PROFESSIONAL ISSUES

Vindicated after his death: Doctor cleared of malpractice in clinical trials done 40 years ago

A federal appeals court overturns lower court findings about a brain tumor study from the 1960s. Some feared the original ruling would have curbed research.

By Tanya Albert, AMNews staff. Sept. 23/30, 2002. Additional information

A physician involved in a medical malpractice case dating back to work he did 40 years ago died before he could see a federal appeals court clear his name.

In an unusual lawsuit, William H. Sweet, MD, one of the world's top neurosurgeons in his day, was taken to court at age 89. After a 1999 trial, the jury found that clinical trials he conducted in 1960 and 1961, in an effort to find a way to treat the most deadly form of brain tumors, hastened the deaths of two patients.

Dr. Sweet died shortly after his trial, which he had been unable to attend because of Parkinson's disease. But his family and colleagues got good news in August when the 1st U.S. Circuit Court of Appeals cleared him and Massachusetts General Hospital of any wrongdoing and overturned an $830,000 award against both.

"I am impressed by what Dr. Sweet did during the course of his lifetime," Joseph L. Doherty Jr., the attorney who represented Mass General, said in an interview. "He didn't deserve this lawsuit. I wish he were alive. To the extent that his reputation had been tarnished, it has been totally vindicated with this opinion."

"I am very, very pleased by the way in which this decision vindicates Dr. Sweet, Mass General Hospital and MIT," added Dr. Sweet's wife, Elizabeth Dutton Sweet, in a separate interview. Mrs. Sweet attended every day of the trial.

An attorney for the patients' families did not return phone calls. While they still have two avenues of appeal, experts say a successful court challenge is considered unlikely.

The lawsuit came as a surprise to the doctors, chemists and others involved in 1960 and 1961 with Dr. Sweet and his team's Boron Neutron Capture Therapy studies, which were designed to find a way to treat glioblastoma multiforme. That work emerged from clinical trials Dr. Sweet did in the early 1950s, with 10 patients.

The theory in the early 1960s was that a compound with boron-10 injected into the bloodstream supplying the brain would be absorbed by the tumor tissue but not normal tissue, court records said. Doctors then would expose the tumor to a neutron beam produced by a nuclear reactor. When the beam interacted with the boron-10, it would produce a fission reaction and destroy the tumor tissue while largely leaving healthy tissue untouched.

The government and several review boards gave the go-ahead for the clinical trials. In all, 19 patients participated in 1960 and 1961. According to court documents, papers that Dr. Sweet and his team published after the trials concluded that the treatment failed for four main reasons, including the lack of appreciation of the full complexity and requirements of our biological system with regard to the boron-10 compound and insufficient information about how to optimize the shape of the neutron beam.

In 1995, after the government released a report about various radiation experiments conducted during the mid-1900s, the families of several patients filed a malpractice lawsuit against Dr. Sweet, Mass General, MIT and the government, claiming that the patients didn't give their informed consent and accusing the physician and institutions of fraud, negligent misrepresentation, negligence and wrongful death.

By the time the case went to trial it involved the families of two patients -- George Heinrich and Eileen Rose Sienkewicz.

Heinrich underwent the BNCT treatment in January 1961 and showed slight improvement, before dying in May -- seven months after his brain tumor diagnosis.

Sienkewicz underwent treatment in November 1960, improved for a few months, but then died in October of 1961 -- 16 months after her diagnosis.

At the time, expected survival was measured in months for brain tumor patients, according to court filings.

At the end of a 15-day trial, the court dismissed the fraud and negligent misrepresentation claims. A jury then cleared MIT on all counts and found that Dr. Sweet and Mass General did have informed consent from Heinrich and Sienkewicz for their participation in the trials. But the jury found that Dr. Sweet and Mass General had been negligent and were involved in the wrongful deaths of Heinrich and Sienkewicz.

Judge William G. Young of the U.S. District Court for the District of Massachusetts upheld the jury's verdict after Dr. Sweet and Mass General filed a motion for a new trial. The judge did, however, slash an $8 million jury verdict down to $830,000.

But the 1st U.S. Circuit Court of Appeals saw things differently when it studied the evidence upon appeal.

Unanswered questions

The Heinrich v. Sweet trial raised a number of interesting questions. For example, should a medical malpractice case be allowed to go forward 40 years later, when most of the physicians and scientists closest to the case aren't available to testify?

But the appeals court stuck closely to the issue at hand and based its opinion solely on whether medical malpractice occurred in 1960 and 1961. It concluded that the evidence just was not there.

"What the 1st Circuit did was apply existing case law," said James B. Re, the attorney who represented Dr. Sweet's estate. "For medical malpractice to exist, you have to find that the level of treatment that should have been rendered wasn't."

The court said there was no evidence that the treatments hastened the patients' deaths. Expert witnesses at the trial depended on research that happened after the 1960-61 clinical trials and did not focus on what was known at the time of the trials, the court said. It also noted that in a paper published in 1972, Dr. Sweet and his colleagues said the patients' survival time was roughly the same as survival time for those who were treated conventionally.

"The court said you can't say that a doctor did something wrong without any proof," said Pamela P. Heacock, one of the attorneys who wrote a friend-of-the court brief that the American Medical Association, Massachusetts Medical Society and the American College of Surgeons filed on behalf of Dr. Sweet.

Procedures for activities -- including informed consent -- that precede clinical trials have changed in the past 40 years and now require more documentation. But some feared that if the jury's decision had been upheld, it could have made researchers more reluctant to try new treatments. The court specifically addressed that.

"There would surely be a chilling effect on research in the medical field and deterrence of important progress in medical treatments if doctors and scientists could not frankly assess the successes and failures of their studies in published academic articles so that others can build on their work and learn from it," the court said.

Dr. Sweet's widow was thrilled to see the court make that connection.

"I have always felt this case was more about the validation of clinical trials, and it is really quite wonderful that the court has recognized the importance of clinical trails when they are properly designed," she said.

Albert Soloway, PhD, who was the principal chemist during the trials, agreed.

"Dr. Sweet was a very ethical person," Dr. Soloway said. "He felt there was absolutely nothing else they could do for the patients being treated. He felt this offered them something. Had the decision gone the other way, it could have had a very chilling effect on clinical research."

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Evelyn Heinrich, on behalf of her husband George Heinrich et al. v. Elizabeth Dutton Sweet and Frederick H. Grein Jr., representatives of the Estate of William H. Sweet MD, et al.

Venue: 1st U.S. Circuit Court of Appeals
At issue: Whether a physician and hospital were negligent and involved in the wrongful death of patients who were part of clinical trials in 1960 and 1961 to treat brain tumors, even though they had the patients' consent. A jury said yes. The appeals court said no.
Potential impact: Some feared that if the jury's decision was upheld, it could have stymied researchers desires to run future clinical trials.

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1960-1961: Boron Neutron Capture Therapy clinical trials involve 19 patients with malignant brain tumors.
1964: Presentation to the American Assn. of Neuropathologists concludes there were four main reasons why BNCT failed, including a lack of appreciation of how the body reacts to the boron compound.
1995: Families of trial patients file a malpractice suit in the U.S. District Court for the Eastern District of New York after release of a government study on radiation trials conducted in the 1940s and '50s.
1997: The case, now restricted to two families, is transferred to the U.S. District Court for the District of Massachusetts.
1999: A jury finds the physician and hospital had informed consent for the trial, but also finds that they were negligent and hastened the patients' deaths. Jury awards $8 million to the two patients' families.
2000: A judge for the U.S. District Court for the District of Massachusetts upholds the decision, but lowers the award to $830,000.
2002: The 1st U.S. Circuit Court of Appeals concludes there was no malpractice. It rules that the physician and hospital were not negligent and did not hasten the deaths. It throws out the judgment.

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Copyright 2002 American Medical Association. All rights reserved.