Response to Defendants’ Motion for Summary Judgment

Flores 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.

Plaintiffs’ opposition to ALZA Corporation and Sandoz, Inc.’s motion for summary adjudication is based on the First Amended Memorandum of Points and Authorities attached hereto; the declarations of Eric Pearson, Michelle West, J.C. Upshaw Downs, M.D., and Kenneth Laugherty, Ph.D.; the Separate Statement of Disputed and Undisputed Materials Facts; and all papers and pleadings on file herein and any oral argument that may be heard at the hearing of this matter. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF SAN DIEGO
RALPH FLORES, Individually and as Guardian ad Litem of JACOB FLORES, and GRETA SANTI,Plaintiffs,v.ALZA CORPORATION, SANDOZ, INC., WILLIAM L. WILSON, M.D., MICHAEL DAVIS, P.A., and JOHN DOES 1-100,

The Drug Companies.

CASE NO. 37-2009-00066204-CU-PL-ECPLAINTIFFS’ FIRST AMENDED MEMORANDUM IN OPPOSITION TO ALZA CORPORATION AND SANDOZ, INC.’S MOTION FOR SUMMARY ADJUDICATION[Separate Statement Of Disputed And Undisputed Materials Facts; Declarations of Eric Pearson, J.C. Upshaw Downs, M.D., Kenneth R. Laughery, Ph.D.]Complaint Filed: April 28, 2009)

Trial Date: June 18, 2010

Date: May 14, 2010

Time: 9:00 a.m.

Dept.: E15 [Hon. Randa Trapp]

TABLE OF CONTENTS

TABLE OF AUTHORITIES …………………………………………………………………………iv

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

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

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

II. Debora Flores dies with a fatal fentanyl-blood level .…………………………………3

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

ARGUMENT AND AUTHORITIES …………………………………………………………………5

Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ warnings claims ………………………………………………………………5
Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ negligent-misrepresentation claims  ……………………………….9
Plaintiffs’ evidence demonstrates that genuine issues of material fact exist as to Plaintiffs’ warranty claims …………………………………………………………….11
Defendants Motion must be denied as to Plaintiffs’ negligent-design claim.……13
Defendant’s Motion is procedurally improper because it does not seek summary adjudication on all of Plaintiffs’ negligence claims …………………………….13
Defendants’ Motion must be denied because Plaintiffs’ design defect claim is recognized by California law…………………………………………………….15
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……………………………………………………….15 Plaintiffs’ design defect claim is not limited to a claim that Decedent’s fentanyl patch had a leak when it left Defendants’ control………………………….17

CONCLUSION ………………………………………………………………………………………17
TABLE OF AUTHORITIES

Decisions

Anderson v. Owens-Corning Fiberglas Corp., 53 Cal. 3d 987 (1993) ……………………………..5, 6

Barker v. Lull Eng’g Co., 20 Cal. 3d 413 (1978) ………………………………………………………13

Carlin v. Super. Ct., 13 Cal. 4th 1104 (1996) ……………………..…………………………5, 6, 12, 13

Catalano v. Superior Court, 82 Cal. App. 4th 91 (2000) ……………………………………………..13

Dunn v. County of Santa Barbara, 135 Cal. App. 4th 1281 (2006) …………………………………13

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

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

Statutes

Cal. Comm. Code § 2313(1)(a) ………….……………………………………………………………12

Cal. Code Civ. Proc. § 437c(f)(1)……….…………………………………………………………… 13

 

MEMORANDUM OF POINTS AND AUTHORITIES

INTRODUCTION

Debora Flores (“Decedent”) received a fatal dose of fentanyl from defective Sandoz fentanyl pain patches designed, manufactured, and distributed by the defendant drug companies (the “Drug Companies”).[1] The defective patches gave Decedent a lethal blood concentration of fentanyl that was higher than a properly designed and manufactured patch should have given her. Decedent’s husband, Ralph Flores, Individually and as Next Friend of Jacob Flores, and Decedent’s daughter, Greta Santi (collectively “Plaintiffs”) assert 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 Motion at p. 1. Thus, their motion is a motion for partial summary adjudication, and Plaintiffs are entitled, at a minimum, to a jury trial on their manufacturing-defect claim. But because disputed issues of material fact preclude summary adjudication on the Plaintiffs’ negligent design, negligent misrepresentation, breach-of-warranty and failure-to-warn claims, they are entitled to a jury trial on these claims as well.

As for Plaintiffs’ warnings claims, the Drug Companies acknowledge that “[w]hether a warning is adequate is usually a question for the jury.” Motion at p. 14. This is one of those usual cases. Plaintiffs have 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 Moon 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 she 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 Plaintiffs’ factual allegations as well as the substance of California product-liability law. Moreover, Defendants’ Motion is procedurally improper because it does not seek summary adjudication on all of Plaintiff’s negligence claims. For these reasons, Defendants; Motion should be denied.

STATEMENT OF FACTS

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

The Drug Companies manufacture, market, and distribute the Sandoz fentanyl transdermal system (“Sandoz patches”). Sandoz 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”) ¶¶ 1-2 (begins at page 7 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 Sandoz patches are manufactured, fentanyl gel is deposited in a “reservoir” between an impermeable layer of polyester backing and a semi-permeable layer of ethyl-acetate vinyl (“EVA”) film. (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. Debora Flores dies with a fatal fentanyl-blood level.

Debora Flores died on February 5, 2008 at the age of fifty-five. (PAF ¶ 5.) Her husband found her unresponsive and short of breath sometime shortly after 1:00 p.m. and drove her to Sharp Grossmont Hospital. (PAF ¶ 6.) She arrived at the hospital at approximately 1:44 p.m. and was asystolic. (PAF ¶ 7.) After being given Narcan, a drug that counteracts the respiratory depressive effects of fentanyl, Mrs. Flores’ pulse returned. She again went into asystole. Again she was given Narcan and her heart rate returned. She was stable but comatose. The doctors diagnosed imminent brain death later that day and care was withdrawn. She died later that evening. (PAF ¶ 8)

Mrs. Flores had been wearing two fentanyl patches at the time of death, one 100 mcg patch and one 25 mcg patch. (PAF ¶ 9.) Her cause of death was determined by the San Diego County Medical Examiner to be “fentanyl and tramadol intoxication.” (PAF ¶ 10.) The medical examiner concluded that the level of tramadol found in her blood was “a therapeutic concentration.” (PAF ¶ 10.) Her antemortem fentanyl level was 5.2 ng/mL, a level the medical examiner classified as “in the range seen in fatalities.” (PAF ¶ 11.)

III. The Drug Companies knew of numerous Sandoz 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 Plaintiffs’ 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 Sandoz 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.)

As the Drug Companies acknowledge, “[w]hether a warning is adequate is usually a question for the jury.” Motion at p. 14. Here, the opinions of Dr. Laughery contradict the opinions of Dr. Moon 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 5.2 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 for a 25 mcg patch to be .6 ng/mL, for a combined mean maximal concentration of 3.1 ng/mL. (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 Flores, who used fentanyl patches long-term.” Motion at p. 11. 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 Exhibit A. Thus, according to the Drug Companies’ witnesses and literature, properly functioning 100 mcg/hr and 25 mcg/hr Sandoz patches should not have given Decedent a blood-fentanyl level of 5.2 ng/mL. Nowhere in their literature do the Drug Companies indicate that a person using a 100 mcg and 25 mcg patch could achieve a fentanyl level of 5.2 ng/mL or any fentanyl level consistent with the fatal level found in various studies. (PAF ¶ 38.)

In his Declaration, forensic pathologist Dr. J.C. Upshaw Downs has opined that the fentanyl level found in Debora Flores’s antemortem blood was in excess of what should have been expected from properly functioning patches:

It is my understanding that Mrs. Flores had been wearing two fentanyl patches at the time of death, one 100 mcg patch and one 25 mcg patch. Her cause of death was determined by the San Diego County Medical Examiner to be “fentanyl and tramadol intoxication.”

* * * * *

The toxicology results in this case document an antemortem blood fentanyl concentration of 5.2 ng/mL. I have found no documentation for an additional excessive exogenous dose of fentanyl other than the patches Debora Flores was wearing at the time of her death. This process of exclusion of other causes leads me to the conclusion that Debora Flores’ fentanyl patches delivered a fatal dose of fentanyl to her blood greater than she was used to receiving from a properly functioning patch.

(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.) Plaintiffs, therefore, have raised an issue of fact as to whether the Drug Companies negligently misrepresented the expected fentanyl level from their patches.

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

The Drug Companies’ motion should be denied to the extent it seeks summary adjudication on Plaintiffs’ 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 Debora Flores should expect to receive from their fentanyl patches. More specifically, the package insert accompanying the Sandoz 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 and .6 ng/mL following the application of the 25 mcg fentanyl patch, for a total of 3.1ng/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 Flores with the promised fentanyl blood concentration of 3.1 ng/mL, the patches provided her with a fatal level of 5.2 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 Plaintiffs’ negligent-design claim.
A. Defendant’s Motion is procedurally improper because it does not seek summary adjudication on all of Plaintiffs’ negligence claims.

Plaintiffs’ claim for negligence was for negligent manufacture, negligent design and negligent warnings. Plaintiffs’ Second Amended Complaint at ¶¶26-28. Defendants admittedly did not move for summary adjudication on Plaintiff’s claim for negligent manufacture. See Defendants’ Motion at 1 (“Because Plaintiffs’ main claims involve an alleged manufacturing defect in the patch, defendants Alza Corporation and Sandoz, Inc. move for summary adjudication of the alternative causes of action based on theories of negligent design and failure to warn. Plaintiff’s manufacturing-based claims are not challenged in this motion and instead will be refuted at trial.”). Therefore, Defendants’ Motion, if granted, would not completely dispose of Plaintiffs’ negligence claim.

Section 437c(f)(1) of the California Code of Civil Procedure provides that a motion for summary adjudication may be granted only if it completely disposes of a cause of action:

A party may move for summary adjudication as to one or more causes of action within an action, one or more affirmative defenses, one or more claims for damages, or one or more issues of duty, if that party contends that the cause of action has no merit or that there is no affirmative defense thereto, or that there is no merit to an affirmative defense as to any cause of action, or both, or that there is no merit to a claim for damages, as specified in Section 3294 of the Civil Code, or that one or more defendants either owed or did not owe a duty to the plaintiff or plaintiffs. A motion for summary adjudication shall be granted only if it completely disposes of a cause of action, an affirmative defense, a claim for damages, or an issue of duty.

Cal. Code Civ. Proc. 437c(f)(1) (emphasis added); see also Dunn v. County of Santa Barbara, 135 Cal. App. 4th 1281, 1290 (2006) (“Summary adjudication is warranted only if the motion completely disposes of a cause of action, an affirmative defense, a claim for damages, or an issue of duty.”). Recently the Superior Court of Sacramento County denied these same Defendants summary adjudication on an identical negligence claim in a similar fentanyl patch lawsuit because their motion did not challenge the entire negligence cause of action but only certain allegations of negligence:

At the outset, the Court concludes that the motion must be denied as to the second cause of action for negligence. Even if the grounds cited as support for the motion were otherwise established by defendant, summary adjudication can be granted “only if it completely disposes of a cause of action.” (Code Civ. Proc. §437c(f)(1) (emphasis added); see also, Dunn v. County of Santa Barbara (2006) 135 Cal.App.4th 1281, 1290 [summary adjudication “warranted only if the motion completely disposes of cause of action,…”].) The complaint ultimately defines which issues are “material” and can therefore be resolved via summary judgment/adjudication. Here, plaintiff’s second cause of action pleads negligence not only in the manufacture and distribution of the fentanyl patch but also in its design. As a result, by its own terms, the present motion does not seek to summarily adjudicate the negligent design claim. Because this design defect theory cannot be defeated via summary adjudication, the motion must be denied as to the second cause of action.

Supplemental Declaration of Eric D. Pearson at Exhibit A; see also Catalano v. Superior Court, 82 Cal. App. 4th 91, 96 (2000) (noting that sponsor of amendment to section 437c stated that “it is a waste of court time to attempt to resolve issues if the resolution of those issues will not result in summary adjudication of a cause of action or affirmative defense. Since the cause of action must still be tried, much of the same evidence will be reconsidered by the court at the time of trial. This bill would instead require summary adjudication of issues only where an entire cause of action, affirmative defense or claim for punitive damages can be resolved.”). This court should likewise hold that Defendants’ Motion must be denied as to Plaintiffs’ negligence claim because it does not seek to completely dispose of that cause of action.

B. Defendants’ Motion must be denied because Plaintiffs’ 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 Sandoz 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

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 this Court 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.

Supplemental Declaration of Eric D. Pearson at Exhibit B at p. 11. 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). Supplemental Declaration of Eric D. Pearson at Exhibit C. 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 while the alternative matrix design patch cannot. See Plaintiffs’ Second 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, Plaintiffs’ 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 Plaintiffs’ claims and should be denied.

CONCLUSION

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

Respectfully submitted,
HEYGOOD, ORR & PEARSON
2331 W. Northwest Highway
Second Floor
Dallas, Texas 75220
(214) 237-9001 (Telephone)
(214) 237-9002 (Telecopier)


[1] ALZA manufactures the fentanyl patch that is sold by Sandoz as a generic competitor to Duragesic®. ALZA also manufactures the Duragesic® and Sandoz patch at the same facility, and they are identical. ALZA is responsible for the contents of the package insert that comes with the Sandoz fentanyl patch. (See Plaintiffs’ Separate Statement of Additional Material Facts (“PAF”) ¶ 1 (begins at page 7 of Plaintiffs’ Separate Statement in Opposition).)