United States District Court, D. New Hampshire
Michael P. Rainboth, Esq.
Michael D. Ramsdell, Esq.
P. Schwartz, Esq.
J. Walz, Esq.
A. DiClerico, Jr. United States District Judge.
Perry brings claims against Insys Therapeutics, Inc. that
arise from Insys's actions to induce Physician Assistant
Christopher Clough to prescribe Subsys, an opioid
manufactured by Insys, to Perry. Insys moves to dismiss
Perry's claims on the grounds that they are barred by the
statute of limitations and that she fails to adequately
allege fraud and a civil conspiracy. Perry 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 Cir. 2018).
Perry had pain in both knees caused by a prior injury.
Beginning in 2013, she was treated at the PainCare Clinic in
Somersworth, New Hampshire. Physician Assistant Christopher
Clough treated her at PainCare with numerous opioid
Perry's Treatment with Subsys
of 2013, Clough told Perry that he had a new miracle drug for
her treatment. When Perry protested that she was doing well
on her current medication, Clough told her that the new drug,
Subsys, was much better and persuaded her to switch. Clough
prescribed Subsys, at the dosage of 400 mcg, and had the drug
sent to Perry by FedEx from a company called Lindencare in
New York. Clough continued to prescribe other opioid
medications for Perry to use along with Subsys.
increased Perry's Subsys dose in July of 2013 to 800 mcg.
In September of 2013, he increased the dose to 1200 mcg every
four hours. Clough continued to increase the dose, without
any medical justification, until Perry was taking 1600 mcg
every four hours in February of 2014.
result, Perry became dependent on Subsys. Several times, she
lost consciousness and had to be revived by her husband who
thought she had stopped breathing. On other occasions she was
in a “zombie like state” and even comatose. She
fell asleep at work, at dinner, and while having
conversations. Perry told Clough she could not tolerate such
high doses of Subsys and that the drug was causing her to
pass out. She asked him to reduce the dose. Despite her
concerns, Clough continued to prescribe Subsys at 1600 mcg
every four hours until November of 2014.
November of 2014, Clough cut the dose of Subsys in half,
which caused Perry to have withdrawal symptoms. Perry called
Clough's office to report the symptoms. Clough told Perry
that he was leaving the practice to work for his mother and
to go back to school. In reality, Clough was under
investigation by the New Hampshire Board of Medicine. His
license was suspended in 2015 and revoked in 2016. A new
physician at Pain Care attempted to wean Perry off of Subsys
beginning in December of 2014. She suffered extreme symptoms
Subsys and Insys Therapeutics
which is manufactured by Insys Therapeutics, is a sublingual
fentanyl spray. Perry alleges that Subsys is classified as a
schedule II substance, which is more powerful than morphine
or heroin. The FDA approved Subsys in January of 2012 for
treatment of breakthrough cancer pain in adults who had
become tolerant of other opioid medications. The approved
dose was no more than 100 mcg. Because of its potency and the
risk of misuse, addiction, and overdose, the FDA imposed
rigorous controls on prescribing and dispensing Subsys.
Hampshire Attorney General's office began an
investigation into Clough's dealings with Insys. The
office learned that 84% of the Subsys prescriptions in New
Hampshire were written by Clough in 2013 and 2014. Clough was
one of the highest prescribers of Subsys in the country and
was the highest prescriber in New Hampshire.
Attorney General's office also learned that Insys paid
Clough $44, 000 to promote Subsys at speaking events, which
were shams. The events actually were social gatherings at
high end restaurants for Clough's family and friends,
which were paid for by Insys sales representatives. The sales
representatives forged the guest lists to inflate the No. of
attendees. Clough also spoke at Insys programs during 2013
and 2014, called the “Speakers Bureau, ” to
promote Subsys. Clough was paid for participating in those
sales representatives were paid bonuses based on the amount
of Subsys they sold. Insys completed forms for prescribers to
induce prescribers and insurance companies to prescribe and
pay for Subsys. Insys had its sales representatives remove
Perry's records from Clough's office in order to
deceive Perry's insurer into paying for Subsys even
though Perry had not been diagnosed with cancer.
Clough was notified in August of 2014 that the New Hampshire
Board of Medicine was investigating his prescription
practices, he informed Insys that he would no longer
participate in their speaker program. Federal authorities
arrested Clough in March of 2017 for receiving financial
kickbacks in exchange for prescribing Subsys. He was