In late June, the U.S. Supreme Court issued a decision saying tort actions are preempted--that is, overridden by federal law, prevented--against generic drug makers for failure to warn about specific hazards. In other words, the Court said persons injured by generic drug products that are claiming the maker of the product failed to warn them about something are, from now on, prevented by federal law from doing so. This represents a big change that affects many companies, and thousands of cases brought by thousands of individuals against the companies.
If you have been following these issues you know that this is the exact opposite of the result that was reached just two years ago in a case involving brand-name drugs. The Supreme Court made clear that it recognized this result was different from the one it reached in the brand-name drug case, Wyeth vs Levine, in 2009, but, in a nutshell, the Court said in June in Pliva vs Mensing that the result is different because the rules are different: the law permits brand-name drug makers to unilaterally strengthen warning labels, without first getting FDA's permission. In a case where they could have strengthened their warnings, but didn't, they could be found to have been negligent or to have created an unreasonably dangerous product. On the other hand, generic drug makers have to ask FDA for permission to change the label, because their products and labels are required to match the brand-name product.
Well, the plaintiffs argued in the Pliva case the generic maker could have easily applied to FDA for permission to make such a change, and had they only done so, they would have been able to provide the missing warning that could have prevented the plaintiff's injury.
Not so fast, said the Court, noting that while the company could have asked FDA for permission, there is no guarantee they would have received it. Moreover, if the manufacturer had changed their labels without checking with FDA in order to avoid this potential liability under state law tort rules, they would have been in violation of the federal laws requirements that their product match the brand-named product's label.
Because such an unavoidable conflict existed, and the company couldn't comply with both the federal and state legal requirements at the same time, the Court found the federal law overrides the state tort liability.
So the current scorecard is, tort actions against brand-name drug companies are not preempted, tort actions against generic drug makers are, and, due to another case from a few years ago, tort actions against makers of medical devices cleared under premarket applications are preempted.
It will be interesting to see if there's any movement by Congress to change the law to undo this decision. You may remember that members of the U.S. Senate said, back when FDA declared there was preemption in the medical device case, that they would be amending the law to overturn that court decision. That still has not been done. If they have the same reaction to this recent decision, they will add it to the list of topics to be overridden by a change in the law. In the meantime, preemption of tort actions against generic drug makers for failure to warn is the rule.
-By Eric F. Greenberg, PC, Legal & Regulatory Affairs
If you have been following these issues you know that this is the exact opposite of the result that was reached just two years ago in a case involving brand-name drugs. The Supreme Court made clear that it recognized this result was different from the one it reached in the brand-name drug case, Wyeth vs Levine, in 2009, but, in a nutshell, the Court said in June in Pliva vs Mensing that the result is different because the rules are different: the law permits brand-name drug makers to unilaterally strengthen warning labels, without first getting FDA's permission. In a case where they could have strengthened their warnings, but didn't, they could be found to have been negligent or to have created an unreasonably dangerous product. On the other hand, generic drug makers have to ask FDA for permission to change the label, because their products and labels are required to match the brand-name product.
Well, the plaintiffs argued in the Pliva case the generic maker could have easily applied to FDA for permission to make such a change, and had they only done so, they would have been able to provide the missing warning that could have prevented the plaintiff's injury.
Not so fast, said the Court, noting that while the company could have asked FDA for permission, there is no guarantee they would have received it. Moreover, if the manufacturer had changed their labels without checking with FDA in order to avoid this potential liability under state law tort rules, they would have been in violation of the federal laws requirements that their product match the brand-named product's label.
Because such an unavoidable conflict existed, and the company couldn't comply with both the federal and state legal requirements at the same time, the Court found the federal law overrides the state tort liability.
So the current scorecard is, tort actions against brand-name drug companies are not preempted, tort actions against generic drug makers are, and, due to another case from a few years ago, tort actions against makers of medical devices cleared under premarket applications are preempted.
It will be interesting to see if there's any movement by Congress to change the law to undo this decision. You may remember that members of the U.S. Senate said, back when FDA declared there was preemption in the medical device case, that they would be amending the law to overturn that court decision. That still has not been done. If they have the same reaction to this recent decision, they will add it to the list of topics to be overridden by a change in the law. In the meantime, preemption of tort actions against generic drug makers for failure to warn is the rule.
-By Eric F. Greenberg, PC, Legal & Regulatory Affairs
