RULE OF LAW: When a Science Debate Gets into the Legal Arena

Eva Echeverria, a woman who was allegedly diagnosed ofovarian cancer due to long-term and consistent use of Johnson & Johnson’s (J&J) famous baby powder, got to see justice being served prior to her last breath.

Barely few days ago, a Los Angeles jury awarded Echeverria $417 million in damages and ordered the cosmetic giant to pay the huge amount to the dying woman.  Echeverria claimed that J&J failed to adequately warn consumers about talcum powder’s potential cancer risks.  She had been using its baby powder on a daily basis for more than 50 years, beginning in 1950’s until 2016, and was found to have ovarian cancer in 2007. She developed ovarian cancer as a “proximate result of the unreasonably dangerous and defective nature of talcum powder”, she said in her lawsuit.

It is expected that J&J will not take the judgment sitting down as it will have various serious repercussions not just on its famous product but on the company’s reputation and financial sustainability as well.

A review of scientific studies conducted by experts show that there seems to be no consensus on the link between the long-term and consistent use of talcum powder to ovarian cancer.There is an ongoing debate among scientists on this issue.  As reported by the www.washingtonpost.com, the debate began in the early 70s when scientists discovered talc particles in ovarian tumors. In 1982, Harvard researcher Daniel Cramer reported a link between talcum powder and ovarian cancer. Other studies also supported his finding.

Critics, however, say that the Cramer study using a case-control approach is doubtful as it is subject to a “recall bias” wherein women may forget what they did, or, if diagnosed with cancer, might inadvertently overestimate their use of suspect substance.  People with a serious disease may be less motivated to remember details.  Other studies found no overall link on the use of talcum powder to ovarian cancer.

Echeverria’s legal team was able to convince the jury that the daily use by Echeverria of J&J’s baby powder for decades ultimately led to her cancer diagnosis.  Her team presented an internal memo from 1964 authored by J&J employees which discussed the possibility of substituting cornstarch for Talc in its baby powder product.  The memo contains a discussion that “cornstarch can be safely absorbed into the vagina and as we all know talc cannot be safely absorbed into the vagina.”  The team also cited the act of the condom manufacturing industry of stopping the use of talc in its products for fear of ovarian cancer risk.  Despite this knowledge, J&J refused to put a warning on its Baby Powder and Shower to Shower products as it adamantly states that its products are safe. (LawyersandSettlements.com)

J&J’s main argument against these allegations is that the studies cited by Echeverria and other plaintiffs are weak and bordering on junk science which were just cherry-picked by lawyers to prove a case which does not exist.As it appears now, this case is a duel among the so-called science experts.

The way J&J presents its case shows that it is banking its defense on two landmark US case dealing with admissibility of scientific evidence: the cases of Frye v. U.S. and Daubert v. Merrell Dow Pharmaceuticals.  In Frye v. U.S., the trial court convicted Frye of murder. Frye appealed his conviction to the Supreme Court of the District of Columbia. During trial, Frye’s counsel offered an expert witness to testify on the result of a systolic blood pressure deception test made on defendant. The state Supreme Court affirmed Frye’s conviction and ruled that “the systolic blood pressure deception test has not yet gained such standing and scientific recognition among physiological and psychological authorities as would justify the courts in admitting expert testimony deduced from the discovery, development, and experiments thus far made.” The Frye standard of general acceptance states as follows: “Just when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs.”

Daubert cautions that departure from the Frye standard of general acceptance does not mean that the Federal Rules do not place limits on the admissibility of scientific evidence. Rather, the judge must ensure that the testimony’s reasoning or method is scientifically valid and is relevant to the issue. Admissibility would depend on factors such as (1) whether the theory or technique can be or has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error; (4) the existence and maintenance of standards controlling the technique’s operation; and (5) whether the theory or technique is generally accepted in the scientific community.(as summarized by the Philippine Supreme Court in Herrera vs. Alba).  In the Philippines, the Frye and Daubert standards are taken into consideration in evaluating the weight and probative value of scientific evidence while in the US, scientific evidence must first hurdle these standards before the same is considered by the jury.

With Johnson&Johnsons’ financial power, it is not too soon that Echeverria will be wheeled to the bank to claim her $417 million.

For talcum powder users, it may not be advisable to wait until the appeal is decided or the science debate is over.

 

 

 

 

 

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