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Congressman introduces legislation to ban Essure permanent birth control


A Pennsylvania congressman has made good on his promise to introduce legislation to ban the permanent birth control implant Essure in response to complaints from thousands of women who say they have been harmed by the device. U.S. Rep. Mike Fitzpatrick introduced the bipartisan bill aimed at revoking the Food and Drug Administration’s (FDA) premarket approval status of Essure and requiring the manufacturer, Bayer Healthcare, to pull the device from the market. Essure was approved by the FDA in 2002, and remains the only FDA-approved non-surgical permanent birth control method available in the United States. Essure is a flexible, nickel-titanium ... Read More

Education Management Corp. Pays $99.5 Million To Settle Whistleblower Lawsuit


The U.S. Justice Department said Monday that it had reached a “landmark global settlement” with Education Management Corporation, the second-largest for-profit education company in the nation, in which the company agreed to pay $95.5 million to resolve whistleblower allegations that it used unlawful methods to recruit and enroll students to its campuses. Education Management Corporation, which is headquartered in Pittsburgh, Penn., operates four post-secondary school brands: the Art Institutes, South University, Argosy University, and Brown-Mackie College. Student enrollment across the company’s schools exceeds 100,000 students. Accusations against Education Management Corp.’s practices have been raging for years, including allegations that its ... Read More

Louisiana man sues 3M over surgical site infection

Bair Hugger

A Louisiana man has filed a lawsuit against a medical device manufacturer alleging that the company’s warming blanket used during his knee replacement surgery caused him to develop a surgical site infection that left him with a permanent disability. Roy E. Templet filed his lawsuit in U.S. District Court for the Eastern District of Louisiana against 3M Company and its subsidiary Arizant Healthcare Inc., claiming the companies were negligent in their manufacturing of a defectively designed forced-air warming blanket, sold under the name Bair Hugger. The Bair Hugger is used primarily to help maintain a patient’s body temperature during surgeries. ... Read More

Women diagnosed with uterine cancer after gynecological procedure may be entitled to compensation


Women who have been diagnosed with advanced uterine cancer after undergoing laparoscopic procedures using a power morcellator could be entitled to huge compensations from the manufacturers of the surgical tool, attorneys for plaintiffs say. Power morcellators are devices that are fitted with a long, tube-like blade that shreds uterine fibroids or entire uteruses inside the body and removes the tissue through a small incision in the abdomen. About a 50,000 power morcellator procedures are performed annually. They are often preferred over open surgeries for hysterectomy or myomectomy (uterine fibroid removal) because they are less invasive, leave less scar tissue, and ... Read More

Lawsuit claims nausea drug Zofran causes birth defects

Pregnant Girl

Deanna Brown was heartbroken when her daughter was born, in 2007, with two severe birth defects – congenital band syndrome and teratologic clubfoot. She had no family history of these conditions and didn’t know what had caused them. Nearly five years later, however, Brown learned that Zofran, the medication she was given to treat morning sickness during pregnancy, has been linked to a variety of birth defects. She was even more startled to learn that despite the fact that Zofran was never approved by the FDA to treat morning sickness and no controlled studies had ever proven its safety in ... Read More

Testosterone replacement therapy lawsuits mounting

Low T

The number of lawsuits waged against manufacturers of testosterone replacement therapies by men who claim the products cause blood clots, heart attacks and other cardiovascular problems have jumped from fewer than 2,000 in August to 2,744. Plaintiffs’ attorneys say that number is expected to grow as both sides begin the process of selecting 12 cases to serve as bellwethers, lawsuits designed to help refine arguments with the goal of moving the overall litigation toward resolution. Claims have been filed against seven manufacturers of testosterone replacement treatments, but AbbVie was chosen as the subject of the first trials. AbbVie manufactures AndroGel, a ... Read More

Women speak out against permanent birth control Essure


Cecilia Bogle dismisses Bayer Healthcare’s claim that recently reported side effects with its permanent birth control, Essure, are “known and included in the Essure instructions.” Bogle says she was never warned by the drug and medical device manufacturer that Essure could cause the kind of harm it did to her. “It completely perforated my (fallopian) tube and I found out within that week (of having the device implanted) that I was pregnant,” she told KVOA. “The coil is now broken into three different pieces and I’ve had two surgeries to fix it, but that’s failed, too.” Bogle is one of ... Read More

Oregon files lawsuit against GNC over dangerous dietary supplements

bodybuilding suppliments

Oregon Attorney General Ellen Rosenblum is suing nutritional products retailer GNC Holdings claiming the company sold dietary supplements containing two illegal and potentially dangerous synthetic drugs. The lawsuit claims that the store violated the Oregon Unlawful Trade Practices Act by selling thousands of products over the past two years that contained the stimulants picamilon or beta-methylphenylethylamine (BMPEA). Picamilon is not approved for use in the United States, however it is approved in some countries to treat neurological conditions including depression, migraine headaches, strokes, glaucoma, senile psychosis, and head traumas. Picamilon side effects include allergic reactions, headaches, dizziness, nausea and a ... Read More

Essure sterilization linked to 10-fold risk of re-operation


Just weeks after the Food and Drug Administration (FDA) announced it was reviewing risks of the permanent birth control insert Essure after a sharp increase in the number of complaints, a new study shows that women who have the inserts implanted are 10 times more likely to need follow up surgery compared to sterilization through other methods. Essure was approved in 2002 and remains the only FDA-approved non-surgical permanent contraceptive method available in the United States. The device is a flexible coil that is permanently placed in each fallopian tube, where they prevent pregnancy by working with the body to ... Read More

Health Care Fraud Task Force nets medical equipment supply operators in Medicare fraud scheme

Pills - Stethoscope on Money

In an effort to put a stop to health care fraud, the U.S. Department of Justice (DOJ) in 2007 established the Medicare Fraud Strike Force, which works as part of the department’s larger Health Care Fraud Prevention and Enforcement Action Team (HEAT). Since its inception, the Strike Force has charged more than 2,300 defendants who have bilked Medicare out of more than $7 billion. The latest lawbreakers to be caught in the DOJ net were accused of operating a $1.5 million Medicare fraud scheme. Amalya Cherniavsky and her husband, Vladislav Tcherniavsky, of Long Beach, Calif., were convicted of defrauding Medicare ... Read More