City of Boston v. Purdue Pharma, LP, 010320 MASUP , 1884CV02860
|Opinion Judge:||Janet L. Sanders Justice of the Superior Court|
|Party Name:||City of Boston et al. v. Purdue Pharma, LP et al. (and a companion case)|
|Judge Panel:||Judge (with first initial, no space for Sullivan, Dorsey, and Walsh): Sanders, Janet L., J.|
|Case Date:||January 03, 2020|
|Court:||Superior Court of Massachusetts|
Judge (with first initial, no space for Sullivan, Dorsey, and Walsh): Sanders, Janet L., J.
MEMORANDUM OF DECISION AND ORDER ON THE DEFENDANT MANUFACTURERS’ RULE 12(b)(6) MOTIONS TO DISMISS
Janet L. Sanders Justice of the Superior Court
The Cities of Boston and Springfield (Cities) commenced these actions against opioid manufacturers (Manufacturer Defendants), opioid distributors, retail pharmacies, and certain individuals, whom they allege each played a role in causing the over-prescription and diversion of prescription opiates in the Cities. The Cities allege that this flood of opiates brought about a crisis of addiction that has caused them severe damage. The matter is presently before the Court on the Manufacturer Defendants’ Motions to Dismiss pursuant to Mass.R.Civ.P. 12(b)(6).4 The Court heard oral argument on the motion on October 21, 2019. For the following reasons, the Motion is DENIED.
The Boston and Springfield Complaints contain substantially similar allegations against many of the same Manufacturer Defendants. Those named in both actions are: Purdue; Teva Pharmaceuticals USA, Inc. and Cephalon, Inc. (collectively, Cephalon); Johnson & Johnson and Janssen Pharmaceuticals, Inc. (collectively, Janssen); Endo Health Solutions, Inc. and Endo Pharmaceuticals, Inc. (collectively, Endo); and Mallinckrodt, LLC and Mallinckrodt, PLC (collectively, Mallinckrodt). In addition, the Springfield Complaint names opioid manufacturers Collegium Pharmaceuticals (Collegium); and Allergan, PLC; Allergan Finance, LLC; Watson Laboratories, Inc.; Actavis, LLC; and Actavis Pharma, Inc. (collectively, Actavis).5 , 6 Except for facts concerning Collegium and Actavis (which are limited to the Springfield Complaint) and as otherwise noted, the following allegations are common to both Complaints and are taken as true for purposes of the instant motions.
1. The Manufacturer Defendants’ Campaign to Sell Opioids for Chronic Pain
Each of the Manufacturer Defendants make and sell prescription opioid medication. Opioids are chemical substances closely related to heroin. As such, they dampen a person’s perception of pain, but they can also cause a euphoric high. Opioid use carries with it the risk of respiratory depression, which at high doses can be fatal.
When a patient takes opioid medication for pain relief, increasing doses are often needed to achieve the same level of relief. As doses increase in response to tolerance, the risk of respiratory depression increases as well. Even after a few weeks of therapy, opioid disuse may trigger withdrawal symptoms, including anxiety, nausea, headache, tremors, delirium, and pain. Where opioids are taken in larger doses, withdrawal symptoms upon cessation of the drugs become worse. High dosing strength and extended therapy are correlated to an increased risk of opioid addiction. Opioid addicts who are unable to satisfy their overwhelming cravings through legally obtained prescriptions will often turn to the illegal drug trade. Due to these serious risks, until the mid-1990s, the market for prescription opioids was limited to palliative, end-of-life care and short-term acute pain relief.
In the late 1990s and early 2000s, certain Manufacturer Defendants (with the exception of Collegium, which entered the market much later) began a campaign within the medical community to change the narrative about opioids from the narrow view previously espoused to one advocating for their use over longer periods of time. The category of patients receiving treatment was also expanded to include, for example, those suffering from lower back pain or osteoarthritis. At the same time that they worked to change the narrative, the Manufacturer Defendants knew that there was no scientific evidence supporting the long-term use of opioids for chronic pain, particularly when compared to less risky treatments. The Manufacturer Defendants nonetheless launched a multi-faceted, misleading, and deceptive marketing campaign touting the use of opiates for chronic pain so that they could sell more products.
One of the keys to the Manufacturer Defendants’ strategy was minimizing addiction risk while at the same time overselling opioids’ therapeutic benefit. The Manufacturer Defendants claimed, with no supporting evidence, for example, that opioid therapy would improve patients’ quality of life and overall functioning. To increase profits, the Manufacturer Defendants asserted that patients’ pain was undertreated, and that higher, more expensive doses were needed if treatment was to be effective. In particular, they advanced the now discredited concept of "pseudo-addiction": unlike true addiction, which would be a cause for alarm, pseudo-addiction meant only that patients needed more opiates because that was what was necessary to relieve their pain. The Manufacturer Defendants falsely asserted that addiction risk was minimal and could be easily managed; at the same time, they failed to disclose just how difficult it was for a patient to discontinue opioid use.7
The Manufacturer Defendants’ deceptive marketing messages were delivered in two ways: 1) through the marketing of particular brands by aggressive sales representatives, and 2) through the use of seemingly independent third-party sources of information designed to influence doctor prescribing. These third-party sources included key opinion leaders (KOLs) and front groups, such as the American Pain Foundation and the American Pain Society. The KOLs were typically doctors who, in return for receiving financial benefits from the Manufacturer Defendants, advocated for the use of opioids through speaking engagements and other work, including in continuing medical education (CME) programs. Front groups, largely funded by the Manufacturer Defendants, published biased "education guides" and other tools that were widely disseminated to doctors and patients.
2. Manufacturer-Specific Allegations
The Complaints also set out allegations specific to each of the Manufacturer Defendants. The allegations against Purdue are substantially similar to those against it in separate litigation brought by the Attorney General and have already been summarized in this Court’s decision dated September 17, 2019 (the September 2019 Purdue Decision), denying Purdue’s Motion to Dismiss and will not be repeated here. See Commonwealth v. Purdue Pharma, 2019 WL 5495866, Civ. No. 1884-01808-BLS 2 (Mass. Super. September 17, 2019) [36 Mass. L. Rptr. 56] (Purdue). Apart from Purdue, allegations specific to each Manufacturer Defendant are as follows.
1. Cephalon. Cephalon manufactures two fentanyl-based opioids: Actiq, a lollipop or lozenge, and Fentora, a buccal tablet, for the treatment of cancer pain in opioid-tolerant individuals. Despite having Food and Drug Administration (FDA) approval for only this use, Cephalon marketed these products for the treatment of chronic pain through its sales force, the use of KOLs, CMEs, speaker programs, and publications.
Cephalon sponsored a 2007 publication of the Federation of State Medical Boards entitled Responsible Opioid Prescribing that falsely stated that long-term opioid therapy improves patient functioning. It purchased the book in bulk to distribute through its sales force. In 2007, Cephalon also sponsored a front group publication and a CME program that each made similar claims about patient functioning. Cephalon sales representatives made the same misrepresentation to prescribers.
Cephalon also misrepresented the risk of opioid addiction through these sponsored publications and its sales force. One such patient guide stated: "patients without a history of abuse or a family history of abuse do not commonly become addicted to opioids." Another sponsored publication provided that patient agreements would prevent addiction, and Responsible Opioid Prescribing described the concept of pseudo-addiction. These publications also suggested that high-dose opioid therapy was safe, and failed to disclose the risks of opioids as compared to other analgesics. Sales representatives further advanced the falsehood that other analgesics are more toxic than Cephalon’s opioids.
In a 2008 plea agreement with the United States, Cephalon agreed to pay $50 million to settle charges against it for the off-label marketing of its products, including Actiq. In a separate civil suit, Cephalon agreed to pay $375 million to resolve False Claims Act charges also related to off-label marketing. Speaking about the charges, the Acting U.S. Attorney involved noted that the company had been selling Actiq lollipops as if they were "actual lollipops." Springfield Complaint Table 9 at...
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