FDA to Permit Generic Drug Makers to Make Changes Leading to Suits

Earlier this week the U.S. Food and Drug Administration (FDA) indicated their intention to permit generic drug manufacturers to make changes in their safety labels. This move could open the door to lawsuits filed against generic drug companies for the first time since the U.S. Supreme Court barred these suits two years ago.

Consumer advocates praise the FDA plan calling it a ‘necessary fix’ for a system they say is unfair to patients who take generic medications.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior advisor to the Health Research Group at Public Citizen, which petitioned the FDA to pass just such a rule in 2011. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”

Since the Supreme Court dismissed dozens of lawsuits against generic drug manufacturers in 2011 because they ruled that generic companies must, by law, use the same label warnings as their brand name counterparts, they cannot be sued for failing to warn patients about the potential risks of taking their drugs. Just a month ago, the Supreme Court ruled that patients also could not sue generic drug makers by claiming that the drug was defectively designed.

The FDA’s intentions came in the form of a bureaucratic step, whereby the agency must notify the Office of Management and Budget of its plans to publish a proposed new rule.  In a summary posted on the budget office’s Web site Wednesday, the FDA said the new proposed rule would “create parity” between generic and brand name drug makers regarding how they update their labels.

Currently, brand name manufacturers can change their label if they receive important new information about their drug.  If the FDA agrees that the label change is needed, the generic manufacturers of the drug must also change their labels.  The rule could also allow generic manufacturers to change their labels if they became aware of safety concerns, for which they could be liable if a court were to find they failed to warn consumers about potential dangers.

The notice that was posted earlier this week indicates the FDA’s intent to publish a proposed rule by this September, when the public would be asked to comment.

As we recently reported, the Supreme Court reversed the decision in Mutual Pharmaceutical Co., Inc. v. Barlett after a New Hampshire jury awarded Karen Bartlett $21 million in damages she suffered after taking their generic NSAID drug.  After the pharmacist exchanged the name brand drug for its generic equivalent, Ms. Bartlett suffered from toxic epidermal necrolysis (TEN), burning 65 percent of her skin off and leaving her nearly blind. There was no warning on the generic label for TEN. This decision puts all consumers at risk.

Hopefully, the FDA will publish a proposed rule so changes can be made to protect all Americans.  Feel free to comment on this blog post. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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