A whistleblower complaint accuses former osteopathic surgeon Dr. John A. King of experimenting on 26 of his patients.
The federal complaint says King used medical devices in ways that hadn't been approved by the FDA and received illegal kickbacks for doing it.
"King and David McNair [King's physician assistant] were conducting clinical research and human patient experimentation when they performed the anterior lumbar inter-body fusions" on eight patients, the "qui tam," or whistleblower, complaint states.
"King and McNair took studies that failed in laboratory animals, and then, without any reasonable basis to conclude that they would be successful, began to experiment on humans," the complaint says.
King generated 124 medical malpractice lawsuits during his short tenure at Putnam General Hospital between November 2002 and June 2003.
He's lost his medical license in numerous states, including West Virginia. Putnam General's former owner, Hospital Corporation of America, has paid out approximately $100 million to settle King-generated lawsuits.
These new charges against King are contained in a previously sealed whistleblower complaint filed against EBI Inc. on May 12, 2006, in federal court in Charleston.
Last month, U.S. District Judge John Copenhaver unsealed the complaint, after giving the Department of Justice the required opportunity to investigate its allegations. The results of that investigation have not been made public.
The whistleblower complaint was filed by eight former King patients who were covered by federally-funded health insurance programs, such as Medicare.
They are seeking to recover money for the federal government. Under the federal False Claims Act, they would be entitled to one-quarter of the money recovered.
Along with King and McNair, the complaint targets two companies:
Wright Medical Technology Inc. based in Arlington, Tenn., made Allomatrix, a bone fusion material that failed to work properly during two experimental studies performed on rats and rabbits. A third study, using pig-tailed macaques, rare primates native to Southeast Asia, showed "questionable" benefits.
EBI Inc., a subsidiary of Biomet Inc. in Parsippany, N.J., made spine stimulating devices King used during his surgeries. EBI allegedly paid King a bonus each time he inserted one of their "Ionic Spacers" into a patient's spine.
The ionic spacer had never been successfully used in an animal or human study to replace a diseased or damaged vertebral disk, according to the complaint.
Last month, Copenhaver also ordered the previously sealed complaint to be served on EBI. The company has not filed a response.
EBI Inc. and Wright Medical officials did not return telephone calls Friday.
No consent, no review
According to the complaint, King and McNair undertook deliberate, well-planned experiments on these patients.
For example, they allegedly made sure half the patients were male and half female. They implanted 12 patients with one type of device, and 14 patients with another.
Despite this, patients say they were never informed they would receive an experimental device.
"If any patients were to have been participants by design in an experimental protocol such as that conducted by King and McNair, appropriate informed consents would have to have been obtained from the patients," the complaint states.
There is no evidence patients were asked to sign a consent form.
"Additionally, institutional review board approval would have had to have been granted by the hospital where the clinical study was undertaken" and all procedures "approved by the research committee of the medical center."
Those procedures were never followed at Putnam General.
EBI was fully aware of what King was doing at that time, the qui tam complaint alleges.
In a July 1, 2004 letter, John M. Blumers, EBI's general counsel and vice president, "acknowledged that King and McNair were using the [ionic spacer] devices for purposes that were never approved by the U.S. Food and Drug Administration," the complaint states.
Blumers also acknowledged King and McNair were using Wright Medical's Allomatrix as a "substitute" for federally approved bone-graft materials.
Greg Ray, an EBI sales representative, was actually in the operating room at Putnam General Hospital at least 10 times when King performed surgeries between Jan. 27 and May 28, 2003, according to patient records.
In 2005, Ray purchased Banana Joe's, a downtown nightclub, according to newspaper articles. Within months, the nightclub was stripped of its liquor license after numerous fights there.
Kickbacks
EBI regularly gave physicians, such as King, kickbacks for using its unapproved ionic spacers, the complaint states.
The EBI sales department allegedly administered these kickbacks.
A whistleblower complaint accuses former osteopathic surgeon Dr. John A. King of experimenting on 26 of his patients.
The federal complaint says King used medical devices in ways that hadn't been approved by the FDA and received illegal kickbacks for doing it.
"King and David McNair [King's physician assistant] were conducting clinical research and human patient experimentation when they performed the anterior lumbar inter-body fusions" on eight patients, the "qui tam," or whistleblower, complaint states.
"King and McNair took studies that failed in laboratory animals, and then, without any reasonable basis to conclude that they would be successful, began to experiment on humans," the complaint says.
King generated 124 medical malpractice lawsuits during his short tenure at Putnam General Hospital between November 2002 and June 2003.
He's lost his medical license in numerous states, including West Virginia. Putnam General's former owner, Hospital Corporation of America, has paid out approximately $100 million to settle King-generated lawsuits.
These new charges against King are contained in a previously sealed whistleblower complaint filed against EBI Inc. on May 12, 2006, in federal court in Charleston.
Last month, U.S. District Judge John Copenhaver unsealed the complaint, after giving the Department of Justice the required opportunity to investigate its allegations. The results of that investigation have not been made public.
The whistleblower complaint was filed by eight former King patients who were covered by federally-funded health insurance programs, such as Medicare.
They are seeking to recover money for the federal government. Under the federal False Claims Act, they would be entitled to one-quarter of the money recovered.
Along with King and McNair, the complaint targets two companies:
Wright Medical Technology Inc. based in Arlington, Tenn., made Allomatrix, a bone fusion material that failed to work properly during two experimental studies performed on rats and rabbits. A third study, using pig-tailed macaques, rare primates native to Southeast Asia, showed "questionable" benefits.
EBI Inc., a subsidiary of Biomet Inc. in Parsippany, N.J., made spine stimulating devices King used during his surgeries. EBI allegedly paid King a bonus each time he inserted one of their "Ionic Spacers" into a patient's spine.
The ionic spacer had never been successfully used in an animal or human study to replace a diseased or damaged vertebral disk, according to the complaint.
Last month, Copenhaver also ordered the previously sealed complaint to be served on EBI. The company has not filed a response.
EBI Inc. and Wright Medical officials did not return telephone calls Friday.
No consent, no review
According to the complaint, King and McNair undertook deliberate, well-planned experiments on these patients.
For example, they allegedly made sure half the patients were male and half female. They implanted 12 patients with one type of device, and 14 patients with another.
Despite this, patients say they were never informed they would receive an experimental device.
"If any patients were to have been participants by design in an experimental protocol such as that conducted by King and McNair, appropriate informed consents would have to have been obtained from the patients," the complaint states.
There is no evidence patients were asked to sign a consent form.
"Additionally, institutional review board approval would have had to have been granted by the hospital where the clinical study was undertaken" and all procedures "approved by the research committee of the medical center."
Those procedures were never followed at Putnam General.
EBI was fully aware of what King was doing at that time, the qui tam complaint alleges.
In a July 1, 2004 letter, John M. Blumers, EBI's general counsel and vice president, "acknowledged that King and McNair were using the [ionic spacer] devices for purposes that were never approved by the U.S. Food and Drug Administration," the complaint states.
Blumers also acknowledged King and McNair were using Wright Medical's Allomatrix as a "substitute" for federally approved bone-graft materials.
Greg Ray, an EBI sales representative, was actually in the operating room at Putnam General Hospital at least 10 times when King performed surgeries between Jan. 27 and May 28, 2003, according to patient records.
In 2005, Ray purchased Banana Joe's, a downtown nightclub, according to newspaper articles. Within months, the nightclub was stripped of its liquor license after numerous fights there.
Kickbacks
EBI regularly gave physicians, such as King, kickbacks for using its unapproved ionic spacers, the complaint states.
The EBI sales department allegedly administered these kickbacks.
But these payments to physicians such as King were "frequently disguised as consultantships, although unrelated to any scientific or educational activity.
"The kickbacks have taken the form of cash payments, travel benefits, entertainment and other benefits."
Calling kickbacks "strictly illegal," the complaint notes they increased the amounts of money federal programs paid for King's surgical procedures.
The complaint against EBI states Putnam General collected at least $404,098 in fees from operations King performed using devices made by EBI.
EBI's parent company, Indiana-based Biomet Inc., previously agreed to pay $26.9 million in federal fines to settle kickback charges.
Biomet was one of five hip and knee replacement companies that agreed to pay fines and/or accept federal compliance oversight to avoid criminal prosecution for giving kickbacks to physicians.
A U.S. Department of Justice news release dated Sept. 27, 2007, detailed violations by Biomet and the other companies.
"This industry routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products," U.S. Attorney Christopher J. Christie stated.
"Prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make - choosing which device to implant by going to the highest bidder.
"With these [settlement] agreements in place, we expect doctors to make decisions based on what is in the best interests of their patients - not the best interests of their bank accounts," Christie added.
No FDA clearance
The federal complaint, as well as patient lawsuits filed in Putnam County Circuit Court, allege Wright Medical Products illegally paid King to use the bone fusion material Allomatrix during his surgeries at Putnam General.
The FDA sent a letter to Wright Medical on April 11, 2001, stating that the company did not have marketing clearance from the agency.
"Wright Medical did not obtain marketing clearance from the FDA for Allomatrix until the year 2004," alleges the lawsuit Steven Dingess filed against King, HCA, EBI and Wright Medical in 2004.
Robert Edwards, the sales agent for Wright Medical, is also a defendant in the lawsuits.
"Wright Medical knew that at the time Allomatrix was supplied to King, McNair and/or Teays Valley [Putnam General Hospital], clearance had not been obtained from the FDA for the sale and distribution of Allomatrix," the lawsuit alleges.
For King to have legally used Allomatrix when he was on Putnam General's staff, he would have needed "an investigational device exemption from the FDA and an institutional review board ... established at Teays Valley for the use of that product."
King met neither requirement, the lawsuit alleges, adding that Wright Medical sold and supplied Allomatrix to King "in direct violation of the prohibitions established by law....
"Wright and Edwards knew that the informed consents necessary for the use of its product on the plaintiff [Dingess] had not [been] obtained."
The use of Allomatrix, instead of FDA-approved bone graft treatments, increased "the likelihood that no fusion would occur" to restore the patient's spinal functions, the suit alleges.
King's whereabouts unclear
During seven months as a staff surgeon at Putnam General Hospital, King generated 124 medical malpractice suits - by far the highest rate in West Virginia history.
Earlier this year, Hospital Corporation of America, the nation's largest for-profit hospital group that owned Putnam General at the time, settled all 124 lawsuits for an estimated $100 million.
Twenty-six patients represented by Charleston law firm Curry and Tolliver have lawsuits pending against EBI and Wright Medical in Putnam County Circuit Court.
The first six lawsuits against EBI are scheduled to go to trial at the Putnam County Courthouse in Winfield on June 1.
John King moved out of West Virginia shortly after Putnam General Hospital restricted his privileges in June 2003.
No criminal charges have been filed against King related to his tenure at Putnam General.
His current residence is unclear. When he filed for bankruptcy in Alabama on Nov. 21, 2007, King listed his residence as his mother's home in Birmingham. His bankruptcy case is still open.
Reach Paul J. Nyden at
pjny...@wvgazette.com or
304-348-5164.
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What about the other people, nurses, tech, etc. in the surgeries? Were the nurses not smart enough to know what was going on?
What kind of companies encourage doctors to use bad equipment on patients? They are murderers in my eyes. Even if someone didn't die from the use of it, their lives as they knew it are gone. What a sick world.
not life!