Cape Cod Personal Injury Lawyer - Medical Devices & Implants

FDA Meeting Held to Address Complaints About the Medical Device Approval Process

Carrie Strasser — Mon, 27 Apr 2009 14:44:55 GMT

The New York Times reported last week that a rare internal meeting was held by the FDA on Wednesday to address the complaints surrounding the medical device approval process.

Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, sent an e-mail message on April 10 announcing an “all-hands meeting” to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

This meeting was spurred by letters to President Obama signed by nine scientists alleging that agency officials had acted improperly and put patients at risk by approving medical devices for use in spite of numerous objections from scientists reviewing the devices.

These letters have led to the opening of a Congressional investigation and a critical report of the device center released by the Government Accountability Office in January. Additionally, Congress is to propose legislation this week asking the Institute of Medicine to investigate the device division.

Specific devices that the scientists complained about were imaging equipment used to detect breast cancer and an orthopedic knee device. The scientists also charged that the agency has allowed hospitals to clean and reuse certain devices intended for only one use.

This meeting will hopefully be the first step toward greater concern for patient safety when it comes to medical devices. As of now, many patients harmed by certain medical devices have no recourse through the judicial system. However, if the approval process becomes more rigid, this could prevent avoidable injuries due to faulty medical devices. For more information on medical devices, click here.

Originally posted at InjuryBoard by Carrie Strasser

Study Suggests Patients Requiring Heart Implant Devices Should Seek Out Specialists

Carrie Strasser — Wed, 22 Apr 2009 09:01:00 GMT

The New York Times reported on a study released Tuesday that indicated that patients who had specialists implant their heart defibrillators had fewer complications than their counterparts whose surgeries were conducted by other doctors.

The study, headed by Dr. Jeptha P. Curtis of Yale University, examined 110,000 patients who had received defibrillators and other heart devices over 1.5 years from 2006 to 2007.

Overall, the study found that the rate of serious complications like heart attacks or internal bleeding that occurred during the implant of a heart device was lowest — about 1.3 percent — when the procedure was performed by an electrophysiologist, the name for a cardiologist formally trained in device use.

The study reported that most implant procedures, approximately 70%, were conducted by electrophysiologists. The highest rate of complication, approximately 2.5%, was reported among thoracic surgeons.

The increase in defibrillator implantation in recent years has led to increased questions regarding physician training in these implant procedures. Some defibrillator makers have even begun training programs for doctors who are not electrophysiologists.

This has caused some specialists to argue that patients requiring heart implant devices should seek out electrophysiologists to conduct their surgery. Other doctors have argued that, in some areas, there are too few specialists to meet the demand.

If you find yourself needing heart surgery, don't hesitate to question your surgeon about his/her experience and training. It is his/her job to put you at ease and instill confidence that he/she is the best person for you to trust. For information about heart health, click here. For information on medical devices and implants, click here.

Originally posted at InjuryBoard by Carrie Strasser

Gov. Patrick Bashes the Consumer Again

Bruce Bierhans — Sat, 06 Dec 2008 11:47:54 GMT

Overlooked to a large degree during his campaign for Massachusetts Governor, was Deval Patricks role on the Board of Directors of Ameriquest at the same time it was creating and marketing the subprime loan products that have destryoyed the international economy. The press, inexplicably,gave him a free ride. Once again, when it comes to the consumer, Patrick has shown that he is a wolf in sheeps clothing.

Today, the Boston Globe reports that the Mass. DPH is proposing regulations that would exempt from public disclosure certain payments by pharmas and medical device companies to physicians receiving remuneration from those companies. Consumer advocates, including many physician led organizations have long opposed such exemptions and seek regulations requiring full disclosure of the relationships between physicians and drug and medical device companies.

In a case we are currently litigating involving suicide and antidepressants, we learned that the defense expert was receiving over $1mill a year from antidepressant manufacturers to fund his organization, as well as his $100k per year salary.

While the Patrick administration claims that the regs will constitute the strictest disclosure law in the country, there are many ways in which the proposed regs can be circumvented so as to not dicsclose large research grants and other financial payments.

The administrations' acts are shameful and Patrick shows, once again, that he is an advocate for corporate America, not the consumer. Perhaps if Mr. Patrick gets nominated for a position in the Obama administration , his true allegiances will be explored by members of Congress that are real advocates for their constituents.

Originally posted at InjuryBoard by Bruce Bierhans