A plaintiff who alleges his use of the dental adhesive cream Fixodent caused his neurological dysfunction is appealing a Philadelphia judge’s decision rejecting his expert witnesses.
Philadelphia Court of Common Pleas Judge Sandra Mazer Moss struck the reports and testimony of three plaintiffs experts in an opinion in April. Defendants Procter & Gamble Manufacturing Co., Procter & Gamble Distributing and Rite Aid Corp. made the motion. There are 196 cases pending in the First Judicial District’s denture adhesive cream program, according to Stanley M. Thompson, director of the court’s Complex Litigation Center.
Dr. Martyn T. Smith, Dr. Frederick K. Askari and Dr. Ebbing Lautenbach opined the zinc in Fixodent can cause copper-deficiency myeloneuropathy, a metabolic disease of the spinal cord arising from a low level of copper in the human body, because excessive zinc in the blood can make some people copper-deficient, Moss said.
Moss said that the experts did not meet the Frye standard, which requires novel scientific testimony to gain general acceptance.
Among other reasons, Moss said she was striking the experts because they cannot “identify the incidence of copper-deficiency myeloneuropathy among denture cream users. There are no epidemiological studies observing the occurrence of copper-deficiency myeloneuropathy among Fixodent users … the leading researcher of copper-deficiency myeloneuropathy, on whom plaintiff’s experts rely, recognizes often the cause of copper deficiency is unclear. Reviewing 55 case reports of copper-deficiency myelopathy, [the researcher] found an identified cause in 20 percent.”
While one study showed that patients who have Wilson disease, an inherited disorder in which people have too much copper in their bodily tissues, had deficient copper after taking 25-milligram doses of zinc acetate within 30 days, “there is an analytical gap between the proposition a 30-day, 25-milligram zinc acetate dose may place a particular person into temporary negative copper balance and the proposition some people who ingest zinc-containing Fixodent will be placed into a negative copper balance. The zinc in Fixodent is in the form of hydrated gantrez calcium-zinc salt. Unlike zinc acetate, this zinc salt can only become bio-available (capable of being absorbed by the body) if it dissociates from the Gantrez salt in Fixodent.”
Moss also said the only direct evidence linking the usage of denture cream to copper-deficiency myeloneuropathy are patient-specific case reports.
Moss said a “‘weight of the evidence methodology’” to demonstrate causation when no existing study is conclusive could not be used in this case because the underlying information provided by the plaintiffs’ experts was “unsound.”
Moss also rejected a “‘totality of evidence’” approach used by one of the experts, who said he used extrapolation to opine Fixodent is capable of causing zinc-induced copper deficiency and neurological injuries.
Moss also rejected the application of the Naranjo Adverse Drug Reaction Probability Scale — which classifies the probability an adverse event is related to drug exposure — to the case reports.
Plaintiffs counsel, Eric T. Chaffin of Chaffin Luhana in New York, said that “rather than evaluating the methodology that was applied by the experts … the court substituted its judgment for the judgment of the experts.”
Moss also did not consider more than 20 medical textbooks that state that dental adhesives can cause myeloneuropathy and that another maker of a dental adhesive with zinc, GlaxoSmithKline, withdrew its product from the marketplace, Chaffin said.
The opinion overlooked “material issues regarding the science … that resulted in an abuse of discretion, which is the appellate standard,” Chaffin said.
Plaintiff Mark A. Jacoby used Fixodent starting in 1992, and because of his myeloneuropathy he has to use a walker or electric wheelchair and has difficulty manipulating handheld objects, Moss said.
Moss also said in her opinion that she found persuasive the ruling of U.S. District Judge Cecilia Altonaga of the Southern District of Florida, who is presiding over the federal denture cream multidistrict litigation, in which the federal judge rejected the same body of evidence under the Daubert standard.
The issue of the experts in the MDL was remanded to the U.S. Court of Appeals for the Fifth Circuit because the appeals court said it could not determine the order was a final order, according to Howard D. Scher, the defendants’ counsel from Buchanan Ingersoll & Rooney.
Jacoby v. Rite Aid is the first dental adhesive cream case in Pennsylvania to have the issue of the experts and causation decided, Chaffin said.
Scher said that, in order to prove causation, an expert in the area of zinc allegedly causing neurological problems would need to answer whether zinc was in Fixodent; how zinc got into the plaintiff’s body; how the zinc, once in the body, affected the plaintiff’s copper levels; and how the copper levels affected the plaintiff’s nerves.
Rite Aid, which is headquartered in Pennsylvania, was added to the case to defeat diversity jurisdiction, Scher said.
During the annual meeting of the Philadelphia Association of Defense Counsel, Moss said it took her “a month of study to actually understand the medicine” in the Jacoby case.
Moss also suggested that the defense lawyers look at the Jacoby case when arguing a Frye motion.
Thomas R. Anapol of Anapol Schwartz is also the plaintiffs’ counsel.
(Copies of the 15-page opinion in Jacoby v. Rite Aid, PICS No. 11-4539, are available from The Legal Intelligencer. Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information.) •