No More Tears: The Dark Secrets of Johnson & Johnson

In Chapter 2, Harris gives a brief history of Johnson & Johnson’s origins. During the American Civil War, Robert Wood Johnson’s parents sent him to Poughkeepsie, New York, to serve as an apprentice apothecary to his cousin, James G. Wood. James taught Johnson how to make medicinal plasters, “an early combination of bandage, cast, and medicated patch” (6). After his apprenticeship, Johnson moved to New York City and in 1873 began to manufacture medicinal plasters with his partner, George J. Seabury. Johnson began to develop antiseptic dressings in 1876. His younger brothers joined the business. In 1885, Seabury left the business. The Johnsons reestablished the company in New Brunswick as Johnson & Johnson. The company quickly grew.

In 1890, the J&J director of scientific affairs, Dr. Fred B. Kilmer, sent a doctor who complained the bandages gave a patient a rash “a small tin of Italian talc” (9) to treat the irritation. Soon, the company began sending talc with many of their plasters. The powder became popular, especially with mothers using it for diaper rash. In 1894, the company introduced Johnson’s Baby Powder made of talc to the market.

The company got a boost during the Spanish-American War during 1898 when it sent bandages for the soldiers. It continued to grow. In 1910, Robert Wood Johnson died. His son, Robert Wood Johnson II, was 16 at the time. His uncle took over the company, but Robert Wood Johnson II was desperate to work there. In 1918, the company made money making masks during the Spanish flu pandemic and in marketing Johnson’s Baby Powder. In 1920, they began to sell Band-Aids, “the most trusted individual product brand in the world” (13). Johnson II began to take on more responsibilities at the company. He pushed for it to become “a conglomerate of largely independent subsidiaries” (14).

In 1959, J&J acquired McNeil Laboratories, which produced Tylenol. Soon after, J&J acquired Janssen Pharmaceutica, which produced the antipsychotic Haldol and fentanyl, along with other key drugs. In 1968, Johnson II died, and the company was no longer family-run. It was the “biggest healthcare conglomerate in the world, a position it retains to this day” (16).

Talc is a common mineral deposit that can be ground into an incredibly fine talcum powder which has a wide variety of uses. However, because it is such a fine powder, it can create respiratory problems when aspirated, especially in infants and children. The first warnings about infants suffocating from talc inhalation were published in 1922. Warnings were again published in 1969 and 1981. 

In 1942 and 1955, studies established talc workers suffered from talcosis, a “fatal lung disease” (20), due to talc inhalation. In the 1950s and 1960s, studies noted that many talc deposits were contaminated with asbestos. Asbestos is a versatile mineral with crystalline needles that “spear DNA itself” (21), causing mutations and cancer growth. Warnings about the cancer risk of asbestos date back to ancient Rome. Concerns about the cancerous potential of even small amounts of asbestos grew louder in the 1950s and 1960s.

In the 1960s, Dr. Irving Selikoff and his researcher Dr. Arthur Langer conducted a series of studies that found women who did not work in industrial environments had high rates of asbestos-linked cancers. They found that talcum powders, like Johnson’s Baby Powder, were contaminated with asbestos. By at least 1967, J&J was aware of the possibility its talc was contaminated by tremolite, a kind of asbestos.

In 1971, the Tenovus Cancer Research Institute published findings that suggested talc itself could be carcinogenic and cause ovarian and cervical cancer. J&J hired Selikoff and Langer to discredit Tenovus’s findings. However, they found that Johnson’s Baby Powder was contaminated with asbestos and hosted a press conference announcing their findings, warning people not to use talc powder. J&J met with the FDA and insisted that their talc contained “only minor amounts (below 1%)” (29) of asbestos. Later, the company would claim that asbestos had “never” been found in their Baby Powder.

In August 1971, the FDA convened a committee to discuss asbestos in talc. Following that, they hired NYU professor Seymour Z. Lewin to test baby powder for asbestos. He found that Johnson’s Baby Powder contained asbestos. The FDA did not publicize these findings. 

J&J hired Dr. Albert Kligman, a dermatology professor at Penn, to discredit Lewin’s findings. Kligman injected asbestos into Black prisoners and asserted that irritations resolved after 30 days, but he did not assess whether they later developed cancer. Internal J&J tests found asbestos contamination in their talc. J&J began to worry that any level of asbestos contamination in talc would be prohibited. Meanwhile, internal assessments of the J&J talc mines in Vermont and Italy found that they all had asbestos contamination.

In Chapter 5, Harris gives a brief history of the Food and Drug Administration (FDA). The FDA was founded in 1909 but it had few powers until 1938, when 73 deaths were linked to a “patent medicine” that included diethylene glycol. In response, Congress passed the Food, Drug, and Cosmetics Act which tasked the FDA with determining “whether a drug was safe, not whether it was effective” (37). 

The FDA won greater public legitimacy in the 1960s when it refused to approve a drug called thalidomide, which was later found to cause birth defects. The agency devoted little attention to cosmetics like baby powder but in 1973 proposed a rule that talc products had to be 99.99% asbestos-free. J&J pushed back against the rule, and it was withdrawn. However, the FDA continued to consider banning talc altogether. 

To head this off, “the industry” developed a testing procedure called J4-1 that was not highly sensitive and would ensure that asbestos would not be detected in talc at high levels. Further, J&J stopped sending asbestos testing results to the FDA in 1974.

In 1972, J&J took a more antagonistic approach toward the scientists and advocates whose research criticized their baby powder. In 1975, Dr. Langer partnered with British mineralogist Dr. Pooley, who had tested J&J’s talc mines and had found asbestos. They prepared a study showing asbestos in Johnson’s Baby Powder and prepared to present it at a conference in Edinburgh. J&J persuaded Pooley to withdraw the study from publication. Dr. Langer and his team at Mount Sinai Hospital in NYC agreed because Pooley was being subjected to “industry harassment.” 

The study was later leaked to The Washington Post. In response, J&J met with Mount Sinai administrators and pressured them into discrediting Langer and Pooley’s study. The president of Mount Sinai, Dr. Thomas Chalmers, agreed after learning that Pooley had asked for the study to be retracted from the conference. Chalmers stated, “baby talc is a useful and safe product” (47).

The Washington Post reporter Marian Burros continued investigating. She quoted Selikoff’s assertation that there is no safe level of asbestos. This opened J&J up to lawsuits from anyone who had used Johnson’s Baby Powder and later developed an asbestos-related cancer. However, other reporters treated the topic more carefully after Chalmers’s retraction of Langer’s study. By 1977, the product was again seen as safe by the public.

In 1976, James E. Burke became Johnson & Johnson’s CEO. His brother co-founded the TV conglomerate Capital Cities, later part of ABC. Thus, J&J focused on friendly television media and otherwise “ended the company’s openness with reporters” (51). Burke pushed the company to invest more in medicine and acquired an Australian opioid maker. He was considered highly ethical by the public. Langer continued to criticize the FDA for its lack of intervention based on his findings of asbestos contamination.

On July 15th, 1982, Dr. Daniel Cramer, an OB-GYN professor at Harvard Medical School, published a study showing that women who used talcum powder on their genital regions “had a 92% increased risk of ovarian cancer” (54). J&J strongly criticized his findings and sent Dr. Bruce Semple to persuade Cramer to stop publicizing his research. Cramer argued that his findings showed talc was carcinogenic. His findings were confirmed by the World Health Organization’s International Agency for Research on Cancer (IARC) in the 2000s. J&J formed the Talc Steering Committee to head off concerns about the safety of baby powder.

In 1966, Engelhard, a mining company, purchased one of J&J’s talc mines in Vermont. It supplied talc to National Latex, which supplied it to balloon manufacturers. In 1977, the balloons were found to be tainted with asbestos. Engelhard’s miners were suffering from asbestos-related illnesses. In 1979, a worker named Howard Westfall, who later died of mesothelioma due to asbestos exposure, sued Windsor Minerals, the J&J talc subsidiary and Engelhard for liability for the exposure.

In January 1983, Hemstock, Engelhard’s research director, sat for a deposition in the Westfall lawsuit. Hemstock confirmed that internal tests had revealed asbestos contamination in the mine. This revelation led J&J and Engelhard to pay a settlement in the case. Engelhard closed the mine. They then initiated a massive document purge to destroy all evidence of their knowledge of asbestos. J&J then filed “false affidavits” claiming they were unaware of asbestos in the mine. In 2019, a J&J executive acknowledged in court the affidavits were a lie.

Although J&J sold its talc subsidiary in 1989, it continued to use talc powder instead of corn starch in its Baby Powder. In 2008, they launched a corn starch version, but debated how to phase out the talcum powder version without admitting fault.

Harris points out that asbestos-linked illnesses kill about 40,000 people in the US every year, but the FDA was slow to take a stand against J&J’s use of contaminated talc. The Cancer Prevention Coalition petitioned the FDA to do so in 2004, but the FDA refused to due to “limited availability of resources” (64). They petitioned again—and were again rejected—in 2008. 

In 2013, J&J “lost its first Baby Powder cancer lawsuit” (64). Six months later, the FDA reiterated its denials of the 2004 and 2008 petitions, insisting that “asbestos-free talc deposits do exist” (65). This is part of a long history of the FDA providing cover for J&J against legal claims.

In 2009, Donna Paduano, the daughter of one of Hemstock’s researchers, sued Engelhard for liability for her asbestos-linked mesothelioma. Hemstock was again deposed and confirmed that internal testing of the mine had found asbestos. Due to the lawsuit, the plaintiff’s lawyer, Mark Lanier, established that some of the documents relating to asbestos in the mine had not been destroyed in the purge.

In 2018, attorney Mark Lanier put together a multi-party civil case arguing that J&J was liable for the cancer-causing asbestos in its Johnson’s Baby Powder. It was called the Ingham case and there were 22 plaintiffs. Lanier argued that J&J knew there was asbestos in the talc used in the Baby Powder. J&J’s lawyer, Peter Bicks, argued that J&J testing confirmed there was no asbestos in the talc used, and that they had FDA approval and oversight. Lanier’s witnesses testified that there was asbestos in most Johnson’s Baby Powder and that the testing method used by J&J was not reliable. Plaintiff Tori Roberts described how she had used baby powder for decades and that the resulting cancer had ruined her quality of life. (She died 14 weeks later.) 

J&J executives and experts argued they had never seen evidence of asbestos in their talc. Shockingly, the company’s talc safety expert, Dr. Susan Nicholson, admitted on the stand that her own mother had used Johnson’s Baby Powder and had died at 63 of ovarian cancer. In its closing, J&J’s attorney insisted it was ridiculous to argue they would knowingly put women and babies at risk. The jury found J&J liable and assessed total damages at $4.14 billion (later reduced to $2.1 billion on appeal). J&J appealed to the Supreme Court, but were denied. They were forced to pay the full $2.5 billion ($2.1 billion plus interest) on June 1st, 2021.

Over its history, J&J received highly favorable media coverage. When news sources tried to publish critical stories, the stories would be pulled when J&J threatened to pull advertising in retaliation. However, the Ingham verdict was widely reported in Reuters and elsewhere. It sparked a “flood of litigation” against J&J. In 2019, the FDA pulled a lot of Johnson’s Baby Powder for asbestos contamination for the first time. In 2020, J&J stopped selling talc Baby Powder in the US and Canada, and in 2023 they pulled the product worldwide. 

In an attempt to mitigate J&J’s liability for future lawsuits about asbestos exposure, J&J tried to transfer “the company’s Baby Powder liabilities” (82) to a subsidiary as part of a bankruptcy proceeding that would limit total payouts in all lawsuits to $2 billion, but in 2023, the federal appeals court blocked the move.

In Chapter 10, Harris gives a short synopsis of the 1982 Tylenol poisonings in the Chicago area. 12-year-old Mary Kellerman was the first victim; she died in the morning on September 29th, 1982, after taking Extra Strength Tylenol purchased at a Jewel-Osco in Elk Grove Village. That afternoon, Adam Janus died after taking Extra Strength Tylenol purchased at a Jewel-Osco in Arlington Heights. Shortly after, Mary Magdalene Reiner and Mary McFarland similarly died after taking Tylenol. Late that evening, Adam Janus’s brother, Stanley, and Stanley’s wife, Theresa, both took Tylenol from the same bottle and died. 

Testing confirmed that the Tylenol had been poisoned with cyanide. The Chicago mayor warned people not to take Tylenol. J&J pulled “every Tylenol on every store shelf” (89) in response. It cost them $100 million. To prevent further tampering, they developed the protective packaging seals common to medication packaging today. They were lauded for this quick response, but Harris argues that “there are a few flaws in this happy narrative” (90).

Harris notes “Tylenol had been tampered with many times before” (91) the 1982 case. J&J was aware of concerns and had already begun to develop more secure packaging seals, which is why it was able to deploy them so quickly after the poisonings. Further, J&J did not issue a full nationwide recall of Tylenol until October 5th, six days after the poisonings, even though there was a copycat poisoning in California on October 1st.

J&J claimed the poisonings were effectuated by one person visiting several stores and placing tampered bottles of Tylenol on the shelves. Harris and others argue that “there are reasons to believe that a wholesale customer within the distribution network was compromised” (91). Specifically, Harris argues that a rack jobber at Jewel Company named Roger Arnold was responsible. A rack jobber is someone who stocks goods on pharmacy and grocery store shelves for companies. 

Arnold had a number of priors and had fallen into a depression after his divorce in 1982. He claimed to have cyanide, and he worked in a warehouse where he had access to wholesale Tylenol boxes. He was arrested, but there was not enough evidence to charge him and he was released. In a rage, he went to a bar to murder the person who had informed on him, Marty Sinclair. Instead, he murdered an innocent man, John Stanisha. Arnold was convicted of Stanisha’s murder and sentenced to 15 years. He died in 2008. 

Chicago PD investigators found links between the Chicago locations where the Tylenol had been purchased and Arnold’s personal history. However, the FBI focused on a con man named James Lewis as their prime suspect. Lewis was never charged with the crime and the case officially remains open.

Harris argues that because the infiltration happened as part of J&J’s supply line, they are partially liable for the deaths. However, most people believe J&J “was a blameless victim” (98) and the case improved J&J’s approval in the public eye.

J&J former employee and whistleblower Bartz claims that J&J hid evidence about the supply chain issues in the Tylenol case from the FDA. He further claims that J&J was aware the killer worked for Jewel and “kept that knowledge” (100) from investigators, even as their subsidiary, McNeil Pharmaceuticals, “made repeated and panicked phone calls” (100) to pharmacies and stores serviced by Jewel rack jobbers in the days after the poisonings. The FDA “almost immediately” cleared J&J of all wrongdoing.

The FDA did not get involved because of a variety of structural issues. In 1982, the FDA was facing a particularly acute funding issue due to a government shutdown that year. Further, the FDA had no authority to investigate over-the-counter medications like Tylenol until 1997. Most importantly, Harris argues that the FDA commissioner at the time, Dr. Arthur Hayes, Jr. was “corrupt.” Dr. Hayes “surreptitiously and illegally took money from drug agencies while he led the agency” (102). Hayes repeatedly insisted that J&J had no liability in the Tylenol poisonings. After he left the FDA, he went to work for a J&J-affiliated public relations firm. Harris argues that Hayes sought a “compromise” with J&J: In exchange for J&J leading the market in tamper-resistant packaging, he would publicly absolve them of wrongdoing.

In 1993, J&J faced another Tylenol scandal. That year, Anthony Benedi, a White House staffer, was hospitalized after taking Extra Strength Tylenol. He required a liver transplant. In the lawsuit, it was revealed that J&J was aware that “moderate drinkers—could suffer catastrophic liver damage from ordinary doses of Tylenol” (107). Acetaminophen, the active ingredient in Tylenol, reduces pain without hurting the stomach or the heart. However, its negative effects on the liver have long been known. In 1976, the FDA approved over-the-counter Extra Strength Tylenol. The FDA issued a warning about its toxic effect on the liver in 1977, but ultimately decided a warning did not have to be printed on the box. 

Extra Strength Tylenol, which was marketed as safer than alternatives, became J&J’s bestseller even though it has a narrow safety window. People die of accidental overdoses of Tylenol, particularly if they are even moderate drinkers. Accidental overdoses of Tylenol are particularly hard to treat because they often present as flu-like symptoms. Other countries place restrictions on acetaminophen because of this risk.

In 1957, J&J subsidiary McNeil introduced an extra strength liquid Tylenol for infants. However, the concentrated dose is very dangerous. In the 2000s, 20 children died of acetaminophen overdoses in the US, in part because the medication does not provide dosing information for infants. The FDA was repeatedly warned of the risks and in 2011 “scheduled yet another advisory committee” (116) about children’s acetaminophen. Two weeks before the committee hearing, J&J pulled its concentrated liquid Tylenol for children from the market.