Posts Tagged ‘Bill Robertson’

Hip Devices Continue To Cause Harm

Monday, October 3rd, 2011

A recent New York Times article highlighted the fast rate of hip implant failures in the United States.  (http://www.nytimes.com/2011/10/01/health/01hip.html?_r=1&scp=1&sq=hip%20surgery%20shows%20signs&st=cse)

The article notes that “[a]ll orthopedic implants, regardless of their composition, shed debris as they wear. But researchers say they believe that the particles released by some all-metal hips pose a special threat because scavenger cells dispatched by the body to neutralize the debris convert it into biologically active metallic ions. In some patients, a chain reaction begins that can destroy tissue and muscle.” Unfortunately, this failure was not a complete surprise.  “More than a decade ago, some researchers had warned that the hips shed tiny pieces of metallic debris that posed potential health threats to patients. ”

If you have a DePuy or other brand of metal hip implant, please call Bill Robertson today.  Bill’s direct dial phone number is 941.364.2433.

 

FDA Warning About Vaginal Mesh

Monday, September 19th, 2011

On July 13, 2011, the FDA issued a new advisory warning about plastic surgical mesh used during transvaginal surgeries to correct common female gynecological problems.  The surgical mesh is made from porous synthetic material and is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat stress urinary incontinence.  Physicians in the U.S. perform about 75,000 surgeries utilizing these mesh products each year.  From 2008 to 2010, the FDA received more than 1,500 Adverse Event Reports related to complications associated with the plastic mesh.

Some of these serious complications include:

  • Infection
  • Extreme Pelvic Pain
  • Bleeding
  • Dyspareunia
  • Erosion/Protrusion of Mesh through the Vaginal Wall
  • Vaginal Scarring/Deformity
  • Multiple Surgeries to Remove imbedded mesh
  • Urinary Problems

Studies indicate that about 10% of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh.  Mesh erosion can require multiple surgeries to repair and can be debilitating for some women.  In some cases, even multiple surgeries will not resolve the complications.

Thousands of women suffering pelvic organ prolapse are treated with plastic mesh each year, but reports indicate surgery can often be performed safely and effectively without the need for mesh.   The FDA  plans to convene an advisory committee of experts this Fall to determine whether to ban the mesh.

If you or a loved one have suffered a serious complication following mesh-repair surgery for pelvic organ prolapse or stress urinary incontinence, please contact Bill Robertson for information about your legal rights.

Internal Medicine

Monday, February 14th, 2011

According to a story in the Archives of Internal Medicine, “medical devicesare reviewed by the US Food and Drug Administration (“FDA”) using2 alternative regulatory standards: (1) premarket approval (“PMA”),which requires clinical testing and inspections; or (2) the510(k) process, which requires that the device be similar toa device already marketed (i.e., there needs to be a “predicate” device).  The second standardis intended for devices that the FDA deems to involve low ormoderate risk.”  (http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30)

A study of the FDA’s high-risk List of DeviceRecalls from 2005 through 2009 determinedthat, of the 113 recalls from this period that could cause serious health problemsor death, only 21 of the 113 devices had been approved throughthe PMA process (19%), eighty were cleared through the 510(k)process (71%), and an additional 8 were exempt from any FDAregulation (7%).

Tort lawyers play an important regulatory role.  Given that nearly 80% of the medical devices recalled for life-threateningor very serious hazards were originally cleared for market usingthe less stringent 510(k) process or were considered so lowrisk that they were exempt from review, tort litigation is necessary to cause manufacturers to more safely prepare medical devices for sale.

If you have been injured by a medical device or the failure of a medical device, call Bill Robertson or Zach Ross at 941.364.2400.

Volkswagen Recall

Wednesday, February 2nd, 2011

Citing concerns about the crashworthiness of Beetles produced in September 2010, the National Highway Traffic Safety Administration has ordered a recall of these VWs. What makes this story interesting is that the crash standards being applied only went into effect in September i.e., cars that were “safe” in the beginning of 2010 are now “unsafe.”

As reported in torquenews, “The NHTSA would like owners of these Beetles to return them to their dealership and in return, Volkswagen will give owners an older model. Sort of like trading down, only the German automaker doesn’t have much of a choice in this situation. What makes this funny is the fact that these replacement vehicles still won’t meet these crash requirements, but because they weren’t produced in or after September 2010, it doesn’t matter. … Only 27 examples of the 2010 Volkswagen Beetle will be recalled … Volkswagen Beetle owners can contact VW at 1-800-822-8987.” (http://www.torquenews.com/109/2010-volkswagen-beetle-recall-very-confusing)

Have you been injured in a car accident? Call Bill Robertson at 941.364.2400 or contact him via email at wrobertson @ kirkpinkerton. com (remove spaces).

Hold On To Your DePuy Explants

Monday, January 3rd, 2011

After DePuy issued its recall notice, it sent a letter to doctors and clinicians  and informed them that DePuy was willing to pay for their patients’ hip revision surgeries, BUT DePuy conditioned its offer on getting back the defective hip implants.  (Here’s the web address for DePuy’s letter – http://asrrecall.depuy.com/sites/default/files/DPYUS1%20Recall%20Notice.pdf)

Never mind the  fact that the patients with the defective hardware are the owners of the defective hardware, the real problem is that the explant is critical evidence in the effected patients’ cases against DePuy.

The hardware is critical evidence because it will allow an expert to determine whether the hip malfunctioned because of DePuy’s defective design and materials or whether the patient’s lifestyle caused the hip problems.  Obviously, DePuy will argue in response to lawsuits that the damages patients suffered are their own fault (or that of their doctors) and are not the fault of the manufacturer.

Hold on to your DePuy explants!  You do not need to agree to DePuy’s demands to get the health care and compensation you deserve.  If you have DePuy’s ASR XL Acetabular Hip System or ASR Hip Resurfacing System, do not sign any paperwork from DePuy and do not agree to release the DePuy explant without consulting with Bill Robertson, 941-364-2400.