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Langlois v. Insys Therapeutics, Inc.

United States District Court, D. New Hampshire

May 16, 2019

Pamela Langlois
v.
Insys Therapeutics, Inc.

          ORDER

          JOSEPH A. DICLERICO, JR. UNITED STATES DISTRICT JUDGE

         Pamela Langlois brings suit against Insys Therapeutics, Inc., alleging claims that are based on Insys's efforts to induce Physician Assistant Christopher Clough to prescribe Subsys, an opioid medication manufactured by Insys, to Langlois. Insys moves to dismiss Langlois's claims on the grounds that they are untimely and that she fails to state claims for fraud and civil conspiracy.[1] Langlois objects.

         Standard of Review

         A motion under Federal Rule of Civil Procedure 12(b)(6) seeks to dismiss on the ground that the plaintiff fails “to state a claim on which relief can be granted.” A motion to dismiss may be based on a defense that the claims are barred by the statute of limitations. Abdallah v. Bain Capital LLC, 752 F.3d 114, 119 (1st Cir. 2014). To decide the motion, the court accepts as true all of the properly pleaded facts and draws reasonable inferences in favor of the nonmoving party. Lemelson v. Bloomberg L.P., 903 F.3d 19, 23 (1st Cir. 2018).

         Background

         Pamela Langlois was a patient at the PainCare clinic in Somersworth, New Hampshire, in 2013 for treatment of osteoarthritic pain. She was treated by Physician Assistant Clough, who used various opioid medications including Oxycodone. Langlois did not have cancer during any time while being treated at PainCare.

         A. Langlois's Treatment with Subsys

         In July of 2013, Clough began prescribing Subsys for Langlois. Clough did not tell Langlois that he had changed her medication. Clough prescribed Subsys at a dose of 400 mcg.

         Langlois received the first shipment of Subsys by FedEx from a company called Lindencare in New York. When Clough's office called Langlois to tell her that someone over eighteen years old would have to sign for the shipment, she asked what the medication was because she had not been told she had a new prescription. In his notes, Clough wrote that he was replacing Langlois's prescription for Roxicodone with Subsys, but in fact he continued to prescribe Roxicodone to Langlois, along with Subsys.

         By November of 2013, Clough had increased the dose of Subsys to 1200 mcg, and then in December he increased the dose to 1600 mcg every four to six hours. Clough continued to prescribe Roxicodone along with Subsys.

         Langlois became dependent on Subsys and experienced symptoms from taking the medication. On several occasions, she lost consciousness. At other times, she became comatose, and she was often in a zombie-like state. Her husband thought that she had stopped breathing on one occasion.

         Clough cut the Subsys prescription in half, to 800 mcg, in July of 2014. By October of 2014, Clough stopped prescribing Subsys to Langlois, but he did not discuss the change with her. Langlois called the office in October to ask about her prescription, and Clough's assistant wrote a note in the file asking if Clough had discussed the change of prescription with Langlois. Clough's response was “hold Subsys.” Langlois experienced serious symptoms of withdrawal after her prescription was cut in half and then discontinued.

         To explain the change, Clough told Langlois that PainCare was no longer prescribing Subsys because drug addicts were using it improperly. Langlois now believes that the real reason was because Clough's license was under investigation in the fall of 2014. The Board of Medicine suspended Clough's license in 2015 and revoked his license in 2016.

         B. Subsys and Insys Therapeutics

         Subsys is a sublingual opioid spray, classified as a Schedule II substance, that is manufactured by Insys. Subsys is more potent than morphine or heroin. The FDA approved Subsys in January of 2012 to manage breakthrough cancer pain in adults when the patient had become tolerant of other opioid medications. The FDA-approved dosage was 100 mcg.

         A TIRF REMS form was completed for Langlois's Subsys prescription. TIRF REMS stands for Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy, which is an FDA program, and enrollment is required to prescribe, dispense, or distribute TIRF medications. Langlois did not sign the form, and instead her name was typed where her signature should have been.

         The New Hampshire Attorney General's Office began an investigation of Clough's dealings with Insys. In the course of that investigation, the Attorney General's office discovered that New Hampshire residents received more than 800 prescriptions for Subsys, consisting of 100, 000 units, in 2013 and 2014 and that Clough wrote 84% of the prescriptions. The investigation uncovered a scheme through which Insys paid Clough to prescribe Subsys

         Insys paid Clough $44, 000.00 to promote Subsys at speaking engagements, which were shams. Instead of business events, the engagements were social gatherings usually attended by Clough's friends and family that were held at high end restaurants.[2]Clough also participated in Insys's Speakers Bureau and became a critical part of that program. He was also paid to speak at those events. ...


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