A new wave of lawsuits alleging an association between ovarian cancer and the use of talcum powder for feminine hygiene purposes – a claim that many believe is based on questionable science – has hit an all-time high.  Last week, a Los Angeles jury returned a verdict against Johnson & Johnson in the amount of $417 million ($70 million in compensatory damages, $347 million in punitive damages), finding that there was a connection between Plaintiff Eva Echeverria’s ovarian cancer and Johnson & Johnson’s talcum powder product.  Plaintiff, a California resident, claimed she developed ovarian cancer as a result of her use of Johnson & Johnson’s Baby Powder over many years, and alleged that Johnson & Johnson had internal knowledge for decades of scientific studies that demonstrated that the use of talc could cause cancer.

 

In support of this allegation, Plaintiff’s lawyers presented to the jury a 1982 study suggesting that women who used baby powder – which is mainly comprised of talc – were at a 92% increased risk for ovarian cancer.  Plaintiff’s lawyers also claimed that the lead researcher for that study advised Johnson & Johnson about the study, and suggested that the company should place a warning label on their product, but Johnson & Johnson refused.  In its defense, Johnson & Johnson took issue with the 1982 study, and argued that talc is inherently safe, analogizing talc to red meat and alcohol – neither of which require warnings.

 

Much of the controversy surrounding this new litigation stems from the science lawyers representing plaintiffs are using to support their claims.  Johnson & Johnson argued during trial that the scientific studies on which Plaintiff relied upon are flawed and “made-for-litigation.”  Specifically, many studies supporting the association between ovarian cancer and talc are based on interviews conducted on women already diagnosed with ovarian cancer, asking them to remember whether they ever used talcum powder; accordingly, such studies run the risk of promoting inaccurate recollection.

 

Epidemiologist Jack Siemiatycki, who testified on behalf of Plaintiffs, stated that it is “more likely than not that talc can cause ovarian cancer.”  Additionally, Laura Plunkett, a pharmacologist and toxicologist hired by Plaintiffs, opined that talc is toxic, and when used on a woman’s lower extremities, can cause ovarian cancer by migrating into the ovaries and causing chronic inflammation, which worsens even from small applications over long periods of time.

 

Johnson & Johnson argued that Plaintiff’s experts base their assertions on unreliable studies, citing to a 2000 cohort study by researchers at Harvard University, in which they concluded that there was “no overall association” between talc and “epithelial ovarian cancer.”  In that study, out of the 78,630 women that stated they used talcum powder products, 307 of them were eventually diagnosed with ovarian cancer.  While the study did state that there was a “modest elevation in risk” for one variety of the disease – invasive serous ovarian cancer – the report concludes that the “results provide little support for any substantial association between perineal talc use and ovarian cancer risk overall.”

 

This is the first ovarian cancer talc trial verdict returned against Johnson & Johnson in a state court outside of Missouri, and by far the largest.  Johnson & Johnson has previously been hit with over $300 million in verdicts among several lawsuits in Missouri, however, Johnson & Johnson has also obtained summary judgments in two cases filed in New Jersey state court based on the same arguments made in Echeverria’s case – namely, that there is not sufficient scientific proof to establish the connection between talc and ovarian cancer.  In fact, in Echeverria’s case, the court granted the talc supplier’s motion for summary judgment, finding that talc is indeed “inherently safe” and that the supplier owed no duty to warn to the Plaintiff.

 

Johnson & Johnson maintains that its Baby Powder is safe, and has indicated that they will appeal this verdict.  Johnson & Johnson’s spokeswoman Carol Goodrich stated after the verdict was issued that they “are guided by the science, which supports the safety of Johnson’s Baby Powder.”

 

Many reputable research organizations maintain that there is insufficient evidence to conclude that talc causes ovarian cancer.  The International Agency for Research on Cancer (IARC) – which is part of the World Health Organization – holds the position that there is no epidemiological evidence that convincingly demonstrates that talc causes ovarian cancer.  Moreover, the National Cancer Institute’s Physician Data Query Editorial Board indicated this past April that the “weight of the evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.”  The United States Food and Drug Administration has also indicated that talc products are not carcinogenic.

 

Despite the inconclusive evidence on this topic, it is expected that the number of claims such as Echeverria’s will infinitely rise, and may very well become the new wave of mass litigation in the United States.

 

 

Mineral talc, as a raw material, was determined to be “inherently safe” by Los Angeles Superior Court Judge Maren Nelson in the days leading up to the first Johnson & Johnson California ovarian cancer trial in the Johnson & Johnson Talcum Powder Cases, number JCCP4872.  According to Law360.com, on July 10 the judge dismissed Imerys Talc based on her finding that talc is “inherently safe.”  This ruling could have a profound effect on talc litigation, at least in California, as it may serve to protect Imerys and other suppliers of raw talc from further liability.

The court based its decision on the 1998 California appellate case of Artiglio v. General ElectricSee 61 Cal. App. 4th 830, 839 (1998).  The Artiglio decision is based on the Restatement Third of Torts and stands for the proposition that component and raw material suppliers are not liable to ultimate consumers when the goods or material they supply are: (1) not inherently dangerous; (2) they sell goods or material in bulk to a sophisticated buyer; (3) the material is substantially changed during the manufacturing process; and (4) the supplier has a limited role in developing and designing the end product.  See id.

A number of other states, including Massachusetts, have similar jurisprudence that recognize the “bulk supplier,” “sophisticated user,” and “component part” doctrines which may lead to similar results for raw material suppliers, such as talc suppliers, in ovarian cancer talc litigation.  See Carrel v. Nat’l Cord & Braid Corp., 447 Mass. 431, 441 (2006); Hoffman v. Houghton Chem. Corp., 434 Mass. 624, 629 (2001).

Unlike California courts, though, Massachusetts courts have not conglomerated the sophisticated user doctrine and the bulk supplier doctrine into one rule that deals with “inherently safe” raw materials.  Massachusetts courts have, however, held that the components of the Artiglio rule (the bulk supplier doctrine and the sophisticated user doctrine) are recognized defenses in Massachusetts.  See Hoffman, 434 Mass. at 629; See Artiglio 61 Cal. App. 4th at 839.  Additionally, Massachusetts courts have recognized the component parts doctrine, which in California, is a counterpart of the Artiglio rule. See 61 Cal. App. 4th at 839.  Therefore, talc defendants certainly have a strong argument for dismissal.

Hoffman, confirms that the first component of the Artiglio rule, the bulk supplier doctrine, is available in Massachusetts.  See Hoffman 434 Mass. at 629.  In Hoffman, the pivotal question on appeal concerned the duty of a bulk supplier to warn all foreseeable users of the risks associated with a product’s use.  See id.  In that case, the court held that the bulk supplier doctrine allows a manufacture-supplier of bulk products, in certain circumstances, to discharge its duty to warn end users of a product’s hazards by reasonable reliance on an intermediary.  See id.  Among the factors that may determine reasonable reliance are: (1) the dangerous condition of the product; (2) the purpose for which the product is used; (3) the form of any warnings given; (4) the reliability of the third party as a conduit of necessary information about the product; (5) the magnitude of the risk involved; and (6) the burden imposed on the supplier by requiring that he directly warn all users.  See Hoffman, 434 Mass. at 632; See Artiglio 61 Cal. App. 4th at 839.

The sophisticated user doctrine, another component of the Artiglio rule, is a separate and conceptually discrete affirmative defense from the “bulk supplier” defense which is also available in Massachusetts.  See Carrel, 447 Mass. at 441.  The sophisticated user doctrine relieves a manufacturer of liability for failing to warn of a product’s latent characteristics or dangers when “the end user knows or reasonably should know of a product’s dangers.”  See id.  In the context of the sophisticated user defense, the “end user” is the person whose sophistication is relevant to determining the defense.  See Taylor v. Am. Chemistry Council, 576 F.3d 16, 25 (1st Cir. 2009). Where a case involves three parties (such as a supplier, an employer who purchases the product from the supplier, and an employee who foreseeably comes into contact with the product and is injured), the “end user” may be either the intermediate party or the plaintiff. See Taylor, 576 F.3d at 25; see also Carrel, 447 Mass. at 441 (examining knowledge of intermediary); Barbosa v. Hopper Feeds, Inc., 404 Mass. 610 (1989) (examining knowledge of plaintiff).  In Carrel a camper was injured when he pulled on the end of a bungee cord, causing a knot in the cord to unwind, striking him in the eye.  See Carrel, 447 Mass. at 432.  At trial on the camper’s claim for failure to warn, the jury was instructed on the sophisticated user defense, and the defendant prevailed.  See Carrel, 447 Mass. at 433.  The Supreme Judicial Court upheld the instruction on appeal, and it noted that it was the practice of the cord’s distributor (not the manufacturer) to include in its shipments a document warning against using the bungee cord in a zip-line course in the precise manner that the camp had used it.  See Carrel, 447 Mass. at 445.

Importantly, Massachusetts courts have also recognized the component part doctrine, which in California, is considered a parallel counterpart to the Artiglio rule.  See Webb v. Special Elec. Co., 63 Cal. 4th 167, 183 (2016).  When a component of an integrated product is not itself defective, the maker of the component is not liable for injury that results from a defect in the integrated product.  See Mitchell v. Sky Climber, Inc., 396 Mass. 629, 631 (1986) (“A supplier of a component part containing no latent defect has no duty to warn the subsequent assembler or its customers of any danger that may arise after the components are assembled.”)  California has also recognized this component parts rule in O’Neil v. Crane Co. when the court stated that a product manufacturer may not be held liable in negligence for harm caused by another manufacturer’s product unless the defendant’s own product contributed substantially to the harm, or the defendant participated substantially in creating a harmful combined use of the products.  See 53 Cal. 4th 335, 266 (2012).

Although Massachusetts courts have not yet created a combined rule, as did the California court in Artiglio, talc suppliers facing cases in Massachusetts may be still able to build an effective defense through the application of the “sophisticated user,” ”bulk supplier,” and “component parts” doctrines.

 

Talc!For the third time this year, a St. Louis, Missouri jury found Johnson & Johnson liable in a case where plaintiff alleged that her ovarian cancer was caused by her use of talcum powder products. At trial, Deborah Giannecchini, a 62 year-old California woman, claimed that her decades-long use of Johnson & Johnson talcum powder caused her to develop ovarian cancer in 2013. After a month-long trial, the jury awarded her more than $70 million in damages, approximately $65 million of which were comprised of punitive damages.

At trial, Giannecchini’s lawyers argued that Johnson & Johnson:  (1) was aware for more than 30 years that use of talc-based products increases the risk of ovarian cancer; and (2) did not warn the public of the potential health hazards associated with the product.

In the two prior St. Louis cases which reached a verdict against Johnson & Johnson, juries found in favor of plaintiffs and awarded $72 million and $55 million, respectively, in damages. While Johnson & Johnson has seen limited success before juries, the company hopes that each of the three St. Louis verdicts will be overturned on appeal. Specifically, Johnson & Johnson’s appellate arguments will focus on the lack of scientific proof to support the recent jury awards. Indeed, Johnson & Johnson successfully used this approach in New Jersey, where a state court dismissed two talc-based actions after ruling that plaintiffs’ scientific experts were unable to provide sufficient evidence that the use of talcum powder causes ovarian cancer.

Johnson & Johnson is currently defending more than 1,500 cases nationwide.  In each of these cases, plaintiffs allege that the company failed to warn consumers of the potential health risks associated with the use of talc products.