Public Justice Fights for Prescription Drug Victims in California Supreme Court
by Leslie A. Brueckner
Generic drugs, anyone?
If you care about access to justice, you might want to just say no.
If that’s too cryptic for you, check out my earlier blog post about T.H. v. Novartis, a California Supreme Court case that will determine whether victims of inadequately labeled generic drugs can seek compensation for their injuries from brand-name drug manufacturers.
The facts of the case are particularly compelling—and the stakes couldn’t be higher, because over 80 percent of all drugs consumed in this country are generic—and this case will determine whether California consumers of those drugs have any right to any remedy in court regarding inadequate warning labels.
The suit was filed on behalf of twin boys who were brain damaged in utero by a dangerous drug that was specifically marketed to pregnant women without any warning that it was hazarous to the developing fetal brain.
In 2001, when the risk became too obvious for the drug’s manufacturer, the giant pharmaceutical company Novartis, to continue to ignore, Novartis simply sold the mislabeled drug to another company for a tidy profit and went on its way.
That was a direct violation of the federal laws, we argue, which place an affirmative obligation on brand-name drug manufacturers to update their labels to immediately warn of any serious risks of their drugs. Novartis simply ignored that obligation, choosing instead to take the money and run.
Then, as Novartis could have predicted, because the drug’s market value was dependent on its continued sales to pregnant women, the successor company also failed to update the drug’s label, leaving the original, inadequate label intact.
A few years later, when Plaintiffs’ mother became pregnant with twin boys, her doctor prescribed a generic version of Brethine to control her pre-term labor. Because federal law requires generic drugs to bear the same labels as their brand-name equivalents, her doctor, in prescribing the drug to the mother, relied on the same, dangerously inaccurate label that was written by Novartis before it sold the drug to another company in 2001.
Because that label said nothing about the drug’s risk to unborn children, the doctor saw no problem with prescribing the drug to Plaintiffs’ mother to control her pre-term labor.
Tragically, plaintiffs were born with brain damage, and it happened as a direct result of Novartis’s original refusal to update its label to disclose the risk it knew about back in 2001—the risk it chose to ignore when it chose profit over the health of American families.
Despite all this, Novartis is asking the California Supreme Court for a complete get-out-of-jail-free-card.
The company wants total immunity for its negligent—possible intentional—failure to update its label, claiming that (a) brand-name drug companies can’t be sued at all for injuries caused by generic versions of their drugs; and (b) even if they could, this lawsuit must fail because Novartis had already sold its inadequately labeled drug to another company by the time the Plaintiffs’ injuries occurred.
Our brief urges the Court to reject Novartis’s argument, arguing a bright-line rule of immunity for all manufacturers of brand-name drugs would represent the worst sort of public policy.
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 failure to warn, they have very little incentive to update their labels.
That’s especially true for brand-name drug companies once their drugs have “gone generic.” 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.
And where, as in this case, the drug’s market value is dependent on the label not being updated to disclose the risk, the incentives to simply toss the “hot potato” of a dangerously mislabeled drug without first changing the label are especially strong. The risk of potential tort liability provides a crucial deterrent to this type of life-threatening corporate misconduct.
We can only hope that the California Supreme Court sees it our way and rejects Novartis’ bid for total immunity. In the context of prescription drugs, it is truly a matter of life and death.