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Generic Zoloft Lawsuit Rules Out Pfizer Liability

A New York state judge has ruled that Pfizer is not liable for birth defects allegedly caused by a generic version of Zoloft. Judge Carol E. Huff of the New York County Supreme Court issued an order on October 8th, in which she explained the the company’s duty  “should not extend to products and labeling over which it has no control, even if those products and labels mirror its own.”

The woman who filed the initial complaint was prescribed sertraline, the generic offspring of Zoloft. She alleged the SSRI antidepressant caused her daughter to be born with serious heart defects – a common allegation made in other lawsuits that did concern Zoloft. Her case rested on the contention that federal law requires generic drugs to display the same warnings as the medication on which they are based. Her generic Zoloft lawsuit claimed that Pfizer’s duty of care was breached because they issued an inadequate warning label with their original product.

Judge Huff concurred that brand-name medical firms seeking new drug approval are responsible for the adequacy and accuracy of their label. But she also noted that any manufacturer seeking approval for a generic version of a brand-name product is responsible for ensuring the label is equivalent to the original.

Judge Hoff added that New York courts have failed to address the question of whether drug manufacturers not directly responsible for a generic product have a responsibility to ensure adequate labeling.

Generic Zoloft lawsuit

The plaintiff cited the case of Palka v. Servicemaster Mgt. Corp. (83 NY2d 579 [1994]) as part of the evidence presented in her generic Zoloft lawsuit. In that case, the plaintiff was injured when a mounted wall fan struck her after falling off the wall at the hospital in which she worked. The company contracted by the hospital to maintain the fan was sued, and the court concluded the defendant took on the responsibility of ensuring a safe work environment when it signed its contract with the hospital’s maintenance department. There was, therefore, a duty imposed on the defendant.

In the generic Zoloft lawsuit, Pfizer was shown to have no intentional role in supplying the plaintiff with sertraline because they were not the seller. In her conclusion, Judge Hoff stated:

“A third party ― a competitor ― manufactured and sold the product. The connection [the] defendant seeks to establish through the warning label is even more attenuated… 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.”

The plaintiff was not informed of the dangers of taking the drug while pregnant at the time she was prescribed the antidepressant. It is not the first Zoloft lawsuit to accuse Pfizer of marketing an unsafe product.

Zoloft and birth defects alleged in litigation

A link between Zoloft and birth defects has been indicated in a number of lawsuits filed against Pfizer. Judge Cynthia M. Rufe is overseeing multidistrict litigation established in the U.S. District Court for the Eastern District of Pennsylvania. Judge Rufe has selected 25 cases for bellwether trials. The first case is due to be heard in October 2014.