Legal Examiner Voices


Email Leslie Brueckner Leslie Brueckner on LinkedIn Leslie Brueckner on Twitter Leslie Brueckner on Facebook
Leslie Brueckner
Leslie Brueckner
Contributor • (510) 622-8150

Defending the Rights of Generic Drug Victims in the California Supreme Court

Comments Off

The California Supreme Court has taken up an issue of enormous importance to victims of inadequately labeled prescription drugs: whether a brand-name drug company can be sued for negligently misrepresenting the dangers of a generic version of its drug.

The case, T.H. v. Novartis Pharmaceuticals Inc., could literally affect millions of people, both in terms of their ability to obtain compensation for their injuries and, more fundamentally, in terms of their ability to predict the dangers of prescription drugs.

California is one of only a few states that allows suits against brand-name drug manufacturers for injuries caused by generic drugs. This case puts that doctrine to the test. If the California Supreme Court disallows such suits going forward, it could spell disaster for public health and safety, because it will eliminate a powerful incentive for drug manufacturers to ensure the accuracy of their labels.

This case is a vivid example of why it’s important to allow lawsuits against brand-name drug companies for injuries caused by generic drugs.

The lawsuit was filed on behalf of fraternal twins who were injured in utero by a generic version of a brand-name drug called “Brethine,” which their mother took to control preterm labor during her pregnancy.

Novartis is the brand-name drug company that wrote the label for Brethine. Novartis knew that Brethine (and its generic equivalents) could cause fetal brain damage, but it didn’t want to say so on the drug’s label because it was making too much money selling Brethine to pregnant women.

So it didn’t change the label; instead, it sold the rights to the drug to another company for a big profit and went on its way. A few years later, the twins’ mother was prescribed Brethine to control her preterm labor. Her prescription was filled with a generic version of the drug, and her children were born with brain damage.

The twins can’t sue the generic drug maker for their injuries because generic drug manufacturers are required, by federal drug laws, to use same label as the brand-name equivalent and can’t be sued as a result.

Instead, they are suing Novartis. They are arguing that the brand-name company should be held liable because Novartis (a) wrote the label for the drug; (b) knew that manufacturers of generic Brethine were required by law to use Novartis’s label; (c) knew its label was inadequate and failed to warn of its drug’s dangers; and yet (d) chose to prioritize profits over safety by declining to update the label in order to protect the drug’s market value as a therapy for preterm labor.

If the California Supreme Court lets Novartis off the hook in this case, then the world will be a much more dangerous place. The risk of tort liability creates an incentive for drug companies to change their labels when new risks emerge. But when drug companies know they can’t be sued for negligent misrepresentation, all bets are off. Unless there’s a risk of liability in the courts, there’s little incentive for drug companies like Novartis to change their labels to warn of newly discovered risks.

The stakes are even higher given the dominance of generic drugs in the prescription-drug marketplace. 75% to 90% of the drugs consumed in the United States are generic forms of brand-name drugs. And the FDA does not have the resources to ensure the many hundreds of prescription drugs on the market bear accurate and up-to-date labels. So cases like this one make up the vast majority of instances where people are harmed by prescription drugs.

We at Public Justice are dedicated to doing everything in our power to making sure right prevails over might in this case. We’ve recently been retained by the plaintiffs to serve as co-counsel in the California Supreme Court, along with Benjamin Siminou of Thorsnes Bartolotta McGuire LLP of San Diego, California, who handled the case at the trial and intermediate appellate court levels.

Stay tuned for more details as we bring the fight to Novartis. And fasten your seatbelts; it’s going to be a bumpy ride.