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- Levaquin Lawyers to Meet with Court to Discuss Status of Litigation, First Trial
- FDA Warns Not to Use Some MRI Contrast Agents With Kidney Patients
- Skilled Healthcare Nursing Home Negligence Suit Settled for $50M
- E-Cigarettes Ads Claiming They Help People Stop Smoking Are Illegal: FDA
- Black & Decker Random Orbit Sander Recall Issued For 200,000 Sanders
Posted: 10 Sep 2010 09:01 AM PDT
The FDA is banning the use of three major brands of MRI contrast agent on patients with kidney problems, and is forcing other manufacturers to change their labels to bring more attention to the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal side effects of the gadolinium-based contrasting agents.
On September 9, the FDA issued a drug safety communication that contraindicated the use of Omniscan, Magnevist and Optimark among individuals with chronic and acute kidney problems due to the high risk of NSF and required label changing for all the rest. The new warnings mark a rare occasion when FDA decided that a black box warning was not sufficient.
The label changes apply to all gadolinium-based contrast agents (GBCAs), which are solutions that are injected before an MRI scan is performed to improve the results. The new label warning will tell healthcare professionals to screen patients before injecting a GBCA to identify those suffering from acute kidney injury or chronic, severe kidney disease.
The FDA is describing three GBCAs as inappropriate for use with anyone with kidney injuries or kidney disease under any circumstances: GE Healthcare's Omniscan, Bayer's Magnevist and Covidien's Optimark.
The three GBCAs identified by the FDA, which are manufactured by GE Healthcare, Bayer and Covidien, have been associated with the highest number of NSF cases, according to the American College of Radiology (ACR). Omniscan has been linked to 382 cases of NSF out of approximately 13 million doses. Magnevist has been associated with 195 NSF cases out of 23 million doses, and Optimark has been linked to 35 cases out of 4.7 million doses.
Nephrogenic systemic fibrosis, which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a GBCA among individuals with impaired kidney function. It is associated with a hardening and thickening of the skin which restricts movement over time. There is no cure for the painful and debilitating condition, and in many cases it results in death over time.
The manufacturers of all types of gadolinium-based agents were required by the FDA to add the same "black box" warning about the risk of NSF from MRI with contrast in the United States in 2007, indicating that individuals with severe kidney problems could develop NSF.
Hundreds of nephrogenic systemic fibrosis lawsuits have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, GE Healthcare’s Omniscan has been associated with the most lawsuits over NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE's contrast agent only accounts for about 30% of the market share.
Posted: 10 Sep 2010 08:46 AM PDT
A settlement agreement has been reached with 32,000 California nursing home residents to dismiss a $677 million verdict against Skilled Healthcare Group Inc. in return for the company paying the residents $50 million for understaffing its nursing homes.
The Skilled Healthcare nursing home negligence lawsuit verdict, issued by a Humboldt County Superior Court in July, was the largest jury award this year, and threatened to drive Skilled Healthcare into bankruptcy. The class action lawsuit accused the company of endangering residents in 22 of its California facilities by failing to abide by a state law that requires nursing homes to provide 3.2 nursing hours per patient per day.
Defense attorneys for the company called the initial verdict "annihilating" and it sent the company's stock value plummeting. The company is one of the largest nursing home franchises in the nation, with 78 facilities.
The lawsuit was originally filed in 2006 and granted status as a nursing home class action suit in 2008. The trial lasted six months before the jury determined that the staffing levels at Skilled Healthcare's nursing homes were insufficient and illegal under California law, hitting the company with the maximum amount for statutory damages, as well as tens of millions in restitution.
In August, Judge Bruce Watson, who is overseeing the case, rejected a mistrial motion by the defense, who tried to get the massive jury award thrown out on juror misconduct claims. But jurors signed sworn statements saying that there was no misconduct or bias.
The $50 million settlement will be divided among the 32,000 patients and will cover their attorneys' fees as well. Many observers expected a settlement for a much lower amount than the initial $677 million, because of the potential for more patients to be harmed, neglected, or deprived of services if the company was forced to close the doors of all 78 facilities nationwide.
Posted: 10 Sep 2010 07:40 AM PDT
Federal regulators are warning electronic cigarette manufacturers that marketing claims that suggest the devices help people quit smoking are unfounded and illegal.
The FDA issued warning letters to five electronic cigarette (e-cigarette) makers on Thursday, in the latest move in an ongoing battle between FDA and the burgeoning industry regarding the agency's right to regulate the devices. The letters were sent to E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC. In some cases, the companies were also warned that they had poor manufacturing standards as well.
E-Cigarettes are battery-powered devices, usually shaped like a pen, cigarette or cigar, which heat up a flavored nicotine solution when the user inhales. The resulting vapors are inhaled in the same manner as smoking a cigarette.
The warning letters state that all five companies have run ads claiming that their products can be used to help quit smoking. The FDA has determined that the liquid in E-cigarettes is a drug and that the E-cigarettes themselves are drug-delivery devices, which the manufacturers dispute. The FDA says in its letters that it is illegal for the manufacturers to claim their drugs can be used as a smoking cessation treatment without FDA approval first. The agency says the companies have conducted no clinical trials or shown scientific evidence supporting their claims.
The FDA has said that it has not had the opportunity to evaluate e-cigarettes for safety or effectiveness, and that limited laboratory studies have raised concerns about the manufacturing process and quality control processes that the FDA says appears to be "substandard or non-existent." The federal regulatory agency has also indicated that E-cigarettes contain toxins and carcinogens.
In addition to the warning regarding the claims that the devices can aid people to stop smoking, the FDA also warned Johnson Creek Enterprises that it found significant deficiencies in its manufacturing process, and that the company did not appear to have any quality control or testing procedures as required by the FDA. Johnson Creek makes Smoke Juice, a liquid used to refill E-cigarette cartridges.
The FDA also warned E-Cig Technology that it is marketing the erectile dysfunction drug, tadalafil, and the weight loss drug, rimonabant, illegally as refill cartridges for e-cigarettes. Rimonabant has not been approved for use in the U.S.
The FDA's jurisdiction has been challenged in court by E-cigarette manufacturers. The agency has been stopping shipments of E-cigarettes, a Chinese invention, at the borders for examination, which has developed into an ongoing legal battle.
E-Cigarettes are sold mostly at mall kiosks and through the internet. The FDA is also concerned that the devices appear to be directly marketed to young people, do not contain any health warnings, and are currently virtually unregulated. They come in flavors such as bubblegum, chocolate, and mint.
Public health experts expressed concern that the cigarettes could increase nicotine addiction in young people, and that they are being marketed as being safer than they really are.
Posted: 10 Sep 2010 07:32 AM PDT
About 200,000 Black & Decker Random Orbit Sanders have been recalled after numerous reports of the disc holding the sandpaper shattering or flying off, resulting in a number of injuries.
The Black & Decker sander recall was announced on Thursday by the U.S. Consumer Product Safety Commission (CPSC) after Black & Decker received 73 reports of the disc, called the platen, breaking apart or flying off the sander. The incidents include 15 reports of injuries from flying debris, including at least one serious injury to the face.
The electric sander recall affects Black & Decker Random Orbit Sanders, which are black and orange, with model numbers RO400, RO400G, RO410, RO410K, RO410LW and FS3000ROS and date codes between 200701 and 200929. The model numbers are printed on the label of the sander and the date codes are located on the underside where the dust bag is inserted.
The sanders were sold by authorized Black & Decker dealers, home improvement, hardware and discount stores nationwide from January 2007 through July 2009 for about $40.
The CPSC recommends that any consumers who own or operate one of the affected sanders stop using it and contact Black & Decker for a free replacement platen at www.blackanddecker.com.