Brand name drug companies could be held liable for patients who were injured by their generic drug counterpart, according to a new Alabama Supreme Court ruling. The court ruled 6-3 that companies are responsible for disclosing potential risks for their brand name drugs and devices, and failure to do so could make them liable in cases where a patient is injured by a drug’s generic counterpart.
The court ruling could affect other companies and products as well, including Bayer pharmaceuticals, which manufactures Mirena intrauterine device (IUD). Doctors recently discussed a plan to release a generic version of the Mirena IUD, which has increasingly been associated with severe complications such as internal bleeding, severe pain and tissue damage when the device perforates the uterus and migrates through the body.
More than 70,000 women have filed Mirena side effects complaints to the U.S Food and Drug Administration since the year 2000. An estimated 2 million women use the birth control device. Bayer could face thousands of lawsuits alleging that the device caused severe injuries.