DOHERTY v. MERCK & CO INC et al

Filing 55

PROCEDURAL ORDER - Comments in writing due no later than 9:00 a.m. on 1/4/2016. By JUDGE D. BROCK HORNBY. (mnw)

TATES DISTRICT COURT
DISTRICT OF MAINE
KAYLA DOHERTY,
PLAINTIFF
V.

MERCK & CO., INC. AND
UNITED STATES OF AMERICA,
DEFENDANTS
AND

ATTORNEY GENERAL FOR THE
STATE OF MAINE,
INTERVENOR DEFENDANT

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CIVIL NO. 1:15-CV-129-DBH

PROCEDURAL ORDER
Attached for review and comment is the court’s proposed certification
order. The parties are DIRECTED to comment in writing no later than 9:00 a.m.
on Monday, January 4, 2016.
SO ORDERED.
DATED THIS 10TH DAY OF DECEMBER, 2015
/S/D. BROCK HORNBY
D. BROCK HORNBY
UNITED STATES DISTRICT JUDGE

UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
KAYLA DOHERTY,

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PLAINTIFF
v.
MERCK & CO., INC. and
UNITED STATES OF AMERICA,
DEFENDANTS
and
ATTORNEY GENERAL FOR THE
STATE OF MAINE,
INTERVENOR DEFENDANT

CIVIL NO. 1:15-cv-129-DBH

CERTIFICATE OF QUESTIONS OF STATE LAW TO THE MAINE
SUPREME JUDICIAL COURT SITTING AS THE LAW COURT
After oral argument on December 3, 2015, the United States District Court
for the District of Maine finds that this case involves questions of law of the State
of Maine that may be determinative of the cause and that there are no clear
controlling precedents thereon in the decisions of the Maine Supreme Judicial
Court. See M.R. App. P. 25(a). Although this case is at an early stage (the
defendants’ motions to dismiss the First Amended Complaint have just been
denied), a decision by the Law Court that no recovery is available to the plaintiff
under Maine law even if all her factual allegations are true (the defendants’
contention in their motions to dismiss that I rejected) would be determinative of
the cause and would end the lawsuit now.
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Specifically, there is a question whether Maine’s Wrongful Birth statute,
24 M.R.S.A. § 2931 (2015)—added in 1986 to the Maine Health Security Act1 as
part of “An Act Relating to Medical and Legal Professional Liability,” L.D. 2400,
§ 16 (112th Legis. 1986)2—applies to drug manufacturers and distributors; and,
if it does not, the scope (as it applies to drug manufacturers and distributors) of
an earlier Law Court decision, Macomber v. Dillman, 505 A.2d 810 (Me. 1986),
that limits damages against health care providers for failed sterilization. There
is also a definitional question regarding the scope of the statutory language in
section 2931(2) allowing limited damages for a “failed sterilization procedure”—
specifically, whether it covers the method of birth control at issue in this case.
The plaintiff contends that the “open courts” provision of article 1, section 19 of
the Maine Constitution bears upon the answers.
The style of the case is Kayla Doherty, Plaintiff, v. Merck & Co., Inc., and
United States of America, Defendants. See M.R. App. P. 25(b). The Attorney
General for the State of Maine has intervened to defend the constitutionality of
Maine’s Wrongful Birth statute. See 28 U.S.C.A. § 2403(b) (2006).
A statement of facts showing the nature of the case and the circumstances
out of which the questions of law arise is attached as Appendix A. See M.R. App.
P. 25(b).

The Maine Health Security Act appears in Title 24 of the Maine Revised Statutes, which
generally deals with insurance and health care providers.
2 The original draft of the bill, L.D. 2065, § 16 (112th Legis. 1986) (“An Act to Expedite the
Resolution of Professional Negligence Claims, to Amend Selective Provisions of the Maine Health
Security Act and to Abolish the Discovery Rule in Claims Against Health Practitioners, Health
Providers and Attorneys”), did not include a limited recovery provision for failed sterilization
procedures that resulted in the birth of a healthy child. See id. After the Law Court’s decision
in Macomber v. Dillman, 505 A.2d 810 (Me. 1986), however, a new draft of the bill effectively
codified the Macomber decision. See Legis. Rec. H-1466 (2d Reg. Sess. 1986).
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The questions of law to be answered are:
1. Does the protection of Maine’s Wrongful Birth statute, 24 M.R.S.A.
§ 2931, extend to the defendant Merck & Co., Inc., as a drug
manufacturer and distributor?
2. If not, does the Law Court’s decision in Macomber v. Dillman, 505 A.2d
810 (Me. 1986), which concerned a failed sterilization by a health care
provider, apply to the plaintiff Kayla Doherty’s claim against Merck as
a drug manufacturer and distributor?
3. Does Maine’s Wrongful Birth statute prohibit all recovery for Doherty
against both defendants (Merck if it is covered by the statute, see
question one, supra) because of the nature of the procedure she
underwent? Or does the statute allow Doherty to proceed with her
claims but limit the recoverable damages to her expenses incurred for
the procedure and pregnancy, pain and suffering connected with the
pregnancy, and loss of earnings during pregnancy?
Guided by the Law Court’s observation that promotion of federal-state comity
counsels that “[w]herever reasonably possible, the state court of last resort
should be given opportunity to decide state law issues on which there are no
state precedents which are controlling or clearly indicative of the developmental
course of the state law,” Dinan v. Alpha Networks Inc., 2013 ME 22, ¶ 12, 60
A.3d 792 (alteration in original) (quoting White v. Edgar, 320 A.2d 668, 675 (Me.
1974)), I respectfully ask for instructions concerning these questions of Maine
law, see 4 M.R.S.A. § 57 (1989 & Pamph. 2015); M.R. App. P. 25(a), now that I
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have denied the defendants’ motions to dismiss that assert that Maine law
prevents any recovery by this plaintiff.
I suggest that the plaintiff Kayla Doherty be treated as the appellant before
the Law Court, see M.R. App. P. 25(b), because she requested the certification.
The Clerk of this Court is hereby DIRECTED to cause twelve (12) copies of
this Order and the Appendix to be certified, under official seal, to the Maine
Supreme Judicial Court sitting as the Law Court. It is FURTHER ORDERED that
the Clerk of this Court be, and is hereby, authorized and directed to provide,
without any cost to the Law Court, upon written request of the Chief Justice or
the Clerk thereof, copies of any and all filings of the parties herein and of the
docket entries pertaining to this case.
SO ORDERED.
DATED THIS ______

DAY OF

_____________, 2016

D. BROCK HORNBY
UNITED STATES DISTRICT JUDGE

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APPENDIX A

STATEMENT OF FACTS SHOWING THE NATURE OF THE CASE AND THE
CIRCUMSTANCES OUT OF WHICH THE QUESTIONS OF LAW ARISE
The parties have quarreled over the adequacy of the First Amended
Complaint under federal pleading standards.

Primarily, the defendants

challenged the plaintiff’s ability to characterize her procedure as “sterilization”—
the term used in the Wrongful Birth statute and in Macomber. But I denied the
defendants’ motions to strike and to dismiss, and I conclude as a matter of
federal law that the following factual allegations are properly pleaded.

The

plaintiff’s factual allegations are therefore taken as true for the purpose of testing
the defendants’ argument that Maine law allows no recovery to the plaintiff even
if her allegations are proven.1 Notably, I have removed any characterization of
the plaintiff’s procedure (leaving in place its factual description) and also some
surplusage not material to the certified questions.
The plaintiff, Kayla Doherty of Pittsfield, Maine, visited the Lovejoy
HealthReach Community Health Center (HRCHC) in Albion, Maine, on
January 26, 2012, to inquire about birth control options. At the time, Doherty
was twenty years old, and wanted to avoid having a baby until she had economic
stability. At Lovejoy, Doherty saw Dr. Amanda Ruxton, D.O., a federal employee
acting within the scope of her employment. Dr. Ruxton recommended the use
of an implantable drug, either Implanon or Nexplanon, manufactured and

If the case proceeds because the Law Court rejects the defendants’ interpretation of Maine’s
Wrongful Birth statute, then the defendants will have the opportunity to challenge the plaintiff’s
allegations in their Answers.

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distributed by the defendant, Merck & Co., Inc.

Merck is a New Jersey

corporation that tests, develops, manufactures, distributes, licenses, labels, and
markets those drugs. On February 28, 2012, Dr. Ruxton purported to carry out
the procedure that she had recommended to Doherty by using a syringe to insert
either Implanon or Nexplanon into Doherty’s arm.
Implanon is a four-centimeters-long and two-centimeters-wide single rod
with an ethylene vinylacetate copolymer core containing sixty-eight milligrams
of etonogestrel, a type of hormone (progestin) effective at inhibiting ovulation and
preventing pregnancy. It is inserted just under the skin on the inner side of a
woman’s arm between the bicep and tricep muscles using a syringe-like
applicator called a trocar.

Around 2010, Merck discontinued Implanon and

replaced it with Nexplanon—a product nearly identical to Implanon except that
the Nexplanon rod contains fifteen milligrams of barium sulphate to make it
radiopaque, meaning it will show up on an x-ray if the rod migrates after
insertion.
Both Implanon and Nexplanon are intended to be long lasting and
irreversible for a period of at least three years, unless removed earlier by a
surgical procedure performed by a physician. Merck knew or should have known
that, due to the design of the rod’s applicator, both products have a history of
failed insertion attempts—the failure remaining unknown to the physician.
Physicians can erroneously believe that the rod has been successfully inserted
because they fail to recognize that the rod remained stuck in the applicator after
the procedure. Unknown failed insertion could lead to unplanned pregnancy.
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Nevertheless, Merck promoted use of the drugs and exaggerated their
effectiveness.
In her treatment of Doherty, Dr. Ruxton was negligent in a number of
respects, including failing to explain risks and dangers to Doherty; failing to
examine Doherty’s arm after insertion to see if insertion of the rod was
successful; failing to give Doherty any handouts or information regarding the
product, including information on failed insertion and how to check for proper
positioning of the rod on a regular basis; and failing to keep an accurate medical
record stating which arm had received the insertion. A positive pregnancy test
at the Lovejoy HRCHC on October 16, 2013, confirmed that Doherty, then age
twenty-one, had become pregnant. Despite extensive effort, Lovejoy staff could
not find the rod in Doherty’s arm or determine the implantation site. Lovejoy
cancelled Doherty’s next appointment and sent her to Inland Hospital for
treatment. Ultrasounds on October 23, 2013, at Inland Hospital could not find
the rod in either of Doherty’s arms. On about October 24, 2013, a Lovejoy nurse
told Doherty that “Dr. Ruxton believes it was never inserted.”
In connection with her pregnancy, Doherty suffered nausea, mental and
physical pain and suffering, insomnia, swelling, and weight gain.

She was

required to attend multiple medical appointments and incurred resulting
expenses, missed time from work, and thus lost wages.

On June 9, 2014,

Doherty underwent a long and painful delivery producing a healthy baby boy.
Since giving birth, she has received mental health counseling and has suffered
emotional distress from rearing a child as a single mother without adequate
preparation, planning, and economic resources.

Doherty, already a certified
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nursing assistant, had hoped to attend nursing school and establish herself in
the profession before starting a family.
Doherty has sued the United States for Dr. Ruxton’s professional
negligence and failure to obtain Doherty’s informed consent. Pursuant to the
Federal Tort Claims Act, 28 U.S.C.A. §§ 2671-2680 (2006), the United States is
liable for Dr. Ruxton’s conduct “in the same manner and to the same extent as
a private individual under like circumstances.” Id. § 2674(a). In connection with
Implanon and Nexplanon (specifically, the defective applicator designs), Doherty
has sued Merck for strict product liability, breach of express and implied
warranties, negligence, and negligent misrepresentation.

Predicting that the

defendants would invoke Maine’s Wrongful Birth statute, 24 M.R.S.A. § 2931, to
shield themselves from liability, Doherty also seeks a declaratory judgment that
section 2931 is unconstitutional under state and federal law if it is interpreted
to bar her from any recovery for her claims (as the defendants contend). I granted
the motion of the Attorney General of the State of Maine to intervene to defend
the constitutionality of the Maine statute.
Both Merck and the United States filed motions to dismiss the lawsuit,
asserting that even if Doherty’s factual allegations are true, section 2931 bars
all of Doherty’s claims—including Doherty’s product liability claims—because
the birth of a healthy child is not a legally cognizable injury under Maine law and
Doherty’s implantation procedure does not fall within the statutory exception of
providing limited relief for a “failed sterilization procedure.” Id. § 2931(2). After
hearing oral argument, I denied their motions from the bench on December 3,
2015.
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