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Bard PowerPort Lawsuit – How Bard Hid Behind a Secret FDA Loophole

By Ethan Cohen, Law Clerk

The Actions against Bard seek to hold the device manufacturer liable for injuries caused by their wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, distribution, labeling, and sale of their PowerPort products.

As part of the claims being alleged in the Bard PowerPort lawsuit, the Plaintiffs are also alleging that in many instances, Bard concealed known device failures and injuries from medical professionals and patients through submission to the FDA’s controversial Alternative Summary Reporting (“ASR”) program.

What is the Alternative Summary Reporting (“ASR”) program?

The ASR program, which permitted device manufacturers to request exemptions, variances or alternatives to reporting requirements pursuant to 21 CFR 803.19, was in effect from 1997 through June of 2019 when a multi-part investigative report exposed the deficiencies of the ASR program.

Up until its discontinuance in 2019, the FDA allowed device-related injury reports to be submitted through the ASR program only if they were “well-known events associated with specific devices.”

In contrast with the FDA’s public Manufacturer and User Facility Device Experience (MAUDE) database, manufacturer reports of device failures submitted through the ASR program were not available to the public, including healthcare providers, until 2019.

From 2004 to 2018, Bard utilized this non-public ASR program in an attempt to hide reports exposing their defective PowerPort products from the public eye.[1]

Now, Bard has nowhere to hide as wrongly affected patients are finally able to seek judgment against them.

Have You Experienced Complications with Bard PowerPort?

If you or a loved one has experienced complications resulting from a Bard PowerPort device, you may be eligible for compensation. Please contact the New York attorneys at Rheingold Giuffra Ruffo Plotkin & Hellman LLP for a free consultation today. Our experienced team has over 50 years of experience with product liability and medical malpractice cases.


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