Update: Federal District Court Rejects Minority View on Pharma “Innovator Liability”

pillsIn a recent post, West Virginia’s High Court Rejects Novel Theory of “Innovator Liability”, WLF Senior Litigation Counsel Cory Andrews discussed a state court decision that declined liability on a pharmaceutical manufacturer for alleged harms caused by a drug it did not produce. In doing so, the West Virginia Supreme Court of Appeals parted company with the highest courts of two other states, California and Massachusetts, which earlier this year embraced the minority view that plaintiffs can recover damages from so-called branded pharmaceutical companies for harms allegedly caused by the generic copy of the the brand-name drug.

On May 21, a U.S. District Court for the District of Massachusetts judge overseeing a multidistrict litigation, In re: Zofran (Ondansetron) Products Liability Litigation, followed the majority view of innovator liability and dismissed three claims filed by plaintiffs who had only ingested the generic version of Zofran.

Judge F. Dennis Saylor IV explained that the plaintiffs were advancing tort-law theories of misrepresentation against Zofran’s manufacturer, GlaxoSmithKline LLC.  The plaintiffs claimed that GSK “created a market for Zofran use during pregnancy” for nausea (an “off-label” use of the product) and thus voluntarily undertook a duty to warn not only about possible side effects of its drug, but also those of generic ondansetron. GSK possesses that duty, the plaintiffs further argued, because it could foresee that pharmacies would substitute the generic for the brand drug when filling prescriptions. The three suits addressed in the May 21 opinion were filed under the laws of Oklahoma, Connecticut, and New Jersey, respectively.

In his analysis, Judge Saylor first surveyed the three recent innovator-liability state high-court rulings while noting that the law of none of those three states were at issue in In re Zofran. He then assessed how courts in Oklahoma, Connecticut, and New Jersey had ruled on innovator liability.  Neither state nor federal courts in Oklahoma and Connecticut have considered the blame-shifting theory. Four New Jersey trial courts have considered and rejected innovator liability in analogous lawsuits.

Though he acknowledged that “the minority view has gained ground in the last year,” that development did not motivate Judge Saylor to accept innovator liability.

The In re Zofran decision comes on the eve of May 30 oral arguments in the U.S. Court of Appeals for the Seventh Circuit on the innovator-liability issue in Dolin v. GlaxoSmithKline LLC.  WLF filed an amicus brief with the court asking it to overturn the trial court’s decision.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s