On November 18, 2014, DePaul’s Health Law Institute welcomed members of the Wolters Kluwer Health Law editorial team, Anthony Nguyen, J.D. and Danielle Capilla, J.D., who gave a lecture on generic drug liability litigation. The lecture helped attendees gain a better understanding of the current implications of generic drug liability litigation and established a platform for future discussion.
Capilla, a senior writer analyst, noted that the scope of this lecture best encompasses “when an individual takes a generic version of a drug, feels that they were injured by the drug, and is seeking to file a law suit against the manufacturers of the drug in order to get financial compensation.” Nguyen, also a senior writer analyst at Wolters Kluwer, followed Capilla by describing how the U.S. Food and Drug Administration (“FDA”) currently requires identical labels on brand name drugs and their generic counterparts. This requirement is attributable to the pharmaceutical industry practice of maintaining the exact same chemical formula of the brand name drug in its generic version.
Nguyen discussed the heavy overlap of federal regulations that oversees pharmaceutical product safety and the additional remedies available for parties injured by these same products at the state level. He described three types of preemption as recognized by the Supreme Court influencing the relationship between federal and state level efforts. First, express preemption requires that federal statute explicitly supersede state law. In the case of medical devices, the Federal Food, Drug & Cosmetic Act contains a provision explicitly stating that federal law will preempt state law for claims brought under state law. Nguyen pointed out the absence of pharmaceutical drugs in this provision and the opportunity this gap in the statute creates for litigants seeking redress for harm caused by pharmaceutical drugs. Second, implied-field preemption requires courts to look closely at congressional intent through federal statutes governing this field to better determine what congressional intent has been historically. Third, implied conflict preemption arises when industry practitioners claim that it is nearly impossible to comply with both the federal regulations, and state level remedies.
Nguyen followed this discussion with an example from current case law and the progression of generic drug litigation by exploring a seminal decision by the United States Supreme Court in Wyeth vs. Levine.  In Wyeth, the plaintiff suffered from gangrene tissue and the eventual amputation of her arm.  The plaintiff claimed the drug label was defective in failing to effectively warn against the direct injection of the drug into her veins, and sued its brand name manufacturer.  The United States Supreme Court affirmed the Virginia Supreme Court decision in favor of the plaintiff asserting that the manufacturer failed to prove that it could not comply with both federal and state requirements due to implied-conflict preemption.  The decision also held that the manufacture had a duty to adequately warn under the “changes being effected” (“CBE”) rule.  The CBE regulation provides drug manufacturers with the right to unilaterally strengthen its warning labels once the drug has entered the market and before it has attained FDA approval. 
Nguyen highlighted the lasting implications of the Wyeth decision and its reach beyond most products liability cases of its kind. After all, the Court reasoned that Congress did not intend for FDA oversight to be the exclusive enforcer of drug safety and that brand name drug manufacturers are ultimately responsible for their drug labels. 
Another relevant decision by the United States Supreme Court that furthered the development of generic drug litigation was Pliva v. Mensing in 2011.  The facts involved claims against a generic drug manufacturer for the failure to warn against potential injuries that could occur after taking the generic medication.  The ingestion of the generic drug caused the plaintiff to develop, tardive dyskinesia, an involuntary movement disorder.  In response, the generic drug manufacturer relied on implied preemption and argued that FDA regulation requires generic drug labels and brand name drug labels to be identical.  The Court held that the generic manufacturer’s contentions were correct and that generic manufacturers cannot unilaterally alter their labels, and thus could not be liable under this action.  Nguyen pointed to the Hatch-Waxman Act as potential motivation for the Court’s ruling. The Hatch-Waxman Act essentially allows generic drugs to show equivalence and enter the market without other substantial hurdles as long as the generic drug label perfectly matches the brand name label.  To rule in the adverse would ultimately hinder the production of generic drugs into the marketplace.
Capilla concluded the presentation by introducing a rule proposed by the FDA in November of 2013 that would allow generic drug manufacturers to independently change their labels before FDA approval.  The policy considerations behind this proposed rule include speeding up and streamlining the processes of both generic and brand name drugs in order to better provide the public with important safety information. The final version of this proposed rule is expected to come out in December of this year after the FDA takes industry feedback into consideration. Capilla and Nguyen, however, expressed doubt about the final rule being issued before the end of 2014.
Danielle Capilla and Anthony Nguyen are senior writer analysts in the Health Law division of Wolters Kluwer Law & Business, a leading global provider of intelligent solutions for legal and business professionals. They are based in Riverwoods, Illinois.
If you missed the lecture, you can view the recording HERE!
Sutapa Adhikari is a current student at DePaul University College of Law in Chicago and a Fellow of the Health Law Institute. Ms. Adhikari received her undergraduate degree in Political Science from the University of Illinois in Urbana-Champaign.
- Wyeth v. Levine, 129 S.Ct. 1187 (2009).
- Id. at 1191.
- Id. at 1191.
- Id. at 1205.
- Id. at 1209.
- 21 C.F.R. § 314.70.
- Wyeth v. Levine, 129 S.Ct. at 1219.
- Pliva, Inc. v. Mensing, 131 S.Ct. 2567 (2011).
- Id. at 2568.
- 10. Id. at 2569.
- 11. Id. at 2570.
- 12. Id. at 2575.
- 13. Daniel E. Troy, Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) (Aug. 1, 2003), http://www.fda.gov/newsevents/testimony/ucm115033.htm.
- Janet Woodcock, M.D., Examining Concerns Regarding FDA’s Proposed Changes to Generic Drug Labeling (Apr. 1, 2014), http://www.fda.gov/newsevents/testimony/ucm389606.htm.