Basics of Pharmaceutical Litigation - Warning: This Can Get Frustrating

There are no federal product liability claims. Plaintiffs must rely on state law claims for recovery. This means there are fifty versions of product liability laws that come into play with a national campaign.

At common law, there are three causes of action: manufacturing defect, design defect, and failure to warn. These are strict liability claims – not to be confused with “absolute” liability. In other words, to prevail, the plaintiff must prove something more than merely a pharmaceutical product caused injury. To establish a manufacturing defect claim, plaintiff must demonstrate that product was manufactured in a manner that deviates from its design. Design defect requires a showing that the product design was unreasonably dangerous. To recover in failure to warn, the plaintiff must show that the manufacturer failed to provide a sufficient warning of risks the manufacturer knew or should have known.

Many states have also adopted product liability acts that may slightly or grossly modify the common law. For example, the Louisiana Product Liability Act, RS 9:2800.51, “establishes the exclusive theories of liability for manufacturers for damage caused by their products,” and thoroughly describes and limits the available causes of action. The Ohio Product Liability Act, on the other hand, permits claims for manufacturing defect, design defect, failure to warn and negligence claims, but no others. Some states permit a much broader range of claims including consumer protection acts, breach of warranty, and breach of contract.


Under the Supremacy Clause of the U.S. Constitution, when it is impossible to comply with both state law and federal law, the federal law prevails and the state law is inapplicable. In the 2009 landmark case of Wyeth v. Levine, Defendant Wyeth Pharmaceuticals, the brand manufacturer of the drug Phenergan, argued that it could not comply with Vermont state law that requires it to strengthen the warning while also complying with the FDA regulations requiring it to maintain the label that it had negotiated with the FDA. The U.S. Supreme Court disagreed, pointing to a section in the Code of the Federal Register (CFR) permitting brand manufacturers to unilaterally change the label to make the drug safer based on new data or new analysis of old data. That CFR section is known as “Changes Being Effected” or simply “CBE.”

Despite the holding of Wyeth v. Levine, which appeared to limit preemption as a defense, generic manufacturers continued to argue that state law claims requiring the design or labeling to be better are preempted by federal law requiring the label to be the same as that of the brand. This is sometimes referred to as the “sameness requirement.” In 2011, in PLIVA v. Mensing, the U.S. Supreme Court sided with the generic pharmaceutical companies, holding that the CBE does not apply to ANDA holders and thus state law failure to warn claims against ANDA holders are preempted.

In 2013, the US Supreme Court again sided with generic drug manufacturers, Mutual Pharmaceutical Co. v. Bartlett, holding that it is impossible to comply with federal requirements that the design of the drug must be identical to that of the brand while at the same time complying with state law that requires the design to be safer. As a practical matter, Mensing and Bartlett made recovering against a generic drug manufacturer for claims based on the design of the drug or its labeling impossible. That means a plaintiff who used a drug and was injured by its unreasonably dangerous design could recover if the plaintiff’s prescription was filled with the brand version of the drug, but not if the prescription was filled with an identical product bearing identical labeling that happened to be manufactured by an ANDA holder.

Innovator Liability

There are four states in which one or more courts have held that a plaintiff can recover against the brand manufacturer of a pharmaceutical product even if that plaintiff only used generic. The theory is that the plaintiff has a viable claim for “fraudulent misrepresentation” or “negligent misrepresentation” against the brand manufacturer because the brand manufacturer (often referred to just as “the brand”), advertised and marketed the brand name version of the product, and those advertisements induced the plaintiff to purchase the drug in its generic form. These states are California, Vermont, Illinois, and Massachusetts.

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