Post Mensing Generic Litigation

A legal decision in the world of post Mensing generic pharmaceutical litigation could be a glimmer of hope for those who have suffered side effects from taking a generic version of a drug. A Nevada court decided that while the Supreme Court ruled that the generic manufacturers could not use the Changes Being Effected (CBE) provision of the FDCAA or send out "Dear Doctor" letters that would add to or change the labeling, generic drug manufacturers could send Dear Doctor letters that do no differ from the existing labeling.

Granting Plaintiff's Motion for Partial Summary Judgement in Carol Keck v. Endoscopy Center of Southern Nevada, L.L.C., et al. as well as two other cases involved in the Las Vegas Endoscopy litigation, Judge Jerry Weise II said the Supreme Court (did not)

"...indicate that "Dear Doctor" letters that were "consistent and not contrary" to the labeling, were preempted. . . . While the FDA apparently believed that no liability may lie for failure to send such a letter unilaterally, the U.S. Supreme Court did not adopt this language, or set forth this holding as their own. Consequently, it is not part of the Mensing ruling, and is not binding upon this Court."

TheLas Vegas Endoscopy litigation involves a gastroenterology clinic that was allegedly reusing vials of propofol. A number of patients ended up getting Hepatitis C. The anesthetic was generally manufacturered by Teva Pharmaceuticals, and the first case resulted in a $500 Million dollar verdict against Teva.