Alabama Personal Injury Blog - Medical Devices & Implants

We Need the Medical Device Safety Act Passed

Billy Cunningham — Thu, 24 Sep 2009 10:50:15 GMT

In the Spring I wrote a blog about the introduction of the Medical Device Safety Act of 2009. in the Senate. The bill was introduced in response to the U.S. Supreme Court’s ruling in Riegel v. Medtronic, 552. U.S. 2 (2008) where the Court ruled that a medical device manufacturer cannot be sued under state law by patients who claim to have been harmed by the device that received marketing approval from the FDA. I referenced an editorial from the New England Journal of Medicine encouraging Congress to swiftly pass the proposed act. After introduction, the bill was referred to committee but has not come out of committee.

I was curious about how treating physicians felt about the ruling in Riegel and the bill. I interviewed Dr. Fred Meyer, a Professor and the Chair of the Department of Orthopedics at the University of South Alabama in Mobile, Alabama. http://www.southalabama.edu/usahs/hsjoin.pl?docID=261 Dr. Meyer has implanted thousands of medical devices over his career. Orthopedic medical devices allow his patients to return to a more normal life after a serious injury or debilitating illness. He relies heavily on the manufacturer to design and manufacture devices that fit the needs of his patients. A great majority of times those devices do exactly what they were designed to do. When they fail, the consequences to his patients can be grave. If they fail because they were not designed correctly or due to a manufacturer’s error, Dr. Meyer believes, like the editors of the New England Journal ,that his patients should have access to the civil justice system to be compensated. He also told me that he has seen how the civil justice system provides a safety net to his patients from manufacturers who fail to provide devices that are manufactured to specified standards.

He reminded me of the Sulzer hip-replacement debacle. Sulzer designed a hip replacement which was presented to and after testing approved by the FDA. However, after implanting the hip replacement, several surgeons reported cases of early failure which led to an investigation. That investigation revealed the failure arose from an attempt to cut costs which resulted in leaving a residue of machining oils on the backside of the shell of the hip-replacement. This residue inhibited the bone growth necessary for bonding between the shell and pelvic bone. This in effect, caused the shell of the hip-replacement to loosen, scar tissue to form, and in some cases additional bone loss. Patients implanted with this defected product experienced pain in the groin and inner thigh, pain when rising from a seated position, and weight-bearing pain. Due to these severe symptoms, many needed revision surgery. The Sulzer hip-replacement implants were recalled and removed from the market.

Dr. Meyer cited this as a perfect example of how FDA approval does not guarantee the success of a device and how without the civil justice system his patients who suffered unnecessarily would have not been compensated due to a cost saving attempt by a manufacturer. He also told me the story of scheduling a surgery for wrist implant and being assured by the company representative that the device was exactly what he needed only to find out the device was sized wrong. Had Dr. Meyer proceeded with the surgery without recognizing the error, under the Riegel case and without the passage of the Medical Device Safety Act of 2009 or a similar act, that patient will be unable to be compensated because the FDA approved the device. Such a result cannot be the law of this country.

I urge everyone to contact their Congressmen and Senators to urge the passage of an act to protect the public from such injustice.

Originally posted at InjuryBoard by Billy Cunningham

The New England Journal of Medicine Supports the Medical Device Safety Act of 2009

Billy Cunningham — Fri, 17 Apr 2009 18:03:48 GMT

An editorial of the April 9, 2009 issue of the prestigious New England Journal of Medicine encourages Congress to swiftly pass Medical Device Safety Act of 2009 and to allow lawsuits by injured patients to proceed in the courts. In doing so, the editors note that allowing lawsuits like this are an important part of the regulatory framework and very effective in keeping medical devices safe.

The Medical Device Safety Act of 2009 was introduced in response to the U.S. Supreme Court’s ruling in Riegel v. Medtronic, 552. U.S. 2 (2008) where the Court ruled that a medical device manufacturer cannot be sued under state law by patients who claim to have been harmed by the device that received marketing approval from the FDA. Since the ruling thousand of lawsuits have been dismissed and the editors express a concern that continued preemption will result in medical devices that are less safe for the American people.

The Medical Device Safety Act of 2009 as introduced along with a companion bill would nullify the Court’s ruling in Riegel by adding language to make explicit that the law does not preempt suits against device companies. The Court has allowed similar failure to warn suits against drug companies that had FDA approval. The inconsistency needs to be corrected and the proposed bill will do just that.

I believe the editors summed it all up rather well in their last sentence: “ The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation’s supply of medical devices and drugs should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.”

Originally posted at InjuryBoard by Billy Cunningham

Lasik surgery expert witness

Pete Burns — Mon, 09 Mar 2009 13:17:29 GMT

Some experts will say anything. The defense Lasik surgery expert, Dr. Woolfson, testified that he has performed approximately 70,0000 Lasik procedures without ever performing the wrong prescription. Even so, he testified that the surgeon who performed the wrong prescription on both of my client’s eyes did not fall below the standard of care!

Originally posted at InjuryBoard by Pete Burns