An Open Letter
By: Lucy Nashed, TLR Communications Director
Consider this letter a standing invitation to move to Texas.
The U.S. Supreme Court just heard argument in a lawsuit filed against you alleging failure to provide an adequate warning about one of your prescription drugs. You had asked the Food and Drug Administration (FDA) to allow you to warn consumers that use of your osteoporosis medicine might create an increased risk for upper-leg fractures. The FDA refused to approve the warning you requested, and so you moved forward using the warning label the FDA did approve, which is the only thing you could do.
Through the years, you continued to work with the FDA on the warning label for your product. Eventually, the FDA agreed with your evidence that the product might increase the risk of an upper leg fracture. The FDA then approved a new warning label for your product, noting the identified risk.
Of course, when the warning label changed, the trial lawyers took notice. After you changed your label, many people who had used your product and allegedly suffered femoral fractures sued you, alleging that you had failed to warn them about the bone-fracture risk. Over 1,000 of these cases were sent to a multi-district litigation proceeding in federal court in New Jersey.
The case of one of the thousand plaintiffs was selected for trial and the question was presented: can a pharmaceutical company that used a prescription medication warning label approved by the FDA be sued under state law for failing to include a particular warning about possible ill-effects of its product?
In other words, can you do exactly what the government tells you to do and still get sued?
We hope the U.S. Supreme Court will conclude that complying with government standards is an absolute defense to liability in a case like this.
Texas amended its product liability laws 15 years ago to provide that if a pharmaceutical company uses a warning label approved by the FDA—and did not lie to the FDA to get the approved label, as is the case here—then the company cannot be liable under Texas law for any deficits in that label.
So Merck, as you can see, Texas is well ahead of the nation on issues like this. We’ve been working for 25 years to keep our legal system fair and efficient, which is why Texas is the best place in the nation to do business.
Come to Texas. It’s warm and sunny here. The people are enterprising, hard-working and friendly. Regulations are reasonable, taxes are low, and the civil justice system is fair and balanced.
The opportunity to do business in Texas is limitless!
Texans for Lawsuit Reform