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Implanted medical devices are used on patients to help combat a particular ailment. Over the past several years more and more patients have encountered serious injuries and even death. Many researchers believe that medical device manufacturers are solely interested in generating revenues, and are taking short cuts when it comes to studying the safety of their devices.

U.S. researchers revealed that black patients are at increased risk of developing life-threatening blood clots after receiving a drug-coated stent to prop open narrowed arteries, according to a recent HealthDay News report.

The new study included more than 7,200 patients who had stents coated with clot-prevention drugs implanted between mid-2003 and the end of 2008. The researchers found that black patients were nearly three times more likely to develop a clot compared to patients of other races. In fact, being black was the strongest predictor that clotting would occur more than one month after implantation of a drug-coated stent, the study authors noted.

When the researchers took into account other known risk factors for clotting including diabetes, high blood pressure and kidney problems; black patients still had a higher rate of developing a blood clot, according to the study results.

The clotting rates for blacks compared to non-blacks were:

• 1.71 percent versus 0.59 percent after 30 days.
• 2.25 percent versus 0.79 percent after one year.
• 2.78 percent versus 1.09 percent after two years.
• 3.67 percent versus 1.25 percent after three years.

The findings held true even though black patients took their prescribed anti-clotting medication at a higher rate than other races, the study authors pointed out. Possible genetic differences in the way the patients’ bodies react to the anti-clotting medication may be one potential cause that needs further study, the researchers suggested in a news release from the American Heart Association.

The study also found that the rate of death from all causes after three years was almost 25 percent for black patients compared to about 13 percent for patients of other races.

The higher death rates among black patients are “not just because this population is sicker or less compliant, but there is something else there that needs to be explored,” lead author Dr. Ron Waksman, associate director of the cardiology division at Washington Hospital Center and a professor of medicine and cardiology at Georgetown University, said in the news release.

The study was released online in advance of publication in an upcoming print issue of the journal Circulation.

On August 26, 2010, Johnson & Johnson’s artificial joint business announced a recall of two hip replacement products, just two days after getting hit with a government warning that it is illegally marketing two other products. This is the 11^th recall the company had announced since September, according to a recent Associated Press news report.

DePuy Orthopaedics Inc. said it is recalling two hip replacement products because new data, about to be released, show higher-than-expected rates of patients needing a second hip replacement procedure. Within five years, one in eight patients needed a revision surgery. That’s required when an artificial joint doesn’t fit perfectly, causing pain and difficulty walking. The products are the ASR Hip Resurfacing System and the ASR XL Acetabular System.

Each of the metal systems is used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into that socket like a ball. Total hip replacement involves replacing both parts at once.

The ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur. The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis.

DePuy, part of Johnson & Johnson of New Brunswick, N.J., said data it received from the National Joint Registry of England and Wales shows that within five years, about 12 percent of people getting the hip resurfacing system and about 13 percent of those getting the acetabular system needed corrective surgery. Women were more likely to need a second surgery than men.

DePuy said previous data “had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.”

The acetabular system, launched in 2004, has been sold worldwide. The resurfacing system, introduced in 2003, is only sold outside the U.S.

DePuy decided last fall to discontinue both, Gawreluk said. The company is working on developing a new generation of both products.

On August 24, 2010, the FDA told DePuy to stop selling its Corail Hip System for two unapproved uses. It also ordered the company to provide information needed to review another product the agency said DePuy has been selling even though it was never approved. It’s called the TruMatch Personalized Solution System, and uses software and high-tech CT scanning technology to create a 3-D view of a patient’s knee to help a surgeon position a knee implant.

Additionally, on August 23, 2010, Johnson & Johnson recalled millions of 1 Day Acuvue TruEye contact lenses sold in Asia and Europe because some users complained of stinging or pain when they inserted the lenses.

Johnson & Johnson remains under scrutiny by the FDA, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September. Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults, for problems including bacterial contamination and tiny metal savings found in some bottles.

Once again Toyota vehicle owners were dealt bad news. On August 26, 2010, Toyota announced a recall of more than 1.1 million 2005 through 2008 model Corolla sedans and Matrix hatchbacks over faulty engine-control computers that could cause the vehicles to stall in traffic, according to a recent USA Today news report.

The huge recall Toyota’s 15th in 2010 came just two days after the National Highway Traffic Safety Administration announced it was ratcheting up its investigation of the stalling problem. NHTSA said it has received 163 complaints. Toyota blamed the faulty computer, called an electronic control module or ECM for the stalling and said it will replace them in the recalled vehicles. The company said it has three unconfirmed reports of crashes, including one involving an injury.

Owners will be informed of the recall by mail in September and then will get a second letter when dealers have the parts for the repair.

Of all of the 5.8 million cars that Toyota has recalled since January 1, this is the first that involves a problem with the engine computer. Toyota continues to defend the ECM against allegations that it might be at fault in some sudden-acceleration incidents, which have already prompted two huge Toyota recalls for mats that can jam the gas pedal and pedals that can stick open.

Some auto-safety advocates say it raises new doubts about the ECMs.

“If you can get it wrong on stalling, you can get it wrong on unintended acceleration,” says Clarence Ditlow, executive director of the Center for Auto Safety in Washington, D.C.

And Sean Kane of Safety Research & Strategies said the stalling problem is similar to runaway car problems in that the computers don’t always create diagnostic trouble codes that let mechanics or investigators figure out what went wrong. “The heart of the problem is really their inability to detect the problem.”

Toyota has known about the stalling problem for years. It issued four technical service bulletins, the most recent in 2007, telling mechanics about the problem and instructing them to replace the module. But it did not deem the problem to be a safety risk needing a recall.

It was only after extreme temperature tests in which four of 32 units malfunctioned that Toyota decided to voluntarily proceed with the recall, Hanson said. It was found stalling could be due to faulty coating on the module’s circuit boards or a crack in the surface of a glass coating.