Generic Drug Liability Primer
Explanation of generic drug manufacturer liability in failure to warn cases after Supreme Court’s Mutual Pharmaceutical v. Bartlett decision.
November 21, 2013
Women for Justice
Generic Drug Liability Primer
Nearly 80% of prescriptions filled in the United States are filled with generic rather than brand-name prescriptions.1 The prevalence of generic drug usage in the United States means that generic drug companies — rather than brand-name manufacturers — have increasingly been a target (often the only target) in state tort-law pharmaceutical litigation. The mainstay in prescription drug litigation is a failure to warn claim, where an injured patient asserts that he or she was not adequately warned about a drug’s risks and that with a proper warning, the patient would not have taken the drug and thus would have not been injured. But, today’s injured consumer is unlikely to be successful on any failure to warn claim against a generic drug manufacturer. In June 2013, the Supreme Court closed one of the last potential avenues for generic drug manufacturer liability in failure to warn cases in Mutual Pharmaceutical v. Bartlett, a follow up decision to the Court’s 2011 decision of PLIVA, Inc. v. Mensing.
The Legal Debate Background
Before 1984, all drug manufacturers — including generic-drug manufacturers — had to file a new drug application (NDA) with the FDA when seeking approval to market a new drug. Congress passed the Hatch-Waxman Amendments in 1984, which modified the requirements for generic manufacturers, allowing them to submit an abbreviated NDA (ANDA) when seeking drug approval.2 In brief, the ANDA process requires generic manufacturers to certify that the generic is chemically and bio-equivalent to a brand-name drug, and that the warning labels are “the same as” those on the brand-name drug.3
The debate that had split the circuit courts on generic drug liability boiled down to this: can a generic manufacturer change or improve its warning under federal law to comply with a duty to warn under state law, or do the Hatch-Waxman Amendments mean that all state failure to warn claims are preempted?
The Mensing Decision in a Nutshell
Two women — one from Owatonna, Minnesota —began taking a generic form of Reglan to treat digestive problems and reflux in the early 2000s. While taking the drug, they both developed a severe and permanent neurological disorder called tardive dyskinesia, which causes involuntary body movements.4 In separate actions, each woman sued the generic manufacturer for failing to provide adequate warnings about this effect. The generic manufacturers argued the claims were preempted. The Fifth Circuit and the Eighth Circuit each held that the women’s claims were not preempted because the generic manufacturers had some options to legally improve their warnings and thus comply with both federal law requiring the same label as the brand-name drug and state law requiring a stronger warning label.
On a consolidated appeal of these two cases, the Supreme Court, in a 5-4 decision in PLIVA, Inc. v. Mensing, reversed the circuit courts, holding that these failure to warn claims were pre-empted by federal law. The Court deferred to the FDA interpretation that generic manufacturers may not modify the brand-name warning label in any way, and that generic manufacturers must copy brand name drug labeling precisely in order to be approved by the FDA. Thus, the Court found it impossible for these generic manufacturers to comply with both federal law (prohibiting labeling changes) and state law (requiring changes) so the claims were preempted, and ultimately, the generic drug manufacturers avoided liability for any injuries they may have caused these women.
Bartlett: The Court Reaffirms Mensing and Closes a Window
Meanwhile, in 2004, Karen Bartlett’s doctor prescribed a generic anti-inflammatory drug called sulindac for shoulder pain.5 After three weeks on sulindac, Bartlett developed toxic epidermal necrolysis resulting in burn-like lesions over nearly two-thirds of her body, a condition that was permanently disfiguring and left her nearly blind. Bartlett sued the generic manufacturers of the drug, including a claim for design defect based on the drug’s warnings. A jury awarded a $21 million verdict. On appeal, the First Circuit held that the claim was not pre-empted because compliance with both federal and state laws was possible since the manufacturer could simply “choose not to make the drug at all.”
However, in another 5-4 decision, the Supreme Court reversed the First Circuit, holding that state-law design defect claims turning on warning adequacy are pre-empted by federal law. The Court rejected the First Circuit’s “stop selling argument,” holding that manufacturers seeking to satisfy both federal and state-law obligations are not required to cease acting entirely to avoid liability.6
What’s Next: A Light at the End of the Tunnel?
The decisions in Mensing and Bartlett essentially immunize generic manufacturers from failure to warn liability (though manufacturing defect claims are still viable against generic manufacturers) — even if a name-brand manufacturer stopped selling a drug after the drug goes generic; even if a risk of injury does not become known until after the drug goes generic; and even if the brand-name manufacturer is held liable for failing to warn consumers of drug risks while the generic escapes liability for similar injuries.
In 2012, both the U.S. Senate and House introduced bills to attempt to overturn the Mensing decision.7 The proposed legislation would have given generic manufacturers the same ability to update or correct warning labels as brand-name manufacturers have. While the bills did not emerge from committee, they did garner support from attorneys general from 41 states and U.S. territories, who jointly signed a letter stating that:
This preemption holding produces arbitrary and unfair results, as both the majority and dissenting opinions [in Mensing] recognized. Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic version are now denied this protection...Fortunately, as the Supreme Court made clear...Congress can readily cure this problem by amending federal law. Congress should do so...8
Renewed energy for legislative reform is occurring, and progress has been made in 2013. First, the United States’ amicus brief in Bartlett indicated that the FDA was considering a regulatory change to allow generic manufacturers to change their labeling and that such a change would eliminate preemption of failure-to-warn claims against generic-drug manufacturers. Then, the Supreme Court in Bartlett explicitly stated that it would welcome congressional action on the issue. Finally, in July 2013, the Office of Budget and Management updated its website to announce that a Notice of Proposed Rulemaking will be issued in September 2013.9
The timeline on FDA rulemaking is anything but certain, and as of press time, no further details have been announced. Until reform is successful, Mensing and Bartlett will continue to immunize generic drug manufacturers from failure-to-warn liability. However, a pinhole of light at the end of the tunnel provides hope that consumers may be able to redress wrongs against generic drug manufacturers in the future.
Kate Jaycox is a Principal in the Mass Tort group at Robins, Kaplan, Miller & Ciresi L.L.P., where she focuses her practice on complex product liability actions involving medical devices and pharmaceuticals. Kate serves on the MAJ Education Committee, Executive Committee, Executive Committee, and Board of Governors, and is a former Chair of Women for Justice. She also serves on the AAJ Board of Governors and various AAJ committees. Kate would like to acknowledge Tucker Chambers for his help in preparing this article. Tucker was a 2013 summer associate at Robins, Kaplan, Miller & Ciresi L.L.P. and will be joining Robins, Kaplan, Miller & Ciresi L.L.P.as an associate in Fall 2014 after graduating from the University of Minnesota Law School.
Reprinted with permission from The Minnesota Association for Justice. ©2013.
1. Generic Pharm. Ass’n, Generic Drug Savings in the U.S. 1-2 (2012), available at www.gphaonline.org.
2. The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments), Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C. § 355).
3. 21 U.S.C. § 355(j)(2)(A)
4. PLIVA, Inc. v. Mensing, 131 S. Ct. 2657, 2572-73 (2011).
5. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2472 (2013).
6. Bartlett, 133 S. Ct. at 2477.
7. Patient Safety and Generic Labeling Improvement Act, S. 2295 and H.R. 4384, 112th Cong. (2012) (both introduced Apr. 18, 2012).
8. Letter to Sen. Patrick J. Leahy and Sen. Al Franken, May 11, 2012, available at www.naag.org.
9. See www.reginfo.gov and search for 0910-AG94.
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