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Is Crestor for Healthy People a Good Idea?

Last month, expanded use of the statin Crestor was approved by the Food & Drug Administration. According to The New York Times, Astrazeneca may now market Crestor to people who don’t have cholesterol problems as a preventive measure.

The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, along with elevated inflammation in the body indicated by the CRP test. According to
the Times, an estimated 6.5 million healthy people in the U.S. could now be considered candidates for Crestor. AstraZeneca, which makes the drug, plans to launch a big advertising blitz next month touting the statin’s preventative benefits. (more…)

NASA Scientists Join Toyota Probe

Apparently, figuring out if Toyota’s unintended acceleration problems are related to electronics is rocket science. The National Highway Transportation Safety Administratio has tapped NASA scientists to help determine if Toyota electronic throttles are causing the problems.

According to a Reuters report, the (NHTSA) has worked with NASA in the past on studies of electronic stability control and airbags. Officials with the NHTSA said nine NASA scientists would bring expertise in electronics, eletromagnetic interference, software integrity and complex problem solving to the Toyota review. The agency expects the review to be completed by late summer, Reuters said. After that, the agency would then determine whether a formal investigation of Toyota throttles is warranted. If that happens, a recall could ultimately be issued.

The NHTSA has also tapped the National Academy of Sciences’ National Research Council to lead a study of unintended acceleration across the auto industry. That review is expected to take 18 months.

Since last fall, Toyota has recalled more than 8 million vehicles worldwide for problems involving sudden acceleration. Toyota and the NHTSA have blamed the speed control issues on defective floor mats and faulty accelerator pedals, but some experts suspect that problems with the vehicles’ electronic throttle control system could really be behind the problems. Such suspicions have increased recently, as dozens of Toyota owners whose vehicles underwent recall repairs have recently complained that their vehicles are still experiencing problems with unintended acceleration.

Boston Scientific Reveals Federal Investigations

Both the Justice Department and the Securities and Exchange Commission (SEC) are investigating Boston Scientific’s recent recall of implantable defibrillators. Boston Scientific halted sales and began retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15. The company said it initiated the recall because it did not get approval from the Food & Drug Administration (FDA) for changes to its manufacturing processes.

The recall impacted seven brands of Boston Scientific defibrillators: COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™. All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion. (more…)

Trial to Start in Kugel Mesh Hernia Patch MDL

Five years after it was recalled, the first lawsuit involving the Kugel Mesh Hernia Patch is set to go to trial. Just over 1,500 Kugel Mesh Hernia Patch lawsuits are currently pending in a multidistrict litigation in U.S. District Court in Rhode Island.

The first trial in the multidistrict litigation will involve a lawsuit filed by John Whitfield of Missouri. Whitfield was implanted with the Kugel patch in 2004. His suit alleges that some of the rings broke under stress, and traveled through his body. As a result, Whitfield suffered a bowel obstruction, and had to have 22 cm of his intestine removed. (more…)

Two Firms Ordered to Stop Making Unapproved Nitroglycernin Tablets

Millions of heart patients have been treated with unapproved nitroglycerin tablets. Earlier this month, the Food & Drug Administration (FDA) ordered Konec Inc. and Glenmark Generics Inc. to stop making and shipping the unapproved drugs.

Drug makers like Konec and Glenmark have marketed unapproved drugs for years, claiming they were grandfathered in when the FDA was established in 1938. However, the FDA disputes this interpretation. According to a report in The New York Times, the agency has recently been cracking down on such drugs. (more…)

Ban on Tanning Bed Use by Minors Urged

People under 18 may no longer be able to use tanning beds, if the Food & Drug Administration (FDA) follows the advice of an advisory panel it convened yesterday.

Members of the panel agreed that the devices should be reclassified, and said that more restrictions are needed to protect teenagers from the cancer risks of tanning beds. “Given the absence of any demonstrated benefit, I think it’s an obligation for us to ban artificial tanning for those under 18,” said panelist Dr. Michael Olding. (more…)

Questions Raised About Use of Toyota’s Technical Bulletins

Was Toyota using “technical service bulletins” to avoid issuing recalls? Some critics think so.

Two years before Toyota issued a recall of defective floor mats implicated in incidents of sudden, unintended acceleration, the automaker warned its dealers of the dangers. Unfortunately, no one in the American driving public ever got this information. (more…)

Menaflex Knee Device Under Review

A Food & Drug Administration (FDA) advisory panel will take up ReGen Biologics Inc.’s Menaflex knee device tomorrow. Menaflex, which was approved under the FDA’s 510(K) process, is meant to repair a torn meniscus.

The 510(K) approval proces doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market. (more…)

Judge Seeks Changes to Proposed WTC Settlement

U.S. District Judge Alvin Hellerstein wants to see some changes made to a proposed settlement for injured World Trade World Trade Center emergency responders.

The settlement proposed earlier this month would have paid individual plaintiffs anywhere from $3,200 to $2 million, before attorney fees, in exchange for dropping their suits. Payouts for the settlement would come from WTC Captive Insurance, an entity created with $1 billion federal grant that provides insurance coverage to the City of New York and its debris-removal contractors. (more…)

Chinese Drywall Trial Now Underway Could Set a Standard

Opening statements were heard yesterday in an important Chinese drywall trial. The case marks the first contested Chinese drywall trial to get underway in the multidistrict litigation that is ongoing in federal court in New Orleans.

Knauf Gips and Knauf Plasterboard Tianjin Co. are named as lead defendants. The lawsuit was filed on behalf of Tatum and Charlene Hernandez of Mandeville, Louisiana. The case is being heard by U.S. District Judge Eldon E. Fallon without a jury. (more…)

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