SHAKING THE SCIENCE BOX. CORCORAN,
On May 2, Quebec Superior Court Judge André Prévost authorized a class-action suit against two Big Pharma corporations on behalf of women who claim Johnson & Johnson Baby Powder and Valeant’s Shower to Shower products caused their ovarian cancer. Similar actions have been filed in Ontario and British Columbia, bringing Canada into the ambit of a U.S. legal stampede to turn the ambiguities of science into a cash machine.
More than 9,000 talcum-powder lawsuits have been filed in the U.S. against Johnson & Johnson, some producing multi-million-dollar awards to plaintiffs. Whether the Quebec suit ever makes it to trial will be determined later this year after the corporate appeal against the certification is heard.
If a trial is held, it will be another test of the dubious legal business of using the science of epidemiology to shake down deep-pocketed corporations. In law, ultimately, the talcum-powder cases are not about corporate responsibility or talcum powder. It’s the science that’s really on trial.
In the jury trial of a California talcum case, the court awarded US$70 million in damages and US$340 million in punitive damages against Johnson & Johnson. But a state Supreme Court appeal quashed the verdict on grounds that the science is flawed and inconclusive.
In a toughly worded decision ordering a new trial, Judge Maren Nelson said that after reviewing all of the evidence “in the light most favorable to” the woman making the claim, “the best that can be said is that there was (and is) an on-going debate in the scientific and medical community about whether talc more probably than not causes ovarian cancer.”
In her review of the science, Nelson rehashed the history and inconclusiveness of the talc-epidemiology science, going back to the work of the International Agency for Research on Cancer. She explored the weaknesses in the science case against talcum powder as presented by the plaintiff ’s lawyers. They had said, for example, that talc-based powders cause 10 per cent of U.S. ovarian cancer cases. Nelson said this is a “misreading” of the epidemiological evidence, which actually concluded that 10 per cent would be accurate “if a cause association” existed.
Canadian judicial conclusions on epidemiology evidence deployed in cases against corporations have been equally tough. A Saskatchewan judge recently declined to certify a class action against Bayer Inc. that had alleged its Essure birthcontrol device caused various adverse reactions, including unreasonable risk of bleeding and bloating. To proceed, said the judge, a class action needs sufficient evidence to establish “some basis in fact” beyond epidemiology to support the allegations. “It is not sufficient for purported expert witness affiants to arrive at opinions, outside their particular fields of expertise, that are based substantially on the review of literature published by those who do possess the necessary expertise.”
Generally, the experience of Canadian plaintiffs’ attempting class actions based on epidemiological evidence has been dismal. Michel Gagné, a partner with McCarthy Tétrault in Montreal, said the reason is simple. “The success rate is not all that great because of the limitations of this type of science,” he said in an interview. Epidemiological evidence is complex, not very clear in its conclusions, often hypothetical. “Very few go to trial on the merits,” said Gagné, in part because the epidemiological evidence produces conflicting results that fly in the face of a court’s usual obligation to reach some minimum level of assurance of some kind of cause and effect.
André Durocher, perhaps Canada’s leading expert on class actions and author of a new book, Environmental Class Action in Canada, adds that “scientific evidence and legal standards of proof are not the same. What is satisfactory evidence for a judge is not the same as what is satisfactory evidence for a group of scientists.” Or vice versa, one might add.
In his book, a 1,104-page review of the history of class actions, Durocher explores the famous attempt — through five different court actions — to extract a verdict against Dow Chemical over the application of the herbicide Agent Orange, which plaintiffs claimed caused various illnesses. The cases, filed in four provinces beginning in 2005, all failed, in part because the science failed. Epidemiology — which uses statistics and correlations to link a substance or factor with an adverse effect — wasn’t good enough. As Durocher reports, epidemiology failed because it could not prove Agent Orange was capable of causing the alleged reactions, nor was there evidence that the individuals suffering symptoms had been exposed to a dose of sufficient magnitude.
The biggest class-action science-trial decision in Canadian history is the 2015 decision by Quebec Superior Court Judge Brian Riordan to award $15 billion in damages against Canada’s major tobacco companies. Behind the judgment, however, stands a curious assessment of the science: “We identify with the challenge faced by most judges forced to wade into controversial scientific waters, a challenge whose difficulty is multiplied when the experts disagree,” said Riordan. He decided that “for tobacco cases, adequate proof of causation with respect to each member of a class can be made through epidemiological evidence. The previous jurisprudence calling for proof that each member suffered a similar prejudice is overridden.” No individual smokers testified. It was all done on the basis of expert scientific evidence.
In the end, said the judge, he opted to “shake the box in every direction” and apply the words of former Supreme Court Justice Ian Binnie, who wrote in 2006: “The judge may not have the luxury of waiting until scientists in the relevant field have reached a consensus. The court is a dispute resolution forum, not a freewheeling scientific inquiry, and the judge must reach a timely decision based on the information available. Even if science has not figured it out yet, the law cannot wait.”
Riordan said he “cannot wait.” He shook the box. But is that good law? The tobacco case is currently being appealed.