Practice Standards for Patient Advocates Defined in Memo to Back Malpractice Suit

Volume 2 Number 6

March 19, 2003

Page 208

ISSN 1539-4530



Practice Standards for Patient Advocates

Defined in Memo to Back Malpractice Suit

Hoping to prevent the nation's first malpractice suit against a patient advocate from being dismissed, human research plaintiffs' attorney Alan C. Milstein has defined patient advocate standards of practice in a court memorandum filed March 7.

Patient advocate Dr. David Casarett was named as a defendant in a suit filed on behalf of the widow of James Quinn after Quinn died in an artificial heart experiment Aug. 26, 2002 (1 MRLR 483, 11/6/02 ).

The suit alleges Casarett failed to warn Quinn of the risks involved in allowing surgeons to replace his own failing heart with the experimental device. Quinn came to regret the decision because of post-operative complications. He died 10 months after the artificial heart was implanted.

Seeking to dismiss the claim, Casarett's lawyers argued that universal standards of practice for patient advocates do not exist. By definition, malpractice is deviation from professional standards, so standards must be defined in order for a suit to stand, they said. A prominent bioethicist told BNA it was the case's "fatal flaw."

Milstein and fellow attorney Derek T. Braslow, both of Sherman, Silverstein, Kohl, Rose & Podolsky, Philadelphia, called the argument "absurd" in the March 7 court memo (Quinn v. Abiomed Inc., Pa. Ct. Com. Pl., No. 001524, memo filed 3/7/03).

Patient advocates are "members of a relatively new profession, though unquestionably a profession nonetheless," the memo stated. "Patient advocates are professional advisors to the potential human research subjects whose role is to help the subjects understand the nature of the experiment as well as its risks and benefits, to help them decide whether or not to participate, and to help them once the experiment begins with any human protection issues that might arise."

Advocates also must ensure that consent is fully informed and uncoerced. The role is akin to that of an attorney, according to the memo.

To be a patient advocate requires specialized knowledge and training. "The field is the subject of lectures and scholarly articles by individuals who are doctors either of medicine or philosophy or both," the memo noted.

If accepted by the court, the arguments could help define the role of advocates and set precedent for future malpractice suits against them, according to observers.

No Universal Standards

Casarett's attorney, Thomas P. Wagner, of Rawle and Henderson, Philadelphia, told BNA he was "not sure that [standards] don't exist," but that they are "still developing and coming from a number of sources."

"Casarett complied with all the standards of care that could conceivably apply, and he had the best interests of the Quinns at heart," Wagner said.

He and fellow Rawle and Henderson attorney Meredith A. Frimpter, who also is defending Casarett, would not explain if and how the memo would change their strategy. The Pennsylvania Court of Common Pleas does not typically entertain replies to briefs, they observed.

However, it is not Milstein's place to "be manufacturing standards," Wagner added.

A source familiar with the case who asked not to be identified faulted Milstein's argument on several counts. Casarett was a member of the Independent Patient Advisory Counsel (IPAC), a trust set up by Abiomed to help counsel transplant candidates about the experiment and provide assistance after the procedure.

It was a precedent-setting arrangement, the source said, because advocates usually counsel patients through the informed consent process, but do not continue to help thereafter. Also, most advocates are paid directly by a hospital. Casarett's work was funded by IPAC, which was independent of Abiomed after its founding.

The uniqueness of the arrangement, the source said, means that Casarett's work with James Quinn did not adhere to a commonly accepted definition of patient advocate practice. The source also noted that the meaning of the term "patient advocate" varies so widely in the nation's health system that it is impossible to talk of universally accepted advocate standards.

First Amendment Issues

Meanwhile, Casarett's lawyers have subpoenaed the notes of the advocate who replaced Casarett at the Quinns' request, Sheldon Zink, a University of Pennsylvania medical anthropologist.

Citing the First Amendment, Zink has pledged to go to jail rather than turn over her record of the 18 months she spent with the Quinns, first as an academic observer and later as a trusted friend and advocate. Zink supports Irene Quinn's suit, Milstein said.

Quinn's claims against Drexel University, Tenet Healthcare, and Hahnemann University Hospital, where the heart was implanted, "have been discontinued," according to the memo. Artificial heart maker Abiomed Inc. and Casarett, however, remain defendants.

Professional Legitimacy at Stake

As a patient advocate, it was up to Casarett to tell Quinn about past problems with artificial hearts, ensure he received 24-hour nursing care after the surgery, and help him resolve home care and billing issues following the operation, according to the memo.

"While he knew that the clinical trial's protocol considered an additional thirty days of survival a successful outcome, Dr. Casarett never revealed this information to the Quinns," the memo alleged. Instead, he allowed Quinn to believe the heart was a viable therapeutic option, never revealing that Abiomed expected Quinn to die within a month of the operation.

According to the memo, Casarett should have revealed he was getting paid by Abiomed, as the suit alleged. He also should have set up communications between Quinn and other artificial heart recipients, the memo said.

Moreover, "At the informed consent conference, Dr. Casarett made no demands and asked no questions of the investigators," the memo noted.

Patient advocacy is "a profession with standards like any other profession," the memo stated. "If not, consider the level of deceit researchers would be engaged in if they provided to a potential subject a Patient Advocate who could say or do anything and whose standard of care was no greater than if he or she had been selected at random off the streets of Philadelphia."

Contacted by BNA, Casarett declined to respond to the allegations, citing the pending litigation.

Milstein's court memorandum is available on the Web at

By M. Alexander Otto

Copyright © 2003 by The Bureau of National Affairs, Inc., Washington D.C.

Reproduced with permission from MedicalResearch Law & Policy Report, Vol. 2, No.6, pp. 208-209 (March 19, 2003). Copyright 2003 by TheBureau of National Affairs, Inc.