Professionalism/The Johnson & Johnson Baby Powder Case

Background
Johnson & Johnson, founded in 1886 by Robert, Edward, and James Johnson, is the world's largest producer of health-related goods, offering a diverse range of products across consumer health, medical technology, and pharmaceuticals. The company was inspired by the work of Joseph Lister on sterile surgical methods and its first products were wound care products. In 1888, the company published "Modern Methods of Antiseptic Wound Treatment," which quickly became a standard text for antiseptic surgery, promoting sterile surgery globally. That same year, Johnson & Johnson also released the first commercial first aid kits. In 1894, the company expanded its product line to include maternity and infant-care products, launching its iconic Johnson & Johnson baby powder. Today, Johnson & Johnson continues to lead the health-related products industry, reporting a revenue of $93.8 billion in 2021.

Timeline leading up to the Baby Powder Controversy
In the 1930s, the first recorded account of the harmful effects of talc on humans emerged. Subsequently, in 1971, a British Journal of Obstetrics & Gynecology study discovered talc particles in 75% of ovarian tumors, while in 1975 an internal Johnson & Johnson memo acknowledges the problematic link between genital talc use and ovarian cancer. Faced with the possibility of a federal ban on cosmetic talcum powder in 1977, Johnson & Johnson began testing baby powder with cornstarch as a replacement. In 1982, Daniel Cramer conducted the first case-control study to link genital talc use with ovarian cancer, discovering that women have 92% increased risk of ovarian cancer when using talc for feminine hygiene purposes. In 1992, an internal Johnson & Johnson memo outlined the planned targeting of Black and Hispanic women through increased marketing to counter a decline in sales of talc-containing products. Following this, the National Toxicology Program reported in 1993 that cosmetic talc could cause tumors in animals, and the condom industry removed talc from all products in 1996 due to ovarian cancer concerns. A large-scale review published by the Anticancer Research Journal in 2003 found a 33% increased risk of ovarian cancer with long-term use. In 2011, Daniel Cramer published a 10-year case-control study that found women with long-term genital talc use had a two-thirds increased risk of developing ovarian cancer. In 2013, Deanne Bergs, the first person to go to trial, won her lawsuit against Johnson & Johnson after it failed to warn consumers of the risk of developing ovarian cancer due to its talcum powder products.

Johnson & Johnson's Failure to Disclose Presence of Asbestos in Talcum Products
Talcum is a mineral that is mined from the earth. In its natural form, talcum can occur in the same geological formations as asbestos. Because of this, when it is mined, some talcum will contain asbestos. The plaintiffs of the Johnson & Johnson baby powder lawsuits allege that the powder led them to develop mesothelioma or ovarian cancer. Asbestos is a known carcinogen and exposure to it is the cause of most cases of mesothelioma and the Mesothelioma Center does not recognize any "safe" level exposure to it. As for talcum, there is currently no scientific consensus on its carcinogenicity. In 2010, the International Agency for Research on Cancer reported that perineal use of talc-based body powders is "possibly carcinogenic to humans." While the National Cancer Institute stated that "studies of women who used talcum powder (talc) dusted on the perineum...have not found clear evidence of an increased risk of ovarian cancer." UVA professor of public health, Joellen Schildkraut, in reference to her studies showing an association between talc and ovarian cancer says "it's not proof positive... these studies are suggestive."

On December 14, 2018, Reuters released a report that claimed that Johnson & Johnson knew that their baby powder products contained asbestos and did not disclose this information to consumers or regulators. Evidence from the report showed that on three occasions between 1972 and 1975, in different labs and tests, there was asbestos found in Johnson & Johnson's talc products, with one of these samples having a "rather high" level of asbestos reported. Despite this, in 1976, Johnson & Johnson told regulators at the FDA that there was no asbestos detect in any of their tested talc samples.

Daniel Cramer
Daniel Cramer is a obstetrics and gynecology professor at Brigham and Women's Hospital in Boston and Harvard Medical School professor. In 1982, he conducted the first epidemiological study on the use of talcum powder in the female genital area, publishing his findings in the journal Cancer. After the study was published, Cramer was approached by Bruce Semple, a Johnson & Johnson executive, and advised him to include a warning on the company's talc-based body powder product. However, Semple did not heed Cramer's advice, despite the evidence presented in in his study.

Undeterred, Cramer continued to advocate for greater awareness of the potential risks of talc-based products and called for companies like Johnson & Johnson to include warnings on their talcum powder products in a 1985 article. Despite the lack of action from Johnson & Johnson, Cramer has remained committed to raising awareness about the potential link between ovarian cancer and the use of talc-based products in the genital area. He has served a a paid consultant in several ovarian cancer cases against Johnson & Johnson.

In a 2011 court filing, Cramer recounted his encounter with Semple, stating, "Dr. Semple spent his time trying to convince that talc use was a harmless habit, while I spent my time trying to persuade him to consider the possibility that my study could be correct and that women should be advised of this potential risk of talc. Cramer's work has been pivotal in raising awareness about the potential risks of talc-based products and advocating for greater transparency and warning labels.

Gavin Hildick-Smith
Gavin Hildick-Smith was the director of medical affairs in the corporate office of science and technology at Johnson & Johnson for 37 years. A blog dedicated to the Hildick-Smith family history states that Dr. Hildick-Smith was born in Johannesburg, South Africa, in 1919, and he later studied Pediatrics at Guy's Hospital in London. Notably, Dr. Hildick-Smith's father was a mining engineer and mine manager. In the late 1960s, scientists were starting to report the presence of asbestos in cosmetic talc products. As a result, in 1971, the FDA held a meeting with federal officials, researchers, and cosmetic companies to discuss the safety of talc and the testing of talc products for asbestos. In the following years, the FDA continued to receive reports from labs about the presence of asbestos in various talc products, while simultaneously being pressured by Johnson & Johnson to not release some of these reports as they believed that the reports were "inaccurate" and that their findings were "erroneous".

A Reuters investigation revealed that in 1974, while working at Johnson & Johnson, Dr. Hildick-Smith sent money to an Italian talc exporter-physician to have him hire a team of researchers. In a letter to the lead researcher, Dr. Hildick-Smith stated that he was interested in obtaining data that "show that the incidence of cancer in these subjects (talc miners and millers) is no different from that of the Italian population," and that he wanted these data to be "published in a suitable journal." To this end, Dr. Hildick-Smith sent a draft of the results from the Italian study to a scientific ghostwriter who would rewrite it and make it meet "form and style" requirements.

In 1976 Dr. Hildick-Smith also wrote a review article titled "The Biology of Talc" in which he cited unpublished research and concluded that “concern … about the possible health hazard from consumer exposure to cosmetic talc is unwarranted … no evidence that its normal use poses a hazard to health.” He cited the Italian study in this review article. Notably, in this article, he is only listed as a Rutgers University clinical assistant and does not disclose his association with Johnson & Johnson. Dr. Hildick-Smith’s actions show that he was someone who was very committed to his career and loyal to his company, but at times he failed to act in alignment with his profession in prioritizing the truth and the well-being of the people potentially affected by his work.

Alex Gorksy
Alex Gorsky served as CEO of Johnson & Johnson from 2012 to 2020, overseeing the company's growth and response to various legal and ethical challenges, including talc powder. Despite this, he faced criticism for allegedly not taking sufficient action to resolve the issue of baby powder.

He was on the witness stand for more than four hours, questioned by lawyers for plaintiffs and J&J. During the trial, the lawyer representing the plaintiffs asked Mr. Gorsky with a collection of company documents dating back to the 1970s. These papers contained statements made by employees and consultants who expressed their reluctance to adopt a new laboratory testing method that could detect asbestos in talc a lower concentrations than the techniques employed by J&J at that time. The plaintiffs' attorney referred to the FDA test results and questioned Mr. Gorsky whether he could swear under oath that there were no test indicating the presence of asbestos in J&J powders. Mr. Gorksy said "That's correct". He also stated that J&J baby powder did not contain asbestos in response to allegations that the product was unsafe and potentially carcinogenic.

In a video posted on J&J's website and a television interview on CNBC's "Mad Money with Jim Cramer" in December 2018, according to Mr. Gorsky, J&J had collaborated with regulatory authorities, and numerous test had confirmed the safety of its talcum powders. However, the plaintiff's attorneys argued that Mr.Gorsky's statements made him a critical witness. They contended that his statements helped to perpetuate the company's efforts to hid the potential risks associated with talcum powders. After his testimony, the US Food and Drug Administration discovered asbestos, a know carcinogen, in a bottle of Johnson's baby powder, raising concerns about the accuracy of Mr. Gorsky's statement.

J&J attempted to prevent Mr. Gorsky from testifying, citing his lack of involvement in the research, development, or testing of J&J's talc-powders. In addition, they claimed that most plaintiffs had used the powders before Mr. Gorsky became the company CEO.

Texas Two Step
The " Texas two-step" is a controversial bankruptcy maneuver that Johnson & Johnson (J&J) has employed to offload its talc liability onto a subsidiary. However, an appeals court invalidated this tactic. As a result, J&J subsidiary, LTL Management, filed for bankruptcy protection for the second time with the intention of presenting a reorganization plan to a judge, The subsidiary has claimed that about 60,000 talc claimants have agreed to the proposed settlement. J&J has created new financing arrangements to avoid running afoul of the appeals court ruling. The ruling determined that LTL Management had no legitimate claim to bankruptcy since it was not in financial distress. Despite this, J&J board has approved the settlement, which involves paying a larger amount to plaintiffs with various gynecological cancers and mesothelioma.

To enhance its previous proposal to talc claimants, LTL is filing for Chapter 11 with a plan support agreement that includes an $8.9 billion commitment from LTL and J&J. this commitment will be funded in a trust over 25 years to settle current and future talc-related claims. However, attorneys representing thousands of plaintiffs have issued a statement opposing the settlement. The Texas two step has been portrayed as an abuse of the bankruptcy system by a multinational conglomerate with a marked capitalization exceeding $400 billion and in little danger of running out of money to pay victims.