Final Chapter of HuffPost’s Risperdal Series Examines Verdict in Pledger Case

In the 15th and final chapter of its series on Johnson & Johnson’s Risperdal (risperidone), the Huffington Post (10/2) “Highline” recounts how the jury in the Pledger case handed down its verdict Feb. 24, 2015, finding J&J was negligent by failing to provide an adequate warning about the risk of gynecomastia associated with Risperdal. The jury awarded $2.5 million to Austin Pledger. Meanwhile, J&J’s “latest SEC filing says there are 4,200 Risperdal claims on dockets across the country.” All in all, author Stephen Brill argues, the Risperdal scandal raises concerns about regulation of drug manufacturers. Indeed, the company’s misconduct “would have gone unchecked” if not for the work of plaintiffs lawyers who “trudged through millions of documents.” The FDA “didn’t do that work.” Meanwhile, the “recent push from the bench, emanating from the Supreme Court, to expand the First Amendment rights of corporations could upend the core principle that a regulatory agency like the FDA can stop drug companies from spending whatever it takes to put their spin on what their products can be used for.”

Supreme Court to Take Different Look at Generic Drug Manufacturer Liability

By Buck Daniel

March 20, 2013 – Two years ago, the Supreme Court severely limited the conditions under which consumers could sue generic drug manufacturers. The Pliva v. Mensing decision stated that generic manufacturers do not have control over a drug’s warning label content due to FDA regulations; and therefore, the companies cannot be sued for failing to alert patients to the risks of taking its drugs. However, a new case is before the Supreme Court testing a different theory of liability. The case, Bartlett v. Mutual Pharmaceutical Co., advances not a theory of  inadequate warnings, but one that claims the generic drug itself was defective. Bartlett comes to the Supreme Court on appeal regarding a decision by the United States Court of Appeals for the First Circuit that upheld a jury verdict for the plaintiff and argued that even if Mutual could not have changed the drug’s design, it had no obligation to continue selling a defective product. The results of this case has far reaching implications, because if the Supreme Court reverses the decision by the First Circuit patients will be left with very few options if they are injured by a generic drug. Which begs the questions, “Can you sue a generic manufacturer for any wrongdoing, no matter how disgusting their behavior?”