A federal judge has dismissed a number of Darvon and Darvocet lawsuits brought against makers of generic versions of the recalled painkillers, applying a broad interpretation of a recent Supreme Court decision that shields generic drug makers from responsibility to warn patients and doctors about the dangers of associated with medications they manufacture and sell.
U.S. District Judge Danny Reeves, who is presiding over all Darvon lawsuits and Darvocet lawsuits pending in the federal court system, dismissed about 50 cases brought against generic drug makers this week.
The dismissals were based on decisions in a number of other courts and Reeves’ interpretation of the U.S. Supreme Court’s 2011 decision in Pliva Inc. v. Mensing, which found that generic drug companies can not be held liable for failing to warn about side effects, so long as their labels are identical to those of the original brand-name product.
The cases involve serious and sometimes fatal injuries that were allegedly caused by side effects of Darvocet and Darvon, two once-popular painkillers that were recalled in late 2010 after it was discovered that they increase the risk of life-threatening heart rhythm problems.
Following the recall of Darvon and Darvocet, a number of product liability lawsuits have been against manufacturers of the name-brand medications, as well as manufacturers of generic equivalents, which were widely used throughout the United States.
All of the complaints involve similar allegations that the manufacturers failed to properly research their medications, provide adequate warnings or recall the drugs after it became known that a large number of consumers were dying after taking the painkiller.
Reeves relied in large part on a June 2011 decision by the U.S. Supreme Court, which ruled in a 5-4 split that failure to warn lawsuits against generic drug makers are pre-empted by federal requirements that the “copycat” medications carry the same warning labels as the brand name versions they clone. Therefore, even if a generic drug maker knew or should have known that their medication causes a dangerous side effect, the Supreme Court ruling allowed them to escape liability for failing to warn consumers or the medical community.
In an Order issued March 5, Judge Reeves took the Supreme Court decision a step further. Following the Supreme Court decision in June 2011, Plaintiffs had filed amended complaints alleging defective design, negligent design, strict liability, breach of implied warranty, and negligent marketing. Reeves said that his interpretation of the decision also bars all of those charges as well, saying that generic manufacturers have a “federal duty of sameness” that requires them to make the drug just like the brand name, thus meaning they cannot be held responsible for those charges, either.
The decision leaves several hundred lawsuits filed by individuals who used name-brand versions of the medication. All complaints filed in federal courts throughout the United States have been consolidated for pretrial proceedings before Judge Reeves in the U.S. District Court for the Eastern District of Kentucky.