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Boston Scientific Sued for Racketeering and Use of Counterfeit Plastic

Device maker Boston Scientific has been sued under the Racketeering and Corrupt Organizations Act (RICO) for allegedly orchestrating a conspiracy to sell transvaginal mesh made from counterfeit plastic smuggled from China.

Transvaginal mesh devices are implanted in about 55,000 women each year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The polymer used to make all of Boston Scientific’s mesh, the polypropylene Marlex HGX-030-1, had been specified in regulatory documents filed for Boston Scientific’s mesh products. No other polymers could be used in its current mesh products, Qmed reports. More Boston Scientific Sued for Racketeering and Use of Counterfeit Plastic

$11 Million Damage Award in First Bellwether Trial for Wright Conserve Hip Device

The first federal bellwether trial involving the Wright Conserve metal hip implant ended with a damage award $11 million for the plaintiff.

Court documents reveal that a Georgia jury returned the $11 million verdict against Wright Medical Technology. Ten million dollars was punitive damages and the remaining $1 million was compensatory damages. More than 500 similar lawsuits are pending in a federal multidistrict litigation (MDL). More $11 Million Damage Award in First Bellwether Trial for Wright Conserve Hip Device

Mentor Corp. Settles Transvaginal Mesh Case Just Ahead of Bellwether Trial

Mentor Corp, a unit of Johnson & Johnson, has settled a transvaginal mesh case less than three weeks before the bellwether trial was scheduled to begin.

Mentor filed settlement documents in Georgia federal court last week, settling a case involving the company’s ObTape vaginal sling. According to the documents, the company was accused of making defective pelvic mesh implants that cause painful infections and other complication, Law360 reports. The trial would have started on November 30. More Mentor Corp. Settles Transvaginal Mesh Case Just Ahead of Bellwether Trial

Infections and Deaths at Pennsylvania Hospital Linked to Heating-Cooling Device Used in Heart Surgery

A heater-cooler system used to heat or cool blood during heart surgery is believed to have spread infections to patients at WellSpan York Hospital in York, Pennylvania. Four deaths have been linked to the device.

The hospital is contacting about 1300 patients who may have been exposed to nontuberculous mycobacterium during open-heart surgeries performed between October 1, 2011 and July 24, 2015, Qmed reports. More Infections and Deaths at Pennsylvania Hospital Linked to Heating-Cooling Device Used in Heart Surgery

Cook Medical Cardiac Catheters Recalled Due to Faulty Tips

Nearly 39,000 Cook Medical Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters have been recalled because their tips may split or separate from the catheter, causing injury or even death.

The Food and Drug Administration (FDA) has classified this a Class 1 recall—the most serious recall category—for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. More Cook Medical Cardiac Catheters Recalled Due to Faulty Tips

Medtronic Core Valve-Related Recall is Deemed A Class I

Medtronic’s recall of its EnVeo R loading system for the CoreValve Evolut transcather aortic valve device has been designated as Class 1 by the U.S. Food and Drug Administration (FDA). The recall was issued last month due to reports of “particulate being observed in a small number of cases,” Medtronic’s CoreValve was first approved in early 2014 for patients at extreme or high risk of open-heart surgery. The device has also since been approved for “valve-in-valve” (VIV) replacement, where a valve is placed within a failing artificial heart valve.

Medtronic received eight complaints associated with this issue, according to a recall letter posted on the website of Germany’s Federal Institute for Drugs and Medical Devices. The particulate was observed during the valve loading procedure in six cases, and observed in the packaged kits in the other two cases. Medtronic notified customers of the recall in an urgent field safety notice, which stated that a blood clot could arise if particulate matter is mistakenly deployed while the Evolut device is being implanted. More Medtronic Core Valve-Related Recall is Deemed A Class I

Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection

Lawsuit Alleges 3M Surgical Blanket Caused Infection


A lawsuit has been filed against Arizant, a 3M subsidiary, alleging that its Bair Hugger forced-air surgical warming blanket caused a deep joint infection. The plaintiff in the case had been undergoing a hip implant revision surgery. Allegedly, the Bair Hugger introduced pathogens from the operating room floor into the surgical site and resulted in Methicillin-resistant Staphylococcus aureus (MRSA) infection. The septic arthritis, or deep joint infection, allegedly caused by the Bair Hugger forced the plaintiff to undergo another six surgeries in less than eleven months. He alleges that he is unable to move freely and continues to suffer physical damages.

The suit alleges although the Bair Hugger is used in 90 percent of major surgeries, it is especially risky in joint replacement and revision procedures. The surgical warming blanket may play a role in the thousands of orthopedic implant infections each year, the suit alleges. Arizant and 3M are accused of hiding the risks of the Bair Hugger. More Lawsuit Alleges 3M Bair Hugger Surgical Blanket Caused Deep Joint Infection

Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits

Medtronic is Paying Millions to the InFuse Research Authors

Medtronic is Paying Millions to the InFuse Research Authors


Medtronic continues to pay millions of dollars to doctors who authored questionable research articles concerning the safety and effectiveness of the company’s InFuse spine growth product.

In 2014, Medtronic Sofamor Danek – Medtronic’s spine division – paid $60.7 million in royalties to 79 doctors and their affiliates, including to the authors of controversial studies of InFuse. Dr. Ken Burkus, a Georgia surgeon and the lead author on six InFuse studies that omitted adverse events, received $374,000 from Medtronic. Dr. Regis Haid, an Atlanta, Georgia, neurosurgeon and the lead author of one study, was paid $2.3 million in royalties. Both doctors received their payments from third-party companies. StarTribune.com reports the company paid $90 million in royalties last year. More Medtronic is Paying the Authors of Controversial InFuse Research Millions of Dollars in Royalties Even as it Faces Thousands of Lawsuits

Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Maquet's FLOW-i Anesthesia System Recalled

Maquet’s FLOW-i Anesthesia System Recalled


Some of Maquet’s FLOW-i Anesthesia Systems reportedly have a malfunction that could result in potentially fatal ventilation stops, the U.S. Food and Drug Administration (FDA) warned. A July 1st safety alert indicated that the issue “may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”

The systems are used in hospitals to provide anesthesia and ventilation support in patients who have difficulty breathing. The recall, which affects 1,641 units worldwide including 80 in the United States, was initiated in April. The FDA labeled its as Class 1 in June, which means that there is a reasonable possibility of serious injury or death associated with the issue. More Maquet’s FLOW-i Anesthesia System Recalled Due to Potentially Fatal Ventilation Problem

Medtronic Unit Says It Will Settle Some of the 11,000 Transvaginal Mesh Lawsuits Facing the Company

Medtronic Will Settle 11,000 Transvaginal Mesh Lawsuits

Medtronic Will Settle 11,000 Transvaginal Mesh Lawsuits


Medtronic’s Covidien unit says it will settle some of the more than 11,000 transvaginal mesh lawsuits that have been filed on behalf of patients who allege the device caused them severe pain and serious side effects.

Covidien made the announcement Tuesday in a court filing in West Virginia federal court that was viewed by Reuters. Covidien said it could not disclose the amount of the settlement nor how many cases the confidential agreement with one of the plaintiffs’ law firms would resolve. More Medtronic Unit Says It Will Settle Some of the 11,000 Transvaginal Mesh Lawsuits Facing the Company