Informed Consent at Issue in Cases Involving Rabies-Infected Kidneys

John Council

Texas Lawyer

March 27, 2006

Families of two people who died after receiving rabies-infected organs have filed separate suits against the hospital and others involved in the transplants, alleging that the defendants failed to provide enough information about the donor to obtain informed consent from the recipients.

Cheri Jean Wells, 50, and Joshua Hightower, 18, received kidneys from Arkansas resident William Beed Jr. in May 2004, and they died the month after their transplant surgeries. Two other recipients of Beed's organs also died, one during the transplant surgery, according to a July 3, 2004, news release from the Centers for Disease Control and Prevention.

The CDC confirmed that the deaths were from the first reported cases of rabies transmission through solid organ transplantation, although rabies transmission had occurred previously through cornea transplants. Confirmation that Beed's organs were infected with rabies came from laboratory testing of autopsy specimens after the deaths of the organ recipients, according to the CDC news release.

Hightower's parents filed Hightower v. Baylor University Medical Center, et al. Feb. 28 in the 115th District Court in Gilmer, Texas. Other defendants in that suit are Dr. Edmund Sanchez, Dr. Srinath Chinnakotla, Dr. Sherfield Dawson III, Dr. Waleed El-Feky and Dr. Robert Fine, physicians at Baylor; Dallas Nephrology Associates; Dallas Pre-Transplant Group; and Dallas Transplant Institute.

The Biggs family filed Biggs, et al. v. Baylor University Medical Center, et al. in November 2005 in the 134th District Court in Dallas. According to the first amended petition, the family is seeking $5 million in damages against Baylor and the other two defendants, Sanchez and Chinnakotla. The suit is tentatively set for trial Oct. 9.

John Scully, Baylor's attorney, says the situation is unprecedented. "I don't know of other lawsuits involving this anywhere," says Scully, a shareholder in Dallas' Cooper & Scully.

Hightower's parents seek an unspecified amount of damages for, among other things, medical expenses, their mental anguish and psychic trauma, and the pain that their son suffered from the time he received a kidney that they claim never functioned until he died.

In their original petition, Hightower's parents allege that a mistake during surgery damaged the lower 40 percent of the kidney transplanted into Hightower. The parents allege in the petition that a biopsy done on the transplanted kidney 10 days after the surgery revealed that the organ was dead.

Hightower was 17 years old when he received Beed's kidney and faced no immediate health crisis, says Robert D. Bennett, attorney for the parents.

"All they accomplished by transplanting the kidney was killing the kid," Bennett, a senior partner in Gilmer's Robert D. Bennett & Associates, says.

In addition to monetary damages, Hightower's parents are asking that the defendants establish procedures for testing donated organs for communicable diseases, either prior to transplant or as soon as possible afterward.

Bennett says health-care providers screen for the AIDS virus, hepatitis B and C, and West Nile encephalitis. At the same time, they could test for rabies, he says.

Scully says testing for rabies isn't required prior to a transplant. The United Network for Organ Sharing establishes protocols for transplantation in the United States. No test or screening method is available that can be completed in the four- to six-hour time frame needed for organ transplantation, Scully says.

Pam Silvestri, public affairs director for Southwest Transplant Alliance, which procured Beed's organs but which is not a defendant in either suit, also says that testing for rabies is not available at all hours of the day or in all places.

Allen Reaves, an associate with Bennett & Associates and another attorney representing Hightower's parents, says postmortem testing for rabies is available for donors. If the recipient of a rabies-infected organ receives the post-exposure prophylaxis before he or she exhibits symptoms of rabies, the individual isn't likely to get the disease, says Reaves, who formerly was a critical care nurse for kidney transplantations.

"If [testing] saved one person's life, it would be worth that," Reaves says.

Willie Briscoe, an attorney representing the Biggs family, says informed consent, not rabies testing, is the key issue in the suits.

"I think Baylor would want this to be strictly about rabies," says Briscoe, an associate with Provost & Umphrey in Dallas. "Our case is primarily based on Baylor's failure to inform the family of known risks with regard to Beed."

The Biggs and Hightower plaintiffs allege in their petitions that the defendants fell below the standard of care by failing to inform the organ recipients and their families about "the high-risk nature and poor donor quality" of Beed.

In the Biggs and Hightower petitions, the plaintiffs allege that Beed had been incarcerated up until two weeks prior to his fatal illness and had ingested rock cocaine just two days before his May 1, 2004, admission to Christus St. Michael Health System in Texarkana, Ark. Beed was pronounced brain dead the day after he was admitted, according to the petitions.

Silvestri, the Southwest Transplant Alliance spokeswoman, says it's not unusual for an organ donor to have a history that includes drug use and jail time.

However, Briscoe maintains there were a number of other factors that made Beed a high-risk donor.

For organs to be used in transplants, donors' families must give their authorization, Silvestri says.

The plaintiffs in Biggs allege in their petition that Beed's medical history revealed that he was admitted to the hospital, through the emergency room, in "an agitated and confused state and that he had multiple episodes of seizing and vomiting." They further allege that medical records indicate the team that procured Beed's kidney felt that the hospital and surgeon receiving the organ for transplant "should be aware of some significant signs of infection in the donor, including evidence of bacteria growing in the donor's sputum and blood."

The Biggs plaintiffs also allege in their petition that Beed's temperature was 106 degrees prior to his death, "indicating an obvious and serious infection" that was unknown to the plaintiffs, Beed's treating physician and the defendants.

The Biggs and Hightower plaintiffs allege in their petitions that Southwest Transplant Alliance offered Beed's kidneys to several hospitals that rejected the organs due to Beed's "high-risk social history, recent incarceration and overall poor donor quality."

Peter Anderson, a partner in Dallas' Chamblee & Ryan and an attorney for Dallas Nephrology Associates, Dallas Pre-Transplant Group and Dallas Transplant Institute, says his clients "absolutely disagree" with the claims being made against them in the Hightower petition. Anderson says the pre-transplant group is a department within Dallas Nephrology Associates, and the transplant institute is an affiliated entity. None of the doctors named as defendants in Hightower is affiliated with Dallas Nephrology Associates, he says.

Stan Thiebaud, attorney for Sanchez, Chinnakolta and Dawson, declines comment about the allegations made in the suits. El-Feky's attorney, Bo Berry, a partner in Dallas' Berry & Randall, and Fine did not return a telephone call to each of their offices before presstime March 16. Thiebaud, a partner in Dallas' Stinnett, Thiebaud and Remington, provided a copy of the Baylor defendants' written statement about the suits, which reads in part:

Each patient in the transplant program is counseled by a transplant physician and coordinator about risks, including infection and rejection, associated with transplantation, the waiting process and life after a transplant. Before patients go into transplant surgery, they are required to complete an organ transplantation disclosure and consent form, attesting that they understand the risks of transplantation.

Briscoe contends that in a situation with a high-risk donor, such as Beed, the physicians should have explained all the problems and risks in accepting the organs, but they failed to do so.

"They got consent from the [Biggs] family, but that consent was not informed," Briscoe says.

In their petitions, the plaintiffs in both suits allege the defendants were negligent for not providing sufficient information about Beed, so that the organ recipients could give informed consent to the transplantations. Both sets of plaintiffs also allege that the defendants acted with malice, which would (subject the defendants to punitive damages, according to the petitions.

"We don't agree with their position and allegations, and Baylor intends to defend the cases," Scully says.

Darrell Keith, a medical-malpractice practitioner and principal in the Keith Law Firm in Fort Worth, says if the plaintiffs in Biggs and Hightower are able to prove their allegations, they have, in his opinion, powerful claims that should have reverberations throughout the medical organ transplant surgical community.

Keith, director of the State Bar of Texas advanced medical malpractice course held last week in San Antonio, isn't involved in Biggs and Hightower but reviewed the petitions in the two suits.

As a general rule, it's difficult for a plaintiff to prevail in a medical-malpractice case that's based largely on informed-consent issues without accompanying accusations of medical negligence in the procedures, Keith says. But if the plaintiffs in Biggs and Hightower prove their allegations, Keith says, he thinks that these suits will be an exception to that general rule.

"I think these are both important cases to Texas medical-malpractice law, because informed consent should be a major issue to patients considering organ transplantation," Keith says.

Keith says Biggs and Hightower also are important to emphasize the need for a high standard of care for organ transplant patients. "Organ donor recipients have an extremely difficult position if faced with information about high-risk donor organs without adequate time to reject bad organs and obtain healthy ones," he says.

Tom Mayo, a professor at the Southern Methodist University Dedman School of Law and an expert on health-care law, says normally the fact that the defendants met the transplantation industry standard of not testing for rabies would be a good defense. But Mayo says the Biggs and Hightower suits raise a further question: Is the industry standard reasonable?

Mayo cites a 1932 decision by the 2nd U.S. Circuit Court of Appeals in T.J. Hooper, et al. v. Northern Barge Corp., et al., a suit over the sinking of barges being towed by tugboats during a storm off the New Jersey coast. In an opinion written by then-Judge Learned Hand, the 2nd Circuit held that the tugs were unseaworthy, because they didn't have radio receiving sets with which they would have learned about the storm, even though such sets weren't standard in the industry.

Mayo says it may have been the industry standard for the defendants in Biggs and Hightower not to test for rabies. "The question is whether they missed the mark in a way that's unreasonable."

Copyright © 2006 ALM Properties, Inc.

This article posted April 15, 2006.