Failure to Warn

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The Evolution of Innovator Liability for Pharmaceutical Manufacturers
Brand-name drug manufacturers are not unfamiliar with the concept of Innovator Liability, under which they can be held liable for injuries caused by a product they did not make. In other words, Innovator Liability holds a manufacturer liable by virtue of being an innovator.

Innovator Liability, usually brought under a failure to warn theory, can be traced back to a 2008 California case, Conte v. Wyeth, Inc., where the Court of Appeal held that a branded drug manufacturer’s duty to warn extends to patients taking the generic counterpart. The court reasoned that it is foreseeable that physicians and pharmacists may rely on the brand drug’s label to prescribe the drug’s generic counterpart for patients.[i] Conte has been rebuffed nationwide. By July 2014, more than 100 courts in 49 states, including the U.S. Courts of Appeals for six different circuits, rejected Innovator Liability.[ii] The Supreme Court of Iowa described Innovator Liability as “deep-pocket jurisprudence [which] is law without principle.”[iii]…

Continue Reading Never-Ending Liability Under Novartis

On March 16, 2018, Massachusetts’s highest court , the Supreme Judicial Court, issued a ruling that we believe will increase the product liability risk exposure for pharmaceutical manufacturers in the state. In the case of Rafferty v. Merck & Co., SJC-12347 (March 16, 2018), the Supreme Judicial Court held that a user of a generic drug may not bring a simple negligence claim against the brand-name manufacturer for failure to warn, but the user could bring a failure to warn claim against the brand-name manufacturer if it could show that that the brand name manufacturer intentionally failed to update a label on its drug, “knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use.” The Supreme Judicial Court’s holding requires a plaintiff to show that the brand-name manufacturer’s actions were reckless, as opposed to only negligent, which is a more stringent standard to prove. The Court’s decision sought to balance protection for the consumers of generic drugs in light of the U.S. Supreme Court decision in Pliva Inc. v. Mensing,[1] while taking into account the burden on brand-name manufacturers. However, by its own admission, this latest decision from Massachusetts’s highest Court stands in the minority of courts that have ruled on this issue. The decision is an important one, however, because brand-name manufacturers can now be held liable to the users of the generic versions of its drug under a theory of reckless failure to warn. It will be interesting to see if other jurisdictions that have not addressed the issue will follow the Massachusetts high court.
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Continue Reading Rafferty v. Merck Expands Potential Liability for Drug Manufacturers in Massachusetts

It’s probably common knowledge to even a novice product liability practitioner that a manufacturer can be held liable for a defect in a component part supplied by another company that is integrated into the manufacturer’s end product.  After all, under most commonly held notions of product liability law, the product manufacturer is subject to liability for a defect even when the defect arises solely from a flaw in a component part manufactured or supplied by another company.  By accepting the component from the supplier and integrating it into the manufacturer’s product, the manufacturer effectively “buys” any liability for a defect that may come with the component. Public policy requires the product manufacturer to make sure that it uses components supplied by reputable companies that are designed with safety in mind. The manufacturer is in the superior position to ferret out defective components and to avoid their use.  Since the manufacturer realizes the benefits (i.e., profits) from marketing the product, it should also be held to answer for any product defects, even those from a component part it did not manufacture.
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Continue Reading How Far Is Too Far? New York Clarifies Potential Warnings Liability for Third-Party Products

87531931Those of us in the business of defending products look at the world in a slightly different way. When I come across a warning label, I actually study it because in a failure to warn case, the language of the warning, the color of the label and its location on the product are relevant to the effectiveness of the warning. In my experience defending manufacturers of various types of products, I have seen plaintiffs make speculative failure to warn claims. Less-experienced plaintiffs’ attorneys assume that a creative theory developed by a well-credentialed “warnings expert” will be enough to leverage a settlement in an otherwise weak case on liability. That is a dangerous assumption to make.
Continue Reading WARNING! If You Assume Your Case Will Survive Because You Have a “Creative” Warnings Expert, You Do So At Your Own Risk