Suzanne Potter
California News Service
SAN DIEGO – Under current law, generic drug companies can rarely be sued when their products cause serious harm. Patient advocates are slamming the FDA for dragging its feet on a new rule to fix the so-called generic safety loophole.
The FDA recently announced it won’t finalize the rule, which was proposed in 2013, until at least April of 2017. 17-year-old Taylor Smoot from San Diego said four years ago she took Zarah, a generic form of the birth control pill Yaz, to regulate her cycle. She developed dozens of blood clots and has since suffered through 24 surgeries.
“I have almost died many times,” Smoot said. “I’ve gone through a coma. All because of this generic drug. On the labels, they did not have a warning. I would have been warned if I had taken the brand name. That is why I’m going to be living with this for the rest of my life.”
The risk of blood clots was known. Bayer, the maker of brand name Yaz, paid out more than a billion dollars to settle lawsuits. But Smoot and others like her can’t sue for a dime. That’s because in 2011, the U.S. Supreme Court determined that since federal regulations don’t require generic companies to update their labels, makers of generic drugs have very limited liability in drug injury lawsuits.
Smoot’s former attorney, Tom Lamb, said insurance companies often insist that patients take the cheaper generics – and millions of Americans have no idea they’re giving up their legal rights when they fill the prescription.
“80 percent of the drugs that are dispensed at pharmacies are generic,” Lamb said. “And people are unaware of this rule that if they’ve got a prescription filled with a generic as opposed to the brand name drug that they have no legal recourse against a manufacturer if they suffer a drug injury.”
According to Lamb, generic drug companies claim it would be confusing to doctors if the labels were different on ten versions of the same drug. But the new federal rule would give the FDA the power to evaluate reported risks and require all brand name and generic versions to carry the same warnings.
To learn more about the 2011 Supreme Court ruling, visit supremecourt.gov.
