United States District Court, D. Maine
JANICE E. MILLER, et al., Plaintiffs
ZIMMER BIOMET INC., et al., Defendants
RECOMMENDED DECISION ON DEFENDANTS' MOTION TO
C. Nivison U.S. Magistrate Judge
products liability action, Plaintiffs Janice and Donald
Miller seek to recover for injuries they claim were caused by
a defective hip implant designed and manufactured by
matter is before the Court on Defendants' motion to
dismiss. (Motion to Dismiss, ECF No. 16.) Through their
motion, Defendants ask the Court to dismiss three of the ten
claims asserted by Plaintiffs. Specifically, Defendants have
moved to dismiss Plaintiffs' claims of fraud, negligence
per se, and punitive damages.
a review of the pleadings, and after consideration of the
parties' arguments, I recommend the Court grant in part
and deny in part the motion.
following facts are drawn from Plaintiffs' complaint and
are accepted as true for purposes of evaluating the pending
motion to dismiss. Beddall v. State St. Bank & Trust
Co., 137 F.3d 12, 16 (1st Cir. 1998).
Janice Miller underwent right hip replacement surgery on
March 22, 2012. Defendants designed and manufactured the hip
implant components, specifically the Zimmer VerSys Hip System
Femoral Head 12/14 Taper and the Zimmer M/L Taper Prostehesis
(“the product”). (Complaint ¶¶ 1 - 2,
24.) On July 1, 2016, Plaintiff required a revision surgery
because, according to Plaintiffs, the implant was emitting
metal debris through a process known as “mechanically
assisted crevice corrosion” (MACC), which debris caused
metallosis and necrosis. (Id. ¶¶ 3, 28,
30, 31.) Subsequently, Plaintiff underwent two irrigation and
debribement procedures, and a further procedure to address an
infection. (Id. ¶¶ 4, 36, 42.) On January
26, 2017, Plaintiff received “an antibiotic laden total
hip replacement, followed on February 6, 2017, by a sixth
surgical procedure. (Id. ¶¶ 44 - 45.)
Plaintiff suffers from a staph infection as a consequence of
the surgeries. (Id. ¶¶ 4 - 5, 40 - 41,
assert that Defendants' product is defective because the
location at which the femoral head and neck of the prosthesis
join is susceptible to fretting and corrosion, which process
releases metal particles and ions that negatively impact
blood and local tissue. (Id. ¶¶ 63.)
Plaintiffs also allege that Defendants knew or should have
known of the defect prior to the hip replacement surgeries,
misrepresented that the product was safe for its intended
use, and purposefully failed to disclose the defect to
surgeons and the public, in violation of the requirements of
the Medical Device Amendments to the Food, Drug, and Cosmetic
Act, 21 U.S.C. §§ 301 et seq.
(Id. ¶¶ 62 - 113.)
assert claims of negligence (count I), strict product
liability (counts II - IV), negligent misrepresentation
(count V), fraudulent misrepresentation and concealment
(count VI), negligence per se (count VII), breach of implied
warranties (count VIII), punitive damages (count IX), and
loss of consortium (count X).
Motion to Dismiss Standard
to Federal Rule of Civil Procedure 12(b)(6), a party may seek
dismissal of “a claim for relief in any pleading”
if that party believes that the pleading fails “to
state a claim upon which relief can be granted.” In its
assessment of the motion, a court must “assume the
truth of all well-plead facts and give the plaintiff the
benefit of all reasonable inferences therefrom.”
Blanco v. Bath Iron Works Corp., 802 F.Supp.2d 215,
221 (D. Me. 2011) (quoting Genzyme Corp. v. Fed. Ins.
Co., 622 F.3d 62, 68 (1st Cir. 2010)). To overcome the
motion, a plaintiff must establish that the allegations raise
a plausible basis for a fact finder to conclude that the
defendant is legally responsible for the claim at issue.
Fraudulent Misrepresentation and Concealment (count
argue Plaintiffs have failed to plead fraud with
particularity, and have failed to assert facts that would
support an inference of detrimental reliance. (Motion at 3 -
5, ECF No. 16.) To prove a claim of fraudulent
misrepresentation, a plaintiff must show that the defendant
supplied false information concerning a material fact, with
knowledge of the falsity or in reckless disregard of the
falsity of the statement, in order to induce another to act
or refrain from acting based on the false representation.
Knowlton v. Shaw, 791 F.Supp.2d 220, 261 (D. Me.
2011). Similarly, to prove a claim of fraudulent concealment,
a plaintiff must show a failure to disclose a material fact,
where there is a legal or equitable duty to disclose, with
the intention of inducing another to act or refrain from
acting in reliance on the non-disclosure. Picher v. Roman
Catholic Bishop of Portland, 2013 ME 99, ¶ 3, 82
A.3d 101, 102 - 103. A plaintiff must also show that he or
she actually relied on the misrepresentation or concealment
to his or her detriment and that the reliance was justified.
Id.; Knowlton, 791 F.Supp.2d at 261.
Rule of Civil Procedure 9(b) provides that a party alleging
fraud “must state with particularity the circumstances
constituting fraud.” “[T]he purpose of the
heightened pleading requirement of Rule 9(b) is ‘to
give notice to defendants of the plaintiffs' claim, to
protect defendants whose reputation may be harmed be
meritless claims of fraud, to discourage ‘strike
suits', and to prevent the filing of suits that simply
hope to uncover relevant information during discovery.”
J.S. McCarthy Co. v. Brausse Diecutting & Converting
Equip., Inc., 340 F.Supp.2d 54, 59 (D. Me.
2004) (quoting Doyle v. Hasbro, 103 F.3d 186, 194
(1st Cir. 1996)).
argue that to the extent their claim is based on fraudulent
concealment, they need not allege with particularity the
details of any particular non-disclosure, but can rely on
allegations that Defendants represented the product was safe
for its intended use, and knew the product was defective.
(Opposition at 6 - 7.) In Taylor v. Ford Motor
Company, this Court denied a motion to dismiss for want
of specificity, where the plaintiff alleged that the
defendant knew a vehicle was not crashworthy based on crash
tests it conducted, but nevertheless falsely described the
vehicle as “tough” in a marketing campaign. No.
1:06-cv-00069, 2006 WL 2228973, at *7 (D. Me. Aug. 3, 2006).
Plaintiffs maintain that the reasoning of Taylor
demonstrates that a plaintiff is not required to specify the
time and place of a failure to disclose where the allegations
are sufficient to notify the defendant of the “precise
misconduct with which they are charged.” (Opposition at
7, quoting Southco, Inv. v. Penn Eng'g & Mrg.
Corp., 768 F.Supp.2d 715, 720 (D. Del.
argue their misrepresentation and concealment allegations are
specific, and that their case “is on all fours with
Taylor.” (Opposition at 6.) They rely on the
following allegations. (See Opposition at 7 - 9.)
25. On or about January 3, 2013, Plaintiff Janice E. Miller
underwent a total hip arthroplasty of her left hip with
insertion of the Products performed by Brian McGrory, M.D.,
at Maine Medical Center in Portland, Maine. ….
30. Based upon these findings and in light of worsening
symptoms, Plaintiff underwent a complex revision surgery of
her right prosthesis on July 1, 2016, performed by Brian
McGrory, M.D., at Maine Medical Center in Portland, Maine.
56. The Zimmer M/L Taper was approved pursuant to a 510(k) on
or about May 12, 2006, and Zimmer proceeded to sell the
components to be used together with the Zimmer VerSys femoral
61. Defendant Zimmer failed to disclose the greater risk of
wear, metal debris and corrosion associated with these
62. Defendant Zimmer used its distributors and its sales
representatives to communicate with the doctors, such as Dr.
McGrory and ...