Generic Drugs may be Held to Lower Standards

 Posted on November 04, 2013 in Drugs

When many patients are diagnosed with a treatable but expensive disease, they turn to generic drugs as a solution. With superstores such as WalMart carrying the availability torch when it comes to generic brand pills, it's no surprise that, according to the New York Times, “now account for 80 percent of all prescriptions in the United States.” Not only are generic drugs cheaper, they're also more likely to be carried by pharmacies that don't require health insurance and offer a store-specific spending plan. Earlier this year, however, a case that is “enough to make anyone squeamish,” according to the New York Times, resulted in a ruling that Supreme Court ruling that generic drug-makers couldn't be sued for bad reactions to their products. While name brand drug-makers are still held responsible for the quality of their products, generic drugs no longer are considered under the same tight restrictions.

In 2004, Karen Bartlett, according to the Times, “developed a rare but severe reaction to” a pain pill prescribed to treat shoulder pain. “Within weeks of taking the drug,” the Times reports, “her skin began to slough off until nearly two-thirds of it was gone.” She sued Mutual Pharmaceutical Company, the manufacturer of the generic drug, and an appeals court upheld a 2010 verdict that awarded Bartlett $21 million in damages.

In 2011, the Supreme Court “severely limited the conditions under which consumers of generic drugs could sue the manufacturers,” because generic drugs, reports the Times, are exempt from the same FDA regulations as their name-brand counterparts. In June of this year, the Supreme Court revisited the argument. According to Reuters News Service, the Court decided that generic drug-makers were indeed not liable to the same extent as name-brand drug-makers, “a decision that consumer advocates called a blow to patient safety.”

A consumer watch group said that the decision was particularly dangerous considering the number of consumers that use only generic drugs, who now have no recourse if their medicine is defective.

If you or someone you know has been affected by a defective medical device or product, the most important step is to seek the counsel of a qualified attorney. Don't go through it alone. Contact the Law Office of Newland & Newland today.