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Virginia Judge Rules Medical Device Pioneer Committed Malpractice
Date:4/29/2008

RICHMOND, Va., April 29 /PRNewswire/ -- The principal U.S. investigator for the Maverick(TM) artificial disc device has been found liable for malpractice in his use of the device by a state court judge in Richmond, Va. Garver v. Mathews, CL No. 07-206, Circuit Court, City of Richmond, Va.

Judge T.J. Markow awarded damages of $650,000 against Hallett H. Mathews, M.D., and Midatlantic Spine Specialists, P.C. Dr. Mathews is a prominent spine surgeon who now works as a vice president for Medtronic, the manufacturer of the Maverick(TM) Artificial Disc.

The damages were awarded to Eric M. Garver, M.D., who is himself a spine surgeon in Bridgeport, Connecticut. Dr. Garver traveled to Richmond in April 2005 to undergo surgery by Dr. Mathews, who installed a Maverick at the L5-S1 level of Dr. Garver's spine.

The device consists of two metal plates that fit into the patient's disc space with a ball and socket between them, which is intended to maintain the natural mobility of the disc as an alternative to traditional spinal fusion. See the manufacturer's web site for more details: http://www.maverickdisc.com/about-maverick-disc.html.

Judge Markow, who heard three days of evidence in a lawsuit brought by Dr. Garver, issued a written decision in which he found that Dr. Mathews had violated "the standard of care in preparing the disc space for insertion of the Maverick artificial disc." The standard for the surgery, written by the defendant himself and other spine surgeons, required that the disc space be "meticulously cleared of materials that might be driven into nerves behind the disc space by insertion of the artificial disc," the judge wrote. In the Garver surgery, Dr. Mathews, while inserting the artificial disc, drove material from the disc space into the patient's S-1 nerve root on his right side. This caused permanent injury to the nerve with pain and difficulty using the right leg.

A fragment of bone and disc the size of an olive was retrieved from Dr. Garver's spine two weeks after the Mathews surgery by a neurosurgeon in Bridgeport, Conn. That surgeon, Dr. Patrick Mastroianni, testified at the trial that he found the fragment pressing against the nerve root. Removal caused some relief of Dr. Garver's symptoms, but he ended up with a chronic pain syndrome that is poorly controlled even taking multiple drugs every day. His previous condition, with back pain and pain going into his left leg, was cured by the Mathews surgery.

At the time of the surgery, Dr. Mathews was a surgeon in private practice who ran one of 32 sites in the United States at which the Maverick device was inserted into selected patients, and who also was the principal U.S. investigator for the manufacturer's application to the Food and Drug Administration. The device is still considered experimental while the Medtronic application to the FDA is pending.

According to testimony at trial, Dr. Mathews received consulting fees from Medtronic of around $700,000 in 2004 and 2005, although he was not paid anything for the clinical trial itself. Dr. Mathews testified that he gave up his surgical practice at the end of 2006 to work full-time for Medtronic. His current position is Vice President Medical Affairs for Medtronic Spine and Biologics' division in Memphis, TN. Mathews is a former member of the board of directors of the North American Spine Society, a group of surgeons who specialize in spine surgery.

Dr. Garver was represented at trial by Patrick Malone of Patrick Malone & Associates, P.C., of Washington, D.C., http://www.patrickmalonelaw.com and Thomas Albro and Lee Livingston of Tremblay and Smith, L.L.P., of Charlottesville, Va.

Contact for further information: Patrick Malone, 202-742-1500, pmalone@patrickmalonelaw.com.


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SOURCE Patrick Malone & Associates, P.C.
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