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FDA Warns Paragard About Omitting Safety Warning

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The FDA has sent a warning letter to the manufacturer of the contraceptive device Paragard concerning its omission of risks with the device.

CooperSurgical failed to submit a marketing campaign to the FDA for approval.  An according to the FDA, CooperSurgical’s direct-to-consumer ad, entitled “Paragard: Family Planning During the Pandemic”, which aired on WBTS’s The Hub Today on October 5, 2020, did not communicate any risks about the ParaGard implant.

“By omitting the risks associated with Paragard, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” the FDA letter warns. “This misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with the drug, such as those contained in the WARNINGS AND PRECAUTIONS section of Paragard’s PI (prescriber information).”

The FDA has called on the medical device company to submit a comprehensive plan concerning the submission of accurate information about Paragard that is neither misleading nor omits risk factors.

Paragard IUD lawsuits are growing and Given common questions of fact and law raised in more than 100 complaints filed throughout the federal court system in recent months, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided last month to consolidate all discovery and pretrial proceedings before U.S. District Judge Leigh Martin May in the Northern District of Georgia, as part of a federal MDL, or multidistrict litigation.

Paragard is an IUD device that has been determined to be dangerous because of incidents of breakage making it difficult to remove without damage to other vital organs. 

Rheingold Giuffra Ruffo & Plotkin have successfully litigated cases against manufacturers of defective medical devices, and are currently speaking with women injured through the use of Paragard IUDs. Our lawyers are investigating Paragard IUD lawsuits and are speaking with women who have been negatively impacted by Paragard. Our firm has aggressively represented clients and has recovered over $2 billion in medical malpractice, mass tort, personal injury, and product liability cases.

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