DRUG COMPANIES EXEMPT FROM LAWSUIT, SUPREME COURT SAYS
Lost in the chaos that was the aftermath of the Trayvon Martin/George Zimmerman decision, people are just getting around to realizing that the Supreme Court controversially decided Karen Barlett v. Mutual Pharmaceutical Company. The decision held that, from now on, eighty percent of all drugs are exempt from legal liability, despite fraud, mislabeling, side effects and accidental death.
The plaintiff in the case was Karen Bartlett, who was prescribed a generic anti-inflammatory drug, Sulindac, in 2004. The drug, manufactured by Mutual Pharmaceutical, was intended to help her sore shoulder. However, just three weeks after taking the drug, Bartlett began suffering from toxic epidermal necrolysis. In lament’s terms, it’s a disease that causes a victim’s skin to peel off, exposing raw flesh in the same manner as third degree burn victims. The condition left Bartlett permanently disfigured over most of her body
Because the drug company included no warning about the possible side effect, Bartlett sued and won in New Hampshire court $21 million. In fact, The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.
However, this month, in a 5-4 vote, the Supreme Court overturned the state court’s verdict and award. The court argued that Bartlett had no legal grounds to sue the corporation because its drugs were exempt from liability. Justices cited the fact that all generic drugs and their manufacturers, some 80% of all drugs consumed in the United States, are exempt from liability for side effects, mislabeling or virtually any other negative reactions caused by their drugs.
The Court ruled, “Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law, New Hampshire’s warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce.” Essentially the Court ruled that the FDA has ultimate authority over pharmaceuticals in the US. And, if the FDA says a drug is safe, that takes precedent over actual facts, real victims and any and all adverse reactions.