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Negligence Claim Prescription Drug Label.

Byline: Derek Hawkins

7th Circuit Court of Appeals

Case Name: Wendy B. Dolin v. GlaxoSmithKline LLC

Case No.: 17-3030

Officials: WOOD, Chief Judge, and SYKES and HAMILTON, Circuit Judges.

Focus: Negligence Claim Prescription Drug Label

Defendant GlaxoSmithKline LLC (GSK) appeals from a jury verdict awarding $3 million to plaintiffWendy Dolin for the death of her husband, Stewart Dolin. Mrs. Dolin alleges that GSK's negligent omissions in the drug label for Paxil caused her husband's death. Stewart did not actually take Paxil. In 2010, a doctor prescribed Paxil, the brand-name version of paroxetine, to treat Stewart's depression and anxiety. But his prescription was filled with generic paroxetine manufactured by another company (one that is no longer a defendant). Six days later, Stewart committed suicide. Blood tests showed that paroxetine was in his system. He was 57 years old.

At the time of Stewart's death, GSK manufactured brand- name Paxil and was responsible under federal law for the content of the drug's label. When Stewart died, the labels for paroxetine and similar antidepressant drugs warned that they were associated with suicide in patients under the age of 24. The labels did not warn about any association between the drugs and an increased risk of suicide in older adults.

In this appeal, GSK challenges the district court's conclusions about liability under Illinois law and preemption. GSK also argues that the evidence at trial did not support the jury's verdict. We agree with GSK that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. On that basis of federal preemption, we reverse the judgment. The case must be dismissed.


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Attorney Derek A. Hawkins is the managing partner at Hawkins Law Offices LLC, where he heads up the firm's startup law practice. He specializes in business formation, corporate governance, intellectual property protection, private equity and venture capital funding and mergers & acquisitions. Check out the website at or contact them at 262-737-8825.[/box]

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Publication:Wisconsin Law Journal
Date:Sep 18, 2018
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