New York appeals court allows single-case evidence
■ Doctors say the decision opens the door for "junk science."
By Amy Lynn Sorrel — Posted May 1, 2006
If a New York appeals court ruling that loosened rules for expert witness testimony allowed in medical liability cases stands, physicians say it will open the gate for unreliable scientific evidence to enter the courtroom.
In a unanimous opinion, the Appellate Division of the Supreme Court, the state's intermediate level, said experts did not need to show peer-reviewed medical literature to prove that their medical opinion was accepted in the scientific community. Judges found that a lower court applied the testimony rule "too restrictively" when it wouldn't allow the testimony and dismissed the case.
Physicians say the appeals court ruling defies state precedent upholding rigorous scrutiny of what testimony is permitted to be heard by jurors. If the courts don't adhere to the standard, physicians say, ripple effects could cause meritless lawsuits to enter the legal system.
Lawyers for the physician in the case are asking the appeals court to reconsider. If that doesn't happen, they will ask the state's high court to overturn the ruling. The medical community has weighed in on the physician's side, with doctors and a pharmaceutical company fearing that the ruling would be used as an example for other courts to relax the rule if it's not reversed.
"There should be a high standard, and it's up to the courts to make sure that any medical theory being [presented] actually has the support of the profession," said Donald Moy, general counsel to the Medical Society of the State of New York, which filed a friend-of-the-court brief with the American Medical Association and Pfizer. The company didn't manufacture the drug in the lawsuit but does not want to see a precedent set.
Allowing only peer-reviewed literature is critical, Moy explained, because it is often difficult for a jury to differentiate between credible science and "junk science."
Mary Beth Ott, who represents the plaintiff, said the appeals court ruling is correct, "and that's the law as it stands now." Ott declined to comment further, citing the pending litigation.
Did a drug trigger a disease?
The case, Zito v. Zabarsky, stems from a November 2003 trial court hearing to screen expert witness testimony. New York courts require the testimony with the plaintiff's filing of a medical liability case to determine the validity of claims made. Judges follow the Frye standard, derived from a 1923 federal ruling that established that novel scientific evidence presented in court must "have gained general acceptance" in the relevant scientific community.
Pamela Zito sued Queens internist Gary Zabarsky, MD, alleging that he had prescribed her an "excessive" dose of the cholesterol drug, Zocor (simvastatin), which caused her to develop an autoimmune disease, court records show. Dr. Zabarsky denies the allegations.
The physician first prescribed 20 mg of another statin drug, Pravachol (pravastatin), to Zito, which he later increased to 40 mg. He then changed Zito's prescription to 80 mg of Zocor, the highest recommended daily dose. Shortly after taking the medication, Zito was diagnosed with polymyositis.
Zito's experts, a pharmacologist and an internist, conceded that there were no studies that linked polymyositis to the Zocor therapy, according to court records. But they presented a single report in a May 1997 article from the medical journal The Lancet of a patient who had developed polymyositis after taking a generic form of Zocor.
Zito's experts explained that she developed a well-known side effect of the drug, a muscle condition called myopathy, which could have triggered the release of an antibody associated with polymyositis. As a general principle, the experts further said, the bigger the dosage of a drug, the bigger the effect it will have on a patient, court records show.
The trial court dismissed the case, finding that the experts did not include any peer-reviewed medical literature to support the theory.
The appeals court reversed that decision. Although the judges agreed the medical opinion was "novel," they determined that the "dose/response" principle and the other evidence was sufficient to support Zito's claims.
The trial court "apparently believed that the Frye test could only be satisfied with medical texts, studies or other literature which supported the plaintiff's theory of causation under circumstances virtually identical to those of the plaintiff. However, the Frye test is not that exacting," Judge Daniel F. Luciano wrote.
The appeals court also expressed concern that under a strict interpretation of the standard, "first users of a new drug" would not be able to sue if they were injured.
Dr. Zabarsky appealed the decision. His attorney, Daniel Doman, said experts did not prove the dosage of Zocor had any link to polymyositis.
The groups' brief argues that the court's rationale suggests a new interpretation of the Frye standard that ignores its purpose.
The panel "misapplied" the standard "by admitting a principle of general causation that lacks any support (beyond a single, unreliable case report based on materially different facts), much less general acceptance, in the scientific community," the medical groups' brief states.
It cites sources doctors typically rely on for proof, such as reports endorsed by the U.S. Food and Drug Administration, including the agency's labeling, which does not list polymyositis as a possible Zocor side effect.
The brief also argues that Zito's experts failed to rule out other possible causes for the woman's condition.
Under the Frye standard, New York case law has held peer-reviewed medical literature as a sign of general acceptance and has consistently warned against using the legal system to test new scientific debates such as with pharmaceuticals, the brief says.
If the contradictory ruling is allowed to stand, "it will have a negative impact on public health that could extend far beyond this case," the brief states.
The danger of the ruling, Moy said, is that it will exacerbate concern that trial courts already fail to keep unsupported theories out of the courtroom. Judges are expected to be the gatekeepers of the evidence, "but here you have an appellate court, as a matter of precedent, saying we don't have to be that tough."
If other courts follow suit, Moy said, "the standard is weakened, and we will go down a path of enabling litigation of questionable theory to be brought forward."