United States District Court, D. New Hampshire
A. DICLERICO, JR. UNITED STATES DISTRICT JUDGE
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. Langlois objects.
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
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
Langlois's Treatment with Subsys
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.
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.
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.
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.
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.
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.
Subsys and Insys Therapeutics
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.
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.
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
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.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. ...