Response to Defendants’ Motion for Summary Judgment

Auburn v. Johnson & Johnson

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 and marketing defects. It also addresses the issue of whether a plaintiff must identify a specific defect in order to make a claim for strict product liability based on an alleged manufacturing defect. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

SUPERIOR COURT OF CALIFORNIA COUNTY OF SACRAMENTO
Robert Auburn, M.D.,Plaintiff,v.

JOHNSON & JOHNSON, a New Jersey Corporation, ALZA CORPORATION, a Delaware Corporation, NOVARTIS PHARMACEUTICALS CORPORATION, a New York Corporation, Sandoz, Inc., a Colorado Corporation, and DOES 1 through 100, inclusive,

Defendants.

Case No.: 34-2008-00008440-CU-PO-GDSPLAINTIFF’S MEMORANDUM IN OPPOSITION TO DEFENDANTS’ MOTION FOR SUMMARY ADJUDICATION[Complaint filed on April 11, 2008]

Date: March 30, 2010

Time: 2:00 p.m.

Dept.: 53

Judge: Hon. Loren McMaster

TABLE OF CONTENTS

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

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

I. The Drug Companies manufactured, marketed, and distributed

the Sandoz patches …………………………………………………………………….2

II. Vickie Auburn dies with a fatal fentanyl-blood level …………………………………2

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

IV. An inspection of the fentanyl patch worn by Decedent reveals

That it was defective and leaked fentanyl gel …………………………………………5

V. A properly manufactured patch should not have given Decedent a

lethal blood-fentanyl level of 16 ng/mL ………………………………………………6

VI. The Drug Companies’ warning are inadequate ……………………………………….7

VII. Additional warnings from the Drug Companies would have changed

Decedent’s physician’s decision to prescribe her fentanyl patches ……………………9

ARGUMENT AND AUTHORITIES ………………………………………………………………..12

I. The Drug Companies have failed to comply with California Rules of Court, Rule

3.1351. Therefore, their notice and separate statement violate due process …………12

II. The plaintiff’s failure-to-warn claims should proceed because numerous

genuine issues of material fact exist …………………………………………………12

A. The Drug Companies failed to warn Dr. Hendrickson of several risks

associated with the Sandoz patches of which he was unaware ………………12

B. Had the Drug Companies warned about the risk of elevated fentanyl

Levels and manufacturing defects, Dr. Hendrickson would not have

Prescribed the Sandoz patches to Decedent ………………………………….13

C. Had the Drug Companies provided additional warnings, Dr. Hendrickson

would have considered them …………………………………………………15

III. The plaintiff’s manufacturing-defect claims should proceed because

numerous genuine issues of material fact exist ………………………………………16

A. Conflicting testimony exists concerning whether the specific patch

Decedent was wearing had a visible defect …………………………………..16

B. Even without a visible defect, the Sandoz patch’s failure to perform

as intended creates an issue of fact for the jury to resolve ……………………17

CONCLUSION ………………………………………………………………………………………19
TABLE OF AUTHORITIES

CASES

Carlin v. Super. Ct., 13 Cal. 4th 1104, 1114-17 (1996) ………………………………………………12

Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004) ……………………………………………..15

Barker v. Lull Eng. Co., 20 Cal. 3d 413, 429 (1978) …………………………………………………17

McCabe v. Am. Honda Motor Co., Inc., 100 Cal. App. 4th 1111, 1120 (2002) ……………………..17

Gonzalez v. Autoliv ASP, Inc., 154 Cal. App. 4th 780, 792 (2007) ………………………………….17

Kunnemann v. Janssen Pharmaceutica Products, L.P., No. 05-C-3211,

2008 U.S. Dist. LEXIS 101724 (N.D. Ill. Dec. 2, 2008) …………………………………….18

(Pursuant to Rule 3.1113(i) a copy of this case is attached hereto as Exhibit A.)

 

RULES

 

California Rules of Court, Rule 3.1351 ………………………………………………………………12

 

INTRODUCTION

Vickie Lynn Auburn (“Decedent”) received a fatal dose of fentanyl from a defective Sandoz fentanyl pain patch designed, manufactured, and distributed by the defendants (the “Drug Companies”). In fact, the defective patch gave Decedent a lethal blood concentration of fentanyl that was more than five times higher than a properly designed and manufactured patch should have given her. Decedent’s husband, Robert Auburn, M.D. (“Dr. Auburn”) asserts strict-products-liability claims against the Drug Companies because the patch (1) was defectively manufactured, and (2) lacked adequate warnings and instructions. He also asserts negligence claims because the Drug Companies negligently designed, manufactured, marketed, sold, distributed, and misrepresented the Sandoz patch. Finally, he asserts a claim for breach of the express warranty of merchantability.

In their partial motion for summary adjudication, the Drug Companies contend that they are entitled to judgment as a matter of law on the plaintiff’s causes of actions “to the extent they are based on a failure to warn and a manufacturing defect.” (Defs.’ Mot. for Summ. Adjudication at 2.) The Drug Companies have not moved for summary adjudication on plaintiff’s claim that their product was negligently designed. Therefore, the Drug Companies’ “Motion for Summary Adjudication” is, in reality, a motion for partial summary adjudication, and plaintiff is entitled—at the very least—to a jury trial on his claim of negligent design. But because disputed issues of material fact preclude summary adjudication on the plaintiff’s manufacturing-defect and failure-to-warn claims, the plaintiff is entitled to a jury trial as to all of his claims.

As to the plaintiff’s warnings claims, he has 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) that properly indicated patients can experience sudden and inexplicable death while using the patch as prescribed, and (3) the risk of defectively manufactured patches. The Drug Companies do not challenge the sufficiency of this evidence. Instead, they argue that Dr. Hendrickson, the physician that prescribed Decedent’s fentanyl patch, would not have changed his prescribing decision had these additional warnings been issued. (Defs.’ Mot. for Summ. Adjudication at 7-12.) This argument fails because Dr. Hendrickson was clear that he would not have prescribed the patch had he been given these additional warnings. Thus, a fact issue exists on the plaintiff’s failure-to-warn claims, and summary adjudication must be denied.

As to the plaintiff’s manufacturing-defect claim, the Drug Companies contend that an opinion from their paid expert that the patch was not defective entitles them to summary adjudication. This argument fails for two reasons. First, summary adjudication must be denied because the plaintiff’s expert has also examined the patch worn by Decedent, and he concluded that it was defective and leaked fentanyl gel. Second, even without this expert testimony, the plaintiff would be entitled to a jury trial on his manufacturing claim because the Drug Companies’ patch delivered a level of fentanyl to Decedent much greater than was intended or designed. Under California law, this performance failure entitles the plaintiff to proceed to a jury on his claim of manufacturing defect.

STATEMENT OF FACTS

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

The Drug Companies manufacture, market, and distribute the Sandoz fentanyl transdermal system (“Sandoz patches”).[1] Sandoz patches are transdermal prescription drugs applied to the patient’s skin and used to treat chronic pain. (See Plaintiff’s Separate Statement of Additional Material Facts (“PAF”) ¶¶ 1-2 (begins at pg. 16 of Plaintiff’s 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. Vickie Auburn dies with a fatal fentanyl-blood level.

To treat Decedent’s chronic pain, her physician, Dr. Jay Hendrickson, prescribed her two 100 mcg/hr Sandoz fentanyl patches, for a total dosage of 200 mcg/hr. (PAF ¶ 17.) Because of concerns about the strength of the medication, Decedent had reduced her dose and was using only one, 100 mcg/hr fentanyl patch when she died. (PAF ¶ 16.) On May 21, 2007, she was found dead in her automobile, with one, 100 mcg/hr fentanyl patch on her arm. (PAF ¶ 18.)

An autopsy was performed, and a gross and microscopic examination of Decedent’s body revealed no natural or traumatic causes of death, and Decedent’s internal organs appeared normal and do not account for her death. (PAF ¶ 19.) A nationally-accredited forensic laboratory tested Decedent’s blood and found a fentanyl level of 16 ng/mL (nanograms per milliliter). (PAF ¶ 20). A treatise relied on by both the forensic pathologist that performed the autopsy and the forensic toxicologist that tested and analyzed Decedent’s blood specimen, indicates that the average blood-fentanyl level in fatal fentanyl cases is 8.3 ng/mL—approximately half of the level of fentanyl found in Decedent’s blood. (PAF ¶ 21.) Another study, focused specifically on adult deaths attributable to transdermal fentanyl patch use, found fatal levels ranging from 4 to 54 ng/mL, with an average fatal level of 18 ng/mL, a level just slightly higher than Decedent’s fatal concentration. (PAF ¶ 22.) The forensic pathologist who conducted the autopsy concluded that Decedent’s death was caused solely by “acute fentanyl intoxication,” and this was the sole cause of Decedent’s death determined by the Department of Coroner for the County of Sacramento. (PAF ¶ 23.)

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 ¶ 24.) The FDA later inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems. (PAF ¶ 25.)

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.

REDACTED

IV. An inspection of the fentanyl patch worn by Decedent reveals that it was defective and leaked fentanyl gel.

Dr. John D. Jarrell, Ph.D., PE, a recognized multi-discipline engineering expert and biomedical research doctor in basic science, materials, medical devices, and mechanical engineering, inspected the fentanyl patch worn by Decedent when she died. (PAF ¶ 36.) Dr. Jarrell is familiar with the design of the patch. (PAF ¶ 37.) He has direct experience with the use and inspection of fentanyl patches and has inspected multiple examples of new and used fentanyl patches. (PAF ¶ 37.) He has personally inspected ALZA’s plant and the equipment used for the manufacture of Duragesic and the generic Sandoz fentanyl patches. (PAF ¶ 37.) He has reviewed the manuals related to this equipment, the Standard Operating Procedures used the manufacture of patches, and the Fentanyl (FFS) In-Process Inspection and Defect Response Procedure. (PAF ¶ 37.) He has also observed the operation of this equipment in the manufacture of fentanyl patches. He has seen examples of patch defects, including “cut system, gel exposed,” “wrinkles,” “gel in the system seal area,” “unsealed channels in system seal area,” “gel exposed, slice in the polyester,” and “folded backing of trilaminate system.” (PAF ¶ 37.)

Dr. Jarrell’s patch inspection of Decedent’s patch involved visual examination with gloved hands as well as standard and macrophotography under various lighting conditions and at various angles. (PAF ¶ 38.) Dr. Jarrell’s inspection revealed that the exterior of the patch is covered in dried gel, clearly identified in photographs taken of the surface of the patch. (PAF ¶ 39.) In other areas of the patch, the dried gel formed a continuous film on the surface of the patch and “glued” folded edges of the patch together. (PAF ¶ 39.) The appearance of this dried gel is consistent with that of dried hydroxyethyl cellulose, used in combination with fentanyl and alcohol to form the gel of the reservoir. (PAF ¶ 39.) Dr. Jarrell also noted dried gel extending beyond the edges of the patch. (PAF ¶ 39.) Dr. Jarrell concludes that it is clearly evident that gel leaked from the patch and beyond the borders of the patch. (PAF ¶ 39.)

With a properly-manufactured patch, the rate limiting membrane and occlusive backing are intended to contain the gel within the reservoir. (PAF ¶ 40.) A breach in the reservoir is needed for the gel to leak out. (PAF ¶ 40.) Dr. Jarrell identified several defective regions of Decedent’s patch as the most likely locations from which the gel leaked. (PAF ¶ 40.) Based on Dr. Jarrell’s inspection of the Decedent’s patch and exemplar fentanyl patches, his training in materials science and engineering, and his experience and knowledge of the manufacturing processes and the materials used in construction of the patch, Dr. Jarrell has concluded that the gel in Decedent’s fentanyl patch leaked. (PAF ¶ 41.) This is clearly demonstrated by the fact that the patch is essentially empty, the presence of dried gel on the surfaces and edges of the patch, and the identification of several defects on the patch as likely locations of the leakage. (PAF ¶ 41.)

V. A properly manufactured patch should not have given Decedent a lethal blood-fentanyl level of 16 ng/mL.

Decedent should not have received a fatal blood-fentanyl level of 16 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 ¶ 9 (emphasis added).) Table A then shows the peak, mean maximal concentration for a 100 mcg/hr patch to be 2.5 ng/mL. (PAF ¶ 9.) 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 defendants 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 ¶ 10 (emphasis added).) The graph above Table A then shows that with repeated applications of a 100 mcg/hr patch the patient reaches a mean (not peak) fentanyl level of something less than 2 ng/mL. (PAF ¶ 13.) Thus, according to the Drug Companies’ witnesses and literature, a properly functioning 100 mcg/hr Sandoz patch should not have given Decedent a blood-fentanyl level of 16 ng/mL.

VI. The Drug Companies’ warnings are inadequate.

Kenneth R. Laughery, Ph.D., an expert in the field of psychology, human factors, 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. Specifically, Dr. Laughery will testify that the 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 ¶ 50.) 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 ¶ 51.) Moreover, nowhere does the package insert warn that a properly-indicated patient may suddenly and inexplicably receive a lethal dose of fentanyl more than five times the projected mean maximal concentration of 2.5 ng/mL. (PAF ¶ 14.)

Although the Drug Companies point to certain warnings related to hypoventilation and respiratory depression,[2] a review of 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 ¶ 49 (emphasis added).)

In sum, none of these warnings 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 may result in death, and (3) there is a risk of receiving a defectively manufactured and potentially-lethal product.

VII. Additional warnings from the Drug Companies would have changed Decedent’s physician’s decision to prescribe her fentanyl patches.

Dr. Hendrickson, the physician that prescribed Decedent her fentanyl patch, has testified that he is familiar with the warnings and contraindications for fentanyl patches, and that he stays apprised of changes to those warnings:

Q. Have you read the – either the package insert itself or the PDR or other online sources where the warnings are repeated?

A. At one point, yes.

Q. Are you familiar with the warnings and contraindications for fentanyl patches?

A. Yes.

Q. Do you follow those warnings and contraindications?

A. Yes.

Q. If . . . there’s a black box warning that says don’t do this with the fentanyl patch, is that a warning that you follow as a doctor?

A. Yes.

Q. Do you use any online sources to keep up-to-date with warnings and risks about particular drugs?

A. Yes.

Q. What online sources do you use?

A. I use Drugs 2009 . . . . Drugs 2009 is – how is the medication going to be worked into a clinical practice.

Q. Does Drugs 2009 contain information that would be in a black box warning?

A. Yes. Yes, it does.

Q. Do you keep abreast of black box warnings for fentanyl?

A. Yes, I do.

Q. Is it likely that you did not read [the package insert] after 2005?

A. I can’t recall everything that I read and so – I mean, we do keep on everything or try to keep [up] on as much as possible, but, again, I can’t cite everything that I’ve read.

(PAF ¶ 42.)

Dr. Hendrickson was very clear that he would want to be warned about the risk that a 100 mcg/hr might actually deliver more than 100 mcg/hr of fentanyl, and Dr. Hendrickson testified that if there was a risk that the patches could deliver fatal fentanyl levels, he would not have prescribed them to Decedent.

Q. Is it important to you as a doctor to know that if you prescribe a . . . hundred microgram per hour patch, that patch will actually give a patient approximately a hundred micrograms per hour?

A. Yes.

Q. If, because of manufacturing defects or design defects of otherwise, patches can give patients wildly elevated fentanyl levels, if that can happen, and I want you to assume it can, is that something that would be important to you as a doctor to know?

A. Yes, it’s something I would want to know.

Q. If there were a warning in the package insert from the manufacturers of the fentanyl patch that said: a certain percentage of our fentanyl patches will malfunction and give patients a fatal fentanyl level, is that something you would want to know?

A. Yes.

Q. If that warning were in the package insert, i.e. a certain percentage of our patches are going to malfunction and give patients a fatal fentanyl level, would you have prescribed or instructed a patient to use a different brand of patch?

A. I would not prescribe that patch.

Q. So as a doctor, is it important for you to be able to rely on fentanyl patches that you prescribe giving patients the dose indicated in the package insert?

A. Yes.

Q. If you could not rely on . . . fentanyl patches to give patients the indicated dose, and there was a warning in the package insert to that effect, saying the levels of fentanyl may vary widely, would you prescribe the patch?

A. I would not prescribe that patch.

(PAF ¶ 43.) Dr. Hendrickson further testified that he would not have prescribed the patches to Decedent had he been warned of the risk of manufacturing defects:

Q. If it were true that the company that makes these patches admits that the machine and processes that it uses to make the patch is incapable of producing patches without seal defects that can allow gel to leak out of the patches, which it admits can cause a fatal fentanyl overdose, is that something that you would want to be warned about as a physician?

A. Yes, I would.

Q. If in addition to the warning about the possibility of leaking patches causing a fatal fentanyl overdose, there was a second sentence that said leaking patches are inherent in the manufacture of this product, and a certain percentage of patches that reach your patients will have this defect, would you have prescribed these patches for Ms. Auburn?

A. I would not prescribe those patches.

(PAF ¶ 44.) Dr. Hendrickson also added that he would want to be specifically alerted if death were an adverse event associated with use of the patch.

Q. If . . . the company that makes the patch, knew that death were an adverse event associated with the patch, I want you to assume that’s true, would you want that adverse event included in the adverse event table as a prescribing doctor?

A. Yes, I would like to know that.

(PAF ¶ 45.)

ARGUMENT AND AUTHORITIES

I. The Drug Companies have failed to comply with California Rules of Court, Rule 3.1351. Therefore, their notice and separate statement violate due process.

 

Rule 3.1350, specifically requires that the Notice of Motion for Summary Adjudication, “the specific cause of action affirmative defense, claims for damages, or issues of duty must be stated specifically in the notice of motion and be repeated, verbatim, in the separate statement of undisputed material facts.” (California Rules of Court, Rule 3.1351.) The defendants’ notice and separate statement fails to comply with this rule. The separate statement simply lists facts without identifying which facts are applicable to which cause of action. As such, this party has had to guess as to which facts are intended to apply to each cause of action. The defendants’ failure constitutes improper notice and is therefore a violation of due process. On that basis alone the motion should be denied.

II. The plaintiff’s failure-to-warn claims should proceed because numerous genuine issues of material fact exist.

 

A. The Drug Companies failed to warn Dr. Hendrickson of several risks associated with the Sandoz patches of which he was unaware.

 

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 plaintiff contends that the Drug Companies failed to warn of the risk that the fentanyl patch can “deliver lethal amounts of fentanyl” and of the “potential manufacturing defects [that the Drug Companies] knew may exist in the product.” (First Am. Compl. ¶¶ 12, 23.) The plaintiff has set forth evidence that these risks exist, and that the Drug Companies knew about them. (PAF ¶¶ 24-35, 50.) With their motion, the Drug Companies do not challenge the existence of these risks. Instead, they assert that their failure to warn of these risks did not cause Decedent’s death. (Defs.’ Mot. for Summ. Adjudication at 7.)

B. Had the Drug Companies warned about the risk of elevated fentanyl levels and manufacturing defects, Dr. Hendrickson would not have prescribed the Sandoz patches to Decedent.

The Drug Companies assert that that Dr. Hendrickson “already knew and appreciated the risks of the Sandoz Patch when he prescribed it to Mrs. Auburn.” (Defs.’ Mot. for Summ. Adjudication at 7.) But in his deposition, Dr. Hendrickson specifically testified that he was not aware of a risk that the Sandoz patches could deliver fatal fentanyl levels in excess of the prescribed dosage strength, and that if he had been aware of this possibility, he would not have prescribed the patches to Decedent. (PAF ¶ 43.) He further testified that he was unaware of the risks that these patches can malfunction and deliver elevated fentanyl levels to patients. (PAF ¶ 44.) Had he been alerted to these risks, he would not have prescribed the fentanyl patches to Decedent. (PAF ¶ 44.) He also testified that he would want to be specifically alerted if death were an adverse event associated with use of the patch, and that the package insert does not warn of death as an adverse event. (PAF ¶ 45.)

The Drug Companies ignore Dr. Hendrickson’s testimony on these points and instead argue that he was more generally aware of a risk of death associated with fentanyl patches. (Defs.’ Mot. for Summ. Adjudication at 8.) They contend he knew that there was a risk of death with fentanyl patches and that there was a risk of death in prescribing fentanyl patches with other medications. (See id.) But Dr. Hendrickson’s testimony reveals that while he was aware of the risk of death to patients who were not opioid tolerant or who were first starting on the medications, he was not aware of the risk of death to a properly-indicated, opioid-tolerant patient:

Q. Why don’t you start opioids on naïve patients?

A. 25 micrograms of fentanyl may overdose them.

Q. You’re aware that the risk of fentanyl patches, transdermal patches is death; is that right?

A. As with any opioid medication, yes.

. . .

Q. All right. Doctor, getting back to fentanyl. You prescribed fentanyl to Mrs. Auburn knowing that there was a risk of death associated with fentanyl, correct?

A. Yes.

Q. You also knew that prescribing fentanyl in combination with the Valium and Percocet, that there was an increased risk of central nervous system depression with a combination of all three of those drugs?

A. When you first start those medications, yes.

(PAF ¶ 46 (emphasis added).) And, as noted above, Dr. Hendrickson was very clear that had he been warned of the risk that the Drug Companies fentanyl patches could deliver a fatal overdose, he would not have prescribed them. (PAF ¶¶ 43-45.)

The Drug Companies also contend that their warning pertaining to “the use of damaged, cut or leaking” patches somehow apprised Dr. Hendrickson of the likelihood of a manufacturing defect or the failure of the fentanyl delivery system. (Defs.’ Mot. for Summ. Adjudication at 8.) But, Dr. Hendrickson did not testify that this provided him with an adequate warning about potentially defective patches:

Q. So would you say, Doctor, that the package insert gives you adequate warning about the leaking patches?

A. I don’t know if I can comment on that. I don’t know what you mean by adequate.

(PAF ¶ 47.) And, contrary to the Drug Companies’ contention, he specifically testified that a warning about the risk of manufacturing defects leading to fatal fentanyl overdoses would have changed his prescribing decision. (PAF ¶ 44.) Dr. Hendrickson’s testimony that his prescribing decision would have been altered is all that California law requires, and the Drug Companies’ motion should be denied.

C. Had the Drug Companies provided additional warnings, Dr. Hendrickson would have considered them.

The Drug Companies further contend that Dr. Hendrickson did not rely on any of their written warnings. Specifically, the Drug Companies focus narrowly on Dr. Hendrickson’s testimony about whether or not he read their specific, physical package insert prior to prescribing Decedent her fentanyl patches. (Defs.’ Mot. for Summ. Adjudication at 9 (“Dr. Hendrickson did not rely on the package insert when he prescribed the Sandoz patch to decedent . . . .”).) As the case law cited by the Drug Companies indicates, the plaintiff must simply show that a “stronger warning would . . . have altered the conduct of the prescribing physician,” not that a prescribing physician actually read a physical package insert. Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004). Dr. Hendrickson was very clear that he keeps up with the warnings pertaining to fentanyl patches and that he follows those warnings:

Q. Are you familiar with the warnings and contraindications for fentanyl patches?

A. Yes.

Q. Do you follow those warnings and contraindications?

A. Yes.

Q. If . . . there’s a black box warning that says don’t do this with the fentanyl patch, is that a warning that you follow as a doctor?

A. Yes.

Q. Do you use any online sources to keep up-to-date with warnings and risks about particular drugs?

A. Yes.

Q. What online sources do you use?

A. I use Drugs 2009 . . . . Drugs 2009 is – how is the medication going to be worked into a clinical practice.

Q. Does Drugs 2009 contain information that would be in a black box warning?

A. Yes. Yes, it does.

Q. Do you keep abreast of black box warnings for fentanyl?

A. Yes, I do.

 

(PAF ¶ 42.) And he has testified that if the defendants had provided warnings about the lack of reliability with their product and the risk of manufacturing defect, he would not have prescribed fentanyl patches to Decedent. (PAF ¶¶ 43-44.) Moreover, Dr. Hendrickson’s testimony that he still prescribes fentanyl patches today, does not mean that his prescribing decision would not have changed had he been given a proper warning. As Dr. Hendrickson explained at his deposition, he is not in a position to know whether or not Ms. Auburn received a defective, leaking patch or whether ALZA produces defective, leaking patches that should be warned of. (PAF ¶ 48.) But when asked to assume that ALZA does produce deadly, defective patches, he stated very clearly that he would want to be warned and that he would not have prescribed the patch to Decedent. (PAF ¶¶ 43-44.) In sum, Dr. Hendrickson’s inability to specifically remember if he looked at a physical copy of a package insert does not entitle the Drug Companies to summary adjudication on the plaintiff’s warnings claims because Dr. Hendrickson testified that he keeps up with fentanyl-patch warnings through online and other sources.

III. The plaintiff’s manufacturing-defect claims should proceed because numerous genuine issues of material fact exist.

 

A. Conflicting testimony exists concerning whether the specific patch Decedent was wearing had a visible defect.

The Drug Companies contend that the plaintiff cannot establish the existence of a manufacturing defect because the Drug Companies’ paid expert, Maureen Reitman, has inspected the patch and opined that it was not defective. (Defs.’ Mot. for Summ. Adjudication at 12-13.) But the plaintiff’s expert also inspected the patch worn by Decedent and reached the opposite conclusion—creating a fact issue for the jury on the issue of manufacturing defect. Specifically, John D. Jarrell, PhD, PE, a recognized multi-discipline engineering expert and biomedical research doctor, who is familiar with the design, specifications, and manufacture of the patch, inspected the patch worn by Decedent when she died. (PAF ¶¶ 36-37.) Dr. Jarrell identified and photographed several areas of the patch containing dried gel—establishing that fentanyl-containing gel leaked from the patch. (PAF ¶¶ 38-39.) He then specifically identifies and photographs several defective areas of the patch from which the fentanyl gel may have leaked. (PAF ¶¶ 40-41.) The conflicting opinions of Dr. Jarrell and Dr. Reitman create a fact issue that must be resolved by the jury.

B. Even without a visible defect, the Sandoz patch’s failure to perform as intended creates an issue of fact for the jury to resolve.

Even if the plaintiff did not have the evidence of a visible manufacturing defect outlined by Dr. Jarrell, he would still be entitled to proceed to jury trial on a manufacturing-defect claim because the patch delivered a lethal, and unintended, level of fentanyl to Decedent. Under California law, “a manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.” Barker v. Lull Eng. Co., 20 Cal. 3d 413, 429 (1978). A manufacturing defect “is often demonstrated by showing the product performed differently from other ostensibly identical units of the same product line.” McCabe v. Am. Honda Motor Co., Inc., 100 Cal. App. 4th 1111, 1120 (2002); accord Gonzalez v. Autoliv ASP, Inc., 154 Cal. App. 4th 780, 792 (2007).

Here, Decedent received a lethal blood-fentanyl level of 16 ng/mL from her patch, which the Sacramento County Coroner determined to be the cause of her death. (PAF ¶¶ 20-23.) Moreover, the Package Insert accompanying the patch shows the mean/maximal level from one, 100 mcg/hr patch to be 2.5 ng/mL, and the Sandoz patch inventor has testified that this is the peak plasma level for a properly functioning patch. (PAF ¶¶ 9, 12.) Moreover, the package insert sets forth a graph indicating the average blood-fentanyl levels over time for a patient using one, 100 mcg/hr patch are less than two ng/mL. (PAF ¶ 13.) Based on this evidence a jury could fairly infer that Decedent, who was found with a 16 ng/mL blood-fentanyl level while wearing one, 100 mcg/hr patch, received a defective product that failed to perform as intended. See Barker, 20 Cal. 3d at 429; McCabe, 100 Cal. App. 4th at 1119; Gonzalez, 154 Cal. App. 4th at 792.

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

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

Id. at *37-38. California law is not different on this point, and summary adjudication should likewise be denied in this case.

CONCLUSION

For the foregoing reasons, the plaintiff respectfully requests that Defendants’ 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® patch, and both the Duragesic® and Sandoz patch are produced at the same facility are identical. ALZA is responsible for the contents of the package insert that comes with the Sandoz fentanyl patch. (PAF ¶ 52.)

[2] See Defs.’ Mot. for Summ. Adjudication at 5-6.