Proposed FDA warnings update may increase product liability claims against generic drug manufacturers, legal experts say
October 24, 2016
Legal experts say that new rules proposed by the Food and Drug Administration regarding warning labels for generic pharmaceutical products could increase the number of product liability lawsuits against generic drug manufacturers. As a result, the proposed rules are being met with opposition from trade groups representing those companies.
Under current FDA rules, generic drug manufacturers are required to publish warning labels that match those issued for their brand-name equivalents. As a result, it is difficult to file product liability lawsuits against generic drug manufacturers based on their failure to warn patients about the potential health risks of their products.
The Supreme Court’s 2011 ruling in Pliva, Inc. v. Mensing essentially preempted federal lawsuits against generic drug manufacturers based on failure-to-warn claims. The court ruled that because generic drug manufacturers are required to follow the warning labels for their brand name equivalents, they cannot be sued for failing to warn patients about the potential health risks of their products. A 2012 Supreme Court ruling in Mutual Pharmaceutical Co. v. Bartlett also preempted failure-to-warn claims filed under state laws regarding product design defects.
Earlier this year, the FDA announced that it would publish new rules regarding warning labels for generic drugs. The new rules would permit generic drug manufacturers to update their own warning labels independent of changes to their brand name equivalents. Both generic and brand name drug manufacturers would be required to update their warning labels based on new safety information regarding their products.
Because the new FDA rules would require generic drugmakers to update their own warning labels, generic manufacturers have strongly opposed the FDA’s proposed rule changes. Generic drug manufacturers say that the new FDA rules would increase the likelihood that they could face product liability lawsuits based on failure-to-warn claims by patients who have been harmed by side effects.
Legal experts say that the generic drug industry’s strong opposition to the new proposed FDA rules makes it uncertain whether the rule changes will ever go into effect. Currently, the FDA says that the proposed rules will not be published until April 2017.
Hurt by a Defective Drug or Medical Product? You Have Legal Rights.
If you or a loved one have been seriously injured as a result of complications from a prescription drugs or other medical products, you may qualify to file a lawsuit. The first step in taking legal action against a drug company is to speak with an attorney who can tell you more about your legal rights and guide you through the process of filing a case.
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