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AstraZeneca escapes liability for man's flesh-eating infection on genitalia; Drug's label was FDA-approved

LEGAL NEWSLINE

Friday, December 27, 2024

AstraZeneca escapes liability for man's flesh-eating infection on genitalia; Drug's label was FDA-approved

State Court
Farxiga

WILMINGTON, Del. (Legal Newsline) – AstraZeneca has received a positive ruling in Delaware in a lawsuit that alleges it failed to warn users of side effects of the blood sugar drug Farxiga.

Judge Sheldon Rennie on April 5 tossed all of the claims of Jeffery and Cynthia Pope against AstraZeneca and Bristol-Myers Squibb. Jeffery alleged Farxiga was responsible for the Fournier’s gangrene – a flesh-eating infection of the genitals.

But Rennie ruled the lawsuit filed by lawyers at Jacobs & Crumplar and Tracey, Fox, King & Walters failed to adequately make that accusation under controlling Texas law.

“Here, the warnings and information that accompanied Farixga’s distribution were approved by the (Food and Drug Administration),” Rennie wrote.

The Popes’ lawyers failed to find fraud on the FDA’s part, that the product was sold after it was ordered removed from the market, that AstraZeneca promoted the product for uses not approved by the FDA, that there existed an off-label prescription or the bribery of a public official.

Lawyers for Jeffery Pope, a diabetic, argued weight loss was also a reason for his prescription and called it an off-label use.

“The Court is unable to reach that conclusion, where Plaintiffs themselves admit that Pope was prescribed Farxiga for an approved an indicated purpose in addition to an off-label purpose,” Rennie wrote.

Because the FDA approved the drug, Rennie dismissed the design defect claim. He concluded all other claims were derivative of it and dismissed them, allowing only the amendment of the Popes’ failure to test claim.

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