A New York state judge has ruled that Pfizer Inc. is not liable for birth defects allegedly caused by generic Zoloft because it did not manufacture the drug and did nothing to put it in the hands of the plaintiff.
In an October 8, 2013 order, Judge Carol E. Huff of the New York County Supreme Court explained that Pfizer’s duty “should not extend to products and labeling over which it had no control, even if those products and labels mirror its own.”
During Torrie Weeses’ pregnancy, she was prescribed and took sertraline, the generic version of Zoloft. Weese alleges that the drug caused her daughter to be born with serious heart defects.
Pfizer manufactures Zoloft but does not manufacture sertraline. Weese contended, however, that because federal law requires a generic drug to display the same warning label as the original medication, Pfizer owed a duty to Weese that it breached by issuing an allegedly inadequate warning label with Zoloft.
Judge Huff noted that brand-name manufacturers seeking new drug approval are responsible for the accuracy and adequacy of their label. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brands label.
The judge noted that New York state courts have not addressed the question of whether a drug manufacturer that did not make the product in question owes a duty to a plaintiff due to the required identity of warning labels.
In seeking to establish a duty in this context, Weese cited to Palka v. Servicemaster Mgt. Corp. In Palka, the plaintiff, a nurse, was injured when a mounted wall fan fell on her while she worked in a hospital. She sued the company that had contracted with the hospital to manage the maintenance department. The Palka court found there was no direct connection between the defendant, the object that caused harm, and the plaintiff. However, the court found the defendant took on the responsibility of ensuring a safe work environment when it contracted with the hospital to manage the maintenance department. The volitional action imposed a duty on the defendant, the Palka court concluded.
However, in this case, Pfizer had no intentional role in placing the generic Zoloft with the plaintiff, Judge Huff found, because Pfizer was not the seller.
“Indeed, a third party—a competitor—manufactured and sold the product. The connection defendant seeks to establish through the warning label is even more attenuated,” the judge found. “The label existed as a requirement of another third party, the federal government, aimed at the generic manufacturer. It is to be expected that Pfizer has a duty in connection with its own products and labels. However, that duty should not extend to products and labeling over which it has no control, even if those products and labels mirror its own, because it has done nothing toward putting them in the hands of consumers.”
Pfizer is facing mounting lawsuits regarding their multi-billion dollar producing anti-depressant, Zoloft. There are more than 250 Zoloft birth defect lawsuits pending in federal court in Philadelphia, accusing Pfizer of advertising Zoloft to pregnant women even though studies showed that Zoloft increases the risk of cardiac birth defects, cleft palate, club feet, spina bifida, skull defects and persistent pulmonary hypertension of the newborn (PPHN). Some of these birth defects can be fatal and the children who do survive are left with serious health issues for most, if not all, of their lives.
Do you think this ruling was fair? Weese believed that the manufacturer of brand name Zoloft did not provide accurate warnings on their label and should be held accountable for her child’s birth defects. It does not matter whether or not Weese took the brand Zoloft or the generic. The issue involves the lack of warnings listed on the labels of the brand as well as the generic version.
However, perhaps if Weese had taken the Zoloft brand while pregnant, the outcome of this lawsuit might be different. The Supreme Court ruled in 2011 that generic drug manufacturers are not responsible for the warning labels placed on the boxes and pill bottles, so long as the labels mimic the brand name manufacturer’s labels. What can parents of babies born with birth defects from anti-depressants during pregnancy do? Who should be held accountable?
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