Response to Defendants’ Motion for Summary Judgment

Miller v. Alza

 

Description: This brief was filed in Illinois 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 also addresses the use of circumstantial evidence to prove a manufacturing defect. Finally, the response addresses the applicability and effect of Comment k to the Restatement (Second) of Torts, which generally applies to products that are “unavoidably unsafe.” This brief was filed by Heygood, Orr & Pearson on behalf of their client.

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
WESTERN DIVISION
WILLIAM MILLER, as Administrator of the Estate of CORNELL PHILLIPS, Deceased,Plaintiff,v.

ALZA CORPORATION and
SANDOZ, INC.

Defendants.

Case No. 3:08cv0402Judge Timothy BlackPlaintiff’s response to defendants’ motion for summary judgment and brief in support

TABLE OF CONTENTS

Introduction. 1

Statement of Facts. 4

I. Sandoz patches. 4

II. Numerous defects in the Sandoz patches known to Defendants. 5

III. Cornell Phillips’ prescribed use of the Sandoz patches. 8

IV. Phillips’ death. 8

V. The autopsy. 10

Argument and Authorities. 11

I. Defendants’ Motion should be denied as to Miller’s warning claims. 12

A. There is a genuine issue of material fact regarding whether or not the prescribing doctor would have changed his behavior had Defendants’ provided adequate warnings. 12

1. Dr. Hale’s testimony was equivocal and was insufficient to overcome the presumption that Defendants’ failure to warn proximately caused Dr. Hale to prescribe Mr. Phillips Defendants’ fentanyl patches. 13

2. Dr. Hale’s testimony was equivocal and was insufficient to overcome the presumption that Defendants’ failure to warn proximately caused Dr. Hale to prescribe Mr. Phillips Defendants’ fentanyl patches. 13

3. A jury is entitled to assess the credibility of Dr. Hale’s testimony. 16

4. Dr. Hale’s testimony, even if unequivocal and credible, is not determinative; the issue of proximate cause is an issue of fact for the jury. 17

B. Miller has offered ample evidence supporting his allegation that Defendants failed to warn of certain known risks of their fentanyl patches. 18

1. Ohio law does not require warnings testimony from a physician. 18

2. Miller has offered physician expert testimony. 18

3. This is a no-warnings case. 20

4. Defendants failed to meet their initial burden of showing the adequacy of their warnings. 21

II. Defendants are not entitled to judgment as a matter of law on Miller’s design defect claim. 22

A. The “unavoidably unsafe” safe-harbor does not apply. 22

B. Ohio law permits a design-defect claim to rest on the manufacturer’s unnecessary use of a design that leads to fatal manufacturing defects. 24

III. Defendants are not entitled to summary judgment on Miller’s manufacturing defect claim. 26

A. Miller’s manufacturing defect claim is not limited to a claim of a leaking patch. 26

B. Miller is not required to offer direct evidence of a manufacturing defect. 27

C. Miller is entitled to rely on circumstantial evidence of a manufacturing defect. 27

D. Miller is not required to eliminate all other possible causes of Phillips’ fatal fentanyl level. 27

IV. Defendants are not entitled to summary judgment on Miller’s OLPA claim for non-conformance to a manufacturer’s representations. 34

V. The OLPA has not abrogated Miller’s warranty claims. 34

VI. Miller asserts no claim for fraud against the FDA, and thus Defendants are seeking to dismiss a claim that has not been pleaded. 35

Conclusion. 36

 

 

TABLE OF AUTHORITIES

Cases

Ackley v. Wyeth Labs. Inc., 919 F.2d 397, 400 (6th Cir. 1990)…………………………………………….. 28

Adams v. Alza, et. al., Civil no. 07-497-GPM (S.D. Ill. May 7, 2009)…………………………………… 13

Auburn v. Johnson & Johnson, et. al., Case No. 2008-00008440-CU-PO (Sacramento County, CA Superior Court, April 15, 2010)…………………………………………………………………………………………………….. 14, 38

Barker v. Lull Eng’g Co., Inc., 573 P.2d 443 (Cal. 1978)……………………………………………………. 30

Bremer v. Egan Healthcare Corp., civil Action No. 03-1418, 2004 U.S. Dist. LEXIS 11385 at *12 (E.D. La. June 21, 2004)…………………………………………………………………………………………………………………… 25

Christensen v. Alza, et. al., Case No. 30-2009-000122600-CU-PL-CJC (Orange County, CA Superior Court, August 16, 2010)…………………………………………………………………………………………………………………… 14

Christian v. Alza, et. al., Case No. 37-2008-00090247-CU-PO-CTL (San Diego County, CA Superior Court, December 18, 2009)…………………………………………………………………………………………………… 13

Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)………………… 8, 23, 29, 35

Deagan v. McLaughlin, No. 99-C.A.-287, 2001 Ohio App. LEXIS 5330, at *18 (Ohio Ct. App. Nov. 30, 2001)  35

Delude v. Johnson & Johnson (In re Levaquin Products Liab. Litig.), MDL No. 08-1943, 2010 U.S. Dist. LEXIS 75054 at *31 (D. Minn. July 26, 2010)…………………………………………………………………………. 19

DiCosolo v. Janssen Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Feb. 8, 2008))      5, 6, 7, 43

Doe v. Miles Laboratories, Inc., 927 F.2d 187, 194 n.32 (4th Cir. 1991)………………………………. 21

Donaldson v. N. Trading Co., 612 N.E.2d 754, 758 (Ohio Ct. App. 1992)…………………………… 34

Electric Corp. v. Dolly Madison Leasing & Furniture Corp., 326 N.E.2d 651, 657 (Ohio 1975) 34

Flores v. Alza, et. al., Case No. 37-2009-00066204-CU-PL-EC (San Diego County, CA Superior Court, June 11, 2010)…………………………………………………………………………………………………………………… 14, 31

Golod v. LaRoche, 964 F.Supp. 841, 857 (S.D.N.Y. 1997)…………………………………………………. 20

Hendelson v. Johnson & Johnson, et al., No. 9:05-cv-81116-DTKH (S.D. Fla. June 5, 2007)…. 14

Jennings v. Alza, et. al., No. 08-2-25794-1 KNT (King County, WA Superior Court, April 16, 2010)        13

Jones v. Roche Labs., 84 Ohio App. 3d 135, 141 (1992)……………………………………………….. 22, 26

Knitz v. Minster Mach. Co., 432 N.E.2d 814, 818 (Ohio 1983)……………………………………………. 30

Kunnemann v. Janssen Pharmaceutica Prods., L.P., No. 1:05-cv-03211, 2008 U.S. Dist. LEXIS 3211 (N.D. Ill. Dec. 2, 2008)…………………………………………………………………………………………………………….. 13

Kurzner v. Sanders, 627 N.E.2d 564, 570 (Ohio Ct. App. 1993)…………………………………………. 34

LaPaglia v. Mylan, Inc., No 1:08-cv-3025 (Dkt. 23), Mem. of Op. & Order (N.D. Ohio May 14, 2009)     42

McClain v. Nw. Cmty. Corrs. Ctr. Judicial Corrs. Bd., 440 F.3d 320, 327 (6th Cir. 2006)……… 12

McNeil v. Wyeth, 462 F.3d 364, 372 (5th Cir. 2006)……………………………………………………………. 18

Miles v. Raymond Corp., 612 F. Supp. 2d 913, 924 (N.D. Ohio 2009)…………………………………. 41

Motus v. Pfizer, 196 F.Supp. 2d 984 (C.D. Cal. 2001)………………………………………………………… 18

Nationwide Mut. Fire Ins. Co. v. B&B Appl. Co., No. 54107, 1988 Ohio App. LEXIS 2870 at *13 (Ohio App. July 14, 1988)…………………………………………………………………………………………………………………… 39

North Carolina v. Rice, 404 U.S. 244, 246 (1971)……………………………………………………………… 42

Pineda v. Ford Motor Co., 520 F.3d 237, 245 (3d Cir. 2008)……………………………………………… 26

Popick v. Kopp Clay Co., Case No. 472, 1985 Ohio App. LEXIS 6211 at *3 (Ohio App. April 1, 1985)   39

Rush v. Wyeth (In re Prempro Prods. Liab. Litig., MDL Docket No. 4:03CV1507-WRW, 2006 U.S. Dist. LEXIS 47472 at *9 (E.D. Ark. July 13, 2006)………………………………………………………………………….. 20

Seley v. Searle, 423 N.E.2d 831, 838 (Ohio 1981)……………………………………………………………… 16

State Farm Fire & Cas. Co. v. Chrysler Corp., 523 N.E.2d 489, 493 (Ohio 1988)……… 33, 37, 39

Thompson v. ALZA Corp., et al., No. 2005-11685 (Dist. Ct. of Harris County, Tex. Feb. 27, 2006)           5

Utz v. Howmedica Osteonics Corp., Case no. 1:06CV1963, 2009 U.S. Dist. LEXIS 123973 at *25-26 (N.D. Ohio March 31, 2009)………………………………………………………………………………………………………… 31

Westinghouse Elec. Co., 326 N.E.2d at 656………………………………………………………………………. 39

White v. Wyeth Labs., Inc., 533 N.E.2d 745, 752 (Ohio 1988)…………………………………………….. 27

Williams v. Lederle Laboratories, 591 F. Supp. 381, 386 (S.D. Ohio 1984)… 16, 19, 21, 23, 24, 29

Yanovich v. Zimmer Austin, Inc., 255 Fed. Appx 957, 966 (6th Cir. Nov. 21, 2007)……………….. 35

 

 

Introduction

On November 6, 2006, fifty-one-year-old Army veteran Cornell Phillips received a fatal dose of fentanyl from a defective Sandoz pain patch designed, manufactured, and distributed by Defendants.  The defective patch gave Phillips a lethal blood concentration of fentanyl of 13 ng/mL, more than four times what he should have received from properly designed and manufactured patches.  The Montgomery County, Ohio coroner’s office determined that Phillips died from “fentanyl intoxication.”   For purposes of their Motion, Defendants do not challenge this conclusion.  (Dkt. 20 at 6).

William Miller, administrator of Mr. Phillip’s estate brought the instant lawsuit against Defendants for the benefit of Mr. Phillips’ wife, Jennifer Phillips, and Mr. Phillips’ three children, Ashley, Aaron and Johnston.  Miller has asserted strict-products-liability claims against Defendants because (1) the patch was defectively designed and manufactured, (2) it did not include adequate warnings and instructions, and (3) it did not conform to the Defendants’ representations.  Miller has also asserted a negligence claim, a negligent misrepresentation claim, and breach-of-warranty claims under the Uniform Commercial Code.  In their motion for summary judgment, Defendants contend that they are entitled to judgment as a matter of law on all of Miller’s claims.  Although Miller acknowledges that his negligence and negligent misrepresentation claims have been abrogated by Ohio’s products-liability code, his strict-products-liability claims and breach-of-warranty claims cannot be decided on summary judgment for the following reasons:

First. A jury must decide Miller’s strict-liability failure-to-warn claim.  Ohio law requires prescription drug manufacturers to warn physicians of potential adverse reactions to their products.  The summary-judgment evidence—including the testimony of expert witnesses, the testimony of Phillips’ physician, and the package insert accompanying the Sandoz patches—demonstrates that Defendants failed to warn adequately of (1) the risk of death associated with the Sandoz patch, (2) the risk of leaking patches resulting from design and/or manufacturing defects, and (3) the risks associated with fentanyl’s narrow therapeutic index.  Moreover, under Ohio law, there is a presumption that a defendants’ inadequate warnings caused their drug to be prescribed.  The equivocal testimony of the prescribing doctor in this case is insufficient to overcome this presumption.  Finally, Ohio law is well established that the issue of proximate cause is one for the jury. (Primary arguments and authority may be found on pages 12 to 21.)

Second. Defendants are not entitled to summary judgment as a matter of law on Miller’s design-defect claim for two reasons.  First, they cannot rely on the safe harbor for unavoidably unsafe drugs because they do not contest that a safer, alternative patch design existed.  Second, they misconstrue Ohio law by arguing that a design-defect claim cannot exist if the design merely increases the risk of manufacturing defects.  To the contrary, the issue under Ohio law is whether risks of the design outweighed the benefits.  Miller has ample evidence that the risk of leaking fentanyl gel outweighed the benefits, if any, of the reservoir-patch design.  (Primary arguments and authority may be found on pages 22 to 26.)

Third. Under Ohio law, a manufacturing defect may be proved by both direct and circumstantial evidence.  Here, Miller has produced more than sufficient evidence that Phillips’ death was caused by a manufacturing defect that permitted his Sandoz patch to provide a fatal dose of fentanyl.  And, contrary to the Defendants’ arguments, his claim is not limited to a leaking patch but, rather, encompasses and any all potential manufacturing defects that could allow Phillips’ patch to produce an excessive level of fentanyl.  Miller has also presented expert evidence of the type of well-known defects (such as a leak) associated with the Sandoz  patch—which utilizes a reservoir design, whereby the fentanyl gel is in a reservoir between two layers—that likely caused Phillips’ overdose.  Ohio law does not require Miller to disprove alternative possibilities put forward by Defendants that are not supported by any evidence.  The jury has overwhelming evidence to decide in Miller’s favor without improper speculation.  Because there is substantial evidence of such defects, summary judgment must be denied.  (Primary arguments and authority may be found on pages 26 to 33.)

Fourth. There is ample evidence to support Miller’s allegation that Phillips’ Sandoz patch failed to conform to the Defendants’ representations. (Primary arguments and authority may be found on Page 34.)

Fifth. Ohio’s Products Liability Code has not abrogated Miller’s statutory warranty claims under the UCC.  (Primary arguments and authority may be found on pages 34-35.)

Sixth. Although Defendants ask this Court to dismiss a hypothetical fraud-on-the-FDA claim, Miller has not pleaded such a claim.  Instead, he has pleaded facts that support his allegations that Defendants deliberately deceived the FDA about the manufacturing defects with the Sandoz patches.  These allegations are relevant and responsive to the defense that Defendants have unsuccessfully used in other Sandoz-overdose cases:  Defendants were working hand in hand with the FDA and thus should not be held liable for the deaths caused by Sandoz patches.  Simply put, there is no fraud-on-the-FDA claim for this Court to dismiss.  (Primary arguments and authority may be found on pages 35 to 36.)

Statement of Facts

I. Sandoz patches.
Sandoz patches are transdermal products used to treat chronic pain.  (See Sandoz Package Insert at 2-3 (Dkt. 21-1); Dep. of B. Gale (inventor of the Sandoz patch) at 10:11-14 (taken in DiCosolo v. Janssen Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Feb. 8, 2008)) (App. Ex. 28.)[1] After they are applied to the patient’s skin, properly functioning patches (sold in various doses, such as 25, 50, 75, or 100 micrograms-per-hour (“mcg/hr”)) continuously deliver the requisite dose of opioid fentanyl to the patient’s bloodstream over a 72-hour period.  (See Sandoz Package Insert at 2-3 (Dkt. 21-1); Dep. of B. Gale at 6:20–8:1 (App. Ex. 28).) When Sandoz patches are manufactured, fentanyl gel is deposited in a “reservoir” between an impermeable layer of polyester backing and a semi-permeable layer of ethyl-acetate vinyl (“EVA”) film.  (See Sandoz Package Insert at 3 (Dkt. 21-1); Dep. of D. Chullino (ALZA’s director of process engineering) at 13:6–14:19 (taken in Thompson v. ALZA Corp., et al., No. 2005-11685 (Dist. Ct. of Harris County, Tex. Feb. 27, 2006) (App. Ex. 1).) The semi-permeable layer is designed to ensure that the patch “releases fentanyl from the reservoir at a nearly constant” rate.  (Sandoz Package Insert at 5 (App. Dkt. 21-1).)  According to the inventor of the Sandoz patch, Robert Gale, the patches are intended to deliver at a steady rate only the dose—and resulting blood fentanyl concentration—set forth in the Sandoz package insert.  (Dep. of B. Gale at 6:24–7:21 (App. Ex. 28).)

Fentanyl is a very powerful narcotic drug that is used to treat moderate to severe chronic pain.  It is eighty times more potent than morphine and has a narrow therapeutic band (i.e., the difference between a therapeutic dose and a fatal dose of fentanyl is small). (Dr. J.C. Upshaw Downs Decl. at Exh. B at ¶ 21 (App. Ex. 2); Sandoz Package Insert (15).)  Accordingly, Sandoz must be administered in a careful and controlled manner.  (Dr. J.C. Upshaw Downs Dec. ¶ 10 (App. Ex. 2).)
II. Numerous defects in the Sandoz patches known to Defendants.
In the years before Phillips’ death, Defendants knew of defects in the Sandoz patches that permit fatal amounts of fentanyl to enter a patient’s bloodstream.  F

RED

or instance, Defendants initiated a February 2004 “Urgent Drug Recall” REDACTEDbecause several patches contained a defect known as the “fold-over defect,” which causes a leak along one edge of the patch.  (See “Urgent Product Recall” (App. Ex. 4); Dep. of S. Engle (senior director of quality control) at 78:2–79:16, 95:24–96:21 (taken in DiCosolo v. Janssen REDharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Oct. 24, 2008)) (App. Ex. 16); FDA Establishment Inspection Report (“FDA EIR”) at 5-7 (App. Ex. 5); Dep. of D. Chullino at 151:20–152:18 (App. Ex. 1).)  Defendants initiated other patch recalls in April 2004, October 2005, February 2008 and December 2008, and their corporate representative has admitted that it is possible that leaking ALZA patches were being sold to the public as late as 2009.  (Excerpts from Deposition of David Chullino (taken January 21, 2009 in West v. ALZA Corporation, No. 19, 955) at 64:23-65:8; 146:8-147:6; 158:10-159:13 (App. Ex. 15.)  Following Defendants’ first recall, the FDA inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems.  (See FDA EIR (App. Ex. 5); FDA Form 483 (App. Ex. 6).)   The FDA determined that during the manufacturing process, the layers of material between which the fentanyl gel is deposited were often misaligned, causing one edge to fold over before the patch was sealed.  (See FDA EIR at 5, 13-15 (App. Ex. 5); FDA Form 483 (App. Ex. 6); Dep. of D. Chullino at 188:8-19 (App. Ex. 1); Dep. of S. Engle at 95:24–96:21 (App. Ex. 16.)  The folded-over edge caused a poor adhesive seal along one side of a manufactured patch.  (Dep. of S. Engle at 95:24–96:21 (App. Ex. 16).)  The weakened seal had a tendency to break open during normal patch use, allowing fentanyl gel to leak directly onto the skin of the patient.  (Dep. of D. Chullino at 18:3-8 (App. Ex. 1); Dep. of S. Engle at 95:24–96:21 (App. Ex. 16).)  The FDA determined that this misalignment of film layers—and the resulting fold-over defect—was a frequent occurrence.  (See FDA EIR at 5, 13-15 (App. Ex. 5); FDA Form 483 (App. Ex. 6).)

In addition to the fold-over defects, the FDA found numerous other defects in the ALZA-manufactured patches, including gel in the seals, seal breaches, holes in the drug reservoir, and slits in the pouches and system.  (See FDA EIR at 11-12 (App. Ex. 5); Dep. of B. Strehlke (director of DEA compliance) at 24:13–29:7 (taken in DiCosolo v. Janssen Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Jan. 14, 2008)) (App. Ex. 24).)  The most prevalent defect—which caused a thin stream of gel to leak out, resembling a string—was so well-known to Defendants that they called it the “classic stringer leaker.”  (See FDA EIR at 6 (App. Ex. 5); Dep. of D. Chullino at 81:9-14 (App. Ex. 1).)  The FDA ultimately concluded that Defendants failed to follow a proper sampling plan in the inspection of Sandoz patches during the manufacturing process.  (See FDA Form 483 (App. Ex. 6).)  The FDA also concluded that the in-process and quality-control checks for Sandoz patches were inadequate to prevent the release of defective Sandoz patches.  (See FDA Form 483 (App. Ex. 6).)

To make matters worse, as the Defendants’ former vice president of quality assurance and technical operations testified, Defendants knew that the production and release of defective, leaking patches was inherent in the process used to manufacture Sandoz.  (Dep. of J. Hawkins at 39:14–40:1 (taken in Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)) (App. Ex. 9).)  Defendants were aware of the fold-over defect in 2001, but the only corrective action they took was to “heighten operator awareness”—an action the FDA determined was insufficient to prevent reoccurrence of the fold-over defect.  (See FDA Form 483 (App. Ex. 6); Dep. of J. Hawkins at 46:23–48:5 (App. Ex. 9); Dep. of B. Strehlke at 24:13–29:7 (App. Ex. 24).)  Hank Avallone, one of Defendants’ employees and a former FDA inspector, sent multiple intercompany emails expressing concern over the Defendants’ failure to manufacture Sandoz using Good Manufacturing Practices (“GMPs”).  In a March 22, 2004 email to William Randolph, senior director of technical development, Avallone said that “[a] good case can be made by FDA that [the recalled lots] were all manufactured under poor GMP’s.”  (Mar. 22, 2004 email from H. Avallone to W. Randolph (App. Ex. 10).)  In another email to Mr. Randolph, dated January 28, 2005, Avallone said that “[i]t is very difficult to partner with the FDA if we keep deceiving them.”  (Jan. 28, 2005 email from H. Avallone to W. Randolph (App. Ex. 11).)  On February 22, 2004, Avallone sent an email to William Cope, an associate director of regulatory compliance, in which he said that it would not be unreasonable to expect that the FDA would prosecute some of the employees in the Defendants’ quality-control department.  (Feb. 22, 2004 email from H. Avallone to W. Cope (App. Ex. 12).)

Avallone and others previously informed Defendants that their in-process controls for the manufacture of Sandoz patches were deficient and that they had an obligation to comply with basic GMPs, regardless of the level of FDA enforcement.  (See Feb. 16, 2004 email from J. Hawkins to H. Avallone and others (App. Ex. 13).)  These manufacturing concerns continue to this day.  In fact, a recent report prepared by Defendants shows that 3,063 Sandoz patches had been reported as having “leaked” between January 1, 2004 and January 22, 2009.  (Excerpts from Issue Detail Alert from Jan. 1, 2004 until Jan. 22, 2009 (App. Ex. 14.)

III. Cornell Phillips’ prescribed use of the Sandoz patches.
Cornell Phillips, a resident of Dayton, Ohio, suffered from chronic pain due to several medical conditions, including chronic intestinal pain and osteoarthritis.  (Dep. of Dr. E. Ronald Hale at 41:2-3 (Dkt 32.).) In 2006, Phillips was diagnosed with nasopharyngeal carcinoma. (Id..)  During his treatment for this disease, Phillips began to suffer from painful mucositis.  (Id. at 448:9-13.) In July 2006, Dr. Hale prescribed Mr. Phillips with a 25 mcg fentanyl patch for pain. (Id. at 51:20-25.)  Later, in August 2006, Dr. Hale increased the dose of the fentanyl patch to 50 mcg by instructing Phillips to use two 25 mcg patches simultaneously.  (Id. at 59:8-19.)  The dosage was subsequently increased to 75 mcg and then 100 mcg.  (Id. at 59:25-60:9, 61:18-62:20.)  Each of the patch prescriptions was filled with a Sandoz fentanyl patch designed, manufactured and marketed by Defendants.[2] Dr. Hale saw no evidence indicating that Mr. Phillips misused or abused his Sandoz patches. (Id. at 77:14-17).)

IV. Phillips’ death.
On November 6, 2006, Phillips was taken to the Miami Valley Hospital after calling 911.   He was declared dead later that afternoon after attempts to revive him failed.  He was wearing two Sandoz fentanyl patches, a 100 mcg patch and a 25 mcg patch.  (Autopsy of Cornell Phillips at 3 (App. Ex. 18).)  While this was higher than the 100 mcg dose he had been prescribed by Dr. Hale, the doctor explained that he often gave his patients wide latitude to increase their dosage if they were feeling increasing pain:

2   Q.        All right.  If you had not increased the

3   prescription, it would be — if you had not

4   increased the prescription and Mr. Phillips was

5   wearing 125 micrograms of fentanyl, that would be

6   an abuse of the drug, would it not?

7             MR. PATE:  Objection.

8   A.        So can you rephrase — can you repeat the

9   question?

10   Q.        If a patient wears, knowingly wears more

11   fentanyl patches than prescribed, at a higher dose

12   than prescribed, do you consider that an abuse?

13   A.        Not necessarily.

14   Q.        Okay.  When — when would you consider it

15   an abuse and when would you not?

16   A.        Well, if they were increase — if they

17   had no worsening pain but they increased the drug,

18   then it could potentially be an abuse situation.

19   But if a patient has increasing pain and they

20   increase their pain medication on their own, I

21   would not classify that as abuse.

22   Q.        Will you recommend it?

23   A.        I actually do.  I oftentimes with my

24   patients will give them pretty wide latitude in

25   titrating their pain medication to a desired

1   effect, which for me is a pain less than three out

2   of ten, three to four out of ten.

((Dep. of Dr. E. Ronald Hale at 129:2-130:2 (Dkt. 32).)   Dr. Hale further testified that he believed another doctor, Dr. Abuerreish, increased Mr. Phillips’ fentanyl dosage from 100 mcg to 125 mcg on or about October 22, 2007, just a few weeks before Mr. Phillips’ death on November 6, 2006:

25   Q.        After you prescribed the 25 mic. patch to

1   Mr. Phillips on or about July 25 of ’06, did you

2   ever increase his dosage?

3   A.        Yes.

4   Q.        And when was that?

5   A.        The dose was increased during the week of

6   the 1st of August, and then subsequently on the

7   22nd of August.

8   Q.        And subsequent to that, was it ever

9   increased or changed in any way?

10   A.        Dr. Abuerreish had increased it on the 11 22nd of October.

* * * * *

4   A.        There is a note written by Dr. Abuerreish

5   for this office visit that says, “I increased the

6   fentanyl patch today.” And he discontinued the

7        Roxicet and started him back on the Roxanol.

* * * * *

14   Q.        Okay.  Earlier we had talked about

15   Dr. Abuerreish sometime around mid to late

16   October of ’06 increasing Mr. Phillips’ fentanyl

17   patch dosage from its previous dosage of 100; is

18   that right?

19   A.        Yes.

20   Q.        Okay.  And based on this, what do you

21   think that that dosage increase would have been to?

22             MR. AUCIELLO:  Objection.

23   A.        125 micrograms per hour.

((Dep. of Dr. E. Ronald Hale at 57:25-58:11, 59:4-7, 86:14-23).)   Either way, the fact that Mr. Phillips was wearing a 100 mcg patch and a 25 mcg patch is no evidence he was abusing the patches or using them in contravention of his doctor’s orders.

V. The autopsy.
After he was declared dead, Mr. Phillips body was examined by the Montgomery County, Ohio coroner’s office.  Toxicology tests revealed that Mr. Phillips had a fentanyl blood level was 13 ng/mL.  (Toxicology Report (App. Ex. 19).)  This level was more than four times the expected level from properly functioning patches totaling 125 mcg.  (Sandoz Package Insert at 6 (Dkt. 21-1); (Prausnitz s Decl. at Exh. B at 2) (App. Ex. 7).)  After a complete autopsy, the Montgomery County, Ohio coroner’s office determined that Mr. Phillips had died from “fentanyl intoxication.” (Death Certificate of Cornell Phillips (App. Ex. 20); Autopsy of Cornell Phillips (App. Ex. 18).)   For purposes of their Motion, Defendants have not challenged this conclusion.  (Dkt. 20 at 6).

Argument and Authorities

Summary judgment must be denied because genuine issues of material fact exist and Defendants are not entitled to judgment as a matter of law.  See McClain v. Nw. Cmty. Corrs. Ctr. Judicial Corrs. Bd., 440 F.3d 320, 327 (6th Cir. 2006).  Despite Defendants’ urging, the Court cannot weigh the evidence or determine the truth of any matter in dispute.  Instead, the Court must construe any conflicting evidence in Miller’s favor and determine only whether sufficient evidence exists from which a jury could reasonably find for him.  See id. In this case, the summary-judgment evidence clearly demonstrates that genuine issues of material fact exist precluding summary judgment.

Defendants have filed similar summary-judgment motions in other wrongful-death cases in which patients died with fatal blood fentanyl concentrations while using prescribed fentanyl patches.  Their motions have been denied in each and every case because the presence of numerous disputed factual issues made summary judgment inappropriate.  See Kunnemann v. Janssen Pharmaceutica Prods., L.P., No. 1:05-cv-03211, 2008 U.S. Dist. LEXIS 3211 (N.D. Ill. Dec. 2, 2008) (denying summary judgment where patient died from a fatal fentanyl dose from a defective Sandoz patch; the case was later settled); Adams v. Alza, et. al., Civil no. 07-497-GPM (S.D. Ill. May 7, 2009) (App. Ex. 22) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch); Christian v. Alza, et. al., Case No. 37-2008-00090247-CU-PO-CTL (San Diego County, CA Superior Court, December 18, 2009) (App. Ex. 23) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch; case later settled);  Jennings v. Alza, et. al., No. 08-2-25794-1 KNT (King County, WA Superior Court, April 16, 2010) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch; case later settled) (App. Ex. 25); Flores v. Alza, et. al., Case No. 37-2009-00066204-CU-PL-EC (San Diego County, CA Superior Court, June 11, 2010) (App. Ex. 26) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch; case later settled); Auburn v. Johnson & Johnson, et. al., Case No. 2008-00008440-CU-PO (Sacramento County, CA Superior Court, April 15, 2010) (App. Ex. 27) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch; case later settled); Christensen v. Alza, et. al., Case No. 30-2009-000122600-CU-PL-CJC (Orange County, CA Superior Court, August 16, 2010) (App. Ex. 17) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch); Hendelson v. Johnson & Johnson, et al., No. 9:05-cv-81116-DTKH (S.D. Fla. June 5, 2007) (App. Ex. 21) (denying summary judgment where a patient died from a fatal fentanyl dose administered by a defective Sandoz patch; the jury subsequently rendered a $5.5 million verdict against the Defendants).  Each of these decisions was proper because summary judgment is inappropriate where the evidence, as here, unquestionably demonstrates that:

●          a decedent died from fentanyl intoxication;

●          the decedent’s fentanyl level was much higher than expected from a properly functioning patch;

●          Defendants’ fentanyl patch was the only possible source of fentanyl;

●          Defendants have had numerous past problems with leaking and defective patches;

●          expert testimony supports the existence of a design, manufacturing and warning defect.

 
I. Defendants’ Motion should be denied as to Miller’s warning claims.

A. There is a genuine issue of material fact regarding whether or not the prescribing doctor would have changed his behavior had Defendants’ provided adequate warnings.

1. Dr. Hale’s testimony was equivocal and was insufficient to overcome the presumption that Defendants’ failure to warn proximately caused Dr. Hale to prescribe Mr. Phillips Defendants’ fentanyl patches.

Under Ohio law, a plaintiff in a case such as this is entitled to a rebuttable presumption that a drug company’s failure to warn was a proximate cause of a prescribing physician’s decision to prescribe its drug:

In a strict liability claim based on failure to warn, Ohio law requires the plaintiff to establish that the lack of adequate warnings was a proximate cause of ingestion of the drug.  The plaintiff is aided by a rebuttable presumption that the failure to provide adequate warnings was a proximate cause of ingestion.  If the defendant does not present rebutting evidence, the presumption satisfies the plaintiff’s burden of demonstrating that the inadequate warning was the proximate cause of the ingestion of the drug.

Williams v. Lederle Laboratories, 591 F. Supp. 381, 386 (S.D. Ohio 1984); see also Seley v. Searle, 423 N.E.2d 831, 838 (Ohio 1981) (“where no warning is given, or where an inadequate warning is given, a rebuttable presumption arises, beneficial to the plaintiff, that the failure to adequately warn was a proximate cause of the plaintiff’s ingestion of the drug. This presumption, absent the production of rebutting evidence by the defendant, is sufficient to satisfy the first branch of the plaintiff’s proximate cause burden.”).  Defendants surprisingly failed to address this presumption in their Motion.

2. Dr. Hale’s testimony was equivocal and was insufficient to overcome the presumption that Defendants’ failure to warn proximately caused Dr. Hale to prescribe Mr. Phillips Defendants’ fentanyl patches.

Defendants seek summary judgment on Miller’s failure to warn claims on two bases.  The first basis is that Dr. Hale, the prescribing doctor, allegedly “testified that he would have prescribed fentanyl patches to Phillips even if additional warnings were added to the prescribing information as advocated by Plaintiff.” (Dkt. 20 at 8).   Defendants claim that Dr. Hale was “unequivocal in his testimony that . . . such increased warnings would not have changed his decision to prescribe a fentanyl patch to Phillips.”  (Dkt. 20 at 11) (emphasis added).  An examination of Dr. Hale’s testimony, however, demonstrates that he was anything but unequivocal on the issue of whether additional warnings would have changed his behavior.  For example, Dr. Hale testified that:

3   Q.        And based on the table you have in front

4   of you, is it fair to assume that the mean maximal

5   concentration that he should have achieved in his

6   blood serum level should have been 3.1, that is a

7   combination of the 2.5 for the 100 mic. patch and

8   the .6 for the 25 mic. patch?

9             MR. AUCIELLO:  Objection.

A.        Yes.

* * * * *

17   Q.        If you had known that the 100 microgram

18   patch that you had prescribed would deliver a level

19   of fentanyl that was not 2.5 but that was four to

20   five times in excess of that, would you have

21   prescribed it?

22             MR. AUCIELLO:  Objection.

23       A.        No.

* * * * *

25   Q.        If the package insert or the warnings in

1   the black box that accompanied the fentanyl patch

2   had warned that despite normal use of the patch, a

3   patient could receive a level of fentanyl that was

4   four to five times the level identified in this

5   table, would you have prescribed the patch?

6             MR. AUCIELLO:  Objection.

7   A.        I may.

8   Q.        And describe the circumstances under

9   which you may?

10   A.        Any drug has risks, and there are times

11   where the benefit of the drug outweighs the risk,

12   even if the risk is severe.  It might require more

13   judicious monitoring of the patient’s condition,

14   but I can’t say that I would categorically deny

using the drug under those conditions.

* * * * *

16   If the black box warnings had advised you

17   that a patient could receive a blood serum level

18   four to five times in excess of the levels

19   identified in this table despite normal use of the

20   patch, would you have more closely monitored

21   Mr. Phillips during the course of his treatment?

22             MR. AUCIELLO:  Objection.

23   A.        Yes.

24   BY MR. PATE:

25   Q.        If the black box warnings accompanying

1   the fentanyl patch had stated that a patient could

2   receive four to five times the fentanyl level above

3   and beyond that identified in this table, would you

4   have advised Mr. Phillips of that risk?

5             MR. AUCIELLO:  Objection.

A.        Yes.

 

* * * * *

25   Q.    The prescribing information stated that

1   some number of fentanyl patches, 100 microgram

2   fentanyl patches aren’t going to administer

3   100 micrograms of fentanyl per hour but instead

4   400 micrograms of fentanyl per hour, would that

5   have changed the course of treatment that you

6   undertook with Mr. Phillips?

7             MR. AUCIELLO:  Objection.

8   A.        In terms of pain control treatment or the

9   cancer treatment?

10   Q.        Pain control treatment, specifically

11   prescription of either the patch or the oxycodone?

12             MR. AUCIELLO:  Objection.

13   A.        It may have affected the — it

14   potentially could have.

((Dep. of Dr. E. Ronald Hale at 89:3-10, 90:17-23, 91:16-92:6, 107:25-108:14 (Dkt. 32).) (emphasis added).  Where, as here, a doctor’s testimony is, at best, equivocal, regarding whether adequate warnings would have changed their prescribing decision, summary judgment is improper.  Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 99-100 (1st Dist. 2008) (summary judgment on plaintiff’s warning claim was reversed where prescribing doctor gave conflicting testimony regarding whether he would have prescribed the drug had the warnings been modified); McNeil v. Wyeth, 462 F.3d 364, 372 (5th Cir. 2006); Motus v. Pfizer, 196 F.Supp. 2d 984 (C.D. Cal. 2001) (”If  Dr. Trostler’s testimony on this point were “equivocal or uncertain,” or if there was evidence placing his credibility in question, the Court might agree that it should “reserve the issue of credibility for the jury’s determination.”).  This is especially true in this case, where Ohio law provides a presumption that the failure to provide adequate warnings was a proximate cause of Dr. Hale’s prescription of Defendants’ patches.

Williams v. Lederle Laboratories, 591 F. Supp. 381, 386 (S.D. Ohio 1984).

3. A jury is entitled to assess the credibility of Dr. Hale’s testimony.
Defendants are also not entitled to summary judgment because, even if it had been unequivocally supportive of Defendants’ position, the credibility of Dr. Hales’ testimony would be for the jury to assess.  As this Court held in Williams v. Lederle Laboratories, 591 F. Supp. 381 (S.D. Ohio 1984):

Defendant emphasizes Dr. Furlong’s testimony that, despite revisions in the Orimune warnings and his own knowledge of plaintiff’s experience, he continues not to warn of the risk of contact polio associated with Orimune. What Dr. Furlong might or might not have done involves to some degree his credibility. Thus, we conclude that it is for the jury to determine whether the presence of an adequate warning would have made no difference in Dr. Furlong’s decision.

* * * * *

Although we stress that we do not disbelieve Dr. Furlong’s testimony that he would not have behaved differently, we nevertheless find that whether he would have is a matter of credibility and thus a determination better made by the finder of fact.  Thus a question at trial will be whether the defendant has affirmatively established that Dr. Furlong would not have responded differently had the warning been adequate.

Id. at 387-88; see also Delude v. Johnson & Johnson (In re Levaquin Products Liab. Litig.), MDL No. 08-1943, 2010 U.S. Dist. LEXIS 75054 at *31 (D. Minn. July 26, 2010) (“The Court notes two additional problems with defendants’ argument. First, after reviewing Dr. Butner’s deposition transcript, the Court finds that Dr. Butner’s testimony regarding what he would have done if he had received a more complete warning of the risks of tendon toxicity presents an issue of credibility that is within the province of the trier of fact.”);  Rush v. Wyeth (In re Prempro Prods. Liab. Litig., MDL Docket No. 4:03CV1507-WRW, 2006 U.S. Dist. LEXIS 47472 at *9 (E.D. Ark. July 13, 2006) (“Additionally, I’m not convinced that a physician’s testimony regarding what he or she would have done in 20/20-hindsight should be considered absolute. It appears to me that such testimony may well hinge on credibility, which is for the jury decide.”); Golod v. LaRoche, 964 F.Supp. 841, 857 (S.D.N.Y. 1997) (“Defendants contend that any inadequacy of its warning was not a proximate cause of Golod’s injuries because Dr. Grossman, who prescribed Tegison for Golod, has testified that he believes Hoffmann’s warnings are adequate despite Golod’s blindness and has not changed his practices in prescribing Tegison since her injury.  However, unless a physician’s claim that she would have prescribed a drug even if adequately warned is self-disserving, the credibility of such a claim is generally a jury question not to be resolved on a motion for summary judgment.  Here, because Dr. Grossman is not a defendant in this action, his statement is not self-disserving in any meaningful way.”).

4. Dr. Hale’s testimony, even if unequivocal and credible, is not determinative; the issue of proximate cause is an issue of fact for the jury.
Finally, even if Dr. Hale’s testimony had been both unequivocal and credible, Defendants would still not be entitled to summary judgment on Miller’s warnings claim.  That is true because a doctor’s testimony of what they might have done under hypothetical circumstances is not determinative.  Ultimately, it is up to a jury to determine whether the doctor would have acted differently had they been provided with different warnings.  As this Court has explained:

Dr. Furlong’s statement that he was aware of the possibility of persons developing contact polio as a result of having read the package insert and PDR, and took that risk into account in deciding whether to warn a patient of the risk does not change our view.  The issue is not whether Dr. Furlong believed he was adequately warned of the risk but whether the factfinder finds that the warning was adequate in light of all of the circumstances.  It is possible that the factfinder may conclude that, given the seriousness of the risk, the warning was inadequate and that Dr. Furlong would have behaved differently had he been provided with a more urgent warning.

Williams, 591 F. Supp. at 385-86; see also Doe v. Miles Laboratories, Inc., 927 F.2d 187, 194 n.32 (4th Cir. 1991) (“although Dr. Martinez testified that she would have administered the drug regardless of the AIDS risk, her hindsight opinion is not conclusive of what she would have done had she been invested with all pertinent facts regarding Koyne. Thus, the causation issue . . . presents a genuine issue of material fact”).  For all of the foregoing reasons, Defendants’ Motion should be denied as to Miller’s warning claims.

B. Miller has offered ample evidence supporting his allegation that Defendants failed to warn of certain known risks of their fentanyl patches.

1. Ohio law does not require warnings testimony from a physician.

Defendants claim that they are entitled to summary judgment because Miller has failed to offer opinions from a licensed physician regarding the adequacy of Defendants’ warnings.  But Ohio law does not require such testimony.  In fact, the primary case cited by Defendants for this proposition actually stated that “only (a physician) or someone with similar experience regarding pharmaceuticals would be qualified to determine whether or not the warning was adequate.”  Jones v. Roche Labs., 84 Ohio App. 3d 135, 141 (1992) (emphasis added).  As set forth in his Declaration, Miller’s expert James Morrison has extensive experience with pharmaceuticals, warnings and FDA regulations.  (Morrison Decl. at Exh. A (App. Ex. 32).)

2. Miller has offered physician expert testimony.
Moreover, even if testimony from a medical doctor were required, Miller has offered such testimony.  As set forth above, Dr. Hale, the prescribing physician, testified that he been warned of the possibility that Defendants’ patches might provide Mr. Phillips with a fentanyl level much higher than the levels indicated in Defendants’ package insert or might deliver a higher amount of fentanyl than the dosage of 100 mcg per hour, he may have changed his prescribing decisions. (Dep. of Dr. E. Ronald Hale at 89:3-10, 90:17-23, 91:16-92:6, 107:25-108:14 (Dkt. 32).)  Here, Miller has offered unrebutted summary judgment evidence that Defendants knew that the production and release of defective, leaking patches was inherent in the process used to manufacture Sandoz and that such leaking patches could and did cause patient deaths by fentanyl overdose.  (Dep. of J. Hawkins at 39:14–40:1 (taken in Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)) (App. Ex. 9).); (Laughery Decl. at Exh. B at p. 4 (App. Ex. 33).)  And there is no question that Defendants failed to inform prescribing doctors like Dr. Hale with any warnings regarding the potential for manufacturing defects and/or the potential for patient’s to receive dangerous fentanyl levels far above those set forth in the package inserts during normal use.  (Sandoz Package Insert (Dkt. 21-1).)

Under Ohio law, a warning is adequate “under all the circumstances, it reasonably discloses to the medical profession all risks inherent in the use of the drug which the manufacturer knew or should have known to exist.”  Williams, 591 F. Supp. at 384.  A warning may be inadequate because of its factual content, its expression of the facts, or the method or form in which it is conveyed.  Id. Moreover, “[a] reasonable warning not only conveys a fair indication of the nature of the dangers involved, but also warns with the degree of intensity demanded by the nature of the risk.  A warning may be found to be unreasonable in that it was unduly delayed, reluctant in tone or lacking in a sense of urgency.”  Id. Here, as set forth above, Defendants were on notice of certain risk and dangers of which they completely failed to warn prescribing doctors.  Dr. Hale testified that had he been aware of such dangers, he may have changed his prescribing decisions.  Such evidence raises an issue of fact that makes summary judgment improper.  As this Court has concluded, “Ohio law requires that the issue of the adequacy of the warning be left to the finder of fact.”  Williams, 591 F. Supp. at 386.

3. This is a no-warnings case.
Defendants’ Motion should also be denied because there is a distinction between a claim based on an inadequate warning and a claim based on a complete lack of a warning.  See, e.g., Bremer v. Egan Healthcare Corp., civil Action No. 03-1418, 2004 U.S. Dist. LEXIS 11385 at *12 (E.D. La. June 21, 2004) (“The plaintiff noted that none of the warnings that the defendant provided suggests that the walker could fail during normal use, and that the failure would be in such a manner that it would lead to a serious life threatening injury. . . . .  The ‘learned intermediary doctrine’ applies when a warning is clear, accurate, and unambiguous, the adequacy of the warning is a question of law.  There were no warnings that the defendant provided suggesting that the walker could fail during normal use, thus there is no warning that is “clear, accurate, or unambiguous.”).  Here, Miller has alleged, and his experts have testified, that Defendants wholly failed to include any warning of potential manufacturing defects or of the potential for dangerous fentanyl levels above those in the package insert during normal use:

There was no mention anywhere in the Full Prescribing Information document of potential manufacturing defects that resulted in leaks or of the potential catastrophic consequences of such leaks.

There was no information in the Full Prescribing Information indicating that there was a potential for dangerous and/or fatal fentanyl levels that were significantly above the expected levels set forth in the Full Prescribing Information.  This potential for high fentanyl levels exists when the patient is a proper candidate for the patch and is using it as prescribed.  There is no mention anywhere in the black box section of Full Prescribing Information of the risk of death from proper use.

(Laughery Decl. at Exh. B at par. 9 (App. Ex. 33).) (emphasis added).  Where, as here, no warning has been given, expert testimony is not required.  See, e.g, Pineda v. Ford Motor Co., 520 F.3d 237, 245 (3d Cir. 2008) (“The wording of the warning or step-by-step instruction are not issues before us because the foundation of Pineda’s claim is that no warning or instruction existed at all.  If, however, Pineda claimed that an existing warning or instruction was ineffective, misleading, or otherwise defective, a true ‘warnings expert’ might be required.”).

4. Defendants failed to meet their initial burden of showing the adequacy of their warnings.

Finally, Defendants’ Motion should be denied as to Miller’s warnings claim because Defendants have failed to meet their initial burden of demonstrating that they provided adequate warnings.  Defendants offered no summary judgment evidence supporting the adequacy of their warnings: no declaration, no affidavits, no expert report and no deposition testimony.  As such, Miler is not required to come forward with evidence of the inadequacy of Defendants’ warnings:

A drug manufacturer’s primary responsibility is to provide adequate warnings concerning its product to prescribing physicians.  Had Roche supported its motion for summary judgment with evidence that such warnings were provided, plaintiff Jones would be required to show that warnings were not given or that warnings given were not reasonably adequate.  As the trial court found, expert opinion evidence is necessary for that showing.  However, the requirement is not imposed on Jones until Roche first makes its showing.  As the record demonstrates no showing by Roche, there was no basis from which the trial court could require proof contra that of plaintiff Jones.

Jones v. Roche Labs., 84 Ohio App. 3d 135, 141 (1992).  For this additional reason, Defendants’ motion should be denied.

 

II. Defendants are not entitled to judgment as a matter of law on Miller’s design defect claim.

Defendants are not entitled to summary judgment on Miller’s design-defect claim.  They do not contend that Miller is unable to satisfy the requirements of Ohio Revised Code § 2307.75 (i.e., that the foreseeable risks associated with the Sandoz patch’s design exceeded the benefits associated with that design).  Instead, they argue that they are not liable as a matter of law because (1) they may take advantage of a safe-harbor provision under Ohio Products Liability Code concerning “unavoidably unsafe” aspects of a product, and (2) a design-defect claim can never be premised on a defect that does not manifest itself in every product that is produced.  These arguments are without merit.

A. The “unavoidably unsafe” safe-harbor does not apply.
Because Defendants have failed to contest Miller’s assertion that an alternate, safer design existed at the time that they distributed the Sandoz patch, the statutory “unavoidably unsafe” affirmative defense does not apply.  Defendants argue that they are entitled to judgment as a matter of law based on Ohio Revised Code 2307.75(D) (emphasis added), which states:

An ethical drug or ethical medical devise is not defective in design or formulation because some aspect of it is unavoidably unsafe, if the manufacturer . . . provides adequate warning and instruction . . . concerning that unavoidable unsafe aspect.

(Dkt. 20 at 14).  Yet, the Ohio Supreme Court held that “a prescription drug, vaccine, or like product is not ‘unavoidably unsafe’ per se.”  White v. Wyeth Labs., Inc., 533 N.E.2d 745, 752 (Ohio 1988).  Instead, “a product is unavoidably unsafe if, at the time of its distribution, there existed no alternative design which would have as effectively accomplished the same purpose or result with less risk.”  Id. at 753; accord Ackley v. Wyeth Labs. Inc., 919 F.2d 397, 400 (6th Cir. 1990) (emphasis added).  Defendants, however, have failed to challenge in any way whatsoever Miller’s assertion in his complaint that a matrix design, as opposed to the reservoir design that they used, was “an alternative design which would have as effectively accomplished the same purposes or result with less risk.”  (See Complaint (Dkt. 1) at ¶¶ 18, 36).)  Indeed, in ALZA’s Citizen Petition to the FDA, it admitted (consistent with Defendants’ current use of a matrix design for their patches) that “matrix products do offer some advantages over reservoir patches in terms of cosmetics, adhesion and elimination the possibility of gel leakage.”  (App. Ex. 29).) Defendants have simply failed to meet their burden of establishing that the “unavoidably safe” affirmative defense applies here.

Yet, even if the safe harbor applied, Defendants’ warning and instructions do not permit them to escape liability.  For the reasons provided in Part I of her Argument, infra, Miller has produced evidence creating a genuine issue of material fact whether Defendants’ warnings were adequate.  Without adequate warnings, the safe harbor does not apply.  Defendants’ argument that they warned of leaking patches (Dkt. 20 at 15) is unavailing.  First, Miller’s warning claims are not limited to the presence of leaking patches.  Rather, his experts have opined that Defendants warnings failed to warn “that there was a potential for dangerous and/or fatal fentanyl levels that were significantly above the expected levels set forth in the Full Prescribing Information” and that “[t]his potential for high fentanyl levels exists when the patient is a proper candidate for the patch and is using it as prescribed.”  (Laughery Decl. at Exh. B at par. 9 (App. Ex. 33).) (emphasis added).  And his Complaint is not limited to the theory that such high levels are the result of leaking patches. (Dkt 1 at ¶¶ 15, 17).  Second, the snippet from the package insert quoted by Defendants does not warn that Defendants were aware that their patches suffered from “potential manufacturing defects that resulted in leaks or of the potential catastrophic consequences of such leaks” or that that the production and release of defective, leaking patches was inherent in the process used to manufacture Sandoz and that such leaking patches could and did cause patient deaths by fentanyl overdose.  (Dep. of J. Hawkins at 39:14–40:1 (taken in Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)) (App. Ex. 9).); (Laughery Decl. at Exh. B at p. 4 (App. Ex. 33).)  Rather, the package insert merely warned doctors and patients not to use “damaged or cut” patches.  (Sandoz Package Insert (app. Ex. 15).)  Finally, as this Court has concluded, “Ohio law requires that the issue of the adequacy of the warning be left to the finder of fact.”  Williams, 591 F. Supp. at 386.  For all of these reasons, Defendants’ Motion should be denied.

B. Ohio law permits a design-defect claim to rest on the manufacturer’s unnecessary use of a design that leads to fatal manufacturing defects.

Under Ohio law, a design-defect claim can rest on the unnecessary risk of manufacturing defects inherent in the design.  A design defect exists when “the foreseeable risks associated with [a product’s] design . . . exceeded the benefits associated with that design[.]”  Ohio Rev. Code § 2307.75(A).  Nothing in this definition suggests that design-defect claims cannot be based on the foreseeable and unnecessary risk of manufacturing defects that arise from an intended design.  See Knitz v. Minster Mach. Co., 432 N.E.2d 814, 818 (Ohio 1983) (quoting Barker v. Lull Eng’g Co., Inc., 573 P.2d 443 (Cal. 1978) (“A product may be found defective in design . . . if . . . the jury determines that the product’s design embodies ‘excessive preventable danger,’ or, in other words, if the jury finds that the risk of danger inherent in the challenged design outweighs the benefits of such design.”)).  At least once court considering this exact argument in another fentanyl pain patch case against these same Defendants has rejected it:

Even if defendants met their initial burden, plaintiffs have provided evidence to show a triable issue as to whether there is a design-defect.  There is testimony from Alza’s former vice president of quality control assurance and technical operation that Alza knew that the production and release of defective, leaking patches was “inherent” in the process used to manufacture fentanyl patches. (See Deposition of Juanita Hawkins lodged as Exhibit S; 39:14-40:22)  Alza’s process engineer, David Chullino, testified that it was ‘inherent that during the manufacture of the Alza reservoir fentanyl patches that some leaking patches will be made and sold to the public and it is simply impossible to avoid.’  (Deposition of David Chullino, lodged as Exhibit X at 32:9-15)  The words ‘inherent manufacturing defect’ seemingly implicates design of the product.

 

Flores v. Alza, et. al., Case No. 37-2009-00066204-CU-PL-EC (San Diego County, CA Superior Court, June 11, 2010) (App. Ex. 26) (denying summary judgment in wrongful death case arising from decedent’s use of defective fentanyl patch); see also Utz v. Howmedica Osteonics Corp., Case no. 1:06CV1963, 2009 U.S. Dist. LEXIS 123973 at *25-26 (N.D. Ohio March 31, 2009) (Accepting plaintiff’s design defect theory that “rods were defectively designed because they were susceptible to and could not withstand surface impressions,” but finding that Plaintiffs’ expert had not opined that “the SR90D rods were susceptible to surface nicks created during the manufacturing or implantation process.”).

Defendants allege that because they did not intend their patches to leak, leaking patches cannot be the result of a design defect!  (Dkt. 20 at 14)  This argument, however, confuses the results of the design defect with the defect itself.  The design defect is that Defendants designed a fentanyl patch using a reservoir of fentanyl gel which is capable of leaking instead of using the safer matrix design that cannot leak.  The result of this design defect is that patches can and do leak.  Defendants’ argument would be tantamount to Ford arguing that the placement of the gas tank in its Pinto automobiles was not a design defect because they did not intend their cars to explode on impact.

Finally, Defendants’ argument is flawed because it assumes that leaking patches are leaking when they roll off Defendant’s assembly line.  But nowhere has Miller made such an allegation.  The truth is that a leak can develop during normal use of the patch, such as, for example, when pressure is placed on the patch.  A patch need not be leaking when it left Defendants’ plant to suffer a leak during normal use.  As Defendants state in their Motion, a design defect “involves a risk caused by the inherent design of the product.”  (Dkt. 20 at 13).  Here, Miller and his experts have alleged not that every patch coming off of Defendants’ assembly line has a leak, but that every patch coming off Defendants’ assembly line carries with it a risk of developing a leak as a result of the defective reservoir design.  (Prausnitz Decl. at Exh. B at 13 (App. Ex. 7) (“In contrast to the reservoir design of the Duragesic patch, there exists an alternative matrix patch design that does not pose the risk of gel leakage and is therefore safer.”).)  Such an allegation clearly alleges a design defect.  Defendants’ Motion should be denied.

III. Defendants are not entitled to summary judgment on Miller’s manufacturing defect claim.

A. Miller’s manufacturing defect claim is not limited to a claim of a leaking patch.

Defendants’ entire manufacturing defect argument is flawed because it rests on the misguided premise that Miller’s claims are based solely on the presence of a leaking patch.  (Dkt. 20 at 15-17).  In his Complaint, however, Miller alleged that “the Patch is unreasonably dangerous because it can and does leak and/or because it otherwise causes lethal levels of fentanyl in patients.”  (Dkt. 1 at ¶ 17).)   His experts have similarly opined that “the high level of fentanyl found in the blood of decedent was most probably the result of a leak or other defect in a Duragesic patch the decedent was wearing.”  (Prausnitz Decl. at Exh. A at 1 (App. Ex. 7).)  Defendants’ focus on whether Miller can prove that Phillips was wearing a leaking patch at the time of death is unduly narrow and ignores the broad allegations of Miller’s Complaint.

B. Miller is not required to offer direct evidence of a manufacturing defect.

Defendants argue that they are entitled to summary judgment because Miller has offered no direct evidence of a manufacturing defect.  (Dkt. 20 at 16).  But, as the very cases Defendants cite make clear, no such direct evidence is required, especially where, as there, the defective product no longer exists.  See Section C below.

C. Miller is entitled to rely on circumstantial evidence of a manufacturing defect.

Under Ohio law, “product defects may be proven by direct or circumstantial evidence.”  State Farm Fire & Cas. Co. v. Chrysler Corp., 523 N.E.2d 489, 493 (Ohio 1988).  Where, as here, the product is unavailable, “a defect in a manufactured product existing at the time the product left the manufacturer may be proven by circumstantial evidence . . . .”  Id. at 493-94.  Moreover, under Ohio law, “[a]s applied to manufacturing defect cases, evidence of unsafe, unexpected performance of a product [is] sufficient to infer the existence of a defect.”  Id.

D. Miller is not required to eliminate all other possible causes of Phillips’ fatal fentanyl level.

Defendants argue that they are entitled to summary judgment because they have advanced other “possible” causes of Phillips’ death.  They argue that “if there are other possible causes that are unrelated to the product, the plaintiff has the burden to sufficiently exclude those other causes.”  (Dkt. 48-1 at 10 (emphasis added).)  But the Ohio Supreme Court has expressly rejected this argument.   In State Farm Fire, the court explained that:

A defect in a manufactured product existing at the time the product left the manufacturer may be proven by circumstantial evidence where a preponderance of that evidence establishes that the loss was caused by a defect and not other possibilities, although not all other possibilities need be eliminated.

 

Id. at 493-94 (emphasis added); see also Westinghouse Electric Corp. v. Dolly Madison Leasing & Furniture Corp., 326 N.E.2d 651, 657 (Ohio 1975) (“The [rule concerning the elimination of multiple probable causes] does not intrude on the jury’s role as the finder of facts, nor does it impose on a plaintiff the burden of always effectively eliminating all other possible causes in order to make his case, which would impose a burden of proof analogous to the burden in criminal cases of proof beyond a reasonable doubt.”);  Kurzner v. Sanders, 627 N.E.2d 564, 570 (Ohio Ct. App. 1993) (“Westinghouse held that only where the evidence is such that no inference of negligence can be drawn from the facts presented does the plaintiff have to disprove all but his or her own theory in order to prevail.”) (emphasis original); Donaldson v. N. Trading Co., 612 N.E.2d 754, 758 (Ohio Ct. App. 1992) (“An inference will be disregarded only where, construing the evidence most strongly for the nonmoving party, reasonable minds cannot help but find that the inference is not supported by the greater weight of the evidence.”).  In other words:

[the limited rule of eliminating multiple probable causes] should be reserved for those cases in which the plaintiff has not presented any credible evidence that the alleged cause of the injury was the probable cause. . . . [The rule is inapplicable] where expert testimony establishes to a reasonable degree of certainty that the defendant probably, rather than merely possibly, caused the plaintiff’s injuries.

Deagan v. McLaughlin, No. 99-C.A.-287, 2001 Ohio App. LEXIS 5330, at *18 (Ohio Ct. App. Nov. 30, 2001) (emphasis original); see also Yanovich v. Zimmer Austin, Inc., 255 Fed. Appx 957, 966 (6th Cir. Nov. 21, 2007) (summary judgment properly denied where plaintiff provides “some affirmative evidence that a non-defective product would not have failed in the manner of the product at issue.”).

Here, Miller has offered a wealth of circumstantial evidence of a manufacturing defect.  As set forth above at pp. 6-8, Defendants were aware of numerous problems with the manufacture of leaking patches and experienced numerous recalls during the timeframe in which Mr. Phillips’ patch was manufactured.  In fact, two of Defendants’ corporate representatives have testified that leaking patches were inherent in the manufacturing process during this timeframe.  (Dep. of J. Hawkins at 39:14–40:1 (taken in Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)) (App. Ex. 9); Excerpts from Deposition of David Chullino at 36:3-37:16 (taken January 21, 2009 in West v. ALZA Corporation, No. 19, 955) (App. Ex. 15)

As stated in the report of Miller’s expert, Mark R. Prausnitz, Ph.D., one of the world’s foremost experts on transdermal technology:

  • Phillips’ fentanyl level of 13 ng/mL was “more than four times higher than expected when wearing the combination of a Duragesic-100 patch and a Duragesic-25 patch;”
  • “There is some patient-to-patient variability in blood fentanyl levels, but that variability cannot reasonably account for a fentanyl level as high as 13 ng/mL;”
  • “If, for some implausibly unlikely reason, the decedent’s blood fentanyl level reached 13 ng/mL from a properly functioning combination of a Duragesic-100 patch and a Duragesic-25 patch at the time of death, then the decedent would most likely have had significantly elevated fentanyl levels for the preceding months during which time the decedent was using Duragesic patches;”
  • “It is equally implausible that the decent could have been living without adverse effects with such a high fentanyl level for such a long time, which further confirms the conclusion that the fentanyl level measured in the decedent’s blood was much higher than expected;”
  • “The high level of fentanyl found in the blood of the decedent was most probably the result of a leak or other defect in a Duragesic patch the decedent was wearing.”
  • “A leaking Duragesic patch can account for the highly elevated fentanyl level in the decedent and is the most likely explanation.

(Prausnitz Decl., Exh. B, at 1-5 (App. Ex. 7).)  Similarly, toxicology expert Christopher Long has opined that “the fentanyl concentration is far greater than that expected from the combined 125 mcg patches and well above the average producing a fatality.”  (Long Decl. at Exh. B at 4) (App. Ex. 30).)  Even the medical examiner in this case testified that he “became aware that there was an issue about — or question about patches or whether or not they were defective in some way as to delivering a higher or a, you know, a rapid dose.”  (Dep. of Dr. Uptegrove at 59:16-19, (App. Ex. 3).)

In the face of this overwhelming evidence, Defendants argue that they are entitled to summary judgment on miller’s manufacturing defect for two reasons.  First, they claim that a study shows that some living patients had fentanyl concentrations of 13 ng/ml or higher. (Dkt. 20 at 17).  But this proves nothing about whether or not Mr. Phillips’ patch was defective.  First, when the report of Defendants’ expert is closely examined, it is apparent that such high fentanyl levels were extremely rare.  According to the data he cites, only 6 out of 1463 blood levels were equivalent to 13 ng/mL or higher with a 125 mcg dose!  (Golan Decl. at Exh. B at ¶ 19).  For all patch dose rates, the number was 11 out of 2102.  (Id. at fn. 8).  The fact that only .004-.005 (4/10ths to 5/10ths of one percent) of the blood levels measured had such a high fentanyl level shows that such levels are abnormal, not normal.  Given the number of known patch defects and recalls, it is entirely possible that these aberrant high levels were caused by defective patches.  This is especially true since another study cited by Defendants’ expert found that the highest measured fentanyl level from 125 mcg of patches was 6.1 ng/mL, less than half of Mr. Phillips’ level of 13 ng/mL   Id. If anything, the studies cited by Dr. Golan support Miller’s claim of a manufacturing defect since under Ohio law, “[a]s applied to manufacturing defect cases, evidence of unsafe, unexpected performance of a product [is] sufficient to infer the existence of a defect.”  State Farm, 523 N.E.2d at 493.

Defendants’ final argument in support of their Motion as to Miller’s manufacturing defect claim is that Miller’s expert, Mark Prausnitz, has admitted that it is possible to achieve a 13 ng/mL fentanyl level from a properly functioning patch.  But what Dr. Prausnitz actually said in the cited deposition is:

10    Q.   So with respect to the Vicki Auburn

11   case, would it be an accurate statement for me

12   to say that the question you were asked to

13   address was what caused the fentanyl blood level

14   measured in Vicki Auburn at the time of her

15   death?

16        A.   Yes.

17        Q.   Okay.  And is it also a fair statement

18   that in your opinion that high blood level was

19   caused by gel that leaked from the Duragesic

20   patch she was wearing at the time of her death?

21        A.   I believe that’s the most likely

22   explanation.

23        Q.   Okay.  Now, stepping back a little bit,

24   I do want to ask in terms of — and the way you

25   said it was you believe it’s the most likely

1   possibility, alternative?  I don’t know —

2        A.   The most likely explanation.

3        Q.   Most likely explanation.  What other

4   potential explanations did you consider in

5   coming to your conclusion that the high blood

6   level was caused by leaking gel?

7        A.   One possibility would be that the patch

8   was performing as expected and that that normal

9   delivery rate of 100 micrograms per hour would

10   lead to such a level.  Based on things that we

11   have discussed before which is supported by

12   various information in the literature in J & J

13   reports, that did not seem reasonable to me,

14   that you could achieve such a high level with a

15   normally functioning patch.

* * * * *

23    Q.   Okay.  And do you recall what, in

24   particular, materials that you are relying on to

25   support your belief that it’s unlikely that a

1   100 microgram per hour patch could lead to a 16

2   nanograms per milliliter blood level?

3        A.   Those are materials and arguments that

4   you can find in recent expert reports that I’ve

5   given in other cases.

(Prausnitz Dep. in Auburn v. Alza at 30:10-31:15, 33:23-34:5) (App. Ex. 37).)

Obviously, Prausnitz testified that while it was theoretically possible, it was not reasonable to expect a properly functioning patch to yield such a high fentanyl level.  Instead, he explained, the probable cause of the excessive fentanyl level and Philips’ consequent death was a defect in the patches.  Under Ohio law, such testimony is more than adequate to support a manufacturing defect claim.  See, e.g., State Farm, 523 N.E.2d at 493-94 (“A defect in a manufactured product existing at the time the product left the manufacturer may be proven by circumstantial evidence where a preponderance of that evidence establishes that the loss was caused by a defect and not other possibilities, although not all other possibilities need be eliminated.”); Nationwide Mut. Fire Ins. Co. v. B&B Appl. Co., No. 54107, 1988 Ohio App. LEXIS 2870 at *13 (Ohio App. July 14, 1988) (“It is true that a television absent a defect would normally not cause a fire.  However, the evidence failed to establish the television caused the fire.  It is equally probable the other electrical equipment near the television caused the fire.  In all the cases relied upon by plaintiffs regarding the proposition a defect may be shown by circumstantial evidence, there was only one probable cause of the fire established at trial.”); Popick v. Kopp Clay Co., Case No. 472, 1985 Ohio App. LEXIS 6211 at *3 (Ohio App. April 1, 1985) (“The lack of direct evidence is not necessarily fatal to appellants’ case. The appellants could prove their case by circumstantial evidence, where a preponderance of that evidence establishes that the accident was caused by a defect and not other possibilities, although not all other possibilities have to be eliminated. The plaintiffs’ evidence in such a case must make out a preponderance of probability.”); Westinghouse Elec. Co., 326 N.E.2d at 656 (“Defendants suggested that other causes of the fire were possible, such as spontaneous combustion, arson, or sparks from a locomotive.  However, all these possible causes were questions of fact for the jury and none acted to prevent the drawing of an inference of defendant’s liability, as they would, for example, if they established that some other cause was the only one possible.  None of defendant’s theories of the cause of the fire amounted to more than the suggestion that other causes were possible, and none amounted to proof that the evidence presented by plaintiffs did not permit an inference that careless smoking by defendant’s employee caused the fire.  Suggestion of other causes is limited only by the limits of human imagination, and are not a basis for taking a case from the jury.”).

For purposes of summary judgment, Defendants have not questioned the medical examiner’s conclusion that Phillips died from fentanyl intoxication.  Nor have they challenged the toxiciology results showing that Phillips received a fentanyl blood level of 13 ng/mL, four times higher than the expected level from a properly functioning patch.  Nor is there alleged to be any source of Phillips’ fentanyl blood level other than Defendants’ product.  Under these facts, Miller has shown ample circumstantial evidence of a manufacturing defect to avoid summary judgment.

IV. Defendants are not entitled to summary judgment on Miller’s OLPA claim for non-conformance to a manufacturer’s representations.

Under the OLPA, a product is defective if it did not conform to representations made by its manufacturer.  R.C. 2307.77.  Defendants claim that Miller has failed to identify any representations to which Phillips’ patches did not conform.  This is simply false.   In his Complaint, Miller alleged that “the Phillips Patches did not conform to the Patch Defendants’ representations concerning the maximum blood concentration of fentanyl that would result from use of the patches.”  (Dkt. 1 at ¶ 38.)  Similarly, his experts have explained that:

According to the manufacturer’s prescribing information (i.e., Duragesic package insert), the combination of a Duragesic-100 patch and a Duragesic-25 patch is expected to administer fentanyl at a rate of 125 mcg/hr and is expected to achieve a peak serum fentanyl concentration of 3.1 ng/mL on average.

The medical examiner reported a plasma fentanyl level of 13 ng/ml in the blood of the decedent and concluded that this elevated fentanyl level was the cause of the decedent’s death. Indeed, this fentanyl level is more than four times higher than expected when wearing the combination of a Duragesic-100 patch and a Duragesic-25 patch.

(Prausnitz Decl. at Exh. B at 2) (App. Ex. 7).)  Defendants are not entitled to judgment on this claim.

V. The OLPA has not abrogated Miller’s warranty claims.
Miller concedes that his common-law negligence and negligent misrepresentation claims have been abrogated by Ohio Revised Code § 2307.71(B).  Similarly he concedes that he is not entitled to punitive damages in this wrongful death case.  He disputes, however, the notion that the OLPA has abrogated his statutory causes of action for breach of express and implied warranty.  Section 2307.71(B) abrogates only “common law product liability claims or causes of action.”  See Miles v. Raymond Corp., 612 F. Supp. 2d 913, 924 (N.D. Ohio 2009) (holding that claims under Ohio’s Products Liability Code and warranty claims under the UCC can coexist in the same action, even though the warranty claims are “not explicitly denominated as [statutory claims] in the complaint”); see also LaPaglia v. Mylan, Inc., No 1:08-cv-3025 (Dkt. 23), Mem. of Op. & Order (N.D. Ohio May 14, 2009) (App. Ex. 34) (refusing to dismiss UCC warranty claims in fentanyl-overdose case despite other causes of action under the Ohio Products Liability Code).  Here, Miller asserts two claims under the UCC:  (1) breach of the implied warranty of fitness and (2) breach of express warranty.  (Dkt. 1 ¶¶ 47-50)  Because Miller seeks to recover on these claims pursuant to the UCC, they are not abrogated and should not be dismissed.  See Miles, 612 F. Supp. 2d at 924.

VI. Miller asserts no claim for fraud against the FDA, and thus Defendants are seeking to dismiss a claim that has not been pleaded.

Defendants are not entitled to summary judgment on a claim that is not pleaded in this case.  Although Miller does not plead a cause of action for fraud on the FDA, Defendants seek summary judgment based on federal preemption and the alleged failure of Miller to produce any evidence of a misrepresentation to the FDA.  Any decision by this Court “dismissing” a hypothetical claim for fraud-on-the-FDA that is not pleaded in this case would be an improper advisory opinion that would neither affect the rights of any parties nor resolve any dispute in this action.  North Carolina v. Rice, 404 U.S. 244, 246 (1971).

Moreover, Miller should be able to reveal to the jury that Defendants were purposefully misleading the FDA when seeking approval of their Sandoz patches.  Defendants have unsuccessfully asserted in similar, prior trials that they should not be found liable because they worked with, and cooperated with, the FDA.  (Trial Tr. at 392:19-24, 395:9-11, 396:12–397:9, 402:4-7, 403:6-10, 405:10-18, 407:6-7 (defense’s opening argument) in DiCosolo v. Janssen Pharmaceutica, Inc., No. 04-L-5351 (Cir. Ct. of Cook County, Ill. Oct. 28, 2008) (App. Ex. 31).)  The jury is entitled to know that the FDA did not have all information that was available to Defendants when it allegedly deemed the Sandoz warnings sufficient.

Conclusion

Plaintiff William Miller respectfully asks the Court to deny Defendants’ Motion for Summary Judgment and grant him such other and further relief to which he may be justly entitled.

By:      /s/ Charles W. Miller_________________

James C. Orr, Jr. (Texas Bar #15313550)

jim@hop-law.com

Charles W. Miller (Texas Bar #24007677)

charles@hop-law.com

Heygood, Orr, and Pearson
2331 Northwest Highway, 2nd Floor
Dallas, Texas 75220
(214) 526-7900 (phone)
(214) 526-7910 (fax)

 


[1] To minimize burdens on the parties and deponents, the parties have agreed that documents and depositions of the Defendants’ Federal Rule of Civil Procedure 30(b)(6) witnesses and their current and former employees taken in one case concerning an alleged fentanyl-related death may be used in other wrongful death cases involving Sandoz.  Miller relies on those documents and depositions here.

[2] Defendants have conceded that Phillips was using their patches at the time of his death.  (See Defs.’ Brief at 3 (“The fentanyl patches at issue in this case were generic versions of Duragesic®, and were manufactured by ALZA Corporation and distributed by defendant Sandoz Inc.”) (Dkt. 20).)