Metropolitan News-Enterprise


Monday, April 7, 2014


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Ninth Circuit: Judge Exceeded ‘Gatekeeper’ Function By Excluding Witness in Zometa Case


By a MetNews Staff Writer


A federal district court judge abused her discretion when she ruled that an expert’s inability to identify a specific cause of the plaintiff’s injury rendered his testimony irrelevant, unreliable and inadmissible, the Ninth U.S. Circuit Court of Appeals ruled Friday.

“While the district court must act as a gatekeeper to exclude ‘junk science’ under Daubert [v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993)] Federal Rule of Evidence 702(a) includes within its scope all evidence that would ‘help the trier of fact . . . to determine a fact in issue,’” Judge Ronald Gould wrote for the panel. “A doctor using a differential diagnosis grounded in significant clinical experience and examination of medical records and literature can certainly aid the trier of fact and cannot be considered to be offering ‘junk science.’”

The court overturned a summary judgment in favor of Novartis Pharmaceuticals Corp. in a products liability suit by Linda Messick. The panel held that Senior U.S. District Judge Susan Illston of the Northern District of California should have considered the testimony of oral surgeon Richard Jackson, and that the testimony established a triable issue of fact on the issue of causation.

Messick’s case is one of several around the country claiming damages resulting from use of the bisphosphonate Zometa, which she took to combat osteoporosis after chemotherapy. Messick claims the drug destroyed her jaw.

Jackson opined that there is a link between Messick’s jawbone damage, known as osteonecrosis of the jaw or ONJ, and bisphosphonate-related osteonecrosis of the jaw, or BRONJ, but Ilston found that his “differential diagnosis only determines that Ms. Messick’s ONJ is related to her bisphosphonate use, and he admits that a diagnosis of BRONJ does not mean that bisphosphonates caused her ONJ.” Gould said Illston “applied too high a relevancy bar.”

“While Dr. Jackson never explicitly stated that Messick’s bisphosphonate use caused her BRONJ, he did say it was at least a substantial factor in her development of BRONJ,” Gould said. “Specifically, Dr. Jackson equated Messick’s use of bisphosphonates leading to BRONJ with the oxygen necessary to start a fire. Although one might imagine more targeted testimony, Dr. Jackson’s testimony indicates that Messick’s bisphosphonate use was a substantial factor in her development of BRONJ, so his testimony is relevant.”

Illston further erred in excluding for lack of a “scientific basis” Jackson’s opinion that it was unlikely for a patient who had not been exposed to radiation to develop a serious case of ONJ without taking bisphosphonates, Gould said.

“Medicine partakes of art as well as science, and there is nothing wrong with a doctor relying on extensive clinical experience when making a differential diagnosis,” he said.

The judge cited a 2009 position paper of the American Association of Oral and Maxillofacial Surgeons, which said “the current level of evidence does not fully support a cause-and-effect relationship between bisphosphonate exposure and necrosis of the jaws,” but that while “causality might never be proven, emerging experimental and epidemiologic studies have established a firm foundation for a strong association between monthly IV bisphosphonate therapy and the development of BRONJ.”

Gould wrote:

“Because of that inherent uncertainty, we do not require that an expert be able to identify the sole cause of a medical condition in order for his or her testimony to be reliable. It is enough that a medical condition be a substantial causative factor.”

Senior Judge Raymond Fisher and Judge Morgan Christen joined in the opinion.

The case is Messick v. Novartis Pharmaceuticals Corp., 13-15433.


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