Court Rules Brand Drug Manufacturers Liable For Their Generic Counterparts

The recent ruling in Weeks v. Wyeth, Inc., No. 1101397, slip. op. (Ala. Aug. 15, 2014), became the most significant case to adopt the minority view that a brand drug manufacturer can be liable for injuries caused by a drug it did not manufacture. People within the pharma industry are probably wondering how Weeks can be overturned in Alabama or avoided in other jurisdictions. Any manufacturers of a brand-name drug should consider legislation and should look to other states’ product liability statutes for guidance. Notably, some states’ product liability statutes would have precluded a court from reaching the same holding as in Weeks, due to the limited causes of action available in those statutes.

Innovator Liability: Implications in Light of Weeks

First, let’s review the most recent ruling on this issue. On August 15, 2014, the Alabama Supreme Court reaffirmed its January 2013 holding that a brand drug manufacturer can be liable for injuries caused when a plaintiff ingests the generic version of its drug. This new opinion essentially adopts the original opinion, which found that a generic drug user’s doctor could foreseeably rely on a brand manufacturer’s warnings when prescribing the generic drug. According to the court, a brand manufacturer’s duty extends to all users of both the brand and generic versions of the drug because federal law requires that generic labels be identical to the brand-name labels.

In reaching its decision, the Court emphasized Alabama misrepresentation law and “the fact that two parties have had no contractual relationship or other dealings does not preclude the finding of a legal duty not to make a material misrepresentation or to suppress a material fact.” The court reiterated that liability for the fraud or misrepresentation claim at issue is based not on a product defect “but as a result of statements made by the brand-name manufacturer that Congress, through the FDA, has mandated be the same on the generic version of the brand-name drug.”

Overturning Weeks by Statute

Wyeth has exhausted its judicial remedies in Alabama on this issue, exposing brand manufacturers to new filings in Alabama and renewed arguments that other jurisdictions should follow suit. Legislative action, while difficult and slow, could provide relief. Manufacturers seeking a model statute after this unwelcome development should look to states like Louisiana and New Jersey for guidance.

The Louisiana Products Liability Act (“LPLA”) provides the exclusive remedy against a manufacturer for damages caused by its product, and a plaintiff cannot recover damages under any theory of liability not set forth in the LPLA.1 The LPLA limits a plaintiff to four theories of recovery: Manufacturing defect, design defect, inadequate labeling and breach of express warranty. Importantly, only those entities within the chain of distribution face liability.2 Similarly, while not intended to codify all issues of product liability law, the New Jersey Products Liability Act (“NJPLA”) is the sole basis for relief from harm caused by defective products,3 and subsumes all New Jersey Consumer Fraud Act claims based on harm caused by a product.4 Under the NJPLA, strict liability also extends only to manufacturers or those within the chain of distribution.5

Statutory remedies limiting liability to product manufacturers, distributors and sellers would supersede Weeks and restore Alabama to the majority view that brand drug manufacturers cannot be held liable for injuries caused by generic equivalents of their drugs.

References:

1. La. Rev. Stat. Ann. § 9:2800.52.

2. La. Rev. Stat. Ann. § 9:2800.53(1).

3. N.J. Stat. Ann. § 2A:58C-1(b)(3).

4. See, e.g., Sinclair v. Merck & Co., Inc., 195 N.J. 51 (2008).

5. See, e.g., Promaulayko v. Johns Manville Sales Corp., 116 N.J. 505 (1989).

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