The Supreme Court has ruled in favor of medical device manufacturers, making it more difficult for consumers to sue the makers of devices that have been federally approved. The court ruled 8-to-1 in favor of Medtronic in a lawsuit filed against the company by Mrs. Charles Riegel. The lawsuit said that a balloon catheter had burst while Mr. Riegel was undergoing an angioplasty. The Supreme Court upheld a federal district court’s decision, dismissing the lawsuit on the ground that the catheter had been given pre-market approval by the FDA.

Siemens AG has received FDA approval for its Versant 440 Molecular System for testing patients’ blood for the Hepatitis C virus. Versant 440 Molecular System, which represents the next generation in automated viral load testing, would be used with the Versant HCV RNA 3.0 assay for the management of patients infected with HCV and undergoing antiviral therapy. Versant 440 has already been approved in Europe, Africa and certain parts of Asia.

Israel-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.

The delay in Trasylol’s withdrawal from the U.S. market may have resulted in the death of 22,000 patients, according to a medical researcher. Trasylol, a blockbuster drug for Bayer that had been approved for stemming bleeding during open heart surgery, had been withdrawn in November at the request of the FDA. According to Dr. Dennis Mangano, who conducted the study that linked the drug to kidney failure, Bayer had known about the dangers of the drug, but had refrained from communicating the same during an FDA advisory panel meeting in September 2006.

The warning image pictured here now appears when you visit the Trasylol Website.

Glucosamine sulfate, a dietary supplement, is not more effective than a placebo in relieving pain for patients of osteoarthritis of the hip, according to a study led by Rianna Rozendaal and published in the Annals of Internal Medicine. The randomized two-year study was conducted on 222 people suffering from mild to moderate osteoarthritis of the hip, with half the group partaking 1,500 milligrams of glucosamine daily and the other half taking a placebo. The researchers concluded that the rate of improvement was insignificant between patients receiving glucosamine sulfate and those receiving the placebo. Critics said, however, that the study may have produced different results if it had been conducted for an additional year or if patients with more severe osteoarthritis had been studied.

The FDA has proposed to allow drug and medical-device manufacturers to promote the unapproved use of their products through “truthful and non-misleading” medical journal articles. The FDA has issued preliminary guidelines for drug companies to distribute medical journal articles to doctors on the “off-label” uses of their FDA-approved drugs. While companies are not allowed to market drugs for off-label uses, doctors are free to prescribe them for unapproved therapies.

Johnson & Johnson’s PriCara unit has voluntarily recalled all lots of 25-microgram-per-hour Duragesic CII pain patches that have an expiration date of on or before December 2009. The recall is due to a possible cut in the lining of the internal reservoir that could cause the gel to leak. Direct exposure to the fentanyl drug can cause serious events, such as breathing problems, or even a potentially fatal overdose.

Abbott Laboratories has received FDA approval for its cholesterol treatment Simcor. The drug is a combination of a statin called simvastatin, which lowers “bad” cholesterol, and Abbott’s Niaspan, an extended-release version of niacin, which raises “good” cholesterol. The drug also lowers triglycerides, a type of blood fats. Abbott is conducting a study to determine Simcor’s effectiveness in preventing heart attacks and strokes. The results of this study are expected in 2011.

Ranbaxy Laboratories has received tentative approval from the FDA to market the generic version of AstraZeneca’s Nexium (esomeprazole magnesium) drug for the treatment of heartburn and gastroesophageal reflux disease (acid reflux). Generic Nexium has been approved in the 20mg and 40mg doses. The company has FTF (first to file) status on the drug, which potentially provides it with marketing exclusivity for 180 days after it receives final approval from the regulator.

Lifestyle-related factors, including maintaining body weight, abstaining from smoking and regular exercise, play a vital role in ensuring one lives to the age of 90, according to researchers led by Dr. Laurel Yates of the Brigham and Women’s hospital in Boston. The researchers followed 2,357 men from 72 years of age and conducted the survey over two decades. The study, published in the Archives of Internal Medicine, showed that the chances of reaching 90 years was 54% in the absence of smoking, diabetes, obesity, hypertension and a sedentary lifestyle.