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MADISON - ST. CLAIR RECORD

Thursday, April 25, 2024

Plaintiff in J&J talc trial relied on Canadian report deemed ‘very low quality’ by defense

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BELLEVILLE – St. Clair County jurors, the first to decide an ovarian cancer trial against Johnson & Johnson since Canada issued an assessment of the topic, apparently found it too weak to support claims of decedent Betty Driscoll of Smithton. 

They rendered a defense verdict after Johnson & Johnson counsel Allison Brown closed her argument last week by calling the assessment “very low quality.” 

Brown told jurors that plaintiff expert witness Ellen Smith, author of a report Canada quoted, relied on lawyers to prepare it rather than do her own research. 

Smith told jurors that Johnson & Johnson talc powder causes ovarian cancer, but Canada’s report didn’t come close to such a declaration.

The assessment found the evidence indicative but not definitive. 

It stated that talc “is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.” 

Canada issued the assessment in April, not as original research but as a summary of studies across 50 years. 

The assessment found that from 2003 to 2019, six broad studies of data from 30 narrow studies reported positive association. 

Odds ratios ran from 1.22 to 1.35, with less than one indicating no association. 

Different odds resulted from different criteria for inclusion, the assessment stated, and authors included and excluded studies for various reasons. 

It stated that the odds showed “small strength of association,” and found them modest but similar and unlikely to be random. 

It found the odds shrank to 1.08 among 250,000 women in four cohorts that provided annual health reports for research. 

That number didn’t qualify as statistically significant. 

The assessment stated, “However, the study authors recognized that the study may have been underpowered to detect a small increase in risk.” 

It stated that cohorts, even when pooled, “may not be sufficiently powered.” 

“Cohort studies are less desirable than case control studies for rare diseases because case control studies can generate a much larger number of cases,” it stated.

It devoted a section to possible routes for powder migration, which authors have found plausible since 1971. 

The last study on that topic attributed migration to inflammation. 

“It has been suggested that talc particles need not reach the ovaries but only need to reach the lower genital tract, where they could trigger changes such as the production of heat shock proteins or decreased levels of antibodies that could contribute to ovarian cancer,” the assessment stated. 

Although some authors divided studies into tumor types with different features, signatures, and trajectories, the assessment made no division. 

It stated that there was little consistency in treatment of subgroups, “leaving the analyses limited and likely underpowered (small sample size).”  

Under a heading of other elements for consideration, the assessment listed bias, chance, error and confusion. 

“There are many unknowns with respect to the causes of ovarian cancer, making it difficult to account for all confounders,” it stated. 

“It is possible that one or more confounders exist and may be at play in the epidemiological studies for perineal talc use that have not yet been recognized as such. 

“Recall bias occurs when individuals in a study tend to have a more vested interest and over report the retrospective exposure.” 

It found an author set an 18 percent buffer to account for recall bias, but it could not be substantiated whether the buffer was reasonable. 

“Recall bias can also be influenced by increased media attention,” it stated. 

“Although there are uncertainties related to bias, there is confidence in the robustness of the available database for use in characterizing ovarian cancer risk attributed to talc exposure. 

“Furthermore, the available data are indicative of a causal relationship.” 

At trial, expert witness Smith testified that powder would have to be applied five to ten thousand times in order to cause ovarian cancer. 

Johnson & Johnson counsel Michael Brown repeated that in closing argument. 

He said the suit alleged that Driscoll used it every day for seven years, even though defense counsel said they failed to prove she used it all. 

Michael Brown explained that every day for seven years comes out to just over 2,500 applications, which doesn’t meet the threshold Smith provided. 

He said no U.S. agencies list talc as a cause for ovarian cancer. 

He said plaintiffs had to use the Canadian assessment because they couldn’t find any U.S. reports supporting their claims. 

He told jurors not to trust it as good science. 

His colleague Allison Brown pressed harder, telling jurors that Smith was a friend of a lawyer for the estate. 

“She just said whatever the lawyers gave her,” Brown said. 

Brown’s power point display showed a windup doll. 

She said Canada cited Smith’s report and Smith didn’t know it. 

“That’s not science,” Brown said. 

She said no independent government study in the U.S. associated Johnson & Johnson talc powder with ovarian cancer.

The last federal examination of talc followed a petition drive for a warning in 2014. 

The Food and Drug Administration reviewed evidence and didn’t find it conclusive. 

The agency stated that a growing body of evidence was difficult to dismiss but didn’t require a definitive warning. 

In 2019, the National Cancer Institute stated that the weight of evidence did not support an association.

Plaintiff attorney John Driscoll, nephew of the deceased, filed the complaint in association with former chief circuit judge John Baricevic and son C.J. Baricevic.

Attorneys from Beasley Allen in Montgomery, Ala. argued the case for the plaintiff at trial.

Driscoll’s estate asked for an award of up to $50 million. Jurors entered a verdict for Johnson & Johnson on July 30.

Circuit Judge Christopher Kolker presided.

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