Response to Defendants’ Motion for Summary Judgment

Fusco v. Alza

Description: This brief was filed in Missouri federal court in response to a summary judgment motion filed by the defendants in a fentanyl pain patch case. The response generally addresses issues relating to manufacturing, design and marketing defects in terms of negligence and strict product liability. It also addresses the use of circumstantial evidence to prove a manufacturing defect. Finally, the response addresses the applicability and effect of the learned intermediary doctrine to plaintiff’s warning claims. This brief was filed by Heygood, Orr & Pearson on behalf of their client.

for the Eastern District of Missouri
Southeast Division
KEICIA MARIE FUSCO, et al.,Plaintiffs




Civil Action No. 1:09-CV-0029-CASJURY TRIAL DEMANDED




Contrary to the impression given in Defendants’ motion for summary judgment, there is a significant amount of evidence that a defective pain patch designed, manufactured, and marketed by Defendants killed Barbara Province by delivering a fatal dose of fentanyl. There is also ample evidence ruling out the possibility that Ms. Province died from abusing fentanyl. Defendants’ motion simply ignores all of this evidence and asks the Court to resolve all issues of fact in their favor. This is an inappropriate request at the summary judgment phase, and a jury must resolve the disputed factual issues raised in Defendants’ motion.

Defendants have moved for summary judgment, arguing that (1) there is no evidence that the patch Ms. Province was wearing when she died suffered from a defect; and (2) Plaintiffs’ warns-based claims fail because the learned-intermediary doctrine bars them. Neither of these arguments is correct. First, Missouri law allows a plaintiff to establish a product’s defect through circumstantial evidence, and Plaintiffs submit with this response an ample amount of such evidence. Second, Plaintiffs’ warning claims should not be dismissed because the summary judgment evidence demonstrates that Dr. Hoja, Ms. Province’s treating physician, was not aware of the risk that a single 50 mcg/hr Duragesic patch could deliver a lethal level of fentanyl to a patient using it as prescribed. For all of these reasons, Defendants’ motion should be denied.


I. Duragesic patches.

Duragesic patches are transdermal products used to treat chronic pain. (See Duragesic Package Insert (Dkt 56-1.); Deposition of B. Gale (inventor of the Duragesic patch) at 10:11-14 (taken in DiCosolo v. Janssen Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Feb. 8, 2008) (Ex. 1.).)[1] After they are applied to the patient’s skin, properly functioning patches (sold in various doses, such as 25, 50, 75, or 100 micrograms-per-hour (“mcg/hr”)) continuously deliver the requisite dose of opioid fentanyl to the patient’s bloodstream over a 72-hour period. (See Duragesic Package Insert (Dkt. 56-1); Deposition of B. Gale at 6:20–8:1 (Ex. 1).) When Duragesic patches are manufactured, fentanyl gel is deposited in a “reservoir” between an impermeable layer of polyester backing and a semi-permeable layer of ethyl-acetate vinyl (“EVA”) film. (See Duragesic Package Insert (Dkt. 56-1); Deposition of D. Chullino (ALZA’s director of process engineering) at 13:6–14:19 (taken in Thompson v. ALZA Corp., et al., No. 2005-11685 (Dist. Ct. of Harris County, Tex. Feb. 27, 2006) (Ex. 2).) The semi-permeable layer is designed to ensure that the patch “releases fentanyl from the reservoir at a nearly constant” rate. (Duragesic Package Insert (Dkt. 56-1).) According to the inventor of the Duragesic patch, Robert Gale, the patches are intended to deliver at a steady rate only the dose—and resulting blood fentanyl concentration—set forth in the Duragesic package insert. (Deposition of B. Gale at 6:24–7:21 (Ex. 1).)

Fentanyl is a very powerful narcotic drug that is used to treat moderate to severe chronic pain. It is eighty times more potent than morphine and has a narrow therapeutic band (i.e., the difference between a therapeutic dose and a fatal dose of fentanyl is small. (Duragesic Package Insert (Dkt 56-1).)

II. Numerous defects in the Duragesic patches known to Defendants.

In the years before Ms. Province’s death, Defendants knew of defects in the Duragesic patches that permit fatal amounts of fentanyl to enter a patient’s bloodstream. For instance, Defendants initiated a February 2004 “Urgent Drug Recall” because several patches contained a defect known as the “fold-over defect,” which causes a leak along one edge of the patch. (See “Urgent Product Recall” (Ex. 4); Deposition of S. Engle (senior director of quality control) at 78:2–79:16, 95:24–96:21 (taken in [REDACTED] Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Oct. 24, 2008)) (Ex. 16); FDA Establishment Inspection Report (“FDA EIR”) at 5-7 (Ex. 5); Deposition of D. Chullino at 151:20–152:18 (Ex. 2).) Defendants initiated other patch recalls in April 2004, October 2005, February 2008 and December 2008, and their corporate representative has admitted that it is possible that leaking ALZA patches were being sold to the public as late as 2009. (Excerpts from Deposition of D. Chullino (taken January 21, 2009 in West v. ALZA Corporation, No. 19, 955) at 64:23-65:8; 146:8-147:6; 158:10-159:13 (Ex. 15).) Following Defendants’ first recall, the FDA inspected ALZA’s manufacturing facility and cited the company for numerous manufacturing problems. (See FDA EIR (Ex. 5); FDA Form 483 (Ex. 6).) The FDA determined that during the manufacturing process, the layers of material between which the fentanyl gel is deposited were often misaligned, causing one edge to fold over before the patch was sealed. (See FDA EIR at 5, 13-15 (Ex. 5); FDA Form 483 (Ex. 6); Deposition of D. Chullino at 188:8-19 (Ex. 2); Deposition of S. Engle at 95:24–96:21 (Ex. 16.) The folded-over edge caused a poor adhesive seal along one side of a manufactured patch. (Deposition of S. Engle at 95:24–96 [REDACTED] The weakened seal had a tendency to break open during normal patch use, allowing fentanyl gel to leak directly onto the skin of the patient. (Deposition of D. Chullino at 18:3-8 (Ex. 2); Deposition of S. Engle at 95:24–96:21 (Ex. 16).) The FDA determined that this—and the resulting fold-over defect—was a frequent occurrence. (See FDA EIR at 5, 13-15 (Ex. 5); FDA Form 483 (Ex. 6).)

In addition to the fold-over defects, the FDA found numerous other defects in the ALZA-manufactured patches, including gel in the seals, seal breaches, holes in the drug reservoir, and slits in the pouches and system. (See FDA EIR at 11-12 (Ex. 5); Deposition of B. Strehlke (director of DEA compliance) at 24:13–29:7 (taken in DiCosolo v. Janssen Pharmaceutica, Inc., No. 04 L5351 (Cir. Ct. of Cook County, Ill. Jan. 14, 2008)) (Ex. 7).) The most prevalent defect—which caused a thin stream of gel to leak out, resembling a string—was so well-known to Defendants that they called it the “classic stringer leaker.” (See FDA EIR at 6 (Ex. 5); Deposition of D. Chullino at 81:9-14 (Ex. 2).) The FDA ultimately concluded that Defendants failed to follow a proper sampling plan in the inspection of Duragesic patches during the manufacturing process. (See FDA Form 483 (Ex. 6).) The FDA also concluded that the in-process and quality-control checks for Duragesic patches were inadequate to prevent the release of defective Duragesic patches. (See FDA Form 483 (Ex. 6).)

To make matters worse, as the Defendants’ former vice president of quality assurance and technical operations testified, Defendants knew that the production and release of defective, leaking patches was inherent in the process used to manufacture Duragesic. (Deposition of J. Hawkins at 39:14–40:1 (taken in Cromar v. Johnson & Johnson, No. 06-cv-1867 (D.N.J. Nov. 27, 2007)) (Ex. 9).) Defendants were aware of the fold-over defect in 2001, but the only corrective action they took was to “heighten operator awareness”—an action the FDA determined was insufficient to prevent reoccurrence of the fold-over defect. (See FDA Form 483 (Ex. 6); Deposition of J. Hawkins at 46:23–48:5 (Ex. 9); Deposition of B. Strehlke at 24:13–29:7 (Ex. 7).) Hank Avallone, one of Defendants’ employees and a former FDA inspector, sent multiple intercompany emails [REDACTED] over the Defendants’ failure to manufacture uragesic using Good Manufacturing Practices (“GMPs”). In a March 22, 2004 email to William Randolph, senior director of technical development, Avallone said that “[a] good case can be made by FDA that [the recalled lots] were all manufactured under poor GMP’s.” (Mar. 22, 2004 email from H. Avallone to W. Randolph (Ex. 10).) In another email to Mr. Randolph, dated January 28, 2005, Avallone said that “[i]t is very difficult to partner with the FDA if we keep deceiving them.” (Jan. 28, 2005 email from H. Avallone to W. Randolph (Ex. 11).) On February 22, 2004, Avallone sent an email to William Cope, an associate director of regulatory compliance, in which he said that it would not be unreasonable to expect that the FDA would prosecute some of the employees in the Defendants’ quality-control department. (Feb. 22, 2004 email from H. Avallone to W. Cope (Ex. 12).)

Avallone and others previously informed Defendants that their in-process controls for the manufacture of Duragesic patches were deficient and that they had an obligation to comply with basic GMPs, regardless of the level of FDA enforcement. (See Feb. 16, 2004 email from J. Hawkins to H. Avallone and others (Ex. 13).) These manufacturing concerns continue to this day. In fact, a recent report prepared by Defendants shows that 3,063 Duragesic patches had been reported as having “leaked” between January 1, 2004 and January 22, 2009. (Excerpts from Issue Detail Alert from Jan. 1, 2004 until Jan. 22, 2009 (Ex. 14).)

III. Barbara Province’s prescribed use of the Duragesic patches.

Barbara Province suffered from chronic pain due to Crohn’s disease. (Deposition of Dr. Michael Hoja 27:11-28:6 (Ex. 3).) In December of 2005, her treating physician, Dr. Michael Hoja, prescribed her 50 mcg/hr fentanyl patches due to the excruciating pain she was suffering. (Id. 62:9-20, 104:4-8; Pharmacy Records at 4, (Ex. 8).) Each of Ms. Province’s fentanyl patch prescriptions was filled with Duragesic fentanyl patches designed, manufactured, and marketed by Defendants.[2] (See Pharmacy Records at 1-4.) Dr. Hoja, who is very familiar with the signs of drug seeking behavior, never saw any signs that Ms. Province abused or misused her medications. (Hoja Deposition at 64:16-68:24, 81:5-8; 91:15-92:9 (Ex. 3).)

IV. Ms. Province’s death.

Ms. Province spent the afternoon of April 1, 2006, shopping with a friend, Tina Vest. (Deposition of Tina Vest 28:21-31:1, (Ex. 17).) Sometime in the evening of April 1, 2006, Melissa Keathley, Ms. Province’s friend, came over and visited with Ms. Province. (Deposition of Melissa Keathley 26:7-28:6, (Ex. 18).) Ms. Keathley left at some point and at around 9:00 pm, Ms. Vest came over and had coffee with Ms. Province. (Deposition of Tina Vest 33:3-5.) At that time, Brenda Ashlock and her husband were also visiting Ms. Province. (Id. 33:3-13.) Ms. Vest left Ms. Province’s home at around 11:00 pm. (Id. 40:7-22.)

The next morning, Ms. Vest went over to Ms. Province’s home and found Ms. Province unresponsive on the couch. (Id. 41:6-42:11.) The authorities were called and Ms. Province was pronounced dead at the scene. (Autopsy Report at 1 (Dkt 56-7).) In accordance with her prescription, Ms. Province was wearing a single, Duragesic 50 mcg/hr patch at the time of her death. (Id.)

V. The autopsy.

After she was declared dead, Ms. Province’s body was examined by the Reynolds County Coroner’s office. The medical examiner found that Ms. Province was wearing a single, 50 mcg/hr Duragesic fentanyl patch on her chest. (Autopsy Report at 1.) Toxicology tests revealed, however, that Ms. Province had a fentanyl blood level of 20 ng/mL. (Toxicology Report (App. Ex. 19).) This level was more than fourteen times the expected level from a properly functioning 50 mcg/hr. (Duragesic Package Insert (56-1) (showing mean maximal concentration for 50 mcg/hr patch is 1.4 ng/mL).) After a complete autopsy, the medical examiner determined that Ms. Province had died from a “mixed drug reaction – lethal levels of fentanyl.” (Autopsy Report (Dkt 56-7).) The medical examiner who performed the autopsy testified that the fentanyl level detected in Ms. Province’s blood was at an independently lethal range. (Deposition of Dr. Michael Zaricor 74:5-13, (Ex. 20).)


“Summary judgment is an extreme remedy which may not be granted unless the movant has established his right to the judgment beyond controversy. . . .” Inland Oil & Transport Co. v. United States, 600 F.2d 725, 727 (8th Cir. 1979). In ruling on a motion for summary judgment, a court must view the facts in the light most favorable to the nonmoving party. Buboltz v. Residential Advantages, Inc., 523 F.3d 864, 868 (8th Cir. 2008). “Credibility determinations, the weighing of evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).


I. Under Missouri law, a plaintiff may establish a defect through circumstantial evidence.

It is well-established (and Defendants do not dispute) that a plaintiff in a product liability action need not have direct evidence of a defect, and instead may establish the defective nature of a product using circumstantial evidence. (See Defs’ Mem. at 10.) The vast majority of jurisdictions have long permitted proof of product defect through circumstantial evidence, and this position is so well established that the Restatement (Third) of Torts adopted it because of the “huge body of [supporting] case law.” See Restatement (Third) of Torts: Prods. Liab. § 3 cmt.1. Examples of circumstantial evidence that a plaintiff may offer to show a defect include, among other things, the following: (1) evidence that product malfunctioned, that is, it did not function as intended; (2) evidence of the same accidents in similar products; (3) evidence eliminating other possible causes of the injury (e.g. evidence of proper use of the product); and (4) evidence that the accident occurred a short time after sale. [3] See Hickerson v. Pride Mobility Prods. Corp., 470 F.3d 1252, 1258 (8th Cir. 2006); Drabik v. Stanley-Bostitch, 1991 U.S. Dist. LEXIS 8694, at *2-3 (W.D. Mo. June 18, 1991); Fain v. GTE Sylvania, Inc., 652 S.W.2d 163, 165 (Mo. App. S.D. 1983); Peters v. General Motors Corp., 200 S.W.3d 1, 9 (Mo. App. W.D. 2006).

The United States Court of Appeals for the Eighth Circuit has provided guidance on the use of circumstantial evidence at the summary judgment phase:

An inference [of defect] need not be justified beyond all doubt and is not precluded by a mere possibility that the contrary may be true. . . . Rather, a case may be given to a jury if circumstantial evidence is strong enough to support reasonable inferences necessary to the plaintiff’s case free from speculation. The circumstantial evidence need not be so strong as to compel the jury to rule in a plaintiff’s favor, and where multiple inferences may be possible, it is for the jury rather than the court to resolve the factual disputes.


Hickerson v. Pride Mobility Prods. Corp., 470 F.3d 1252, 1258 (8th Cir. 2006) (cited by Defendants). Critically, plaintiff’s circumstantial evidence of defect does not need to “exclude all possibility of another cause of [the] injuries,” nor is a plaintiff “required to present undisputed evidence.” Peters, 200 S.W.3d at 18 (Mo. App. W.D. 2006) (relied on by Defendants); see also Daniel v. Indiana Mills and Manufacturing, Inc., 103 S.W.3d 302, 310 (Mo. App. S.D. 2003). The plaintiff’s evidence need only “fairly warrant the conclusion” that the product was defective. Id.

A. There is ample circumstantial evidence of product defect.


Defendants’ motion simply ignores all of the circumstantial evidence showing that the fentanyl patch Ms. Province was wearing was defective. First, there is evidence that the patch malfunctioned and delivered a lethal dose of fentanyl to Ms. Province far in excess of what it was supposed to deliver. A 50-mcg/hour patch, the same size Ms. Province was wearing at the time of her death, is supposed to provide a mean fentanyl concentration level of 1.4 ng/mL: Ms. Province had a blood-fentanyl level of 20 ng/mL when she died, more than fourteen (14) times higher than the expected level. (See supra Page 7.) The coroner’s office, which performed the autopsy on Ms. Province concluded that Ms. Province had “lethal levels of fentanyl.” (Autopsy Report at 5 (Dkt 56-7).)

Second, there is evidence of the same accidents in similar products. Specifically, there is evidence that by the time of Ms. Province’s death, there were numerous adverse events and deaths from leaking Duragesic fentanyl patches, of which Defendants were aware. (See supra Pages 3-6.) Indeed, from 2004 through 2008, Defendants initiated no fewer than five (5) recalls of Duragesic fentanyl patches due to the problem of leaking patches, and their corporate representative has admitted that it is possible that leaking ALZA patches were being sold to the public as late as 2009. (See supra Page 3.)

Third, there is evidence that eliminates the possibility that Ms. Province’s death was caused by her misuse or abuse of the patch. When a plaintiff relies on circumstantial evidence, the plaintiff must typically proffer evidence tending to negate other causes for the death aside from the defect in the product. But the plaintiff does not need to “exclude all possibility of another cause of [the] injuries,” nor is a plaintiff “required to present undisputed evidence.” Peters, 200 S.W.3d at 18. The plaintiff’s evidence need only produce evidence that “fairly warrants the conclusion” that the product was defective. Id.

Dr. Hoja, Ms. Province’s treating physician, testified that during his treatment, he never observed any signs that Ms. Province was abusing or misusing her medications. (Hoja Deposition at 64:16-68:24, 81:5-8; 91:15-92:9, (Ex. 3).) Keicia Fusco, Ms. Province’s daughter, corroborates Dr. Hoja’s testimony. Ms. Fusco, who visited her mother on a daily basis often for hours at a time, testified that she never saw Ms. Province abuse or misuse the fentanyl patch, nor did she ever see any evidence of misuse or abuse, such as cut fentanyl patches. (Declaration of Keicia Fusco ¶ 2 (Ex. 21).) Both Dr. Hoja’s and Ms. Fusco’s testimony are confirmed by the fact Ms. Province was found with a single, Duragesic 50 mcg/hr fentanyl patch on her body per her prescription. (See Autopsy Report at 1 (Dkt 56-7).) Finally, the police report that details the investigation of Ms. Province’s death is devoid of any suggestion that Ms. Province died from abusing the fentanyl patch. (See Police Report, (Dkt 56-8).) All of this evidence rules out the possibility that Ms. Province died from abusing the fentanyl patch.

Fourth, the evidence shows that Ms. Province’s death occurred shortly after the sale of the patches to Ms. Province. Ms. Fusco’s last prescription for the patch was filled on March, 17, 2006, and she died on April 2, 2006. (See Pharmacy Records (Ex. 8).)

B. There are significant issues of fact regarding Ms. Province’s purported past abuse of fentanyl.


There are a number of problems with Defendants’ claim that it is undisputed that Ms. Province died from abusing her fentanyl patches. First, almost all of Defendants’ “evidence” of abuse involves testimony of past misuse or abuse, not evidence that Ms. Province was engaging in this type of conduct at the time of her death. (See Defs’ Mem. at 3-4.)

Second, and more importantly, Defendants’ evidence of abuse is directly contradicted by multiple witnesses and physical evidence. As set forth above, both Ms. Province’s treating physician and daughter testified that they never Ms. Province abuse or misuse fentanyl patches. Indeed, Ms. Province’s daughter visited her on a daily basis, often for hours, and never saw Ms. Province abuse or misuse the fentanyl patch. (See supra Page 10.) Moreover, she was found with a single patch on her body, exactly as prescribed.

Third, Defendants’ evidence of “abuse” is so questionable that a jury would most likely disregard it. For example, Defendants repeatedly cite to the deposition testimony of Deanna McMeans as evidence that Ms. Province “regularly abused fentanyl by cutting the patches open and eating the contents.” (Defs’ Mem. At 3-4.) Defendants neglect to mention, however, that Ms. McMeans has been convicted of no less than four felonies, and was in fact deposed at the prison where she is currently serving her most recent sentence.[4] (See Deposition of Ms. McMeans 57:1-4.) Further, Ms. Province fired Ms. McMeans because she was stealing Ms. Province’s medication and money. (Deposition of Brenda Ashlock 26:13-27:6, 75:15-23.) These significant credibility issues make Defendants’ evidence highly suspect and further preclude an award of summary judgment. See, e.g., Secure Energy, Inc. v. Coal Synthetics, LLC, 708 F. Supp. 2d 923, 930 (E.D. Mo. 2010) (denying summary judgment because “the issue of whether this information was misappropriated rests on a credibility decision for the jury.”).

C. Defendants’ only “direct” evidence that Ms. Province died from abuse is contradicted by at least two witnesses, as well as the documentary evidence.


Defendants cite to the deposition testimony of a single witness, Stuart Cox, who testified that he saw Ms. Province’s body on the day she died and that there was a cut fentanyl patch near the couch on which her body was found.[5] (See Defs’ Mem. at 5.) Defendants seize on this testimony as direct evidence that Ms. Fusco died from abuse.

The problem for Defendants is that the issue of this purported cut patch is hotly contested, as at least two witnesses have testified that there was no such patch. Ms. Fusco, Ms. Province’s daughter, testified that she went over to her mother’s home on the day she died and observed, among other things, her mother’s body, the couch on which it was located, and the nearby floor. (Declaration of Keicia Fusco ¶ 4 (Ex. 21).) She testified that she did not see a fentanyl patch, damaged or intact, near her mother’s body or anywhere else in the home, including the couch or floor nearby. (Id.) She further testified that she did not hear anyone, including law enforcement officers, state that there was a cut fentanyl patch present in her mother’s home, either near the couch or anywhere else. (Id.) Moreover, Melissa Keathley, one of the last people to see Ms. Province alive, corroborated Ms. Fusco’s testimony, testifying that she sat next to Ms. Province the night before she died and that there was no such patch on the floor. (Deposition of Melissa Keathley, 26:7-27:6.)

The documentary evidence in this case confirms both Ms. Fusco’s and Ms. Keathley’s version of events. There is no mention in any report of any kind, including any police report or medical examiner report, of any fentanyl patch, damaged or intact, near Ms. Fusco’s body. (See, e.g., Police Report, (Dkt 56-8); Autopsy Report (Dkt 56-7).) No fewer than twenty-three (23) witnesses have been deposed in this case and no one, besides Mr. Cox, has ever testified about a cut fentanyl patch near Ms. Province’s body. The only fentanyl patch identified is the single fentanyl patch found on Ms. Province’s body. (See Autopsy Report at 1.) It is highly unlikely that such a critical piece of evidence would go unnoted in all of the documentation associated with this case, and the omission of any such discussion calls into serious question Mr. Cox’s testimony.

Finally, there is evidence that Mr. Cox, the sole witness to this purported cut fentanyl patch, never even went into Ms. Provinces’ home the day she died, and thus a jury would likely find his testimony not credible. (See Declaration of Keicia Fusco ¶ 4 (Ex. 21).) In light of the conflicting evidence, the Court may not award Defendants summary judgment. See Yates v. Rexton, Inc., 267 F.3d 793, 800 (8th Cir. 2001) (“In determining whether a plaintiff has met its burden with respect to pretext in a summary judgment motion, a district court is prohibited from making a credibility judgment or a factual finding from conflicting evidence.”); Sowers v. Gatehouse Media Missouri Holdings, Inc., Case No. 4:08-cv-633, 2010 U.S. Dist. LEXIS 39613, at *32 (E.D. Mo. April 22, 2010) (denying summary judgment because “[r]esolution of this issue will depend upon credibility determinations that cannot be made by the Court at this stage of the proceeding”).

D. Defendants misstate the evidence developed to date and rely on cases with no bearing on this case.


Defendants are simply wrong when they claim that they are entitled to summary judgment because Plaintiffs “cannot present any evidence to eliminate a cause unrelated to Defendants’ actions—Ms. Province’s fentanyl abuse.” (Defs’ Mem. at 11.) As set forth above, there is ample evidence that Ms. Province did not die from fentanyl abuse. (See supra Page 10.)

Defendants’ misstatements of the evidence makes their reliance on cases such as Willard v. Bic Corp., 788 F. Supp. 1059 (W.D. Mo. 1991) and Hill v. Ozark Border Electric Cooperative, 710 S.W.2d 338 (Mo. App. S.D. 1986) misplaced. (See Defs’ Mem. at 11.) In both of those cases, the plaintiffs did not produce any evidence that would tend to eliminate other possible causes of the injuries. That is not the case here. Defendants’ motion is at bottom a request the court consider and weigh the evidence to date and conclude that their version of events is more plausible. That is simply not the correct standard at the summary judgment phase. See El-Karanchawy v. AED Enterprises, LLC., 2010 U.S. Dist. LEXIS 76480, at *21 (E.D. Mo. July 29, 2010) (rejecting award of summary judgment when the defendants’ argument was essentially that “its version of events is more plausible and is supported by a greater quantity of evidence”).

II. Defendants inadequately warned Ms. Province’s treating physician, Dr. Hoja.

Missouri has adopted the “learned intermediary” doctrine, which requires the manufacturer of a prescription drug to properly warn the physician, not the patient, of dangers associated with the drug. See Does v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo. App. E.D. 1999). This requires that a plaintiff show that a warning would have altered the physician’s behavior. See Klugesherz v. Am Honda Motor Co., 929 S.W.2d 811, 814 (Mo. App. E.D. 1996).

A. Dr. Hoja relied on the warnings that accompany the Duragesic fentanyl patch, as well as Defendants’ drug representatives.


Defendants contend that they are entitled to summary judgment on Plaintiffs’ warns claims because Dr. Hoja purportedly testified that he did not read and rely on the warnings that accompany the Duragesic fentanyl patch. (Defs’ Mem. at 13.) Defendants are wrong for a host of reasons. First, Dr. Hoja did in fact testify that he read the prescribing information and relied on it. Dr. Hoja specifically testified that he had looked at the prescribing information a number of times and that he would “scan it and make sure there’s nothing new or anything big.” (Hoja Deposition 87:3-7; 127:25-128:1 (Ex. 3).) Dr. Hoja further testified that he used “the package insert as a guide . . . to teach, to warn to inform.” (Id. 128:16-21.)

Defendants seize on snippets of his testimony in which Dr. Hoja testified that he “scanned” and “perused” the prescribing information and did not rely on it “very deeply,” but at most all this does is raise a fact question for the jury about the extent of his reliance on the prescribing information. (See Defs’ Mem. at 7); American Airlines v. KLM Royal Dutch Airlines, 114 F.3d 108, 111 (8th Cir. 1997) (recognizing that “[a]mbiguities and even conflicts in a deponent’s testimony are generally matters for the jury to sort out.”); McNeil v. Wyeth, 462 F.3d 364, 372 (5th Cir. 2006) (conflicting testimony about whether the label’s inadequacy caused the treating physician to prescribe the medication precludes the award of summary judgment); Motus v. Pfizer, 196 F. Supp. 2d 984 (C.D. Cal. 2001) (”If Dr. Trostler’s testimony on this point were “equivocal or uncertain,” or if there was evidence placing his credibility in question, the Court might agree that it should “reserve the issue of credibility for the jury’s determination.”).[6]

Moreover, Defendants’ claim that Dr. Hoja did not rely on the prescribing information because he did not review it immediately before he prescribed Ms. Province fentanyl patches is preposterous. (See Defs’ Mem. at 7, 13.) Dr. Hoja explained:

I know that I had looked at it at times in the past, but I didn’t have a habit of looking at it each — at each time of each patient visit of occurrence of a prescription because it was a fairly common prescription in those days.

(Hoja Deposition 87:3-7.) As set forth above, Dr. Hoja testified that he read and relied on the prescribing information, and the fact that he did not do so immediately before prescribing fentanyl to Ms. Province does not change this fact.

In focusing on the prescribing information, Defendants also completely ignore another source of warnings upon which Dr. Hoja relied: Defendants’ drug representatives. Dr. Hoja testified that he learned about Duragesic fentanyl patches when Defendants’ drug representatives “came through and said that they had this nice, new thing that was a fancy way to control pain.” (Id. 83:13-16.) Dr. Hoja explained that he met Duragesic drug representatives no fewer than six (6) times over the years and described the meetings as follows:

But I do recall them telling me that this is — this was one of the safest possible ways to manage chronic pain, that it was abuse proof, and that it kept people from getting huge amounts of narcotics inappropriately, that it couldn’t be tampered with, and it was a great system, and that I should try it on my chronic pain patients.

(Id. 85:1-22.) Dr. Hoja further testified he relies “deeply and intensely” on pharmaceutical representatives to “let me know if there’s big changes or something new or something up.” (Id. 128:1-7.) Dr. Hoja also stated that he relies on pharmaceutical representatives to make the package insert more succinct and “make us aware of what’s important.” (Id. 141:25-142:4.) Dr. Hoja also informs drug representatives that he expects them to let him know if there are any problems with the drug they are promoting. (Id. 142:20-24.) As set forth below, it is clear that if Dr. Hoja had been properly warned about risks of the Duragesic fentanyl patch, either through the prescribing information or by Defendants’ drug representatives, he would not have prescribed the product to Ms. Province.

B. Dr. Hoja would not have prescribed Ms. Province the Duragesic fentanyl patch if he had been warned that a single patch could deliver a lethal level of fentanyl to an individual using it as prescribed.


Dr. Hoja testified as follows about what he would have done if he had been properly warned about the risks associated with the Duragesic fentanyl patch.

Q. (By Mr. Angwin) Okay. And if a single 50-microgram per hour Duragesic Patch such as what’s used in this case could cause a Fentanyl level to be achieved that was lethal, even to a person who is opioid tolerant such as Ms. Province, is that information you would want to know?

THE WITNESS: Absolutely, yes.

Q. (By Mr. Angwin) And if you had known that information — assuming what I just told you was true, if you had known that information prior to the time you prescribed the 50-microgram Duragesic Patch for Ms. Province, would it have altered in any way you prescribing decision?

THE WITNESS: Absolutely, yes.

Q. (By Mr. Angwin) And how would it have altered it?

A. I’d have been afraid to use. I wouldn’t have prescribed it.

(Hoja Deposition 146:11-147:5.)

Moreover, Dr. Hoja testified that he quit prescribing Duragesic fentanyl patches to patients after Ms. Province died.

Q. Okay. Have you — do you still prescribe Duragesic?

A. I do not and have not since a few months after Barbara Province’s death.

Q. Okay. And why have you not?

A. The circumstances of her death were very troubling to me. She was — she had multiple medical problems but none rising to the level that should have killed her, resulted in her death. I had given her a very — in my mind, a very limited dosage and number of that medication. I felt that it was safe, yet she expired with the only information I had after that being the post-mortem findings of lethal doses of the active drug in her system from the Duragesic of the Fentanyl.

That scared me to death. I’m here to help my patients not to harm them. And I didn’t understand what had occurred, how it occurred, why it occurred, but I wasn’t about to risk that with any further patients, and so I ceased prescribing it, period, that year. I think probably a few months after her death.

(Hoja Deposition 87:8-88:3.) All of this testimony shows that Dr. Hoja would have heeded warnings about the risk of death from proper use of the Duragesic fentanyl patch and would not have prescribed the medication to Ms. Province had he been properly warned.

Defendants cite to deposition testimony in which Dr. Hoja acknowledges that the risk of respiratory depression is present with fentanyl along with all other classes of drugs that have the potential side effect of depressing the central nervous system. (Defs’ Mem. at 14.) But none of this testimony indicates that he was aware of the risk that a single 50 mcg/hr Duragesic patch could deliver a lethal dose of fentanyl, more than fourteen (14) times in excess of the levels represented in Defendants’ package insert. Accordingly, Plaintiffs have proffered sufficient evidence for a jury to find that Defedants’ warnings were inadequate, and Defendants are not entitled to summary judgment on the Plaintiffs’ warning claims.


For the foregoing reasons, Plaintiffs respectfully request that the Court deny the Defendants’ Motion for Summary Judgment.

Respectfully submitted,

/s/ Charles W. Miller

Charles W. Miller


James C. Orr (Texas Bar #15313550)

Charles W. Miller (Texas Bar #24007677)

Heygood, Orr & Pearson
2331 Northwest Highway, 2nd Floor
Dallas, Texas 75220
(214) 237-9001 (phone)
(214) 237-9002 (fax)

Trial Attorney for Plaintiff

[1] To minimize the burdens on the parties and deponents, the parties have agreed that documents and depositions of the Defendants’ Federal Rule of Civil Procedure 30(b)(6) witnesses and their current and former employees taken in one case concerning an alleged fentanyl-related death may be used in other wrongful death cases involving Duragesic. Plaintiffs rely on those documents and depositions here.

[2] Defendants do not appear to dispute in their motion that Ms. Province was using their patch at the time of her death.

[3] Circumstantial evidence may also include expert testimony, but “expert testimony is not required for a submissible case of product defect.” Lawson v. deBoer Transp., Inc., No. 4:09-cv-250, 2009 U.S. Dist. LEXIS 39768 (E.D. Mo. May 11, 2009).

[4] Ms. McMeans was convicted in October 2009 of felony drug possession and is currently serving a five-year sentence. (McMeans Deposition 56:2-6.) Ms. McMeans was previously convicted of forgery and twice for burglary, with the result that she served three and a half years in prison before her current sentence. (Id. 57:1-59:13.)

[5] Defendants also cite to testimony by Dr. Zaricor, the medical examiner that conducted the autopsy on Ms. Province, that he did not see any leaks on the patch and did not recall if the patch was wet. (See Defs’ Mem. at 6 (citing Zaricor Deposition 18:11-21, 110:20-111:7).) But Dr. Zaricor clarified that (1) he did not extensively examine the patch; (2) he has never seen a leaking fentanyl patch; and (3) he did not have any opinion as to whether the patch was in fact leaking. (Zaricor Deposition 76:24-78:16 (Ex. 20).)

[6] See also Delude v. Johnson & Johnson (In re Levaquin Products Liab. Litig.), MDL No. 08-1943, 2010 U.S. Dist. LEXIS 75054 at *31 (D. Minn. July 26, 2010) (“The Court notes two additional problems with defendants’ argument. First, after reviewing Dr. Butner’s deposition transcript, the Court finds that Dr. Butner’s testimony regarding what he would have done if he had received a more complete warning of the risks of tendon toxicity presents an issue of credibility that is within the province of the trier of fact.”); Rush v. Wyeth (In re Prempro Prods. Liab. Litig., MDL Docket No. 4:03CV1507-WRW, 2006 U.S. Dist. LEXIS 47472 at *9 (E.D. Ark. July 13, 2006) (“Additionally, I’m not convinced that a physician’s testimony regarding what he or she would have done in 20/20-hindsight should be considered absolute. It appears to me that such testimony may well hinge on credibility, which is for the jury decide.”); Golod v. LaRoche, 964 F.Supp. 841, 857 (S.D.N.Y. 1997) (“Defendants contend that any inadequacy of its warning was not a proximate cause of Golod’s injuries because Dr. Grossman, who prescribed Tegison for Golod, has testified that he believes Hoffmann’s warnings are adequate despite Golod’s blindness and has not changed his practices in prescribing Tegison since her injury. However, unless a physician’s claim that she would have prescribed a drug even if adequately warned is self-disserving, the credibility of such a claim is generally a jury question not to be resolved on a motion for summary judgment. Here, because Dr. Grossman is not a defendant in this action, his statement is not self-disserving in any meaningful way.”).