Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, December 10, 2013

Experts’ reliance on novel science to establish link between denture cream and neurological injuries rejected

By Pamela C. Maloney, J.D.

Expert testimony offered on behalf of a consumer who developed neurological disorders allegedly as a result of his use of denture cream was based on novel science and lacked proper foundation, the Pennsylvania Superior Court ruled in a non-precedential decision. Therefore, the trial court did not abuse its discretion in striking the report and testimony of the consumer’s general causation experts (Jacoby v. Rite Aid Corp.December 9, 2013, Lazarus, A.).

Background. A consumer, Mark Jacoby, began using the denture cream, Fixodent, in 1992. According to his statement of facts, Jacoby used the product twice daily from 1992 until 1995. In 1995, when he began working at a chemical plant, he increased his use of the denture cream to approximately seven times a day. In 1998 he began experiencing tingling and numbness in his extremities. These conditions worsened until late 2000 when he stopped working at the plant. Jacoby, who was diagnosed with severe myeloneuropathy, brought negligence, strict liability design defect, strict liability failure to warn, breach of implied warranties, and gross negligence claims against Proctor & Gamble, the manufacturer of the denture cream, and Rite Aid, the retail seller. His claims were based on allegations that use of the denture cream caused excessive amounts of zinc to be absorbed in the body’s tissues, which, in turn, resulted in the depletion of the body’s copper levels. The copper depletion led to the development of a host of neurological symptoms and injuries including myeloneuropathy. Following a Frye hearing, the trial court excluded the reports and testimony of the consumer’s experts. Subsequently, the trial court granted summary judgment to the manufacturer and retailer on the basis that the consumer failed to produce admissible evidence of causation. The consumer challenged the trial court’s exclusion of his expert witnesses.

Expert testimony. The primary basis for the consumer’s objection was the trial court’s error in concluding that zinc-induced copper deficiency myeloneuropathy was novel science and in evaluating the scientific evidence underlying his general causation experts’ opinions after finding that their methodologies were generally accepted. The consumer also claimed that the trial court erred in substituting its own limited analysis of the scientific evidence for that of his general causation experts.

In upholding the trial court’s determination that the experts’ opinions were based on novel science, the superior court noted that scientists legitimately dispute the notion that the denture cream could cause myeloneuropathy and that the opinion of the consumer’s experts that the product could cause a neurological injury was relatively new. In addition, because the methodologies employed by these experts—weight of the evidence, totality of the evidence, and the Naranjo scale (adverse reaction probability scale) used in a non-clinical context—had not been specifically addressed by Pennsylvania courts, the court was required to examine these methodologies. The consumer could not evade a Frye inquiry by merely making reference to accepted methods in the abstract. The superior court cited a prior decision in which the court had explained that the weight of the evidence and totality of the evidence were not scientific methodologies because they were not verifiable or replicable. Instead, they were based on subjective judgment. In this case, the experts relying on these methodologies did not define their approach, and they did not define which forms of evidence they considered, nor did they engage in any systematic weighing of factors.

As a result, the experts’ theories contained large analytical gaps, upon which the trial court focused its analysis. Those gaps included (1) that there was no basis on which to opine that the amount of zinc absorbed into the body from the denture cream could result in a copper deficiency; and (2) that there was a lack of evidence regarding how low a person’s copper must be or for how long a duration before it potentially could result in myeloneuropathy. The only materials relating to the development of neurological problems consisted of anecdotal case reports and case series, which failed to provide a proper foundation for extrapolation by the experts. Therefore, the trial court did not abuse its discretion in determining that the consumer’s experts lacked a sound foundation from which to extrapolate that the denture cream could cause neurological injuries.

The case number is 1508 EDA 2012.

Attorneys: Thomas Richard Anapol (Anapol Schwartz) for Mark A. Jacoby. Howard D. Scher (Buchanan Ingersoll & Rooney, PC) for Rite Aid Corp. and The Procter & Gamble Co.

Companies: Rite Aid Corp. and The Procter & Gamble Co.

MainStory: TopStory ExpertEvidenceNews HouseholdProductsNews PennsylvaniaNews

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.