New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.

Supreme Court Sides with Merck on Warning Label Issue

The FDA blocked Merck’s attempt to add a femoral fracture warning to its osteoporosis drug Fosamax.

Merck HQ / Image: Reuters
Merck HQ / Image: Reuters

A recent Reuters article discussed a label issue that went all the way to the Supreme Court. Merck & Co has received multiple lawsuits claiming the company failed to properly warn patients of the risk of femoral fractures while taking its osteoporosis drug Fosamax. In 2008, Merck submitted data to the FDA that suggested Fosamax could be linked to certain bone fractures, but the FDA denied the warning label proposal. Two years later, the FDA ordered manufacturers to revise labels to include the warning, which Merck did.

In order to alleviate the drug company of any liability, the Supreme Court said it must show that it “fully informed” the FDA of the need for a warning label. Last Monday, the Supreme Court unanimously directed the Circuit Court of Appeals to reconsider its decision to let lawsuits against Merck move forward. The ruling clarifies that product liability claims brought under state law are preempted by the actions of a federal agency since federal law trumps state law under the U.S. Constitution. In other words, Merck cannot be penalized for failing to issue a warning that the FDA blocked.

How to Honor a Leader
Induction into the Packaging & Processing Hall of Fame is the highest honor in our industry. Submit your leader to be considered for the Class of 2024 now through June 10th. New members will be inducted at PACK EXPO International in Chicago.
Read More
How to Honor a Leader
Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Read More
Test Your Supply Chain Smarts