Latest News

Federal Jury Awards U.S. $92 Million In Allied Mortgage Fraud Case

whistleblower-3

A Texas federal court jury awarded the U.S. government about $92 million in a False Claims Act case brought against Allied Capital and bank principal Jim Hodge by a whistleblower who accused the company and some affiliates of knowingly originating and underwriting more than a thousand home loans that did not meet the Federal Housing Administration’s (FHA) insurance requirements. The U.S. Department of Justice intervened in the case in 2011, the same year a whistleblower filed it in a New York federal court, naming both Allied Home Mortgage Capital and Allied Home Mortgage Corp. as defendants. The government moved the ... Read More

Lawsuits filed over injuries allegedly caused by Ethicon’s Physiomesh for hernia repair

hernia mesh - Wikimedia Commons

A Florida woman is suing Johnson & Johnson’s Ethicon alleging the company’s Physiomesh device implanted in her during hernia repair embedded into her abdominal wall, blocked her intestines and caused her chronic pain. Her lawsuit comes just five months after an Illinois man filed a similar lawsuit over Ethicon’s Physiomesh alleging the device caused him to develop an infection, two abscesses and an intestinal fistula. Physiomesh is a fibrous plastic device that is intended for hernia repair. It is made from polypropylene, the same product used in Ethicon’s controversial transvaginal mesh, which has been the subject of hundreds of lawsuits ... Read More

Understanding Burn Injuries and Sources Makes For Safer Holidays

kitchen fire prevention - CPSC image

Holiday decorations, a busy kitchen, fireplaces and space heaters — these are just some of the common sources of burn injuries that often turn a festive time of year into a time of excruciating pain and sometimes even a fight for life. Hospitals across the U.S. typically report a significant spike in the number of patients seeking emergency treatment for burn injuries between Thanksgiving and New Year’s Day. According to the U.S. Centers for Disease Control and Prevention (CDC), cooking injuries are the most common holiday-related injuries hospitals see each year, with scalding being the most frequent type of burn ... Read More

China heparin producer warned by FDA over violations of current good manufacturing practices

heparin_15515_4_(big)_

U.S. Food and Drug Administration (FDA) officials inspecting Chinese drug maker Dongying Tiadong Pharmaceuticals Co., Ltd., found “significant deviations” from current good manufacturing practices in its manufacturing of the blood thinner heparin. Dongying Tiadong was warned by French regulators over similar violations last March. The agency cited the company in its testing of crude heparin batches saying it failed to adequately investigate and document out-of-specification (OOS) results “repeatedly and without justification.” “Disregarding the OOS results, and resampling and retesting without scientific justification, constitutes ‘testing into compliance.’ This practice is unscientific and objectionable under current good manufacturing practices,” the agency said ... Read More

FDA approves two new combination type 2 diabetes treatments

diabetes_illus250x03

Two new treatments for type 2 diabetes were approved by the Food and Drug Administration (FDA), and both contain a combination of the same types of medications – an anti-diabetic drug from the GLP-1 receptor class, and a long-acting insulin. The approvals for both Sanofi’s LixiLan and Novo Nordisk’s IDegLira, were delayed for three months after being recommended for approval by FDA advisory panels last May. LixLan’s approval in the U.S. is its first worldwide for the combination treatment, which includes the GLP-1 receptor agonist lixisenatide (Lyxumia/Adlyxin)and the insulin glargine (Lantus). It is intended for patients with type 2 diabetes ... Read More

AbbVie asks judge to toss bellwether case in testosterone side effects MDL

androgel

Drug maker AbbVie Inc. asked a federal judge to toss a lawsuit alleging the company’s testosterone replacement therapy AndroGel causes injuries, arguing the plaintiff withheld information about his condition until after the discovery process was completed. AbbVie told U.S. District Judge Matthew Kennelly in Chicago that Froylan Garcia’s claim was no longer valid because his attorney did not find an expert witness to back up his claims that AndroGel caused him to develop a blood clot in 2013. Garcia’s case was one of eight selected by Judge Kennelly to serve as bellwether trials in a multidistrict litigation (MDL) of more than 5,500 ... Read More

Laser hair removal should be considered a biohazard for health care workers, according to researchers

laser hair removal, Dr Braun - Flickr image

Researchers have recently reported that the “burning hair” plume that occurs during laser hair removal (LHR) should be considered a biohazard, especially for health care workers, because it contains chemicals such as benzene, formaldehyde, carbon monoxide and hydrogen cyanide. Although laser hair removal is one of the most popular cosmetic procedures in the world, it doesn’t come without risks. The study analysis of captured 30-second laser plumes revealed a shocking 377 chemical compounds. Of the compounds, 62 of them are easily absorbed, 20 of them are environmental toxins, and 13 of them are known or suspected carcinogens. “These findings establish the concern that the burning-hair ... Read More

FDA warns against dietary supplements saying they often contain hidden harmful ingredients

dietary supplements - pills, probiotics

In a recent warning, the Food and Drug Administration (FDA) stated that “FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for weight loss.” Just a week before this warning about Tainted Weight Loss Products the FDA released a public notification regarding weight loss product Supreme Slim 5.7 ... Read More

Generic drug maker cited for lax adverse event reporting

pills

Pennsylvania-based generic drug maker STI Pharma LLC was warned by the Food and Drug Administration (FDA) for its lax approach in handling post-market adverse event reports related to its products. The FDA said that the company did not accurately convey adverse drug events to its contractors who manufacture and distribute its products, a requirement for all companies that market medications in the United States. In one case, a patient taking an unnamed STI Pharma drug to treat red spots on his scalp reported having a dry mouth. The patient also said he was using an inhaler but he did not know ... Read More

J&J pays big for Risperdal’s gynecomastia side effect

risperdal

Johnson & Johnson and its subsidiary Janssen Pharmaceuticals face more than 13,000 lawsuits over claims that their antipsychotic drug Risperdal causes adolescent boys to grow large, disfiguring breasts. The sixth trial is currently underway and time will tell if jurors will hold the drug companies accountable. In February 2015, the first Risperdal side effects lawsuit went to trial. The jury awarded Austin Pledger, who was 20 at the time, $2.5 million after finding that Johnson & Johnson and Janssen didn’t adequately warn that the medication could cause boys and young men to grow female breasts, a condition known as gynecomastia. ... Read More