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August 29, 2014

Generic Drug Labeling: Brand-name drug manufacturers can be held liable for warnings on generic versions

by: Fred Thompson III

The controversial Wyeth v. Weeks decision, which was confirmed by the Alabama Supreme Court this past August 15, 2014, provided a welcome ray of hope in a preemption landscape made desolate by the Mensing decision of 2011.

In a salient strike to one of the most pro-corporate, anti-consumer decisions of the past several years, Pliva, et al v. Mensing, in which the United States Supreme Court immunized generic drug makers from liability for injuries resulting from inadequate warnings on generic drugs, the Alabama Court ruled that a brand-name drug manufacturer can be held liable for its generic counterpart’s failure-to-warn.

Mensing’s harsh preclusion to any remedy for injured consumers has resulted in great injustice, particularly where the drug in question has undoubtedly caused injury and where there was either no warning or an inadequate warning supplied by the manufacturer. Subsequent to Mensing, the United States Supreme Court has underscored its effort to deny consumers any remedy to generic drug injuries. By a bare 5-4 majority in Mutual Pharmaceutical Co. v. Bartlett (2013), the Court extended its failure-to-warn holding to New Hampshire state law, again granting immunity to the generic drug maker under that claim as well.

The hyper-technical interpretation of the Food, Drug, and Cosmetic Act in Mensing andBartlett creates a situation where the original patent holder had no incentive to update the label, and generics had no obligation to update their labels since:

  1. the original manufacturer had an approved label at the time the drug became generic (off-patent), and
  2. generic forms of the drug were allowed to be produced and sold.

Because of this extreme outcome, many courts have sought to find limits to the ruling to allow a remedy.

For example, where the original patent holder produced the generic drug either directly, through a subsidiary or under a joint enterprise with a generic, the courts have searched for ways to enforce their continuing duties to update labels with warnings of known risks and adverse effects. Some courts have even investigated whether they could enforce an action against the patent holder who has a continuing duty to update the label, even if the sale of the drug was from the generic maker to consumer.

In Wyeth v. Weeks, the Alabama Supreme Court specifically addressed a certified question from the Federal District Court:

“Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?”

Under Alabama procedure, the State Supreme Court may interpret its state law in response to questions from other Courts that have Alabama statutory or common law issues before them. In an exhaustive decision covering some 145 pages of text, The Weeks Court held:

“In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated, as allowed by the FDA, by the generic manufacturer.”

In other words, since generic equivalents are required by the FDA to use the same warning and information labeling as the brand-name manufacturer, the generic shouldn’t be held responsible for failure-to-warn; the brand-name manufacturer should.

Thus, Weeksbecomes the latest in the line of cases setting limits to the immunities granted by the Mensing decision. And even though Weeks applies only to Alabama law, it is useful to plaintiffs injured elsewhere as an example of careful analysis of the role of traditional state law remedies in providing redress for injured consumers.

The Weeks decision gives us hope that state law can provide opportunity and that Congress will address the injustice of the Mensing decision by a proper revision to the Food, Drug, and Cosmetic Act or by FDA regulation. While we work toward that goal, however, people are injured every day by generic drugs and they should have an opportunity to seek a remedy through our court system.

You may be interested in reading Generic drug makers not being held accountable by Motley Rice attorney Carmen Scott.