Appeals Court Rules Drug Makers Can Be Sued Even When Labels Meet FDA Standards

By January 26, 2011Dangerous Drugs

As a dangerous drug attorney, I was very pleased to see a ruling from a federal appeals court confirming Americans’ right to sue drug manufacturers who fail to warn them about known safety problems. As the San Francisco Chronicle reported Jan. 25, the Ninth U.S. Circuit Court of Appeals ruled that day that a family may sue an over-the-counter drug maker for not marking the label of its ibuprofen to let patients know that it shouldn’t be mixed with other drugs that affect the liver. In the ruling, the Ninth Circuit said over-the-counter manufacturers are subject to the same rules as prescription manufacturers requiring them to issue warnings with new safety information. The ruling applies in the western states covered by the Ninth Circuit, but may be applied as guidance in other areas.
Ibuprofen, which is a common over-the-counter painkiller, is known to have effects on the liver at high doses. In fact, the FDA considered warning patients about the problem in 2002, but decided it didn’t have enough information. In this lawsuit, the son of Margaret Gaeta underwent minor surgery when he was 10 and was given an anesthetic that can harm the liver. He was prescribed ibuprofen for post-surgical pain and took it for four days. A week after surgery, he suffered liver and kidney failure and septic shock. As a result, he needed a liver transplant and has also had some fingers and toes removed. The family alleged that Perrigo Pharmaceuticals Co. should have included a warning on the label not to mix the drug with other drugs that can cause liver failure.
The trial judge dismissed their claim, saying a 2009 Supreme Court ruling did not apply. In that case, the court said FDA approval of a prescription drug’s label didn’t shield it from failure to warn claims based on new information. The Ninth Circuit applied the same logic to over-the-counter drugs, saying it found no indication that Congress intended to keep drug costs low at the expense of safety.
As a defective prescription drug lawyer, I am very pleased with this court decision. It seems like common sense, as well as the intent of Congress, that safety should come first. That may be especially important with over-the-counter drugs, because they are not necessarily prescribed and taken under a doctor’s supervision. Unless the patient happens to be an ardent watcher of FDA safety news, he or she has no way of knowing anything that the drug’s label doesn’t disclose. To make matters worse, the list of things ibuprofen might interact with to cause liver damage includes alcohol, one of the nation’s most common drugs, as well as other common over-the-counter remedies like acetaminophen (the active ingredient in Tylenol) and naproxen sodium (the active ingredient in Aleve). Patients taking these drugs deserve tools they can use to make good decisions.


If your family has suffered a serious illness after taking any kind of medicine, you should consider calling Carey, Danis & Lowe. We represent people who were hurt by defective drugs and medical devices, including over-the-counter drugs with serious safety issues. Like all manufacturers, drug makers have a legal obligation to warn their customers about potential safety risks, including risks discovered after the labels were approved by the FDA. Our pharmaceutical liability attorneys help hold pharmaceutical companies responsible when they don’t meet that obligation and someone is seriously hurt as a result. We help clients, as individuals or as part of a class action, request compensation for their injuries, their pain and any permanent losses caused by the drug, as well as all of the past and future medical costs.
Carey, Danis & Lowe offers free, confidential case evaluations, so you can speak to us without any further obligation. To set up a meeting, call us today at 1-877-678-3400 or send us an email.