Jury Instruction 1006(A)……………………………………………………………..4

Restatement (Third) of Torts: Prods. Liab. § 3…………………………………………………5, 7

 

Introduction

Ronald Grange, Sr., received a fatal dose of fentanyl, a powerful opioid, from a defective pain patch that the Mylan Defendants’ designed, manufactured, and marketed. Grange was wearing a single prescribed 75 mcg/hr Mylan fentanyl patch when he died. The defective patch gave Grange a lethal blood-fentanyl concentration that was approximately thirteen times higher than a properly functioning patch should have provided. The Deputy Medical Examiner for the State of Utah certified that Grange died from “fentanyl toxicity” and rejected the Mylan Defendants’ purported explanation for Grange’s elevated fentanyl level.

Grange’s wrongful-death beneficiaries assert strict-liability manufacturing- and marketing-defect, negligence, gross negligence, negligent-misrepresentation, and breach-of-warranty claims against the Mylan Defendants. The Mylan Defendants move for summary judgment. They argue that (1) insufficient evidence exists that fentanyl toxicity caused Grange’s death; (2) insufficient evidence exists of a manufacturing defect; (3) the entire case should be dismissed because the plaintiffs discarded Grange’s leftover fentanyl patches; (4) insufficient evidence supports the plaintiffs’ failure-to-warn, negligent misrepresentation, and breach-of-warranty claims; and (5) Utah law proscribes negligent-design claims against drug manufacturers. (The Mylan Defendants do not seek summary judgment on the plaintiffs’ other negligence theories, aside from arguing that no evidence of causation exists.) All of their contentions are unfounded.

First, overwhelming evidence reveals that fentanyl toxicity caused Grange’s death. His postmortem fentanyl-blood concentration was 22 ng/mL. This concentration is more than twice the average reported fatal concentration of 8.3 ng/mL and more than thirteen times the average peak concentration of 1.7 ng/mL listed in the Mylan Defendants’ own prescribing information. Thus, Utah’s Deputy Chief Medical Examiner certified Grange’s cause of death as “fentanyl toxicity.” In his deposition, he affirmed that fentanyl toxicity was a cause of Grange’s death; he was not willing to assume that Grange’s prior, treated coronary disease caused Grange’s death. Moreover, he rejected the Mylan Defendants’ contention that postmortem redistribution (a toxicological theory discussed below) rendered Grange’s reported fentanyl-blood concentration unreliable. (See, infra, pp. 1–3.)

Second, significant circumstantial evidence demonstrates that the 75 mcg/hr Mylan patch that Grange wore when he died malfunctioned and was unreasonably dangerous. A properly manufactured 75 mcg/hr patch—according to the Mylan Defendants’ package insert and corporate representative—should have provided an average peak fentanyl-blood concentration of 1.7 ng/mL. Grange’s postmortem blood-fentanyl concentration, however, was 22 ng/mL—approximately thirteen times higher than expected. There is no evidence that Grange was abusing or misusing his prescription fentanyl patch, which he had purchased only days before. And the medical examiner and the plaintiffs’ toxicological expert have rejected the Mylan Defendants’ contention that Grange’s postmortem blood-fentanyl level is unreliable. Finally, although unnecessary, the plaintiffs have expert evidence that Grange’s fentanyl patch malfunctioned in one of six ways—directly contradicting the Mylan Defendants’ position that their patches cannot malfunction. (See, infra, pp. 3–13.)

Third, the Mylan Defendants are not entitled to a spoliation sanction. Plaintiff Ronald Grange, Jr., did not improperly discard Grange’s fentanyl patches because he discarded the unused patches at the instruction of police officers at the scene of Grange’s death. But even if he did improperly destroy them, he would have only discarded unused fentanyl patches, not the defectively manufactured fentanyl patch that Grange was wearing when he died. The Mylan Defendants’ request for spoliation sanctions is inconsistent with their position in other fentanyl-death investigations that an examination of unused patches (and even used patches more than two years old) will not reveal a defect. Because no spoliation of any evidence (much less, critical evidence) occurred, no spoliation sanction is appropriate here. (See, infra, pp. 13–18.)

Fourth, a jury could reasonably find that the Mylan Defendants’ fentanyl patch was defective because it lacked adequate warnings. The plaintiffs have proffered expert evidence that the Mylan Defendants’ warnings were inadequate because they did not warn prescribing physicians of the risk (1) that death due to respiratory arrest despite proper use could occur and (2) that the fentanyl patches can malfunction. Grange’s prescribing physician testified that he would not have prescribed the fentanyl patch had he received these warnings. (See, infra, pp. 18–22.)

Finally, the jury could reasonably determine that the Mylan Defendants breached their duty of care by negligently designing their fentanyl patch. Prior to Grange’s death, Mylan knew that other test subjects and patients had received elevated fentanyl levels from proper use of the patch. But they have steadfastly and unreasonably ignored the possibility that their patch was the cause of the elevated levels and failed to perform necessary testing. Internal communications reveal that the Mylan Defendants recognized that they could not tell the FDA that their product did not cause elevated fentanyl levels and that they sought to avoid discussing the matter with the FDA. Thus, a genuine issue of material fact exists as to whether the Mylan Defendants negligently designed their fentanyl patches. (See, infra, pp. 23–28.)

For all of these reasons and the reasons that follow, the Mylan Defendants’ motion for summary judgment must be denied.

Statement of Material Facts in Genuine Dispute

  1. A genuine issue of material fact exists as to whether Grange died from fentanyl toxicity.
  2. A genuine issue of material fact exists as to whether the phenomenon of postmortem redistribution affected Grange’s postmortem fentanyl-blood concentration and the reliability of that concentration for purposes of determining Grange’s cause of death.
  3. A genuine issue of material fact exists as to whether the Mylan fentanyl patch that Grange was wearing when he died had a manufacturing defect.
  4. A genuine issue of material fact exists as to whether the Mylan fentanyl patch that Grange was wearing when he died was defective because the Mylan Defendants failed to warn adequately of the risk of a fentanyl overdose and death from proper use of the patch.
  5. A genuine issue of material fact exists as to whether Grange’s prescribing physician would have prescribed the patch to Grange if the Mylan Defendants had provided adequate warnings about the risk of fentanyl overdose and death from proper use of the patch (that the plaintiffs and their expert contend should have been provided).
  6. A genuine issue of material fact exists as to whether the Mylan Defendants were negligent in, among other things, designing, manufacturing, warning, and performing quality control for the Mylan fentanyl patch.
  7. A genuine issue of material fact exists as to whether the Mylan Defendants acted reasonably by failing, prior to Grange’s death, to investigate why patients had received higher-than-expected blood-fentanyl concentrations.
  8. A genuine issue of material fact exists as to whether Mylan negligently misrepresented the safety of the Mylan fentanyl patch.
  9. A genuine issue of material fact exists as to whether Mylan breached express and implied warranties concerning its Mylan fentanyl patch.

10. A genuine issue of material fact exists as to whether any leftover patches that Grange did not use were discarded after this litigation began, whether the leftover patches constitute “critical evidence,” and whether any discarding renders spoliation sanctions appropriate.

Response to the Mylan Defendants’ Statement of Undisputed Facts

  1. The Plaintiffs, Ronald T. Grange, Jr., as personal representative of the Estate of his late father, Ronald T. Grange, Sr. (“Grange”), and April Grange Holmes, originally brought this action against Mylan Inc. (“MI”) and Mylan Technologies Inc. (“MTI”) alleging that the death of Ronald T. Grange, Sr. on August 3, 2005, was caused by his use of a fentanyl transdermal system. The fentanyl transdermal system is a prescription drug product indicated for chronic pain that has been approved by the United States Food and Drug Administration (“FDA”) as safe and effective when used in accordance with its approved labeling.

UNDISPUTED EXCEPT: that, while the FDA has approved the labeling on the Mylan fentanyl patches, the labeling and the product are not safe and effective. The labeling does not warn prescribing physicians of the risk of death due to respiratory arrest despite proper use or of the risk that the fentanyl patches will malfunction. (Decl. of Dr. Christopher Grubb ¶ 4 (Ex.1); Dep. of Dr. Christopher Grubb at 90:13-17; 200:18–211:23; 223:9-20 (Ex. 2).)[1]

As part of this approval, the Mylan Fentanyl Transdermal System (“MFTS”) had to carry labeling that was approved by the FDA. Plaintiffs do not contend that the MFTS at issue in this case was provided to decedent or his physician without this FDA-approved labeling, which states under the section heading “Intended Use/Indications” that:

Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

(See Package Insert, attached as Exhibit I).

UNDISPUTED

The Full Prescribing Information contains a “black box” warning, directed to the prescribing physician, indicating that, among other things:

Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated:

  • in patients who are not opioid-tolerant
  • in the management of acute pain or in patients who require opioid analgesia for a short period of time
  • in the management of postoperative pain, including use after out-patient or day surgeries (e.g., tonsillectomies)
  • in the management of mild pain
  • in the management of intermittent pain [e.g., use on an as needed basis (prn)] .

. . . .

Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing fentanyl transdermal system in situations where the healthcare professional is concerned about increased risk of misuse, abuse or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Id.

UNDISPUTED EXCEPT: to the extent that the Mylan Defendants suggest that the black box warning warns prescribing physicians of the risk of death due to respiratory arrest despite proper use and of the risk that the fentanyl patches will malfunction. (See Dr. Grubb Decl. ¶ 4 (Ex. 1); Dr. Grubb Dep. at 90:13-17; 200:18–211:23; 223:9-20 (Ex. 2).) The fact that the black box warning warns of hypoventilation when the fentanyl patch is used in contraindicated ways, does not warn of the risks of sudden death with proper use or of product malfunction with proper use. (Package Insert at 1 (Dkt. 96-9); Dr. Grubb Dep. pp. 203–208 (Ex. 2); see, infra, p. 20 n.19.)

 

B. Background of Ronald Grange, Sr. (Decedent)

At the time of his death, Mr. Grange was 54 years of age and had suffered multiple heart attacks, had high blood pressure, high cholesterol, Lou Gehrig’s Disease, coronary artery disease, arterial sclerosis, and chronic back pain. (See Ogden Police Report, p. 6, attached as Exhibit A).

UNDISPUTED EXCEPT: that Grange did not have multiple heart attacks. He had a heart attack seven years before his death in 1998. (See Univ. of Utah Hosps. & Clinics Recs. at 84 (Ex. 3); Dep. of Ryan Horning, P.A. at 18:24–19:2 (Ex. 4) (“[Mr. Grange] states that he believes he may have had one heart attack.”); Dep. of Dr. Grace O’Brien at 14:13-18 (Ex. 5) (indicating that she did not know how many heart attacks Grange had).) Grange received a bypass operation in 2000 to treat his heart disease. (See Univ. of Utah Hosps. & Clinics Recs. at 14 (Ex. 3).) The plaintiffs are also unaware of any medical reports or confirmation indicating that Grange had Lou Gehrig’s disease.

 

Ronald Grange, Sr., was found deceased on August 3, 2005. He was last seen alive on July 31, 2005. (See Exhibit A).

UNDISPUTED

 

On August 3, 2005, the investigator employed with the Office of the Medical Examiner for the State of Utah, Gregory G. Whinham, initially listed the cause of death as a cardiac event and Mr. Grange’s original Certificate of Death indicated his death was a result of “Natural Disease Not Otherwise Specified.” No autopsy was performed. (See p. 1 Report of Investigation and Certificate of Death, Office of the Medical Examiner, attached as Exhibit B).

UNDISPUTED

Subsequently, on August 4, 2005, a post-mortem examination was undertaken by Dr. Edward Leis, M.D. Dr. Leis found nothing during his post-mortem examination inconsistent with cardiac failure as the cause of death. (See Deposition Transcript of Dr. Leis at p. 81, attached as Exhibit C). Nevertheless, based solely on a post-mortem heart blood sample, and without the benefit of an autopsy, Dr. Leis ultimately issued a Death Certificate listing the cause of death as fentanyl toxicity.

UNDISPUTED EXCEPT: to the extent that the Mylan Defendants suggest that an autopsy was necessary to determine that fentanyl toxicity was a cause of Grange’s death or that reliance upon a postmortem blood sample to determine drug toxicity as a cause of death is improper or unreliable. The Mylan Defendants have not offered any evidence to support their insinuation. (See, infra, Pls.’ Stmt. of Undisputed Facts ¶¶ 6–11.) Moreover, Dr. Leis’ examination did not uncover any evidence contrary to the plaintiffs’ contention that Grange was wearing one prescribed 75 mcg/hr fentanyl patch and not abusing or misusing his prescription. (See Dep. of Dr. Edward Leis at 18:10–19:22; 101:17-19 (Ex.6).)

 

When deposed, Dr. Leis testified that myocardial infarction could not be ruled out as Grange’s cause of death and acknowledged that his investigation was less than “ideal.” (Id. at 76-77, 109).

UNDISPUTED EXCEPT: to the extent that the Mylan Defendants suggest that Dr. Leis could not say whether fentanyl toxicity was a cause of Grange’s death. Dr. Leis testified that fentanyl was “at least one of the causes of [Grange’s] death.” (Id. at 102:23–103:1 (Ex. 6).) Moreover, the Mylan Defendants’ insinuation that an “ideal” investigation must occur before a cause of death can be determined is belied by Dr. Leis’s testimony. (Id. at 16:20-25; 72:16-21; 76:8-10 (Ex. 6).) Moreover, no autopsy is necessary to determine that fentanyl toxicity was a cause of Grange’s death. (Id. at 25:3-4; 81:23-24 (Ex. 6).)

C. Plaintiffs’ Claims and Lack of Evidence

[The Mylan Defendants’ brief omits any paragraph 9.]

10. [The Mylan Defendants’ brief omits any paragraph 10.]

11. Despite this, in their First Amended Complaint, Plaintiffs brought claims for strict liability, negligence, negligent misrepresentation, gross negligence and breach of warranty. (See Plaintiffs’ First Amended Complaint, Docket No. 50, attached as Exhibit E).

UNDISPUTED

12. Plaintiffs have offered one alleged expert, Bret Berner, Ph.D., for the proposition that a defect existed in the design or manufacture of the MFTS. Dr. Berner admits, however, that he cannot specify which, if any, of his hypotheses of a manufacturing defect contained in his report might have occurred in this case. (See Deposition Transcript of Bret Berner, Volume I, pp. 35-36, attached as Exhibit H).

UNDISPUTED EXCEPT: that, although Dr. Berner has opined that he cannot determine which of the six defects listed in his report caused Grange’s patch to malfunction, he has opined that, to a reasonable degree of certainty, “at least one of these mechanisms was the cause of the fatal overdose of fentanyl that Mr. Grange suffered.” Decl. of Dr. Bret Berner ¶ 55 (Ex. 7); Dep. of Dr. Bret Berner (Vol. II) at 217:21-25 (Ex. 8).) He also has opined that Grange’s fentanyl patch did not work as designed or intended because it delivered more than the 1.7 (with a standard deviation of 0.7) ng/mL of fentanyl to Grange. (Dr. Berner Decl. ¶ 55 (Ex. 7).) Moreover, the Mylan Defendants have not argued that Dr. Berner lacks the education and experiences necessary to testify in this case, and thus he is not merely an “alleged” expert. Dr. Leis, the medical examiner, and Dr. Iain McIntyre, the plaintiffs’ toxicology expert, determined that Grange’s concentration was “above what would be expected for using a 75 [mcg/hr] patch.” (Dr. Leis Dep. at 28:6-7 (Ex. 6); McIntyre Decl. ¶ 14 (Ex. 9).)

 

13. In fact, when deposed, Berner stated the following when asked what specific defect allegedly existed in the patch at issue that purportedly caused Grange’s death:

Q. Which one of these six hypotheticals that you mentioned happened in the case of Mr. Grange?

A. Could I say specifically which one? I cannot identify specifically which one it would be.

Id.

UNDISPUTED

14. Grange’s treating physician, Scott Stanley, M.D., testified that fentanyl was a safe

and helpful product, that he knew and understood the risks of fentanyl, that he understood the label for the drug, and that a hypothetical label change would not have altered his decision to

prescribe the drug for Grange. (See Deposition Transcript of Dr. Scott Stanley at pp. 105, 127,134-37, attached as Exhibit F.)

DISPUTED: As explained below, Dr. Stanley testified that he would not have prescribed fentanyl had he been adequately warned of the danger of malfunction, that his patient would not receive the amount of fentanyl indicated on the package insert, or that a patient could suddenly die while using the fentanyl patch. (Dr. Stanley Dep. 39:12–40:2; 50:5-19; 54:11-19; 56:22–57:5; 57:14–58:3; 58:16-24; 63:17–64:8; 76:17–77:7; 80:13–81:12; 177:22–178:20 (Ex. 10).) A full discussion of Dr. Stanley’s testimony with quoted portions of his deposition testimony is below. (See, infra, pp. xxvii–xxx.)

15. Dr. Stanley also testified that he knew Grange to misuse and abuse his prescribed narcotic pharmaceuticals. (Id. at 171-73.)

DISPUTED: Dr. Stanley testified that Grange had once taken too many of an oral medication. (Id. at 171:14–172:6 (Ex. 10).) He did not testify that he knew Grange “to abuse” or “to misuse” his medications.

D. Plaintiffs’ [Alleged] Destruction of Evidence

16. Mr. Grange was treated by Dr. Stanley from January 20, 2005 until the time of his death. On July 29, 2009, Dr. Stanley prescribed Ronald Grange, Sr. ten (10) 75 mcg/hr fentanyl patches, to be applied one at a time and change every 72 hours. (See Terrace Pharmacy Records, attached as Exhibit J).

UNDISPUTED

17. Plaintiffs have represented that any and all remaining patches from this prescription have been lost, destroyed, or are now otherwise unavailable. (See Plaintiffs’ Appeal of Magistrate Judge’s Order Granting Defendants’ Motion to Compel, Docket No. 93).

UNDISPUTED EXCEPT: that, contrary to the Mylan Defendants’ insinuation, the fact that unused patches (and even the patch that Grange was wearing when he died) are missing is not probative of whether the plaintiffs’ allegations are meritorious. The Mylan Defendants’ documents from other fentanyl-death investigations and their behavior in other fentanyl-death lawsuits demonstrate the inspection of such patches does not assist in determining whether a manufacturing defect exists. (See FDA Telephone Rpt. at 1 (June 6–7, 2005) (MYLAN 157192) (Conf. Ex. 11); see MTI QA Investigation Rpt. at 2 (MYLAN 290193) (Conf. Ex. 12); Eric Pearson Decl. ¶ 4 (Ex. 13).)

18. Accordingly, Plaintiffs have no admissible evidence to support their claims.

DISPUTED for the reasons listed above and below.

 

The Plaintiffs’ Statement of Undisputed Facts

A. The Mylan Fentanyl Patch

1. The Mylan Defendants’ fentanyl patches are transdermal prescription drugs applied to the patient’s skin and used to treat chronic pain. (See Dfs.’ Undisputed Facts (“DUF”) ¶ 2.) Fentanyl is a very potent opioid drug with a narrow therapeutic index (i.e., the difference between a therapeutic and a fatal dose is small). (See Dep. of Dr. Iain McIntyre at 245:25–246:19 (Ex. 14).) Properly functioning patches continuously deliver the requisite dose of fentanyl through the skin to the bloodstream over a 72-hour period. (See Package Insert at 3 (Dkt. 96-9).) After several sequential uses, “patients reach and maintain a steady state serum concentration.” (Id. at 4 (Dkt. 96-6).) In other words, absent a product defect, a patient should be obtaining the same fentanyl-blood concentration from day to day. At the time of Ronald Grange’s death, the patches were sold in various doses, such as 25, 50, 75, or 100 micrograms-per-hour (“mcg/hr”). (Id. at 4 (Table A) (Dkt. 96-6).)
2. According to the prescribing information that accompanies the Mylan fentanyl patch, the average peak fentanyl-blood concentration that a patient should receive from a 75-mcg/hr fentanyl patch is 1.7 ng/mL, with a standard deviation of 0.7. (See Package Insert at 4 (Table A) (Dkt. 96-9); Houghton Dep. at 81:20–82:2 (Ex. 15).)[2] Ronald Grange’s 75 mcg/hr patch delivered a fatal dose of 22 ng/mL, a level approximately thirteen times higher than the patch was supposed to provide. (See Toxicology Results at 1 (Ex. 18); Dr. McIntyre Decl. ¶ 14 (Ex. 9).

B. Ronald Grange’s Chronic Pain, Fentanyl Prescription, and Death

3. Prior to his death, Grange had suffered from various conditions, including chronic back pain. (See Dep. of Dr. Scott Stanley at 20:9-17 (Ex. 10); DUF ¶ 4.) To treat his pain, Scott Stanley, M.D., prescribed Grange 75-mcg/hr fentanyl patches. (See Dr. Stanley Dep. at 34:21–35:2 (Ex. 10); The Medicine Shoppe Pharmacy Recs. (Ex. 19).) Grange obtained his last prescription of 10 fentanyl patches on July 29, 2005. (Terrace Pharmacy Recs. (Ex. 20.) Dr. Stanley testified that he was unaware of any information that Grange was overmedicated on fentanyl, that he had unique skin that caused him to receive a higher fentanyl dose than intended, or that he had problems with his kidneys that would cause him not to excrete fentanyl. (Dr. Stanley Dep. at 35:12–37:10 (Ex. 10).) He also did not have any knowledge indicating that Grange had misused fentanyl patches. (Id. at 59:6-12 (Ex. 10).) Had Dr. Stanley been aware of such information, he would not have prescribed Grange fentanyl. (See id. at 36:24–37:20; 59:13-19 (Ex. 10).)[3] Indeed, the Mylan Defendants have touted reduced potential for patient abuse of their fentanyl patches (as compared to the name brand with a different patch design). (See at Mylan 3-Day Fentanyl Transdermal System PowerPoint Presentation at 3 (MYLAN 355556-69) (Conf. Ex. 21).)

4. Ronald Grange was 54 years old when he was found dead on August 3, 2005 at his apartment in Ogden. (See Death Certificate (Ex. 22); see generally Police Rpt. (Dkt. 96-1); see also DUF ¶ 5.) Grange’s son, Ronald Grange, Jr., at the direction of the police officers who reported to the scene of Grange’s death, flushed eight unused fentanyl patches down the toilet, and Grange’s daughter, April Holmes, stated that she had discarded one fentanyl patch in 2005, more than a year before the plaintiffs filed suit in this case. (See Police Rpt. at 8 (Dkt. 96-1); Decl. of Ronald Grange, Jr. ¶ 2 (Ex. 23).)

5. In other fentanyl-death investigations and lawsuits, the Mylan Defendants have stated or indicated that the inspection of any missing patches will not reveal whether a defect exists. For instance, Mylan’s Frank Sisto informed the FDA that “we prefer to not take back product from the field for analysis since we have no knowledge as to how the product was stored, and therefore, any data obtained would not necessarily be representative of the actual quality of the lot in question. Instead, we would prefer to analyze retain[ed] samples of the lot in question which are held under appropriate conditions by company personnel.” (See FDA Telephone Rpt. at 1 (Mylan 157192) (Conf. Ex. 11).) Similarly, in yet another fentanyl-death case, the Mylan Defendants did not seek the return of samples for inspection because, as would also be true in this matter, “the shelf life of Mylan’s FTS is 24 months and more than two years have elapsed since the event reportedly occurred.” (See MTI QA Investigation Rpt. at 2 (MYLAN 290193) (Conf. Ex. 12).) Indeed, in other fentanyl-death lawsuits in which the plaintiffs’ counsel represents other beneficiaries and in which unused Mylan patches are available, the Mylan Defendants have never sought to inspect the unused patches made available to them. (See Pearson Decl. ¶ 4 (Ex. 13).)

C. The Medical Examiner Certifies “Fentanyl Toxicity” as Grange’s Cause of Death

6. Dr. Edward Leis, the Deputy Chief Medical Examiner for the State of Utah and forensic pathologist, examined Grange’s body, reviewed toxicological testing, and certified Grange’s cause of death. He testified that he found one 75-mcg/hr fentanyl patch on the “back of [Grange’s] right arm.” (Dr. Leis Dep. at 18:10-12 (Ex. 6).) The medical examiner’s office destroyed the patch on October 14, 2005. (Id. at 18:13-20 (Ex. 6).) Dr. Leis testified that he saw no evidence that Mr. Grange was wearing more than one patch when he died. (Id. at 18:21–19:22 (Ex. 6).) Although he observed “no obvious tears or leaking, . . . there could be other defects that [he] couldn’t see.” (Id. at 101:17-19 (Ex. 6).)[4]

7. Dr. Leis decided not to perform an autopsy in this case. (Id. at 16:20-25 (Ex. 6).) He testified that, “given [the office’s] caseload,” (id. at 76:8-10 (Ex. 6)), “not everyone that comes here gets an autopsy. . . . [I]f we have sufficient medical history and no circumstances to make the death suspicious, we may do an external examination.” (Id. at 72:16-21 (Ex. 6).) Dr. Leis originally listed Grange’s death as “Natural Disease, Not Otherwise Specified.” (See id. at 17:16-20 (Ex. 6); Death Cert. (Ex. 22).)

8. Dr. Leis, however, drew blood from Grange’s heart for toxicological testing at National Medical Services, a reputable national laboratory that Utah typically uses when it does not test the blood “in house.” (Dr. Leis Dep. at 17:7-11; 23:4–24:7 (Ex. 6).) The blood test indicated that Grange’s blood-fentanyl level was 22 ng/mL. (Id. at 24:5-7 (Ex. 6).) Dr. Leis consulted “Disposition of Toxic Drugs and Chemicals in Man” by Randall Baselt, a reference routinely relied upon by medical examiners and toxicologists, which indicated that the fentanyl “blood range [for a 75 mcg/hr patch] should be 1.1 to 2.6 micrograms per liter.” (Dr. Leis Dep. at 28:4–30:8 (Ex. 6); see also Dr. McIntyre Dep. at 31:7-8 (Ex. 14) (referring to Baselt’s treatise as “the commonly-referenced book”); Dr. McIntyre Decl. ¶ 15 & Exhibit D thereto (Ex. 9); Dep. of Dr. Laura Labay at 54:12-23 (Ex. 6) (forensic toxicologist at lab that tested Grange’s blood; she uses Baselt’s treatise in her practice).) Not only was Grange’s blood-fentanyl level of 22 ng/mL more than Dr. Leis expected from a properly functioning 75 mcg/hr patch, (Dr. Leis Dep. at 30:1-7, 30:5-17 (Ex. 6)), but Grange’s fentanyl level was also “a little over two and a half” times higher than the reported average fatal postmortem fentanyl-blood level of 8.3 ng/mL. (Id. at 31:16-25 (Ex. 6); see also Dr. McIntyre Decl. ¶ 14 (Ex. 9).)

9. Based on Grange’s fentanyl-blood concentration, Dr. Leis amended the cause of death to “fentanyl toxicity.” (Id. at 24:14-17 (Ex. 6).) He confirmed at his deposition that fentanyl toxicity was “at least one of the causes of [Grange’s] death.” (Id. at 102:16–103:1 (Ex. 6).) Although he also testified that atherosclerotic disease may possibly have been a “strong contributory factor” in Grange’s death, (id. at 25:10-12 (Ex. 6)), he testified at his deposition that “I would stand by the fentanyl toxicity for a cause of death,” (id. at 25:3-4 (Ex. 6)). After all, he testified that “a heart attack would not explain [Grange’s] elevated level of fentanyl.” (Id. at 81:23-24 (Ex. 6); see also id. at 102:20–103:1 (Ex. 6).) And Grange had had a bypass operation in 2000 to treat his coronary disease. (See Univ. of Utah Hosps. & Clinics Recs. at 14 (Ex. 3).)

10. Dr. Leis determined that the phenomenon of postmortem redistribution—by which “some drugs are thought to either be released – [after having] been previously bound by tissues, and then following death are released into the blood . . . .”—did not explain Grange’s excessive blood-fentanyl level. (Dr. Leis Dep. at 13:24–14:8; 28:1-7 (Ex. 6).)[5] Notably, the fatal concentrations provided in Baselt’s treatise are derived from postmortem blood samples. (See id. at 32:15–33:15 (Ex. 6).) Thus, if postmortem redistribution occurs, Grange’s blood sample and those to which it was compared would all have been subject to that phenomenon.

11. Moreover, Dr. Leis does not believe that postmortem samples are inherently unreliable. He testified that, in the “vast majority of cases,” his office uses postmortem blood samples to determine causes of death (because most patients do not have the foresight to have antemortem blood samples drawn immediately before dying). (Id. at 13:6-13 (Ex. 6).) He is not aware of any court striking the testimony of a medical examiner in his office based on reliance on postmortem blood levels. (Id. at 15:8-14 (Ex. 6).)

D. The Mylan Defendants’ Knew of Patients’ Elevated Levels Prior to Grange’s Death

12. By the time of Grange’s death and after their fentanyl patches had been on the market for less than a year, the Mylan Defendants had notice of at least one death by a patient using the Mylan fentanyl patch.

E. The Mylan Defendants’ Failure to Provide Adequate Warnings for Their Patches

13. Christopher Grubb, M.D., a pain-management specialist who has prescribed fentanyl “hundreds of times,” has opined that the Mylan Defendants’ fentanyl patches fail to warn prescribing physicians of the risk of death due to respiratory arrest with proper use and the risk that the fentanyl patches will malfunction. (Dr. Grubb Decl. ¶ 4 (Ex. 1); Dr. Grubb Dep. at 90:13-17; 200:18–211:23; 223:9-20 (Ex. 2).) Specifically, Dr. Grubb opines:

While the black box section of the label references the possibility of fatal overdose and life threatening hypoventilation, these risks are referenced only in connection with abuse/misuse of the product, use of the product in listed contraindicated ways and use of the product during the initial application period of the product. In my opinion, a prescriber who reads the black box section of the label would come away from the reading with the impression that as long as the product is used properly, it is safe and there is no risk of death.

As referenced above, in my view, the label for Mylan fentanyl patches should warn of the risk of product malfunction (i.e., the patch producing substantially greater fentanyl blood concentrations than the patch was intended to produce). Not only does the label not warn of this risk, but the label instructs regarding expected fentanyl blood concentrations, giving prescribers the impression that the product will reliably produce fentanyl blood concentrations within the reported ranges. Fentanyl has a very narrow therapeutic index. Thus, giving prescribers the impression that the product produces fentanyl concentrations reliably and consistently within a reasonably narrow range, when in fact the product does not always perform as such, is unreasonable and dangerous.

(Dr. Grubb Decl. ¶¶ 6–8 (Ex. 1).) Dr. Grubb also provides the specific language that the Mylan Defendants should include in their warning to physicians:

Fentanyl Transdermal System contains a high concentration of a potent Schedule II opioid agonist, Fentanyl, which is 80 to 100 times more potent than morphine. Reports have been received of patients dying from respiratory arrest with proper use of Fentanyl Transdermal Systems. Thus, use of Fentanyl Transdermal System involves a risk of death from respiratory arrest, even with proper use. Fentanyl Transdermal System should only be used for management of persistent, moderate to severe chronic pain that cannot be managed by other means. Use of Fentanyl Transdermal System may produce toxic or fatal serum fentanyl concentrations, far in excess of the mean maximal concentrations referenced in the Pharmacokinetics section below.

(Dr. Grubb Decl. ¶ 9 (Ex. 1).)

14. Despite the Mylan Defendants’ counsel’s numerous improper speaking objections at Dr. Stanley’s deposition, Dr. Stanley testified that such warnings would have influenced his decision to prescribe fentanyl to Grange. (Contra DUF ¶ 14.) He testified that he attempts to stay abreast of warnings in drug-package inserts that govern drugs related to his field. (Dr. Stanley Dep. at 38:1-10 (Ex. 10).) Although he testified that he was not a warnings expert, (see id. at 67:8-17 (Ex. 10)), he testified that several warnings would have caused him not to prescribe Grange fentanyl:

Q. If there was a black box or other prominent warning in the package insert stating that a certain percentage of Fentanyl patches malfunction and give patients fatal Fentanyl levels and you believe that to be a substantial risk for your patients, would you have prescribed it for Mr. Grange?

MR. TRISCHLER: Objection, argumentative, assumes facts not in evidence. It’s an incomplete and improper hypothetical when there’s not any evidence whatsoever from a scientific basis that any Mylan patch has malfunctioned. And so to try and pollute this witness with pure garbage questions that have no basis in fact is entirely inappropriate.

Q. (By Mr. Miller) You can answer.

A. Okay. If I had that information that a significant percentage could cause death, then, no, I probably would not prescribe it.

(Dr. Stanley Dep. 63:17–64:8 (Ex. 10) (emphasis added).) Similarly, he testified, over another of the Mylan Defendants’ counsel’s speaking objections:

Q. If you had been aware of a warning that there was a significant risk that a patch could malfunction and give Mr. Grange a fatal dose of Fentanyl, would you have prescribed it for him?

MR. TRISCHLER: Objection to form. It’s an incomplete hypothetical. It assumes facts not in evidence and misstates the record because there’s absolutely no evidence whatsoever that a Mylan patch can or will malfunction or that a Mylan patch is not

capable of delivering Fentanyl at a reliable controlled rate, and so the question is inappropriate. You cannot ask a hypothetical question that has absolutely no basis in fact to this witness. I move

to strike it.

A. If that was true, I probably would not prescribe it for any patient.

(Id. at 39:12–40:2 (Ex. 10).) He also testified, again over another improper speaking objection, that he was relying on the fentanyl patch to work as designed and intended:

Q. Are you aware of anything in the package insert or other prescribing information available to you that warned you as a doctor that it was possible for a 75-microgram patch to give a patient 22 nanograms per milliliter of Fentanyl or something close to that?

MR. TRISCHLER: Objection to the form of the question. Assumes facts not in evidence. It’s an incomplete and improper hypothetical. Counsel’s – this witness has never indicated that he has any foundation to answer opinion questions relating to

postmortem toxicology. You’re asking him now to compare postmortem toxicology results to antemortem concentrations. It’s

entirely unfair and inappropriate, and I object to it and move to strike the question and any response from the witness.

A. No.

Q. When you prescribed the 75-microgram patches for Mr. Grange on July 29th, 2005, . . . were you relying on the drug companies who made the patch to produce patches that would perform as designed and give the appropriate dose of fentanyl?

A. Yes.

(Id. at 80:13–81:12 (Ex. 10).) Likewise, Dr. Stanley testified that he would want to know if his patients could suddenly die from using the fentanyl patch or if the fentanyl patch should not be prescribed with other medications prescribed for Grange. (Id. at 76:17–77:7; 50:5-19; 54:11-19; 56:22–57:5; 57:14–58:3; 58:16-24 (Ex. 10).)

15. After the Mylan Defendants’ counsel asked Dr. Stanley questions, the plaintiffs’ counsel told Dr. Stanley that “there’s a bit of an inconsistency at least in my mind between your testimony on direct and your testimony on cross” concerning whether certain warnings would have affected his prescribing decision. (Id. at 175:8-10 (Ex. 10); see also Dfs.’ Br. at 24–25.) Dr. Stanley clarified—once again over an improper speaking objection—that although he was aware of certain risks with the Mylan fentanyl patch, he would not have prescribed it had he known that the Mylan patch may not provide a consistent level of fentanyl as intended:

Q. [I]f the manufacturer of this product had told you that due to a manufacturing problem or some other issue they could not manufacture Fentanyl patches that would give patients a consistent safe delivery of Fentanyl and would periodically

malfunction and give patients a massive dose of Fentanyl and you had known that, would that have affected your decision to prescribe the product?

MR. TRISCHLER: Objection to the question. It’s argumentative. It’s improper. It has no basis in fact whatsoever. It’s an incomplete and improper hypothetical. Move to strike. Go ahead and answer, Doctor. It’s like asking you when did you stop beating your wife, but go ahead and answer it.

A. I’m not trying to be difficult, but, yes, in that instance if I had that information that the product was defective, if I knew that and it was a significant risk, the answer is yes, I would not use the drug. But I don’t think that changes my answer to this gentleman when he says do I know there are risks and I still use the drug. Yes, I know there are risks, but it’s a different question so the answer is going to be a little bit different.

(Dr. Stanley Dep. at 177:22–178:20 (Ex. 10) (emphasis added).)

Argument & Authorities

Summary judgment is inappropriate because the plaintiffs can proffer evidence to support all of their claims. The Court must view the record in the light most favorable to the plaintiffs. Warren v. Liberty Mut. Fire Ins. Co., 555 F.3d 1141, 1145 (10th Cir. 2009). As the Mylan Defendants’ concede, to obtain summary judgment, they bear the burden of establishing that no genuine issue of material fact exists. (Dfs.’ Br. at 11.) The Mylan Defendants—having failed to consider the record as a whole and the applicable law—fall far short of satisfying their burden.

A. The plaintiffs have produced ample evidence that Grange died of fentanyl toxicity.

 

Contrary to the Mylan Defendants’ contention, the plaintiffs have proffered significant evidence that Mr. Grange died of fentanyl toxicity. (See Dfs.’ Br. at 29–30.) The plaintiffs need only prove that fentanyl toxicity was a cause of Grange’s death; Utah law does not require them to prove that fentanyl toxicity was the only cause of Grange’s death. See Model Utah Jury Instruction (“MUJI”) 1002 (“You must decide whether: . . . (4) the . . . defect was a cause of [Grange’s death].” (emphasis added)); Lamb v. B & B Amusements Corp., 869 P.2d 926, 929 (Utah 1993) (stating that a plaintiff must show that “the defective condition was a cause of the plaintiff’s injuries”) (referring to W. Page Keeton et al., Prosser and Keeton on the Law of Torts, § 103 at 713 (5th ed. 1984)); Dfs.’ Br. at 12). And, as the Mylan Defendants concede, “ordinarily what constitutes proximate cause is a question of fact.” (Dfs.’ Br. at 29.)

The plaintiffs’ evidence makes clear that fentanyl was a cause of Grange’s death, but, at minimum, a question of fact exists. Utah’s Deputy Chief Medical Examiner has testified and certified that fentanyl toxicity was a cause of Grange’s death. (See, supra, pp. xxi–xxiii; Dr. Leis Dep. at 25:3-4 (Ex. 6); Death Cert. at 2 (Ex. 22).) “A certified copy of death is made ‘prima facie evidence in all courts and places of the facts therein stated.’” Griffin v. Prudential Ins. Co., 133 P.2d 333, 335–36 (Utah 1943) (quoting Bozicevich v. Kenilworth Mercantile Co., 199 P. 406 (Utah 1921)); accord Whitlock v. Old Am. Ins. Co., 442 P.2d 26, 27 (Utah 1968). Grange’s 22 ng/mL fentanyl-blood concentration was more than twice the average fatal fentanyl level (when compared to other fatal postmortem fentanyl concentrations) and more than approximately thirteen times the average peak concentration that the Mylan Defendants intended. (See Package Insert at 4 (Table A) (Dkt. 96-9). Although Dr. Leis could not rule out with 100% certainty an anatomic cause of death, he testified that such a cause of death would not account for Grange’s fatal fentanyl level. (Id. at 81:23-24 (Ex. 6) (“[A] heart attack would not explain why we have an elevated level of fentanyl. So once the tox results were received, then the death certificate was amended.”); id. at 102:16–103:1 (Ex. 6) (testifying that fentanyl toxicity was “at least one of the causes of Grange’s death”).) Despite the fact that the medical examiner’s certification is sufficient for Utah’s official purposes and supported by expert testimony in this matter, Mylan is ultimately contending (without even pointing to any evidence suggesting that fentanyl was not a cause of Grange’s death) that Dr. Leis’s certification does not create a genuine issue of material fact. Unsurprisingly, they have referred to no authority for such an anomalous proposition.

The plaintiffs have done far more than “merely contend that a defect existed, show an accident occurred, and assume that the two are necessarily related.” (Dfs.’ Br. at 30 (citing Burns v. Cannondale Bicycle Co., 876 P.2d 415, 418 (Utah Ct. App. 1994)). Instead, the plaintiffs have demonstrated that

(1) the Mylan fentanyl patches can suffer from numerous defects, see infra, pp. 10 n.15,

(2) Grange died,

(3) Grange was using a prescribed Mylan fentanyl patch when he died,

(4) Mylan’s fentanyl patches contain sufficient concentrations of fentanyl to cause a fatal overdose if the fentanyl is not released in a controlled manner,

(5) a Mylan patch was intended to provide a consistent fentanyl-blood concentration of no more than 1.7 ng/mL,

(6) the average reported fatal fentanyl level is 8.3 ng/mL,[6]

(7) Grange’s postmortem fentanyl level was 22 ng/mL—more than approximately thirteen times Mylan’s intended average peak fentanyl-blood concentration and more than twice the average fatal fentanyl-blood level,

(8) the medical examiner testified that 22 ng/mL blood-fentanyl concentration is more than he would expect from a properly functioning fentanyl patch to deliver,

(9) the medical examiner certified “fentanyl toxicity” as the cause of death,

(10) the medical examiner considered and rejected the phenomenon of postmortem redistribution as an explanation of the fatal level, and

(11) the medical examiner stated that an anatomic cause of death would not account for Grange’s fatal fentanyl levels.

The plaintiffs have not simply alleged that Grange’s death by itself establishes that he died of fentanyl toxicity. Summary judgment is, therefore, inappropriate on causation.

B. A jury could reasonably find that Grange’s patch had a manufacturing defect.

Grange received his fatal dose of fentanyl from a defective Mylan fentanyl patch. The plaintiffs can demonstrate that:

(1) There was a manufacturing defect in the Mylan fentanyl patch;

(2) The manufacturing defect made the Mylan fentanyl patch unreasonably dangerous;

(3) The manufacturing defect was present when Mylan sold the fentanyl patch;[7] and

(4) The manufacturing defect was a cause of Grange’s death.

MUJI 1002. Grange’s fentanyl patch is “unreasonably dangerous” because—by delivering a much higher dose of fentanyl than intended—it was “more dangerous than an ordinary user of the fentanyl patch would expect considering the product’s characteristics, risks, dangers, uses, together with any actual knowledge, training, or experience that the user had.” MUJI 1006(A); Utah Code § 78B-6-703(2).[8] The Mylan Defendants’ motion to dismiss the strict-liability claims should be denied.[9]

1. The plaintiffs can rely on circumstantial evidence to prove malfunction.

Contrary to the Mylan Defendants’ insinuations, the plaintiffs can demonstrate a manufacturing-defect claim under Utah law by relying on circumstantial evidence that Grange’s Mylan fentanyl patch malfunctioned. The Mylan Defendants argue that the plaintiffs’ transdermal expert Dr. Bret Berner has failed to point to direct evidence to identify how Grange’s patch specifically malfunctioned. (See Dfs.’ Br. at 14–19.) But their argument is unavailing. First, direct evidence is not necessary because the Tenth Circuit has held that Utah law permits “the plaintiffs [to] prove product defect through circumstantial evidence.” Taylor v. Cooper Tire & Rubber Co., 130 F.3d 1395, 1398 (10th Cir. 1997). Second, expert evidence is unnecessary to prove a product defect. See id.

Instead, as the Tenth Circuit noted in Taylor, numerous jurisdictions have long permitted proof of product defect through circumstantial evidence of malfunction.[10] Indeed, this position is so well established that the Restatement (Third) of Torts adopted it because of the “huge body of [supporting] case law.” See Restatement (Third) of Torts: Prods. Liab. § 3 cmt.1.[11] The Utah Supreme Court, while not specifically addressing this section, has favorably referred to the Restatement (Third) and adopted its other provisions. See, e.g., Gudmundson v. Del Ozone, 2010 UT 33, ¶ 55 (Utah 2010) (adopting nondefective-component-parts doctrine); Egbert, 167 P.3d 1062–63 (adopting the enhanced-injury doctrine); Bishop v. Gentec, 48 P.3d 218, 225–26 (Utah 2002) (referring favorably to section permitting alternative theories of liability). But see Egbert v. Nissan Motor Co., 228 P.3d 737, 747 (Utah 2010) (not adopting section 16(b)-(d), although it resembles Utah law). Thus, if presented with the question, the Utah Supreme Court would almost certainly follow this overwhelming authority that requires only circumstantial evidence of product malfunction. See Pehle v. Farm Bureau Life Ins. Co., 397 F.3d 897, 902 (10th Cir. 2005) (federal courts must determine how Utah Supreme Court would rule).

Nevertheless, the Mylan Defendants contend that the plaintiffs must prove a “specific defect,” i.e., how the product malfunctioned. (See Dfs.’ Br. at 13.) But Utah law does not require a plaintiff to demonstrate how the product was defective; the plaintiff must only demonstrate that a manufacturing defect rendered the product unreasonably safe. See MUJI 1002. The Utah Supreme Court has already indicated that the concept of res ipsa loquitur—which permits the jury to infer that unspecified negligence or defect occurred based on circumstantial evidence—applies to strict liability and negligence products-liability actions. See King v. Searle Pharms., 832 P.2d 858, 861 (Utah 1992). And Talyor belies the contention that proof of anything more than a malfunction is required. See Taylor, 130 F.3d at 1398–99 & n.3.

The Mylan Defendants rely upon Burns v. Cannondale Bicycle Co., 876 P.2d 415, 418 (Utah Ct. App. 1994), to suggest otherwise. But the Tenth Circuit considered Burns in Taylor and still determined that the Utah Supreme Court, like numerous other jurisdictions, was likely to permit plaintiffs to prove a manufacturing defect through circumstantial evidence, whether expert or not, of a defect. See Taylor, 130 F.3d at 1398–99 & n.3. As the Taylor court noted, the plaintiff in Burns conceded that he lacked any evidence whatsoever of a defect, and he also lacked any evidence of causation. See Taylor, 130 F.3d at 1398; Burns, 876 P.2d at 419–20. The Burns court’s dicta concerning a “specific” defect is neither controlling nor—in light of the overwhelming contrary authority permitting circumstantial evidence of malfunction—persuasive.

Moreover, if the Defendants’ position were correct, it would be impossible for plaintiffs to recover when the product at issue had been destroyed through proper use (such as with a pill or tainted food), through the defect itself (such as with a fire), or through the action of someone whom the plaintiff does not control because “direct evidence of specific defect may not be available. Under that circumstance, [the nonspecific-defect or malfunction theory] may offer the plaintiff the only fair opportunity to recover.” Restatement (Third) of Torts: Prods. Liab. § 3 cmt. b; see also Weir, 811 F.2d at 1392 (quoting Union Ins. Co. v. RCA Corp., 724 P.2d 80 (Colo. Ct. App. 1986)). Requiring more in these situations would allow manufacturers to escape liability even when, as here, there is overwhelming evidence that the Mylan fentanyl patch did not perform as intended and caused Grange’s death.

2. Circumstantial evidence of product malfunction is overwhelming in this case.

Here, the plaintiffs have proffered significant circumstantial evidence of malfunction. Numerous patients have received fatal levels of fentanyl from Mylan patches despite no apparent signs of misuse. (See Dr. Grubb Decl. ¶ 4 (Ex. 1). The fentanyl patch contains sufficient concentrations of fentanyl to cause a fatal overdose if the drug’s release is uncontrolled. (Dr. McIntyre Decl. ¶ 10 (Ex. 9). Grange’s 75 mcg/hr fentanyl patch was intended and expected to deliver a controlled, therapeutic fentanyl dose, creating a blood-fentanyl level of 1.7 (± 0.7) ng/mL. (Package Insert at 4 (Table A) (Dkt. 96-9); Dr. Leis Dep. at 30:1-7, 30:5-17 (Ex. 6).) The average fatal fentanyl level reported in Baselt’s treatise (relied upon by the medical examiner) is 8.3 ng/mL. (Dr. Leis Dep. at 31:16-25 (Ex. 6).) Grange’s fentanyl patch, however, gave Grange a fentanyl-blood level of 22 ng/mL—approximately thirteen times higher than intended and more than double the average reported fatal fentanyl level. (Id. at 24:5-10 (Ex 6_).) Drs. Leis and McIntyre determined that Grange’s level was “above what would be expected for using a 75 [mcg/hr] patch.” (Id. at 28:6-7 (Ex. 6); McIntyre Decl. ¶ 14 (Ex. 9).) Despite the Mylan Defendants’ contention that their product cannot malfunction, (see Dr. Stanley Dep. at 39:18-20 (Ex. 10) (objection by defendants’ counsel)), the plaintiffs’ expert Dr. Bret Berner opines that Grange’s patch can malfunction in one of six ways, (see Dr. Berner Decl. ¶ 33 (Ex. 7)).

In short, the Mylan fentanyl patch was intended to produce a constant therapeutic concentration of fentanyl with an average peak of 1.7 ng/mL (±0.7). Instead, it produced a fatal 22 ng/mL concentration of fentanyl in Mr. Grange. Accordingly, the evidence overwhelmingly suggests that Grange’s Mylan patch malfunctioned and was—by causing death—unreasonably dangerous.

Because there is no evidence indicating that Grange was misusing or abusing his fentanyl patches when he died or that Grange had access to any other source of fentanyl, “[t]he inference of defect is permissible.” Weir, 811 F.2d at 1392. When plaintiffs rely on circumstantial evidence, they must typically proffer evidence tending to negate other causes for the death aside from the defect in the product. But the “quantum of proof” required is “not great.” Mays v. Ciba-Geigy Corp., 661 P.2d 348, 359 (Kan. 1983) (quoting Stewart v. Ford Motor Co., 553 F.2d 130, 137 (D.C. Cir. 1977)). “The plaintiff is not required to eliminate all other possibilities, and so prove his case beyond a reasonable doubt. . . . It is enough to make out a preponderance of probability.” See id. at 358. Here, Dr. Leis saw no evidence of misuse or that Grange was using more than one patch. (See Dr. Leis Dep. at 18:21–19:22 (Ex. 6).) Dr. Stanley knew of nothing indicating that Grange had misused his fentanyl prescription when he died. (Dr. Stanley Dep. at 59:6-12 (Ex. 10).) Indeed, the Mylan Defendants have touted reduced potential for patient abuse of their fentanyl patches (as compared to the name brand with a different patch design). (See at Mylan 3-Day Fentanyl Transdermal System PowerPoint Presentation at 3 (MYLAN 355556-69) (Conf. Ex. 21).) Moreover, Grange’s prior use of fentanyl patches indicates that there was nothing unique about him that would cause him to be an aberrational patient. (See, e.g., The Medicine Shoppe Recs. at 2 (showing filled prescriptions for fentanyl patches) (Ex. 19).) Simply put, the evidence points only to product defect to explain Grange’s fatal level of fentanyl. (See Dr. Berner Decl. ¶ 55 (Ex. 7).)

Finally, because Grange’s level was so excessive, Dr. Leis rejected the Mylan Defendants’ contention that postmortem redistribution explains away Grange’s fatal fentanyl level. (Dr. Leis Dep. at 28:1-7 (Ex. 6).) The plaintiffs’ toxicological expert also rejects the contention that postmortem redistribution accounts for Grange’s reported fatal postmortem level. (Dr. McIntyre Dep. at 161:18-20 (Ex. 14); Dr. McIntyre Decl. ¶¶ 12–14 (Ex. 9).) Yet, even if the Mylan Defendants can proffer sufficient evidence to support their theory, such evidence “does not prevent the jury from relying upon the plaintiff’s evidence and inferring a defect.” Weir, 811 F.2d at 1392; see also Barnish v. KWI Bldg. Co., 980 A.2d 535, 542 (Pa. 2009) (“[I]f the plaintiff presents a prima facie case free of abnormal use and secondary causes and the defense counters with a separate theory of causation, the case should go to the jury to resolve the question of fact.”).[12]

3. Dr. Berner opines that, contrary to the Mylan Defendants’ contention, the Mylan patch can and did malfunction.

Without directly contesting the circumstantial evidence above, the Mylan Defendants’ concentrate primarily on attacking Dr. Berner’s testimony. (Dfs.’ Br. at 14–19.) They argue that Dr. Berner provides no indication of precisely how Grange’s Mylan fentanyl patch failed to perform as intended. The Mylan Defendants’ misunderstand the purpose—and necessity—of Dr. Berner’s opinion. See Taylor, 130 F.3d at 1398 (holding that Utah law does not require expert evidence to prove defect).

First, Dr. Berner’s testimony will aid the jury because he can explain the technical aspects of transdermal delivery, the manufacture of fentanyl patches, and the ways in which the Mylan fentanyl patches can malfunction. Second, the Mylan Defendants have argued that “there’s absolutely no evidence whatsoever that a Mylan patch can or will malfunction.” (Dr. Stanley Dep. at 39:18–20 (Ex. 10) (the Mylan Defendants’ counsel’s improper speaking objection). But Dr. Berner opines that the Mylan Defendants’ position is incorrect because the patch can malfunction in at least six ways and thereby deliver more fentanyl to the patient than intended.[13] (See Dr. Berner Decl. ¶ 33 (Ex. 7).) He also opines that, to a reasonable degree of scientific certainty, the patch that Grange was wearing when he died malfunctioned in one of those six ways. (Dr. Berner Decl. ¶ 55 (Ex. 7).)

The Mylan Defendants take issue in their brief with only three of the six malfunctions that Berner identifies. They first argue that there is no basis for Dr. Berner’s testimony that a soap or surfactant contaminated Grange’s patch and thus no basis for Dr. Berner’s opinion that contamination (whether by soap, surfactant, solvent, or otherwise) could have occurred. (See Dfs.’ Br. at 15–16.) But Berner testified that it is typical for surfactants and soaps to be used somewhere in the manufacturing facility, contamination is possible, and that Mylan should (but does not) test for inadvertent contamination. (Dr. Berner Dep. at 42:12-22 (Vol. II) (Ex. 8).) Moreover, even if Mylan has no soaps or surfactants at the facility in which it manufactures fentanyl patches, the Mylan Defendants have not undermined Dr. Berner’s opinion that contamination by some other substance, including another solvent, could have occurred. (See Dr. Berner Decl. ¶¶ 34–36 (Ex. 7).) Indeed, Dr. Berner refers to the Mylan Defendants’ rejection of fentanyl-patch lots after undetermined, particulate contamination occurred. (See Dr. Berner Decl. ¶ 35 (Ex. 7).) Dr. Berner noted that such contamination—especially if localized—would be “difficult to detect by Mylan’s current methods.” (See Dr. Berner Decl. ¶ 36 (Ex. 7).)[14] Indeed, contaminants other than heptanes “are not tested for and would not be detected.” (Id. ¶¶ 34, 36 (Ex.7).)

The Mylan Defendants next contend that Dr. Berner has no basis for opining that an adhesive ring on Grange’s skin could have caused Grange to receive more fentanyl than intended. (See Dfs.’ Br. at 17.) The fact that Dr. Berner has not done testing concerning the effect of a residual ring on fentanyl is of no moment because Dr. Berner has relied upon his experience with other transdermal patches. (See Dr. Berner Dep. at 98:17–99:2 (Vol. II) (Ex. 8).) Berner also noted that the Mylan Defendants recognized in their own emails the need for “rheological correlation with wear,” but have not established that correlation. Dr. Berner opined that “[b]ased on [his] experience with a plasticized amine-resistant silicone adhesive, residue on skin was a problem and control though rheological testing with specifications were needed.” (See Dr. Berner Decl. ¶ 39 (Ex. 7).) Moreover, that the medical examiner did not remember a residual ring on Grange’s corpse does not mean that Grange did not have such a ring or otherwise account for his fatal level of fentanyl.

Finally, the Mylan Defendants chastise Dr. Berner for not having direct evidence that polymorphs (fentanyl in different crystalline forms that can increase skin penetration) were present in Grange’s fentanyl patch. (See Dfs.’ Br. at 18.) But because the medical examiner discarded Grange’s patch shortly after Grange’s death, (Dr. Leis Dep. at 18:13-20 (Ex. 6)), Berner could not have direct evidence of polymorphs. Even more importantly, no direct evidence is required. (See, supra, pp. 4–7.) Dr. Berner has opined that although Mylan tested fentanyl from one of its suppliers and found no evidence of polymorphs, Mylan has not tested and investigated whether polymorphs exist in fentanyl received from a second supplier. (See Dr. Berner Decl. ¶ 52–54 (Ex. 7).)

Simply put, Dr. Berner’s testimony specifically contradicts the Mylan Defendants’ position that their fentanyl patches cannot malfunction. Grange’s death from a fatal blood-fentanyl level is circumstantial evidence that the patch malfunctioned in one of the six ways that Dr. Berner describes. Dr. Berner’s testimony assists the jury in understanding that the fentanyl patch can malfunction and the Mylan Defendants’ testing would not detect the listed problems that cause the fentanyl patches to malfunction. That Dr. Berner cannot identify exactly which of the six defects infected Grange’s Mylan fentanyl patch is inapposite because the fact of malfunction is clear—the patch was intended to produce a therapeutic blood-fentanyl level of 1.7 (± 0.7), but instead gave Grange a fatal concentration of 22 ng/mL. The plaintiffs need not specify how this malfunction occurred. (See, supra, pp. 4–7.)

C. No fentanyl patches were improperly discarded, but—even if they were—dismissal of this action is not an appropriate sanction.

The Mylan Defendants next argue that they are entitled to have the entire action dismissed because the plaintiffs have allegedly improperly discarded certain fentanyl patches. (Dfs.’ Br. at 19–23.) Their argument is wrong for numerous reasons. First, contrary to the Mylan Defendants’ representation to the Court, the allegedly discarded patches were unused patches, not the patch that Grange wore when he died. Second, no spoliation of any evidence occurred. Ronald Grange, Jr., has declared under oath that his deposition testimony concerning existing fentanyl patches was mistaken. In actuality, he discarded Grange’s unused fentanyl patches at the police officer’s direction when his father died—well before any litigation concerning fentanyl was contemplated. Third, even if unused patches were improperly discarded, the Mylan Defendants have represented that such unused patches (or even the defective patch itself) is not critical to establishing whether a manufacturing defect exists. Accordingly, no spoliation sanction is appropriate.

1. The plaintiffs did not discard the fentanyl patch at issue.

The Mylan Defendants’ contention that “the product which the Plaintiffs are now claiming to be defectively manufactured was, at some point in time, conveniently discarded by these same Plaintiffs” is simply not true. (Dfs.’ Br. at 20.) The patch that Grange was wearing when he died and that suffers from a manufacturing defect was discarded by the medical examiner’s office in October 2005. (Dr. Leis Dep. at 18:13-20 (Ex. 6).) There is no evidence indicating that the plaintiffs have had that patch in their possession or that they had anything to do with its discarding. Instead, the patches that plaintiff Ronald Grange, Jr., allegedly discarded were the leftover patches that Grange had not used. (Grange Decl. ¶¶ 2–4 (Ex. 23).) Accordingly, the Mylan Defendants misplace their reliance on decisions where courts dismissed lawsuits after the plaintiff discarded the defective product itself. (See Dfs.’ Br. at 21–22.)[15]

2. No fentanyl patches were improperly discarded.

When the facts are properly taken in a light most favorable to the plaintiffs, no patches were improperly discarded. During Ronald Grange, Jr.’s deposition on January 7, 2010, he mistakenly testified that a cardboard box in his garage contained leftover fentanyl patches that he had found in his father’s residence at the time of his death in August 2005. But in truth, the cardboard box contains no such patches or patch boxes. Rather, as Ronald Grange, Jr., explained in the attached affidavit:

  1. At the time of my father’s death, I found two boxes of Mylan fentanyl patches in his house. There were about 8 leftover patches if I remember correctly. One of the police officers on the scene told me to flush the unused patches down the toilet, which I did. I gave the two empty patch boxes to my attorneys at Heygood, Orr & Pearson. At this time, I do not have any leftover patches, patch boxes or any other medication in my possession.
  1. I gave my deposition in this case on January 7, 2010. During the deposition, I was very nervous. I could not concentrate. I felt like the Mylan attorney was attacking me. All I could think about was my dead father. Also, several of the questions asked me about a “box” and it was not clear whether the attorney was asking about a large cardboard box I described to him or asking me about the box the fentanyl patches came in.
  1. During the deposition, I testified that there was a box of fentanyl patches in a cardboard box in my garage. This testimony was mistaken. As I stated above, I threw out the leftover fentanyl patches after my father’s death and sent the empty patch boxes to my attorneys. The cardboard box I described in my deposition does not have any leftover patches, patch boxes or any other medication in it.

(Grange Decl. ¶¶ 2–4 (Ex. 23).) His declaration is consistent with the police report prepared by the Ogden Police Department in 2005. According to that report, the leftover fentanyl patches had been discarded shortly after Grange’s death by Ronald Grange, Jr., and his sister. (Police Rpt. at 8 (Dkt. 96-1).) Indeed, a police officer at the scene of Grange’s death told Ronald Grange, Jr., to flush the unused patches down the toilet, in accord with instructions in Mylan’s package insert. (Package Insert at 9 (Dkt. 96-9); Grange Decl. ¶ 2 (Ex. 23).) The plaintiffs’ counsel has had the two empty fentanyl boxes in their possession for more than a year; they have not been in Ronald Grange’s garage. (Pearson Decl. ¶ 2 (Ex. 13).) The plaintiffs’ attorneys had previously informed the Mylan Defendants in April 2009 that they had the empty fentanyl boxes in their possession and that they were available for inspection and copying. (See id. ¶ 3 (Ex. 13); Resp. & Objs. to Dfs.’ First Set of Req. for Prod. at 4–5, Req. 9 (Ex. 33); Pictures of Empty Boxes (Ex. 34).) Thus, when the facts are properly considered in the light most favorable to the plaintiffs, no improper discarding of evidence occurred.

3. No spoliation sanction is proper because, even if inappropriately discarded, the unused patches are not critical evidence.

But even if Ronald Grange, Jr., had improperly discarded unused patches, no spoliation sanction is proper because those patches are not critical to the Mylan Defendants’ defense. (See Dfs.’ Br. at 23.) To impose spoliation sanctions, the Court must determine that “the adverse party [is] prejudiced by the destruction of evidence.” See Turner v. Pub. Serv. Co., 563 F.3d 1136, 1149 (10th Cir. 2009). In Turner, the Tenth Circuit affirmed a district court’s refusal to impose spoliation sanctions when “there [was] no evidence that [the proponent for the sanction] was ‘actually rather than merely theoretically’ prejudiced by [the loss of evidence].” Id. at 1150 (citing Burlington N. & Santa Fe Ry. v. Grant, 505 F.3d 1013, 1032–33 (10th Cir. 2007)); see also Jordan F. Miller Corp. v. Mid-Continent Aircraft Serv., No. 97-5089, 1998 U.S. App. LEXIS 2739, *13–14 (10th Cir. Feb. 20, 1998) (stating that key factors to consider are the discarding party’s culpability and “the degree of actual prejudice to the other party”). The Mylan Defendants’ own statements and conduct in other fentanyl-death investigations and lawsuits demonstrate that they cannot satisfy their burden of showing that prejudice exists here. See Rowe v. Albertson’s Inc., 178 F. App’x 859, 861 (10th Cir. 2006) (quoting Michael H. Graham, Federal Practice & Procedure § 7003 n.12 at 39 (interim ed. 2006)).

Rasbury v. Bainum, 387 P.2d 239 (Utah 1963), does not support the Mylan Defendants’ position. (Dfs.’ Br. at 21.) In that case, the court dismissed a cause of action based on a promissory note because missing books and records were critical evidence to the defendant’s affirmative defense. Here, in contrast, the unused patches—by the Mylan Defendants’ own admissions in other fentanyl-death investigations—are not critical to determining whether a defect existed. See Turner, 563 F.3d at 1150. The discarding of immaterial evidence does not warrant sanction.

Yet, even if some sanction were appropriate, dismissing the entire action is excessive. “Dismissal represents the most severe sanction available to a federal court, and therefore should only be exercised where there is a showing of bad faith and where lesser sanctions will not suffice.” Flury v. Daimler Chrysler Corp., 427 F.3d 939, 944 (11th Cir. 2005). Here, the unused patches can have, at most, only some unidentified bearing on the plaintiffs’ manufacturing claims. An inspection of those patches is not germane to the plaintiffs’ warning-defect, negligence, and related warranty claims. Because the Mylan Defendants have not even suggested how those patches could meaningfully affect those claims, it would be unfair to dismiss all of the plaintiffs’ claims. See North v. Ford Motor Co., 505 F. Supp. 2d 1113, 1117 n.11 (D. Utah 2007) (refusing to impose sanction when, among other reasons, the absence of the allegedly defective vehicle was not as prejudicial to a design-defect claim) (citing cases, including Drysdale v. Ford, 947 P.2d 678, 681 (Utah 1997), in which the Utah Supreme Court “rejected Ford’s theory that the plaintiff would not be able to prove its [design-defect claim] simply because the vehicle in question was lost”).

Accordingly, no spoliation occurred, and no sanction is appropriate here.

D. The Mylan Defendants inadequately warned Grange’s physician.

 

For their warning claims, the plaintiffs are required to demonstrate that (1) the Mylan Defendants failed to provide an adequate warning and thereby rendered the fentanyl patches unreasonably dangerous and (2) the lack of an adequate warning caused harm. See MUJI 1008; House v. Armour of Am., 929 P.2d 340, 343 (Utah 1996). The Mylan Defendants incorrectly assert that the plaintiffs have failed to satisfy either element. (Dfs.’ Br. at 24–26.) There are, at minimum, genuine issues of material fact concerning the plaintiffs’ warning claims.

1. The Mylan Defendants’ fentanyl-patch warnings were inadequate.

Christopher Grubb, M.D., a pain-management specialist, has opined that the Mylan Defendants’ warnings were inadequate. Specifically, he has opined that fentanyl patches fail to warn prescribing physicians of the risk (1) that death due to respiratory arrest despite proper use may occur and (2) that the fentanyl patches will malfunction. (Dr. Grubb Decl. ¶ 4 (Ex.1); Dr. Grubb Dep. at 90:13-17; 200:18–211:23; 223:9-20 (Ex. 2).) Specifically, Dr. Grubb opines:

While the black box section of the label references the possibility of fatal overdose and life threatening hypoventilation, these risks are referenced only in connection with abuse/misuse of the product, use of the product in listed contraindicated ways and use of the product during the initial application period of the product. In my opinion, a prescriber who reads the black box section of the label would come away from the reading with the impression that as long as the product is used properly, it is safe and there is no risk of death.

In reading Andrea Miller’s deposition, I noted that she asserted that the black box did warn of the risk of death with proper use where the following language appears: “Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated: ….” First, in my opinion, this language does not reference in any way risks associated with proper use. Second, if it was intended to reference risk of death with proper use, it is baffling as to why it would be veiled in language regarding contraindicated uses. A warning regarding risk of death with proper use should be clear and prominent in my opinion, and at the top of the black box.

As referenced above, in my view, the label for Mylan fentanyl patches should warn of the risk of product malfunction (i.e., the patch producing substantially greater fentanyl blood concentrations than the patch was intended to produce). Not only does the label not warn of this risk, but the label instructs regarding expected fentanyl blood concentrations, giving prescribers the impression that the product will reliably produce fentanyl blood concentrations within the reported ranges. Fentanyl has a very narrow therapeutic index. Thus, giving prescribers the impression that the product produces fentanyl concentrations reliably and consistently within a reasonably narrow range, when in fact the product does not always perform as such, is unreasonable and dangerous.

(Dr. Grubb Decl. ¶¶ 6–8 (Ex. 1).) Similarly, Dr. Grubb testified in his deposition, “I’m claiming that there was a risk based on all of the information I’ve looked at that . . . patients could suffer a fatal outcome when everything was done correctly and none of the extenuating circumstances that the package insert identifies were present.” (Dr. Grubb Dep. at 200:18-25 (Ex. 2).)

Dr. Grubb has proposed language for the Mylan Defendants’ black-box warning (the place in the prescribing information for the most important warnings):

Fentanyl Transdermal System contains a high concentration of a potent Schedule II opioid agonist, Fentanyl, which is 80 to 100 times more potent than morphine. Reports have been received of patients dying from respiratory arrest with proper use of Fentanyl Transdermal Systems. Thus, use of Fentanyl Transdermal System involves a risk of death from respiratory arrest, even with proper use. Fentanyl Transdermal System should only be used for management of persistent, moderate to severe chronic pain that cannot be managed by other means. Use of Fentanyl Transdermal System may produce toxic or fatal serum fentanyl concentrations, far in excess of the mean maximal concentrations referenced in the Pharmacokinetics section below.

(Dr. Grubb Decl. ¶ 9 (Ex. 1).) Therefore, the Mylan Defendants’ argument that no evidence supports finding that the warnings were inadequate is belied by contrary expert evidence.[16]

2. Dr. Stanley would not have prescribed fentanyl for Grange had the Mylan Defendants adequately warned him.

Dr. Stanley would not have prescribed fentanyl to Grange had he received adequate warnings. Contrary to the Mylan Defendants’ suggestion that Dr. Stanley did not concern himself with warnings in the package insert when he prescribed Grange’s fentanyl patch, (Dfs.’ Br. at 24–25), Dr. Stanley testified that he attempts to stay abreast of warnings in drug-package inserts that govern drugs related to his field, (see Dr. Stanley Dep. at 38:1-10 (Ex. 10)). He testified that several warnings would have influenced his prescribing of fentanyl:

Q. If there was a black box or other prominent warning in the package insert stating that a certain percentage of Fentanyl patches malfunction and give patients fatal Fentanyl levels and you believe that to be a substantial risk for your patients, would you have prescribed it for Mr. Grange?

A. Okay. If I had that information that a significant percentage could cause death, then, no, I probably would not prescribe it.

(Dr. Stanley Dep. 63:17–64:8 (Ex. 10) (emphasis added) (speaking objection omitted).) Similarly, he testified, over another of the Mylan Defendants’ counsel’s speaking objections:

Q. If you had been aware of a warning that there was a significant risk that a patch could malfunction and give Mr. Grange a fatal dose of Fentanyl, would you have prescribed it for him?

A. If that was true, I probably would not prescribe it for any patient.

(Id. at 39:12–40:2 (Ex. 10) (speaking objection omitted).) He also testified that he was relying on the fentanyl patch to work as designed and intended:

Q. Are you aware of anything in the package insert or other prescribing information available to you that warned you as a doctor that it was possible for a 75-microgram patch to give a patient 22 nanograms per milliliter of Fentanyl or something close to that?

A. No.

Q. When you prescribed the 75-microgram patches for Mr. Grange on July 29th, 2005, . . . were you relying on the drug companies who made the patch to produce patches that would perform as designed and give the appropriate dose of fentanyl?

A. Yes.

(Id. at 80:13–81:12 (Ex. 10) (speaking objection omitted).) Likewise, Dr. Stanley testified that he would want to know if his patients could suddenly die from using the fentanyl patch or if the fentanyl patch should not be prescribed with other medications that Grange was prescribed. (Id. at 76:17–77:7; 50:5-19; 54:11-19; 56:22–57:5; 57:14–58:3; 58:16-24 (Ex. 10).)

After the Mylan Defendants’ counsel asked Dr. Stanley questions, the plaintiffs’ counsel told Dr. Stanley that “there’s a bit of an inconsistency at least in my mind between your testimony on direct and your testimony on cross” concerning whether certain warnings would have affected his prescribing decision. (Id. at 175:8-10 (Ex. 10); see also Dfs.’ Br. at 24–25.) Dr. Stanley clarified that although he was aware of certain risks with the Mylan fentanyl patch, he would not have prescribed it if he had known that the Mylan patch may not provide a consistent level of fentanyl as intended:

Q. I’m just saying if the manufacturer of this product had told you that due to a manufacturing problem or some other issue they could not manufacture Fentanyl patches that would give patients a consistent safe delivery of Fentanyl and would periodically

malfunction and give patients a massive dose of Fentanyl and you had known that, would that have affected your decision to prescribe the product?

A. I’m not trying to be difficult, but, yes, in that instance if I had that information that the product was defective, if I knew that and it was a significant risk, the answer is yes, I would not use the drug. But I don’t think that changes my answer to this gentleman when he says do I know there are risks and I still use the drug. Yes, I know there are risks, but it’s a different question so the answer is going to be a little bit different.

(Id. at 177:22–178:20 (Ex. 10) (emphasis added) (speaking objection omitted).)

Accordingly, the plaintiffs have proffered sufficient evidence for a jury to find that Mylan’s warnings were inadequate and that Grange’s prescribing physician, had he been provided adequate warnings, would not have prescribed Grange fentanyl. The Mylan Defendants are not entitled to summary judgment on the plaintiffs’ warning claims.[17]

E. The defendants breached their duty of care when designing their fentanyl-patch.

Although the plaintiffs assert negligence claim based on several theories (including—among others—negligent inspection, testing, manufacturing, marketing, and design), (see Second Am. Compl. ¶ 16 (Dkt. 104)), the plaintiffs only argue that the plaintiffs’ negligent-design claim must be dismissed. (See Dfs.’ Br. at 27–29.)[18] They contend only that the plaintiffs cannot establish any duty that the Mylan Defendants have breached in designing their product. But Utah law permits negligent-design claims, and evidence supports the plaintiffs’ claim here. Accordingly, summary judgment is improper.

1. Utah permits negligent-design claims.

Utah law permits negligent-design claims. In Grundberg v. The Upjohn Co., 813 P.2d 89 (Utah 1991), the Utah Supreme Court held that strict-liability design-defect claims for FDA-approved drugs were not permitted. The supreme court did not mention negligence claims and thus did not intimate that negligent design-defect claims are barred. Indeed, in another fentanyl-death case in Utah, U.S. District Judge Kimball held that Utah law does not bar negligent-design claims against a drug manufacturer and that Grundberg is not to the contrary. See Lake-Allen v. Johnson & Johnson, L.P., No. 2:08-cv-930, 2009 U.S. Dist. LEXIS 64860, at *7 (D. Utah July 27, 2009). Judge Kimball’s decision comports with California decisions that have recognized that, despite California law’s similar proscription of strict-liability design-defect claims, negligent-design claims are permissible. See Artiglio v. Super. Ct., 22 Cal. App. 4th 1388, 1393 (Cal. Ct. App. 1994); see also Carlin v. Super. Ct., 13 Cal. 4th 1104, 1129 (1996) (Kennard, J., concurring and dissenting) (noting that California had “adopt[ed] a negligence standard for prescription drug design defects”).

The Mylan Defendants argue, however, that a negligent-design claim would essentially permit plaintiffs to assert a disguised strict-liability design-defect claim. (Dfs.’ Br. at 28.) But no policy rationale (or even logic) supports holding that drug manufacturers can act unreasonably when designing a product as dangerous as the fentanyl patch. Moreover, the Utah Supreme Court has expressly held that negligence and strict-liability claims can proceed simultaneously. Slisze v. Stanley-Bostitch, 979 P.2d 317, 319 (Utah 1999); Utah Local Gov’t Trust v. Wheeler Mach. Co., 199 P.3d 949, 952 (Utah 2008) (noting that plaintiffs can assert numerous claims, including negligence and/or strict liability, in a products-liability action). And the claims are not superfluous of one another—especially when the plaintiffs cannot assert a strict-liability design claim—because, to prevail on a negligence claim, the plaintiffs must prove that the Mylan Defendants failed to act with the prudence of a reasonable drug designer. Compare MUJI 1002 (strict-liability elements), with Webb v. Univ. of Utah, 125 P.3d 906, 909 (Utah 2005) (listing elements for a negligence claim). Thus, the plaintiffs may proceed under a negligent-design theory.

2. Sufficient evidence exists of the Mylan Defendants’ negligent design.

 

The Mylan Defendants next argue that because a manufacturer has no duty to implement a safer alternative design of a nondefective product, the plaintiffs cannot establish a negligent design claim concerning the Mylan fentanyl patch. (See Dfs.’ Br. at 28 (citing Slisze).) But, unlike the plaintiff in Slisze, the plaintiffs here do more than merely point to a safer alternative design to demonstrate the Mylan Defendants’ negligence. (See Berner Decl. ¶¶ 29–32 (Ex. 7).)[19]

The Mylan Defendants negligently ignored reports that their patches were producing much higher fentanyl-blood concentrations than intended. By the time of Grange’s death and after their fentanyl patches had been on the market for less than a year, the Mylan Defendants had notice of at least one death by a patient using the Mylan fentanyl patch.

Based on these facts, the Mylan Defendants failed to use reasonable care in designing and testing their product. Nothing in Utah law permits drug manufacturers to ignore whether their product’s design or manufacture causes the product not to perform as intended. The evidence demonstrates that, at a minimum, a genuine issue of material fact exists as to whether the Mylan Defendants negligently designed their product.[20]

Conclusion

The Mylan Defendants’ motion for summary judgment should be denied.

Respectfully Submitted,

/s/Charles W. Miller

James C. Orr (Texas Bar #15313550)

jim@hop-law.com

Charles W. Miller (Texas Bar #24007677)

charles@hop-law.com

Heygood, Orr & Pearson
2331 Northwest Highway, 2nd Floor
Dallas, Texas 75220
(214) 237-9001 (phone)
(214) 237-9002 (fax)


[1] “Ex.” refers to the numbered exhibits that the plaintiffs have submitted through conventional filing. “Conf. Ex.” indicates that the Mylan Defendants have deemed the exhibit confidential. To avoid overloading the Court with numerous copies of the same documents and with voluminous documents that are only minimally relevant to the Mylan Defendants’ motion, the plaintiffs have attached as exhibits to the submitted declarations only those documents that are either not otherwise included in the record or not likely to be meaningful to the parties’ dispute.

The plaintiffs asked the Mylan Defendants to agree that the plaintiffs need not attach documents that are already included in the summary-judgment record or otherwise not meaningful to the proceedings. The plaintiffs explained that they would gladly supplement the declarations with additional referenced documents if the Mylan Defendants believed that documents meaningful to these summary-judgment proceedings were omitted. They have refused to do so. Accordingly, the remaining referenced documents not specifically attached as exhibits to the expert declarations (and listed in the index of exhibits) are included on CDs attached to the declarations.

[2]In fact, a graph on the Mylan Defendants’ prescribing information reveals the intended fentanyl-blood concentrations after multiple applications of a 100 mcg/hr patch (which is 25% stronger than the 75 mcg/hr patch that Grange wore). (See Package Insert at 4 (Dkt. 96-6).) It provides that the highest concentration should be approximately 4.5 ng/mL. (Id.)

[3]Although some evidence indicates that, contrary to his physician’s instructions, Grange on occasion consumed alcohol while using his fentanyl patch, Dr. Leis testified that Grange did not, to a reasonable degree of medical certainty, have alcohol in his blood when he died. (See Dr. Leis Dep. at 21:11–16 (Ex. 6).)

[4]Dr. Leis testified that he did not have an opinion on whether Grange’s fatal fentanyl level arose from a defective patch. He is not a transdermal expert; how a patch malfunctions is not a topic upon which Utah expects him to opine. (See Dr. Leis Dep. at 40:12–41:23 (Ex. 6).)

[5]The plaintiffs have also provided expert evidence from Dr. Iain McIntyre that “fentanyl is [not] a compound prone to huge variations in postmortem blood.” (Dr. McIntyre Dep. at 161:18-20 (Ex. 14).) But—for brevity’s sake— because the Defendants do not appear to argue that no fact issue exists as to postmortem redistribution’s effect in this case, (see Dfs.’ Br. at 2 n.1), the Plaintiffs will not detail the facts that support Dr. McIntyre’s opinion. (See generally Dr. McIntyre Decl. (Ex. 9).)

[6]Importantly, the fatal concentrations in Baselt’s treatise already account for postmortem redistribution (assuming that it happens at all). Baselt’s concentrations are also postmortem samples that would have been subject to postmortem redistribution just like Grange’s postmortem sample. (See Dr. Leis Dep. at 32:15­–33:15 (Ex. 6).)

[7]The Mylan Defendants do not appear to contest that if the plaintiffs have proffered sufficient evidence of a manufacturing defect, a jury could reasonably infer that the defect existed when Grange’s patch was manufactured. After all, “[e]ach [patch] is sealed in its own protective pouch” in a “sealed package” until used, (see FTS Patient Information at 2 (Ex. 30); Prescribing Information at 8 (Dkt. 96-9)), and Grange’s death occurred within days of his purchasing the patches, (see Terrace Pharmacy Recs. at 2 (Ex. 20)). Moreover, the patch is intended to be, and was, used only once (as opposed to numerous times), and there is no evidence that the patch was altered between the time of its manufacture and its use. See Parsons v. Ford Motor Co., 85 S.W.3d 323, 330 (Tex. Ct. App. 2002) (noting that age and history of use of the product is a relevant to determining whether defect existed when product left manufacturer); cf. Gower v. Savage Arms, Inc., No. 99-cv-1572, 2002 U.S. Dist. LEXIS 11261, at *4 n.2 (E.D. Pa. June 12, 2002) (unpublished) (prolonged use tends to demonstrate defect did not exist when the product left the manufacturer); Harker v. Black & Decker, No. 93-3273, 1994 U.S. App. LEXIS 7439, at *12 (6th Cir. Apr. 11, 1994) (unpublished) (absence of evidence that the product was misused, damaged, or mistreated permits the jury to infer that the “product was defective at the time it was manufactured”) (citing Nash v. Gen. Elec. Co., 410 N.E.2d 792 (Ohio Ct. App. 1979)); Stewart v. Ford Motor Co., 553 F.2d 130, 137 (D.C. Cir. 1977) (noting that plaintiffs’ burden is “not great” on whether defect existed when manufactured) (citing cases).

[8]The statutory presumption that the Mylan fentanyl patches are not defective is irrelevant to the Mylan Defendants’ motion. (See Dfs.’ Br. at 13.) The Utah Supreme Court has ruled that the presumption places no additional burden of proof on plaintiffs and that the presumption’s purpose is merely to highlight a plaintiff’s burden for the jury. See Egbert v. Nissan N. Am., Inc., 167 P.3d 1058, 1062 (Utah 2007).

[9]When the Mylan Defendants moved to dismiss strict-liability claims in another wrongful-death case concerning their fentanyl patches, the court held that genuine issues of material fact surrounded those claims. (See Order Granting in Part & Denying in Part the Mylan Dfs.’ Mot. for Summ. J., No. D-1:26-cv-2006-111 (N.M. 12th Jud. Dist. Ct. May 28, 2008) (Ex. 31).) That lawsuit ultimately settled.

[10] See, e.g., Henderson v. Sunbeam Corp., 46 F.3d 1151 (10th Cir. 1995) (applying Oklahoma law); Orth v. Emerson Elec. Co., 980 F.2d 632, 636 (10th Cir. 1992) (Kansas law); Weir v. Fed. Ins. Co., 811 F.2d 1387, 1392 (10th Cir. 1987) (Colorado law) (rejecting premise that plaintiff must demonstrate how a defect occurred)); Martin v. Unit Rig & Equip. Co., 715 F.2d 1434, 1439 (10th Cir. 1983) (New Mexico law); see also DeWitt v. Eveready Battery Co., 565 S.E.2d 140, 148 (N.C. 2002); Soule v. Gen. Motors Corp., 8 Cal. 4th 548, 562 (1994) (“[A]n injured plaintiff will frequently be able to demonstrate the defectiveness of the product by resort to circumstantial evidence, even when the accident itself precludes identification of the specific defect at fault.”); Doyle v. White Metal Rolling & Stamping Corp., 618 N.E.2d 909, 916 (Ill. 1993); Rogers v. Johnson & Johnson Prods., Inc., 565 A.2d 751 (Pa. 1989) (stating that “the occurrence of a malfunction is merely circumstantial evidence that the product had a defect, even though the defect cannot be identified”) (internal quotations omitted); Holloway v. Gen. Motors Corp., 271 N.W.2d 777, 783 (Mich. 1978); Gen. Motors Corp. v. Hopkins, 548 S.W.2d 344, 349-50 (Tex. 1977) (“If the plaintiff has no evidence of a specific defect in the . . . manufacture of the product, he may offer evidence of its malfunction as circumstantial proof of the product’s defect.”); Moraca v. Ford Motor Co., 332 A.2d 599, 601 (N.J. 1975); Williams v. Am. Med. Sys., 548 S.E.2d 371, 374 (Ga. Ct. App. 2001).

[11]Section 3 provides:

It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution.

 

[12]As demonstrated on pages 1 through 3, the plaintiffs have proffered sufficient evidence that Mylan’s defective fentanyl patch—by delivering a fatal level of fentanyl—was a cause of Grange’s death. Thus, the plaintiffs can satisfy the causation element.

[13] The six ways include (1) the presence of a contaminant that alters the skin barrier properties to fentanyl, (2) the delivery of fentanyl to too large of an area of skin resulting from adhesive residue surrounding the patch, (3) exposure of a patch to excessive heat during transport or storage, (4) excessive heating and shear during the adhesive-mixing process, (5) release of drug into collected sweat or transdermal water loss, and (6) inclusion of a different polymorph of fentanyl. (See Dr. Berner Decl. ¶ 33 (Ex. 7).)

[14]Without identifying anything specific, the Mylan Defendants also point to 12 pages of Dr. Berner’s deposition testimony for the proposition that a contaminant was not in sufficient quantities to impact drug delivery. (See Dfs.’ Br. at 16.) Dr. Berner testified, however, that, based on his research concerning compounds similar to fentanyl, an introduction of one to two percent of certain chemicals into the patches could alter the delivery rate of fentanyl. (See Dr. Berner Dep. 71:7–72:6 (Vol. II) (Ex. 8).) Similarly, the Mylan Defendants’ reference to whether the Mylan Defendants manufactured Grange’s fentanyl patch in accord with FDA requirements or Mylan’s “own accepted criteria” is beside the point. (See Dfs.’ Br. at 16.) Dr. Berner opined that the Mylan Defendants do not perform testing that would detect contaminants (other than heptanes). (See Dr. Berner Decl. ¶¶ 34–36 (Ex. 7).).

[15]The Mylan Defendants do not argue that any spoliation occurred because the medical examiner discarded the fentanyl patch that Grange was wearing when he died. (See Dfs.’ Br. at 19–23.) See Burns, 876 P.2d at 419 (spoliation requires that a party to an action fail to provide or destroy evidence favorable to the opposing party).

[16]Dr. Grubb testified at his deposition that a statement on page 7 of the package insert (not in the “black box,” which contains the most important warnings for physicians) did not alter his opinion. On page 7, the package insert states that “[s]erious or life-threatening hypoventilation [respiratory depression] may occur at any time during the use of fentanyl transdermal system, especially during the initial 24 to 72 hours following initiation of therapy and following increases in dose.” (Package Insert at 7 (Dkt 96-9).) Dr. Grubb testified that this so-called warning would, in his opinion, be read by reasonable physicians to mean that “untreated, life-threatening hypoventilation obviously could lead to death.” (Dr. Grubb Dep. 207:20–208:5 (Ex. 2).) He opined that “[t]hat’s not the same risk, though, as someone getting . . . toxic levels of a drug . . . and having immediate death.” (Id. at 207:17-20 (Ex. 2).) After all, he noted, “[w]hen someone hypoventilates, I can treat them for that. I can give them an opioid antagonist. I can reduce the dose. [¶] Hypoventilation can take place over a period of weeks and months.” (Id. at 203:9-13 (Ex.2).) Indeed, “Hypoventilation is not necessarily an acute event. In fact for opioid users [like Mr. Grange], it’s hardly ever an acute event.” (Id. at 206:22-24 (Ex. 2.) Accordingly, a warning about life-threatening hypoventilation does not adequately warn of sudden death. (See, e.g., id. at 203:7-9; 207:17–208:5 (Ex. 2).)

[17]The Mylan Defendants argue they are entitled to summary judgment on the plaintiffs’ negligent misrepresentation and implied warranty claims for the same reasons as they are entitled to summary judgment on the plaintiffs’ warnings- or manufacturing-defect claims. (Dfs.’ Br. at 27, 28 n.6.) But, because genuine issues of material fact exist as to the warnings- and manufacturing-defect claims, the Mylan Defendants are not entitled to summary judgment on the plaintiffs’ negligent misrepresentation or implied warranty claims. (See, supra, pp. 1–13, 18–22.)

[18]The plaintiffs’ negligence claim based on theories besides negligent design should be submitted to the jury. The Mylan Defendants have waived any contention to the contrary by failing to provide any argument why these other negligence claims should be dismissed. Harsco Corp. v. Renner, 475 F.3d 1179, 1190 (10th Cir. 2007) (“[A] party waives those arguments that its opening brief inadequately addresses.”).

[19]Dr. Berner’s discussion of the reasonable alternatives to the Mylan fentanyl patch support the plaintiffs negligent-design claim. (See Dr. Berner Decl. ¶¶ 29–32 (Ex. 7).) Thus, contrary to the Mylan Defendants’ assertion, the plaintiffs are not improperly attempting to litigate a strict-liability design-defect claim. (Dfs.’ Br. at 14.) Notably, the Mylan Defendants have not challenged the plaintiffs’ contention that alternative fentanyl-patch designs were available.

[20]The plaintiffs will not proceed with their gross negligence claims in this matter.