Many courts are eyeing this case because federal law has essentially left users of generic drugs without much remedy when the drug they use proves defective. That’s because the warning and usage labels are created by the brand name manufacturer, but because brand name manufacturers aren’t the ones making the drugs at issue, many courts have held they cannot be liable. Then, the U.S. Supreme Court’s decision in Pliva v. Mensing limited generic drug makers’ pharmaceutical injury liability. The Pliva decision is complicated, but the gist of it is that generic manufacturers aren’t liable for the injuries caused by their drugs.
In T.H. v. Novartis Pharm. Corp., granted review by the California Supreme Court earlier this month, the appeals court rejected the invitation by the defendant manufacturer to follow other state authorities that have held brand name drug manufacturers can’t be held liable under any theory for injury caused by a product other than its own. Will the California Supreme Court affirm?
It’s tough to say, but California has been in the minority of states in its decision to allow plaintiffs harmed by generic drugs to sue the brand-name counterparts.
In this case, the plaintiffs are twins, now almost 10, whose mother was prescribed and took a drug called terbutaline during her pregnancy. It’s an asthma drug that used to go by the brand named Brethine. However, when defendant Novartis sold the rights to the drug in 2001, six years before plaintiff’s pregnancy, other generic companies started marketing the generic version for the unapproved purpose of preventing pre-term labor.
Plaintiff alleges that when the brand name manufacturer owed a duty when it still had ownership of the drug to update the warning label to make it clear there was a possible risk to fetal development. Court records show the defendant was aware of this risk because there were a number of independent studies – beginning with one conducted in 1978 that was published in the British Journal of Obstetrics and Gynecology – that indicated use a labor inhibitor was potentially dangerous and could “unfavorably alter the fetal, placental or maternal circulation.” Another study showed a single dose of the drug given to pregnant rats stimulated beta receptors in the fetal brain and interfered with the developing fetal brain. Others studies showed children of pregnant women who had taken the drug tested poorer academically than those whose mothers had not and were more likely to suffer cognitive impairments. Research further indicated that any use of the drug for the purpose of delaying or preventing birth had not yet been deemed safe and could not be considered so until there were good clinic trials conducted.
Our defective product lawyers know plaintiff alleges that because defendant drug maker did not do so, her children suffered a range of injuries, including an autism diagnosis at age 3.
The appeals court had applied an earlier appellate decision, Conte v. Wyeth Inc., in ruling in 2008 that the maker of a drug called Reglan could be liable to a plaintiff who used the generic version.The state supreme court declined to hear the Conte case, so this will be the first time that court will consider a challenge like this. A decision in favor of plaintiffs here could mean we may see this or a similar case ultimately before the U.S. Supreme Court.
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Calif. Top Court to Mull Brand Liability for Generics, June 15, 2016, By Julia A. Steinberg, Bloomberg
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Florida Playground Injury Lawsuit to Proceed, Says 4th DCA, June 3, 2016, Boca Raton Drug Liability Lawyer Blog