Some patients who have been implanted with spinal-cord stimulators have ended up with paralysis, Wall Street Journal reports. These devices are manufactured by a number of companies, the biggest of which include Medtronic, St. Jude Medical and Boston Scientific. The devices use stimulation therapy to help manage chronic pain; a small external remote is used to send low currents of electricity to the implanted generator and the electrical current from the leads creates a tingling sensation that it supposed to mask pain signals being sent to the brain, WSJ says. According to a Wall Street Journal analysis of the U.S. Food and Drug Administration’s (FDA) adverse-event reports and a review of medical malpractice lawsuits, more than 100 patients have experienced partial or permanent paralysis after having a spinal-cord stimulator inserted into their backs. Continue reading
A federal class action alleges that General Motors Corp. fraudulently concealed a defect in the ignition switches of 2.6 million Chevrolet, Pontiac and Saturn vehicles, and that the defect is linked to at least 13 deaths.
The complaint, Ruff v. General Motors, was filed Monday in Trenton, New Jersey, and it claims company engineers first learned in 2001 that ignition switches in these vehicles can accidentally move from the “run” to the “accessory” or “off” position, shutting off the engine and disabling such systems as power steering, antilock brakes, and air bags, the New Jersey Law Journal (Law.com) reports. Plaintiffs claim the number of deaths may be far higher than the 13 GM has acknowledged. They cite 303, from a study of airbag deployment failures in crashes of Chevrolet Cobalt and Saturn Ion cars. Continue reading
The Consumer Product Safety Commission (CPSC) has announced the recall of the STX Shield Throat Protector because the product can crack or break when struck by a lacrosse ball, posing an injury risk to the user.
The STX Shield throat protector is black and has the letters STX engraved on the outer surface of the protector. The shield attaches to the goalie’s helmet below the chin guard with straps on each side and the bottom. The shield sold for $20 to $25 at specialty sporting goods stores such as Athlete’s Connection, Commonwealth Lacrosse, Lacrosse Unlimited, Play It Again Sports, Sport Stop USA and Universal Lacrosse and online at www.LAX.com from September 2013 through February 2014.
STX has received one report of the throat protector breaking, which reportedly resulted in bruising and lacerations to the user’s neck, according to the CPSC.
The CPSC said consumers should stop using the Shield and return the product to STX for a full refund. Consumers can contact STX toll-free at 888.789.7894, 8:30 a.m. to 5 p.m. ET Monday through Friday or online at www.stx.com. Click on RECALL–Shield Throat Protector for more information. Continue reading
Matt Cahill, who runs Driven Sports, has received a warning letter from the U.S. Food and Drug Administration (FDA) over concerns about the ingredients in Craze, a controversial workout supplement that is reported to have a methamphetamine-like compound. According to the letter, the agency questions whether several ingredients that are claimed to be from dendrobium orchids actually come from the plant. The FDA says that the proprietary blend of ingredients listed as “Dendrobex” made the product adulterated under federal law, since the agency was not aware of evidence that the ingredient was present in food supply. Additionally, the company never submitted any paperwork to have it permitted as a new dietary ingredient. Continue reading
No state is exempt from abuse reports. According to a study by the Special Investigations Division of the House Government Reform Committee, 5,283 facilities in the U.S. were involved in almost 9,000 instances of abuse over a two-year period from January 1999 to January 2001, Carbonated.tv.com reports. The National Center on Elder Abuse (NCEA) of the Department of Health and Human Services estimates that only 1 in 14 cases of elder abuse ever comes to the attention of authorities.
The European Medicines Agency (EMA) is reviewing the cardiovascular risks of testosterone drugs, MedPage Today reports. Like the U.S. Food and Drug Administration (FDA) the agency is basing its investigation on two recent studies showing that the drugs are associated with a higher risk of heart attack and cardiovascular death. The review was prompted by the Estonian State Agency of Medicines and will be conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Continue reading
Tenants in a Harlem apartment building near the site of last month’s deadly gas explosion are suing their landlord and the city of New York for failing to test for allegedly unsafe levels of toxic substances, including lead and asbestos, inside their apartments.
The suit was filed on Friday in housing court by tenants of the12 apartments in the building at 89 East 116Street. The blast broke windows in their building, and dust and debris settled in the apartments. The explosion destroyed two buildings, 1146 and 1144 Park Avenue, Law360 reports. The Department of Housing Preservation and Development (HPD) initially issued a vacate order for 89 East 116, but rescinded it after finding no dangerous asbestos levels in the air around the building. Continue reading
The Remington firearms company has initiated a voluntary safety recall of certain Model 700 and Model Seven rifles that can fire unintentionally, causing injury and possibly death.
The recalled rifles were manufactured between May 1, 2006 and April 9, 2014 and are equipped with X-Mark Pro, or XMP triggers. An “excess bonding agent being applied in the assembly process,” causes the problem, not the trigger itself, the recall notice says. Remington discovered that these rifles can fire unintentionally, creating a dangerous, possibly fatal, situation. The problem is specific to the XMP trigger only and other Model 700 and Model Seven rifles are unaffected by the recall, Guns.com reports. Rifles made after April 9, 2014 are not subject to recall. Continue reading
Abbott FreeStyle and FreeStyle Flash Blood Glucose Meters, Including those Built into OmniPod Personal Diabetes Manager Get Most Serious Recall Status
A class I recall was issued for Abbott Diabetes Care glucose meters FreeStyle and FressStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manage (PDM). The recall, which was initiated on February 19th, was issued due to an error that can cause the meters to falsely give a low blood sugar reading. The Class I recall is the most dangerous recall status, and the FDA states that “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Continue reading
Device maker Covidien has recalled some of its Pipeline and Alligator brain embolism devices after discovering a potentially lethal problem with the devices’ guidewires.
Covidien identified a problem in the plastic coating on the device’s guidewire; the coating can delaminate and detach from the device, MassDevice.com reports. In a company press release Covidien explained, “Delamination of the PTFE coating could potentially lead to embolic occlusion [blockage] in the cerebral vasculature with the risk of stroke and/or death.” Covidien says that, to date, it has not received any reports of injuries related to the problem. The company has informed the U.S. Food and Drug Administration (FDA) and other regulatory agencies of the recall. Continue reading