New U.S. Food and Drug Administration Commissioner Scott Gottlieb will almost certainly halt a long-awaited rule letting generic drug makers update warning labels, which would reopen the door for consumers to sue for a failure to warn them adequately. Michael S. Burg, a veteran Denver mass tort attorney and co-founder at Burg Simpson Eldredge Hersh & Jardine, is worried about the rule’s future.
“I see him taking actions in terms of trying to firm up preemption and keep people from being able to sue,” Burg predicted.
Colorado mass tort lawyers have been waiting more than a year for an update on the rule already, which Gottlieb has gone on record as saying would inflate already high drug prices and offer “no public health benefit.
Gottlieb’s ties to the pharmaceutical industry also have many legal experts concerned.
“We’re going to have people who are going to get seriously injured by a drug that they never should be taking,” Burg said. “The FDA is supposed to be a watchdog for the public … and I see Gottlieb taking it more in the direction of an arm for Big Pharma.”
Read more on the story posted in Law360 here.