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Your pulse on medical device recalls, warnings and lawsuits

CONSUMER ALERT

Attune Knee Replacement System

Recall Information
Recalled in June 2015 for early failure and destabilization of the knee.
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News & Alerts on the Medical Device Industry

ATTUNE® Knee Replacement System
In June of 2015 the FDA recalled the ATTUNE® Knee Replacement System which is made and marketed by DePuy Synthes, a medical device division of Johnson & Johnson. In its warning letter to DuPuy, the FDA stated that parts of the knee replacement system were changed or replaced without FDA approval and that these parts were dangerous and could result in painful, costly and time consuming revision surgery. Worldwide, more than 700,000 total knee replacement surgeries used the Attune device.
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May 28, 2019
Ethicon Files Change of Venue Motion

Ethicon, a subsidiary of Johnson & Johnson, is the primary defendant in almost 90 pelvic mesh personal injury cases filed in Pennsylvania. They filed a motion to move the trials outside of the Philadelphia area or to have a pre-trial cooling off period. Attorneys for Ethicon contend that the amount of pelic mesh media coverage will unfairly influence the jury in this mass tort matter.

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May 24, 2019
Medical Device Guardians Act to Empower Doctors

The Medical Device Guardians Act, H.R. 2915 will amend the Federal Food, Drug and Cosmetic Act to classify physicians as covered medical device users. This bill states that doctors are in the best position to identify and report defective devices. This bill will also provide some civil lawsuit protection to doctors who filed FDA reports.

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May 23, 2019
Pelvic Mesh MDL Gets Big Verdicts--and Cases Return to Local Districts

$120 million settlement for McFarland vs. Ethicon litigation is one of several huge awards in 2019. Dozens of cases are now being sent back to Pennsylvania, New York, Texas, California and other states to expedite resolution. Plaintiff's attorneys feel that juries are questioning Ethicon's integrity.

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May 21, 2019
FDA and Medtronics Buried 50,000 Sprint Fidelis Heart Device Complaints

In 2007 Medtronics' Sprint Fidelis heart device was recalled after it was determined that the device gave patients random electrical jolts and failed to fire in real cardiac events. In May 2008, the FDA granted Medtronics a remedial action exemption from reporting adverse events in MAUDE, the FDA's public database. The numbers: 286,000 patients are implanted with the device and 50,000 reports of harm or malfunction in 37,00 cases. Medtronics reported 13 deaths. Read the full article.

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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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