Lawyer Resources for Medical Device Failures

Pancreas Although the latest warning from the FDA regarding drugs like Byetta and Januvia only came in March 2013, the dangers have been known for many years. The recent information released by the FDA that researchers have found pre-cancerous cells in deceased patients using the drugs came after several previous warnings dating back to 2007. Although the FDA has yet to confirm the link between these drugs and pancreatic cancer, many believe that it is only a matter of time.

Bad News From The Beginning

Byetta still had that new-drug smell when reports began trickling in that patients using the drug were having a higher incidence of pancreatitis.  The FDA approved Byetta in 2005 and by 2007, the first FDA alert was issued that patients using the drug had reported to the FDA that they had pancreatitis. The next year, another alert was issued, with reports of patients dying from the disease.

Granuflo-death-attorney-300x200Fresenius Medical Care, a German-based company, is the largest provider of dialysis services and products in the U.S., providing dialysis to over a third of the patients in need of the treatment. The FDA is looking into allegations that the company knowingly failed to notify patients of a possible heart risk with the use of their products, GranuFlo and Naturalyte. The company issued a warning about the product to consumers in late March 2012 and a Class 1 recall was issued but this only occurred after internal sources within the company leaked a memo to the FDA that indicates that the company knew of the problem months earlier.

FDA Investigation

The internal memo that was leaked to the FDA was written in November 2011, over four months before the recall of the products in the end of March 2012. The memo was addressed to physicians within the organization’s dialysis centers, stating that improper use of one of their products was attributing to an increased risk of cardiac arrest in their patients. In fact, 941 patients had a cardiac arrest episode within their centers in 2010. However, they did not warn any other dialysis centers or doctors externally that use their product of the increased risk of heart problems to their patients.

stryker-rejuvenate-attorneys-258x300A growing number of lawsuits have been filed against Stryker Corporation related to its defective hips. One of the more recent Stryker Rejuvenate lawsuits involves a man from Georgia who required a revision surgery less than one-year after he developed complications following his original hip replacement. The lawsuit alleges that the defective design of the Stryker Rejuvenate product resulted in complications such as:

  • Pseudo-tumors
  • Fretting and corrosion of the metal used in the device

DePuy ASR Cases ValueAll civil lawsuits come down to one thing— money. Sure, there will always be people who claim that they have filed their lawsuit out of a a sense of social responsibility and a genuine desire to help mankind, but injury cases– and medical device cases in particular– are really about getting financial compensation for an injury.

As soon as the DePuy ASR hip prosthesis was pulled from the market in August, 2010, a stream of people with these defective metal hip implants filed lawsuits against the manufacturer alleging amongst several things that the device resulted in pain, disability which may had resulted in the need for additional medical care or perhaps prevented a person from going about their employment.

Status of the current lawsuits

Signs and Symptoms of Hip Implant FailureWith all the medical advances that are made year after year, some you would never expect. The fact that the majority of hip implants being used today (and over the last decade) have high failure rates and risk of injury is simply unacceptable. While many manufacturers of these dangerous products have recalled their faulty hip implants, many are still suffering the consequences.

Manufacturers of medical devices have an obligation to provide patients with a safe device. When they recognize that there are any defects or hazards associated with their product they must promptly respond to and rectify the situation by alerting patients, doctors, and the proper government agencies.

Recognizing the Signs Of Hip Failure

British Medical JournalA scathing report issued by the British Medical Journal (BMJ) says DePuy Orthopaedics was well aware that several of its hip implants were faulty, even as it continued to aggressively market the products to surgeons.

The report, written by BMJ investigations editor Deborah Cohen, cites an internal DePuy memo from 2005. The memo reads:

“In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic. The mechanism is not known and only 24 local malignancies have been reported in patients with joint replacements. Also worrying is the possibility of distant effect. One study suggested a threefold risk of lymphoma and leukemia 10 years after joint replacement.”

As I wrote about yesterday, the latest developments in the DePuy hip implant recall reveal the company was putting profits before patient well-being by continuing to allow the hips to be implanted despite knowledge of numerous problems with the devices. In an interview recorded earlier today with LXBN TV, I discuss that and the background of the recall with Colin O’Keefe.



depuy hip x-rayIt seems like the more we learn about the inner workings at the corporate offices of DePuy, the well known manufacturer of artificial hips and a subsidiary of Johnson & Johnson, the more disturbing image we have about a company that clearly puts its bottom line ahead of everything else— even patient safety.

A recent New York Times article, “Hip Device Phaseout Followed F.D.A, Data Request” depicts a company so focused on corporate profitability that the company continued to allow their artificial hips to be implanted in patients after mounting data suggested problems with the devices including: premature failure, metal poisoning and other disabilities in patients.

The Times article cites a 2009 letter from the FDA to executives at DePuy highlighting concerns about the manufacturer’s ASR hip implant devices lackluster track record for safety.  In contrast to a safe hip replacement device that was promoted to last an anticipated 15 years in patients, the FDA letter voiced concerns over the devices longevity and metal-on-metal design that seemed to correlate with a higher than anticipated failure rate.

metal artifical hipThe artificial hip failure problems that began with DePuy now have cast a broader spotlight on the entire artificial hip industry that utilizes similar metal-on-metal designs.  

The acknowledgement of problems with the DePuy ASR device last year, may yet precipitate similar acknowledgements from other manufacturers about defects with their artificial hips comprised of similar metals.

Over the next decade, an estimated 50,000 people per year will likely require a revisionary surgery due to a defective metal-on-metal hip that they we originally given.  The heart of the probelm stems from the fact that metal particles shear off from the hip in large number of patients.  

hip pain.jpgFollowing the well-publicized troubles associated with all-metal hip replacement devices manufactured by DePuy and others, a recent study casts concerns about a similar hip surgery known as “hip resurfacing”.  

The New York Times reported on a study study conducted by the California Technology Assessment Forum, found that the metal hip resurfacing devices had higher premature failure rates than expected and exposed patients to potential health problems when the metal debris from the devices splintered off from wear than initially expected.

Hip resurfacing procedures have been embraced by the medical community as a less invasive procedure compared with a complete hip replacement as the resurfacing procedures can preserve more of the patient’s bone and a perceived shorter recovery time.

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