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From Products Liability Law Daily, September 12, 2014

Fixodent user could not prove it caused her neurological problems without experts

By John W. Scanlan, J.D.

A regular user of Fixodent could not prove without expert testimony that her copper-deficiency myelopathy (CDM) was caused by her use of the denture adhesive over eight years, the U.S. Court of Appeals for the Eleventh Circuit held in upholding a district court’s grant of summary judgment to Procter & Gamble (P&G) and her strict liability, negligence, and other state law claims against the company (Chapman v. Procter & Gamble Distributing, LLC, September 11, 2014, Fay, P.).

Background. Marianne Chapman began developing a number of neurological symptoms in 2006 and was eventually diagnosed with myelopathy, a condition that affects the upper and lower extremities. She had been using two to four 68-gram tubes of P&G’s Fixodent denture adhesive each week for eight years. Fixodent had been reformulated in 1990 to include a calcium-zinc compound; after a case report issued in 2008 hypothesized that zinc in denture adhesives can lead to copper deficiency, which can cause neurologic injuries, hundreds of lawsuits were filed against P&G, as well as GlaxoSmithKline, the manufacturer of Poligrip, a similar product.

She and her husband David filed suit against P&G in Florida state court in 2009, alleging claims for strict liability, negligence, and other state law claims, along with her husband’s claim for loss of consortium. After P&G removed the case to federal court, the Southern District of Florida handled certain pretrial proceedings for it as part of multi-district litigation, but the Chapman case remained in that court after other cases were remanded to their respective districts.

The Chapmans sought to introduce the testimony of four expert witnesses: Dr. George J. Brewer, Dr. Joseph R. Landolph, and Dr. Ebbing Lautenbach, who would testify that Fixodent was capable of causing myelopathy, and Dr. Steven A. Greenberg, who would testify that Chapman’s illness was caused by her use of Fixodent. The district court granted P&G’s motion to exclude the testimony of these experts. The parties stipulated to a final judgment to have this Daubertorder addressed on appeal, but the Eleventh Circuit determined it lacked jurisdiction because the Chapmans were not adverse to the judgment. After the district court vacated the final judgment, it found that the Chapmans could not use Marianne Chapman’s treating physicians as experts at trial to testify on specific or general causation because none of them had been designated as experts. It therefore granted P&G’s motion for summary judgment. The Chapmans appealed.

General causation. The Eleventh Circuit upheld the district court’s finding that while the three experts on general causation had sufficient credentials, their methodologies were not sufficiently reliable and would not assist the trier of fact. The district court determined that none of the experts nor the articles upon which they relied determined the amount of Fixodent that must be used or for what period of time in order to increase the risk of a copper deficiency and for how long a copper deficiency would have to persist to cause the increased risk of developing a myelopathy. In addition, they had no epidemiological evidence on which to base their causation opinions. Finally, they admitted they did not know the background risk of copper deficiency myelopathy. The Eleventh Circuit stated that it had recognized these methodologies as indispensable to proving the effect of an ingested substance. Because they could not prove general causation using the primary methodologies of dose-response, epidemiological evidence, and background risk, their use of secondary methodologies, including “plausible explanations, generalized case reports, hypotheses, and animal studies,” was insufficient to do so and could mislead the jury.

Specific causation. The district court’s finding that Dr. Greenberg’s differential diagnosis methodology was not reliable as a matter of law was also upheld by the Eleventh Circuit. She was not professionally diagnosed with CDM until Dr. Greenberg examined her as part of the course of litigation as the specific causation expert. She had neurological ailments both before and after her use of Fixodent, and he failed to fully explore other potential causes, having identified structural spinal cord injury, multiple sclerosis, and Vitamin B12 deficiency among other possible causes. The district court observed that he also failed to consider other obvious possible causes, including hereditary and acquired conditions known to cause myelopathies, and said that his failure to perform an additional, reasonable test prior to completing his report on her showed a lack of methodological rigor. Instead, Dr. Greenberg pursued his view that copper deficiency caused by zinc was responsible for her symptoms and omitted consideration of idiopathic causes, further placing his methodology in question. The Eleventh Circuit ruled that the district judge had not abused her discretion or committed manifest error by excluding Dr. Greenberg’s expert testimony on specific causation.

Summary judgment/alternative witnesses. Finally, the Eleventh Circuit upheld the district court’s grant of summary judgment to P&G on the ground that the consumer could not provide enough admissible evidence without the testimony of the excluded experts. The consumer asserted that summary judgment based on a lack of expert witnesses was inappropriate because she had proffered the testimony of Dr. Joseph Prohaska, whose testimony P&G had not contested; she could call witnesses and experts from P&G to testify that excessive zinc consumption could cause copper deficiency, which could cause CDM; and the consumer’s treating physicians could testify regarding causation.

The Eleventh Circuit agreed with the district court’s assessment that Dr. Prohaska’s testimony would be irrelevant because his report discussed only hematological disorders, not myelopathy. Furthermore, the consumer could not create a triable issue of fact regarding causation using P&G experts and witnesses: the consumer did not propose using them as experts and witnesses until nearly six months after the deadline to identify expert witnesses, and the consumer could not prove her case with them because the P&G experts had concluded that Fixodent does not cause CDM and other witnesses had not been vetted for reliability. The district court ruled that the treating physicians would be treated as fact witnesses and not experts; because the consumer did not brief on appeal her argument that they should testify as experts, the appellate court deemed this argument abandoned. As none of the alternative possible expert witnesses could provide admissible evidence, summary judgment was appropriate.

The case number is 12-14502.

Attorneys: David Charles Frederick (Kellogg Huber Hansen Todd Evans & Figel, PLLC) for Marianne Chapman. Christopher R.J. Pace (Jones Day), Mary-Jo Pullen (Dinsmore & Shohl, LLP), and Edward Soto (Weil Gotshal & Manges, LLP) for The Procter & Gamble Distributing, LLC, and The Procter & Gamble Manufacturing Co.

Companies: The Procter & Gamble Distributing, LLC; The Procter & Gamble Manufacturing Co.

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