Response to Defendants’ Motion for Summary Judgment

Jennings v. Janssen

Description: This brief was filed in Washington state 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 under both the consumer expectation test and the risk-utility test. Finally, the response discusses issues relating to postmortem redistribution. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

Hon. Hollis R. Hill

Hearing Date: April 16, 2010

Hearing Time: 10:00 a.m.

With Oral Argument

Opposing Party

SUPERIOR COURT OF WASHINGTON FOR KING COUNTY
DAVID JENNINGS and SUZETTE JENNINGS, Individually, and DAVID JENNINGS, as Administrator of the ESTATE OF TIMOTHY D. JENNINGS, Deceased,Plaintiffs,

v.

DALE E. ALSAGER, D.O., and BETTY ALSAGER, and the marital community composed thereof; OSTEOPATHIC MEDICAL SERVICES, INC. d/b/a COUNTRY DOCTOR CLINIC; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. f/k/a JANSSEN PHARMACEUTICA PRODUCTS, LP; and ALZA CORPORATION,

Defendants.

NO. 08-2-25794-1KNTPLAINTIFFS’ OPPOSITION TO DEFENDANTS ALZA CORPORATION AND ORTHO-MCNEIL-JANSEEN PHARMACEUTICALS, INC.’S MOTION FOR SUMMARY JUDGMENT

Introduction and Relief Requested

This case concerns the death of 24-year-old Tim Jennings. Dr. Dale Alsager, a defendant in this action, gave Tim a 100 mcg/hr (micrograms-per-hour ) Duragesic fentanyl patch that was designed and manufactured by the moving defendants. Tim was found dead the next morning. A blood sample tested by a reputable national toxicology lab determined that Tim’s postmortem fentanyl level was 12 ng/mL—more than four times greater than the 2.5 ng/mL level that the a 100 mcg/hr patch was supposed to provide. The medical examiner determined that the cause of death was “acute intoxication due to the combined effects of diazepam, oxycodone, carbamazepine and fentanyl.” There is no evidence in this case that Tim misused or abused his fentanyl patch. And the medical examiner found no anatomic cause of death, such as evidence that Tim died from a seizure. An expert in materials science will also opine that a leak in the fentanyl patch that Tim was wearing is visible in a photograph that the medical examiner had taken at Tim’s autopsy.

Despite this overwhelming evidence that the defendants Ortho-McNeil-Janssen Pharmaceuticals, Inc. and ALZA Corporation’s (the “Drug Companies”) 100 mcg/hr fentanyl patch was defective, they have moved for summary judgment on the same or similar grounds as they have unsuccessfully done in numerous prior fentanyl-patch lawsuits. As in the other litigation, they continue to ignore the facts in the record that create genuine issues of material fact and case law that demonstrates that the record contains sufficient evidence for a jury to decide the Jenningses’ claims. At the very least, the record creates a genuine issue of material fact as to whether the Drug Companies’ fentanyl patch—with a history of “inherent” fatal defects—was defective, whether the Drug Companies adequately warned of risks concerning the fentanyl patch, and whether the Drug Companies’ fentanyl patch caused Tim’s death.

First. The Jenningses have proffered substantial evidence that the Drug Companies’ fentanyl patch was defective and caused Tim’s death. As set forth below, their expert has opined that Tim’s patch had various specific defects. In addition to this direct evidence, the Jenningses have submitted a wealth of circumstantial evidence to support their allegations of a nonspecific defect. Among other things, the Jenningses have proffered evidence that Tim died from fentanyl intoxication and that his fentanyl-blood level was well in excess of both the fentanyl concentration that he should have received from a properly functioning patch and the average fatal fentanyl concentration. Moreover, they have proffered expert testimony indicating that any postmortem redistribution that occurred was not significant.

Second. The Drug Companies contend that they cannot be held liable for a negligently failing to warn because they have warned of the risks associated with their patch. But the Drug Companies have long known that their patch suffers from inherent problems that can result in leaking fentanyl gel. They have known that individuals who properly use the patch can receive fatal blood-fentanyl levels far greater than those described in their package insert. Yet they do not disclose these risks as required by Washington law. Further, Dr. Alsager has testified that had he been warned of these possibilities, he would not have given the patch to Tim. Because this testimony creates a fact issue on the warnings claim, summary judgment must be denied.

Accordingly, with the exception of the claims for breach of express and implied warranty,[1] the Drug Companies’ motion for summary judgment must be denied.

Statement of Facts

I. Duragesic Patches

Duragesic patches are transdermal products that contain the powerful opioid fentanyl used to treat chronic pain. (See Package Insert at 1 (Ex. 1).)[2] Fentanyl is eighty times more potent than morphine, and the difference between a therapeutic and fatal dose of fentanyl is small. (Downs Decl. ¶ 14.) Thus, Duragesic must be administered in a careful and controlled manner. (Id.)

After the patches are applied to the patient’s skin, properly functioning patches (sold in various doses, such as 25, 50, 75, or 100 mcg/hr) continuously deliver the requisite dose of fentanyl to the patient’s bloodstream over a 72-hour period. (See Package Insert at 1 (Dkt. 48-2); Dep. of R. Gale (inventor of the Duragesic patch) at 6:20–8:1 (Ex. 2).) When Duragesic 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 Package Insert at 1 (Ex. 1).) The semi-permeable film is designed to ensure a steady rate of fentanyl delivery into the body. (Package Insert at 1 (Ex. 1).)

Table A of the Package Insert sets notes that “[p]eak serum concentration of fentanyl generally occurred between 24 and 72 hours after initial application (see Table A)” and that “[s]erum fentanyl concentrations achieved are proportional to the DURAGESIC® delivery rate.” (Package Insert at 1 (emphasis added) (Ex. 1).) Table A then shows the peak, mean maximal concentration for a 100 mcg/hr patch to be 2.5 ng/mL. (Id. at 2 (Table A).) The information in Table A providing the patient’s “peak” or maximum amount of fentanyl-blood concentration is consistent with the Drug Companies’ promotional materials. (Excerpts from Promotional Brochure at CR 041 (Q: How long does it take before DURAGESIC reaches peak and steady-state levels of fentanyl? A: Maximum serum levels will be achieved within 24 hours of the first application, with steady-state serum concentrations usually achieved during the second or third application.”) (emphasis added) (Ex. 4).)

II. Numerous Defects in the Duragesic Patches Known to the Drug Companies

In the years before Tim’s death, the Drug Companies knew of defects in their patches that permit fatal amounts of fentanyl to enter a patient’s bloodstream. For instance, the Drug Companies initiated a February 2004 “Urgent Drug Recall” because 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” (Ex. 5).

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III. Tim’s Use of the Duragesic Patch and His Death

Tim suffered from chronic gastrointestinal and joint pain. (Dep. of Dr. Alsager at 97:19–98:3 (Ex. 17).) On September 13, 2005, approximately nine months after the Drug Companies’ employee (and former FDA inspector) wrote that the Drug Companies were deceiving the FDA, Dr. Alsager gave Tim a 100 mcg/hr Duragesic patch for chronic pain. (Id. at 113:14-15.)

Tim had the patch applied to his body shortly after his appointment with Dr. Alsager. (Dep. of D. Jennings at 103:4-10 (Ex. 18).) The next morning Tim was found dead in his bedroom. Although the investigator estimated that Tim died at 1:00 a.m., the medical examiner at the King County Medical Examiner’s Office, Dr. J. Matthew Lacy, testified that “[t]here’s very little accuracy within half a day either way for these sorts of determinations.” (Dep. of Dr. Lacy at 31:5-7 (Ex. 19).)[3]

IV. The Autopsy and Toxicology Results

On the morning following Tim’s death, Dr. Lacy performed an autopsy on Tim’s body. Dr. Lacy observed the fentanyl patch on “the right upper chest.” (Autopsy Rpt. at 2 (Ex. 20); Dep. of Dr. Lacy at 33:13-17 (Ex. 19).) Dr. Lacy did not have the patch scientifically tested, compare the patch with pictures of defective patches, apply pressure to the patch to test the patch’s seals, or analyze the amount of gel remaining inside the patch. (Dep. of Dr. Lacy at 34:24–35:2 (Ex. 19)3.) He testified that it was not his job “to determine whether or not the patch on Tim[’s] . . . body malfunctioned.” (Id. at 35:24–36:2.) He also testified that he saw no anatomic evidence that Tim was using any fentanyl patch other than the one found on his body. (Id. at 33:24–34:3; 36:22–37:25.) He noted that he found foam in Tim’s mouth, which serves as “external evidence that there’s underlying pulmonary edema,” a “classic sign[] of overdose with a narcotic agent by a living person.” (Id. at 25:21-25; 38:6-18.) He also observed that Tim had a full bladder, a “soft sign” that Tim responded to an opioid when he died. (Id. at 68:8-23.)

As part of the autopsy, he collected, among other things, a femoral blood sample (i.e., a sample from an artery in the thigh). (Dep. of Dr. Lacy at 16:14-17 (Ex. 19).) He chose a femoral sample, as opposed to a blood sample taken from around the heart and other organs, to “minimize[]” any effects of postmortem redistribution—the phenomenon by which certain drugs are absorbed by a body’s organs prior to death and then, after death, released into a decedent’s blood stream or other tissues. (Id. at 16:22–18:3.) Testing of Tim’s femoral blood sample revealed that his postmortem fentanyl level was 12 ng/mL.[4] (Id. at 46:14-16; Autopsy Rpt. (unpaginated) at 8 (Ex. 20).) Dr. Lacy considered postmortem redistribution and determined that the 12 ng/mL level was “close to what was circulating at the time of [Tim’s] death.” (Dep. of Dr. Lacy at 56:2-8 (Ex. 19).) Similarly, the then-Washington State Toxicologist, Dr. Barry Logan, testified that the Tim’s femoral blood was “unlikely to be subject to significant postmortem redistribution” because “there’s no reservoir or depot [such as in organs such as the heart or liver] for fentanyl to affect or to change the femoral blood concentration.” (Dep. of Dr. B. Logan at 69:7–70:7 (Ex. 22).)

Fentanyl has proven lethal at concentrations as low as 3.0 ng/mL and, according to a leading text used by pathologists and health professionals to determine if a drug played a role in a person’s death, the average fatal blood concentration of fentanyl is 8.3 ng/ml. (Barbieri, Decl. ¶ 11.) The package insert accompanying the 100 mcg/hr patch indicated that the average maximum concentration of fentanyl in Tim’s blood should have only been approximately 2.5 ng/mL (with a standard deviation of 1.2 ng/mL). (See Package Insert at 6 (Table A) (Ex. 1).) In other words, Tim’s level of fentanyl was (1) more than four times higher than it should have been at its peak had his patch functioned properly and (2) well above the average fatal fentanyl-blood concentration.

In light of the toxicology report, Dr. Lacy concluded that Tim died of “acute intoxication due to the combined effects of fentanyl, diazepam, oxycodone, and carbamazepine.” (Autopsy Rpt. at 1 (Ex. 20); see also Dep. of Dr. Lacy at 71:14-19 (Ex. 19).) Experts in this matter have concluded with a reasonable degree of scientific certainty that none of the drugs in Tim’s system other than fentanyl caused his death. (Downs Decl. ¶¶ 13-14; Barbieri Decl. ¶¶ 13-17.) (Indeed, the Drug Companies do not argue in their motion that these other drugs (together or alone) caused Tim’s death.) (See generally Mot. for Summ. J.) Dr. Lacy found no “anatomic cause of death . . . apart from the drugs.” (Dep. of Dr. Lacy at 48:3-6 (Ex. 19).) Because Tim “had no signs of severe ongoing seizure disorder in the hippocampus,” . . . . “[Dr. Lacy’s] opinion is that [Tim’s] death was not due to epilepsy.” (Id. at 69:20–72:12.)

On July 30, 2008, the Jenningses filed suit against the Drug Companies—asserting claims for, among other things, product liability and negligence—because the 100 mcg/hr patch delivered an excessive, fatal dose of fentanyl. (See generally Corrected Am. Compl.).

Statement of Issues

Genuine issues of material fact exist whether the Drug Companies’ fentanyl patch was defective and caused Tim’s death.

The Drug Companies have failed to establish, as a matter of law, that (1) they adequately warned of the risks associated with Duragesic, and (2) a corrected warning would not have changed Dr. Alsager’s prescribing decision.

Argument and Authorities

I. Genuine issues of material fact exist as to whether the Drug Companies’ fentanyl patch was unreasonably dangerous and defective.

The Drug Companies incorrectly argue that the Jenningses cannot prove as a matter of law that the Duragesic fentanyl patch that Tim was wearing at the time of his death was defective or that a defective patch caused Tim’s death. They argue that the Jenningses’ claims must fail because (1) Dr. Lacy, the medical examiner, did not testify that the patch was defective and (2) the phenomenon of postmortem redistribution precludes the Jenningses as a matter of law from relying upon Tim’s postmortem fentanyl-blood level. (Mot. for Summ. J. at 19–22.) These arguments must fail. First, the Jenningses have expert testimony that the subject patch had numerous specific defects, testimony that refutes the testimony of Dr. Lacy and raises an issue of fact for the jury. Second, under Washington law, direct evidence of a specific product defect is not required. Rather, a nonspecific defect may be inferred from circumstantial evidence that the product failed to perform as designed and intended. Third, numerous courts have repeatedly held that the effect, if any, of postmortem redistribution on Tim’s fentanyl-blood level is an issue for the jury. Finally, as set forth below, the Jenningses’ experts have offered substantial testimony raising a fact issue under both the consumer expectation and risk-utility tests that precludes summary judgment for the Drug Companies.

A. Plaintiffs have raised an issue of fact that precludes summary judgment on their claims for negligent and strict-liability manufacturing defects.
1. Dr. Lacy’s testimony is not reliable on the topic of produce defect and, at any rate, has been controverted by the Jenningses’ expert.

The Drug Companies incorrectly suggest that they are entitled to summary judgment because the medical examiner’s office did not retain the patch that Tim was wearing and because the medical examiner observed no specific, visible defect. (Mot. for Summ. J. at 19.) This argument improperly focuses on one piece of evidence—Dr. Lacy’s testimony—to the exclusion of all other evidence. Second, the Drug Companies’ argument misstates Dr. Lacy’s testimony. Dr. Lacy did not testify that the patch at issue looked “normal” or did not have any defects. Moreover, he admitted that he did not have the patch scientifically tested, did not compare the patch with pictures of defective patches, did not apply pressure to the exterior of the patch to test the patch’s seals and did not analyze the amount of gel remaining inside the patch. (Dep. of Dr. Lacy at 34:24–35:23 (Ex. 19).) He testified that it was not his job “to determine whether or not the patch on Tim Jennings’s body malfunctioned.” (Id. at 35:24–36:2.) Moreover, Dr. Lacy was not qualified to offer expert opinions about the patch’s condition.

By contrast, the Jenningses’ expert, Dr. John Jarrell, is well qualified to offer such opinions. He has extensive experience, education and training in engineering, biomedical research, materials science, and mechanical failure analysis, including specific relevant experience in the area of transdermal technology. (Jarrell Decl. ¶¶ 1–3.) He has inspected numerous fentanyl patches, has inspected the plant where the Drug Companies’ manufacture the patch, and is familiar with the ingredients and manufacturing processes for the patch. (Jarrell Decl. ¶¶ 4–6.) Dr. Jarrell has inspected high-quality digital photographs of the fentanyl patch found on Tim’s body at autopsy. (Jarrell Decl. ¶ 7.) Based on his review of these photographs as well as his education, training and experience, Dr. Jarrell has opined that Tim’s fentanyl patch had several specific defects that likely caused fentanyl gel to leak from the patch. Specifically, he has opined that:

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This evidence refutes the opinions of the medical examiner and raises a fact issue on the existence of a specific defect that precludes summary judgment.

2. Plaintiffs may rely on circumstantial evidence to show a manufacturing defect and are not required to demonstrate a specific defect.

 

Even if the Jenningses could not demonstrate a specific identifiable defect, the Drug Companies would still not be entitled to summary judgment. Under Washington law, no evidence of a specific defect is required; a nonspecific defect is equally actionable. See, e.g., Ruiz-Guzman v. Amvac Chem. Corp., 141 Wn.2d 493, 503 (2000); Baughn v. Honda Motor Co., 107 Wn.2d 127, 136 (1986). The Jenningses may rely upon circumstantial evidence to prove a nonspecific defect in Tim’s fentanyl patch, whether or not that patch is available for inspection. See Santosa v. Chrysler Corp., No. 48823-6-I, 2002 Wash. App. LEXIS 2152 at *26-27 (Sept. 9, 2002) (relying upon Bruns v. Paccar, Inc., 77 Wn. App. 201 (1995)); Potter v. Van Waters & Rogers, 19 Wn. App. 746, 756 (1978); Bombardi v. Pochel’s Appliance & TV Co., 10 Wn. App. 243 (1973); see also Pagnotta v. Beall Trailers, 99 Wn. App. 28, 37 (2000) (same). The Drug Companies do not appear to challenge these legal propositions.

3. Substantial circumstantial evidence of a manufacturing defect exists.

Here, the Jenningses have substantial circumstantial evidence—more than enough for the jury to find—that Tim’s Duragesic patch was defective. Plaintiffs have raised an issue of fact that precludes summary judgment on their claims for negligent manufacture and strict liability manufacturing defects. Under Washington law:

A product is not reasonably safe in construction if, when the product left the control of the manufacturer, the product deviated in some material way from the design specifications or performance standards of the manufacturer, or deviated in some material way from otherwise identical units of the same product line.

Rev. Code § 7.72.030(2)(a) (emphasis added). The evidence supports such a finding here.

The Drug Companies have had numerous manufacturing problems, recalls, and fatalities associated with their fentanyl patches. (See, supra, at 5–7.) Tim received a Duragesic 100 mcg/hr fentanyl patch from Dr. Alsager on September 13, 2005. (Dep. of Dr. Alsager at 113:14-15 (Ex. 17).) Tim was wearing the 100 mcg/hr patch before and after he died. (See Dep. of S. Jennings 104:1-2 (defense counsel conceding that Tim was wearing the patch) (Ex. 23); Dep. of D. Jennings 103:4-10; Dep. of Dr. Lacy at 33:13-17 (Ex. 18).) There is no evidence indicating that Tim had any additional fentanyl patches or other access to any other forms of fentanyl. (See, e.g., Dep. of Dr. Alsager at 113:11-13 (Ex. 17).) The medical examiner observed no evidence that Tim abused or misused his fentanyl patch. (Dep. of Dr. Lacy at 33:24–34:31; 36:22–37:25 (Ex. 19).)

According to the Drug Companies’ package insert, the 100 mcg/hr patch that Tim received from Dr. Alsager should have provided a peak, mean maximal concentration of 2.5 ng/mL. (Package Insert at 6 (Table A) (Ex. 1). But Tim had a postmortem blood-fentanyl concentration of 12 ng/mL—nearly five times more than he should have received. (Dep. of Dr. Lacy at 46:14-16 (Ex. 19); Autopsy Rpt. (unpag.) at 8 (Ex. 20).) Tim’s level was well above proven lethal concentrations as low as 3.0 ng/mL and the average lethal concentration of 8.3 ng/ml. (Downs Decl. ¶ 9.) The medical examiner found no anatomic cause of death and listed Tim’s cause of death as “acute intoxication due to the combined effects of fentanyl, diuazepam, oxycodone, and carbamazepine,” (Autopsy Rpt. at 1 (Ex. 20); see also Dep. of Dr. Lacy at 48:3-6, 71:17-19 (Ex. 19)), which the Drug Companies concede must be assumed true for purposes of their motion. (Mot. for Summ. J. at 1-2 n.1.)

This overwhelming evidence of a product defect is more than sufficient for the jury to find that the Drug Companies’ patch was defective and “that Tim Jennings would have lived but for the alleged defect.” (Mot. for Summ. J. at 22.) Evidence that Tim’s patch gave him a fentanyl blood level nearly five times the expected level according to the Drug Companies’ product insert is strong evidence that his patch “deviated in some material way from the design specifications or performance standards of the manufacturer.” Rev. Code § 7.72.030. As such, the Drug Companies are not entitled to summary judgment. See Transue v. Aesthetech Corp., 341 F.3d 911, 920 (9th Cir. 2003) ( “circumstantial evidence may be a sufficient basis for instructing a jury” on the existence of a manufacturing defect).

4. Postmortem redistribution merely presents a fact issue for the jury.

The Drug Companies argue that, due to postmortem redistribution, postmortem blood concentration is an unreliable indicator of Tim’s actual blood concentration when he died. They attempt to support their argument by pointing to expert testimony that fentanyl is subject to postmortem redistribution and a string citation in a footnote to decisions concerning postmortem redistribution’s effect on blood samples concerning other drugs. (See Mot. for Summ. J. at 20.) The Drug Companies’ argument is without merit for the following reasons.

Although the Drug Companies intimate that reliance on postmortem blood samples is unreliable and not used by toxicologists or medical examiners, toxicologists and medical examiners routinely rely upon postmortem blood samples to estimate a decedent’s antemortem blood concentration to a reasonable degree of scientific certainty. Most decedents, after all, do not have the foresight to have a blood sample taken immediately before their death. The fact that postmortem redistribution occurs with fentanyl does not mean that it is significant. Dr. Barry Logan, a board certified forensic toxicologist, testified that the femoral blood that was tested in this case was “unlikely to be subject to significant postmortem redistribution . . . [because] there’s no reservoir or depot [such as the heart or liver] for fentanyl to affect or to change the femoral blood concentration.” (Dep. of Dr. B. Logan at 69:10–70:2 (Ex. 22).) He also stated that “it’s highly unlikely” that a Duragesic patch on Tim’s left upper chest could affect any fentanyl depot found in Tim’s femoral artery. (Id. at 71:11-18.) Forensic pathologist Dr. Downs has testified that:

Postmortem distribution (PMR) did not occur to any significant degree in this case. PMR is a process by which many drugs, including fentanyl, are believed to possibly be released into blood from tissue stores following death. In this case, the toxicology samples tested were femoral (peripheral) blood. In assessing possible PMR, peripheral blood is the standard against which such an assessment is made. As such, since the single best sample (femoral blood) was analyzed for postmortem toxicology, the issue of PMR is moot.

(Downs Decl. ¶ 10.) Forensic toxicologist Edward Barbieri has similarly testified that “the sample in this case is a peripheral blood sample and not likely to be affected by postmortem changes.” (Barbieri Decl. ¶ 12.) Therefore, it is not surprising that Dr. Lacy, the pathologist who performed Tim’s autopsy and is not an expert retained by the parties, testified that the postmortem fentanyl-blood level of 12 ng/mL “is close to what was circulating at the time of [Tim’s] death.” (Dep. of Dr. J. Lacy at 56:7-8 (Ex. 19).)

Moreover, contrary to the Drug Companies’ suggestion, no decision of which the Jenningses are aware suggests that determining approximate fentanyl concentration at death from postmortem blood draws from peripheral sites is not reliable and probative. Indeed, every court to have considered the Drug Companies’ argument that postmortem fentanyl levels are unreliable as a matter of law has rejected it. For instance, the Texas Court of Appeals recently affirmed a jury’s verdict against defendant ALZA Corporation in another fentanyl-death case despite ALZA argument that postmortem redistribution rendered postmortem blood levels unreliable. ALZA Corp. v. Thompson, No. 13-07-00090-CV, at 34 (Tex. Ct. App. Apr. 1, 2010) (slip copy) (Ex. 25). In addition, the Circuit Court of Seminole County, Florida denied the Drug Companies’ motion to exclude a postmortem fentanyl concentration based on postmortem redistribution in a case in which the jury ultimately found that a defective patch caused the decedent’s death. (Order, Hogemire v. ALZA, No. 2004CA001311 (Cir. Ct. Seminole County, Fla.).) Similarly, postmortem fentanyl levels have been admitted in previous trials involving Duragesic and generic fentanyl patches to demonstrate patch malfunction. (See Trial Tr. of Hendelson v. ALZA, et al., No. 05-8116-cv, at 208–243 (S.D. Fla. June 8, 2007) (Ex. 24); Order, Scott v. Mylan Labs., Inc., No. D-1226-cv-2006-111 (12th Jud. Dist. Ct., Lincoln County, N.M. Aug. 5, 2008).)[5]

These decisions are sound because, as numerous courts around the country have held, the parties’ dispute as to postmortem redistribution’s effect on postmortem toxicological results goes to the weight of the evidence and is for the jury to decide. See McAlpine v. Midland Elec. Co., 634 P.2d 1166, 1171 (Mont. 1981) (“At most, appellant laid the basis for a suggestion that a change in the blood of the victims occurred between the time of death and the time the blood was drawn. Such a suggestion goes to the weight, not admissibility.”); People v. Stiller, 617 N.W.2d 697, 705 (Mich. Ct. App. 2000) (“Assuming, arguendo, that postmortem redistribution affected the level of drugs found in Sloan’s body at the autopsy . . . , such evidence is relevant to the weight, not the admissibility, of Cohle’s testimony.”); Burns v. Workmen’s Comp. Appeal Bd., 654 A.2d 81, 85 (Pa. Commonw. Ct. 1995); Montana v. Bieber, 170 P.3d 444, 453–55 (Mont. 2007); Ohio v. Aeh, No. 95APA11-1449, 1996 Ohio App. LEXIS 2774, at *25 (Ohio Ct. App. June 27, 1996) (noting that the jury was permitted to determine whether postmortem redistribution affected central-blood samples); see also Ohio v. Uselton, No. 03-COA-032, 2005 Ohio App. LEXIS 2119, at *15-16 (Ohio Ct. App. May 14, 2004). The effect of postmortem redistribution is for the jury to evaluate.

In contrast, the decisions to which the Drug Companies refer in a footnote do not support their argument. (See Mot. for Summ. J. at 20 n.14.) First, none of the cases cited by the Drug Companies involved fentanyl. Second, one decision concerns a central-heart-blood draw, not the more reliable peripheral femoral draw in Tim’s case. See Hawthorne v. Zurich Am. Ins. Co., No. CV06-0374RSL, 2007 WL 1795319, at *11 (W.D. Wash. June 18, 2007). Third, another decision concerns a sample taken from autopsies performed seven to ten days after death, as opposed to Tim’s autopsy, which occurred around, at most, 31 hours after Tim’s estimated time of death. See Connor v. Halifax Hosp. Med. Ctr., No. 01-16207, 2002 WL 32290997, at *1 (11th Cir. June 26, 2002) (per curiam). Fourth, one of the cases was a criminal case—operating under the beyond-a-reasonable-doubt standard—in which the Court held that the one of several problems with determining that the decedent died of a Ritalin overdose was that the medical examiner obtained only one blood sample (whose origin is not specified) and no other tissue or blood sample to determine whether postmortem redistribution had occurred. See United States v. Shultice, No. CR 98-54, 2000 WL 34030842, at *7 (N.D. Iowa Apr. 4, 2000). Finally, the remaining decisions to which the Drug Companies refer did not strike expert testimony or hold that postmortem results were unreliable as a matter of law. Accordingly, the Drug Companies’ supposed authority is not controlling or persuasive here.

5. The evidence creates a fact issue under the consumer-expectation test.

Under Washington law, a plaintiff seeking to impose liability against a manufacturer for a product defect may utilize one of two tests, the consumer-expectation test or the risk-utility test. See, e.g., Soproni v. Polygon Apt. Partners, 137 Wn.2d 319, 326 (1999); Falk v. Keene Corp., 113 Wn.2d 645, 653 (1989). Under the consumer expectation test, a product is unreasonably dangerous and defective if it is “unsafe to an extent beyond which would be reasonably contemplated by the ordinary consumer.” Seattle-First Nat’l Bank v. Tabert, 86 Wn.2d 145, 154 (Wash. 1975); see also Baughn, 107 Wn.2d at 133 (“The Tabert ‘consumer expectations’ test has been consistently applied . . . in determining whether a manufacturer is strictly liable for manufacturing an unreasonably dangerous and therefore defective product.”).

The foregoing facts clearly raise an issue for trial as to whether the patch at issue was unreasonably dangerous under the consumer-expectation test. The Jenningses’ transdermal expert, Dr. Prausnitz, has stated that “[t]he fentanyl level measured in the blood of the decedent was much higher than a Duragesic-100 patch is designed and intended to produce.” (Prausnitz Decl. at 4 (Conclusion 1), ¶¶ 6-11.) Dr. Downs—the Jenningses’ forensic pathology expert—reached the same opinion, stating that “Timothy Jennings’ fentanyl patch delivered a dose of fentanyl to his blood much greater than it was intended or designed to deliver.” (Downs Decl. ¶ 8.) Finally, the Jenningses’ forensic toxicologist, Dr. Barbieri, has similarly stated that “the postmortem femoral blood concentration of fentanyl found in Timothy Jennings was not consistent with that expected from the prescribed use of a properly functioning 100 mcg/h Duragesic transdermal patch.” (Barbieri Decl. ¶ 14.) For the foregoing reasons, the Jenningses have raised a fact issue under the consumer-expectation test.

6. The foregoing evidence raises a fact issue under the risk-utility test.

Under the risk-utility test, “a plaintiff may attempt to establish liability by showing that, at time of manufacture, the likelihood that the product would cause the plaintiff’s harm or similar harms, and the seriousness of those harms, outweighed the manufacturer’s burden to design a product that would have prevented those harms and any adverse effect a practical, feasible alternative would have on the product’s usefulness.” Soproni, 137 Wn.2d at 326. Here, the evidence is that the Drug Companies have undergone numerous manufacturing problems and regulatory issues related to its manufacture of fentanyl patches. For instance, ALZA initiated a February 2004 “Urgent Drug Recall” because several patches contained a defect known as the “fold-over defect,” which causes a leak along one edge of the patch. It later expanded the recall to additional patches in April 2004. A later product recall occurred in February 2008 because of a cut along one side of the drug reservoir that may have led to a leak of fentanyl gel from the patch. In December 2008, another recall was issued due to a “cut-system defect” that could result in a leak. In the instant case, the Jenningses’ experts have found evidence of specific defects in Tim’s patch and have offered testimony regarding the way in which such a defect would have led to an excessive fentanyl level and caused Tim’s death.

As for the likelihood that the Drug Companies’ patch would cause Timothy Jennings’ death, the evidence is that “there have been a number of recalls of Duragesic patches due to defective manufacturing, both before and after decedent’s death, and many patient complaints of incorrect Duragesic patch performance filed in the intervening years, which suggests that a patch worn by the decedent may have been similarly defective.” (Prausnitz Decl. ¶ 12.) And death certainly qualifies as a significantly serious harm.

Finally, the evidence demonstrates that the burden on the Drug Companies to design a product that would have prevented or minimized the harms of their product was minimal and that a practical, feasible alternative would not have adversely affected the product’s usefulness. As the Jenningses’ experts have opined, the Drug Companies could and should have adopted a “matrix design” that cannot leak. (Prausnitz Decl. ¶¶ 38–46.)

REDACTED

This evidence of a safer alternative design also raises a fact issue on the existence of a defect under the risk-utility test that precludes summary judgment for the Drug Companies. See, e.g., Ruiz-Guzman, 141 Wn.2d at 503 (“If another product can more safely serve the same purpose as the challenged product at a comparable cost and in a similar manner, a jury [can] conclude that the risks of the challenged product outweigh its utility.”).

The Jenningses’ transdermal expert, Dr. Prausnitz, has concluded that the foregoing evidence clearly establishes that “[t]he reservoir design of the Duragesic patch worn by the decedent is unreasonably dangerous because drug can leak onto the skin from a defective patch.” (Prausnitz Decl. ¶ 49.) As the Washington Supreme Court has held, “[i]f a product is unreasonably dangerous, it is necessarily defective. The plaintiff may, but should not be required to prove defectiveness as a separate matter.” See Tabert, 86 Wn.2d at 154.

 

B. The Drug Companies failed to move for summary judgment on Plaintiffs’ claims for negligent design defect.

Under Washington law, a manufacturer is strictly liable for harm caused by an unreasonably dangerous product. A product may be unreasonably dangerous because of its manufacture or its design. Tabert, 86 Wn.2d at 149–50. The Jenningses assert claims for both manufacturing and negligent design defects. (Corr. Am. Compl. ¶ 8.3) Despite this fact, the Drug Companies did not move for summary judgment on the design-defect claims. Rather, their motion frames the defect issue as solely “[w]hether Plaintiffs’ claim of defective construction should be dismissed because there is no evidence the Duragesic patch deviated in any material way from the design specifications or performance standards when it left the manufacturer . . . .” Mot. for Summ. J. at 12 (emphasis added). Nowhere in their Motion did the Drug Companies address Plaintiffs’ claims for a design defect. As such, Defendants are not entitled to summary judgment on that claim.

C. Plaintiffs have raised an issue of fact that precludes summary judgment on their claims for negligent design defects.

Putting aside the fact that the Drug Companies have not moved for summary judgment on the Jenningses’ design-defect claims, the Jenningses have raised an issue of fact that precludes summary judgment on their claims for negligent design defect. Their transdermal expert, Dr. Prausnitz, has submitted a lengthy, detailed declaration explaining why the design of the patch used by Timothy Jennings was unreasonably dangerous and identifying a safer alternative design. (Prausnitz Decl. at ¶¶ 35–49.) Such evidence precludes summary judgment for the Drug Companies on the Jenningses’ design-defect claims.

D. The Jenningses have raised an issue of fact on proximate cause.

Finally, the Jenningses have raised an issue of fact as to whether the unreasonably dangerous and defective condition of Tim’s patch proximately caused his death. First, the Drug Companies have stated that for purposes of their motion, they will not challenge the conclusion of the medical examiner that Timothy Jennings’ cause of death was “acute intoxication due to the combined effects of fentanyl, diazepam, oxycodone and carbamazepine.” (Mot. for Summ. J. at 1–2 n.2.) According to the Jenningses’ forensic toxicology expert, Dr. Barbieri, the levels of diazepam, oxycodone and carbamazepine indicate that none of those substances—either alone or in combination—were an independent cause of Timothy Jennings’ death. (Barbieri Decl. ¶¶ 4–6.) Rather, as he explained, “[t]he concentration of fentanyl found in [Tim’s] blood was in the reported lethal range for fentanyl alone and was clearly high enough to be an independent cause of his death. . . . [I]n my opinion, the high concentration of fentanyl found in [Tim’s] blood was a proximate cause of his death.” (Id. ¶¶ 13, 15.) The Jenningses’ forensic pathology expert, Dr. Downs, similarly has opined that “to a reasonable degree of scientific certainty, the excessive level of fentanyl in [Tim’s] blood was a proximate cause . . . of his death.” (Downs Decl. ¶ 14.)

And—besides the overwhelming evidence indicating that Tim’s patch was defective mentioned in Parts I.A through I.C of this opposition—Dr. Prausnitz, the Jenningses’ transdermal expert, has testified that “a leaking Duragesic patch can account for the highly elevated fentanyl level in the decedent and is the most likely explanation.” (Prausnitz Decl. at ¶ 12.) He further elaborated that:

To a reasonable degree of engineering and scientific certainty, the rate of fentanyl delivery into the decedent’s body was increased due to a combination of factors associated with leakage from the patch: (i) the increase in skin area contacting fentanyl gel, (ii) the lack of a rate control membrane between the skin and fentanyl gel, (iii) the leakage of fentanyl gel onto skin not previously exposed to fentanyl and (iv) supersaturation of fentanyl during rapid evaporation of gel.

(Prausnitz Decl. ¶¶ 47–48.) Here, ample evidence exists that a defective patch proximately caused Tim’s death. Accordingly, the Drug Companies’ motion must be denied. See Owen v. Burlington N. & Santa Fe R.R., 153 Wn. 2d 780, 788 (2005) (“[I]ssues of negligence and proximate cause are generally not susceptible to summary judgment.”) (internal quotations omitted); Ruff v. County of King, 125 Wn. 2d 697, 702 (1995) (same).

II. Genuine issues of material fact exist as to whether the Drug Companies provided adequate warnings that would have changed Dr. Alsager’s prescribing decision.

Washington law requires a product manufacturer to provide a warning “sufficient to catch the attention of persons who could be expected to use the product; to apprise them of its dangers and to advise them of the measures to take to avoid those dangers.” Little v. PPG Indus., Inc., 92 Wn.2d 118,122 (Wash. 1979). For a prescription-drug warning to be adequate as a matter of law, it must “provide specific and detailed information about the risks of using the drug.” Estate of LaMontagne v. Bristol-Myers Squibb, 127 Wn. App. 335, 344 (2005) (citing Restatement (Second) of Torts § 402A, cmt. k (1965)). “To determine whether a [prescription-drug] warning is adequate requires an analysis of the warnings as a whole and the language used in the package insert. The court must examine the meaning and context of the language and the manner of expression to determine if the warning is accurate, clear, and consistent and whether the warning portrays the risks involved in taking the prescription drugs.” Id. (citing Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993); Little, 92 Wn.2d 118). “If the manufacturer of unnavoidably unsafe product fails to provider an adequate warning, it has been negligent. . . .” Rogers v. Miles Labs., 116 Wn. 2d 195, 207 (1991).

Taken as a whole, the Drug Companies’ labeling falls short of the standards imposed by Washington law. The Drug Companies contend that simply because their package insert refers to death as a potential side effect, they have adequately warned of that risk. (Mot. for Summ. J. at 18.) But none of these death-related warnings apprise physicians of a risk of death resulting from the patch delivering fentanyl levels far greater than those shown in the Package Insert. (See generally Package Insert (Ex. 1).) Instead, they focus largely on the risk of death associated with individuals who (1) misuse or abuse the product,[6] (2) lack opioid tolerance,[7] or (3) are prescribed an excessive dose during the initial application period.[8]

Nowhere in the package insert do the Drug Companies explain that the delivery system is unreliable or that defective, leaking patches are inherent in the production of Duragesic. Yet all of these factors were known to the Drug Companies long before Tim’s patch was produced. (See, supra, at 4–6.) And Dr. Alsager, Tim’s prescribing physician, stated that he would not have prescribed the patch had he known of these facts:

Q: [I]f you had information as a doctor that an opioid delivery system could not be counted on to give the intended dose to patients in all cases and that there was a substantial risk of death from product malfunction, would you prescribe that drug for your patients?

A: No.

Q: If you had information indicating to you as a . . . prescribing doctor that a particular opioid medication’s delivery system had such a long history of manufacturing defects that company officials characterized defects as “inherent in the manufacture of the product” . . . and that was in the black box warning of the package insert and you knew about that, would you prescribe that drug for your patients?

A: No.

Q: If in the black box and in the patient instruction that we looked at it had said in bold prominent letters that the Duragesic system cannot be counted on to give patients a therapeutic dose, a certain percentage of patients will get fatal fentanyl overdoses while properly using the patch, is that the sort of information that you would pass on to a patient like Tim . . . if that warning had been in there?

A: If that kind of warning was in there, it wouldn’t even get to that point. I wouldn’t consider it as a method of therapy. It wouldn’t be in my office.

(Dep. of Dr. Alsager at 154:3-21, 160:15–161:5 (objections omitted) (Ex. 17).)

The Drug Companies’ packaging also set forth an expected blood-fentanyl level of 2.5 ng/mL for a properly-functioning 100 mcg/hr patch. (See generally Package Insert (Ex. 1).) The Drug Companies never informed Dr. Alsager that a single patch could deliver a lethal, 12 ng/mL blood-fentanyl concentration. (Dep. of Dr. Alsager at 201:7-15 (Ex. 17).) Dr. Alsager stated affirmatively that if the Drug Companies knew that such levels were possible from the proper use of a 100 mcg patch, he would expect the Drug Companies to inform him by correcting the chart in the package insert. (Id. at 201:16-23.) This is further evidence that the Drug Companies’ warnings were inadequate. See Young v. Key Pharms., 130 Wn. 2d 160, 178 (1996) (duty to warn in context of a prescription drug is “based on what a reasonably prudent drug manufacturer would do under the circumstances, including the consideration that a physician may have wanted to have all available information about the drug.”).

Conclusion

For the foregoing reasons, the Court should deny the Drug Companies’ motion for summary judgment.

DATED: April 2, 2010.

 

Charles W. Miller, Admitted Pro Hac Vice

HEYGOOD, ORR & PEARSON

2331 W. Northwest Highway, 2nd Floor

Dallas, Texas 75220

(214)232-9001 (T)

(214)237-9002 (F)

Charles@hop-law.com


[1] The plaintiffs do not intend to pursue these warranty claims at trial and will stipulate to their dismissal.

[2] To minimize burdens on the parties and deponents, the parties have agreed that documents and depositions of the Drug Companies’ 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 Duragesic. “Ex.” refers to the exhibit number in the authenticating declaration of Eric Pearson where the referenced document or testimony may be found.

[3] Although the Drug Companies intimate, by repeating that 31 hours passed between Tim’s estimated time of death and his autopsy, that an inordinate delay existed between his death and autopsy, (see Mot. for Summ. J. at 3, 4), the medical examiner testified that such an interval was “very typical” and did not “interfere at all with [my] ability to perform the autopsy or post death investigation.” (Dep. of Dr. Lacy at 44:18–45:3 (Ex. 19).)

[4] The Drug Companies state in their motion that they “have obtained evidence from the Washington State Toxicology Laboratory . . . [that calls] into question the accuracy of the test results reported as 12 ng/mL.” (Mot. for Summ. J. at 4 n.7). Interestingly, they do not refer to any evidence to support their statement. In contrast, the state employee who performed the toxicological testing, Mary Wilson, testified that the equipment that tested for fentanyl was well calibrated. (See Dep. of M. Wilson at 52:4–58:9 (Ex. 21).) Moreover, Dr. Barry Logan, Washington’s former state toxicologist (the state official ultimately responsible for the toxicological testing of Tim Jennings’s blood), testified that, in his opinion, the concentration of Tim’s 12 ng/mL blood-fentanyl level could be determined to a reasonable scientific certainty. (See Dep. of Dr. B. Logan at 53:21–54:5 (Ex. 22).)

[5] Moreover, the Drug Companies are precluded by issue preclusion from arguing that the existence of postmortem redistribution establishes that postmortem blood samples are inherently unreliable as a matter of law. See Gold Star Resorts, Inc. v. Futurewise, 167 Wn. 2d 723, 737-38 (2009). After all, the same issue has been decided, litigated, and necessarily decided in Thompson, in which a final judgment was entered against defendant ALZA (who is a privy of the other Drug Companies in this action), and no injustice exists by applying the doctrine. See id.

[6] “DURAGESIC contains a high concentration of . . . fentanyl [and has] the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. (Package Insert at 1 (emphasis added) (Ex. 1).)

[7] “Because serious of life-threatening hypoventilation could occur, DURAGESIC is contraindicated in patients who are not opioid tolerant.” (Package Insert at 1 (emphasis added) (Ex. 1).)

[8] “Overestimating the DURAGESIC dose when converting patients from another opioid medication can result in fatal overdose with the first dose.” “Since the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.” (Package Insert at 1 (Ex. 19).)