On the back of last week’s announcement that Johnson & Johnson and three other drug wholesalers agreed to pay a $589-million settlement to hundreds of native tribes for contributing to the opioid crisis in their communities, let’s take a brief (and woefully incomplete) look at the outright criminal history of those to whom we have so readily handed control of our health and wellbeing over the past two years.
2004: Pfizer agreed to pay $430 million in fines and pled guilty to charges that a company it had acquired four years previous promoted a drug for non-approved uses, in part by plying doctors with favours to get them to talk up the medication. Warner-Lambert acknowledged spending hundreds of thousands of dollars to promote the anti-seizure medication Neurontin––approved only as an epilepsy drug––for relieving pain, headaches and psychiatric illnesses such as manic depression. “This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk”, said U.S. Atty. Michael Sullivan.
2009: Pfizer was ordered to pay $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs: the painkiller Bextra; Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. Pfizer subsidiary Pharmacia & Upjohn pleaded guilty to a felony violation for promoting off-label uses of Bextra, such as for pain relief after knee replacement surgery. At the FDA’s request, Pfizer pulled Bextra off the market in April 2005 because of its risks, including a rare, sometimes fatal, skin reaction.
2009: Pfizer reached an out-of-court settlement with the Kano state government worth $75m. It was sued after 11 children died in a clinical trial when the northern state of Kano was hit by Africa’s worst ever meningitis epidemic in 1996. A hundred children were given an experimental oral antibiotic called Trovan, while a further hundred received ceftriaxone. Five children died on Trovan and six on ceftriaxone. But later it was claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children and questions were raised over the documentation of the trial. Legal action filed against the company alleged that some received a dose lower than recommended, leaving many children with brain damage, paralysis or slurred speech.
2010: Pfizer was ordered to pay $142 million in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin. Data revealed in a string of U.S. lawsuits indicated the drug was promoted by the company as a treatment for pain, migraines and bipolar disorder—even though it wasn’t effective in treating those conditions and was actually toxic in certain cases, according to an independent drug research group at the University of British Columbia.
2012: For three years, Pfizer Italy provided free cell phones, photocopiers, printers and televisions to doctors, arranged for vacations and even made direct cash payments (under the guise of lecture fees and honoraria) in return for promises by doctors to recommend or prescribe Pfizer’s products. The New York headquarters of the pharmaceutical giant agreed to pay a total of $60.2 million in penalties to settle the documented charges of bribery. The Securities and Exchange Commission (SEC) said that Pfizer Italy employees went out of their way to “falsely” book the expenses under “misleading” labels like “Professional Training” and “Advertising in Scientific Journals”. The penalty was roughly half a percent of the company annual profits that exceeded $10 billion a year on global sales of $67.4 billion in 2011.
2012: Pfizer was ordered to pay a total of about $1.2 billion to settle lawsuits claiming that side effects of Prempro caused women to develop breast cancer. The drug maker had already paid out $896 million to settle approximately 6,000 Prempro breast cancer lawsuits, and Pfizer now set aside an additional $330 million to cover the remaining 4,000, according to a filing with the SEC. The Prempro settlements came after six years of trials, in which several plaintiffs were awarded tens of millions of dollars, including punitive damages for the drug maker’s actions in withholding information about the risk of breast cancer from Prempro.
JUNE 2021: The Supreme Court rejected an appeal from J&J seeking to undo a $2.1 billion award against it over allegations that asbestos in its talc powder products, including baby powder, caused women to develop ovarian cancer. The company said that it was facing more than 21,800 lawsuits over its talc products. Prosecutor Ken Starr wrote in his brief that J&J “knew for decades that their talc powders contained asbestos, a highly carcinogenic substance with no known safe exposure level.” “They could have protected customers by switching from talc to cornstarch, as their own scientists proposed as early as 1973. But talc was cheaper and petitioners were unwilling to sacrifice profits for a safer product”, he wrote.
OCT 2021: J&J put into bankruptcy tens of thousands of legal claims alleging its Baby Powder and other talc-based products caused cancer, offloading the potential liabilities into a newly created subsidiary. The plaintiffs included women suffering from ovarian cancer and others battling mesothelioma. In that process, a J&J business split in two creating LTL. The new entity was saddled with J&J’s talc liabilities. J&J, with a market value exceeding $400 billion, said the talc cases would be halted while LTL navigated bankruptcy proceedings.
2021: Landmark $26 billion settlement resolving claims that the three largest U.S. drug distributors and drug maker J&J helped fuel a deadly nationwide opioid epidemic. The distributors were accused of lax controls that allowed massive amounts of addictive painkillers to be diverted into illegal channels, devastating communities, while J&J was accused of downplaying the addiction risk in its opioid marketing.
2013: J&J and its subsidiaries agreed to pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution included criminal fines and forfeiture totalling $485 million and civil settlements with the federal government and states totalling $1.72 billion.
2011: J&J agreed to pay a $21.4 million criminal penalty as part of a deferred prosecution agreement with the Department of Justice to resolve improper payments by J&J subsidiaries to government officials in Greece, Poland, and Romania in violation of the Foreign Corrupt Practices Act (FCPA). The agreement also resolved kickbacks paid to the former government of Iraq under the United Nations Oil for Food Program.
2011: Doctors without Borders criticized J&J for refusing to make patents on three HIV drugs available to a program that would reduce the cost of the medicines in developing countries. High prices on new medicines force HIV patients in the poorest parts of the world to take older, more toxic drugs and leave them with few options if they become resistant to their existing treatments. “Johnson & Johnson has a unique opportunity to transform this situation,’’ said Sophie Delaunay, a spokeswoman for the international medical humanitarian group. “Instead it has chosen to turn its back on these patients.’’
2010: American pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of J&J, agreed to pay more than $81 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax. According to the agreement reached with the government, Ortho-McNeil Pharmaceutical LLC agreed to plead guilty to a misdemeanour and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act.
2004: J&J agreed to pay up to $90 million to settle claims by patients who claimed the company’s withdrawn heartburn drug, Propulsid, caused heart problems. About 4,000 plaintiffs were included in the settlement, including 300 who are alleged to have died from taking the drug, which was linked to heart problems.
But hey, I’m sure they’ve all seen the error of their way and are no longer all about profits over people, huh?
‘Big Pharma: A Big List of Crimes’, by Ultan Banan. Please note: flash fiction, nonfiction and all other content is the sole work of Black Tarn. Ask before republishing.