Pharmaceutical

Generic Fosamax makers can be held liable for not updating warning labels

fosamax70 Generic Fosamax makers can be held liable for not updating warning labelsMakers of generic versions of the osteoporosis drug Fosamax can be held liable in multidistrict litigation (MDL) for not matching the warning labels on their drugs on to the brand-name equivalent, a New York federal judge has ruled.

Merck & Co. updated the warning label on its drug Fosamax in March 2010 to include information about the risk of developing osteonecrosis of the jaw, or ONJ, a condition also known as bone death or jaw death. Merck faces thousands of lawsuits for not adequately warning doctors or patients of the potential risk of ONJ.

When generic drugs are approved by the Food and Drug Administration (FDA) they are required to have the same safety labels as their brand name equivalent. Generic Fosamax makers, which include Teva Pharmaceuticals, Barr Pharmaceuticals, Watson Pharmaceuticals, and Mylan Inc., are now facing hundreds of ONJ lawsuits alleging the companies failed to update their labels when Merck updated its label.

Federal appeals courts are split as to whether the failure-to-update claims waged against the generic Fosamax makers were preempted by federal law. However, U.S. District Judge John Keenan noted that “although generic defendants were preempted by federal law from including additional warnings, they were required under federal law to ensure that their labeling reflected (FDA)-approved warnings for the name-brand drug.”

Judge Keenan cautioned the drug companies that their duty under the alleged “failure to update” claims was to update their labels within a reasonable time when Merck did. “Plaintiffs are left to argue only that the generic defendants’ warning was inadequate to the extent that it did not include the language contained in the updated label.”

Beasley Allen lawyer Chad Cook is on the Plaintiff’s Discovery Committee for In re Fosamax Products Liability Litigation, MDL-1789 which is venued in the Southern District of New York Federal Court before Judge Keenan, involving cases of osteonecrosis of the jaw. Chad also assists with serving on the Fosamax Science and Administrative Committees for this litigation.

Additionally, Chad is one of 11 lawyers from around the country selected to oversee the consolidated litigation as part of the Plaintiffs Steering Committee (PSC) for In re: Fosamax Products Liability Litigation (No. II), MDL 2243. This litigation, which encompasses hundreds of cases against Merck Sharp & Dohme, Corp., involves femur fracture injuries, and is consolidated under U.S. District Judge Garrett E. Brown, Jr., in the District of New Jersey.

Source: Law360