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Toyota expands Takata airbag recall; adds another six million vehicles worldwide

Takata airbag - image source alexauto321, wikicommons

Nearly six million more Toyota vehicles are now under recall worldwide due to the infamous and ever-growing Takata airbag recall. The deadly defect within the Takata airbags has been linked to as many as 16 fatalities thus far, as well as several injuries. Toyota claims the latest Takata airbag recall spans across 1.4 million vehicles in Europe, 1.1 million in Japan and another 820,000 in China. All of the vehicles affected were manufactured from April 2006 through December 2014. Toyota is now responsible for recalling more than 23 million vehicles worldwide containing the defective airbags, including the following U.S. vehicles: ... Read More

Lawyers lose fight to pull Risperdal from market over safety risks


A Philadelphia-based law firm representing boys who allege they were disfigured after taking Johnson & Johnson’s Janssen Pharmaceutical’s antipsychotic drug Risperdal has no standing to challenge the Food and Drug Administration’s (FDA) denial of a citizen’s petition asking the agency to revoke marketing approval for the drug until its long-term safety can be proven. The attorneys also asked the companies to hand over confidential documents describing the risks associated with the drug. The firm had argued that the FDA’s rejection of its citizen petition, which was filed in July 2012, led to increased cost from Risperdal-related personal injury lawsuits against ... Read More

FDA cites 15 hospitals for failing to report medical device-related adverse events


Fifteen hospitals – including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital – have been called out by the Food and Drug Administration (FDA) for failing to report adverse events involving medical devices. From December 2015 to April 2016, the agency conducted inspections of 17 hospitals that were selected because high-profile medical device-related adverse events had been reported at the facilities. Those included uterine cancer spread from a gynecological device called a power morcellator, and bacterial infections caused by contaminated specialized endoscopes, called duodenoscopes. Both highly publicized medical device errors resulted in a call for more government ... Read More

Nursing home industry fights new CMS rule allowing patients to sue negligent facilities

contract, arbitration agreement - Pixabay image

The nursing home industry is fighting new rules set by the Centers for Medicare and Medicaid Services (CMS) that forces facilities that receive government benefits in compensation for the care of their patients to stop requiring new residents and their family members to sign binding arbitration contracts. These agreements essentially force patients to waive their Constitutional right to a trial by jury in the event of elder abuse, sexual abuse or wrongful death. The arbitration clause is often slipped into new resident contracts and forces patients and family members to settle disputes privately with an arbitrator. The nursing home industry says ... Read More

NCI researcher waited too long to report deaths during lymphoma clinical trial

clinical trial, research test tubes

A National Cancer Institute (NCI) researcher did not follow protocol and waited too long to report two deaths from fungal infections that may have been caused by a lymphoma treatment used during a clinical trial, health officials concluded. The protocol breach was reviewed by National Institutes of Health Director Francis Collins, acting NCI Director Doug Lowy, and other officials during a board meeting on patient safety at the Clinical Center, the NCI’s flagship hospital. The early stage clinical trial in question began enrolling patients in 2014. The patients had been diagnosed with lymphoma of the central nervous system, an often ... Read More

Eliquis sales poised to top Xarelto on heels of new safety study


Sales of Eliquis, the third drug in a novel new oral anticoagulant (NOAC) class to hit the market, are booming and may soon eclipse that of the market leader, Xarelto, according to recent data from IMS Health. Xarelto, known chemically as rivaroxaban, now has 46.5 percent of the NOAC market followed by Eliquis, known chemically as apixaban, with 42.5 percent. Xarelto’s growth has tapered since it peaked at about 60 percent of the market. Eliquis, on the other hand, has enjoyed continuous growth in the market. Pradaxa, the first drug in the class to hit the market, has 10.5 percent ... Read More

Oil Pipeline Breaks At Nation’s Largest Oil Hub In Oklahoma

pipeline break, Oklahoma - NewsOn6 file photo

A major pipeline break in the country’s largest oil hub has released up to 50,000 barrels of crude oil in Cushing, Okla., further stoking fears about aging pipelines, environmental disasters, and disruptions in the nation’s oil supply. Enterprise Products Partners, which co-owns the Seaway Crude Pipeline Co. with partner Enbridge Inc., told the press that the companies cannot say at this point when the pipeline will be operational again. The pipeline break in Cushing, about 70 miles northeast of Oklahoma City, released thousands of barrels of crude onto the land and in a retention pond at an Enbridge facility. The ... Read More

Nursing Home Company Pays $145 Million To Settle Medicare Fraud Allegations

Pills - Stethoscope on Money

The nation’s largest private nursing home company and its owner have agreed to pay the U.S. government $145 million to settle a False Claims Act lawsuit initiated by a pair of whistleblowers who claim that the company defrauded Medicare and TRICARE by misclassifying patients and billing for services that were not needed or never provided. Life Care Centers of America, a Tennessee company, will also enter into a corporate integrity agreement with federal regulators, an arrangement that puts its government billings under close regulatory scrutiny and independent monitoring to ensure compliance with billing rules. “This resolution is the largest settlement ... Read More

Drug company accused of falsely marketing cancer drug Taxotere now faces lawsuits

bald woman, Taxotere - Pixabay image

Chemotherapy drug Taxotere is under fire not only for allegedly causing permanent hair loss, but also because drugmaker Sonafi SA allegedly falsely marketed the drug’s “superior efficacy” compared to similar competing drugs. According to Law360, one suit against the pharmaceutical company alleges that the company based its marketing on self-sponsored clinical trials while other studies were finding that competing drugs were more effective in certain patients. “Contrary to defendants’ claims of superior efficacy, post-market surveillance has shown that the more potent and more toxic Taxotere does not, in fact, offer increased efficacy or benefits over other taxanes, as defendants have ... Read More

HeartWare recalls defective heart pump


HeartWare Inc. is recalling HVAD pumps used to pump blood through the bodies of deathly ill patients with end-stage left ventricular heart failure awaiting a heart transplant, due to a design defect that may cause the pump to malfunction or stop working, which could result in dire consequences for patients. The issue involves the driveline, a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious health consequences, including death. The HVAD ... Read More