A U.S. District Chief Judge in Kentucky recently preserved two claims that drug maker Bayer Healthcare Pharmaceuticals Inc. wanted thrown out. The claims were based on two forms of negligence, strict liability and negligent representation. Bayer sought to have the claims dismissed, along with a claim for breach of implied warranty. Bayer's argument that Kentucky law does recognize negligent misrepresentation as a cause of action in products liability suits involving personal injury was not found to be persuasive. The plaintiff, Kara Stanley, will be allowed to pursue those claims in an attempt to recover damages for the harm done to her by the Mirena intrauterine birth control device.
A new study has called into question the safety of the popular drug Zofran. GlaxoSmithKline manufactures Zofran, also known as ondansetron. Zofran is approved by the Food and Drug Administration to treat nausea and vomiting caused by chemotherapy, radiation treatment and surgery. It is also prescribed by some doctors to treat nausea experienced by pregnant women. The study indicates that pregnant women who take Zofran may suffer an increased risk of severe birth defects and other injuries.
Dangerous and defective drugs can be hazardous to consumers in several ways. Some drugs pose dangers to a certain percentage of users, leading to harmful side effects that make the drug a hazard. Some drugs are manufactured or processed in an unsafe manner and pose a danger to anyone who is exposed to them. The actions of one pharmaceutical company in Massachusetts led to the release of highly contaminated drugs. The products released caused many people to become ill and led to the deaths of 64 people.
The Food and Drug Administration is responsible for regulating the safety, efficacy and security of drugs, medical devices, foods, cosmetics and biological products. The FDA investigates claims of dangerous drugs and other agents and, in some cases, orders recalls for products that pose a threat. Unfortunately, one of the fastest growing and most poorly understood markets is one where the FDA has the least power.