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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

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

The Largest Food Vendor for the Washington D.C. Public School System Agrees to Pay $19 Million to Settle Whistleblower Lawsuit

D.C. Public Schoo  Food Vendor Agrees to Pay $19M

D.C. Public Schoo Food Vendor Agrees to Pay $19M


The largest food vendor for the public school system is Washington, D.C., has agreed to pay $19 million to settle a whistleblower lawsuit alleging that the company overcharged the district and mismanaged the school meals programs, with food often arriving at schools late, often spoiled or in short supply.

The whistleblower served as director of the D.C. Public School’s (DCPS) Office of Food and Nutritional Services from 2010 until he was fired in early 2013. The tipster filed a suit against Chartwells and Thompson Hospitality, two companies that formed a joint venture that provided food services for DCPS starting in 2008. The District’s attorney general issued a complaint and launched an investigation into the allegations, according to The Washington Post (The Post). More The Largest Food Vendor for the Washington D.C. Public School System Agrees to Pay $19 Million to Settle Whistleblower Lawsuit

Hundreds of Women Sue Johnson & Johnson over Use of Talcum Powder

Women Sue Johnson & Johnson over Use of Talcum Powder

Women Sue Johnson & Johnson over Use of Talcum Powder


The litigation against Johnson & Johnson over talcum powder continues to grow, as hundreds of women have filed a lawsuit alleging that the soft powder product caused ovarian cancer. The pharmaceutical giant was allegedly negligent with regards to the risks of their talcum powder products, such include Baby Powder and Shower to Shower. The women allege that J&J should have warned that use of talcum powder in the genital area could increase the risk of ovarian cancer.

FairWarning, a non-profit investigative news organization, reports that a number of studies link talcum powder to an increased risk of ovarian cancer. “Since the early 1980s, a slew of studies had found that women who regularly used talc powder for feminine hygiene had higher than average rates of ovarian cancer.” according to an article posted April 29th. More Hundreds of Women Sue Johnson & Johnson over Use of Talcum Powder