Consumers, under the law, are able to sue for damages for defective products as a result of negligence or strict liability. Recovery can be based on defects in the manufacturing, inadequate warnings, fraud, defects in the design, and implied warranty (where the product is not fit for the ordinary purpose for which it was sold).
Toxic Tort litigation involving defective drugs is governed by both the FDA under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U.S.C. §§ 301-1012, 42 U.S.C. §§ 262, 264, 266, 282, 284, the Public Health Service Act, as well as State law.
FDA approval of “new drugs” includes virtually all prescription drugs, as well as, some drugs which are sold over the counter. And testing of the new drug may take up to 12 years or longer before FDA approval is obtained.
In approving a drug, claims of the drug’s “effectiveness” must be supported by “substantial evidence that the drug will have the effect it purports to have under the indicated conditions of use.” And in the event that the labeling of the drug is determined to have been false or misleading in any particular, the drug will have been considered to be “misbranded.”
The content of the drug label (i.e., directions for use, warnings, precautions, adverse reactions, etc.) is part of the drug approval process.
Just a few of the drugs that have been involved in recalls include Accutane, Vioxx, and Actos. Accutane is an acne medicine, which was later linked to serious birth defects when taken by pregnant women, in addition to side effects of depression, bowel diseases including “Crohn’s”, and suicidal thoughts.
Vioxx, a prescription pain killer, approved by the FDA in 1999, was withdrawn by Merck in 2004 after allegations that the risk of heart attacks and death were doubled through the use of the drug. It was estimated that up to 38,000 or more deaths were related to Vioxx. It is also estimated that Vioxx had been taken by up to 25 million Americans.
Actos is a type 2 diabetes drug. Actos has been recalled in Germany and France. Actos has been linked to serious side effects such as bone fractures, liver failure, as well as, a high percentage risk of bladder cancer.
Although not recalled, Yaz Birth Control is being monitored by consumer watchdogs over concerns about the safety of the drug.
Medical devices such as Transvaginal Mesh, used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has been the subject of postmarket surveillance study orders issued by the FDA. Lawsuits have been filed pertaining to this product. Some mesh manufacturers have withdrawn their products from the market. Women have experienced post-surgery complications such as infections and severe bleeding, as well as, reports pointing to the synthetic mesh eroding organs in close proximity and cutting through the vaginal wall.
DePuy ASR Hip Replacement Systems and Stryker Rejuvenate & ABG II Hip Systems have been the subject of several law suits.
Toxic Tort litigation includes what may be identified as a toxic substance that has invaded or contaminated the body of the complaining Plaintiff resulting in injury. And this invasion may include adulterated food, pharmaceuticals, and defective medical devices. There are many ongoing lawsuits involving defective drugs and devices, and many of the ongoing cases have achieved “class action” status.
Due to the complexity of Toxic Tort litigation, it is imperative that you immediately seek the advice and/or representation of an Attorney if you believe that you or your loved one has been injured as a result of a drug or medical device. You may contact VANJOHNSON LAW FIRM, LLC, to discuss your legal matter (404) 551-2428.