A new bill would lift certain restrictions on the right to sue generic drug manufacturers, and would allow individuals who experienced serious side effects from taking the generic equivalent of drugs like Fosamax and Zithromax to file lawsuits.

New Legislation Would Restore Right To Sue Generic Drug Manufacturers

On April 18, 2012, Senator Patrick J. Leahy of Vermont introduced a new bill called the “Patient Safety and Generic Labeling Improvement Act,” which would restore the right for patients to sue generic drug manufacturers for failure to warn about dangerous side effects. On May 11, 2012, the National Association of Attorneys General (“NAAG”) sent a letter to Senators Patrick J. Leahy and Al Franken in support of this proposed legislation. Attorneys general from 41 states signed the letter. In the letter, they argued for consumers of generic drugs to have the same protections that exist for consumers of brand-name drugs: “Consumers whose prescriptions happen to be filled with the brand-name version of a drug are protected by state law from inadequate warnings, but consumers whose pharmacists fill their prescriptions with the generic version are now denied this protection.” This is especially alarming considering that “the adverse consequences are magnified by the fact that over 70% of prescriptions in the United States are filled with generic drugs.”

New Bill Would Prevent Dismissal Of Litigation Against Generic Drug Manufacturers

The new bill, if passed, would reverse a Supreme Court ruling last year in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which ruled that generic drug makers cannot be held liable for failure to warn about risks associated with their medications, even if they are, or should be, aware that the drug’s warning label is insufficient. The court decided that the FDA regulations which require generic drug labels to match brand-name counterparts made it impossible for generic drug makers to comply with both federal and state law. As a result, thousands of lawsuits pending against generic drug manufacturers have been dismissed. The new proposed legislation would overturn the ruling and restore the right to pursue litigation against generic drug equivalents of brand name drugs such as Fosamax and Zithromax.

Litigation Mounting For Dangerous Drugs Like Fosamax and Zithromax

While litigation is mounting for individuals who took Fosamax and suffered femur fractures or experienced Zithromax side effects, unfortunately, many individuals who suffered side effects after taking the generic equivalent of these drugs currently have limited legal recourse. Bernstein Liebhard LLP is hopeful that the new law will pass and hold the manufacturers of generic and brand-name drugs equally accountable to consumers.

Published June 8, 2012 by