A Nevada State Court Judge ruled that plaintiffs can sue generic drug manufacturers despite the Supreme Court’s recent ruling protecting drug companies from lawsuits in PLIVA, Inc. v. Mensing
The Food and Drug Agency (FDA) requires drug companies to send letters to physicians informing them of new warnings in approved labels. These are “Dear Doctor” letters and the FDA considers them part of a label. It is this label that provides the avenue to sue generic drug manufacturers.
In the Nevada case, the plaintiffs allege that the Endoscopy Center of Southern Nevada, L.L.C. reused vials containing a drug propofol, which caused hepatitis in patients. The manufacturers of the drug were also sued. Plaintiffs moved for summary judgment and won.
The Nevada Court based it’s decision on the fact that generic drug manufacturers could have, but did not, send “Dear Doctor” letters to physicians. Because of this failure, one could argue, the generic drug manufacturer failed to warn physicians about the risks of using their products (keep in mind this still causes a preemption issue).
This is good news for plaintiffs, however it is only the first battle in a long war.
Cases:
Carol Keck v. Endoscopy Center of Southern Nevada, L.L.C., et al., No. 08A575837
Megan T. Gasper, et al. v. Endoscopy Center of Southern Nevada, L.L.C., et al., No. 08A579660
Betty Hymas v. Endoscopy Center of Southern Nevada, L.L.C., et al., No. 08A582492
Venue: Nevada District Court, Clark County