Johnson & Johnson’s talcum powder journey dates back more than a century to 1894 when it was introduced to the market after receiving an overwhelming response from mothers following childbirth. The credit for inventing this product goes to Dr. Frederick B. Kilmer, the first director of scientific affairs of Johnson & Johnson. In 1893, Dr. Kilmer had first suggested the talc for skin irritation caused by medicated plasters. Later, it became popular amongst mothers post-delivery who demanded more of it and the rest, as they say, is history.
Owing to the popularity, J&J’s baby powder soon became a household name; by 1985, more than 70 percent of Americans were using it daily. Only in the late 1970s when research studies identified its possible link to ovarian cancer did acceptance start changing to suspicion. The conflicting reports gave rise to a vicious blame game.
This awareness of the link between talcum powder and ovarian cancer prompted hundreds of women to file lawsuits against the manufacturer. J&J faced its first loss in February 2016, when the jury issued a $72 million verdict in favor of a woman who had died of ovarian cancer in 2015.
Why J&J bypassed the FDA’s review?
J&J bypassed the two most important laws pertaining to cosmetics marketed in the U.S.: the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) according to which the FDA regulates cosmetics in the market. J&J’s talcum powder fell in the cosmetic product range and was not required to obtain an FDA approval before being launched; secondly, J&J was able to obtain an FDA approval for its manufacturing unit which it used to promote the alleged safety of its product and address doubts of adulteration or misbranding.
The AMA Analytical Services Inc.’s results from September 28, 2009 to September 27, 2010, detected no asbestos in Johnson’s Talcum powder; this further tied FDA’s hands. As of this date, the FDA has required no label warning updates by J&J.
Talcum Powder-Ovarian Cancer Lawsuits’ Status
Johnson & Johnson’s talcum powder lawsuits are emerging as highly controversial conversational topics within and outside the legal community. The sixth verdict of $417 million, announced recently in favor of the plaintiff sent shock waves across the nation. At just under four times the previous high verdict of $110 million, it was the highest in the series of talcum powder verdict amounts so far and caught the attention of the press as well as all mass-tort lawyers.
The sizes of the talcum powder-ovarian cancer verdicts are noteworthy. And the failure to warn the consumers of the known risk of cancer is being highlighted by the press.
In November 2016, Talcum Powder Cancer MDL 2738 was established in the U.S. District Court for the District of New Jersey. Two female attorneys were chosen as Co-Lead Counsels, a decision made by the federal MDL that focuses on women’s health issues. Judge Freda L. Wolfson, U. S. District Judge for the District of New Jersey in Trenton, and Hon. Lois H. Goodman, U.S.M.J., were appointed by JPML to preside over the MDL.
Why no cancer warnings yet?
Though verdicts have been announced favoring the plaintiffs along with mounting requests by medical experts for cancer warning labels, there is still no requirement for any safety warning update from the FDA. Shielded by the ‘cosmetic products’ factor, the companies only have a legal responsibility for the safety and labeling of their products and ingredients and by law are not required to share their safety information with FDA.
The FDA also rejected numerous petitions citing insufficient evidence, despite being provided with research papers linking the talc to an increased risk for ovarian cancer. Despite losing in the courtroom, despite being held liable for hefty amounts as punitive damages, despite the mounting medical evidence, J&J maintains stoic silence, reiterating time and again the safety and efficacy of its product. Maybe these large jury awards will make a difference and J&J will put profit aside in favor of consumer safety. We can only hope.
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