Response to Defendants’ Motion for Summary Judgment

Arpajian 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 claims for negligent misrepresentation and breach of warranty in the context of the sale of a prescription drug.

This Opposition is based on the Memorandum of Points and Authorities attached hereto, the Declarations of Charles Miller, J.C. Upshaw Downs, M.D., Mark R. Prausnitz, Ph.D., and Cheryl Blume, 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
FOR THE COUNTY OF SAN DIEGO
BARBARA CHRISTIAN; MICHAEL CARDINAL; CHRIS FREED; and JACQUELINE FINCH,Plaintiffs,v.

ALZA CORPORATION; NOVARTIS PHARMACEUTICALS CORPORATION; SANDOZ INC., SANDOZ PHARMACEUTICALS CORPORATION; and DOES 1 through 150, inclusive,

Defendants.

Case No. 34-2008-00090247-CU-PO-CTLPLAINTIFFs’ OPPOSITION AND MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF their OPPOSITION TO DEFENDANTS’ MOTION FOR SUMMARY ADJUDICATION[Separate Statement Of Disputed And Undisputed Materials Facts; Declarations of Charles Miller, J.C. Upshaw Downs, M.D., Mark R. Prausnitz, Ph.D., and Cheryl Blume, Ph.D.,and Proposed Order]

Hearing Date: December 11, 2009

Hearing Time: 1:30 p.m.

Department: 75

Judge: Hon. Richard Strauss

Complaint filed: August 21, 2008

Trial Date: January 15, 2010

 

TABLE OF CONTENTS

Page

 

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

STATEMENT OF FACTS ……………………………………………………………………….3

  1. The Sandoz Patches ………………………………………………………………3
  2. Cardinal’s Death ………………………………………………………………….4
  3. The Drug Companies Knew of Numerous Sandoz Patch Defects ………………..5
  4. This Lawsuit ………………………………………………………………………5

ARGUMENT …………………………………………………………..………..………………..6

I. Plaintiffs’ failure-to-warn claims should proceed because numerous genuine issues of material fact exist ……………………………………………………….6

II. Plaintiffs’ design-defect claim based on negligence is proper under

California law ……………………………………………………………………14

III. Issues of material fact exist concerning plaintiffs’

negligent-misrepresentation claim ………………………………………………16

IV. Plaintiffs have stated a claim for breach of express warranty because the

Package insert accompanying the Sandoz patch asserted that Cardinal

would receive a level of fentanyl significantly less than the lethal dose that was delivered …………………………………………………………………………17

The Drug Companies are not entitled to summary adjudication as to plaintiffs’ implied warranty claim ………………………………………………………….18

CONCLUSION …………………………………………………………..………..……………19

 

TABLE OF AUTHORITIES

Page

 

CASES

Artiglio v. Super. Ct., 22 Cal. App. 4th 1388, 1393 (4th Dist. 1994) ……………………………15

Barker v. Lull Eng’g Co., Inc., 573 P.2d 443 (1978) …………..………………………………..15

Brown v. Superior Court, 44 Cal. 3d 1049 (1988) ……………………………………………2, 14

Carlin v. Superior Court, 13 Cal. 4th 1104, 1117-1118 (1998) ……………………………2, 6, 15

Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (1st Dist. 2008) …………………………………….13

Conroy v. Regents of Univ. of Cal., 45 Cal. 4th 1244, 1255-56 (2009) …………………………15

Molko v. Holy Spirit Ass’n., 46 Cal. 3d 1092, 1107 (1988) ………………..……………………..6

Roland v. Christian, 69 Cal. 2d 108, 111 (1968) …………………………………………………6

Slobojan v. W. Travelers Life Ins. Co., 70 Cal. 2d 432, 437 (1969) ………..…….………………6

Stationers v. Dunn & Bradstreet, 62 Cal. 2d 412, 417 (1965) ……………………..…………….6

Walsh v. Walsh, 18 Cal. 2d 439, 441 (1941) ………………………………………………………6

STATUTES

Cal. Comm. Code § 2314 ………………………………………………………………….……18

Cal. Comm. Code § 2313(1)(a) …………………………………………………………………..…17


MEMORANDUM OF POINTS AND AUTHORITIES

INTRODUCTION

Leo Cardinal (“Cardinal”) received a fatal dose of fentanyl from a defective Sandoz fentanyl pain patch designed, manufactured, and distributed by the defendants (the “Drug Companies”).[1] In fact, the defective patch gave Cardinal a lethal blood concentration of fentanyl that was ­­­­more than ten times higher than a properly designed and manufactured patch should have given him. Cardinal’s wife, Barbara Christian, and his children assert strict-products-liability claims against the Drug Companies because the patch (1) was defectively manufactured, and (2) lacked adequate warnings and instructions. They also assert negligence claims because the Drug Companies negligently designed, manufactured, marketed, sold, distributed, and misrepresented the Sandoz patch. Finally, they assert express and implied breach-of-warranty claims. In their partial motion for summary adjudication, the Drug Companies contend that they are entitled to judgment as a matter of law on plaintiffs’ failure-to-warn, negligent-design, negligent-misrepresentation, and warranty claims. None of plaintiffs’ claims can be decided on summary judgment for the following reasons:

First. The Drug Companies have not moved for summary judgment on plaintiffs’ strict liability or negligent manufacturing-defect claims. Therefore, the Drug Companies’ “Motion for Summary Adjudication” is, in reality, a motion for partial summary adjudication, and plaintiffs are entitled to a jury trial on all manufacturing-defect claims.

Second. The existence of disputed issues of material fact precludes summary judgment on plaintiffs’ strict liability and negligent failure-to-warn claims. Plaintiffs have produced evidence that the Drug Companies failed to warn of all known or scientifically knowable risks related to the patch, including (1) that patients can and do receive fatal fentanyl levels—far exceeding the mean maximal levels in the prescribing information—while properly using the patch,[2] (2) that properly indicated patients can experience sudden and inexplicable death while using the patch as prescribed, (3) the risk of defectively manufactured patches, and (4) the narrow range between a therapeutic and lethal dose of fentanyl. Furthermore, the testimony of Cardinal’s physician as to whether he would have changed his prescribing decision based on these warnings was equivocal, rendering summary adjudication on the reliance issue inappropriate.

Third. The Drug Companies are not entitled to summary adjudication on plaintiffs’ negligent design-defect claim. Contrary to the Drug Companies’ contention, California law permits negligent design-defect claims. The only authority to which the Drug Companies refer is Brown v. Superior Court, 44 Cal. 3d 1049 (1988), which they argue bars negligent design-defect claims concerning prescription drugs. But that decision merely barred (and only discussed) design-defect claims concerning prescription drugs based on strict liability. Indeed, the Fourth District Court of Appeals has recognized that Browns holding permits negligent design-defect claims. Moreover, California law permits design-defect claims premised on a design’s unnecessary, increased risk of manufacturing defects because that design “embodies excessive preventable danger.”

Fourth. The Drug Companies’ argument for summary adjudication on plaintiffs’ negligent misrepresentation claim fails for many of the same reasons their argument on plaintiffs’ warnings claims fail. As with the warnings claims, Cardinal’s physician offered mixed testimony related to his reliance on the Drug Companies’ prescribing information, and the import of his testimony is an issue for the jury to resolve.

Fifth. Plaintiffs have stated a claim for breach of express warranty because the Drug Companies represent in the package insert that a patient will receive a certain blood fentanyl level from their product. Despite proper use, Cardinal received a lethal level of fentanyl approximately ten times more than promised. The product’s failure to comply with this representation constitutes a breach of express warranty under California law.

Sixth. The Drug Companies’ assertion that plaintiffs’ implied warranty claims are impermissible under California law was rejected by the California Supreme Court in Carlin v. Superior Court, 13 Cal. 4th 1104, 1117-1118 (1998). Accordingly, their motion for summary adjudication on plaintiffs’ implied warranty claim must be denied.

 

STATEMENT OF FACTS

I. The Sandoz Patches

The Drug Companies manufacture, market, and distribute the Sandoz fentanyl transdermal system (“Sandoz patches”).[3] 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 (begins at pg. 34 of Plaintiffs’ Separate Statement in Opposition.) Properly functioning patches continuously deliver the requisite dose of opioid fentanyl through the skin to the patient’s bloodstream over a 72-hour period. (See id.) 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 ¶ 2.) The patches are intended to release fentanyl to the patient “from the reservoir at a nearly constant amount per unit time.” (PAF ¶ 3.)

At the time of Cardinal’s death, the patches were sold in various doses, such as 25, 50, 75, or 100 micrograms-per-hour (“mcg/hr”). (PAF ¶ 1.) Fentanyl, which is eighty to one hundred times more powerful than morphine, is a very potent narcotic drug with a narrow therapeutic index (i.e., the difference between a therapeutic dose and a fatal dose of fentanyl is small) that is used to treat moderate to severe chronic pain. (PAF ¶ 4.)

Each box of Sandoz patches is accompanied by an insert with full prescribing information. According to that prescribing information, a properly functioning 100 mcg/hr dosage strength fentanyl transdermal patch should produce a mean maximal fentanyl concentration of 2.5 ng/mL in a patient’s blood. (PAF ¶ 5.) Nowhere does the package insert warn that a properly-indicated patient may suddenly and inexplicably receive a lethal dose of fentanyl more than ten times the projected mean maximal concentration. (PAF ¶ 7.)

II. Cardinal’s Death

To treat Cardinal’s chronic pain, his physician, Dr. Naja Thota, prescribed 100 mcg/hr Sandoz fentanyl patches for him. (PAF ¶ 9.) On the morning of Cardinal’s death, his wife found him in bed in a “deep sleep” and could not wake him. (PAF ¶ 10.) Because it was time to change Cardinal’s Sandoz patch, Christian removed it. She did not replace the patch because it was difficult to affix the replacement patch unless Cardinal was in his wheelchair. (PAF ¶ 10.)

Later that morning, Christian returned to the room and found Cardinal breathing shallowly with blue lips. (PAF ¶ 10.) After unsuccessful attempts were made to resuscitate him, Cardinal was pronounced dead. The investigator with the medical examiner’s office collected several boxes of prescribed Sandoz patches from the Cardinal’s home. (PAF ¶ 11.) At autopsy, the medical examiner discovered the outline of a patch on Cardinal’s back. (PAF ¶ 12.) Neither the medical examiner nor his investigator found any evidence that Cardinal had misused or abused the Sandoz patch. (PAF ¶ 13.)

The San Diego County Medical Examiner’s office tested Cardinal’s blood and found a fentanyl level of 27 ng/mL (nanograms per milliliter). (PAF ¶ 14). Cardinal’s fentanyl-blood level of 27 ng/mL is more than ten times greater than the mean maximal fentanyl concentration of 2.5 ng/mL that should have resulted from a properly functioning 100 mcg/hr Sandoz patch. (PAF ¶ 5.) The San Diego County Medical Examiner concluded that fentanyl intoxication was a cause of Cardinal’s death and that the level of 27 ng/mL found in the blood was a level associated with fatalities. (PAF ¶ 15.) Moreover, Dr. J.C. Upshaw Downs, a forensic pathologist who has been employed as a medical examiner since 1989, will testify, based on his review of the autopsy report, toxicology analysis, and other records in this case, that “[t]here in no other legitimate independent acute primary cause of death in this case other than the acute fentanyl toxicity. In other words, but for the fentanyl, Cardinal would not have died when he did.” (PAF ¶ 16.)

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 along one edge of the patch. (PAF ¶ 17.) The FDA later inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems. (PAF ¶ 18.)

REDACTED

This long-standing history of Good Manufacturing Practices (“GMPs”) concerns and violations and inadequate oversight have resulted in repeated manufacturing failures and permitted defective fentanyl transdermal patches to enter the marketplace. (PAF ¶ 23.)

REDACTED

IV. This Lawsuit

In August 2008, plaintiffs brought this wrongful-death action against the Drug Companies. (See Compl.) Plaintiffs contend that Cardinal’s death was caused by his proper and prescribed use of a defective Sandoz patch, as the fatal levels of fentanyl in his blood and the medical examiner’s report indicate. Plaintiffs assert causes of action for (1) strict products liability, based on manufacturing defects and failure to warn; (2) negligence (including negligent design defect); (3) negligent misrepresentation; (4) breach of implied warranty of fitness; and (5) breach of express warranties. (See id.) The Drug Companies have brought this motion seeking partial summary adjudication on some causes of action, but not on plaintiffs’ claims of strict liability and negligence based on manufacturing defects.

ARGUMENT

The function of the trial court in ruling on a motion for summary judgment is to determine whether issues of fact exist, not to decide the merits of the issues or claims themselves. Walsh v. Walsh, 18 Cal. 2d 439, 441 (1941). In Molko v. Holy Spirit Association., 46 Cal. 3d 1092, 1107 (1988), the Supreme Court warned that “[s]ummary judgment is a drastic measure that deprives a losing party of a trial on the merits. It should therefore be used with caution, so that it does not become a substitute for trial. Roland v. Christian, 69 Cal. 2d 108, 111 (1968). To that end, the Drug Companies’ affidavits should be strictly construed and plaintiffs’ liberally construed. Stationers v. Dunn & Bradstreet, 62 Cal. 2d 412, 417 (1965). Any doubts as to the propriety of granting the motion should be resolved in plaintiffs’ favor. Slobojan v. W. Travelers Life Ins. Co., 70 Cal. 2d 432, 437 (1969).

I. Plaintiffs’ failure-to-warn claims should proceed because numerous genuine issues of material fact exist.

A. The Drug Companies failed to warn of several known or scientifically knowable risks associated with the Sandoz patches.

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, 1114-17 (1996). Negligence principles require the Drug Companies to warn of those risks that “a reasonably prudent manufacturer would have known and warned about.” Id. at 1113. The Drug Companies seek summary judgment on these claims contending that their package insert adequately warns of the risks associated with the patches. (Mem. at 6.) But, for the reasons below, the warnings accompanying the Sandoz patches fail to disclose several risks that were known or scientifically knowable.

1. The Drug Companies failed to warn of the risk of death associated with use of Sandoz patches by properly indicated patients.

Cheryl Blume Ph.D., an expert in the field of pharmaceutical product development and warnings, will testify to several different ways in which the Drug Companies failed to warn of known and scientifically knowable risks as required by California law. Dr. Blume will testify that the package insert should have contained “enhanced warnings describing the risk of sudden, inexplicable deaths following use by properly indicated patients.” (PAF ¶ 26.) Dr. Blume will explain that the Drug Companies were on notice, through a variety of sources, of a significant number of deaths associated with the proper and therapeutic use of fentanyl patches. (PAF ¶ 27.) More specifically, various post-marketing, adverse-event databases reported increases in overdoses, respiratory events, and fatalities associated with fentanyl patches. (PAF ¶ 28.) In fact, these databases include many reports in which patients died as a result of fentanyl toxicity even though the fentanyl patch was used correctly and according to the prescribing instructions. (Id.) Moreover, over 140 autopsies from medical examiners’ offices around the country, which were freely available to the Drug Companies, reveal deaths related to fentanyl toxicity with no indication of misuse or abuse of the fentanyl patch. (PAF ¶ 29.) Because of these numerous, known fatalities associated with proper use of the patch, Dr. Blume opines that “the Sandoz Fentanyl Transdermal label employed during the time of Cardinal’s prescriptions did not adequately warn of this fatal outcome with appropriate dosing.” (PAF ¶ 30.)

The Drug Companies respond that the risk of death is adequately addressed in the warnings related to “hypoventilation” and “respiratory depression” included in the package insert accompanying the Sandoz patches. (See Mem. at 6.) But Dr. Blume explains that the warnings related to hypoventilation and respiratory depression appear in the context of inappropriate or contraindicated use, and they do not adequately explain the risk of sudden death from proper and therapeutic use:

[T]he label [does not] sufficiently warn of the potential for serious adverse events (including sudden death) when the patch is properly used. Alza did mention the possibility of death associated with the use of fentanyl transdermal patches in the context of inappropriate use (abuse) or when used in contraindicated patients. This language inappropriately suggests that the risk of death is only associated with the use of fentanyl transdermal patches under one of the contraindicated circumstances. As such, prescribers and their patients could not have been aware of the potential serious risks associated with appropriate use of the product and could thus have been inappropriately reassured.

(PAF ¶ 31.)

Indeed, a review of the references to hypoventilation and respiratory depression in the Sandoz package insert reveals that these warnings are consistently limited by references to 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.

(PAF ¶ 32.)

The Drug Companies also argue that statements in the package insert related to the use of the fentanyl patch concurrently with other CNS depressants relieve them of liability. (Mem. at 7.) The insert, however, does not prohibit the use of the patch with Cardinal’s other medications and does not indicate that sudden death may occur in an opioid-tolerant patient, such as Cardinal, who had been prescribed a combination of CNS depressants for many years.[4] (PAF ¶ 33.) In fact, the package insert specifically contemplates that “patients may still require periodic supplemental doses of other short-acting analgesics,” and the dosing instructions encourage physicians to consider the patients “average daily use of a supplemental analgesic” when considering an increased fentanyl patch dosage. (PAF ¶ 34.) In short, nowhere on the label does it warn that a properly indicated, opioid-tolerant patient may suddenly and inexplicably die from use of the Sandoz patch, even if that individual is prescribed other CNS depressants.

The Drug Companies further contend that their label warns of “additional risks” associated with use of the patch by elderly, debilitated, or renally impaired patients. (Mem. at 7.) As an initial matter, the Drug Companies have presented no evidence that Cardinal suffered from a renal impairment (loss of kidney function) that specifically inhibited his ability to process fentanyl. To the contrary, Cardinal’s prescribing physician testified that he had no information to indicate that Cardinal’s kidneys were not processing the fentanyl properly. (PAF ¶ 35.) And the medical examiner, who found evidence of kidney disease at autopsy, could not say whether that disease “impaired [Cardinal’s] fentanyl excretion or metabolism.” (PAF ¶ 36.) Furthermore, as Cardinal’s prescribing physician testified, the warnings concerning elderly and debilitated patients focus on initial dosing and not on long-time patch users such as Cardinal:

Q: [The Drug Companies’ attorney] read to you from the sentence that said, “Since elderly, cachectic, or debilitated patients may have altered pharmacokinetics due to poor fat storage, muscles wasting may have altered pharmacokinetics, they should not be started on Fentanyl Transdermal Systems higher than 25 micrograms per hour unless they’re already tolerating around-the-clock opiod dose.” . . . . Did you start . . . Mr. Cardinal on fentanyl?

A: No, I did not. That’s why that . . . sentence doesn’t make any – –

Q: Does it even apply to Mr. Cardinal?

A: No. It does not apply to him. He was already on Fentanyl by the time he reached me.

Q: Is there anything in the package insert that you saw that warns you not to give fentanyl to a 70-year-old man who had been tolerating fentanyl for a long time and had clinically normal signs?

A: There’s nothing in the insert that stops me [from] giving fentanyl for this patient, no.

(PAF ¶ 37.)

In sum, as Dr. Blume explained at deposition, none of these veiled warnings reveal that proper and prescribed use of the patch may result in a sudden inexplicable death. (PAF ¶ 38.)

2. The Drug Companies failed to warn of the risks of defectively manufactured patches.

Besides failing to warn of the risk of death, the Drug Companies also failed to warn adequately of the risk of defectively-manufactured, leaking patches. As explained in the declaration of Dr. Blume, ALZA has had a lengthy history of manufacturing defective fentanyl patches. (PAF ¶ 39.)

REDACTED

In light of these problematic manufacturing processes, Dr. Blume has testified that “the labeling should note that there have been manufacturing concerns with the patches, and that patches have been released with breaches in them that have nothing to do with what the patient does with the patch, and that patients need to be on notice of that, physicians need to be on notice of that . . . . I think that physicians and patients need to be on notice that there have been manufacturing concerns with the patch which may lead to certain patches having breaches or cuts and release of the gel from the rate control membrane.” (PAF ¶ 42.)

The Drug Companies—having provided no case law indicating that a pharmaceutical manufacturer need not warn of the likelihood of manufacturing defects and leaking patches as described by Dr. Blume—assert, alternatively, that they did warn of these manufacturing defects by cautioning users not to use “damaged or cut fentanyl transdermal system patches” or patches with broken seals. (Mem. at 7-8.) Dr. Blume has explained, however, that this warning does not fully apprise a physician of the risks associated with defectively manufactured patches:

Q.: First, as an FDA approved statement regarding damaged or cut [fentanyl transdermal] patches, does that adequately inform physicians regarding the risk of using damaged or cut patches?

A.: I think it discusses patches that are visually damaged or cut. I don’t think it adequately describes that this has a manufacturing defect which has occurred with patches that haven’t been damaged or cut by the patient. . . . . I think that physicians and patients need to know that there have been manufacturing concerns with the patch which may lead to certain patches having breaches or cuts and release of the gel from the rate control membrane.

(PAF ¶ 42.)

In short, whether the Drug Companies knew of and adequately warned of these manufacturing defects is a fact issue that must be resolved by a jury.

3. The Drug Companies have also failed to warn of the narrow index between Sandoz patches’ efficacious and toxic levels.

The drug fentanyl has a narrow therapeutic index, meaning that it is a drug “in which there is either an overlap between therapeutic levels [and] toxic levels or a very small interval between therapeutic and toxic levels.” (PAF ¶ 4.) The Sandoz patch label in place at the time of Cardinal’s death does not warn of this narrow index between efficacious and toxic levels. (PAF ¶ 43.) Dr. Blume will testify that this narrow therapeutic index was a risk of which physicians should have been apprised:

Given the narrow and overlapping range between efficacious and toxic blood levels associated with [the Sandoz patch], its labeling omissions are surprising given the inclusion of this information in the labeling of related analgesics. Given these differences, prescribers could be inappropriately reassured of [the Sandoz Patch’s] safety.

(PAF ¶ 44.)

B. Dr. Thota’s deposition testimony is equivocal about whether he would have prescribed Sandoz patches had he known of their numerous defects.

Contrary to the Drug Companies’ assertion, a genuine issue of fact remains as to causation, that is, whether Dr. Thota would have prescribed the fentanyl patches had the Drug Companies warned him of the inherent fatal design and manufacturing defects in the Sandoz patches. Dr. Thota’s actions after Cardinal’s death belie his testimony that he would have prescribed fentanyl patches to Cardinal even if he received additional warnings. When asked whether, for purposes of prescribing Sandoz patches, he would want to know that “the machine and process used to make the patches is incapable of making patches without seal defects,” he answered, “Yes, sir.” (PAF ¶ 45.) In fact, he continued:

Actually, to tell the truth, in the recent one year or so, the amount of transdermal patches we are writing has decreased dramatically because of the overdose problems that we had.

Even in the hospital, in the pharmacy committee, we also formulated stating that, unless the patient had patches before, we can’t even put the patches in the hospital, that we made it very clear, not only for me, any other practitioners who wanted to put a patch on. If they write on the orders, we don’t put it right away because of the problems we are facing with the patches.

So the usage of patches has dramatically decreased in the last one, one and a half years in the hospitals, too. I work in Alvarado and Grossmont. Both we have very strict restrictions on Fentanyl patches.

(PAF ¶ 46.) Similarly, when asked why he had greatly reduced the number of patches that he had prescribed, he stated:

We have a lot of problems with the drug delivery system, and we had a couple of meetings in the hospital thinking—we’ve discussed and say that we have a few patients we lost on the Fentanyl patches. The drug delivery system is not working as [the Drug Companies] claim [it’s] supposed to work.

(PAF ¶ 47.) From these candid statements concerning Dr. Thota’s reluctance to prescribe fentanyl patches because of “overdose problems” he observed after Cardinal’s death, a jury could reasonably find that Dr. Thota would not have prescribed the patches for Cardinal had the Drug Companies warned him—while Cardinal was alive—of the patches’ fatal, inherent defects that caused the “overdose problems.”

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

So it is here. Although Dr. Thota testified that he would have prescribed Cardinal fentanyl patches even had he been provide additional warnings, a reasonable jury could determine otherwise based upon his reluctance to prescribe fentanyl patches after learning of the very defects that are at issue in this lawsuit. Dr. Thota testified (without any prompting from plaintiffs’ counsel) that, in light of the “overdose problems” from fentanyl patches, “in the recent one year or so, the amount of transdermal patches we are writing has decreased dramatically.” (PAF ¶ 46.) Indeed, he stated that physicians at the hospitals where he has privileges will now only prescribe the fentanyl patches if a patient was previously prescribed patches. (Id.) These “overdose problems” resulted from “a lot of problems with the drug delivery system,” (PAF ¶ 47), the exact problem that plaintiffs allege in this action. He now prescribes, as alternatives, “Oxycodone, Oxycontin, MS Contin,” and an oral form of fentanyl that is slowly released over time. (PAF ¶ 48.)

Dr. Thota’s testimony concerning his actions after Cardinal’s death renders his post-hoc assertion that he would have prescribed fentanyl patches for Cardinal even if he had known of the inherent fatal defects unlikely. None of the cases relied on by the Drug Companies indicate that summary judgment is proper where a physician actually changed his prescribing behavior after learning of the dangerous propensities of the drug at issue. At the very least, there is a genuine issue of disputed fact as to whether he would have done so. Based on his contradictory testimony, summary judgment is improper. It is for the jury to decide whether—in light of Dr. Thota’s current practice developed after “a lot of problems with the drug delivery system”—Dr. Thota would have prescribed fentanyl patches to Cardinal if he had known of those same inherent problems when Cardinal was alive.

II. Plaintiffs’ design-defect claim based on negligence is proper under California law.

Although California does not permit strict-liability claims against drug manufacturers for design defect, California permits plaintiffs’ design-defect claim based on negligence. The Drug Companies refer only to Brown v. Superior Court, 44 Cal. 3d 1049 (1988), for their argument that all design-defect claims—whether based on strict liability or negligence—are proscribed. (See Mem. at 10.) But Brown made clear that it prohibited only design-defect claims based on strict liability: “Our first and broadest inquiry is whether such a manufacturer may be held strictly liable for a product that is defective in design.” Brown, 44 Cal. 3d at 1054; see id. at 1061 (“We shall conclude that a drug manufacturer’s liability for a defectively designed drug should not be measured by the standards of strict liability.”). Indeed, not only did the Supreme Court never mention design defect claims based on negligence,[5] but the Fourth District Court of Appeals described Brown as holding that “[l]iability for defective design could not be premised on strict liability, but would require proof of negligence.” Artiglio v. Super. Ct., 22 Cal. App. 4th 1388, 1393 (4th Dist. 1994); see also Carlin, 13 Cal. 4th at 1129 (Kennard, J., concurring and dissenting) (noting that Brown . . . adopt[ed] a negligence standard for prescription drug design defects”).

The Drug Companies’ backup argument—that a design-defect claim cannot be premised on the fact that a design is subject to an unnecessary, increased risk of fatal manufacturing defects—also fails. (See Mem. at 10-11.) 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. This unnecessary risk would not exist if the Drug Companies had used a matrix, as opposed to a reservoir, design, which was available when they distributed the fentanyl patch that Cardinal used—an allegation in the complaint that the Drug Companies do not challenge on summary judgment. (PAF ¶ 49.) Indeed, in ALZA’s Citizen Petition to the FDA, it admitted (consistent with the Drug Companies’ current use of a matrix design for their patches) that “matrix products do afford some advantages over reservoir patches in terms of cosmetics, adhesion and elimination the possibility of gel leakage.” (PAF ¶ 50.) In short, plaintiffs’ contention that the Drug Companies negligently designed the Sandoz patches is permissible under California law and supported by the pleadings and summary-judgment evidence.

III. Issues of material fact exist concerning plaintiffs’ negligent-misrepresentation claim.

The Drug Companies are not entitled to summary adjudication on plaintiff’s negligent-misrepresentation claims. The tort of negligent misrepresentation requires “only the assertion, as a fact, of that which is not true, by one who has no reasonable grounds for believing it to be true” and justifiable reliance upon that fact. Conroy v. Regents of Univ. of Cal., 45 Cal. 4th 1244, 1255-56 (Cal. 2009). The Drug Companies argue that that (1) they made no misrepresentations and, at any rate, (2) Cardinal’s physician, Dr. Thota, did not rely upon any representations. (See Mem. at 11-13 (“Because plaintiffs have no evidence of any misrepresentations defendants made to Dr. Thota, on which he relied when making his prescription decision for Cardinal, the Court should grant summary adjudication . . . .”).) But, as demonstrated in Part I, supra, genuine issues of material fact exist as to whether the Drug Companies omitted certain warnings and instructions and whether Dr. Thota would have prescribed fentanyl to Cardinal had the Drug Companies not omitted this information. In interests of brevity, plaintiffs rely on the same arguments in Part I for their response to the Drug Companies’ challenge to their negligent-misrepresentation claim.

Moreover, the Drug Companies made affirmative misrepresentations in their package insert that the Sandoz patches would produce a mean maximum fentanyl blood concentration that was much lower that the lethal fentanyl concentration found in Decedent’s blood at the time of his death. (PAF ¶¶ 5-6.)[6] The Drug Companies did not have a reasonable basis for this representation.

REDACTED

The Drug Companies indicate that they never represented the maximum blood concentrations in postmortem samples. (Mem. at 12.) The Drug Companies attach no summary judgment evidence to indicate that postmortem testing of blood for fentanyl does not accurately reflect antemortem levels. And the competent summary judgment evidence suggest otherwise. Specifically, both the toxicologist that tested Cardinal’s blood and the pathologist that performed the autopsy have testified that they routinely rely on postmortem testing to determine antemortem levels. (PAF ¶ 53.)

IV. Plaintiffs have stated a claim for breach of express warranty because the package insert accompanying the Sandoz patch asserted that Cardinal would receive a level of fentanyl significantly less than the lethal dose that was delivered.

“Any 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 Leo Cardinal should expect to receive from a 100 mcg/hr fentanyl patch. 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 (plus or minus a standard deviation of 1.2) following the application of the 100 mcg fentanyl patch. (PAF ¶¶ 5-6.) And physicians are 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 ¶ 54.) Thus, doctors and their patients can rely on the fentanyl transdermal system to “release[] fentanyl at a nearly constant amount per unit time.” (Id.)[7] Instead of providing Cardinal with the promised fentanyl blood concentration of 2.5 ng/mL, Cardinal’s fentanyl level at autopsy was 27 ng/mL—more than ten times the promised concentration. (PAF ¶ 14.)

The Drug Companies argue that this express warranty claim fails because of Dr. Thota’s testimony that he did not rely on representations in the package insert. But, as described in Part II. B, supra, Dr. Thota indicated that he has actually reduced the number of fentanyl patch prescriptions he has written after learning of problems and deaths associated with the patch’s fentanyl delivery system. And he also contradicted himself at deposition, testifying at one point that he did rely on the package insert:

Q: When you prescribed the 100 microgram does for Mr. Cardinal, did you expect the product to perform or give him the dose the package insert said it would?

A: I believe so.

(PAF ¶ 55.)

This contradictory testimony and the related fact issue of causation must be sorted out at trial by a jury, not by this Court on summary adjudication. Accordingly, the Drug Companies’ motion should be denied.

V. The Drug Companies are not entitled to summary adjudication as to plaintiffs’ implied warranty claim.

The Drug Companies contend that plaintiffs’ implied warranty claim is barred as a matter of law and that plaintiffs have no evidence to support their claim. These arguments are without merit. Although the Drug Companies argue that Brown, 44 Cal. 3d at 1072, forecloses plaintiffs’ implied warranty claims, the Supreme Court rejected that argument in Carlin, 13 Cal. 4th at 1117-1118. In Carlin, the drug company argued that “Brown precludes any such cause of action for breach of warranty against manufacturers of prescription drugs.” Id. The Supreme Court responded, “Not so. In Brown, we held only that ‘a manufacturer of prescription drugs is not strictly liable for injuries caused by such a defect that is neither known nor knowable at the time the drug is distributed’ and that, accordingly, an action for breach of warranty for such unknown defect does not lie against drug manufacturers.” Id. at 18 (emphasis original). Plaintiffs’ implied warranty claims are based on the Drug Companies’ warranty that “the Cardinal Patch, including each and every component part thereof, was fit for the purpose for which it was to be used and was free from design and manufacturing defects to consumers and users.” (Compl. ¶ 33.) Because plaintiffs do not premise any of their implied warranty claims on defects that were “neither known nor knowable at the time that [the Sandoz patches were] distributed,” their implied warranty claim can proceed.

A seller impliedly warrants that the goods (1) are “fit for the ordinary purposes for which such goods are used” and (2) “conform to the promises or affirmations of fact made on the container or label.” Cal. Comm. Code § 2314. In Part IV, supra, plaintiffs presented ample evidence to show that the fentanyl patch did not conform to promises made in the package insert concerning mean maximal levels of fentanyl that the patch delivers. Furthermore, according to Randall C. Baselt’s “Disposition of Toxic Drugs and Chemicals in Man,” (a treatise widely consulted by medical examiners to determine if a drug played a role in a person’s death), post-mortem, fatal blood concentration for fentanyl ranges from 3 ng/mL to 28 ng/mL. (PAF ¶ 56.) Cardinal received a fentanyl blood concentration of 27 ng/mL from his Sandoz patch. (PAF ¶ 14.) Thus, his Sandoz patch delivered a fentanyl-blood level at the high-end of the scientifically-observed, fatal range. As a result, a jury should decide whether such a product is “fit for the ordinary purposes for which” such a product is used.

CONCLUSION

Plaintiffs respectfully request the Court to deny the Drug Companies’ Motion for Summary Judgment and grant them such other and further relief to which they may be justly entitled.

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


[1] The defendants are ALZA Corporation and Sandoz, Inc.

[2] In this case, the prescribing information that came with the 100 mcg patch that Cardinal was using at the time of his death indicated that the patch would produce a mean maximal blood fentanyl concentration of 2.5 ng/mL. While properly using the patch, Cardinal died with a fentanyl level of 27 ng/mL, a level at the high end of the reported lethal range and over 10 times higher than the mean maximal level listed in the prescribing information.

[3] 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. (PAF ¶ 57.)

[4] Dr. Thota, Cardinal’s prescribing physician, testified that Cardinal had been on a combination of fentanyl patch, morphine, diazepam, and amitryptyline for a long period of time preceding his death and that he was “fully alert” on that combination of medications and that Cardinal never appeared to have trouble metabolizing these drugs. (PAF ¶ 51.)

[5] The Court referred only to section 402A of the Restatement (Second) of Torts, which concerns strict products liability, see, e.g., Brown, 44 Cal. 3d at 1056-57, 1065, not section 398 of the Restatement (Second) of Torts, which concerns negligent products liability.

[6] In interests of brevity, Plaintiffs rely on the arguments found in Part IV, infra, in support of this response.

[7] Bob Gale, the inventor of the fentanyl patch for Defendant ALZA Corporation, testified that the package insert sets forth the amount of fentanyl intended to be delivered and that “it was designed and intended to deliver a therapeutic level of fentanyl in patients using it.” (PAF ¶ 6.) And Gale specifically notes that the package insert (including graphs) provides the floor and ceiling for expected fentanyl blood levels. (PAF ¶ 6.)