Recent News

Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder

Zimmer Biomet has issued a Class I recall for its Comprehensive Reverse Shoulder as the devices have exhibited higher rates of fracturing than previously stated. In December 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice to customers who may have undergone surgery in which a Comprehensive Reverse Shoulder was implanted.  This recall has…

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FDA: Adverse Events Reported for Intragastric Balloons

The ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System are fluid-filled weight loss systems used to surgically treat obesity. Both systems were approved by the FDA in 2015 to be used by patients in conjunction with diet and exercise programs. Placement of the systems requires patients to undergo a minimally invasive endoscopic…

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Takata Airbag Recall Grows in 2017

Over the past two years, Takata has remained at the center of the largest automobile vehicle recall ever recorded in the United States. This is because the airbags that the manufacturer produces, which are standard in over 45 different models of cars made between 2000 and 2008, were found to be defective and potentially dangerous…

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Jury Awards Damages to Metal on Metal Hip Victims

Last month, a Texas jury awarded more than $1 billion in damages to plaintiffs who claimed they suffered injuries after receiving DePuy Pinnacle metal-on-metal hip implants. Metal-on-metal hip implants, such as the DePuy Pinnacle implants, are surgical devices used during hip replacement surgery that have been claimed to be more durable and provide a greater…

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FDA Warning: Rare but Serious Allergic Reactions from Skin Antiseptic

On February 2, 2017, the Food and Drug Administration (FDA) issued a warning regarding reports of rare but serious allergic reactions on the skin of individuals who have used over-the-counter (OTC) products containing chlorhexidine gluconate. The FDA has requested that manufacturers, which produce antiseptic containing the ingredient, issue a warning detailing the risk on the…

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Duodenoscope Manufacturer Chose Not to Warn of Risks

UPDATE: On January 17, 2017, the United States Food and Drug Administration updated safety information regarding the Pentax ED-3490TK video duodenoscope. Within this update, the FDA warned consumers that the device had the capacity to crack—making the transfer of fluids and bacteria to the device possible. Similar to other duodenoscope devices, the Pentax device can…

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Study Suggests IVC Filter Use Offers No Benefit to Trauma Patients

A Journal of the American Medical Association study released in September, 2016, suggests that IVC filters do not provide benefits to trauma patients. Physicians began using inferior vena cava (IVC) filters as an alternative preventative treatment for patients who could not take blood thinners. The devices are intended to temporarily to block dangerous blood clots—known…

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Xarelto®: A Year in Review

In November, 2015, the U.S. District Court for the Eastern District of Louisiana announced that the first of the Xarelto® bellwether trials, stemming from the Xarelto® multidistrict litigation, would begin in February, 2017. Since that announcement, there have been many updates in the ongoing legal battle against Xarelto® manufacturer Bayer AG and distributer Janssen Pharmaceuticals….

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Jury Awards $70 Million to Victim of Talcum Powder

On October 27, 2016, a jury awarded a California woman more than $70 million in a lawsuit filed against talcum powder manufacturer Johnson & Johnson. This decision brings the total awards for three ovarian cancer victims in talcum powder lawsuits in 2016 to nearly $200 million.  Nearly 2,000 additional suits have been filed claiming primarily…

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Families Claim that Manufacturer Should Have Warned of Zofran Risks

The FDA approved Zofran, an antiemetic medication manufactured by GlaxoSmithKline (GSK) to prevent nausea and vomiting caused by cancer chemo therapy, radiation therapy, and surgery. Although Zofran was approved for distribution only for chemotherapy and radiation patients, GSK promoted the drug as an effective means to fight the same symptoms in pregnant women. Over the…

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