FDA Considering Generic Drug Labelling Changes

The U.S. Supreme Court recently refused to hear an appeal by generic drug manufacturers, allowing a Fosamax failure-to-warn lawsuit to move forward. This could have far-reaching effects for patients injured by generic drugs throughout the country. Dangerous drug lawyers at Pintas & Mullins Law Firm explain what is at stake in this lawsuit and how the FDA plans to react.

The case brought before the Supreme Court was based on Teva Pharmaceuticals USA et al v. Olga Pikerie, which was filed by a woman seriously injured by the generic form of the drug Fosamax. Olga Pikerie was prescribed Fosamax and its generic equivalent (alendronate sodium) to help treat and prevent osteoporosis. She took the drug from 2006 to 2011.

Fosamax Femur Fractures

Within those four years, Pikerie suffered a left femur fracture, a serious side effect that thousands of other patients have experienced. Although Fosamax was developed and intended to be a bone-strengthening drug, it can actually have the opposite effect in some patients, causing thigh bones to break while engaging in normal activities like walking or standing. The risk is highest in women taking the drug for about five years or longer. More information on Fosamax and its risks can be found here on the New York Times wellness blog.

Fosamax was released in 1995 and heavily marketed to women at risk of osteoporosis – by 2008, medical researchers found a clear association between Fosamax and low-impact femur fractures. Two years later the FDA began its own investigation into the drug and its side effects, ultimately concluding that there was indeed a link between Fosamax use and unusual but serious thigh bone fractures. The FDA further stated that there was little if any benefit from the drug after three to five years of use.

Despite these known risks, when Fosamax’s brand patent expired in 2008 generic drug makers started selling the drug. Like millions of others, Pikerie took both the brand name and its generic equivalents, ultimately suing all companies that sold her the drug.

Her claims against all companies are the same: that they manufactured and sold a drug they knew to be unreasonably dangerous, that they failed to produce a safe product, failed to adequately warn patents about the side effects, and failed to take other available steps within their control to protect patients from injury.

SCOTUS Decision Points to Federal Drug Law Changes

The generic drug manufacturers attempted to appeal the case, arguing that Pikerie’s claims were preempted by federal law; specifically, the U.S. Supreme Court’s (SCOTUS) decision in PLIVA v. Mensing. We have written extensively about the PLIVA case, in which SCOTUS held that generic drug companies must exactly match the warning labels of its brand name equivalents.

Thus, even if generic drug makers knew that a drug was excessively dangerous, it would be impossible for the company to add additional information or warnings to its labels. Generic drug labels must exactly match the labels provided by the brand name company.

Pikerie is arguing, however, that Fosamax’s brand name labels had been updated to reflect the risk of serious bone fracture, but the generic companies did not update their products accordingly. In other words, the generic labels did not match the brand name’s. This is why her case is allowed to move forward.

For its part, the FDA recently revealed its plan to finally allow generic drug makers to update their own labels as they see fit, which would change the landscape of these types of lawsuits completely. Under the new federal law, generic drug makers will be required to update their labels according to the latest safety information, ultimately exposing them from drug injury claims like Pikerie’s. Currently, generic drug companies are completely protected from injury lawsuits.

The FDA will finalize this new law proposal in the fall of 2015, which is a large reason why SCOTUS refused to hear the Teva case and allowed it to move forward in California court. There are more than 11,000 drugs currently sold in the U.S., and the FDA does not have the resources to oversee each and every label. The agency is now asserting that the drug manufacturers hold primary responsibility for proper drug labelling at all times.

We will continue to report on all updates concerning this issue as they arise. Our team of drug injury lawyers has been fighting on behalf of injured patients for over 30 years. We have a wide network of legal professionals, medical experts, and investigators that allows us to take on clients from all 50 states. If you have any questions about an injury suffered from a drug, contact our office immediately for a free legal consultation.

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