Teri Cassel of Danbury, Wisconsin passed away in 2009 while wearing two recently FDA-approved Duragesic brand patches containing the drug fentanyl. On behalf of Ms. Cassel’s estate, Heygood, Orr & Pearson filed a wrongful death lawsuit against ALZA Corporation (“ALZA”) and Janssen Pharmaceuticals, Inc. (“Janssen”), alleging that manufacturing, marketing and design defects caused Ms. Cassel’s death by accidental fentanyl overdose.
The drug company defendants moved for partial summary judgment on the design defect claims, arguing that those claims are barred by “impossibility preemption” as articulated by the United States Supreme Court in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011); Wyeth v. Levine, 555 U.S. 555 (2009), and, most recently, Mut. Pharm. Co. v. Bartlett, 133 S.Ct. 2466 (2013). On March 5, the court denied the defendants’ motion. Estate of Cassel v. Alza Corp., No. 12–cv–771–WMC, 2014 WL 856023 (W.D.Wis. March 05, 2014).
The defendants designed and manufactured the first transdermal fentanyl patch drug for use in the United States under the brand name “Duragesic Reservoir Patch.” The Reservoir Patch sold between 1990 and 2009. The Reservoir Patch contained the active ingredient fentanyl in a “form-fill-seal reservoir,” within which the fentanyl was mixed in a gel with water and alcohol. There are four layers in a Reservoir Patch: (1) a backing layer of polyester film; (2) a drug reservoir of fentanyl and alcohol in a gel solution; (3) a rate-control membrane, which controls the rate of fentanyl delivery to the skin surface; and (4) an adhesive lawyer. Before use, a protective liner covering the adhesive layer is removed and discarded.
The lawsuit alleges that the fentanyl patches that ALZA designed and manufactured and that Janssen sold, supplied and distributed lacked a rate-control membrane or laminated face adhesive layer, causing Teri Cassel’s death by fentanyl overdose. Due to these alleged design defects, plaintiffs allege that the Duragesic Matrix Patch “fail[s] to provide adequate protection against uncontrolled fentanyl delivery” and can produce lethal levels of fentanyl in patients.
The defendants argued that they were entitled to judgment as a matter of law on plaintiffs’ design defect claims based on the doctrine of “impossibility preemption.” Under that doctrine, a state law claim is “preempted” if it would be impossible for the defendant to comply with both state and federal law.
In Mutual Pharmaceutical Co., Inc. v. Bartlett, the Supreme Court considered conflict preemption in the context of a design-defect case. The plaintiff in Bartlett was prescribed a generic form of an anti-inflammatory pain reliever known as sulindac. As a result, she developed an acute case of toxic epidermal necrolysis. At the time that she was prescribed sulindac, its label did not refer to the risks of toxic epidermal necrolysis or the related condition Stevens–Johnson syndrome, though the label did warn that the drug could cause “severe skin reactions” and “fatalities.”
Bartlett prevailed at trial on a design-defect claim but the Supreme Court reversed, holding that impossibility preemption barred the claims. In Bartlett, the Supreme Court found that “redesign” of the generic drug at issue was not possible for two reasons: (1) the FDCA requires generics to have the “same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based”; and (2) sulindac (the drug at issue) is “chemically incapable” of being redesigned.
In Estate of Cassel v. Alza Corp., the district court held that the Supreme Court’s Wyeth and Mensing decisions suggested a three-part test in analyzing impossibility preemption. First, the court must identify the steps a defendant should have taken to avoid liability under state tort law. Next, the court must determine as a matter of law whether federal law expressly prohibited the defendant from taking these steps. If the answer to this second question is ‘No,’ the court must determine whether the defendant has presented ‘clear evidence’ that the regulatory agency would have stepped in and exercised its discretionary authority to prohibit the defendant from taking the necessary steps under state law. Applying that test, this court found that (1) plaintiffs were alleging a duty to design the patches differently before FDA approval (rather than to change the design after the fact); and (2) no federal laws or regulations appear to have prohibited them from doing so. Accordingly, the court proceeded to step three.
The defendants argued that Bartlett stands for the proposition that “federal preemption bars any state-law claim, including design-defect claims, premised on a manufacturer’s failure to market a drug with a new design feature that would constitute a ‘major change’ or render it a new drug, either of which requires prior FDA approval.” They argued that adding a rate-control membrane to the patch would have been a “major change” requiring FDA approval, and thus defendants were barred from the redesign that state law allegedly required. The district court disagreed:
As an initial matter, the court does not read Bartlett so broadly. In Bartlett, the Supreme Court found that designing sulindac differently was impossible for two specifically enumerated reasons, neither of which is true in this case: (1) generic drugs must have the same active ingredients, route of administration, dosage form, strength and labeling as their brand-name counterparts; and (2) sulindac is chemically incapable of being designed differently. Id. at 2475. Here, defendants are not subject to any such duty of sameness, since their patches are brand-name, and their own proposed findings of fact demonstrate that fentanyl patches are amenable to various designs. […] Thus, at a minimum, Bartlett is factually distinct from this case.
More importantly, the bulk of defendants’ argument is premised on a mischaracterization of plaintiffs’ theory of the case. […] Plaintiff’s theory here is that defendants had a duty to employ an alternative design—such as a design with a rate-control membrane, or a multi-laminate design-from the beginning, before FDA approval. [… D]efendants’ emphasis on altering their patches after FDA approval is misplaced and does not entitle them to summary judgment.
The defendants responded that it should be irrelevant whether they could have initially created and submitted to the FDA a different design—such as a multi-laminate patch or a matrix patch with a rate-control membrane. In defendants’ view, the “need to ask the FDA for its approval before marketing the new design … is dispositive of the preemption issue.” The district court found the defendants’ argument unconvincing. The court noted that such an argument would “effectively foreclose all design-defect claims against drug manufacturers.” Id.
Since defendants would find preemption wherever a manufacturer needs to ask for FDA approval before marketing, and since all new drugs require FDA approval before marketing, no drug manufacturer could ever be liable for a defectively designed product under defendants’ interpretation of the doctrine.
The district court summarized its decision to deny the motion for summary judgment as follows:
Under plaintiffs’ theory, state law required defendants to design their Duragesic Matrix Patches differently. […] No federal law prohibited defendants from submitting a different design (or at least, defendants have pointed to none). Similarly, defendants have offered no evidence that the FDA would have exercised its authority to prohibit defendants from creating and submitting such a design for approval. The court, therefore, cannot say that defendants have met their burden to demonstrate as a matter of law the “demanding defense” of impossibility preemption.
Id., citing Wyeth, 555 U.S. at 573.
Fentanyl Patch Litigation at Heygood, Orr & Pearson
Heygood, Orr & Pearson has successfully prosecuted more cases involving deaths due to fentanyl products than all the other firms in the country combined. We have spent years studying fentanyl, its uses and its misuses. We have deposed hundreds of doctors, scientists and experts on the subject of fentanyl products.
In the very first jury trial by the lawyers of Heygood, Orr & Pearson against makers of a fentanyl transdermal pain patch, a Florida jury awarded a $5.5 million verdict to the family of a man who died while wearing a Duragesic pain patch. More recently, Heygood, Orr & Pearson obtained a $16 million verdict for the family of a Cicero, Illinois woman who died while wearing a Duragesic pain patch. That verdict was upheld on appeal, resulting in a payment of more than $21 million.
Fatal mistakes that our firm has seen doctors commit in prescribing fentanyl patches include:
- Overestimating the initial dose of fentanyl patches
- Prescribing them for acute or post operative pain
- Prescribing fentanyl patches to opioid naïve patients
- Prescribing fentanyl patches to patients with significant pulmonary problems
- Prescribing fentanyl patches at the same time as other CNS depressants
If you or a loved one has experienced the tragedy of losing a family member as a result of fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.
To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form.