Supreme Court Assesses Liability of Generic Drug Makers

The U.S. Supreme Court recently heard arguments regarding whether or not federal law regulating generic drugs preempts New Hampshire’s design-defect law. The case may determine whether or not the injured plaintiff is able to recover from the generic manufacturer. The trial court and lower appellate court found that federal law did not preempt New Hampshire’s strict product liability law. However, other recent Supreme Court decisions barring recovery may guide the result of this case, depending on whether there’s enough of a distinction between a state law requiring a duty to warn and a state law allowing recovery under strict liability.

Florida also allows recovery under the theory of strict liability for defective products, where negligence and intent to cause harm does not have to be shown in order for an injured plaintiff to recover. The design has to be defective, and injury or other damage shown to be caused as a result of the defect. Florida’s law includes both consumers and bystanders and does not require that the product be shown to be “unreasonably dangerous”.

The injured plaintiff in the current Supreme Court case took a prescribed, generic anti-inflammatory medicine for shoulder pain. As a result, she suffered from two painful syndromes, Stevens-Johnsons Syndrome and toxic epidermal necrolysis which caused her skin to slough off, esophageal burns, near-blindness, and lung injuries. She sued the manufacturer of the generic drug, claiming the medication was “unreasonably dangerous”, and that the risks outweighed the potential benefits.

handicap.jpgThe Food and Drug Administration had previously deemed the brand-named version of the drug as “safe and effective”. That not only allowed the brand-named drug to sell its product on the market, but the generic versions to sell with that designation as well, including the drug that harmed the plaintiff in this case before the Court. The F.D.A. says that a generic drug, by law, must contain the same active ingredients in identical amounts as the brand named product. It should also be the same in dosage, safety, strength, how it is taken, quality, performance, and intended use. These are supposed to be seen as the “therapeutic equivalent” to brand-named drugs. They are also required to have the same warning labels as their brand-named counterpart.

The outcome of this case will guide whether or not an injured plaintiff will be able to sue in state court for injuries caused by generic drugs. The manufacturers of the drug argue that the strict liability imposed by the state adds duties to the drug manufacturers that are not congruent with federal laws requiring “sameness” between generic and brand-named drugs. Other recent Supreme Court decisions have held that federal law preempted a state failure-to-warn action. The injured plaintiff’s attorney, however, is arguing that there is a distinction between her action, centered around strict liability, and the ruling of the prior Supreme Court decision.


The attorneys of Friedman, Rodman & Frank have handled several multi-million dollar personal injury cases, fighting for compensation for those injured by defective products. The defective drug recall attorneys prepare each case as if it is going to trial, and have worked with several industry experts to reveal inadequate testing processes and knowledge of foreseeable problems. If you have been injured and would like to speak with one of our South Florida defective drug attorneys at one of our multiple locations, call today for a free, confidential conversation at (877) 448-8585.

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