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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

Congress Members Press FDA to Revoke Approval for Essure Birth Control System

In the next few weeks, Pennsylvania Congressman Mike Fitzpatrick plans to introduce legislation to revoke the approval the Food and Drug Administration (FDA) granted to the Essure birth control system in 2002.

If passed, the bill calls for withdrawing Essure’s approval within 60 days, ABC station WRIC in Richmond, Virginia reports. More Congress Members Press FDA to Revoke Approval for Essure Birth Control System

Actos Bladder Cancer Trial Underway in Nevada

A jury in Las Vegas, Nevada has been hearing arguments over safety issues associated with Takeda Pharmaceuticals’ type 2 diabetes medication, Actos.

The trial began on August 27, 2015 and is being heard before Judge Jerry Wiese in the Supreme Court of the State of Nevada, a consolidated case on behalf of a living plaintiff and the widow of a deceased man. Both men had been taking Actos (pioglitazone) and developed bladder cancer, which they allege was caused by the drug. Counsel for the plaintiffs will likely seek $2 billion in damages for the living man and for the widow. More Actos Bladder Cancer Trial Underway in Nevada

California Rabbi Arrested on Multiple Felony Child Sexual Abuse Charges

Last week, Santa Monica, California police arrested Rabbi Sholom Doyber Levitansky on multiple felony charges of child sexual abuse.

Police are seeking further information and are attempting to locate any additional abuse victims, the Santa Monica Daily Press (SMDP) reports. More California Rabbi Arrested on Multiple Felony Child Sexual Abuse Charges

Thoratec Issues Device Correction after 2 HeartMate II Patients Die

Thoratec has issued a voluntary Urgent Medical Device Correction Letter after two patients using HeartMate II left ventricular assist system (LVAS) died and one became seriously injured. According to FierceMedicalDevices.com, the deaths occurred when patients were not able to connect their devices to a backup system controller in time.

The deaths and serious injury arose from confusion over how to properly use the device, FierceMedicalDevices.com reports. The problem stems from a “yellow wrench” alarm that goes off to remind users to check up on the expiration date of the backup battery; it does not mean that system is malfunctioning. The adverse events occurred when patients mistakenly tried to swtich to the backup system after the alarm went off. Thoratec said in a release, “The Urgent Medical Device Correction Letter is intended to prevent the occurrence of certain preventable advisory alarms that may result in patients deciding to attempt a System Controller exchange. Thoratec is working with hospital staff to identify patients that may be close to reaching the 36-month expiration date of their System Controller backup battery in order to facilitate priority replacement and to ensure routine monitoring of backup battery lifetime during clinic visits, as specified in the product Instructions for Use,” More Thoratec Issues Device Correction after 2 HeartMate II Patients Die

Drug Maker Amgen Agrees to $71 Million Settlement of Claims of Unlawful Marketing of Aranesp and Enbrel

Facing claims of unlawful marketing of the drugs Aranesp and Enbrel, Amgen has agreed to a $71 million settlement with 48 states and the District of Columbia.

The consent judgment was announced last week, Law360 reports. The settlement resolved claims that Amgen had marketed Aranesp (darbepoetin alfa) for cancer-related anemia without FDA approval and had promoted Enbrel (etarnecept) to treat mild plaque psoriasis though Enbrel is approved only for moderate to severe cases of the autoimmune disorder that causes scaling and flaking of the skin. More Drug Maker Amgen Agrees to $71 Million Settlement of Claims of Unlawful Marketing of Aranesp and Enbrel

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

Bayer Settles Yaz Blood Clot Claims for $57 Million

Bayer Corp. has agreed to settle Yaz, Yasmin and Ocella lawsuits for $57 million over allegations that the birth control pills caused arterial blood clots, leading to injuries such as stroke and heart attacks. According to Law360, the settlement would resolve cases pending in the Illinois multidistrict litigation in federal court, as well as lawsuits filed in Pennsylvania, New Jersey and California state courts.

Plaintiffs in the litigation allege that the drospirenone-containing birth control pills caused blood clots and blood-clot related injuries. Previously, Bayer already agreed to pay nearly $2 billion to settle claims over venous blood clots, including pulmonary embolisms and deep vein thrombosis. The latest settlement resolves lawsuits over injuries from arterial blood clots, which were not previously addressed. The proposed settlement fund, announced Monday, would resolve about 1,200 lawsuits nationwide. More Bayer Settles Yaz Blood Clot Claims for $57 Million

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