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Weeks II: Alabama bucks the trend and accepts the Innovator-Liability Theory

October 10, 2014

On August 15th, the Alabama Supreme Court endorsed the theory of “innovator liability” and held for the second time in Wyeth, Inc. v. Weeks, 2014 Ala. LEXIS 109 (Ala. Aug. 15, 2014), that a plaintiff who took only the generic version of the heartburn medication Reglan could still make a claim against the brand-name manufacturers. Plaintiff Danny Weeks brought suit against the generic and brand-name manufacturers, claiming he developed tardive dyskinesia, a movement disorder, after using generic Reglan.

The Weeks case was originally decided in January of 2013. In that opinion, the Alabama Supreme Court held that brand drug manufacturers could be liable for injuries caused by generic drugs because the warnings and labels relied on were those of the brand drug. The Alabama court agreed in June 2013 to reconsider its previous decision.  In concluding once again that the brand-name manufacturers could be held liable under Alabama law, the court emphasized that, under these circumstances, liability is premised not on product defect, but on the alleged misrepresentations in the brand-name product's labeling, which FDA regulations require generic manufacturers to use. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (state-law failure-to-warn claims against generic drug manufacturers are preempted by federal law because the generic manufacturers are required to utilize the same labeling as the equivalent branded drug).

Despite the fact that the court did, in practical terms, accept the “innovator liability” theory, the court stated that it was not creating a new tort of "innovator liability" or "turning products-liability law . . . on its head" because the ruling applies only to brand-name and generic drug manufacturers, which the court says have a "unique relationship" due to the distinctive federal statutory and regulatory framework in which they operate.

There were three dissenting opinions. Chief Justice Moore took the position that the court should not have addressed the issue because "critical facts" were not before the Court. Justice Parker stated that “nothing in federal legislation or regulations at issue here requires this Court to ignore, modify, or override our bedrock legal principles of duty and privity with regard to the originator of a pharmaceutical drug and a consumer who has not consumed a drug manufactured by the originator of the drug.” He warned that the Court’s modification of these principles could have “grave and unforeseen effects in other areas.” Justice Murdock opined that plaintiffs' inability to hold a generic drug-maker accountable after the U.S. Supreme Court decided PLIVA, Inc. v. Mensing, "is not a ‘wrong' that this or any court should attempt to correct with a second ‘wrong.'" 

The Alabama Supreme Court’s position remains the minority view at this time. The vast majority of courts to address this issue have rejected the innovator-liability theory. To date, Alabama (Weeks), California (Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008)), Vermont (Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010)) and Illinois (Dolin v. SmithKline Beecham Corp., No. 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014)) are the only states with opinions to the contrary. The Sixth Circuit Court of Appeals rejected Dolin, however, holding that the Illinois Supreme Court would not hold brand-name manufacturers liable for injuries caused by generic drugs. See In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 2014 WL 2959271 at *22-24 (6th Cir. June 27, 2014). There are cases from the following jurisdictions (primarily decisions in which federal courts are predicting state law) rejecting the innovator-liability theory:

Arkansas

New Jersey

Colorado

New York

Florida

North Carolina

Georgia

Oklahoma

Iowa

Oregon

Kentucky

Pennsylvania

Louisiana

South Carolina

Maryland

Texas

Massachusetts

Utah

Minnesota

West Virginia

Nevada

 

What is clear from these differing opinions is that while the innovator-liability theory has gained traction in some state courts, federal courts are continuing to reject it. We can expect this theory to remain hotly debated for the foreseeable future, but it is already apparent that this theory is not likely to be successful in most federal courts.  

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The BSCR Drug / Device Law Blog examines topics and legal developments of interest to the drug and device industry. Learn more about the editor, Angela Higgins, and our Drug and Device practice.

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