Defective and dangerous medical device products rushed to market

In just the last 10 years, a great many medical devices have been recalled, but only after they had been given to patients, often through a surgery, and then a significant number of patients experienced health risks, sometimes even early death, the need for another surgery to correct the recalled device, and perhaps lifelong complications from the recalled device.

Experts put blame on an FDA approval process that allows an expedited review of a product when it is, "substantially similar," to previous products. About 90% of medical device applications use this expedited review.

"Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled." [1]

Even Senators have become concerned about the ability to track medical devices once they have been approved by the FDA, in order to have an earlier ability to identify problems.

U.S. regulators would gain greater authority to track the use of devices, such as hip implants from Johnson & Johnson (JNJ) and vaginal meshes made by Boston Scientific Corp., that have sparked thousands of patient lawsuits, under a bill introduced in the Senate. [...]

"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," said U.S. Senator Herb Kohl, one of the bill's three sponsors, in a statement. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem and that the drive toward getting new technologies to market won't come at the risk of patient safety." [2]

But the experts have widely different figures on these devices and the percentages of recalls for those fast tracked FDA approval. The experts don't even necessarily agree with what most people would consider what would classify "injury" in the classifying of these medical devices, even when the potential for injury means another surgery if that medical device is recalled. Considering that pace makers fall into this problem, hip and knee implants; it is not just the pain and suffering but individuals who experience these medical device recalls may have shortened lives, end up with loss mobility, loss of quality of life, cancer, blood poisoning, the list goes on and on.

For instance, "According to figures from the Institute of Medicine (IOM), 1.5 percent of all devices approved through the 510(k) process are recalled. " [1]

But, other experts arrive at different numbers and percentages.

Diana Zuckerman, president of the National Research Center for Women and Families, found that in 2010 more than 437 million devices were recalled out of fear that they might kill or permanently harm patients. [3]

But a recent review by Dr. Steven Nissen of the Cleveland Clinic suggests recalls often involve devices approved through the 510(k) process. In Nissen's review of 113 urgent recalls from 2005 to 2009, more than 70 percent of the recalled devices were found to have been cleared via the 510(k) program — compared with 19 percent approved through the FDA's more rigorous premarket approval (PMA) system. Diana Zuckerman, PhD, president of the National Research Center for Women and Families and one of the co-authors of Nissen's study, said the figures vary so much because the IOM figure doesn't include recalls for devices whose malfunction poses just a "moderate" risk of injury. [1]

For instance, recipients of the Depuy ASR recalled hip implant, even though suffering blood poisoning of heavy metals cobalt and chromium at 1000% higher, and having to under go a second revision surgery, unknown long term consequences from damages of the heavy metal poisoning not to mention the potential future early loss of mobility because of the need in a short time for the second hip revision surgery, are considered under these disputed criteria, to only consitute a moderate risk of injury. Clearly, individuals who received these Depuy ASR hip implants might argue otherwise.

So what are you to do?

They suggest, before you choose your device for a hip or knee implant, ask your doctor if they are paid by the device maker.

The device maker must by law disclose any doctors it pays. So, look up on the device maker's website, and directly ask your doctor.

You can also research the medical device maker's history of recalls at the FDA website, and look specifically for the type of device that affects you.


1. FDA's Fast-Track Medical Device Approval Process Under Fire

2. Medical Devices Need Greater Follow Up After U.S. Approval, Senators Say

3. Experts Say FDA Should Abandon Approval Process


December 16, 2010 New York Times "The Implants Loophole" By BARRY MEIER

You need an experienced San Diego personal injury attorney who is a skilled and proven trial lawyer to help hold these corporations accountable.

If you are injured by a dangerous or defective product, you will need an experienced and skilled product liability attorney. Call me for a free initial legal consultation so that you will know your rights and options.


Related Informational Links:

Metal on Metal Hip Device Recall - Depuy

Dean A. Goetz and the Gomez Law Firm were the attorneys for Mr. Loren Kranksy, the Plaintiff in the first Depuy trial in the USA. 3/6/13 at 9:38 a.m. PST A jury found Depuy liable to Mr. Loren Bill Kransky today in a Los Angeles Superior Court. FIRST verdict in the USA against Depuy for $8,328,000. We Are The Kransky Lawyers

Kranksy vs. Depuy and Johnson and Johnson, Los Angeles County Superior Court Case #BC456086

The Walking Wounded - Dean Goetz interviewed ABC Investigative Report - watch the whole investigative story on Depuy, aired 5/26/14, "Reporter Quentin McDermott reveals how a healthcare giant deceived doctors and patients using its ASR hip replacement implant." Australian class action cases go to trial in 2015.