Generic Paxil & Zoloft Birth Defects – Manufacturers Have Duty To Warn

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 16, 2021

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While hundreds of Paxil and Zoloft birth defect lawsuits have been filed against GlaxoSmithKline and Pfizer, a number of lawsuits have been filed against manufacturers of generic Paxil (sold as Paroxetine) and Zoloft (sold as Sertraline) as well. Legal experts say that manufacturers of generic antidepressant drugs have the same duty to warn consumers of birth defects that brand label manufacturers do.

Generic manufacturers claiming preemption

Bryan Aylstock, a Florida attorney whose practice represents parents and their children who have suffered birth defect injuries due to an SSRI (selective serotonin reuptake inhibitor) drug such as Paxil and Zoloft, says that while a number of lawsuits have been filed against generic manufacturers, they have not yet reached the trial stage. He says that generic manufacturers are claiming a legal defense called preemption. He explained:

Preemption is the legal principle that if Congress intended to regulate an entity or entities to the point of excluding any private lawsuits, then the court will not allow such lawsuits. The Supreme Court of the United States recently commented on that in the context of a name brand pharmaceutical and determined that there was no preemption. What the Court said is that Congress never intended to preempt the field and prohibit lawsuits by creating the U.S. Food & Drug Administration (FDA) and the Food, Drug and Cosmetic Act. In fact, the opposite is true and the legislative history bears that out.

Generic manufacturers have same duty to warn

Aylstock and other Paxil birth defect attorneys say that generic manufacturers of various drugs are still defending on the basis of preemption with very mixed results.

Most courts have reviewed the [U.S. Supreme Court] decision, Wyeth vs. Levine, and they understand that the generic manufacturers also have duties. They can change the label as well and do not have to rely on what the FDA approved as the name brand label. As they get information, they also have legal obligations to put out safe products and properly warn about any risks associated with those products.

The foregoing article has been prepared by an attorney who is a regular contributor to FreeAdvice, and is now undergoing review by the site’s editorial staff.

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