Editing Abbott Laboratories (section)

==Litigation and controversies==

=== Leuprorelin ===
In October 2001, the US Department of Justice, states attorneys general, and TAP Pharmaceutical Products, a subsidiary of Abbott Laboratories, settled criminal and civil charges against TAP related to federal and state [[Medicare fraud]] and illegal marketing of the drug [[leuprorelin]].<ref>{{Cite journal|last=Charatan|first=Fred|date=2001-10-13|title=Drug companies defrauded Medicare of millions|journal=BMJ: British Medical Journal|volume=323|issue=7317|pages=828|doi=10.1136/bmj.323.7317.828a|issn=0959-8138|pmc=1121385|pmid=11597964}}</ref> TAP paid a total of $875 million,  a [[List of largest pharmaceutical settlements|record high pharmaceutical settlement]].<ref name=":1">{{Cite news|last=Petersen|first=Melody|date=2001-10-04|title=2 Drug Makers to Pay $875 Million to Settle Fraud Case|language=en-US|work=The New York Times|url=https://www.nytimes.com/2001/10/04/business/2-drug-makers-to-pay-875-million-to-settle-fraud-case.html|access-date=2022-01-24|issn=0362-4331}}</ref><ref name=":2">{{Cite web|title=#513: 10-03-01 TAP PHARMACEUTICAL PRODUCTS INC. AND SEVEN OTHERS CHARGED WITH HEALTH CARE CRIMES COMPANY AGREES TO PAY $875 MILLION TO SETTLE CHARGES|url=https://www.justice.gov/archive/opa/pr/2001/October/513civ.htm|access-date=2022-01-24|website=www.justice.gov|archive-date=11 November 2020|archive-url=https://web.archive.org/web/20201111201014/https://www.justice.gov/archive/opa/pr/2001/October/513civ.htm|url-status=live}}</ref> This comprised $290 million for violating the Prescription Drug Marketing Act, $559.5 million to settle federal fraud charges for overcharging Medicare, and $25.5 million reimbursement to 50 states and Washington, D.C., for filing false claims with the states' Medicaid programs.<ref name=":2" /> The case arose under the [[False Claims Act]] with claims filed by Douglas Durand, a former TAP vice president of sales, and Joseph Gerstein, a doctor at [[Tufts University]]'s HMO practice.<ref name=":1" /> Durand, Gerstein, and Tufts shared $95 million of the settlement.<ref name=":1" />

There have since been various suits concerning leuprorelin use, none successful.<ref>{{Cite web |date=2021-05-08 |title=What You Should Know About Lupron Class Action Lawsuit |url=https://lawanswer.org/what-you-should-know-about-lupron-class-action-lawsuit/ |access-date=2022-02-28 |website=Law Answer |language=en-US |archive-date=28 February 2022 |archive-url=https://web.archive.org/web/20220228112017/https://lawanswer.org/what-you-should-know-about-lupron-class-action-lawsuit/ |url-status=live }}</ref><ref>{{Cite web |title=Abbott, AbbVie Defeat Long-Running Lupron Bone, Joint Suit (1) |url=https://news.bloomberglaw.com/product-liability-and-toxics-law/abbott-abbvie-defeat-long-running-lupron-bone-joint-lawsuit |access-date=2022-02-28 |website=news.bloomberglaw.com |language=en |archive-date=28 February 2022 |archive-url=https://web.archive.org/web/20220228112014/https://news.bloomberglaw.com/product-liability-and-toxics-law/abbott-abbvie-defeat-long-running-lupron-bone-joint-lawsuit |url-status=live }}</ref> These lawsuits have focused on either the over-prescription of the drug or the lack of warnings about its potential [[side effect]]s. Between 2010 and 2013, the FDA updated the Lupron drug label to include new safety information on the risk of thromboembolism, loss of bone density and convulsions.<ref>{{Cite web |date=2019-02-12 |title=More women come forward with complaints about Lupron side effects |url=https://www.ktnv.com/news/investigations/more-women-come-forward-with-complaints-about-lupron-side-effects |access-date=2022-02-28 |website=KTNV |language=en}}</ref> The FDA then said that the benefits of leuprorelin outweighed its risks when used according to its approved labeling. From 2017 the FDA  evaluated leuprorelin's connection to pain and discomfort in musculoskeletal and connective tissue.<ref>{{Cite web |title=January - March 2017 {{!}} Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) |date=3 January 2023 |url=https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/january-march-2017-potential-signals-serious-risksnew-safety-information-identified-fda-adverse |publisher=FDA |language=en |access-date=28 February 2022 |archive-date=28 February 2022 |archive-url=https://web.archive.org/web/20220228112016/https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/january-march-2017-potential-signals-serious-risksnew-safety-information-identified-fda-adverse |url-status=dead }} With updates; last update 6 January 2023.</ref>

===Humira===
In March 2003, British company Cambridge Antibody Technology (CAT) stated its wish to "initiate discussions regarding the applicability of the royalty offset provisions for Humira" ([[Adalimumab]]) with Abbott Laboratories in the High Court of London. In December 2004, the judgment ruled for CAT.<ref>{{cite web |url=https://www.bloomberg.com/apps/news?pid=newsarchive&sid=af.37juYEPaQ |title=Cambridge Antibody Wins Lawsuit Against Abbott Labs (Update5) – Bloomberg |website=[[Bloomberg News]] |date=16 July 2023 |access-date=5 March 2017 |archive-date=24 September 2015 |archive-url=https://web.archive.org/web/20150924173217/http://www.bloomberg.com/apps/news?pid=newsarchive&sid=af.37juYEPaQ |url-status=live }}</ref>

Abbott was required to pay CAT US$255 million in lieu of royalties the MRC, the Scripps Research Institute and Stratagene would have received on sales of Humira after December 2004. Some of this sum was to be passed to its partners in development, including US$191 million for the [[Medical Research Council (United Kingdom)|UK Medical Research Council]] (MRC), plus a further $7.5 million over five years from 2006 providing that Humira remained on the market.<ref>{{Cite web |date=2005-10-26 |title=MRC to receive over USD200m |url=https://www.lifearc.org/news/2005/mrc-to-receive-over-usd200m/ |access-date=2022-02-28 |website=LifeArc |language=en-GB |archive-date=27 September 2022 |archive-url=https://web.archive.org/web/20220927170442/https://www.lifearc.org/news/2005/mrc-to-receive-over-usd200m/ |url-status=live }}</ref>

=== Operation Headwaters ===
In October 2003, Abbott Laboratories and two of its units agreed to pay a total of $600 million in the first combined civil settlement and criminal conviction for offering kickbacks to agents of "Operations Headwaters", an undercover investigation by the FBI.<ref>{{Cite web|title=#613: 11-10-03 JUSTICE DEPT. CIVIL FRAUD RECOVERIES TOTAL $2.1 BILLION FOR FY 2003 FALSE CLAIMS ACT RECOVERIES EXCEED $12 BILLION SINCE 1986|url=https://www.justice.gov/archive/opa/pr/2003/November/03_civ_613.htm|access-date=2022-01-24|website=www.justice.gov|archive-date=24 January 2022|archive-url=https://web.archive.org/web/20220124195613/https://www.justice.gov/archive/opa/pr/2003/November/03_civ_613.htm|url-status=live}}</ref>

===Depakote===
On 2 October 2012, the company was charged with a $500 million fine and $198.5 million forfeiture for illegal marketing of [[Depakote]] for uses not approved by the FDA. The court also sentenced Abbott to a five-year term of probation and court supervision.<ref name="doj">[https://www.justice.gov/opa/pr/2012/May/12-civ-585.html Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote] {{Webarchive|url=https://web.archive.org/web/20140821040621/http://www.justice.gov/opa/pr/2012/May/12-civ-585.html |date=21 August 2014 }}, Press Release, [[United States Department of Justice]] Office of Public Affairs, 7 May 2012. Retrieved 17 August 2014.</ref> Shareholders then brought derivative suits against the company directors for breach of fiduciary duty.<ref>U.S. ex rel. McCoyd v. Abbott Laboratories, 1:07-cv-00081 (W.D. Va.); U.S. ex rel. Mulcahy v. Abbott Laboratories, 1:08-cv-0054 (W.D. Va.); U.S. ex rel. Dietzler v. Abbott Laboratories, 1:09-cv-00051 (W.D. Va.); U.S. ex rel. Spetter v. Abbott Laboratories, 1:10-cv-00006 (W.D. Va.).</ref><ref>{{Cite web|url=https://www.law360.com/articles/516296/abbott-shareholders-agree-to-settle-depakote-marketing-suit|title=Abbott, Shareholders Agree To Settle Depakote Marketing Suit - Law360|website=www.law360.com|access-date=5 July 2023|archive-date=4 March 2016|archive-url=https://web.archive.org/web/20160304072158/http://www.law360.com/articles/516296/abbott-shareholders-agree-to-settle-depakote-marketing-suit|url-status=live}}</ref> Following Abbott's spinoff of its research-based pharmaceuticals business, it no longer owns the commercial rights and associated responsibilities for Humira and Depakote.<ref>{{cite news|url=https://www.reuters.com/article/abbott/update-2-abbott-ultra-bullish-on-humira-despite-spinoff-plan-idUSN1E79K06F20111021|title=Abbott ultra-bullish on Humira despite spinoff plan|work=Reuters|date=21 October 2011|last1=Krauskopf|first1=Ransdell Pierson|access-date=22 November 2019|archive-date=20 August 2020|archive-url=https://web.archive.org/web/20200820201630/https://www.reuters.com/article/abbott/update-2-abbott-ultra-bullish-on-humira-despite-spinoff-plan-idUSN1E79K06F20111021|url-status=live}}</ref>

=== Glucose monitors ===
In 2021, two of Abbott Laboratories' subsidiaries, Arriva Medical LLC and Alere Inc, had to pay $160m to resolve claims that they had fraudulently billed [[Medicare (United States)|Medicare]] for glucose monitors. The [[US Department of Justice]] said that Arriva used free glucose monitors to induce patients to order more consumable supplies, then took [[Kickback (bribery)|kickback]]s on the increased sales. The company was also accused of charging Medicare for glucose monitors given to patients who were ineligible, or even dead.<ref>{{Cite news|last=Stempel|first=Jonathan|date=2021-08-02|title=Abbott Labs to pay $160 mln over kickbacks, false diabetes claims to Medicare|language=en|work=Reuters|url=https://www.reuters.com/business/healthcare-pharmaceuticals/us-says-abbott-units-pay-160-mln-resolve-alleged-false-medicare-claims-2021-08-02/|access-date=2022-01-24|archive-date=24 January 2022|archive-url=https://web.archive.org/web/20220124011240/https://www.reuters.com/business/healthcare-pharmaceuticals/us-says-abbott-units-pay-160-mln-resolve-alleged-false-medicare-claims-2021-08-02/|url-status=live}}</ref>

=== Plant shutdown ===
In February 2022, Abbott recalled baby formulas from the market and shut down their Michigan plant after complaints of illness and death in infants caused by serious bacterial infections. Following Abbotts' meeting the initial requirement of the [[U.S. Food & Drug Administration]], the facility reopened in June 2022.<ref>{{Cite news |date=2022-05-17 |title=Explainer: What happened with Abbott baby formula that worsened a U.S. shortage? |language=en |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/what-happened-with-abbott-baby-formula-that-worsened-us-shortage-2022-05-16/ |access-date=2022-06-04 |archive-date=4 June 2022 |archive-url=https://web.archive.org/web/20220604180124/https://www.reuters.com/business/healthcare-pharmaceuticals/what-happened-with-abbott-baby-formula-that-worsened-us-shortage-2022-05-16/ |url-status=live }}</ref><ref>{{Cite news |last1=Aboulenein |first1=Ahmed |last2=Heavey |first2=Susan |date=2022-05-19 |title=U.S. FDA says Abbott baby formula plant on track to reopen in 1-2 weeks |language=en |work=Reuters |url=https://www.reuters.com/business/retail-consumer/abbott-baby-formula-plant-track-reopen-within-1-2-weeks-fda-commissioner-2022-05-19/ |access-date=2022-06-04}}</ref><ref>{{Cite news |date=2022-06-04 |title=Baby formula shortage could ease as Abbott reopens Michigan plant |language=en |work=Reuters |url=https://www.reuters.com/business/healthcare-pharmaceuticals/abbott-reopens-baby-formula-plant-michigan-2022-06-04/ |access-date=2022-06-04}}</ref><ref>{{Cite web |title=Abbott baby formula aftermath: One dead child and another with brain damage so bad she has constant seizures and crying bouts |url=https://fortune.com/well/2023/12/08/abbott-baby-formula-recall-dead-child-brain-damage/ |access-date=2024-03-18 |website=Fortune Well |language=en |archive-date=18 March 2024 |archive-url=https://web.archive.org/web/20240318173113/https://fortune.com/well/2023/12/08/abbott-baby-formula-recall-dead-child-brain-damage/ |url-status=live }}</ref>

=== Deep Brain Stimulation Device Recall ===
On July 18, 2023, Abbott recalled its Proclaim and Infinity IPGs due to complaints from patients who are unable to exit MRI mode. The use of the affected IPGs may require surgery to remove the device and replace it with a new device.

There have been 186 reported incidents and 73 reported injuries. There have been no reports of death.<ref>{{Cite journal |last=Health |first=Center for Devices and Radiological |date=2023-09-13 |title=Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode |url=https://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-proclaim-and-infinity-ipgs-inability-exit-magnetic-resonance-imaging-mri-mode |journal=FDA |language=en |access-date=22 September 2023 |archive-date=20 September 2023 |archive-url=https://web.archive.org/web/20230920082218/https://www.fda.gov/medical-devices/medical-device-recalls/abbott-medical-recalls-proclaim-and-infinity-ipgs-inability-exit-magnetic-resonance-imaging-mri-mode |url-status=dead }}</ref> Noted by Gita Amar, a PR representative for Abbott Laboratories on this issue. "The company has communicated this action to physicians and regulatory bodies. No products need to be returned to the company or replaced."<ref>{{Cite web |date=2023-09-13 |title=Abbott Recalls Certain Proclaim, Infinity Neurostimulation Devices |url=https://wallstreetwaves.com/abbott-recalls-certain-proclaim-infinity-neurostimulation-devices/ |access-date=2023-09-22 |language=en-US |archive-date=28 October 2023 |archive-url=https://web.archive.org/web/20231028173116/https://wallstreetwaves.com/abbott-recalls-certain-proclaim-infinity-neurostimulation-devices/ |url-status=live }}</ref>

=== Necrotizing Enterocolitis (NEC) Lawsuit ===
On July 26, 2024, a jury ordered Abbott Laboratories to pay $495 million in the case of Margo Gill vs. Abbott Laboratories, comprising $95 million in compensatory damages and $400 million in punitive damages.<ref>{{Cite web |date=2025-04-03 |title=TorHoerman Law Obtains $495 Million NEC Verdict as Lead Counsel in Infant Formula NEC Trial Against Abbott Laboratories |url=https://www.torhoermanlaw.com/toxic-baby-formula-nec-lawsuit/495-million-verdict-obtained-by-torhoerman-law-as-lead-counsel-in-infant-formula-nec-trial-against-abbott-laboratories/ |access-date=2025-04-03 |website=TorHoerman Law, LLC |language=en}}</ref> The lawsuit alleged that Abbott's infant formula for premature babies increased the risk of necrotizing enterocolitis (NEC), a gastrointestinal disease that can cause intestinal tissue death and can be life-threatening.