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== Recalls and litigation == === 1982 Chicago Tylenol murders === {{Main|Chicago Tylenol murders}} On September 29, 1982, a "Tylenol scare" began when the first of seven individuals died in [[Chicago metropolitan area]], after ingesting Extra Strength Tylenol that had been deliberately laced with [[cyanide]].<ref name="nytrecall" /> Within a week, the company pulled 31 million bottles of capsules back from retailers, making it one of the first major recalls in American history.<ref name="nytrecall">{{Cite news |work=[[The New York Times]] | url = https://www.nytimes.com/2002/03/23/your-money/23iht-mjj_ed3_.html | title = Tylenol made a hero of Johnson & Johnson : The recall that started them all | date = March 23, 2002 | author=Judith Rehak }}</ref> The incident led to reforms in the packaging of [[over-the-counter substance]]s and to federal anti-tampering laws. The case remains unsolved and no suspects have been charged. Johnson & Johnson's quick response, including a nationwide recall, was widely praised by [[public relations]] experts and the media and was the gold standard for corporate crisis management.<ref>[http://www.latimes.com/business/la-fi-lazarus11-2010feb11,0,3768807.column Toyota, what's so hard about doing the right thing?], ''[[Los Angeles Times]]'', February 11, 2010</ref><ref>Jennifer Latson for Time Magazine September 29, 2014 [https://time.com/3423136/tylenol-deaths-1982/ How Poisoned Tylenol Became a Crisis-Management Teaching Model]</ref><ref>Judith Rehak for The New York Times. March 23, 2002 [https://www.nytimes.com/2002/03/23/your-money/23iht-mjj_ed3_.html Tylenol made a hero of Johnson & Johnson : The recall that started them all]</ref> === 2010 children's product recall === {{Main|2010 Johnson & Johnson children's product recall}} On April 30, 2010, [[McNeil Consumer Healthcare]], a subsidiary of Johnson & Johnson, voluntarily [[product recall|recalled]] 43 [[over-the-counter drug|over-the-counter]] children's medicines, including [[Tylenol (brand)|Tylenol]], Tylenol Plus, [[Motrin]], [[Zyrtec]] and [[Benadryl]]. The recall was conducted after a routine inspection at a manufacturing facility in [[Fort Washington, Pennsylvania]], United States, revealed that some "products may not fully meet the required manufacturing specifications".<ref name="US firm recalls children's drugs"/><ref name="Warning As Baby Medicines Are Recalled"/> Affected products may contain a "higher concentration of active ingredients" or exhibit other manufacturing defects.<ref name="Warning As Baby Medicines Are Recalled">{{cite news | vauthors = Watts A |title=Warning As Baby Medicines Are Recalled |url=http://news.sky.com/skynews/Home/World-News/Baby-Medicines-Massive-Recall-Of-Johnson--Johnson-Products-Made-By-McNeil-Consumer-Healthcare/Article/201005115623926?lpos=World_News_Top_Stories_Header_3&lid=ARTICLE_15623926_Baby_Medicines%3A_Massive_Recall_Of_Johnson__Johnson_Products_Made_By_McNeil_Consumer_Healthcare |work=Sky News |date=May 2, 2010 |access-date=May 3, 2010}}</ref> Products shipped to Canada, [[Dominican Republic]], Mexico, [[Guam]], [[Guatemala]], [[Jamaica]], [[Puerto Rico]], [[Panama]], [[Trinidad and Tobago]], the [[United Arab Emirates]], [[Kuwait]] and [[Fiji]] were included in the recall.<ref name="US firm recalls children's drugs"/> In a statement, Johnson & Johnson said "a comprehensive quality assessment across its manufacturing operations" was underway.<ref name="US firm recalls children's drugs">{{Cite news |title=US firm recalls children's drugs |url=http://english.aljazeera.net/news/americas/2010/05/2010518535960539.html |work=[[Al Jazeera Arabic|Al Jazeera]] |date=May 1, 2010 |access-date=May 3, 2010}}</ref><ref name="Warning As Baby Medicines Are Recalled"/> A dedicated website was established by the company listing affected products and other consumer information.<ref name="Warning As Baby Medicines Are Recalled"/> === 2010 hip-replacement recall === {{Main|2010 DePuy Hip Recall}} 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.<ref name="Out of joint">{{Cite news | url = http://www.bmj.com/content/342/bmj.d2905.full | title = Out of joint: The story of the ASR | date = May 14, 2011 | author=Deborah Cohen }}</ref> 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{{snd}}the metals from which the implant was made{{snd}}were also released into the blood and [[cerebrospinal fluid]] in some patients.<ref name="fda1">{{Cite news | url = https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm | title = FDA. Concerns about metal-on-metal hip implant systems. 2011 | year = 2011 }}</ref> In March 2013, a jury in Los Angeles ordered Johnson & Johnson to pay more than $8.3{{nbs}}million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the company in connection with the now-recalled DePuy hip.<ref name="Meier">{{Cite news| vauthors = Meier B |title=J.&J. Loses First Case Over Faulty Hip Implant|url=https://www.nytimes.com/2013/03/09/business/johnson-johnson-must-pay-in-first-hip-implant-case.html|access-date=September 4, 2013|newspaper=[[The New York Times]]|date=March 8, 2013}}</ref> Some lawyers and industry analysts have estimated that the suits ultimately will cost Johnson & Johnson billions of dollars to resolve.<ref name="Meier"/> === 2010 Tylenol recall === In 2010 and 2011, Johnson & Johnson voluntarily recalled some [[over-the-counter]] products, including Tylenol, due to an odor caused by tribromoanisole.<ref name=WebMd>[http://arthritis.webmd.com/news/20091229/tylenol-recall-expands Tylenol Recall Expands] {{Webarchive|url=https://web.archive.org/web/20140127132458/http://arthritis.webmd.com/news/20091229/tylenol-recall-expands |date=January 27, 2014 }}, WebMD Health News, January 18, 2010</ref><ref>{{Cite web|url=https://www.fda.gov/Safety/Recalls/ucm261498.htm/|title=McNeil Consumer Healthcare Announces Voluntary Recall Of One Product Lot Of TYLENOL® Extra Strength Caplets 225 Count Distributed In The U.S.|website=[[Food and Drug Administration]]}}</ref> In this case, [[2,4,6-tribromophenol]] was used to treat wooden pallets on which product packaging materials were transported and stored.<ref name=WebMd/> === Shareholders lawsuit === 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.<ref>{{Cite web|url=http://www.law.du.edu/documents/corporate-governance/independent-director/johnsonjohnson/Opinion-In-re-Johnson-and-Johnson-10-cv-2033-D-NJ-Sept-29-2011.PDF|title=10-cv-2033, D. NJ., Sept. 29, 2011|access-date=April 12, 2013|archive-date=January 27, 2018|archive-url=https://web.archive.org/web/20180127064442/http://www.law.du.edu/documents/corporate-governance/independent-director/johnsonjohnson/Opinion-In-re-Johnson-and-Johnson-10-cv-2033-D-NJ-Sept-29-2011.PDF|url-status=dead}}</ref> 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.<ref>[http://www.boston.com/business/healthcare/2012/07/12/shareholders-reach-tentative-deal-lawsuit/6wGyy1rFpcVUR6OEdvYPTL/story.html J&J, shareholders reach tentative deal in lawsuit] By Linda A. Johnson, AP Business Writer / July 12, 2012</ref> === Illegal marketing of Risperdal === 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, to promote it to doctors and patients as better than cheaper generics, and of falsely marketing it for treating patients with [[dementia]].<ref name="CNNMoney">{{Cite web | url = https://money.cnn.com/2013/11/04/news/companies/johnson-and-johnson-settlement/ | title = Johnson & Johnson to pay $2 billion for false marketing | date = November 4, 2013 | website = CNN Money | author = Gregory Wallace |access-date=November 6, 2013}}</ref> States that have awarded damages include [[Texas]] ($158{{nbs}}million), [[South Carolina]] ($327{{nbs}}million), [[Louisiana]] ($258{{nbs}}million), and most notably [[Arkansas]] ($1.2{{nbs}}billion).<ref>[https://www.nytimes.com/2012/04/12/business/drug-giant-is-fined-1-2-billion-in-arkansas.html?_r=0 J.&J. Fined $1.2{{nbs}}Billion in Drug Case] NY Times, By KATIE THOMAS Published: April 11, 2012</ref> 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.<ref name="Hilzenrath">{{Cite news|author=Hilzenrath, David S.|date=January 16, 2010|title=Justice suit accuses Johnson & Johnson of paying kickbacks|url=https://www.washingtonpost.com/wp-dyn/content/article/2010/01/15/AR2010011503903.html|newspaper=[[The Washington Post]] |access-date=January 17, 2010}}</ref><ref>{{Cite news|author=Singer, Natasha|date=January 15, 2010|title=Johnson & Johnson Accused of Drug Kickbacks |url=https://www.nytimes.com/2010/01/16/business/16drug.html|work=[[The New York Times]] |access-date=January 17, 2010}}</ref> 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.<ref>[https://www.bloomberg.com/news/2012-06-11/j-j-said-to-pay-2-2-billion-to-end-risperdal-sales-probe.html J&J Said to Agree to $2.2{{nbs}}Billion Drug Marketing Accord] Bloomberg News. By Margaret Cronin Fisk, Jef Feeley & David Voreacos{{snd}}June 11, 2012</ref> The settlement was finalized on November 4, 2013, with J&J agreeing to pay a penalty of around $2.2{{nbs}}billion, "including criminal fines and forfeiture totaling $485{{nbs}}million and civil settlements with the federal government and states totaling $1.72{{nbs}}billion".<ref name="DOH2013">{{Cite web|last1=Office of Public Affairs|first1=Department of Justice|title=Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations|url=https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations|publisher=United States Department of Justice|access-date=June 16, 2015|date=November 4, 2015}}</ref> Johnson & Johnson has also been subject to congressional investigations related to payments given to [[psychiatrists]] to promote its products and [[ghost writer|ghost write]] articles, notably [[Joseph Biederman]] and his pediatric [[bipolar disorder]] research unit.<ref>[https://www.nytimes.com/2008/11/25/health/25psych.html Research Center Tied to Drug Company] By Gardiner Harris, The New York Times, 2008</ref> === Foreign bribery === 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.<ref>{{Cite web|url=https://www.sec.gov/litigation/litreleases/2011/lr21922.htm|title=Johnson & Johnson|website=www.sec.gov|language=en|access-date=July 5, 2017}}</ref> 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.<ref>{{Cite news|url=https://www.reuters.com/article/us-jj-bribery-idUSTRE7374ZB20110408|title=J&J settles U.S., UK bribery, kickback charges|date=April 8, 2011|work=[[Reuters]]|access-date=July 5, 2017}}</ref> J&J fully cooperated with the investigation once the problems came to light.<ref name="FCPA2011">{{Cite news|title=SEC Charges Johnson & Johnson With Foreign Bribery|url=https://www.sec.gov/news/press/2011/2011-87.htm|work=SEC|date=April 7, 2011}}</ref> === Consumer fraud settlements === In May 2017, J&J reached an agreement to pay $33{{nbs}}million to several states to settle consumer fraud allegations in some of the company's over-the-counter drugs.<ref>{{Cite web|url=https://www.drugwatch.com/2017/05/26/jj-33-million-settlement-states/|title=J&J Reaches $33 Million Settlement with States|website=DrugWatch|access-date=July 5, 2017}}</ref><ref>{{Cite news|url=http://economictimes.indiatimes.com/news/international/business/johnson-johnson-settles-drug-manufacturing-probe-by-us-states-for-33-million/articleshow/58829546.cms|title=Johnson & Johnson settles drug manufacturing probe by US states for $33 million|agency=[[Reuters]]|date=May 24, 2017 |work=[[The Economic Times]] |location=India |access-date=July 5, 2017}}{{Dead link|date=July 2018 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{Cite news|url=http://www.businessinsider.com/r-update-1-jj-settles-drug-manufacturing-probe-by-us-states-for-33-mln-2017-5|title=UPDATE 1-J&J settles drug manufacturing probe by U.S. states for $33 mln|work=[[Business Insider]]|access-date=July 5, 2017|language=en|archive-date=April 12, 2019|archive-url=https://web.archive.org/web/20190412190202/https://www.businessinsider.com/r-update-1-jj-settles-drug-manufacturing-probe-by-us-states-for-33-mln-2017-5|url-status=dead}}</ref> === Use of the Red Cross symbol === {{Further|Emblems of the International Red Cross and Red Crescent Movement#Use of the emblems}} [[File:Flag of the Red Cross.svg|thumb|150px|Flag of the [[Red Cross]]]] Johnson & Johnson registered the [[Red Cross]] as a U.S. trademark for "medicinal and surgical plasters" in 1905 and has used the design since 1887.<ref>{{Cite web|url=http://tarr.uspto.gov/servlet/tarr?regser=serial&entry=71013666|title=Trademark Status & Document Retrieval|work=uspto.gov}}</ref> The [[Geneva Conventions]], which reserved the [[Emblems of the International Red Cross and Red Crescent Movement#Red Cross|Red Cross emblem]] for specific uses, were first approved in 1864 and ratified by the United States in 1882. However, the emblem was not protected by U.S. law for the use of the [[American Red Cross]] (ARC) and the U.S. military until after Johnson & Johnson had obtained its trademark. A clause in this law (now 18 U.S.C. 706) permits this pre-existing use of the Red Cross to continue.<ref>{{Cite web |title=1205.01 Statutory Protection |url=https://tmep.uspto.gov/RDMS/TMEP/print?version=July2015&href=TMEP-1200d1e4447.html |access-date=April 26, 2023 |website=tmep.uspto.gov}}</ref><ref>{{Cite journal |last=Sturges |first=Wesley |date=1957 |title=The Legal Status of the Red Cross |url=https://repository.law.umich.edu/cgi/viewcontent.cgi?article=6915&context=mlr |journal=Michigan Law Review |volume=56 |issue=1 |pages=24–25 |doi=10.2307/1285901 |jstor=1285901 |via=Michigan Law Scholarship Repository}}</ref><ref>{{Cite web |title=§ 706. Red Cross |url=https://www.govregs.com/uscode/title18_partI_chapter33_section706 |access-date=April 26, 2023 |website=GovRegs}}</ref> <!-- Please do NOT insert any further assertions that continued Johnson & Johnson use of the Red Cross violates the Geneva Conventions; as a the paragraph below states, the U.S. specifically excluded that application of the Geneva Conventions thru a reservation. --> A declaration made by the U.S. upon its ratification of the 1949 Geneva Conventions includes a [[Reservation (law)|reservation]] that pre-1905 U.S. domestic uses of the Red Cross, such as Johnson & Johnson's, would remain lawful as long as the cross is not used on "aircraft, vessels, vehicles, buildings or other structures, or upon the ground", i.e., uses which could be confused with its military uses.<ref>[http://www.icrc.org/ihl.nsf/NORM/D6B53F5B5D14F35AC1256402003F9920?OpenDocument U.S. reservations to the 1949 Geneva Conventions] ([[International Committee of the Red Cross]] website)</ref> This means that the U.S. did not agree to any interpretation of the 1949 Geneva Conventions that would overrule Johnson & Johnson's trademark. The American Red Cross continues to recognize the validity of Johnson & Johnson's trademark.<ref>{{Cite web |date=August 10, 2007 |title=American Red Cross Defends Use of Emblem and Mission |url=http://www.redcross.org/pressrelease/0%2C1077%2C0_314_6910%2C00.html |url-status=dead |archive-url=https://web.archive.org/web/20070818044717/http://www.redcross.org/pressrelease/0,1077,0_314_6910,00.html |archive-date=August 18, 2007}}</ref> In August 2007, Johnson & Johnson filed a lawsuit against the ARC, demanding that the charity halt the use of the red cross symbol on products it sells to the public, though the company takes no issue with the charity's use of the mark for nonprofit purposes.<ref>[https://www.wsj.com/articles/SB118662527980592590 "Red Cross Is Sued by J&J Over Signature Emblem"] ''[[The Wall Street Journal]]'' August 9, 2007</ref> In May 2008, the judge in the case dismissed most of Johnson & Johnson's claims, and a month later the two organizations announced a settlement had been reached in which both parties would continue to use the symbol.<ref>{{Cite news | url = https://www.nytimes.com/2008/06/18/business/18cross.html | title = Claim Over Red Cross Symbol Is Settled |work=[[The New York Times]] | date = June 18, 2008 | vauthors = Saul S |author-link1=Stephanie Saul }}</ref> === Boston Scientific lawsuits === Since 2003, Johnson & Johnson and [[Boston Scientific]] have both claimed that the other had infringed on their patents covering [[heart stent]] medical devices. The litigation was settled when Boston Scientific agreed to pay $716{{nbs}}million to Johnson & Johnson in September 2009 and an additional $1.73{{nbs}}billion in February 2010.<ref>[https://www.wsj.com/articles/SB10001424052748704107204575039430685168478 Boston Scientific to Pay J&J $1.73B to Settle Stent Patent Disputes], ''[[The Wall Street Journal]]'', February 2, 2010</ref> Their dispute was renewed in 2014, now on the grounds of a contract dispute.<ref>[https://www.reuters.com/article/us-johnson-johnson-boston-scient-trial-idUSKCN0J30CS20141119 J&J seeks over $5{{nbs}}billion in damages from Boston Scientific at trial]. [[Reuters]], November 19, 2014</ref> === Patent-infringement case against Abbott === In 2007, Johnson & Johnson sued [[Abbott Laboratories]] over the development and sale of the arthritis drug [[Humira]], claiming Abbott used technology licensed exclusively to Johnson & Johnson's [[Centocor]] division. Johnson & Johnson won the court case, and in 2009 Abbott was ordered to pay Johnson & Johnson $1.17{{nbs}}billion in lost revenues and $504{{nbs}}million in royalties.<ref name=Bloomberg2009>[https://www.bloomberg.com/apps/news?pid=newsarchive&sid=aF0Qoxe0JCiw Abbott Told to Pay Record $1.67{{nbs}}billion Award to J&J], ''Bloomberg News'', June 29, 2009</ref> The judge also added $175.6{{nbs}}million in interest to bring the total to $1.84{{nbs}}billion.<ref name= bloomberg2010>[https://www.bloomberg.com/news/2010-11-02/abbott-challenges-1-67-billion-patent-loss-to-j-j-over-arthritis-therapy.html Abbott Challenges $1.67{{nbs}}billion Patent Loss to J&J Over Humira], ''Bloomberg News'', November 2, 2010</ref> This was the largest patent-infringement award in U.S. history<ref name=Bloomberg2009/> until the 2013 decision against Teva in favor of [[Takeda Pharmaceutical Company|Takeda]] and [[Pfizer]] for over $2.1{{nbs}}billion.<ref name= WSJ2013>[https://online.wsj.com/news/articles/SB10001424127887324188604578541080995659790 Pfizer, Takeda to Get $2.15{{nbs}}Billion Settlement], ''WSJ'', December 6, 2013</ref> In 2010 Abbott appealed the verdict<ref name= bloomberg2010/> and in 2011 won the appeal.<ref name="BusinessWeek2011">{{Cite web|url=http://www.businessweek.com/news/2011-02-23/abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory.html|title=abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory|work=[[Bloomberg News|Bloomberg]]|url-status=dead|archive-url=https://web.archive.org/web/20110506001424/http://www.businessweek.com/news/2011-02-23/abbott-wins-reversal-of-j-j-s-1-67-billion-patent-victory.html|archive-date=May 6, 2011}}</ref> === Vaginal mesh implants === Tens of thousands of women worldwide have taken legal action against Johnson & Johnson after suffering serious complications following a vaginal mesh implant procedure.<ref name="cbsnews.com">{{Cite web|url=https://www.cbsnews.com/news/states-file-lawsuit-against-johnson-johnson-over-pelvic-mesh-implants/|title=States file lawsuit against Johnson & Johnson over pelvic mesh implants|website=www.cbsnews.com|date=May 25, 2016 }}</ref> In Australia, 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".<ref>{{Cite web|url=https://www.theguardian.com/australia-news/2017/jul/04/vaginal-mesh-risks-downplayed-by-johnson-johnson-court-told|title=Vaginal mesh risks downplayed by Johnson & Johnson, court told | vauthors = Knaus C |date=July 4, 2017|website=[[The Guardian]]}}</ref> Emails between executives show the company was aware of the risks in 2005 but still went ahead and made the product available.<ref>{{Cite news|url=https://www.theguardian.com/society/2018/nov/27/vaginal-mesh-implant-sold-despite-warnings-could-cause-pain-johnson-johnson|title=Pharma giant sold mesh implant despite pain warnings| vauthors = Devlin H |date=November 27, 2018|work=[[The Guardian]]|access-date=November 25, 2019|language=en-GB|issn=0261-3077}}</ref> In November 2019 the [[Federal Court of Australia]] found Johnson & Johnson negligent.<ref name=":2">{{Cite web |date=September 12, 2022 |title=Johnson & Johnson to pay pelvic mesh victims record $300m settlement |url=https://www.afr.com/companies/healthcare-and-fitness/johnson-and-johnson-to-pay-pelvic-mesh-victims-record-300m-settlement-20220912-p5bhco |access-date=December 5, 2022 |website=Australian Financial Review |language=en}}</ref> The judgment was appealed, with the appeals court upholding all findings of Justice [[Anna Katzmann|Anna Katzman]].<ref>{{Cite web |last1=King |last2=Madar |first2=Wood Mallesons-Suzy |last3=McDonnell |first3=Justin |last4=Saville |first4=Moira |last5=Stevenson |first5=Peta |last6=Swinn |first6=Matthew |date=March 9, 2021 |title=Appeal in Ethicon pelvic mesh class action – what risks need to be disclosed? |url=https://www.lexology.com/library/detail.aspx?g=8da9bd1e-7799-4525-a686-12803a416713 |access-date=December 5, 2022 |website=Lexology |language=en}}</ref> Ethicon then sought a High Court decision but this was not permitted by the High Court of Australia. Subsequently (September 2022) a A$300,000,000 compensation agreement was reached between [[Shine Lawyers]] and J&J but this agreement remains subject to approval by the Federal Court of Australia.<ref name=":2" /> In the US in 2016 the U.S. states of California and [[Washington (state)|Washington]] filed a lawsuit against the company, accusing it of deception.<ref name="cbsnews.com" /> 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 US market in 2012. The amount settled in the suit was about $117{{nbs}}million.<ref>{{cite news | vauthors = Sebastian D |title=Johnson & Johnson to Pay $117{{nbs}}Million Over Surgical Device Marketing |url=https://www.wsj.com/articles/johnson-johnson-to-pay-117-million-over-surgical-device-marketing-11571334613 |work=[[The Wall Street Journal]] |publisher=Dow Jones and Company |date=October 17, 2019 |location=New York NY}}</ref> === Baby powder === J&J has been the subject of over 60,000 lawsuits claiming that its [[baby powder]] causes [[ovarian cancer]].<ref>{{Cite web |date=2025-02-18 |title=Johnson & Johnson begins battle over $10 billion case linking baby powder to cancer |url=https://www.independent.co.uk/news/world/americas/johnson-baby-powder-ovarian-cancer-b2700095.html |access-date=2025-02-19 |website=The Independent |language=en}}</ref> The lawsuits focus on [[Talc#Association with asbestos|claims]] that the [[talc]]-based powder is contaminated with [[asbestos]], a known [[carcinogen]] commonly found in places where talc is mined.<ref name=":8">{{Cite news|last1=Stohr|first1=Greg|last2=Feeley|first2=Jef|date=June 1, 2021|title=J&J to Pay $2.1 Billion Talc Award as Top Court Nixes Appeal|work=[[Bloomberg News]]|url=https://www.bloomberg.com/news/articles/2021-06-01/j-j-must-pay-2-1-billion-talc-award-as-top-court-rejects-appeal?srnd=premium&sref=qZlN2rKN|access-date=June 1, 2021}}</ref> In 2016, J&J was ordered to pay $72{{nbs}}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.<ref name="BBC">{{Cite news|title=Johnson & Johnson hit with $72m damages in talc-cancer case|url=https://www.bbc.co.uk/news/world-us-canada-35648252|access-date=February 24, 2016|work=[[BBC News]]|date=February 24, 2016}}</ref> A year later, 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.<ref>[https://www.bloomberg.com/features/2016-baby-powder-cancer-lawsuits/ Johnson & Johnson Has a Baby Powder Problem] Bloomberg, Retrieved April 20, 2017.</ref> Later that year, a California jury ordered Johnson & Johnson to pay $417{{nbs}}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{{nbs}}million in compensatory damages and $347{{nbs}}million in punitive damages. J&J said they would appeal the verdict.<ref>{{Cite news|url=https://www.reuters.com/article/us-johnson-johnson-cancer-lawsuit/jj-ordered-to-pay-417-million-in-trial-over-talc-cancer-risks-idUSKCN1B121D|title=J&J ordered to pay $417{{nbs}}million in trial over talc cancer risks|date=August 21, 2017|newspaper=[[Reuters]]|last1=Raymond|first1=Nate}}</ref> The [[Missouri]] Eastern District appeals court later negated a $72{{nbs}}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. Subsequently, this ruling killed three other recent St. Louis jury verdicts of more than $200{{nbs}}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.<ref>{{Cite web|url=http://www.stltoday.com/news/local/crime-and-courts/missouri-appeals-court-tosses-out-million-dollar-johnson-johnson-talcum/article_e976d9eb-c9dc-5fdf-b136-8d94bc6cfbdd.html|title=Missouri appeals court tosses out $72 million Johnson & Johnson talcum powder verdict | vauthors = Currier J |date=October 17, 2017 }}</ref> A St. Louis jury awarded nearly $4.7{{nbs}}billion in damages to 22 women and their families in 2018 after they claimed that asbestos in Johnson & Johnson talcum powder caused their ovarian cancer.<ref>{{Cite news | vauthors = Bever L |title=Johnson & Johnson ordered to pay $4.7 billion to women who say baby powder gave them cancer |url=https://www.washingtonpost.com/news/to-your-health/wp/2018/07/13/johnson-johnson-ordered-to-pay-4-7-billion-to-women-who-say-baby-powder-gave-them-cancer/ |newspaper=[[The Washington Post]] |access-date=July 28, 2018 |language=en |date=July 13, 2018}}</ref> 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.<ref>{{Cite web|url=https://www.livemint.com/Companies/f2z1TqJx9HtNRwmAEiIXXK/Johnson-and-Johnsonremoveschemicals-to-make-products-safer.html|title=Johnson and Johnson removes chemicals to make products safer|date=August 7, 2018|access-date=August 25, 2018}}</ref> The company was forced to release internal documents 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.<ref>{{Cite web|url=https://www.nbcnews.com/health/health-news/johnson-johnson-knew-decades-asbestos-lurked-its-baby-powder-n948016|title=Johnson & Johnson knew for decades that asbestos lurked in some of its baby powder|website=[[NBC News]]|date=December 14, 2018 }}</ref> 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{{nbs}}billion in punitive damages and $550{{nbs}}million in compensatory damages.<ref>{{Cite web|url=https://www.foxbusiness.com/features/jj-loses-its-battle-to-overturn-a-4-7b-baby-power-verdict|title=J&J loses its battle to overturn a $4.7B baby powder verdict| vauthors = Scipioni J |date=December 19, 2018|website=FOXBusiness|language=en-US|access-date=December 19, 2018}}</ref> 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-report]]ing, 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]]).<ref>{{Cite web|url=https://theness.com/neurologicablog/index.php/the-johnson-and-johnson-talc-cancer-case/|title=The Johnson and Johnson Talc Cancer Case|author=Steven Novella|website=Neurologica blog|date=February 25, 2016|access-date=September 30, 2019|author-link=Steven Novella}}</ref> Conversely, 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.<ref>{{Cite news|url=https://www.seattletimes.com/business/st-louis-jury-sides-with-johnson-johnson-in-talc-case/|title=St. Louis jury sides with Johnson & Johnson in talc case| vauthors = Salter J |date=December 23, 2019|work=[[The Seattle Times]]|access-date=December 24, 2019|agency=[[Associated Press]]}}</ref> 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.<ref>{{Cite web|url=https://www.aljazeera.com/ajimpact/johnson-johnson-ceo-refuses-attend-hearing-carcinogens-191210004346338.html|title=Johnson & Johnson CEO refuses to attend US hearing on carcinogens|date=December 10, 2019|website=www.aljazeera.com|access-date=December 11, 2019}}</ref> 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 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 [[Corn starch|cornstarch]]-based baby powder will continue to sell in the United States and Canada.<ref>{{Cite web|title=Johnson & Johnson to discontinue sales of talc-based baby powder in U.S., Canada|url=https://www.cbsnews.com/news/johnson-johnson-talc-baby-powder-discontinued-us-canada/| vauthors = Albert V |date=May 19, 2020|website=[[CBS News]]|language=en-US|access-date=May 19, 2020}}</ref> The [[Supreme Court of Missouri]] refused to consider J&J's appeal of a $2.12 billion damages award to women who blamed their ovarian cancer on its talc-based products.<ref>{{cite web|url=https://www.reuters.com/article/us-johnson-johnson-talc-ruling-idUKKBN27J2N4|title=Johnson & Johnson fails to overturn $2.12 billion baby powder verdict, plans Supreme Court appeal|website=[[Reuters]]|date=November 3, 2020|author=Jonathan Stempel|access-date=March 24, 2022}}</ref><ref>{{cite web|url=https://www.nytimes.com/2020/06/23/health/baby-powder-cancer.html|title=Women With Cancer Awarded Billions in Baby Powder Suit|website=[[The New York Times]]|date=June 23, 2020|author=Roni Caryn Rabin|access-date=March 24, 2022}}</ref> The [[Supreme Court of the United States]] also 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.<ref>{{cite web|url=https://www.cnn.com/2021/06/01/politics/johnson--johnson-supreme-court-2-billion-verdict/index.html|title=Supreme Court won't review $2 billion verdict against Johnson & Johnson in talc powder case|website=[[CNN]]|date=June 1, 2021|author1=Ariane de Vogue|author2=Jen Christensen|access-date=March 24, 2022}}</ref> 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, [[W. Mark Lanier|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."<ref>{{Cite web|title=Supreme Court Won't Consider Johnson & Johnson Challenge to Baby Powder Judgment|url=https://www.wsj.com/articles/supreme-court-won-t-consider-johnson-johnson-challenge-to-2-1-billion-judgment-in-baby-powder-case-11622555345|author1=Brent Kendall|author2=Peter Loftus |date=June 1, 2021|website=[[The Wall Street Journal]]|language=en-US|access-date=June 11, 2021}}</ref><ref>{{Cite web|title=Supreme Court Says A $2 Billion Verdict In A Baby Powder Cancer Case Should Remain|url=https://www.npr.org/2021/06/01/1002149828/supreme-court-johnson-johnson-talc-verdict-ovarian-cancer|date=June 1, 2021|website=[[NPR]]|language=en-US|access-date=June 11, 2021}}</ref> 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.<ref name=":8" /> In 2021, Johnson & Johnson subsidiary LTL Management LLC, using a process called a [[Texas two-step bankruptcy|Texas divisional merger]], filed for [[Chapter 11 bankruptcy]] in [[North Carolina]]. The process allowed by [[Texas]] law lets a company create a separate subsidiary to take over liabilities, with the existing company operating normally. The new company, with a different name, can locate in a state such as North Carolina where bankruptcy laws are different, and then declare bankruptcy, paying less than the original company would have. In the case of LTL, a $2 billion trust will be created, compared to $25 billion if Johnson & Johnson had declared bankruptcy. According to the filing, a company known as Old JJCI took on the baby powder related liabilities in 1979, while Johnson & Johnson remained a defendant. LTL and New JJCI were created with LTL taking the baby powder related liabilities and some assets, and New JJCI taking the remaining assets. Johnson & Johnson says LTL is now based in [[New Jersey]].<ref>{{cite news|url=https://www.dallasnews.com/business/2021/10/14/johnson-johnson-forms-new-texas-subsidiary-to-take-ovarian-cancer-claims-into-bankruptcy-court/|title=Johnson & Johnson forms new subsidiary to take ovarian cancer claims into bankruptcy court|last=Walters|first=Natalie|work=[[The Dallas Morning News]]|date=October 14, 2021|accessdate=October 16, 2021}}</ref><ref>{{Cite news|title=J&J is using a bankruptcy maneuver to block lawsuits over baby powder cancer claims|language=en|work=[[NPR]]|url=https://www.npr.org/2021/10/21/1047828535/baby-powder-cancer-johnson-johnson-bankruptcy?t=1634916799719|access-date=October 22, 2021}}</ref> The company announced that it would stop making talc-based powder by 2023 and replace it with cornstarch-based powders. The company says the talc-based powder is safe to use and does not contain asbestos.<ref>{{cite news|url=https://www.bbc.com/news/business-62514263 | title=J&J to replace talc-based powder with cornstarch after cancer lawsuits | date=August 12, 2022 | publisher=[[BBC News]] |access-date=August 12, 2022 }}</ref> Lawsuits showed connections between Johnson & Johnson and the [[Holmesburg Prison#Experiments on inmates|Holmesburg Prison experiments]].<ref>{{Cite web |last=Blohm |first=Eike |title=Experimenting on Prisoners: New California Lawsuits Reveal Old Abuses |url=https://www.prisonlegalnews.org/news/2022/oct/31/experimenting-prisoners-new-california-lawsuits-reveal-old-abuses/ |access-date= |website=[[Prison Legal News]]}}</ref><ref>{{Cite news |last=Feeley |first=Jef |date=March 7, 2022 |title=J&J's Controversial Prison Testing Resurfaces in Baby Powder Lawsuits |url=https://www.bloomberg.com/news/articles/2022-03-07/j-j-s-controversial-prison-testing-resurfaces-in-baby-powder-lawsuits |work=[[Bloomberg News|Bloomberg]]}}</ref><ref>{{Cite web |title=New Docs Show J&J Funded Study That Injected Inmates With Asbestos In 1971 |url=https://kffhealthnews.org/morning-breakout/new-docs-show-jj-funded-study-that-injected-inmates-with-asbestos-in-1971/ |access-date=2025-03-24 |website=[[KFF Health News]] |language=en-US}}</ref><ref>{{Cite web |last=Feeley |first=Jef |date=2022-03-08 |title=J&J's controversial prison testing with a Penn doctor resurfaces in baby powder lawsuits |url=https://www.inquirer.com/business/health/jj-talc-powder-skin-penn-testsprison-20220308.html |access-date=2025-03-24 |website=[[The Philadelphia Inquirer]] |language=en}}</ref> In 2023, the number of lawsuits regarding talc-based baby powder exceeded 40,000 as more claimants came forward to say that the company's product caused them to have cancer. Johnson & Johnson offered $9 billion to settle all the lawsuits against the company, up from the previous figure of $2 billion.<ref>{{cite news|url=https://www.bbc.com/news/business-65180131 | title=Johnson & Johnson offers $9bn to settle talc claims | date=April 5, 2023 | publisher=[[BBC News]] |access-date=April 5, 2023}}</ref> In February 2025, as the number of talc-based powder related lawsuits sits at over 62,000, Johnson & Johnson offered a settlement of $10 billion to end litigation, funded by a subsidiary's filing for Chapter 11 bankruptcy, reliant on the approval from Houston bankruptcy judge, Judge Christopher Lopez. While the proposal showed significantly more support compared to their last bankruptcy attempts, there are accusations of the company pushing against negative votes, and widely accepting positive ones. Adam Silverstein, an attorney representing plaintiffs rejecting the proposal, branded the move as a "blatant double standard" in a statement to Lopez.<ref>{{Cite web |last=Knauth |first=Dietrich |date=18 Feb 2025 |title=J&J begins crucial battle over $10 billion baby powder settlement |url=https://www.reuters.com/legal/jj-begins-crucial-battle-over-10-billion-baby-powder-settlement-2025-02-18/ |access-date=18 Feb 2025 |website=Reuters}}</ref> === Opioid epidemic === {{Further|Opioid epidemic in the United States}} By 2018, the company had become embroiled in the [[opioid epidemic in the United States]] and had become a target of [[lawsuit]]s.<ref>{{Cite news|url=https://www.dddmag.com/news/2018/03/doj-support-lawsuits-against-companies-selling-opioids|title=DOJ to Support Lawsuits Against Companies Selling Opioids| vauthors = Gurman S, Mulvihill G | date = March 2, 2018 |work=Drug Discovery & Development|access-date=March 2, 2018|publisher=Advantage Business Media|agency=[[Associated Press]]}}</ref><ref>{{Cite news|url=https://www.cnn.com/2019/03/12/health/oklahoma-opioid-trial-johnson-and-johnson-kingpin/index.html|title=Johnson & Johnson acted as opioid kingpin, Oklahoma attorney general says|date=March 12, 2019|access-date=March 14, 2019|publisher=[[CNN]]}}</ref> Over 500 opioid-related cases have been filed as of May 2018 against J&J and its competitors.<ref>{{Cite web|url=https://seekingalpha.com/article/4200206-trump-insurance-johnson-and-johnson|title=Trump Insurance For Johnson & Johnson|date=August 17, 2018 |access-date=August 25, 2018}}</ref> In Idaho, J&J is part of a lawsuit accusing the company for being partially to blame for opioid-related overdose deaths.<ref>{{Cite web|url=https://www.idahostatesman.com/living/health-fitness/article216893150.html|title=11 Idaho counties take on Walmart, CVS, drug companies in opioid lawsuit|access-date=August 25, 2018}}</ref> The first major trial began in Oklahoma in May 2019.<ref>{{Cite news|url=https://www.wsj.com/articles/first-big-trial-in-opioid-crisis-set-to-kick-off-in-oklahoma-11558958401|title=First Big Trial in Opioid Crisis Set to Kick Off in Oklahoma| vauthors = Randazzo S |date=May 27, 2019|work=[[The Wall Street Journal]]|access-date=May 28, 2019|language=en-US|issn=0099-9660}}</ref> On August 26, 2019, the Oklahoma judge ordered J&J to pay $572{{nbs}}million for their part in the opioid crisis,<ref>{{Cite web|url=https://www.cnn.com/2019/08/26/health/oklahoma-opioid-trial-verdict-bn/index.html|title=Oklahoma wins case against drugmaker in historic opioid trial|work=[[CNN]]| vauthors = Howard J, Drash W | date=August 26, 2019 | access-date=August 26, 2019}}</ref> and in October J&J paid $20.4{{nbs}}million to two Ohio counties fighting the opioid epidemic.<ref>{{Cite web|url=https://www.usnews.com/news/healthiest-communities/articles/2019-10-02/johnson-and-johnson-agrees-to-pay-ohio-counties-204m-opioid-settlement|title=Johnson & Johnson to Pay Ohio Counties $20.4M Opioid Settlement|website=www.usnews.com}}</ref> In January 2022, Johnson & Johnson agreed to pay up to $5 billion as part of a $26 billion settlement which included [[McKesson Corporation|McKesson]], [[AmerisourceBergen]], and [[Cardinal Health]].<ref>{{Cite news|last=Raymond|first=Nate|date=January 27, 2022|title=Most U.S. local governments opt to join $26 bln opioid settlement|language=en|work=[[Reuters]]|url=https://www.reuters.com/world/us/most-us-local-governments-opt-join-26-bln-opioid-settlement-2022-01-26/|access-date=February 21, 2022}}</ref> Had the states gone to court, the companies could have faced up to $95 billion in penalties.<ref>{{Cite news|last=Raymond|first=Nate|date=November 16, 2021|title=Washington state, in $95 billion opioid trial, blames drug distributors for crisis|language=en|work=[[Reuters]]|url=https://www.reuters.com/world/us/mckesson-drug-distributors-face-95-billion-opioid-trial-washington-state-2021-11-15/|access-date=February 21, 2022}}</ref> ==== Northeastern Ohio Settlement ==== In October 2019, the company agreed to a settlement of $20.4{{nbs}}million with [[Greater Cleveland|northeastern]] [[Ohio]]'s most populous counties of [[Cuyahoga County, Ohio|Cuyahoga]] (containing [[Cleveland]]) and [[Summit County, Ohio|Summit]] ([[Akron, Ohio|Akron]]). The settlement allows the company avoidance of a trial accusing J&J and many other pharmaceutical manufacturers of helping to spark the US opioid epidemic. The trial was thought to be an indicator for thousands of opioid-related lawsuits against many drug manufacturers. The arrangement, which contains no admission of liability by the company, provides the counties $10{{nbs}}million in cash, $5{{nbs}}million for legal expenses and $5.4{{nbs}}million in contributions to opioid-related nonprofit organizations in the counties.<ref>{{cite news |vauthors = Randazzo S |title=Johnson & Johnson Agrees to Settle Ohio Opioid Lawsuits for $20.4 Million |url=https://www.wsj.com/articles/johnson-johnson-agrees-to-settle-ohio-opioid-lawsuits-for-20-4-million-11569977306?mod=article_inline |work=[[The Wall Street Journal]] |publisher=Dow Jones and Company |date=October 1, 2019 |location=New York NY}}</ref>
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