December 22, 2017

Unending tort liability for innovators

By Deborah J. La Fetra Senior Attorney

In 2007, the expectant mother of twins used a generic form of an asthma medication for the off-label purpose of preventing pre-term labor. Novartis innovated, developed and manufactured the brand-name version of the medication, then sold its rights to the product in 2001. The twins were diagnosed with autism in 2012, allegedly tied to the medication. They sued Novartis, claiming the company knew of the dangers prior to 2001, had a duty to revise the label warnings at that time, and the failure to do so contributed to the twins’ autism.

Yesterday, in T.H. v. Novartis Pharmaceuticals Corp., the California Supreme Court issued a 4-3 decision allowing the twins’ lawsuit to go forward. In doing so, the Court went further than it has ever gone before in applying the tort of negligent misrepresentation, holding that a brand pharmaceutical manufacturer owes a duty to a plaintiff that consumed a generic version of the product years after the manufacturer left the market and sold the production rights to someone else. This effectively ends any limits on brand manufacturers’ duties to users of generic drugs under the tort and fails to advance either public policy or fairness. As PLF argued in our amicus brief, imposing liability when the harm is so attenuated to the defendants’ actions does not promote the goal of deterrence, unfairly imposes liability for conduct only tangentially related to the harm, and stifles worthy economic enterprises—including the production of potentially life-saving drugs.

As others have noted, the decision is a strong candidate for “transition rehearing” because the 4-justice majority includes a temporarily assigned pro tem judge from the Court of Appeal, filling the slot that’s been empty since Justice Kathryn Werdegar’s retirement. The Court may yet have the opportunity to reverse course and impose liability only where the risk of harm is reasonably foreseeable, and where it is necessary to deter unreasonably dangerous conduct.

learn more about

T.H. v. Novartis Pharmaceuticals Corporation

In 2007, the expectant mother of twins used a generic form of an asthma medication for the off-label purpose of preventing pre-term labor. Novartis was the former manufacturer of the brand-name version of the medication until it sold its rights to the product in 2001. The twins were diagnosed with autism in 2012, allegedly tied to the medication. They sued Novartis, claiming the company knew of the dangers prior to 2001, had a duty to revise the label warnings at that time, and the failure to do so contributed to the twins’ autism. The California Court of Appeal held they could state a claim against Novartis for negligence and the company appealed. PLF filed an amicus brief in the California Supreme Court opposing “innovator liability.”

Read more

What to read next