On August 24, 2010, DePuy, a subsidiary of American giant Johnson & Johnson, recalled its ASR (articular surface replacement) hip prostheses from the market. DePuy said the recall was due to unpublished National Joint Registry data showing a 12% revision rate for resurfacing at five years and an ASR XL revision rate of 13%. All hip prostheses fail in some patients, but it is expected that the rate will be about 1% a year.[173] Pathologically, the failing prosthesis had several effects. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium – the metals from which the implant was made – were also released into the blood and cerebral spinal fluid in some patients.
In 2010 a group of shareholders sued the board for allegedly failing to take action to prevent serious failings and illegalities since the 1990s, including manufacturing problems, bribing officials, covering up adverse effects and misleading marketing for unapproved uses. The judge initially dismissed the case in September 2011, but allowed the plaintiffs opportunity to refile at a later time.[178] In 2012 Johnson and Johnson proposed a settlement with the shareholders, whereby the company would institute new oversight, quality and compliance procedures binding for five years.[179]
Juries in several US states have found J&J guilty of concealing the adverse effects of Janssen Pharmaceuticals' antipsychotic medication Risperdal, produced by its unit, in order to promote it to doctors and patients as better than cheaper generics, and of falsely marketing it for treating patients with dementia.[180] States that have awarded damages include Texas ($158 million), South Carolina ($327 million), Louisiana ($258 million), and most notably Arkansas ($1.2 billion).[181]
In 2010, the United States Department of Justice joined a whistleblowers suit accusing the company of illegally marketing Risperdal through Omnicare, the largest company supplying pharmaceuticals to nursing homes.[182][183] The allegations include that J&J were warned by the FDA to not promote Risperdal as effective and safe for elderly patients, but they did so, and that they paid Omnicare to promote the drug to care home physicians.[184] The settlement was finalized on November 4, 2013, with J&J agreeing to pay a penalty of around $2.2 billion, "including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion".[185]
Johnson & Johnson has also been subject to congressional investigations related to payments given to psychiatrists to promote its products and ghost write articles, notably Joseph Biederman and his pediatric bipolar disorder research unit.[186]
In 2011, J&J settled litigation brought by the US Securities and Exchange Commission under the Foreign Corrupt Practices Act and paid around $70M in disgorgement and fines.[187] J&J's employees had given kickbacks and bribes to doctors in Greece, Poland, and Romania to obtain business selling drugs and medical devices and had bribed officials in Iraq to win contracts under the Oil for Food program.[188] J&J fully cooperated with the investigation once the problems came to light.[189]
Tens of thousands of women worldwide have taken legal action against Johnson & Johnson after suffering serious complications following a vaginal mesh implant procedure.[204] In 2016 the U.S. states of California and Washington filed a lawsuit against the company, accusing it of deception.[204] More than 700 women began a class action against the company in the Federal Court of Australia in 2017, telling the court they "suffered irreparable, debilitating pain after the devices began to erode into surrounding tissue and organs, causing infections and complications". The class action alleged that Johnson & Johnson, which "aggressively marketed" the implants "failed to properly warn patients and surgeons of the risk, or test the devices adequately".[205] Emails between executives show the company was aware of the risks in 2005 but still went ahead and made the product available.[206]
In October 2019, the company and its subsidiary, Ethicon, Inc. reached a settlement with 41 states and the District of Columbia, with no admission of liability, in a suit alleging deceptive marketing of transvaginal surgical-mesh devices. The suit also alleges that the company failed to disclose risks associated with the product, which J&J pulled from the market in 2012. The amount settled in the suit was about $117 million.[207]
J&J has been the subject of over 26,000 lawsuits claiming that its baby powder causes ovarian cancer. The lawsuits focus on claims that the talc-based powder is contaminated with asbestos, a known carcinogen commonly found in places where talc is mined.[208]
In February 2016, J&J was ordered to pay $72 million in damages to the family of Jacqueline Fox, a 62-year-old woman who died of ovarian cancer in 2015. The company said it would appeal.[209]
By March 2017, over 1,000 U.S. women had sued J&J for covering up the possible cancer risk from its Baby Powder product. The company says that 70% of its Baby Powder is used by adults.[210] In August, a California jury ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian cancer after using the company's talc-based products like Johnson's Baby Powder for feminine hygiene. The verdict included $70 million in compensatory damages and $347 million in punitive damages. J&J said they would appeal the verdict.[211] The Missouri Eastern District appeals court later negated a $72 million jury verdict in the Jacqueline Fox lawsuit, ruling it lacked jurisdiction in Missouri because of a U.S. Supreme Court decision that imposed limits on where injury lawsuit can be filed. The court said, "... establishing a lawsuit's jurisdiction requires a stronger connection between the forum state and a plaintiff's claims." Subsequently, this ruling killed three other recent St. Louis jury verdicts of more than $200 million combined. Fox, 62, of Birmingham, Alabama, died in 2015, about four months before her trial was held in St. Louis Circuit Court. She was among 65 plaintiffs, of whom only two were from Missouri.[212]
In July 2018, a St. Louis jury awarded nearly $4.7 billion in damages to 22 women and their families after they claimed that asbestos in Johnson & Johnson talcum powder caused their ovarian cancer.[213] In August, J&J said that it removed several chemicals from baby powder products and re-engineered them to make consumers more confident that products were safer for children.[214] The company was forced to release internal documents in December, with 11,700 people suing J&J over cancers allegedly caused by baby powder. The documents showed that the company had known about asbestos contamination since at least as early as 1971 and had spent decades finding ways to conceal the evidence from the public.[215] On December 19, 2018, the company lost its request to reverse a jury verdict that ruled in favor of the accusers, which required the company to pay $4.14 billion in punitive damages and $550 million in compensatory damages.[216] Though asbestos is a known carcinogen, the potential link between asbestos-free talc and cancer also alleged in these lawsuits is a subject of scientific controversy, as discussed on the Neurologica blog by Steven Novella. A large study performed in 2003 found that ovarian cancer risk increased from a baseline of 0.0121% to 0.0161% in people who reported regularly using talc in the genital area. Two more studies over the next twelve years, which also relied on self-reporting, had similar results. However, none of the three studies showed a relationship between how long someone used talc and how much their cancer risk increased, which is expected in experiments with carcinogens and other toxic substances (see dose-response relationship).[217]
Conversely, in December the following year, a St. Louis jury ruled in favor of Johnson & Johnson in the case of a single plaintiff who had used the company's talc-containing baby powder for thirty years with a similar claim.[218] In 2019, the company's CEO, Alex Gorsky, declined to appear at a United States congressional hearing on the safety of J&J's Baby Powder and other talc-based cosmetics. J&J spokesman Ernie Knewitz said that the subcommittee had rejected the company's offers to send a talc testing expert or a J&J executive in charge of consumer products.[219] In response to declining demand, J&J announced it would discontinue the sale of talc-based baby powder in the United States and Canada in May 2020, but would continue to sell it in other markets. In a statement, the company said that the existing retail inventory of the talc-based powder will sell until it runs out, while the company's cornstarch-based baby powder will continue to sell in the United States and Canada.[220]
In June 2021, the Supreme Court of the United States refused to consider an appeal from J&J, leaving in place a judgment from a state appeal court that had cut the original award to $2.1 billion. Two of the justices had to recuse: Samuel Alito because either he and/or his wife owning or recently owning stock in J&J, and Brett Kavanaugh, whose father led an industry group lobbying against safety warnings on talc products. Representing the affected women during the trial, Mark Lanier remarked that the Supreme Court's decision sent "a clear message to the rich and powerful: You will be held to account when you cause grievous harm under our system of equal justice under law.”[221][222] J&J had argued that the combined claims in the St. Louis trial were too different, yet the short jury deliberation and identical payouts were, therefore, a violation of the company's due process and also that the high punitive award was unconstitutional.[208]
By 2018, the company had become embroiled in the opioid epidemic in the United States and had become a target of lawsuits.[223][224] Over 500 opioid-related cases have been filed as of May 2018 against J&J and its competitors.[225] In Idaho, J&J is part of a lawsuit accusing the company for being partially to blame for opioid-related overdose deaths.[226] The first major trial began in Oklahoma in May 2019.[227] On August 26, 2019, the Oklahoma judge ordered J&J to pay $572 million for their part in the opioid crisis,[228] and in October J&J paid $20.4 million to two Ohio counties fighting the opioid epidemic.[229]
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