UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE
Kyle, et al.
v. Case No. 19-cv-646-PB Opinion No. 2020 DNH 058 Linden Care, LLC, and Rochester Drug Co-Operative, Inc.
MEMORANDUM AND ORDER
Plaintiffs in these consolidated cases 1 allege they became
dependent on a prescribed under-the-tongue fentanyl spray,
Subsys, and later suffered withdrawal symptoms. They have
brought negligence claims against Linden Care, LLC (“Linden
Care”), the concierge pharmacy that filled their prescriptions,
and Rochester Drug Co-Operative, Inc. (“RDC”), the wholesale
drug distributor that filled Linden Care’s orders for Subsys.
Linden Care and RDC have responded with motions to dismiss
arguing both that plaintiffs failed to plead viable negligence
claims and that their claims are barred by the New Hampshire
statute of limitations for personal actions. RDC recently filed
1 Plaintiffs initially filed individual cases: Jeffrey and Polly Kyle (19-cv-646-PB); Pamela Langlois (19-cv-722-LM); Paul Dooley (19-cv-898-JL); and Colleen Perry (19-cv-723-JL). The cases have been consolidated for pretrial purposes with Kyle et al. v. Linden Care, LLC, Rochester Drug Co-Operative, Inc., 19-cv-646- PB, the named case. for bankruptcy protection. Def. RDC’s Suggestion of Bankruptcy,
Doc No. 45. Accordingly, in this Memorandum and Order, I resolve
only Linden Care’s motions to dismiss.
I. STANDARD OF REVIEW
To overcome a motion to dismiss under Rule 12(b)(6), the
plaintiff must make sufficient factual allegations to “state a
claim to relief that is plausible on its face.” Ashcroft v.
Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868
(2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544,
570, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007)). Under this
plausibility standard, the plaintiff must plead “factual content
that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Id. This
pleading requirement demands “more than a sheer possibility that
[the] defendant has acted unlawfully,” or “facts that are merely
consistent with [the] defendant’s liability.” Id. Although the
complaint need not set forth detailed factual allegations, it
must provide “more than an unadorned, the-defendant-unlawfully-
harmed-me accusation.” Id.
In evaluating the pleadings, I excise any conclusory
statements from the complaint and credit as true all non-
conclusory factual allegations and reasonable inferences drawn
from those allegations. Ocasio-Hernández v. Fortuño-Burset, 640
2 F.3d 1, 12 (1st Cir. 2011). I “may also consider ‘facts subject
to judicial notice, implications from documents incorporated
into the complaint, and concessions in the complainant’s
response to the motion to dismiss.’” Breiding v. Eversource
Energy, 939 F.3d 47, 49 (1st Cir. 2019) (quoting Arturet-Vélez
v. R.J. Reynolds Tobacco Co., 429 F.3d 10, 13 n.2 (1st Cir.
2005)).
Motions to dismiss may be based on affirmative defenses
such as a statute of limitations defense. Rodi v. S. New Eng.
Sch. of Law, 389 F.3d 5, 17 (1st Cir. 2004) (citing LaChapelle
v. Berkshire Life Ins. Co., 142 F.3d 507, 509 (1st Cir. 1998)).
When considering a statute of limitations defense presented in a
Rule 12(b)(6) motion, I must determine “whether the complaint
and any documents that properly may be read in conjunction with
it show beyond doubt that the claim asserted is out of time.”
Id.; accord LaChapelle, 142 F.3d at 509 (“Granting a motion to
dismiss based on a limitations defense is entirely appropriate
when the pleader’s allegations leave no doubt that an asserted
claim is time-barred.”).
II. BACKGROUND
A. Federal Statutory and Regulatory Scheme
Plaintiffs refer to the regulatory scheme of the Federal
Food, Drug, and Cosmetic Act (“FDCA”) when alleging negligence
3 on the part of Linden Care. The FDCA and its amendments empower
the Food and Drug Administration (“FDA”) to regulate food,
drugs, medical devices, and cosmetics. See 21 U.S.C. § 301 et
seq. The FDA oversees Risk Evaluation and Mitigation Strategy
(“REMS”) programs under the FDA Amendments Act of 2007, which
amended the FDCA. 21 U.S.C. § 355-1; see Questions and Answers:
FDA Approves a Class Risk Evaluation and Mitigation Strategy
(REMS) for Transmucosal Immediate-Release Fentanyl (TIRF)
Medicines (“Q&A”), FDA (July 9, 2015),
https://www.fda.gov/drugs/information-drug-class/questions-and-
answers-fda-approves-class-risk-evaluation-and-mitigation-
strategy-rems-transmucosal. “A REMS is a risk management plan
that uses minimization strategies beyond approved labeling to
manage serious risks associated with a drug.” Q&A, supra. It
“can include a Medication Guide or patient package insert,
communication plan, one or more elements to assure safe use, an
implementation system, and a timetable for submission of the
REMS assessment.” Id.
The FDA approved a REMS program, effective in March 2012,
for a class of drugs known as transmucosal immediate-release
fentanyl (“TIRF”) medicines. Id. These “medicines are used to
manage breakthrough pain in adults with cancer who are routinely
taking other opioid pain medicines around-the-clock for pain.”
Id. The TIRF REMS Program provides several safeguards designed
4 to prevent opioid “misuse, abuse, addiction, overdose, and
serious complications.” About the TIRF REMS Program (“About the
Program”), TIRF REMS Access,
https://www.tirfremsaccess.com/TirfUI/rems/about.action (last
(allowing participants in the program to register and manage
their TIRF REMS Account). “Patients must complete a Patient-
Prescriber Agreement Form before they can be prescribed a TIRF
medicine . . . .” Id. Outpatient pharmacies are also unable to
dispense TIRF medicines
unless an authorized pharmacist has reviewed the TIRF REMS Access Education Program and successfully completed the Knowledge Assessment and enrollment form. Enrolled pharmacies can only dispense prescriptions for TIRF medicines if the prescriber and pharmacy are enrolled and active and the patient has not been inactivated in the program.
Id.
Subsys is a TIRF medicine that is approved only “for the
management of breakthrough pain in adult cancer patients who are
already receiving and who are tolerant to around-the-clock
opioid therapy for their underlying persistent cancer pain.” FDA
Approval Letter for Subsys (Jan. 2, 2012) at 1, available at
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Or
ig1s000Approv.pdf; see, e.g., Doc. No. 17 at ¶ 9. The FDA caps
the initial dosage at 100 mcg, followed by carefully titrated
higher dosages in the smallest increments possible to manage the
patient’s pain. “TIRF Products REMS,” TIRF REMS Access Program
5 Education Program for Prescribers and Pharmacists, at 19,
available at
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Or
ig1s000Rems.pdfa/2012/202788Orig1s000Rems.pdf; accord Doc. No.
17 at 2 ¶ 10.
B. Allegations in the Amended Complaints
Plaintiffs Jeffrey Kyle, Paul Dooley, Colleen Perry, and
Pamela Langlois were prescribed Subsys by Christopher Clough, a
former physician assistant at the PainCare clinic in
Somersworth, New Hampshire. Kyle Am. Compl., Doc. No. 17 at 2 ¶¶
4–5, 7–8; Perry Am. Compl., Doc. No. 33 at 1–2 ¶¶ 4–9; Dooley
Am. Compl. at 2 ¶¶ 4–5, 7–9, 19-cv-898-PB (D.N.H. Nov. 14,
2019), ECF No. 13; Langlois Am. Compl. at 2 ¶¶ 4–8, 19-cv-722-PB
(D.N.H. Nov. 6, 2019), ECF No. 17. Linden Care filled all of the
plaintiffs’ Subsys prescriptions.
Plaintiffs allege that when Linden Care filled plaintiffs’
prescriptions, it certified that it knew it could only fill
Subsys prescriptions for patients with medical conditions
warranting its prescription . . . [and] that it would comply
with the dosage instructions . . . .” E.g., Doc. No. 17 at 7 ¶
42. Further, plaintiffs allege that “Linden Care knew that it
could not dispense TIRF[]REMS drugs to patients who were not
enrolled in the TIRF[]REMS program, and . . . under the [CSA]
that it could not dispense . . . Fentanyl without physical
6 possession of the original prescription.” E.g., Doc. No. 17 at 8
¶ 42. Nevertheless, plaintiffs allege that Linden Care
repeatedly filled their Subsys prescriptions even though they
were not eligible to receive them under the TIRF REMS Access
Program.
C. Plaintiffs’ Injuries
Because plaintiffs’ claims against Linden Care require a
fact-intensive inquiry, the events giving rise to each
plaintiff’s alleged injuries are discussed below in detail.
1. Jeffrey Kyle
Jeffrey Kyle received his first shipment of Subsys from
Linden Care in July 2013. Doc. No. 17 at 3 ¶ 12. He “was given
an initial dose of 600 mcg[,]” which is six times higher than
the maximum initial dose allowed by the TIRF REMS Program. Doc.
No. 17 at 2 ¶ 10. Although the FDA approved Subsys only for
cancer patients’ breakthrough pain, Kyle was not being treated
for cancer-related pain, but rather for “lower extremity pain”
in his legs. Doc. No. 17 at 2 ¶ 4. He also did not sign the
required TIRF REMS consent form before receiving his Subsys
prescription, Doc. No. 17 at 2 ¶ 11, and Linden Care failed to
confirm that valid forms had been submitted, Doc. No. 17 at 8 ¶¶
44–45. In fact, an unsigned form was submitted for Kyle after
his first prescription was filled. Doc. No. 17 at 8 ¶ 45
(emphasis added). Despite these warning signs, Linden Care
7 continued to fill subsequent “prescriptions without proper
titration practices.” Doc. No. 17 at 8 ¶ 43; accord Doc. No. 17
at 3 ¶ 13 (“Over the next four months[,] . . . Clough increased
the prescribed dose . . . without medical justification, from
600 mcg to 800 mcg to 1600 mcg . . . .”).
As a result, “Kyle became highly dependent on Subsys.” Doc.
No. 17 at 3 ¶ 14. When his medical insurance provider refused to
pay for Subsys in September 2014, Doc. No. 17 at 3 ¶ 15, “Kyle
began experiencing severe symptoms of withdrawal[,]” including
“sweating, abdominal discomfort, chills, restless legs, hot
flashes[,] and vomiting. He felt like [he] was going to die. He
felt extreme pain all over his body and was in a state of high
anxiety and panic,” Doc. No. 17 at 3 ¶ 16. Kyle filed his
initial complaint on June 13, 2019.
2. Paul Dooley
Paul Dooley received his first shipment of Subsys from
Linden Care in October 2013. Dooley Am. Compl., supra, at 3 ¶
14. His initial dose was “originally written” for 200 mcg but
“was doubled without explanation to 400 mcg before the drug was
dispensed. This initial dose . . . was [four] times more than
the FDA[-]mandated initial dose of 100 mcg.” Dooley Am. Compl.,
supra, at 2 ¶ 8. Dooley was not prescribed Subsys for cancer-
related pain, either. See Dooley Am. Compl., supra, at 2 ¶ 4.
Clough increased Dooley’s prescription on October 21, 2013 and
8 on November 11, 2013, at which point Dooley was on the highest
dose possible, 1600 mcg. Dooley Am. Compl., supra, at 3 ¶¶ 17–
19. He, too, “became highly dependent on Subsys[,]” experiencing
“zombie[-]like symptoms” while on the medication. Dooley Am.
Compl., supra, at 3 ¶ 19. Clough took Dooley off the highest
dose possible on August 18, 2014 “without any downward
titration[,]” resulting in Dooley suffering from “severe
withdrawal symptoms . . . .” Dooley Am. Compl., supra, at 4 ¶¶
21–22. Dooley filed his initial complaint on September 4, 2019.
3. Colleen Perry
Colleen Perry received her first shipment of Subsys from
Linden Care “within a few days” of her June 27, 2013 visit with
Clough. Doc. No. 33 at 2 ¶ 7, 3 ¶ 13. He prescribed Subsys to
her despite her protests, Doc. No. 33 at 2 ¶ 8, and even though
he was not treating her for cancer-related pain, see Doc. No. 33
at 1 ¶ 4. Her initial dosage was also inappropriately high at
400 mcg. Doc. No. 33 at 2 ¶ 8. Clough increased her dosages on
July 19, 2013; September 23, 2013; and February 9, 2014, by
which point “she was on the maximum dosage of 1600 mcg . . . .”
See Doc. No. 33 at 3 ¶¶ 15–16. She, too, became “highly
dependent on Subsys. On several occasions she lost consciousness
. . . and had to be revived . . . . She would fall asleep at
work, at dinner[,] and during conversations.” Doc. No. 33 at 3 ¶
17. Even though she asked Clough to reduce her dose, he refused
9 to do so until November 24, 2014. Doc. No. 33 at ¶¶ 17–18. She
then had a new physician who weaned her off Subsys gradually by
March 27, 2015. Doc. No. 33 at 4 ¶ 21. 2 Later, she had a third
physician who put her back on Subsys but took her off by
December 1, 2015. 3 Doc. No. 33 at 4 ¶ 22. Perry filed her initial
complaint on July 9, 2019.
4. Pamela Langlois
Pamela Langlois received her first shipment of Subsys from
Linden Care “within a few days of” her July 29, 2013 visit to
Clough. Langlois Am. Compl., supra, at 2 ¶¶ 7, 11. Clough did
not discuss the prescription with Langlois and gave her an
initial dose of 400 mcg. Langlois Am. Compl., supra, at 2 ¶¶ 7,
10. She was not being treated for cancer-related pain. See
Langlois Am. Compl., supra, at 2 ¶ 4. She “was never shown, nor
did she sign[,] a TIRF[]REMS enrollment form.” Langlois Am.
Compl., supra, at 3 ¶ 13. Instead, her “name is typed into this
form in place of the necessary signature, and the form is dated
. . . several days after [she] had already received her first
2 Despite this physician’s attempt to wean Perry off Subsys, she still suffered withdrawal after her prescription ended “on or about March 27, 2015.” Doc. No. 33 at 4 ¶ 22.
3 Perry does not explicitly allege that Linden Care filled the prescriptions not written by Clough or that these prescriptions should have raised the same red flags under the TIRF REMS Program.
10 prescription of Subsys.” Langlois Am. Compl., supra, at 3 ¶ 13.
Clough subsequently increased her prescription on or around
November 2013, December 2013, and on a third occasion at a time
not specified, at which point she was taking the maximum
possible dose, 1600 mcg. Langlois Am. Compl., supra, at 3 ¶¶ 16–
17. Just like Kyle, Dooley, and Perry, Langlois also “became
highly dependent on Subsys. On several occasions she lost
consciousness due to the side effects of Subsys and had to be
revived by her husband who thought she had stopped breathing.”
Langlois Am. Compl., supra, at 3 ¶ 18. Once, Langlois’s “husband
nearly called 911, because [her] breathing became very shallow
and he could not get [her] to ‘wake up.’” Langlois Am. Compl.,
supra, at 4 ¶ 18. Clough then cut her prescription sharply,
without titration, in July 2014 and completely cancelled her
prescription around October 23, 2014 without any warning.
Langlois Am. Compl., supra, at 4 ¶¶ 19–20. She “experienced
serious withdrawal symptoms” due to the abrupt decreases in
dosages, including “diarrhea, cramping, cold sweats, significant
increases in pain, depression[,] and suicidal ideations.”
Langlois Am. Compl., supra, at 4 ¶ 21. Langlois filed her
initial complaint on July 9, 2019.
11 III. ANALYSIS
Linden Care argues that plaintiffs have failed to plead
cognizable negligence claims against it because their complaints
do not sufficiently allege the elements of negligence. 4 In the
alternative, Linden Care invokes the New Hampshire statute of
limitations as an affirmative defense. I address each argument
in turn.
A. Insufficient Pleading
Linden Care asserts that the complaints do not allege that
it breached any duty it owed to the plaintiffs, e.g., Def.’s
Mem. of Law in Support of Mot. to Dismiss Pls.’ Am. Compl. in
Lieu of Answer, Doc. No. 19-1 at 11–14, but this assertion is
clearly incorrect.
Plaintiffs allege that Linden Care “had a duty to abide by
safety standards of care for their [sic] industry[,]” e.g., Doc.
No. 17 at 12 ¶ 61, as well as “a duty to use professional skill,
knowledge[,] and care from its education, training[,] and
experience[,] and to abide by the standards of its profession;
4 Linden Care also mistakenly claims that the plaintiffs have improperly pleaded an implied private right of action under the Comprehensive Drug Abuse Prevention and Control Act of 1970, better known as the Controlled Substances Act (“CSA”), see 21 U.S.C. § 801 et seq. This argument is unavailing because plaintiffs have expressly disclaimed that they are seeking to enforce an implied private right of action. See, e.g., Pls.’ Obj. to Def., Linden Care’s Mot. to Dismiss Am. Compl., Doc. No. 25 at 8 ¶ 30.
12 and a duty to comply with applicable federal and state laws when
filling, dispensing, and authorizing . . . Subsys
prescriptions,” e.g., Doc. No. 17 at 12 ¶¶ 61–62. They also
allege that Linden Care breached its duty “when it failed to
report suspicious activity” surrounding their Subsys
prescriptions, e.g., Doc. No. 17 at 12 ¶ 63; fulfilled
prescriptions for Subsys that plaintiffs did not need based on
their diagnoses, e.g., Doc. No. 17 at 12 ¶ 64; “accept[ed] faxed
prescriptions[,]” instead of demanding original copies from
Clough, e.g., Doc. No. 17 at 13 ¶ 65; “fail[ed] to verify”
patients’ proper TIRF REMS enrollments, e.g., Doc. No. 17 at 13
¶ 66; filled initial prescriptions that exceeded the TIRF REMS
limit for initial doses, e.g., Doc. No. 17 at 13 ¶ 67; and
continued to increase the doses without proper titration, e.g.,
Doc. No. 17 at 13 ¶ 68.
These allegations are plainly sufficient to support
plaintiffs’ negligence claims against Linden Care if the duties
alleged are ones that New Hampshire is prepared to recognize.
Because Linden Care has not presented a developed argument that
New Hampshire law does not recognize the duties on which
plaintiffs’ claims are based, I decline to take that issue up on
my own. Accordingly, I deny Linden Care’s motion to dismiss on
this basis without prejudice to the company’s right to raise the
matter again on summary judgment.
13 B. Statute of Limitations
Linden Care argues in the alternative that the complaints
must be dismissed because they are barred by New Hampshire’s
three-year statute of limitations for personal actions, N.H.
Rev. Stat. Ann. § 508:4. That statute specifies that the
limitation period for personal actions begins to run “from the
act or omission complained of” unless the discovery rule
applies. Id. Under the discovery rule, “when the injury and its
causal relationship to the act or omission were not discovered
and could not reasonably have been discovered at the time of the
act or omission,” the plaintiff must bring suit “within [three]
years of the time the plaintiff discovers, or in the exercise of
reasonable diligence should have discovered, the injury and its
causal relation to the act or omission complained of.” Id.;
accord Beane v. Dana S. Beane & Co., P.C., 160 N.H. 708, 712
(2010) (quoting Conrad v. Hazen, 140 N.H. 249, 252 (1995)) (“[A]
cause of action . . . does not accrue ‘until the plaintiff
discovers, or in the exercise of reasonable diligence should
have discovered, both the fact of an injury and the cause
thereof.’”). “The defendant bears the burden of proving that the
defense applies by showing that the action was not filed within
the limitation period. The burden then shifts to the plaintiff
to prove that the discovery rule saves the claims.” Mareld Co.,
14 Inc. v. New Eng. Tel. & Tel. Co., No. 16-cv-390-PB, 2018 WL
6251342, at *3 (D.N.H. Nov. 28, 2018) (citations omitted).
Although plaintiffs plainly waited more than three years
from Linden Care’s last allegedly injurious act to bring their
claims, I cannot determine on the present record whether their
claims are time-barred. This is because plaintiffs have invoked
the discovery rule, and whether the rule applies turns on issues
of fact that have not yet been properly developed. See id.
(recognizing that “[w]hether the plaintiff exercised reasonable
diligence in discovering the injury and its causal relationship
to the defendant’s conduct is a question of fact”).
Linden Care relies on Keshishian v. CMC Radiologists, 142
N.H. 168 (1997) for the proposition that the court must decide
whether a plaintiff is entitled to benefit from the discovery
rule when the court is presented with a Rule 12(b)(6) motion
asserting a statute of limitations defense. This argument is
based on a misreading of Keshishian. That case merely provides
that the applicability of the discovery rule must be decided by
the judge rather than the jury. See Keshishian, 142 N.H. at 179–
81. It does not purport to require a judge decide the issue on a
Rule 12(b)(6) motion. Instead, as First Circuit law clearly
recognizes, the only time when it is appropriate to enforce a
statute of limitations defense when ruling on a Rule 12(b)(6)
motion is when it is “beyond doubt” that the claim is time-
15 barred. Rodi, 389 F.3d at 17; accord LaChapelle, 142 F.3d at
509. This standard has not been met given the current state of
the pleadings. Accordingly, I deny Linden Care’s motions to
dismiss without prejudice to its right to raise the statute of
limitations issue again either by filing a properly supported
motion for summary judgment or by requesting an evidentiary
hearing on the issue.
IV. CONCLUSION
For the foregoing reasons, I deny Linden Care’s motions to
dismiss (Doc. Nos. 19, 23, 24, 37) without prejudice. RDC’s
motions to dismiss (Doc. Nos. 21, 22, 38) are stayed during its
bankruptcy proceeding (Doc. No. 45), pursuant to 11 U.S.C. §
362(a).
SO ORDERED. /s/ Paul J. Barbadoro Paul J. Barbadoro United States District Judge April 13, 2020
cc: Michael P. Rainboth, Esq. Leif A. Becker, Esq. Christina Ann Ferrari, Esq. Michelle L. Greenberg, Esq. Edward J. Sackman, Esq. Kendra E. Pannitti, Esq. Sean E. Sanders, Esq. John C. LaLiberte, Esq.