Massachusetts v. Purdue is a lawsuit filed on August 14, 2018, suing the Stamford, Connecticut-based company Purdue Pharma LP, which created and manufactures OxyContin, "one of the most widely used and prescribed opioid drugs on the market", and Purdue's owners, the Sacklers accusing them of "widespread fraud and deception in the marketing of opioids, and contributing to the opioid crisis, the nationwide epidemic that has killed thousands." Purdue denied the allegations.
The case On June 1, 2018, Massachusetts Attorney General Maura Healey notified eight members of the Sackler familyAccording to the February 2018 article in The Guardian, three of Mortimer David Sackler's children, Ilene Sackler Lefcourt, Kathe Sackler, and Mortimer David Alfons (Mortimer) Sackler are currently on Purdue Pharma's Board of Directors along with Theresa Sackler, the third wife of Mortimer David Sackler. Current Purdue Board of Directors also include Raymond Sackler's sons, Jonathan Sackler, Richard Stephen Sackler, former Purdue CEO and current director, and his son David Sackler. Richard wife, Beverly Sackler, is a former Purdue director. Richard Stephen Sackler, Beverly Sackler, David Sackler, Ilene Sackler Lefcourt, Jonathan Sackler, Kathe Sackler, Mortimer David Alfons (Mortimer) Sackler, Theresa Sackler, as well as Purdue's Peter Boer, Judith Lewent, Cecil Pickett, Paulo Costa, Ralph Snyderman, John Stewart, Mark Timney, and Craig Landau of her intention to file a 300-page lawsuit accusing Purdue and eight members of the Sackler family and nine other people currently or formerly associated with the company "of misleading doctors and patients about the risks of OxyContin." Healey alleged that "Purdue deceived patients and doctors to get them to prescribe and take the addictive drug." Healey said in the court complaint that, "Revealing the truth about Purdue's misconduct is important to achieve justice and make sure deception like Purdue's never happens again." On June 16, NBC described Healey's lawsuit that named eight of the Sackler family members, as an "unusual step".
On December 21, 2018, AG Healey filed an amended complaint to Massachusetts v. Purdue with 700 redacted sections. Purdue Pharma had unsuccessfully attempted to prevent documents that were part of the AG's complaint, public. According to CNN, in a ruling by Massachusetts Superior Court Judge Janet L. Sanders, an "unredacted amended complaint must be publicly released by February 1". In response, Purdue Pharma filed a motion on January 30 to stay Judge Sanders' order that "could expose details about one of America's richest families and their connection to the nation's opioid crisis." In the lawsuit, Healey said that eight members of the Sackler family are "personally responsible" for the deception. She alleges they "micromanaged" a "deceptive sales campaign." On January 31, Judge Sanders agreed with The Times and other media organizations, that the entire complaint related to Massachusetts v. Purdue, should be made public, in spite of Purdue's efforts to block the release.
Background
In 1995, Purdue Pharma laboratory tests showed that "68% of the oxycodone could be extracted from an OxyContin tablet when crushed". A July 1996 study co-authored by Paul D. Goldenheim MD - who later became Purdue's chief medical officer - published in the Journal of Clinical Pharmacology reported that the controlled-release (CR) formulation - by mouth - had a variable duration of action ranging from 10 to 12 hours. The report by eight authors said that, "[t]reatment with CR oxycodone was safe and effective in this study, and its characteristics will be beneficial in the treatment of pain." Wikipedia article Oxycodone: A July 1996 study independent of Purdue Pharma, found the controlled-release formulation (OxyContin, Xtampza ER) had a variable duration of action ranging from 10–12 hours. By mouth (CR): 10–12 hrs The report said that the study was independent of Purdue Pharma.
In 1996, Purdue Pharma "began a massive marketing campaign", based on a "unique claim" for OxyContin, with FDA permission, that, "as a long-acting opioid, it might be less likely to cause abuse and addiction than shorter-acting painkillers like Percocet." By 1998, Purdue's audiotapes, brochures, videotapes, literature and its website "Partners Against Pain", "claimed that the risk of addiction from OxyContin was extremely small."
In 2001 New York Times journalist Barry Meier, who is the author of Pain Killer: A Wonder Drug's Trail of Addiction and Death, began investigating Purdue Pharma and OxyContin, then a relatively unknown drug made by a relatively unknown family the Sacklers, who were at that time "one of the wealthiest families in the United States". In an August 24, 2001 taped-interview with three top Purdue executives, CEO Michael Friedman, Howard Udell and Dr. Paul Goldenheim, the executives told Meier that "they had learned of OxyContin's growing abuse only in early 2000, a statement they also made before congressional committees".
The number of prescriptions of OxyContin rose to more than 14 million in 2001 and 2002 up from 316, 000 prescriptions in 1996. This represented almost $3 billion in sales compared to $44 million in 1996. Purdue directly sponsored and/or gave grants for over "20, 000 pain-related educational programs" influencing doctors' prescribing in the United States from 1996 to July 2002. In 2002 during the United States Senate Committee on Health, Education, Labor, and Pensions Hearing on "OxyContin: balancing risks and benefits", Paul Goldenheim reported that in 2001 alone Purdue spent $200 million marketing OxyContin.
A 2004 New York Times review of Meier's 2003 book, Pain Killer, described how "For years, doctors who prescribed OxyContin were told that the risk of addiction to the painkiller was less than 1 percent. Only after the drug had devastated thousands of lives was it revealed that this figure, touted as scientific fact, was based on a small study that had no relevance for the general public."
In 2014, the Office of the Attorney General (OAG) of the State of New York began an investigation of Purdue's Abuse and Diversion Detection (ADD) Program and Purdue's unbranded website www.inthefaceofpain.com. In 2015, Purdue entered into an Assurance of Discontinuance with the New York Attorney General.
In a 2015 article in the Annual Review of Public Health, researchers wrote that, "Between 1996 and 2002, Purdue Pharma funded more than 20,000 pain-related educational programs through direct sponsorship or financial grants and launched a multifaceted campaign to encourage long-term use of [opioid painkillers] for chronic non-cancer pain. As part of this campaign, Purdue provided financial support to the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the Joint Commission, pain patient groups, and other organizations. In turn, these groups all advocated for more aggressive identification and treatment of pain, especially use of [opioid painkillers]."
In 2016, investigative journalists Harriet Ryan, Lisa Girion, and Scott Glover of the Los Angeles Times published the results of their extensive investigation into OxyContin, reporting that Purdue had "marketed OxyContin for its supposed ability to provide 12 hours of pain relief", which put it at a competitive advantage over other pain killers. However,"[e]ven before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. Since the drug's debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research." In response to the series, Senator Edward J. Markey, (D-MASS) asked the DOJ, the FDA, and the Federal Trade Commission to launch an investigation into Purdue Pharma. In 2017, "Purdue sold $1.74 billion of OxyContin...according to Symphony Health Solutions". Governor Andrew Cuomo said, "The opioid epidemic was manufactured by unscrupulous distributors who developed a $400 billion industry pumping human misery into our communities."
On October 30, 2017, The New Yorker published a lengthy exposé on Raymond Sackler, who was the co-founder along with his brother Mortimer Sackler of Purdue Pharma, and the Sackler family, that linked Raymond and his older brother, Arthur Sackler's business acumen with the rise of direct pharmaceutical marketing and eventually to the rise of addiction to OxyContin. The article implies that the Sackler family bears a moral responsibility for the opioid epidemic in the United States.
By August 2018, the U.S. Food and Drug Administration continued to approve Purdue's "scientific and medical information it has provided to doctors". By 2018, 27 States, including Puerto Rico, counties and cities, including New York City, Bridgeport, New Haven and Waterbury, had filed lawsuits, accusing "Opioid makers and distributors" of "using deceptive marketing to sell the painkillers".
Prior history A 2004 New York Times review of Meier's 2003 book, Pain Killer, described how "For years, doctors who prescribed OxyContin were told that the risk of addiction to the painkiller was less than 1 percent. Only after the drug had devastated thousands of lives was it revealed that this figure, touted as scientific fact, was based on a small study that had no relevance for the general public." The U.S. Department of Justice investigated the allegations.
On May 10, 2007, Purdue Frederick Company Inc, a holding company affiliated with Purdue Pharma, along with 3 company executives, pleaded guilty to criminal charges of misbranding OxyContin by claiming that it was less addictive and less subject to abuse and diversion than other opioids" after the U.S. Department of Justice investigated the allegations. They pleaded guilty to a felony charge that it had fraudulently to misled the public about Oxycontin's risk of addiction and had claimed to doctors and patients that OxyContin would cause less abuse and addiction than competing short-acting narcotics like Percocet and Vicodin." It was fined a total of , one of the largest pharmaceutical settlements in U.S. history was put on five years' probation.Sue Lindsey, (May 11, 2007) OxyContin Maker, Execs Guilty of Deceit USA Today reproducing and Associated Press reportBarry Meier, (May 11, 2007) "In Guilty Plea, OxyContin Maker to Pay $600 Million", New York Times
Purdue Pharma's three top executives, president Michael Friedman, top lawyer, Howard R. Udell, and former chief medical officer Paul D. Goldenheim, pleaded guilty as individuals to misleading the public about Oxycontin's risk of addiction, a misbranding charge — a criminal violation. At their sentencing hearing in July 2007, Judge James P. Jones of the United States District Court sentenced Friedman, Udell and Goldenheim to three years' probation", and community service in drug treatment programs and , and in fines, respectively, representing $34.5 million in fines.
Just before the trial, John Brownlee, the federal attorney in Roanoke in rural Virginia met privately with Barry Meier, author of Pain Killer: A Wonder Drug's Trail of Addiction and Death, to tell him that his August 2001 interview with the three top Purdue executives Friedman, Udell, and Goldenheim, had helped "inform" the DOJ's investigation. Meier and a New York Times photographer met the three executives on May 10, 2007, as they had left the federal courthouse in Roanoke, heading to their corporate jet to go back to Connecticut, just before Brownlee's public announcement of their guilty pleas of "misbranding" OxyContin.