The First Amendment Clashes with Commerce: Can We Muzzle Bad Science if it Strangles Business?

Johnson’s Baby Powder once conjured cooing babies, satiny-smooth skin, and wholesome purity. But claims the talc was contaminated with asbestos invoked the fear of cancer, leading to thousands of personal injury suits and millions of dollars in damages, which relied on expert testimony for support. Denying any causal connection, J&J’s spin-off declared bankruptcy but now is fighting back – suing doctors whose “research” shored up the awards. While J&J has a right to protect its product brand, don’t doctors have the right to free speech?
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“Early lawsuits against the company pointed to talc as a cause of ovarian cancer, though the scientific evidence was not conclusive. In later cases, plaintiffs’ lawyers zeroed in on asbestos contamination as the culprit, saying the carcinogen could cause cancer even in trace amounts.”NY Times

The J&J saga over asbestos in their baby powder began in the 1950s. The scare and the fear that the naturally soft talc was contaminated with a dangerous mineral catapulted the lawsuits – culminating in a $2 billion award in 2020 by a Missouri court to 22 women. Internal documents revealed the company was concerned over potential contamination, but only after the FDA detected asbestos in an online supply of baby powder did J&J remove the powder from American shelves (It still is marketed abroad). J&J’s testing did not detect asbestos in the powder.  

But the mere mention of the A-word (asbestos) beckons plaintiff’s attorneys. Occupational health physicians, acting as expert witnesses, also turned out to be winners, as many, once concerned with high-level workplace exposures, turned their attention to low-level environmental scares, replete with lucrative testifying gigs.

A few weeks ago,  J&J’s spin-off, LTL Management, decided to fight back, launching a 62-page lawsuit against three of its most-potent opponents: Drs. Theresa Swain Emory, Richard Lawrence Kradin, and John Coulter Maddox. The suit, which claimed product defamation and fraud, sought to have these physicians "retract and/or issue a correction" of a study that claimed asbestos-contaminated consumer talc products caused mesothelioma.

In May, a 205-page lawsuit with 67 pages of allegations was filed against Dr. Jacqueline Moline, no stranger to the expert witness stage, not only in asbestos-contaminated talc but other workplace toxins, as well. The suit against Moline alleged that her research was promulgated for personal gain, fame, and self-aggrandizement.  (LTL claims Moline receives between $250,000 and $300,000 per year, about 40% of her total income, in aggregate, over $3 million, for testifying for the plaintiff’s bar). Similarly, that suit sought to have Moline retract and correct a separate article she wrote, claiming talc products could cause mesothelioma.

 Both suits claimed the articles reached false conclusions based on flawed data.

Similar to the suit filed against the American Anesthesiologists Association by a manufacturer whose product was disparaged as costing stratospheric sums but without more efficacy than existing treatment, LTL claims the doctors knowingly disparaged J&J products, a type of defamation of property. In the Anesthesiologist case, the basis for that case was careful research seeking to protect the public purse. In the talc case, the research is claimed to be shoddy, even deceitful, bolstering the plaintiffs’ bar and crashing an industry that provided useful and cost-effective products — the same claim used in different ways.

The basis for the talc cases is the two articles by Moline and the three physicians who studied 33 and 75 patients (aka litigants), respectively, claiming their only asbestos exposure was from talc products. In every case, the patients developed mesothelioma, once thought to be a signal cancer or pathognomic of asbestos exposure, i.e., solely caused by that agent. More recent studies identify other mineral fibers and genetic changes as additional causes.

The physicians concluded that the mesothelioma of the lining of the abdomen, the peritoneum that the litigants suffered, was caused by the allegedly asbestos-contaminated talc they used, raising a correlation to causation.

“We couldn’t find any other source [of exposure] apart from the cosmetic talc.”

“We present 75 additional subjects with malignant mesothelioma, whose only known exposure to asbestos was cosmetic talc.”

Based on their “exhaustive,” “objective,” “unequivocal,” and, of course, non-financially motivated data collection, the authors concluded:

“Exposure to asbestos-contaminated talcum powders can cause mesothelioma. Clinicians should elicit a history of talcum powder usage in all patients presenting with mesothelioma.”

- Dr. Jacqueline Moline

But the correlation was based on false data; in several cases, the plaintiffs were provably exposed to sources of asbestos other than exposure that may have derived from talc. [1]

 The “Gift” that Keeps on Giving

Courts often restrict medical testimony when the causal information comes from litigation data. Such was the case when Dr. Moline was locked out of courtroom testimony by multiple appellate courts, which excluded her opinions that asbestos in talc products caused the claimed mesothelioma.

So, she end-ran the system. Publishing her “study,” based entirely on litigation cases in a medical journal where she served on the editorial board -  her “study” rising to the level of research. Now, not only was she allowed to testify, but 20 other plaintiff experts in 63 different cases were allowed to rely on this “research” in their depositions or testimony. Dr. Kradin and his coauthors submitted the article to the American Journal of Industrial Medicine, where he and Dr. Moline are contributing editors, where it held similar sway.

The Legal Antidote

From a legal perspective, the physicians might be able to defend their position on a general causation basis, although it’s rather far-fetched and tortured: i.e., that:

  • asbestos causes mesothelioma,
  • talc may be contaminated with asbestos
  • therefore, talc products can cause mesothelioma.
  • Indeed, “we found mesothelioma in cases exposed only to talc.”

Prudent and scientifically-astute judges, recognizing the leaps of logic, can reject the testimony on principles of admissibility of scientific evidence (Joiner v. General Electric) or because the plaintiff must also establish specific causation, i.e., that the substance in question not only can but did cause the disease in a particular case.

Proving specific causation requires demonstrating an adequate dose, which requires objective measurements and precision. As one court ruled in excluding Dr. Moline’s testimony, seven minutes of unmeasured daily exposure to talc in a small bathroom won’t do, nor will calling such exposure “excessive .”[2] The court reviewed the literature Dr. Moline cited and found no estimate of causative levels of exposure

Damage to Science

Legally, the expert testimony “assumes a fact not in evidence,” i.e., that all mesothelioma is caused by asbestos. Surely adequate peer review should have disqualified the articles on this basis as well; nothing new was found. But there is more at stake here, what I term the “Selikoff-approach.”

Irving Selikoff, the dean of plaintiff’s medical experts in asbestos litigation, conducted extensive research on asbestos-related diseases and was instrumental in identifying the health risks faced by asbestos workers and those living near asbestos manufacturing plants, revealing a connection between asbestos exposure and mesothelioma. [3] So positive was he that all mesothelioma cases were caused by asbestos exposure that he began every mesothelioma investigation by asking, “When were you exposed to asbestos?” He reported that every patient, save one, had asbestos exposure. But even the lone holdout vindicated herself when suddenly, after two weeks of exhaustive probing, she recanted, recalling that she had used a hair dryer that contained asbestos decades earlier.  Or so Selikoff told conference audiences.

Moline, a co-worker of Selikoff’s, learned her lesson well.

The travesty is that while we witch-hunt solely for asbestos exposures, other culprits might be lurking, ones we might be regulating – if we only looked. This is not a soapbox I stand on for the first time today. I’ve been raising this cudgel since 1986. Indeed, we’ve long known that other mineral fibers like erionite, naturally found in North Dakota, can cause mesothelioma and that genetic factors are also contributory.

Sadly, LTL’s allegations are not that the plaintiff’s mesothelioma came from some cause than asbestos. Instead, their point is to blame some other manufacturer’s asbestos products, highlighting the author’s deception. While undoubtedly true, that’s not a good enough basis to stop Moline from advising doctors to include talc exposure in a mesothelioma case history in a journal article and demand its retraction. It should, however, be good enough to bar her testimony (and that of her three confrere-physicians) on causation in a lawsuit.

 

[1] Determined false in Bell v. Am. Int’l Indus. et al., excoriating” Dr. Moline for “concealment” of information.”

[2] Nemeth v. Whittaker, Clark, & Daniels, Inc. 2022 NY Slip Op 02769 (April 26, 2022).  

[3] “Professor Irving J. Selikoff (1915-1992) was America's foremost medical expert on asbestos-related diseases between the 1960s and early 1990s. He was also well-known to the public for his media appearances on the burgeoning asbestos problem. Yet his reputation has been strikingly mixed. On the one hand, he has been portrayed as a mischief-maker and irresponsible demagogue, who exaggerated the risks of asbestos and so destroyed an industry; on the other, as a pioneer in asbestos epidemiology whose landmark studies of insulation (and other) workers demonstrated the severity of a modern occupational and public health tragedy.”

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