DePuy Hip Replacement Failures Lead to Massive Recall

Failure to Warn 002
People with a DePuy ASR hip replacement implant are experiencing a high rate of failure and pain associated with this device, sometimes shortly after surgery.  See New York Times Johnson & Johnson Recalls Hip Implants

Hip replacement surgery explained  Hip replacement xray right

People with the DePuy ASR have filed lawsuits because, despite reports of injury with this device, the manufacturer failed to inform doctors and patients of the known risks associated with this device and waited to issue a DePuy recall until August 2010.

Recalled x-ray 001The Manufacturer of the DePuy ASR has Issued a DePuy Recall Due to a High Rate of Failure (Bloomberg). The DePuy ASR is a Metal on Metal (MoM) prosthetic device consisting of a ball and corresponding socket implanted in thousands of patients around the world during hip replacement surgery. DePuy Orthopaedics, Inc., the medical device maker and part of the Johnson & Johnson Family of Companies, marketed this hip prosthetic in a “resurfacing” version called DePuy ASR Hip Resurfacing System and as total hip replacement called the DePuy ASR XL Acetabular System.

Fda warningSince 2008, there have been more than 300 complaints about this device filed with the U.S. Food and Drug Administration (FDA), with more than 90% of these cases requiring another hip replacement surgery to replace the defective implant. Still, there was no DePuy recall.  See FDA Warning Letter to DePuy Orthopaedics, Inc. 

The design of the device made it difficult for surgeons to implant, causing improper fusing with the bone and loose implants. Friction from movement of the metal on metal socket also creates metal shavings or debris in the soft tissue surrounding the device, causing pain, inflammation and necrosis or tissue death. This damage and inflammation can cause severe pain and disability, can be irreversible and complicate future replacement surgery. MoM hip implants, such as the DePuy ASR also release metal ions into the body.

Side effects 002

In 2009, the manufacturer voluntarily removed the DePuy ASR from the Australian market due to the device’s high failure rate, but they failed to issue a DePuy recall in the U.S. and doctors unknowingly continued use of the devices for patient’s hip replacement surgery. The company notified U.S. physicians about the Australian higher than anticipated failure rates in a March 2010 letter, only advising physicians that proper surgical positioning of the implant was essential.

On August 26, 2010, DePuy Orthopaedics, Inc. finally issued a DePuy recall, citing that 12%-13 % of patients with these defective implants would need to have a revision surgery.

Justice For Your Injuries 

JusticeIf you or a family member or close friend has undergone a DePuy hip replacement that has been the subject of this recall, you may have the right to file a lawsuit against the manufacturers (namely Johnson & Johnson and DePuy Orthopaedics, Inc.).

Contact me to evaluate your concerns and provide you with the utmost in legal guidance.

 

Contact Attorney Lowell Steiger to Discuss Your Legal Rights

Your Consultation is FREE

            (323) 852-1100      

            (877) 487-8221      

e-mail lowell@steigerlaw.com

 

Actos Users Beware: Danger of Heart Attacks, Bladder Cancer

Actos Lawsuits 002
The dangers of the Type II Diabetes drug Actos have led to a plethora of lawsuits around the United States.  What are the possible side effects of Actos?

 

  Actos Side Effects
New or worsening heart problems

(including congestive heart failure)

Bladder Cancer

The side effects are of such a serious nature that a new WARNING was issued by FDA in June 2011.  Here's a direct quote from the FDA Warning:

Fda warning 002"The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer."

RxAvailable only by medical prescription, Actos (pioglitazone) is in a class of medications called thiazolidinediones. Patients may have taken this drug under the brand name Actos or under the brand names Actoplus Met (pioglitazone and Metformin) or Duetact (pioglitazone and glimepiride) for combination products.

More than two million Americans with Type 2 Diabetes take Actos and many are increasingly concerned about Actos side effects. It is the most prescribed medication for the treatment of Type 2 Diabetes generating $3.4 billion in sales in 2009. However, recent studies show a link between Actos and bladder cancer. Some Actos users are considering the filing of an Actos lawsuit for their injury.

 

Sept 2010 FDA Warning Actos
The U.S. Food and Drug Administration (FDA) first issued a Warning in September 2010 about Actos and bladder cancer after reviewing data from a ten-year study conducted by Takeda Pharmaceutical Company, the drug manufacturer. Data showed a link between Actos and bladder cancer. People taking the highest doses of the drug, or had taken the drug for a long time, were most at risk for bladder cancer Actos side effects.

Before the labeling change, patients taking Actos may not have known about or understood the link between Actos and bladder cancer. They may even be have bladder cancer symptoms and not realize they are Actos side effects.

Bladder cancer symptoms

Justice For Your Injuries 

JusticeIf you have Type II Diabetes and took (or are taking) Actos and suffered any of the side effects mentioned here – new or worsening heart problems (including congestive heart failure) or bladder cancer – you may want to file a lawsuit against the manufacturers of Actos.

If you haven't taken Actos yourself but a family member or close friend has, tell them to contact me to evaluate your concerns and provide you with the utmost in legal guidance.

Contact Attorney Lowell Steiger to Discuss Your Legal Rights

Your Consultation is FREE

            (323) 852-1100      

            (877) 487-8221      

e-mail lowell@steigerlaw.com