Response to Defendants’ Motion for Summary Judgment

Christensen v. Alza

Description: This brief was filed in California 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 availability of a negligent misrepresentation claim in the context of the sale of a prescription drug. Finally, it addresses the issue of whether California recognizes a cause of action for negligent design. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF ORANGE
JOAN CHRISTENSEN, as Guardian ad Litem for JASON CHRISTENSEN, a minor,Plaintiffs,

v.

ALZA CORPORATION, ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC., and JOHN DOES 1-100,

Defendants.

CASE NO. 30-2009-00122600[Hon. Steven Perk, Department C32]

PLAINTIFF’S MEMORANDUM OF POINTS AND AUTHORITIES IN OPPOSITION TO DEFENDANT’S MOTION FOR SUMMARY ADJUDICATION

Date: August 13, 2010

Time: 11:00 a.m.

Dept.: C32

First Amended Complaint Filed: 06/18/09

Trial Date: 9/13/10

TABLE OF CONTENTS

INTRODUCTION …………………………………………………………………………………….1

STATEMENT OF FACTS ……………………………………………………………………………2

I. The Drug Companies designed, marketed, and distributed the Duragesic patches………………………………………………………………….2

II. Einar Christensen dies with a fatal fentanyl-blood level ……………………………2

III. The Drug Companies knew of numerous Duragesic patch defects……………………3

ARGUMENT AND AUTHORITIES ……………………………………………………………….. 4

I. Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ warning claims ………………………………………………….………….4

II. Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ megligent-misrepresentation claims ………………………………………..8

III. Plaintiff’s evidence demonstrates that genuine issues of material fact exist as to Plaintiff’s warranty claims. ………………………………………………………..…11

IV. Defendants’ motion must be denied as to Plaintiff’s negligent-design claim…………13

A. Defendants’ Motion must be denied because Plaintiff’s design defect claim is recognized by California law…………………………………………………13

1. Defendants cite no case law supporting the argument that a design that renders a product inherently susceptible to a manufacturing defect cannot lead to a negligent design claim………………………………13

2. Plaintiffs’ design defect claim is not limited to a claim that Decedent’s fentanyl patch had a leak when it left Defendants’ control……………15

CONCLUSION ………………………………………………………………………………………16

TABLE OF AUTHORITIES

CASES

Carlin v. Super. Ct., 13 Cal. 4th 1104, 1114-17 (1996) ………………………………………………4

Anderson v. Owens-Corning Fiberglass Corp., 53 Cal. 3d 987 (1993)………………………………4

Jackson v. Deft, Inc., 223 Cal App. 3d 1305 (1990)………………………………………………….8

Schwoerer v. Union Oil Co., 14 Cal. App. 4th 103, 111 (1993) ………………………………………8

Gillespie v. Los Angeles, 36 Cal. 2d 553, 567 (1950) ………………………………………………..8

CAL. COMM. CODE § 2313(1)(a)…………………… ……………………………………………..12

Barker v. Lull Eng. Co.,573 P.2d 443 (Cal. 1978) ……………………………………………………13

 

MEMORANDUM OF POINTS AND AUTHORITIES

INTRODUCTION

Einar Christensen (“Decedent”) received a fatal dose of fentanyl from defective Duragesic fentanyl pain patches designed, manufactured, and distributed by the defendant drug companies (the “Drug Companies”). The defective patches gave Decedent a lethal blood concentration of fentanyl that was higher than a properly designed and manufactured patch should have given him. Decedent’s wife, Joan Christensen, as Guardian Ad Litem for Jason Christensen, a minor, asserts negligence and strict-products-liability claims against the Drug Companies because the patch (1) was defectively manufactured, (2) was negligently designed, manufactured, marketed, sold and distributed, (3) was the subject of misrepresentations by the Drug Companies, (4) lacked adequate warnings and instructions and (5) was sold in breach of express and implied warranties.

The Drug Companies have not moved for summary adjudication on Plaintiffs’ claim for manufacturing defect. (See Defs’ Mem. at 1.) Thus, their motion is a motion for partial summary adjudication, and Plaintiff is entitled, at a minimum, to a jury trial on her manufacturing-defect claim. But because disputed issues of material fact preclude summary adjudication on the Plaintiff’s negligent design, negligent misrepresentation, breach-of-warranty and failure-to-warn claims, she is to a jury trial on these claims as well.

With respect to her failure-to-warn claim, Plaintiff has produced evidence that the Drug Companies failed to warn of all known or scientifically knowable risks related to the patches, including (1) that patients can and do receive fatal fentanyl levels—exceeding the mean maximal levels in the prescribing information—while properly using the patch, (2) that properly indicated patients can suffer a fatal fentanyl overdose while using the patch as prescribed, and (3) that there is a risk of patients receiving a defectively manufactured patch. Specifically, Plaintiffs have offered the testimony of Dr. Kenneth Laughery, a noted expert in the areas of human factors and warnings. Dr. Laughery’s testimony controverts the warnings testimony of Dr. Michael Ferrante offered by the Drug Companies and raises an issue of fact for the jury. Plaintiffs have also offered the testimony of forensic pathologist J.C. Upshaw Downs that Decedent died from a fatal dose of fentanyl that was greater than he was used to receiving from properly functioning patches, a risk of which the Drug Companies did not warn. The testimony of Drs. Laughery and Downs also raises an issue of fact on whether the Drug Companies made negligent misrepresentations and breached warranties applicable to the patches, precluding summary judgment on such claims as well.

The Drug Companies’ motion also seeks judgment as a matter of law on Plaintiffs’ claims for negligent design. It does so not by asserting an absence of an issue of fact, but by claiming that Plaintiffs’ design claim is actually a manufacturing-defect claim. This assertion misstates the substance of Plaintiff’s factual allegations as well as the substance of California product-liability law. For these reasons, Defendants’ Motion should be denied.

STATEMENT OF FACTS

I. The Drug Companies designed, marketed, and distributed the Duragesic patches.

The Drug Companies manufacture, market, and distribute the Duragesic fentanyl transdermal system (“Duragesic patches”). Duragesic patches are transdermal prescription drugs applied to the patient’s skin and used to treat chronic pain. (See Plaintiffs’ Separate Statement of Additional Material Facts (“PAF”) ¶ 2 (begins at page 20 of Plaintiffs’ Separate Statement in Opposition).) Properly functioning patches continuously deliver the requisite dose of the potent opioid fentanyl through the skin to the patient’s bloodstream over a 72-hour period. (PAF ¶ 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. (PAF ¶ 3.) The patches are intended to release fentanyl to the patient “from the reservoir at a nearly constant amount per unit time.” (PAF ¶ 4.)

II. Einar Christensen dies with a fatal fentanyl-blood level.

Einar Christensen died on May 16, 2006 at the age of 43. (Defs’ Mem. at 2.) At the time of his death, he was wearing two, 100 mcg/hr, dosage-strength Duragesic fentanyl patches as prescribed to him by his physician. (PAF ¶ 5.) The medical examiner drew a blood sample from Mr. Christensen’s femoral vessel, and the toxicology testing revealed a blood-fentanyl level of 19 ng/mL (PAF ¶ 1.) The medical examiner testified that 19 ng/mL blood-fentanyl concentration was within the lethal range for fentanyl. (PAF ¶ 6.) He performed an autopsy and found several anatomic signs of a drug-related death including heavy lungs and a full bladder. (PAF ¶ 7.) Based on the autopsy, toxicology report, and all the information available to him, the medical examiner concluded that Mr. Christensen’s death was caused by fentanyl toxicity. (PAF ¶ 8.)

The medical examiner testified that based on his education, training, and experience, that he believes the 19 ng/mL fentanyl level measured in Mr. Christensen’s blood closely approximates the level in his system just prior to his death. (PAF ¶ 9.)

III. The Drug Companies knew of numerous Duragesic patch defects.

ALZA has 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 of the fentanyl gel along one edge of the patch. (PAF ¶ 12.) The FDA later inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems. (PAF ¶ 13.)

 

REDACTED

 

ARGUMENT AND AUTHORITIES

I. Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ warnings claims.

The Drug Companies are not entitled to summary adjudication on Plaintiff’s failure-to-warn claims. California’s strict-products-liability law requires the manufacturer of a prescription drug to warn of known or reasonably scientifically knowable risks associated with its product. Carlin v. Super. Ct., 13 Cal. 4th 1104, 1109 (1996) (“In prior cases, we have expressly and repeatedly applied a strict liability standard to manufacturers of prescription drugs for failure to warn of known or reasonably scientifically knowable risks. We merely reaffirm those precedents here.”). In Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987 (1993), the California Supreme Court held that manufacturers are strictly liable for injuries caused by their failure to give warning of dangers that were known to the scientific community at the time they manufactured and distributed the product:

the manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product. Whatever may be reasonable from the point of view of the manufacturer, the user of the product must be given the option either to refrain from using the product at all or to use it in such a way as to minimize the degree of danger.

Id. at 1004. In addition to claims for strict liability, drug manufacturers may also be held liable under negligence standards. Specifically, negligence principles require drug companies to warn of those risks that “a reasonably prudent manufacturer would have known and warned about.” Carlin, 13 Cal. 4th at 1113.

In the instant case, there is abundant evidence that the Drug Companies failed to warn of those risks about which a reasonably prudent drug manufacturer would have warned. Likewise, there is ample evidence that they failed to warn about all of the dangers that were known or reasonably knowable to the scientific community when they manufactured or distributed the product. For these reasons, the Drug Companies’ motion should be denied.

Kenneth R. Laughery, Ph.D. is an expert in the field of psychology, human factors, and warnings. (PAF ¶ 24.) He has stated in his declaration that there are several different ways in which the Drug Companies failed to warn of known and scientifically knowable risks as required by California law. Specifically, Dr. Laughery has testified that the Drug Companies’ package insert fails to address the following critical issues, all of which were known to the Drug Companies:

Even when the patient is a proper candidate for the patch and when it is being used as prescribed, there is a hazard of high levels of fentanyl leading to severe or catastrophic consequences, including death.

It is possible that the reservoir patches be present with or can develop leaks that lead to hazardous levels of fentanyl with severe or catastrophic consequences, including death.

(PAF ¶ 25.) Indeed, a review of the package insert shows a complete absence of warnings pertaining to the risk of death associated with proper use of the patch and says nothing about the risk of manufacturing defects that can result in dangerously defective patches. (PAF ¶ 26.) Moreover, nowhere does the package insert warn that a properly-indicated patient may suddenly and inexplicably receive a lethal dose of fentanyl greater than the projected mean maximal concentrations. (PAF ¶ 27.)

The Drug Companies point to certain warnings related to hypoventilation and respiratory depression as evidence that they provided adequate warnings. But a review of the Duragesic package insert reveals that these warnings are consistently limited by references to first use, misuse, contraindicated use, or use by a specific type of individual, and none of these warnings indicate that death can result from properly indicated use:

  • Schedule II opioid substances which include fentanyl . . . have the highest potential for abuse and associated risks of fatal overdoses due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion.
  • Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated:
    • in patients who are not opioid-tolerant

 

  • in the management of acute pain or in patients who require opioid analgesia for a short period of time

 

  • in the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectiomies)

 

  • in the management of mild pain

 

  • in the management of intermittent pain . . . .
  • Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression.
  • 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 opiod-tolerant patients, during the initial application period.

(PAF ¶ 28 (emphasis added); see Motion at pp. 8–9.) As Dr. Laughery states in his declaration, the foregoing warnings are inadequate because none of them inform physicians or their patients that (1) patients may receive elevated levels of fentanyl in the lethal range, (2) proper use of the patch by a properly indicated patient with previous patch use may result in death, and (3) there is a risk of receiving a defectively manufactured and potentially-lethal product:

The Full Prescribing Information was also inadequate because it failed to inform the prescribing doctors that there was a known potential for manufacturing defects that resulted in leaks or of the potential catastrophic consequences of such leaks. Similarly, there was no information in the Full Prescribing Information indicating that there was a potential for dangerous and/or fatal fentanyl levels that were significantly above the expected levels set forth in the Full Prescribing Information. This potential for high fentanyl levels exists when the patient is a proper candidate for the patch and is using it as prescribed. There is no mention anywhere in the black box section of the Full Prescribing Information of the risk of death from proper use. For all of the reasons, Defendants’ warnings were defective and inadequate.

(PAF 29.)

In addition, Dr. Thomas Basch, Mr. Christensen’s prescribing physician, explained that the warnings in the Duragesic package insert do not explain that a patient such as Mr. Christensen who was using his Duragesic properly and who was tolerant to his dose could suddenly receive a lethal dose of fentanyl and die:

Q. On Page 1, at the top of the page where it says, it talks about that Fentanyl in a class of drugs and including some of the drugs that have the highest potential for abuse and associated risk of fatal Fentanyl overdose?

A. Yes.

Q. That’s not talking about proper use?

A. Correct.

Q. So that doesn’t apply to Mr. Christensen, does it?

A. I wouldn’t think so, no.

Q. And then right below it, there is a list of contraindications regarding hypoventilation?

A. Yes.

Q. Were you giving Fentanyl to Mr. Christensen for any of these contraindicated reasons?

A. I don’t believe so.

Q. So does that warning apply to him?

A. No.

Q. Below that there is a warning that Mr. Zellers had you read about, it says since the peak Fentanyl levels occur between 24 and 72 hours of treatment, prescriber should be aware that serious or life-threatening hypoventilation may occur during the initial application period. Do you see that?

A. During the initial application period I think

Q. Right. I mean was, at that time Mr. Christensen was using Fentanyl patches in May 2006, was he in the initial application period?

A. No.

Q. Did that warning have any application to him?

A. I don’t think that particular one did, no.

Q. (BY MR. MILLER): And then you were directedto Page 3. The hypoventilation section?

A. Yes.

Q. And Mr. Zellers has asked you about the phrase serious or life-threatening hypoventilation can occur at any time during the use of Duragesic. Did you see that?

A. Yes.

Q. And do you see what the, would you agree that the rest of the sentence qualifies that and says that is especially true during the initial application period?

A. Well, the sentence says serious or life-threatening hypoventilation may occur at any time during the use of Duragesic especially during the initial 24 to 72 hours following initiation of therapy and following increases in dose.

Q. (BY MR. MILLER): Was Mr. Christensen’s initial 72 hours of application of use of Duragesic?

A. No.

Q. Was he, did he die right after an increase in dose from you?

A. No.

Q. Have you seen anything in the package insert from any of the warnings we have talked about that a patient who is stable on Duragesic, has been using it for a long time, is a proper candidate for the patch and who should be getting about a five level from two 100 microgram patch might suddenly die of a fatal Fentanyl overdose with a 19 level?

A. I saw nothing along those lines. I simply saw the sentence that said that hypoventilation could occur at any during the use of the medication.

(PAF ¶ 10.)

“In most cases . . . the adequacy of a warning is question of fact for the jury. Jackson v. Deft, Inc., 223 Cal. App. 3d 1305, 1320 (1990). Here, the opinions of Dr. Laughery and the testimony of Mr. Christensen’s prescribing physician contradict the opinions of Dr. Ferrante offered by the Drug Companies. These contradictory warning opinions raise a fact issue for the jury that requires that the Drug Companies’ motion be denied. See, e.g., Schwoerer v. Union Oil Co., 14 Cal. App. 4th 103, 111 (1993) (“Under California law, a product may be defective because of the absence of an adequate warning of the dangers inherent in its use. . . . Whether the warning is adequate is usually a question of fact.”); Gillespie v. Los Angeles, 36 Cal. 2d 553, 567 (1950) (“In order to escape liability the city must either eliminate the dangerous condition or protect the public by adequate warning, and the sufficiency of such warning is a question of fact in each case.”).

II. Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ negligent-misrepresentation claims.

Decedent should not have received a fatal blood-fentanyl level of 19 ng/mL from a properly functioning patch.

REDACTED

Table A of the Package Insert sets forth the “peak plasma levels for a properly functioning” patch referenced by its inventor. Specifically, the Package Insert notes that “peak serum concentration of fentanyl generally occurred between 24 and 72 hours after initial application (see Table A)” and that “serum fentanyl concentrations are proportional to the fentanyl transdermal system delivery rate.” (PAF ¶ 34 (emphasis added).) Table A then shows the peak, mean maximal concentration for a 100 mcg/hr patch to be 2.5 ng/mL (and thus a total combined mean maximal concentration of 5.0 ng/mL for two 100 mcg/hr patches). (PAF ¶ 35.) The information in Table A providing the patient’s “peak” or maximum amount of fentanyl-blood concentration (which is expected to be reached during the patient’s application of the first patch) is consistent with promotional materials produced by the Drug Companies for the ALZA-manufactured Duragesic fentanyl transdermal system that provide the following information in a question and answer format:

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.

(PAF ¶ 36 (emphasis added).)

The Drug Companies argue that Table A does not apply to “someone like Mr. Christensen, who used fentanyl patches long-term.” Motion at p. 14. But this argument is not supported by the language of the insert itself. Even if the Court assumes this claim is accurate, the Drug Companies offer no explanation for the inaccuracy of the graph above Table A, which is meant to indicate the “serum fentanyl concentrations following multiple applications of fentanyl transdermal system 100 mcg/h.” (PAF ¶ 37 (emphasis added).) That graph shows a mean maximal fentanyl level of around 2.0 ng/mL, a level actually lower than the level set forth in Table A. Thus, according to the Drug Companies’ witnesses and literature, two properly functioning 100 mcg/hr Duragesic patches should not have given Mr. Christensen a blood-fentanyl level of 19 ng/mL. Nowhere in their literature do the Drug Companies indicate that a person using two 100 mcg patches could achieve a fentanyl level of 19 ng/mL or any fentanyl level consistent with the fatal levels found in various studies. (PAF ¶ 38.)

Dr. Thomas Basch, the physician that prescribed the fentanyl patches to Mr. Christensen, testified that there is nothing in the package insert that tells him, as a physician, that he could expect that Mr. Christensen would receive a 19 ng/mL level from the two 100 mcg/hr fentanyl patches that he prescribed:

Q: And you see the graph above Table A at the top of Page 2 that says serum Fentanyl concentrations following multiple applications of Duragesic, a hundred?

A. Yes.

Q. Now you see the dotted line that is the mean?

A. Yes.

Q. Would you agree that no point on that mean is above two nanograms per milliliter?

A. Yes.

Q. So how does anything about this warning or this graph tell you that patients are likely to get a higher blood level with continuous use?

A. Well, this particular graph would suggest that the blood level is more likely to remain at two or below with the hundred micrograms patch.

Q. And do you see any point where any of the patients who got higher levels got higher than the 4.5?

A. No. It looks like the highest patient was on day 13 achieved 4.5 nanograms.

Q. Does anything that you have read suggest that a patient might get a nine or a 10 level from a hundred microgram patch which is what it would have to be to get Mr. Christensen to a 19?

A. I don’t see anything that would indicate that.

Q. Let me rephrase my question. Do you see anything in what you have read so far that would warn you as a prescribing doctor that Mr. Christensen might get a 19 from the patches you prescribed for him?

A. There is nothing that I would see that would specifically warn of a level that high.

(PAF ¶11.)

The Drug Companies contend that any representations they make pertain only to blood levels in living patients, and they they make no “representations about maximum or expected postmortem blood fentanyl levels.” (Defs.’ Mem. 14.) But whether or not Mr. Christensen’s postmortem fentanyl blood concentration accurately reflects the level circulating in his body just before death is, at a minimum, a fact issue for the jury. The medical examiner that performed the autopsy has testified that based on his education, training, and experience, that he believes the 19 ng/mL fentanyl level measured in Mr. Christensen’s blood closely approximates the level in his system just prior to his death. (PAF ¶ 9.) Likewise, forensic pathologist Dr. J.C. Upshaw Downs has opined that the fentanyl level found in Einar Christensen’s blood was in excess of what should have been expected from two properly-functioning patches 100 mcg/hr patches (even given some hypothetical degree of postmortem redistribution). (PAF ¶ 39.) And as stated above, Dr. Laughery has opined that the Drug Companies’ package insert was inadequate because “there was no information in the Full Prescribing Information indicating that there was a potential for dangerous and/or fatal fentanyl levels that were significantly above the expected levels set forth in the Full Prescribing Information.” (PAF 29.) Plaintiff, therefore, has raised an issue of fact as to whether the Drug Companies negligently misrepresented the expected fentanyl level from their patches.

III. Plaintiff’s evidence demonstrates that genuine issues of material fact exist as to Plaintiff’s warranty claims.

The Drug Companies’ motion should be denied to the extent it seeks summary adjudication on Plaintiff’s claims for breach of express warranty. Under California law, “[a]ny affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.” Cal. Comm. Code § 2313(1)(a). The Drug Companies made such a promise regarding the levels of fentanyl a patient such as Mr. Christensen should expect to receive from their fentanyl patches. More specifically, the package insert accompanying the Duragesic fentanyl patch indicates a patient should expect to receive a mean maximum fentanyl blood concentration of 2.5 ng/mL following the application of the 100 mcg fentanyl patch for a total of 5 ng/mL. And physicians were promised that:

[w]hile there is variation in dose delivered among patients, the nominal flux of the systems (25, 50, 75, and 100 mcg of fentanyl per hour) is sufficiently accurate as to allow individual titration of dosage for a given patient.

(PAF 40.) Thus, doctors and their patients were told they could rely on the fentanyl transdermal system to “release[] fentanyl . . . at a nearly constant amount per unit time.” (PAF 4.) Instead of providing Mr. Christensen with the promised fentanyl blood concentration of 5 ng/mL, the patches provided him with a fatal level of 19 ng/mL. (PAF 11.)

The Drug Companies’ motion should also be denied to the extent it seeks summary adjudication on Plaintiffs’ claims for breach of implied warranty. Under California law, a breach-of-warranty claim lies when a plaintiff can show a drug companies’ “failure to warn about the known or reasonably scientifically knowable dangerous propensities of [a] product.” Carlin, 13 Cal. 4th at 1116. Here, as set forth above, the Drug Companies failed to adequately warn of the dangers associated with their fentanyl patches. The Drug Companies imply that warranty claims are somehow impermissible when the goods at issue are prescription drugs. See Motion at p. 15. But the California Supreme Court has stated unequivocally that:

Since Brown merely held that drug manufacturers could not be held strictly liable for failure to warn of unknown and unknowable risks, it did not purport to reject the suitability of warranty claims when a drug posed a known or scientifically knowable health risk. In view of our conclusion that no special exception should be created for drug manufacturers, we discern nothing “mischevious” about permitting plaintiff to pursue her claim for breach of warranty.

Carlin, 13 Cal. 4th at 1118. Because Plaintiffs have raised an issue of fact, The Drug Companies’ motion for summary judgment on their breach of warranty claim must be denied.

IV. Defendants’ motion must be denied as to Plaintiff’s negligent-design claim.

A. Defendants’ Motion must be denied because Plaintiff’s design defect claim is recognized by California law.

1. Defendants cite no case law supporting the argument that a design that renders a product inherently susceptible to a manufacturing defect cannot lead to a negligent design claim.

Defendants contend that a negligent-design claim cannot be premised on the fact that a design is subject to an unnecessary, increased risk of fatal manufacturing defects. But California products-liability law does not provide sanctuary to drug companies who unnecessarily employ a product whose design regularly (and unnecessarily) permits fatal defects. “A product may be found defective in design . . . if . . . the jury determines that the product’s design embodies ‘excessive preventable danger,’ or, in other words, if the jury finds that the risk of danger inherent in the challenged design outweighs the benefits of such design.” Barker v. Lull Eng’g Co., Inc., 573 P.2d 443 (Cal. 1978). Nothing in this definition suggests that design-defect claims cannot be based on the unnecessary risk of manufacturing defects that arise from an intended design, particularly when a safer, alternative design exists.

The inherent design of the Drug Companies’ patches creates a risk (too often realized) in every Duragesic patch that a manufacturing defect will cause fatal fentanyl overdoses

REDACTED

The unnecessary risk of a customer receiving a leaking fentanyl patch would not exist if the Drug Companies had used a matrix, as opposed to a reservoir, design.

REDACTED

Dr. Mark Prausnitz, a respected expert in the field of transdermal delivery devices, has performed an extensive analysis of the Duragesic patch and its flaws and has concluded there were feasible, safer alternative designs that should have been used. (PAF ¶ 47.)

Given the foregoing facts, there is ample evidence that the Drug Companies manufactured a fentanyl patch whose reservoir design made leaking patches inherent in the manufacturing process. By contrast, the alternative matrix design could not leak. Despite numerous reports of deaths from leaking patches, the Drug Companies continued to manufacture and market the reservoir design patch in the U.S. until mid-2009 while selling the alternative matrix design patch in Europe. Sometime in 2008, Debora Flores received a reservoir design fentanyl patch from the Drug Companies. She used it properly and as prescribed. It nonetheless provided her with a fatal fentanyl level higher than was expected from properly functioning patches. Defendants cite no case law supporting the argument that a design that renders a product inherently susceptible to a manufacturing defect cannot lead to a negligent design claim.

Defendants previously moved for summary adjudication in a similar fentanyl pain patch case pending in California on the same basis. In the case of Christian v. Alza Corporation, et. al., Case No. 37-2008-00090247-CU-PO-CTL, these same Defendants argued that the plaintiffs’ claim for negligent design was in fact a claim for negligent manufacture:

[P]laintiffs do not allege a design defect. They assert that “if a patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl.” Moreover, Plaintiffs allege that the “patch [Mr. Cardinal used] was defective because it malfunctioned and did not perform as intended and designed,” specifically that it contained a “seal defect” that resulted in fatal fentanyl toxicity. In other words, plaintiffs allege a manufacturing defect.

(PAF ¶ 48.. Judge Richard Strauss rejected Defendants’ argument and denied their motion as to Plaintiff’s negligent design claim (and as to all of their other causes of action as well). (PAF ¶ 48.) Under the doctrines of res judicata and collateral estoppel, this Court should reach the same conclusion.

2. Plaintiffs’ design defect claim is not limited to a claim that Decedent’s fentanyl patch had a leak when it left Defendants’ control.

Defendants’ argument that Plaintiffs’ design defect claim is in reality a disguised manufacturing defect claim is based on the misguided notion that Plaintiff’s claim is limited to an allegation that Decedent’s fentanyl patch had a leak when it left Defendants’ control. But this is clearly not the sum and substance of Plaintiffs’ design defect allegations. Rather, Plaintiffs have alleged that Decedent’s reservoir-design patch was defective in design because it can develop post-manufacture leaks (as well as leaks during manufacture) while the alternative matrix design patch cannot. See Plaintiff’s First Amended Complaint at ¶¶16, 17. Plaintiffs also alleged that the reservoir design patch can “otherwise cause lethal levels of fentanyl in patients.” Id. at ¶16. Thus, Plaintiff’s design defect claims are neither limited to a claim of a leak nor limited to a claim of leaks caused by manufacturing problems. Defendants’ Motion is premised on a mischaracterization of Plaintiff’s claims and should be denied.

CONCLUSION

For the foregoing reasons, Plaintiffs respectfully requests that the Drug Companies’ motion for summary adjudication be denied.

DATED: July 29, 2010 HEYGOOD, ORR & PEARSON

By:

Eric D. Pearson

Attorneys for Plaintiffs