Medical Device Claims Archives - Page 8 of 20

Medtronic Recalls HawkOne Directional Atherectomy System Due To Risk Of Tip Damage During Use

February 13, 2022

On January 21, 2022, the FDA announced a Class I recall, the most serious type of recall, of Medtronic Inc.’s (“Medtronic”) HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. Th[...]

Lap-Band Surgeon Convicted Of 28 Counts Of Wire Fraud, 3 Counts Of Mail Fraud

January 11, 2022

On December 16, 2021, a former lap-band surgeon and his company were found guilty by a federal jury of scheming to defraud private insurance companies and the Tricare health care program for military service members by fraudulently submitting an estimated $355 million in claims related to the 1-800-[...]

Medical Device Company Arthrex To Pay $16 Million To Resolve Kickback Allegations

December 22, 2021

The U.S. Department of Justice announced on November 8, 2021 that Arthrex Inc., a Florida-based medical device company, has agreed to resolve allegations that it violated the False Claims Act by paying kickbacks that caused the submission of false claims to the Medicare program. The federal governm[...]

We Are Investigating Filshie Clip Migration Claims

November 30, 2021

A Filshie clip is a silicone-lined, titanium occlusive device, originally designed for surgical contraception that was approved by the FDA in September 1996 for permanent contraception in women. The Filshie clip is placed with an applicator and designed to permanently occlude the mid-isthmic portion[...]

Federal Appellate Court Rules State-Based Claims Alleging Defective Cardiac Defibrillator Were Preempted

November 18, 2021

In its unpublished opinion dated October 18, 2021, the United States Court of Appeals for the Fifth Circuit stated, “21 U.S.C. § 360k … expressly preempts state laws which impose “different” or “addition[al]” safety requirements on medical devices subject to the FDA’s PMA [pre[...]

$8.2M Verdict Against 3M Company For Defective Combat Earplugs

October 19, 2021

On October 1, 2021, a federal jury in Pensacola, Florida found 3M Company and its subsidiary Aearo Technologies LLC liable for a former service member’s hearing loss and tinnitus, and awarded the plaintiff $8.2 million in damages for 3M’s failure to disclose that their combat earplugs w[...]

FiberCel Viable Bone Matrix Associated With Tuberculosis

September 23, 2021

On June 2, 2021, the FDA issued an “Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011” stating: “Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) [...]

Federal Appellate Court Applies Discovery Rule In Reinstating Pelvic Mesh Lawsuit Against J & J

September 17, 2021

The United States Court of Appeals for the Seventh Circuit (“Federal Appellate Court”) held in its opinion dated August 24, 2021: “The statute of limitations began to run only when Ms. Stark should have realized that her mesh-related complications might have been wrongfully caused [...]

Alere Inc. And Alere San Diego Inc. Agree To Pay $38.75M To Settle False Claims Act Allegations

August 14, 2021

The U.S. Department of Justice announced on July 8, 2021 that medical device manufacturers Alere Inc. and Alere San Diego Inc. (collectively, “Alere”) have agreed to pay $38.75 million to resolve allegations that the companies violated the False Claims Act by billing, and causing others [...]

Avanos Medical Inc. Pays $22M To Resolve Criminal Charge Related To Fraudulent Misbranding Of Its MicroCool Surgical Gowns

August 13, 2021

The U.S. Department of Justice announced on July 8, 2021 that Avanos Medical Inc. (“Avanos”), a U.S.-based multinational medical device corporation, has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s fraudulent misbranding of its MicroCool su[...]

St. Jude Medical To Pay $27 Million For Allegedly Selling Defective Heart Devices

August 12, 2021

The U.S. Department of Justice announced on July 8, 2021 that St. Jude Medical Inc. (“St. Jude”) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilitie[...]

$3.3M Defective Vein Filter Verdict Against C.R. Bard

July 7, 2021

On July 17, 2021, a federal jury in Wisconsin found in favor of a woman who claimed that a vein filter manufactured by C.R Bard fractured and caused her serious injuries, awarding her $3.3 million in damages after a nine-day trial. In 2013, plaintiff Natalie Johnson was implanted with a Bard “Me[...]

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Category: Medical Device Claims