Are lawsuits linking talcum powder to ovarian cancer based on junk science?
Toward the end of the great adventure movie âA High Wind in Jamaica,â a gang of pirates is sentenced to hang for a murder they didnât commit.
âI donât want to die innocent!â a crewman cries out to his captain.
âZac,â replies the captain, âyou must be guilty of something.â
One could cite that line to explain the lawsuits lodged against the giant consumer company Johnson & Johnson by more than a thousand women suffering from ovarian cancer, and their families. They claim their disease was caused by dusting themselves over a lifetime with talc that the company marketed to women under brand names such as Johnsonâs Baby Powder and Shower to Shower and the jingle, âA sprinkle a day helps keep odor away.â
State court juries in St. Louis have hit J&J with awards totaling more than $300 million in actual and punitive damages so far. (The company has said it will appeal.)
Another 2,400 lawsuits are pending around the country. The trial of one brought by Eva Echeverria, a 63-year-old Los Angeles resident, is due to start next week in L.A. County Superior Court. Related lawsuits have been filed by six other Southern California women, and those trials presumably will follow.
The plaintiffs say they trusted that Johnson & Johnson wouldnât market an unsafe product, only to learn after they fell ill that research had established a link between talc and ovarian cancer years earlier, and the company had refused to place a warning label on its packaging.
Yet these cases should raise the same doubts as the other lawsuits, which we aired last year. Put simply, is the science strong enough to support judgments of this magnitude? The answer seems to be no.
Some studies have reported a link between talc and ovarian cancer. But theyâre generally retrospective case control studies. These rely on their subjects to report their past experiences, which could be marred by poor recollection or biased by the desire to pinpoint a cause of disease.
On the other side of the ledger are prospective studies, which select their subjects first and then follow them over a period of years. One such study reported in 2000 by researchers at Harvard was part of the National Nurses Health Study of more than 121,000 women, including 78,630 who said they had used talc. Ovarian cancer eventually struck 307 of them. The study revealed âno overall associationâ between talc use and âepithelial ovarian cancer,â though there was a âmodest elevation in riskâ for one variety of the disease. That variety, invasive serous ovarian cancer, is what Echeverria is suffering from, according to court papers.
âOur results provide little support for any substantial association between perineal talc use and ovarian cancer risk overall,â the researchers reported.
Another prospective study performed by the University of Massachusetts followed 61 ,576 post-menopausal women without a history of cancer for more than 12 years. It found âno associationâ with risk of ovarian cancer.
As I observed in relation to the St. Louis jury awards last year, cases like these present an extraordinary challenge for the American jury system.
The scientific evidence is equivocal. Talcâs role may well be incremental or marginal, swamped by other potential contributing factors such as obesity, genetics and other aspects of the patientsâ medical histories.
Ovarian cancer accounts for only 1.3% of all new cancer cases in the U.S., according to the National Cancer Institute. But it's the eighth most common cancer and the fifth leading cause of cancer-related death among women. Fewer than half of all patients survive five years after diagnosis. Still, pinpointing one factor as a âcauseâ of an individual patientâs disease is no simple matter.
Perhaps most important, the verdicts may reflect the decline of scienceâs reputation for objectivity. Some studies on the link between talc and ovarian cancer, pro and con, have financial ties to one side or another. The author of an influential paper asserting the connection has been a paid consultant for plaintiffs; but one of the more comprehensive papers debunking the link was paid for partially by a law firm representing a talc manufacturer. It's unsurprising that the public, and jurors, canât decide who to believe.
So what really underlies these lawsuits? Itâs quite possible that itâs the David-and-Goliath factor: On one side of the courtroom is a plaintiff who is undeniably sick with a terrible disease, or if she has passed away, her survivors. On the other side, Johnson & Johnson, which earned a profit of $16.5 billion last year and doesnât have an entirely spotless record of corporate integrity.
Getting across to a jury the message that Johnson & Johnson may have deliberately suppressed evidence of health risks to sell baby powder shouldnât be beyond the capability of a reasonably experienced trial lawyer. The discovery process in such litigation almost inevitably yields all sorts of seemingly incriminating paperwork: Letters, say, from Alfred Wehner, an epidemiologist working for the talc industry, acknowledging that research exists pointing to a talc-cancer connection.
In 1997, Wehner upbraided a J&J executive for dismissing the research in PR statements. âAnybody who denies this,â Wehner wrote, ârisks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence t o the contrary.â
But Wehner wasnât arguing that thereâs anything to the connection. He was saying the industry had gone too far in addressing the research. âThe industry does have powerful, valid arguments to support its position,â he wrote, but those would be undermined if it acted as though the evidence cited by its critics didnât exist at all.
Further muddying the water is the fact that some research has associated talc with cancer and other diseasesâ" but diseases of the lung, in cases where victims inhaled the mineral, especially when the talc was contaminated with asbestos. Talc marketed to the public has had to be asbestos-free since the 1970s.
Thereâs been very little judicial pushback against the plaintiffsâ claims. Last September, a New Jersey state judge, Nelson C. Johnson, threw out expert testimony promoting the ovarian cancer link from Daniel W. Cramer, a Harvard researcher who has produced the leading research indicating the link. Johnsonâs ruling was provided to me by representatives of Johnson & Johnson.
Johnson cited the differences between the conclusions of Cramerâs retrospective research and those of the prospective studies. He noted that Cramerâ s work and other studies pointing to a link donât have conclusive descriptions why talc would cause ovarian cancer. He called the expertsâ failure to âarticulate a plausible hypothesis for the biological mechanismâ a âhuge holeâ in the plaintiffsâ case. None of the plaintiffsâ witnesses, he said, âventured to articulate just how it is that talc in the ovaries, or what it is about talc in the ovaries, that sets off a chain of events which purportedly causes ovarian cancer.â
Even if there was a statistical increase in the cases of ovarian cancer by talc users, Johnson observed, there was scant evidence that it was a causal factor for the two women bringing the New Jersey lawsuit, both of whom had other risk factors for the disease.
The assumption that a corporate behemoth such as Johnson & Johnson might be totally in the clear in high-profile product liability cases certainly cuts across the grain. Itâs conceivable that company officials had great er concerns about their talc products than they let on, that they knew the prudent course would have been to post a health warning on Shower to Shower, but that their hands were stayed by a calculation of what that would do to sales. But based on the scientific evidence, blaming the product for the plaintiffsâ illness looks way excessive.
Itâs tempting, as Wehner acknowledged, to draw a line from the tobacco industryâs decades of denialism of the health risks of smoking, or even the fossil fuel industryâs denial of climate change, and conclude that J&J must be lying.
But those industriesâ suppression of incontrovertible scientific data doesnât prove a link between talc and ovarian cancer, since large, objective scientific studies have found no link. While it may be true, to quote the pirate captain from âA High Wind in Jamaica,â that Johnson & Johnson is guilty of something, this may well be a crime it didnât commit.
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