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Judge Deals Blow To Zoloft Lawsuits

undefinedEarlier this month, U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania dealt a blow to a group of products liability plaintiffs by dismissing more than 300 lawsuits filed against Pfizer, Inc. which alleged that Zoloft, an antidepressant prescription drug Pfizer manufactures, caused birth defects in children born to women who took the drug while pregnant. Zoloft is one of several widely prescribed antidepressants known as selective serotonin reuptake inhibitors, or SSRIs.

The written opinion states that the plaintiffs did not present sufficient evidence to prove a valid scientific link between the drug and the birth defects. According to Judge Rufe, “[t]he court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years. . . . Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

This decision came on the heels of several previous rulings by Judge Rufe which excluded testimony from the plaintiffs’ key expert witnesses.

The plaintiffs alleged that Pfizer downplayed the risk of birth-defects associated with this popular drug in order to boost sales. In contrast, Pfizer denied any improper actions and said that several major medical groups, such as the American Heart Association, support its position.

According to a Pfizer spokesperson, this decision “affirms that plaintiffs have failed to produce any reliable scientific evidence demonstrating that Zoloft causes the injuries they alleged.” Additionally, Pfizer previously won two trials involving Zoloft birth-defect claims in Philadelphia and Missouri state courts.

In recent years, prescription drugs have increasingly become the basis for products liability lawsuits. Manufacturers have a duty to appropriately test prescription drugs before releasing them into the market, using testing criteria established by the U.S. Food and Drug Administration (“FDA”). Although these criteria are considered to be industry standards, unfortunately, they are not always sufficient to protect consumers from bad drugs.

It is possible for a manufacturer to be held liable to an injured plaintiff despite the fact that the drug was properly licensed by the FDA if the plaintiff is able to prove that the drug is otherwise defective.

In addition to testing, manufacturers also have a duty to warn of a drug’s side effects when such effects are understood to occur. In order to fulfill this duty, manufacturers often provide the necessary information to the patient’s prescribing physician or to the pharmacist. Since manufacturers are considered to be experts in their field, they also have a continuing duty to remain informed of, and to update medical professionals on, new side effects.

Some drugs are considered to be “unavoidably unsafe” because they cannot be made completely safe no matter how carefully they are manufactured. These types of drugs are prescribed when the benefit to the patient is reasonably expected to outweigh the potentially harmful side effects.

If a manufacturer properly prepares unavoidably unsafe drugs and provides an adequate warning of the side effects, then these drugs typically cannot form the basis of a successful products liability lawsuit. Conversely, manufacturers do not have a duty to warn of unknown dangers or to warn of possible side effects which are only experienced by unusually susceptible patients.