Name Brand Companies Now Responsible for Generic Side Effects

In a monumental win for consumers injured by defective medications, the California Supreme Court will now allow generic medication victims the right to hold the name-brand companies liable for their injuries. In a 73-page ruling, the court ruled that the name brand drug maker Novartis is accountable for negligent misrepresentation and failure to warn of the dangers their generic version of its medication can cause. This is a pivotal decision that will change the course of litigation for years.

About the Novartis Lawsuit

This important decision comes after the generic form of Brethine, an asthma medication injured two twins in utero.  In 2007, doctors prescribed the medication to the twins to stop their mother’s preterm labor. The pharmacy filled the mother’s prescription with the generic version, terbutaline, and her children were born with brain damage.

In 2011, the FDA warned doctors should not give injectable terbutaline to pregnant women to prevent preterm labor or treat it for a prolonged period. Studies dating back to the 1970s raised concerns about using terbutaline on pregnant women.

Novartis, the manufacturer of Brethine asked the courts to review their presence in the suit at all. The plaintiffs included them since Novartis wrote the label. Plus, six years before the injury of the twins, Novartis sold the rights to the drug to another company for $26.2 million.

Plaintiff Arguments

The twins insist that Novartis is still responsible regardless. According to federal law, generic drug makers must use the same label as the brand-name equivalent and cannot be sued. So, Novartis had to know the label for the generic version was inadequate since they wrote it. The pharmaceutical company chose profits over safety. They were making too much money selling the drug to pregnant women and chose not to update the label to warn women.

California Supreme Court Holds Novartis Responsible

The California Supreme Court agreed with the plaintiffs. Not only did the court feel that Novartis the brand-name manufacturer has a duty to victims of generic drugs, they also felt selling the drug to another company doesn’t remove the responsibility.

 “If the person exposed to the generic drug can reasonably allege that the brand-name drug manufacturer’s failure to update its warning label foreseeably and proximately caused physical injury, then the brand-name manufacturer’s liability for its own negligence does not automatically terminate merely because [it] transferred its rights in the brand-name to a successor manufacturer.”

Future of Generic Lawsuits

Generic medications represent over 90% of all drugs sold in the United States. This now means that those victims of generic medications have the right to seek compensation for their injuries just as those hurt the brand-name counterpart.

Also, since there are no federal issues involved in the lawsuit, the U.S. Supreme Court can’t overrule the decision of the California Supreme Court. Other state supreme courts will need to have their own individual rulings. But, this will surely be influential in their decision-making. Currently, federal law holds generic manufactures immune from legal recourse since the brand-name company controls the label. Until now, generic consumers could not sue anyone for their injuries. Finally, generic consumers can seek justice for their damages.

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