Response to Defendants’ Motion for Summary Judgment

Richardson v. Mylan

Description: This brief was filed in California 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. The response also addresses issues of pre-emption and causation. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA
WALTER RICHARDSON, MICHAEL REMERAZ, SAM BLOOM, CHRISS BLOOM, and STEPHANIE LEEWRIGHT,Plaintiffs,

v.

MYLAN, INC., MYLAN

PHARMACEUTICALS, INC., MYLAN TECHNOLOGIES, INC., and JOHN DOES 1-100

Defendants.

Case No.: 09-cv1041-JM (BLM)PLAINTIFFS’ ANSWERING MEMORANDUM OF POINTS AND AUTHORITIES IN OPPOSITION TO DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

Date: August 24, 2010

Time: 11:00 a.m.

Courtroom: Dept. 16

Table of Contents

STATEMENT OF FACTS. 1

A. The Mylan Fentanyl Patch. 1

B. Ms. Richardson’s Chronic Pain, Fentanyl Patch Prescription, and Death. 2

1. Dr. Jaffe prescribes Ms. Richardson 100 mcg/hr fentanyl patches. 2

2. Ms. Richardson dies from a 22 ng/mL fatal blood-fentanyl level. 2

3. The medical examiner’s conclusion that a 22 ng/mL blood-fentanyl level was fatal is supported by established science. 4

4. The Mylan Defendants have admitted to the FDA that a 22 ng/mL postmortem blood-fentanyl concentration is “fatal.”. 4

C. The evidence shows Ms. Richardson was using her fentanyl patches exactly as prescribed by her doctor and as intended by the Mylan Defendants. 5

D. The Mylan Defendants’ Knew of Patients’ Elevated Levels Prior to Ms. Richardson’s Death. 6

ARGUMENT AND AUTHORITIES. 8

A. The evidence shows that a defective Mylan fentanyl pain patch killed Ms. Richardson. 8

1. Under California law, a plaintiff may establish a defect through circumstantial evidence. 8

2. The circumstantial evidence of defect is overwhelming in this case. 9

B. Plantiff’s claims are premised on reliable science. 12

1. The evidence demonstrates that fentanyl is subject to, at most, modest postmortem redistribution that does not render postmortem blood samples unreliable. 12

2. The Mylan Defendants themselves have relied on postmortem fentanyl levels in making representations to the FDA. 16

3. Dr. Iain McIntyre agrees with the current state of science. 17

4. Trial courts have specifically rejected the argument that a postmortem blood-fentanyl level cannot be used as evidence of defect in a fentanyl patch. 18

C. The Mylan Defendants inadequately warned Ms. Richardson’s physician. 20

D. Plaintiffs’ failure-to-warn claims are not preempted. 23

E. The Mylan Defendants are not entitled to summary judgment on Plaintiffs’ negligence, negligent misrepresentation, and warranty claims. 24

F. Mylan Inc. is not entitled to summary judgment because it has not met the burden of proof on its affirmative defense. 25

CONCLUSION.. 25

CERTIFICATE OF SERVICE.. 27

 

TABLE OF AUTHORITES

Cases

Allen v. Johnson & Johnson, No. 1:08-CV-105 (M.D.N.C.)……………………………………………………. 20

Allen v. Johnson & Johnson, No. 1:08-CV-105 (M.D.N.C.) 66-67…………………………………………… 17

Auburn v. Johnson & Johnson, 2008-00008440-CU-PO…………………………………………………………. 22

Barker v. Lull Eng. Co., 20 Cal. 3d 413, 429 (Cal. 1978)…………………………………………………… 10, 11

Carlin v. Superior Court, 13 Cal.4th 1104, 1118 (Ca. 1996)……………………………………………………. 27

Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (1st Dist. 2008), review denied by 2009 Cal. LEXIS 233 (Cal. Jan. 21, 2009)…………………………………………………………………………………………………………………………….. 24

Demahy v. Actavis, Inc., 593 F.3d 428, 436-49 (5th Cir. 2010)………………………………………………… 26

Dorsett v. Sandoz, Inc., No. CV-06-7821, 2010 U.S. Dist. LEXIS 39804, at *47-56 (C.D. Cal. Mar. 26, 2010 ) 25

Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994)………………………………………… 26

Gherna v. Ford Motor Co., 246 Cal. App. 2d 639, 650 (Cal. Ct. App. 1st Dist. 1966)……………….. 10

Gonzalez v. Autoliv ASP, Inc., 154 Cal. App. 4th 780, 792 (Cal. Ct. App. 2nd Dist. 2007)…………. 11

Henderson v. Harnischfeger, 12 Cal. 3d 663 (Cal. 1974)………………………………………………………… 13

Hinckley v. LaMesa R.V. Center, 158 Cal. App. 3d 630, 642 (Cal. Ct. App. 4th Dist. 1984)……….. 10

Houghton v. South, 965 F.2d 1532, 1536-37 (9th Cir. 1992)……………………………………………………. 28

Jennings v. Alsager, No. 08-2-25794 (Sup. Ct. King County, WA)………………………………………….. 18

Jiminez v. Sears, 4 Cal 3d 379, 383-87 (Cal. 1971)………………………………………………………………… 26

Mays v. Ciba-Geigy Corp., 661 P.2d 348, 359 (Kan. 1983)…………………………………………………….. 12

McCabe v. American Honda Motor Co., Inc., 100 Cal. App. 4th 1111, 1119 (Cal. Ct. App. 2nd Dist. 2002) 11

Mensing v. Wyeth, Inc., 588 F.3d 603, 608-609 (8th Cir. 2009)……………………………………………….. 26

Nix v. Smithkline, 2007 U.S. Dist. LEXIS 65860 (D. Ariz. Sept. 5, 2007)…………………………………. 25

Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051, 1059-60 (N.D. Cal. 2007)……………………………. 10

Soule v. Gen. Motors Corp., 8 Cal. 4th 548, 562 (Cal. 1994) ……………………………………………………. 9

Stevns v. Parke, Davis & Co., 9 Cal. 3d 51, 65 (1973)……………………………………………………………. 22

Stewart v. Ford Motor Co., 553 F.2d 130, 137 (D.C. Cir. 1977)………………………………………………. 12

Vandermark v. Ford Motor Co., 61 Cal. 2d 256, 260 (Cal. 1964)…………………………………………….. 10

Woodcock v. Mylan, Inc., 661 F. Supp. 2d 602 (S.D. W. Va. 2009)………………………………………….. 21

 

The Mylan Defendants’ motion should be denied because there is a significant amount of evidence Sandra Richardson received a fatal dose of fentanyl from a defective Mylan fentanyl pain patch designed, manufactured, and distributed by the Mylan Defendants.[1] The Mylan patch gave Ms. Richardson a lethal blood concentration of fentanyl that was more than eight (8) times higher than a properly designed and manufactured patch should have given her. For this and a host other reasons, the Mylan Defendants’ motion should be denied.

STATEMENT OF FACTS

A. The Mylan Fentanyl Patch

The Mylan Defendants’ fentanyl patches are transdermal prescription drugs applied to the patient’s skin and used to treat chronic pain. (See Mylan Package Insert at Mylan-466525-26, Declaration of Charles Miller in Support of Plaintiffs’ Opposition to Summary Judgment and Daubert Challenges (“Miller Decl.”), Ex. 1) 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). (Dep. of Dr. Iain McIntyre at 245:25–246:19, Miller Decl., Ex. 2.) Properly functioning patches continuously deliver the requisite dose of fentanyl through the skin and, after several sequential uses, “patients reach and maintain a steady state [blood] serum concentration.” (See Miller Decl., Ex. 1.) In other words, absent a product defect, a patient should be obtaining the same fentanyl-blood concentration from day to day.

According to the prescribing information that accompanies the Mylan fentanyl patch, the Mylan 100 mcg/hr fentanyl patch was designed and intended by Mylan to produce in patients fentanyl levels no higher than 2.5 ng/ml, with a standard deviation of only 1.2 ng/ml. (Miller Decl., Ex. 3; Package Insert at Mylan-466527 (Table A) Miller Decl., Ex. 1.)[2] Ms. Richardson had a fentanyl level of 22 ng/mL when she died, a level eight (8) times greater than the intended fentanyl level of the 100 mcg/hr patch. (See Toxicology Report, Exhibit J to Victory Decl. )

B. Ms. Richardson’s Chronic Pain, Fentanyl Patch Prescription, and Death

1. Dr. Jaffe prescribes Ms. Richardson 100 mcg/hr fentanyl patches.

Prior to her death, Ms. Richardson had suffered from chronic pain in her knee and back. (Dep. of Dr. Michael Jaffe 20:5-11, Miller, Decl. Ex. 37.) Dr. Michael Jaffe, who is board certified in pain management, treated her from May 2006 until she died. (Id. at 12:17-19, 27:11-15.) At the time of Ms. Richardson’s death, Dr. Jaffe had prescribed her a 100 mcg/hr fentanyl patch. (Dep. of Dr. Jaffe 29:13-30:8, 37:5-21) Dr. Jaffe monitored Ms. Richardson every six weeks to assess the drug’s efficacy, as well as any side effects. (Id. at 35:2-15.) Dr. Jaffe testified that Ms. Richardson appeared to tolerate the medication well along with all of her other medications, and he never observed any signs of overmedication or drug seeking behavior. (Id. at 28:3-10; 31:18-32:6; 45:2-10; 50:19-51:22.)

2. Ms. Richardson dies from a 22 ng/mL fatal blood-fentanyl level.

On March 10, 2007, Mr. Richardson, Ms. Richardson’s husband, woke up early and saw his wife, Ms. Richardson, who was still alive. (Richardson Dep. 118:2-13.) Later, he went back into the bedroom discovered that she was cold that her lips were purple. (Id. 118:12-16.) Mr. Richardson called 911, but the paramedics were unsuccessful in reviving his wife, and she was pronounced dead at scene. (Id. 118:17-33; 120:16 -121:21.) At the time of here death, Ms. Richardson was wearing a Mylan fentanyl patch. (Richardson Dep. 108:12-14., 114:15-19.) The patch on her body came off when the first responders were moving her body. (Richardson Dep. at 122:13-124:11, Medical Examiner’s Investigative Report at 2, Exhibit F to Victory Decl.)

Dr. Christina Stanley, a board-certified pathologist who has conducted thousands of autopsies performed an autopsy on Ms. Richardson’s body and was charged with determining her cause of death. (Dep. of Dr. Christina Stanley at 6:18-29, 8:11-9:23, 23:14-15, Miller Decl. Ex 38.) She found no anatomic cause of death (meaning that nothing in his examination of her body or internal organs such as the heart revealed a cause of death) or any alternate cause of death other than opiate overdose. (Id. at 30:11-12, 31:18-23.) Instead, after receiving the toxicology results from Ms. Richardson’s blood sample, she concluded that Ms. Richardson died from “acute fentanyl, diphenhydramine, and amphetamine intoxication,” with fentanyl being the “most significant cause of death.”[3] (Autopsy Report, Miller Decl., Ex. 35; Dep. of Dr. Stanley 77:19-24.) Dr. Stanley also concluded that “in consideration of the reported scene investigation, autopsy findings, toxicology report, and circumstances, surrounding death, there is no clear evidence of suicidal ideation; therefore the manner of death is classified as accident.” (Autopsy Report, Miller Decl., Ex. 35.) Dr. McIntyre, who is the laboratory manager of the toxicology division that tested Ms. Richardson’s blood, testified that with the exception of fentanyl, all of the drugs found in Ms. Richardson’s system were at therapeutic levels. (Dep. of McIntyre 6:13-15, 57:20-25, 76:1-21, 82:14-22, 88:3-9, Miller Decl., Ex. 39. )

3. The medical examiner’s conclusion that a 22 ng/mL blood-fentanyl level was fatal is supported by established science.

The Medical Examiner’s conclusion that Ms. Richardson’s 22 ng/mL blood-fentanyl level was fatal is consistent with the body of scientific literature that has developed pertaining to lethal blood-fentanyl concentrations. Dr. Iain McIntyre, the forensic toxicologist who tested Ms. Richardson’s blood, testified that the 22 ng/mL level was a lethal level. (Dep. of Dr. McIntyre 82:14-22, Miller Decl, Ex. 39.) Dr. Laureen Marinetti, a board-certified forensic toxicologist and the Chief Forensic Toxicologist at the Montgomery County Coroner’s Office and Miami Valley Regional Crime Lab in Dayton, Ohio, has testified that Ms. Richardson’s 22 ng/mL blood-fentanyl level is a “significantly elevated concentration of fentanyl consistent with a level that can cause death.” (Decl. of Laureen Marinetti ¶ 8.) And peer-reviewed articles show that a 22 ng/mL postmortem blood-fentanyl level is universally regarded as fatal.[4]

4. The Mylan Defendants have admitted to the FDA that a 22 ng/mL postmortem blood-fentanyl concentration is “fatal.”

When seeking approval for their fentanyl patch, the Mylan Defendants sent a letter to the FDA seeking to avoid additional testing by informing the FDA that the last time such testing was done on live patients many of the patients in the study received dangerously high blood-fentanyl levels. (See Letter from W.E. Brochu, Ph.D., Mylan Technologies, Inc., to the FDA dated May 13, 2002 at MYLAN-6696-97, Miller Decl., Ex. 8.) In their letter, the Mylan Defendants explained that lethal postmortem blood-fentanyl levels range from 3-17 ng/mL based on a review of four articles.

(Id.) Each of the four articles cited by the Mylan Defendants to establish this 3-17 ng/mL fatal range for blood-fentanyl levels relied on postmortem blood samples (i.e. blood that was taken from the decedent after he or she died).[5] Notably, the postmortem blood-fentanyl level that was determined to be fatal in all of these cases was lower than the fatal level found in Ms. Richardson’s blood after her death. Thus, the medical examiner’s conclusion that Ms. Richardson 22 ng/mL blood-fentanyl concentration represents a fatal level is entirely consistent with and supported by the position that the Mylan Defendants took when seeking FDA approval of their patch.

C. The evidence shows Ms. Richardson was using her fentanyl patches exactly as prescribed by her doctor and as intended by the Mylan Defendants.

The coroner’s office classified Ms. Richardson’s death as “accidental,” meaning that homicide, suicide, and natural causes were all ruled out as the manner of death. (Autopsy report, Miller Decl., Ex. 35.) There was no evidence of suicide. (Dep. of Dr. Stanley at 82:2-20.) There is no evidence that Ms. Richardson was misusing fentanyl patches around the time of her death, and the only evidence of usage at the time of her death is that she was wearing a single patch. (Dep. of Richardson 108:12-109:17.)[6] The Mylan Defendants do not – because they cannot – claim that the number of unused fentanyl patches recovered by the medical examiner show that Ms. Richardson was overusing fentanyl patches. Morover, there is also evidence that Ms. Richardson could not have been overusing fentanyl as, at the time, she filled her last prescription she was completely out of patches, and her doctor would not her fill her prescription until the expected prescription period had expired. (See Dep. of Richardson 108:22-109:2.)

Against the weight of the evidence, the Mylan Defendants insinuate that Ms. Richardson was abusing patches and/or committed suicide using the patch. (See Defs’ Mem. at 2-3.) The Mylan Defendants point to past psychiatric issues and an ambiguous note in which Ms. Richardson complained about Mr. Richardson’s attitude toward the family budget. (Id. at 3.) None of this evidence, however, contradicts the evidence set forth above or the medical examiner’s ultimate opinion “that she did not commit suicide in this case.” (Dep. Dr. Stanley 127:3-4, Miller Decl. Ex. 38.) In short, the Mylan Defendants’ suggestion of suicide is nothing more than innuendo.

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

By the time of Sandra Richardson’s death, the Mylan Defendants were aware of numerous adverse events and deaths related to unexpectedly high fentanyl levels from use of their Mylan Patches. REDACTED

ARGUMENT AND AUTHORITIES

A. The evidence shows that a defective Mylan fentanyl pain patch killed Ms. Richardson.

Although the Mylan Defendants touch on a variety of arguments in their motion, their fundamental contention appears to be that Plaintiffs have no evidence that a defective patch caused Ms. Richardson’s death. (Defs’ Mem. at 10.) The Mylan Defendants are incorrect because there is ample circumstantial evidence of defect in this case.

1. Under California law, a plaintiff may establish a defect through circumstantial evidence.

Under California law, “an injured plaintiff will frequently be able to demonstrate the defectiveness of a product by resort to circumstantial evidence, even when the accident itself precludes identification of the specific defect at fault.” Soule v. Gen. Motors Corp., 8 Cal. 4th 548, 562 (Cal. 1994) (citing Barker, 20 Cal. 3d at 430). California’s approach is not unusual. The vast majority of jurisdictions have long permitted proof of product defect through circumstantial evidence, and 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.[7] Examples of circumstantial evidence that a plaintiff may offer to show a defect include, among other things, the following: (1) evidence that product malfunctioned, that is, it did not function as intended; (2) evidence of the same accidents in similar products; (3) evidence eliminating other causes of the accident; (4) evidence that the accident occurred a short time after sale; and (5) expert testimony as to possible causes. See Barker v. Lull Eng. Co., 20 Cal. 3d 413, 429 (Cal. 1978); Hinckley v. LaMesa R.V. Center, 158 Cal. App. 3d 630, 642 (Cal. Ct. App. 4th Dist. 1984); accord Notmeyer v. Stryker Corp., 502 F. Supp. 2d 1051, 1059-60 (N.D. Cal. 2007); see also Gherna v. Ford Motor Co., 246 Cal. App. 2d 639, 650 (Cal. Ct. App. 1st Dist. 1966) (“The burden is on plaintiff to show that the automobile was defective and that the defect caused the fire. However, as pointed out in Vandermark, supra, at page 260, he may do so by circumstantial evidence. . . . here, the damage to the engine compartment by the fire precluded any direct determination that the fire was caused by a short in the wiring system, but the deposition of the witness Jacobson in regard to the burned wire furnished circumstantial evidence from which such a determination could be reasonably inferred.”); Vandermark v. Ford Motor Co., 61 Cal. 2d 256, 260 (Cal. 1964) As set forth below, all five (5) of these types of circumstantial evidence are present in this case.

2. The circumstantial evidence of defect is overwhelming in this case.

The Mylan Defendants’ motion simply ignores all of the circumstantial evidence showing that the patch was defective. First, there is evidence that the patch malfunctioned and delivered a lethal dose of fentanyl to Ms. Richardson far in excess of what it supposed to deliver. This is itself is sufficient to show defect because, under California law, “a manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.” Barker v. Lull Eng. Co., 20 Cal. 3d 413, 429 (Cal. 1978). A manufacturing defect “is often demonstrated by showing the product performed differently from other ostensibly identical units of the same production line.” McCabe v. American Honda Motor Co., Inc., 100 Cal. App. 4th 1111, 1119 (Cal. Ct. App. 2nd Dist. 2002); Gonzalez v. Autoliv ASP, Inc., 154 Cal. App. 4th 780, 792 (Cal. Ct. App. 2nd Dist. 2007) (finding no manufacturing defect where airbag “fully deployed . . . as it was intended to do”). In short, a product that fails to perform as the designer intended suffers from a manufacturing defect.

Here, the evidence shows that the Mylan patch performed differently from other similar patches by giving Ms. Richardson an excessive, fatal dose of fentanyl. As set forth above, the Mylan’s corporate representative has testified that the mylan patch was designed and manufactured to provide patients with a reliable, predictable fentanyl level, and that for the 100 mcg patch Ms. Richardson was wearing, that level as 2.5 ng/mL. Rather than delivering a dose in the intended range of 2.5 ng/mL, Ms. Richardson’s 100 mcg patch delivered a fatal dose of 22 ng/mL, a level eight (8) times higher than the patch was supposed to provide.[8] This is clearly some evidence that the patch performed differently from other patches and outside of the product specifications, and requires that the Court deny the defendants’ Motion.

Second there is evidence of the same accidents in similar products. Specifically, there is evidence that by the time of Ms. Richardson’s death, there were numerous adverse events and deaths reported from use of Mylan patches, of which the Mylan Defendants were aware. See supra Pages 6-8.

Third, there is evidence that eliminates the possibility that Ms. Richardson’s death was caused by her misuse or abuse of the patch. See Murray, 796 P.2d (recognizing that a defect may be shown through circumstantial evidence by “‘elimination of other likely causes by satisfactory evidence’”) (quoting W. Prosser, Law of Torts, 673-74 (4th ed. 1971)). When a plaintiff relies on circumstantial evidence, the plaintiff 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.

Fourth, the evidence shows that Ms. Richardson’s death occurred shortly after the sale of the patches to Ms. Richardson. Ms. Richardson’s prescription for the patch was filled on February 16, 2007, and she died on March 10, 2007. (See supra Pages 2-3; Def’s Mem. at 4.)

Fifth, there is expert testimony by Dr. Bret Berner as to the possible causes of the defect. See Vandermark, 61 Cal. at 260 (recognizing that testimony as to possible causes is circumstantial evidence of defect.”). Dr. Berner has opined that the 100 mcg “fentanyl patch Mrs. Richardson was using at the time of her death was intended to produce a peak fentanyl level of 2.5 ± 1.2 ng/ml, but instead produced a fentanyl concentration far in excess of this amount.” (Berner Decl. ¶ 51.) Dr. Berner states that “[i]n delivering this excessive fentanyl, the patch was not functioning as intended,” and then identifies seven (7) possible mechanisms by which the patch could have malfunctioned. (Id. ¶¶ 3-50.) Dr. Berner concludes that “at least one of [the potential] mechanisms was the cause of the fatal overdose of fentanyl that Ms. Richardson suffered.” (emphasis added). (Id. ¶ 51.) All of the evidence discussed above, whether taken in isolation or considered together, is more than sufficient to raise a genuine issue of material fact as to whether the Mylan patch that killed Ms. Richardson was defective.

The Mylan Defendants cite Henderson v. Harnischfeger, 12 Cal. 3d 663 (Cal. 1974) for the proposition that “[t]he defect must be affirmatively established, and an inference of defect as a result of the accident is not to be drawn.” (Defs.’ Mem. at 11.)[9] While an inference may not be drawn solely from an accident, as discussed above, the jury may infer a defect from circumstantial evidence. Hinckley, 158 Cal. App. 3d at 642; Notmeyer, 502 F. Supp. 2d at 1059-60 Moreover, Plaintiff does not attempt to prove a manufacturing defect merely from the fact that Ms. Richardson died while wearing a Mylan patch. Rather, the inference of a defect is found in the fact that patch failed to perform as it was designed and manufactured to perform and instead gave Ms. Richardson a fentanyl level eight (8) times the expected and intended level. California law clearly permits the inference of a manufacturing defect from such evidence that a product performed differently than other similar products. See, e.g., Barker, 20 Cal. 3d at 429 (“[A] manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.”).

B. Plantiff’s claims are premised on reliable science.

The Mylan Defendants make the sweeping statement that Plaintiffs’ entire complaint should be dismissed because Plaintiffs’ evidence of defect is based on “unscientific opinion testimony.” (Defs’ Mem. at 6.) First, they claim that Ms. Richardon’s postmortem fentanyl blood level should be disregarded because postmortem fentanyl levels are unreliable due to the phenomenon known as postmortem redistribution. (Id. at 5,7-8.) Second, they claim that Dr. Berner’s testimony is speculative, and thus admissible pursuant to Fed. R. Evid. 702 and Daubert, because there is no evidence that any of the seven (7) potential mechanisms for patch failure Dr. Berner identified actually occurred in this case. (Id. at 9.)

As a preliminary matter, the Mylan Defendants’ Daubert challenge to Dr. Berner’s testimony is addressed in the separately filed opposition to Dr. Berner’s Daubert challenge. For all of the reasons set forth in that opposition, Dr. Berner’s testimony is admissible. Moreover, as set forth below the weight of scientific authority is contrary to the Mylan Defendants’ position that postmortem levels are unreliable.

1. The evidence demonstrates that fentanyl is subject to, at most, modest postmortem redistribution that does not render postmortem blood samples unreliable.

The Mylan Defendants ignore the great weight of scientific authority when they claim that Ms. Richardson’s postmortem blood level is unreliable. (Defs’ Mem. at 5, 7-8.) It is generally accepted within the relevant scientific community that fentanyl is subject to, at most, modest postmortem redistribution that does not render postmortem blood samples unreliable, especially where, as here, the blood is taken from a peripheral site.

Generally, to assess a particular drug’s propensity to redistribute postmortem, doctors and scientists compare the concentrations of the drug in the heart to concentrations of the drug in peripheral blood vessels (typically in the femur), where postmortem redistribution is thought to occur only nominally or not at all. (See Jerrold B. Leikin and William A. Watson, Post-Mortem Toxicology: What the Dead Can and Cannot Tell Us, 41 Journal of Toxicology 47, 48 (2003) (“The cardiac to peripheral (c/p) ratio of drug concentrations in postmortem blood samples has been evaluated as a measure of the potential for postmortem drug redistribution.”) Miller Decl., Ex. 24; Graham R. Jones & Derrick J. Pounder, Site Dependence of Drug Concentrations in Postmortem Blood – A Case Study, 11 Journal of Analytical Toxicology 186, 186 (1987), Miller Decl., Ex. 25.) This comparison allows doctors and scientists to determine whether and to what extent a particular drug is susceptible to postmortem redistribution.

The actual studies that have been done on fentanyl demonstrate that it is subject to, at most, modest postmortem redistribution. An October, 2000 study in the Journal of Analytical Toxicology involving postmortem tissue distribution of fentanyl showed that in 13 cases, the heart to peripheral postmortem fentanyl ratio was 1.62. (Daniel T. Anderson & Joseph J. Muto, Duragesic Transdermal Patch: Postmortem Distribution of Fentanyl in 25 Cases, 24 Journal of Analytical Toxicology 627-634 (2000), Miller Decl., Ex. 27.) While Drs. Anderson and Muto ultimately determined that this study was insufficient to support any general conclusions about PMR because the sample size was too small, Dr. Anderson subsequently performed a study of 137 fentanyl-positive deaths collected from the L.A. Coroner’s Office over a seven-year time period (2000-2007) (“The Anderson Study”), Miller Decl., Exs. 28 and 29.) The Anderson Study showed that the average effect of post-mortem redistribution, based on the central to femoral blood ratio, was an increase of 1.18 times. In 67% of the cases, the heart to femoral ratio was less than 1.5; 85% had a ratio of less than 2.0; and in 93% of cases, the ratio was less than 2.5. (Id.) In nearly half of the cases (42%), the heart to femoral blood ratios were equal or less than 1.0, meaning that the concentration of fentanyl found in the femoral blood was equal to or greater than that found in the heart blood, thereby demonstrating no postmortem redistribution at all. (See id.) Other studies have similarly demonstrated little to no postmortem redistribution with fentanyl.[10]

Even defense expert Graham Jones has testified that it is both reasonable and generally accepted in the field of toxicology to rely on postmortem blood data in determining what levels of fentanyl are lethal:

Q: [Y]ou agree that postmortem data taken in the past is an apples-to-apples comparison with postmortem data taken from Janice DiCosolo in this case, right?

A: [I]f the dosage rate is similar, the degree of tolerance is similar, yes, then I agree it would then be an apples-to-apples comparison.

Q: I just meant in terms of postmortem data. Isn’t that how Baselt comes up with fatal ranges or ranges where people have found have died generally throughout the Baselt manual is that you take cases where people have died with a particular drug in your system where the drug was thought to have been part of the cause of the person’s death, collect those and come up with a range, isn’t that how Baselt works?

A: It is. And that’s reasonable. It’s something that’s done within our field.

(Dep. of Graham Jones in DiCosolo v. Janssen Pharmeceutical, Inc., No. 04 L 5351 (Cir. Ct. Cook County, Ill.) at 127-28, Miller Decl., Ex. 50.)

Finally, it should be emphasized that the blood sample in the instant case was a peripheral draw, that is, the sample was a femoral draw. (See Dep. Dr. Stanley 17:22-18:21, Miller Decl., Ex. 38.) Tests and studies by experts in the field have universally concluded that where, as here, postmortem blood is taken from a peripheral site, postmortem redistribution occurs minimally, if at all. Defendants’ expert Graham Jones has stated in a published article, “[i]t is generally recommended that to avoid the effects of postmortem redistribution from the major organs, femoral blood should be sampled wherever possible.” (Graham Jones, Interpretation of Postmortem Drug Levels, at p. 4, Miller Decl., Ex. 33; see also Jim Gerostomoulos, Postmortem Redistribution of Morphine and its Metabolites, Journal of Forensic Science (2000) (“The use of peripheral blood has been previously recommended. Paterson recommended that femoral vein blood be used for toxicological analysis since femoral blood provides a more representative concentration at the time of death.”), Miller Decl., Ex. 32; JJ O’Sullivan, Differences in Amiodarone, Digoxin, Flecainide and Sotalol Concentrations between Antemortem Serum and Femoral Postmortem Blood, Human & Experimental Toxicology (1995) at 607 (“No difference in the concentration of amiodarone/desethylamiodarone, flecainide and sotalol were observed in samples from the femoral vein and artery. Femoral bloods collected postmortem are usually considered to be most representative of antemortem concentrations”), Miller Decl. Ex. 49, Alan Jones, Concentration Distributions of the Drugs Most Frequently Identified in Post-Mortem Femoral Blood representing all Causes of Death, Med. Sci. Law (2009) at 270 (“If the time between death and autopsy is relatively short and there is no evidence of trauma or decomposition of the body, the concentration of a drug in femoral blood is the closest way of knowing the peri-mortem concentration.”), Miller Decl., Ex. 50.)

In reality, forensic toxicologists and forensic pathologists throughout the United States have testified that postmortem fentanyl levels taken from a peripheral site represent a reasonable and reliable approximation of a decedent’s ante-mortem fentanyl level because peripheral blood is subject to little, if any, PMR. (See, e.g., Dep. of Laureen Marinetti at 36-37 in Ford v. Alza, No. C2-08-0319 (S.D. Ohio) (forensic toxicologist testified with respect to potential PMR with decedent’s postmortem fentanyl level that “I don’t believe that there was any, or a very unsubstantial amount, if there was any at all” and that “the 10 nanograms per milliliter of fentanyl level that was found is a close approximation to the level that was in Barbara Wells’s system at the time she died”), Miller Decl., Ex. 36; Dep. Ruth Winecker at 66-67 in Allen v. Johnson & Johnson, No. 1:08-CV-105 (M.D.N.C.) 66-67 (forensic toxicologist testified with respect to femoral fentanyl blood levels that “there is very little redistribution”), Miller Decl., Ex. 52; Dep. of Amanda Cooke at 18-19 in Vincent v. ALZA, No. 1:09-CV-249LG (S.D. Miss.) (forensic toxicologist testified that PMR is “not an issue in peripheral blood” and that the level of fentanyl found in a postmortem peripheral sample is “about what was circulating at the time of death.”) Miller Decl., Ex. 53; Dep. of Barry Logan in at 72 in Jennings v. Alsager, No. 08-2-25794 (Sup. Ct. King County, WA) (stating that it was a “reasonable conclusion” that postmortem femoral fentanyl level was a “close approximation of the level circulating at or near the time of death.”), Miller Decl., Ex. 54.) The “theory” that fentanyl is subject to, at most, modest postmortem redistribution that does not render postmortem blood samples unreliable, especially where, as here, the blood is taken from a peripheral site, enjoys general acceptance within the relevant scientific community. For this additional reason, Defendants’ Motion should be denied.

2. Dr. Iain McIntyre agrees with the current state of science.

The Mylan Defendants selectively quote from Dr. McIntyre’s testimony in this case in an attempt to paint the picture that he agrees that Ms. Richardson’s postmortem fentanyl levels are unreliable. (Defs’ Mem. 7-8.) To the contrary, Dr. McIntyre, who has himself conducted research on postmortem redistribution, repeatedly testified that Ms. Richardson’s 22 ng/ML was a “close approximation of the level that circulating in the body at or near the time of death.” (McIntyre Dep. 78:12-24, 20:3-13; see also id. 14:2-16:22 (discussing Dr. McIntyre’s research on postmortem redistribution).) Moreover, Dr. McIntyre repeatedly testified that, based on the literature and his own experience, postmortem redistribution does not occur to any great degree with fentanyl. (Id. 19:8-20:2 (“I believe with my experience and my own work, and from what I’ve read, that fentanyl is definitely at the low end of that scale, less prone to postmortem reidistribution than any other drug.”); 146:16-19 (“[T]here are measures of postmortem redistribution, which I’ve alluded to previously, that indicate that it doesn’t occur to any great degree with fentanyl.”); 154:7-9 (“It’s the work from Anderson and others that show that there is minimal postmortem redistribution of fentanyl.”); 158:15-17.)

Contrary to the Mylan Defendants’ suggestion, medical examiners and toxicologists routinely rely on postmortem drug levels to form their opinions. (See Defs’ Mem. at 16-17.) This is true because most people do not have the foresight to obtain a pre-death toxicological examination immediately before they die. Other than rare occasions where a hospitalized patient fortuitously obtains a drug screen or toxicology report shortly before their death, medical examiners and toxicologists must usual rely on postmortem testing to determine cause of death and to calculate approximate antemortem (pre-death) drug levels. Were such methods not permitted, coroners, medical examiners and toxicologists would be unable to determine a cause of death in most cases. (See, e.g., Dep. of Laureen Marinetti (forensic toxicologist) at 80-81 in Ford v. Alza, No. C2-08-0319 (“Q. Hypothetically, if there was some rule stating that medical examiners and forensic toxicologists cannot testify based on these postmortem levels, they can only testify on antemortem levels, would that make it easier or more difficult for you to do your job? A. It would make it impossible.”), Miller Decl., Ex. 36; Dep. of Ruth Winecker at 76 in Allen v. Johnson & Johnson, No. 1:08-CV-105 (M.D.N.C.) (“Q. Okay. If hypothetically there were a rule in place stating that you could not use drug levels determine – to assist in determining cause or manner of death unless the blood level was taken from an antemortem sample, would that make it hard to do your job? A. Make it nearly impossible to do our job.”), Miller Decl., Ex. 52.)

4. Trial courts have specifically rejected the argument that a postmortem blood-fentanyl level cannot be used as evidence of defect in a fentanyl patch.

For example, the Mylan Defendants filed for summary judgment in a fentanyl-patch-death case filed in New Mexico and argued to that court that summary judgment was proper because “there simply are no facts to support a claim that Mylan’s Fentanyl Transdermal System was defective in any manner.” (Mot. and Br. for Summ. J. of Defs., Mylan Inc., Mylan Technologies Inc., and Mylan Pharmaceuticals, Inc. at 12, Miller Decl, Ex. 21.) In response, the plaintiffs argued that they “may prove existence of defect in the fentanyl patch that killed [the decedent] simply by showing that it malfunctioned, i.e. that it delivered a concentration of 14.4 – 15 ng/ml of the narcotic when it was designed and intended to deliver a concentration of approximately 2.5 ng/ml.” (Pls. Resp. to Mylan Defs.’ Mot. for Summ. J. at 7, Miller Decl, Ex. 26.) After hearing these competing arguments, the court concluded that “there are genuine issues of material fact in dispute as to Plaintiffs’ strict liability claim.” (Order Granting in Part and Denying in Part the Mylan Defendants’ Motion for Summary Judgment filed in Case No. CV-06-111, District court of Lincoln County, N.M., Miller Decl. Ex. 22; See also Alza Corp. v. Thompson, No 13-07-00090, 2010 Tex. App. LEXIS 2347 at *50-*58 (Tex. App.—Corpus Christi, April 1, 2010) (rejecting fentanyl patch manufacturer’s argument that possibility of postmortem redistribution means postmortem fentanyl levels are insufficient evidence of defect in patch).

Likewise, in the case of Kunnemann v. Janssen Pharmaceutica Products, L.P., Case No. 05-C-3211, 2008 U.S. Dist. LEXIS 101724 (N.D. Ill. Dec. 2, 2008), the plaintiffs brought claims for, among other things, manufacturing defects when their daughter died after her fentanyl pain patch delivered a fatal overdose of fentanyl. Everyone who inspected the patch after the decedent’s death found no visible defect, and the plaintiff admitted that she had no evidence of any specific defect in the patch. Id. at *34. In response to the defendants’ summary judgment motion, the plaintiffs argued that evidence that the patch produced a lethal level of fentanyl was evidence of defect sufficient to avoid summary judgment even though they could not explain “what happened or what the defect was.” Id. The court agreed, noting a distinction between using evidence of mere injury or death to infer a defect and using evidence of a product malfunction:

First, although there is no evidence of any kind of obvious defect in the particular patch involved here, there is evidence in the record suggesting that the Duragesic patch was designed to deliver a level of fentanyl and that the level present in Ms. Kunnemann at the time of her death was significantly higher than that level. Saying that the patch was defective because it delivered more fentanyl than intended is not the same as saying the patch was defective because Ms. Kunnemann died; the latter would clearly run contrary to Illinois law providing that injury alone is not sufficient to establish a defect, while the former does not. It is a subtle distinction, but it is enough to get the plaintiff to a jury on the issue.

Id. at *37-38.

A similar result was reach reached in the case of Woodcock v. Mylan, Inc., 661 F. Supp. 2d 602 (S.D. W. Va. 2009), where the undersigned counsel brought suit against these same defendants based on a death caused by a Mylan Patch. Among other claims, the plaintiffs brought a claim for a manufacturing defect. Mylan filed a motion to dismiss alleging that plaintiffs had failed to allege a specific defect in the patch and instead merely sought to infer a defect based on “a mere product failure or an accident involving the product.” Id. at 609-10. The court denied the motion, holding that allegations that the Mylan Patch produced an excessive fentanyl level “sufficiently pleaded a cause of action for a manufacturing defect” and explaining as follows:

Contrary to Mylan’s assertions, the plaintiff has sufficiently alleged that the patch suffered from a manufacturing defect that was the proximate cause of Mr. Woodcock’s death. The plaintiff has alleged that a properly manufactured patch “will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. In other words, if a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful does of fentanyl.” The patch used by Mr. Woodcock, the plaintiff asserts, was manufactured defectively because it “can and does cause lethal levels of fentanyl in patients” and “decedent had a lethal fentanyl blood concentration at the time of his death” despite “never abus[ing] the Patch or us[ing] it inappropriately.”

Id. at *18-19.

More recently, a California trial court denied a fentanyl-patch manufacturer’s motion for summary judgment on a fentanyl patch strict-liability-manufacturing-defect claim noting that “to the extent it appears undisputed that the decedent died as a result of fentanyl intoxication, this alone may be sufficient evidence from which a trier of fact could reasonably infer the existence of a manufacturing defect that at least contributed to death.” (See Minute Order dated April 15, 2010 issued in Auburn v. Johnson & Johnson, 2008-00008440-CU-PO, (Superior Court of California for County of Sacramento), Miller Decl., Ex. 23.)

C. The Mylan Defendants inadequately warned Ms. Richardson’s physician.

California has adopted the “learned intermediary” doctrine, which requires the manufacturer of a prescription drug to warn the physician, not the patient. Stevns v. Parke, Davis & Co., 9 Cal. 3d 51, 65 (1973). The Mylan Defendants contend that they are entitled to summary judgment on Plaintiffs’ failure-to-warn claim because Dr. Jaffe was adequately warned by Mylan’s package insert of the risk associated with fentanyl. (Defs’ Mem. at 11-13.) This contention fails because the summary judgment evidence demonstrates that that Mylan’s package insert is inadequate and Dr. Jaffe was not aware of the risk that a single 100 mcg/hr Mylan patch could deliver a lethal level of fentanyl to a patient using it as prescribed.

First, there is evidence that the Mylan’s warning is inadequate. As described above, the risk that a single patch can deliver more fentanyl than intended is one that the Mylan Defendants’ were aware of. See supra Pages 12-17. Plaintiffs’ experts, Dr. Christopher Grubb, a medical doctor specializing in the field of pain management, Dr. Motyka, a Ph.D. scientist with more than 25 years of experience in the pharmaceutical industry—including extensive experience with FDA regulations and warnings, have both testified that the warning is inadequate.[11] (Decl. of Christopher Grubb ¶¶ 3, 6-7; Decl. of Linda Motyka ¶¶ 15-16, 22.)

These were risks that were not explained to Ms. Richardson’s prescribing physician Dr. Jaffe. During his deposition he explained that based on the information provided by Mylan he would expect a 100 mcg/hr Mylan fentanyl patch to deliver a dose within the therapeutic range, not a lethal overdose:

Q. When you gave her a 100 patch, did you expect it to give her 100 per hour?

A. Yes.

Q. If the companies that made the fentanyl patches you prescribed had internal studies or other information indicating that the patches could not be relied on to give patients the indicated dose, that they periodically malfunction and give people fatal doses, if that sort of

information existed, is that something that you’d want to know as a prescribing doctor?

A. Yes.

Q. For example, we — you brought the package insert here. If, on the first page in the

black box, there was a warning stating that a certain percentage of fentanyl mal- — mal- — patches malfunction and give patients fatal overdoses, would you have prescribed that kind of drug for your patients?

No.

(Dep. of Dr. Jaffe at 46:17-47:13, Miller Decl., Ex. 37,) The Mylan Defendants cite to deposition testimony where Dr. Jaffe acknowledges that the risk of respiratory depression is present with fentanyl along with all other classes of drugs that have the potential side effect of depressing the central nervous system. (Defs’ Mem. at 12-13.) But none of this testimony indicates that he was aware of the risk that a single 100 mcg/hr Mylan patch could deliver a lethal dose of fentanyl far, more than eight (8) times in excess of the levels represented in Mylan’s package insert.

The Mylan Defendants also argue that Plaintiffs’ failure to warn claim fails because Dr. Jaffe “unequivocally” testified that he would have prescribed the fentanyl patches to Ms. Richardson, regardless of any hypothetical warning. (See Defs’ Mem. at 14 citing Dep. of Jaffe, 57:7-20.) But this assertion is belied by the very testimony to which they cite. Dr. Jaffe testified that he would want more information about the risk of death and that if there were was a “remote possibility” of death, then there is a “chance” he would have still prescribed the fentanyl patches. (Id.) Moreover, he testified that if there was more than a remote possibility, then he “probably would have chosen not to use it.” Id. (emphasis added). At the very least, Dr. Jaffe’s is equivocal on the topic of whether he would have prescribed fentanyl had he been aware of the risk, and this precludes the award of summary judgment. In cases in which a physician’s testimony is equivocal as to whether he relied upon the Drug Companies’ warnings, the California Court of Appeals has held a failure-to-warn claim should be submitted to the jury. See In Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (1st Dist. 2008), review denied by 2009 Cal. LEXIS 233 (Cal. Jan. 21, 2009).[12]

The Mylan Defendants reliance on the case of Nix v. Smithkline, 2007 U.S. Dist. LEXIS 65860 (D. Ariz. Sept. 5, 2007) is misplaced, as the physician’s testimony in that case strongly supported the conclusion that the physician that he would have prescribed the relevant drug, even without an updated warning. (See Defs’ Mem.at 14-15.) Critically, the physician testified that despite the decedent’s death and despite having received updated warnings from the manufacturer, he continued to prescribe the drug to patients. Id. at 9. Moreover, the physician testified that he assigned little consideration to information provided by drug manufacturers and relied primarily on medical journals and nation meetings in prescribing medicines. 2007 U.S. Dist. LEXIS 65860, at *8-9. The only testimony that a revised warning might have changed the physician’s mind was general testimony that the physician “would liked to have known more about deaths associated with [the drug] and that generally the lack of accurate information about potential side effects makes it difficult to perform a risk-benefit analysis.” Id. at 9. Accordingly, Plaintiffs have proffered sufficient evidence for a jury to find that Mylan’s warnings provided to Ms. Richardson’s prescribing physician were inadequate.

D. Plaintiffs’ failure-to-warn claims are not preempted.

The Mylan Defendants argue that Plaintiffs’ failure-to-warn claim is preempted because it conflicts with federal regulations that purportedly preclude a generic drug manufacturer from warning consumers or physicians of the potentially deadly consequences of using their product. (Defs.’ Mem. at 16-17.) This argument has been rejected by every Circuit Court to consider it and was recently rejected by the United States District Court for the Central District of California.[13] In fact, the particular interpretation of the regulations that Mylan describes in their brief was explicitly analyzed and refuted by the Fifth Circuit. See Demahy., 593 F.3d at 436-49. For all of the well-articulated reasons in these Circuit Court opinions, the Mylan Defendants’ preemption argument fails.

E. The Mylan Defendants are not entitled to summary judgment on Plaintiffs’ negligence, negligent misrepresentation, and warranty claims.

The Mylan Defendants claim that Plaintiffs’ both negligence, negligent misrepresentation, and warranty claims fails for the same reason that that Plaintiffs’ strict-liability claims purportedly fail, lack of evidence as to defect. (Defs’ Mem. at 17-20, 22.) But this argument fails because, as set forth above, there is ample circumstantial evidence of defect in this case.[14] See supra Pages 9-12.

The Mylan Defendants also claim that the negligent misrepresentation and warranty claims must be dismissed because Plaintiffs cannot show reliance.[15] Specifically, the Mylan Defendants claim that Dr. Jaffe did not rely on any statement by Mylan related to fentanyl patches in prescribing fentanyl patches and did not consult or read the Mylan label. (Defs’ Mem. 20-22.) But this assertion is contradicted by Dr. Jaffe’s testimony, in which he testified that it is practice to read the relevant labels, that he read the relevant label before prescribing the fentanyl to Ms. Richardson, and that it is his practice to keep abreast of new or changed black box warnings. (Dep. of Dr. Jaffe 15:3-24, Miller Decl., Ex. 37.)

The Mylan Defendants also claim that Plaintiffs’ express warranty claim fails because Plaintiffs cannot identify any express statement or representation. (Defs’ Mem. at 22.) The Mylan Defendants are wrong: the express statement is contained in Mylan’s label which represents that properly functioning patches continuously deliver the requisite dose of fentanyl through the skin to the bloodstream over a 72-hour period and that after several sequential uses, “patients reach and maintain a steady state [blood] serum concentration.” (Miller Decl., Ex. 1.) The label also represents, and Mylan’s corporate representative confirmed, that the Mylan 100 mcg/hr fentanyl patch was designed and intended by Mylan to produce in patients fentanyl levels no higher than 2.5 ng/ml, with a standard deviation of only 1.2 ng/ml. (See supra Pages 1-2.) The evidence shows that these representations were false, as Ms. Richardson’s patch delivered a fatal level of fentanyl, eight (8) times greater than what the label said she should have received.

F. Mylan Inc. is not entitled to summary judgment because it has not met the burden of proof on its affirmative defense.

Finally, defendant Mylan Inc. is not entitled to summary judgment on its assertion that it “is a holding company and was not responsible for the design, development, manufacture, marketing sale and or distribution of Mylan’s fentanyl transdermal system.” (Defs’ Mem. at 25.) As the Mylan Defendants state in their memorandum, this issue was raised by Mylan Inc. as an affirmative defense. (Id.) Thus, Mylan Inc “bears the initial burden of establishing the absence of a genuine issue of fact on each issue of material to [its] affirmative defense.” Houghton v. South, 965 F.2d 1532, 1536-37 (9th Cir. 1992). Rather than offer any evidence, Mylan Inc. simply points to an allegation in its Answer. (Defs’ Mem. at 25.) Such an allegation is not evidence, and Mylan has therefore failed to meets its summary judgment burden as a matter of law. Accordingly, Mylan Inc.’s motion must also be denied.

CONCLUSION

For the foregoing reasons, the plaintiffs respectfully request that the Mylan Defendants’ Motion for Summary Judgment be denied.

DATED: August 9, 2010

Respectfully Submitted,

/s/ Charles W. Miller__________________

Michael E. Heygood (Texas Bar #00784269)

michael@hop-law.com

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] The Mylan Defendants refers to defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Mylan Technologies Inc.

[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 the same as the patch that Ms. Richardson wore). (See Package Miller Decl., Ex. 1.) It provides that the highest concentration should be approximately 4.5 ng/mL. (Id.)

[3] Both Dr. Stanley, and the toxicologist who tested Mrs. Richardson’s blood, Dr. Iain McIntyre concluded that of the three drugs identified in the autopsy report, only fentanyl was detected at an independently lethal level in Ms. Richardson’s blood. (Dep. of Dr. Stanley 70:21-71:71:7, Miller Decl., Ex. 38; Dep. of Dr. McIntyre 57:20-25, 76:1-21, 82:14-22, 88:3-9, Miller Decl., Ex. 39.)

[4] See Baselt, RC, Disposition of Toxic Drugs and Chemicals in Man, (Eighth Edition) (gathering studies), Miller Decl., Ex. 5; Teri Martin, Fentanyl-Related Death in Ontario, Canada: Toxicological Findings and Circumstances of Death in 112 Cases, Journal of Analytical Toxicology (2006) (postmortem blood fentanyl levels averaged 18 ng/mL in 27 adults who died as a result of transdermal use) Miller Decl., Ex. 6; Smialek, A Fentanyl Epidemic in Maryland 1992, J Forensic Sci. (1994) (In a series of 30 adult abuse deaths, blood fentanyl concentrations averaged 18 ng/mL), Miller Decl., Ex. 7.

[5] Kramer, C, A Fatal Overdose of Transdermal Administered Fentanyl, Journal of American Osteopathic Association (1998), Miller Decl., Ex. 9; Garriott J., A Death from Fentanyl Overdose, Journal of Analytical Toxicology (1984) Miller Decl., Ex. 10; Chaturvedi, A., A Death Due to Self-Administered Fentanyl, Journal of Analytical Toxicology (1990) Miller Decl., Ex. 11; Pare, E., A Death Involving Fentanyl, Journal of Analytical Toxicology (1987) Miller Decl., Ex. 12.

 

[6] There is evidence that the patch came off Ms. Richardson’s body when it was moved across the carpet and was likely disposed of by the medics. (Medical Examiner’s Investigation, Exh. F. to Victory Decl. in Support of Defs’ Mem.)

[7]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.

 

[8] Moreover, Plaintiffs’ experts have testified that this toxic fentanyl level indicates the patch malfunctioned. Dr. Laureen Marinetti, a board-certified forensic toxicologist who runs the Montgomery County Coroner’s Office and Miami Valley Regional Crime Lab in Dayton, Ohio, has testified that “[t]he concentration of fentanyl detected . . . is not consistent with that expected from the prescribed use of a properly functioning 100 mcg/hr patch.” (Marinetti Decl. ¶ 8.) Plaintiffs’ transdermal expert, Bret Berner, has testified that the subject Mylan patch malfunctioned and provided Ms. Richardson with an excessive, fatal level of fentanyl. (Berner Decl. ¶ 51.) In addition, the toxicologist who tested Ms. Richardson’s blood testified that Ms. Richardson’s fentanyl level was a lethal level. (Dep. of Dr. McIntyre at 82:14-22, Miller Decl., Ex. 39.)

[9] In addition, the phrase quoted by the defendants does not appear in the opinion they cite. See generally Henderson v. Harnischfeger, 12 Cal. 3d 663 (Cal. 1974).

[10] A recent study of fentanyl-related deaths in Ontario, Canada provides further evidence that fentanyl is only minimally subject to postmortem redistribution. (See Teri Martin, Fentanyl-Related Deaths in Ontario, Canada: Toxicological Findings and Circumstances of Death in 112 Cases, Journal of Analytical Toxicology (2006) (the “Martin Study”) at 608, Miller Decl., Ex. 6.) The four cases in that study that had heart and femoral blood concentrations had a heart to femoral ratio of 1.14. In addition, Dr. McIntyre, the toxicologist who tested Ms. Richardson’s blood, has collected data in the San Diego County Medical Examiner’s Office that shows that the heart to femoral ratio for fentanyl is close to 1 to 1. (Dep. of McIntyre at 7:25 – 8:10, 8:24 – 9:7 in Richardson v. Mylan, et al., Case No. 09-CV-1041 (S.D. Cal.), Miller Decl., Ex. 30.) This is consistent with the Anderson-Muto Study and Anderson Study that shows that postmortem redistribution of fentanyl is minimal.

[11] Dr. Grubb’s opinion is based on his experience, training, and a review Mylan’s Periodic Safety Update Reports to the FDA and many autopsy reports related to fentanyl deaths. (Grubb Decl. ¶ 3.) Dr. Motyka bases her opinion on her experience, training and a review of Mylan’s adverse event re event reports and internal documentation and found many examples of deaths/overdoses associated with the proper use of Mylan’s patch (evidencing patch malfunction). (Motyka Decl. ¶¶ 15-16.)

[12] In Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (1st Dist. 2008), review denied by 2009 Cal. LEXIS 233 (Cal. Jan. 21, 2009), the drug company argued that the plaintiff could not establish causation as a matter of law because the prescribing physician declared that “[a]t no time did I rely in any way on representations made in the PDR monograph, package insert, labeling materials or other information from [the drug company] regarding the medication [at issue] in order to formulate my course of care and treatment for [the plaintiff.]” Id. at 99. The court of appeals held, however, that summary judgment was improper because the prescribing physician’s other statements indicated that (1) “he ‘probably’ read [materials prepared by the manufacturer] during his residency training; [(2)] that [one of the manufacturer-prepared materials] was one of the sources he generally refers to in his clinical practice when he considers prescribing [the drug at issue] to his patients; and [(3)] that he believed the information it contained was accurate.” Id. The court held that “[t]his evidence supports a reasonable inference that [one of the manufacturer’s materials] was a causal factor in the [prescribing physician’s] decision to treat [plaintiff with the drug at issue] and raises a sufficient question of fact to defeat summary judgment on that ground.” Id. at 100.

[13] See Dorsett v. Sandoz, Inc., No. CV-06-7821, 2010 U.S. Dist. LEXIS 39804, at *47-56 (C.D. Cal. Mar. 26, 2010 ); Mensing v. Wyeth, Inc., 588 F.3d 603, 608-609 (8th Cir. 2009) (citing 21 C.F.R. § 201.57(e) (“The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug. Generic manufacturers are subject to the requirement that their labeling shall be revised as soon as there is reasonable evidence of an association of a serious hazard with a drug.”); Demahy v. Actavis, Inc., 593 F.3d 428, 436-49 (5th Cir. 2010); Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir. 1994).

[14] California courts recognize that evidence of defect can be the same for both negligence and strict liability claims. See Jiminez v. Sears, 4 Cal 3d 379, 383-87 (Ca. 1971) (recognizing that though negligence liability requires proof an element (negligence) in addition to defect and causation, a plaintiff is entitled to an instruction on negligence, as well as on strict liability, when the evidence supports both forms of liability.) Though the Mylan Defendants do not raise the issue in their motion, there is evidence of their negligence because there is ample evidence that the patch that killed Ms. Richardson was defective (supra Pages 9-11) and that the Mylan Defendants were aware, prior to Ms. Richardson’s death, that their patches were malfunctioning and killing people (supra Pages 6-7).

[15] The Mylan Defendants suggest that Plaintiffs cannot prevail on their warranty claims because no representations were made to Ms. Richardson upon which she relied. (Defs’ Mem. at 22-24.) But this suggestion is wrong as California law is clear that in warranty actions involving prescription drugs, reliance is shown by constructive reliance, that is, evidence of the prescribing physician’s reliance. See Carlin v. Superior Court, 13 Cal.4th 1104, 1118 (Ca. 1996).