What’s in a Name? Branded Drug Makers Could be Liable for Adverse Effects of Generic Counterparts

Contributed by Natalie Blazer

When choosing a generic drug over its brand-name counterpart, is it reasonable to rely on product information provided by the brand-name drug company? Can a physician rely on such information when prescribing medication, knowing the patient is likely to fill the prescription with a generic brand? The answer may not be obvious, particularly given two recent conflicting federal court decisions that could cause confusion for pharmaceutical companies and consumers alike.

On Sept. 5, the U.S. District Court for the Eastern District of Kentucky allowed two California plaintiffs who used only generic propoxyphene painkillers to pursue misrepresentation claims under California law against the branded products manufacturer (In re Darvocet, Darvon, and Propoxyphene Litigation, E.D. Ky., No. 11-202, 9/5/12). Plaintiffs Mark Niebuhr and Karen Curtis each alleged they suffered serious heart damage caused by generic propoxyphene products. They sued Xanodyne Pharmaceuticals Inc., which made the branded Darvon and Darvocet products. Xanodyne sought dismissal, arguing that the plaintiffs failed to state a claim on which relief could be granted because they did not ingest its products.

In allowing the misrepresentation-based claims, the MDL court in In re Darvocet applied Conte v. Wyeth Inc., 85 Cal. Reptr. 3d 299 (Cal. Ct. App. 2008), a minority decision in which a California appeals court allowed misrepresentation claims against a name-brand drug manufacturer by a plaintiff who used generic metoclopramide. Conte reasoned that it is foreseeable that doctors and patients would rely on the branded maker’s product information, even if the prescription is filled with a generic drug. The In re Darvocet court upheld the continuing viability of Conte, despite a recent California asbestos decision finding that one manufacturer cannot be liable for harm attributable to another manufacturer’s products.

Although the In re Darvocet court ultimately did dismiss the product liability and negligence claims against Xanodyne, because the plaintiffs did not allege they took a Xanodyne product, survival of the misrepresentation claims in this case marks a departure from decisions in other parts of the country.

The day after In re Darvocet was decided, a federal court in Nevada dismissed plaintiffs’ misrepresentation claims and rejected any reliance on Conte. In Baymiller v. Ranbaxy Pharmaceuticals Inc.,  D. Nev., No. 11-858, 9/6/12, the U.S. District Court for the District of Nevada held that, under Nevada law, a plaintiff seeking product-related damages must show that the defendant manufactured or sold the product. In Baymiller, Mary Baymiller’s family contended that her dosage increase of paroxetine HCL, a generic version of the antidepressant Paxil, caused an episode of homicidal behavior in October 2009 that included Mary stabbing her husband repeatedly with knives and injuring herself. The husband, Charles Baymiller, died on Oct. 5, 2009.

The Baymillers asserted various causes of action against the generic drug manufacturers, the pharmacies, and GlaxoSmithKline LLC, alleging that the drugs taken by Mary did not contain adequate warnings concerning safe use. After the generic defendants and pharmacies were dismissed in July, GSK sought summary judgment as the only remaining defendant. The company argued there can be no liability under Nevada law because Mary never used its product, asserting that Nevada law lines up with dozens of decisions across the country that have held a brand-name manufacturer cannot be liable to a plaintiff who only used the generic version of the drug.

The Baymiller court agreed, citing the only Nevada case to address this issue, Moretti v. Wyeth Inc., No. 08-00396 (D. Nev., 3/20/09). Moretti rejected a host of product liability and misrepresentation claims because the plaintiff in that case had not used the defendant’s product, and held that Conte was contrary to Nevada law and public policy. Applying the reasoning of Moretti, the Baymiller court rejected plaintiffs’ misrepresentation claims, stating that  “Glaxo does not have a duty to warn or otherwise disseminate information about the risks associated with their generic competitors’ drugs because Mary Baymiller did not purchase or ingest a Glaxo product. As such, Mary Baymiller did not have a relationship with Glaxo and Glaxo did not owe Mary Baymiller any duty to warn.”

Given that the Conte decision relied on by In re Darvocet is a distinctly minority position, future outcomes would presumably align with Baymiller  instead.  However, given the flexibility that can surround a foreseeability standard (such as the one used in Conte and In re Darvocet), branded drug makers should remain vigilant when making representations about their products, particularly in markets where generic brand substitution is common, and in jurisdictions that have followed or are likely to follow Conte.