NOVAK v. MENTOR WORLDWIDE LLC
ORDER ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT - granting 5 Motion for Summary Judgment. By JUDGE NANCY TORRESEN. (mnw)
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
MENTOR WORLDWIDE LLC,
) Docket No. 2:17-cv-00328-NT
ORDER ON DEFENDANT’S MOTION FOR SUMMARY JUDGMENT
In this products liability action, Plaintiff Janice Novak (“Ms. Novak”) has
asserted nine claims related to injuries that she allegedly sustained from a
transobturator sling called ObTape (the “ObTape”) manufactured by Defendant
Mentor Worldwide LLC (“Mentor”). This matter comes before me on Mentor’s motion
for summary judgment. (ECF No. 5.) For the reasons set out below I GRANT
Ms. Novak is one of dozens of individuals who have brought suit against
Mentor for injuries allegedly caused by the ObTape. On December 3, 2008, the Panel
on Multidistrict Litigation consolidated the Mentor ObTape cases before Chief Judge
Land of the District Court for the Middle District of Georgia. Order, In re Mentor
Corp. ObTape Transobturator Sling Prods. Liab. Litig. (“In re Mentor”), No. 4:08-md2004-CDL (M.D. Ga. Dec. 3, 2008) (ECF No. 1). On January 14, 2016, Ms. Novak filed
her Complaint in the Middle District of Georgia pursuant to a direct-filing order
issued by Chief Judge Land on December 12, 2011. Compl. ¶ 3 (ECF No. 1); see
Stipulation and Order Regarding Direct Filing, In re Mentor, No. 4:08-md-2004-CDL
(M.D. Ga. Dec. 12, 2011) (ECF No. 446). In her Complaint, Ms. Novak averred that
but for the direct-filing order she would have filed her action in this Court. Compl. ¶ 3.
On April 24, 2017, Mentor moved for summary judgment on all of Ms. Novak’s
claims. Def.’s Mot. for Summ. J. 1. The parties completed briefing on Mentor’s
summary judgment motion on May 15, 2017. On August 16, 2017, Judge Land found
that the parties’ briefing raised a dispute regarding when Ms. Novak’s claims accrued
under Maine law. Order of Transfer 2 (ECF No. 9). Judge Land accordingly
transferred Ms. Novak’s action to this Court. Order of Transfer 2.
On November 28, 2017, I issued an order pursuant to Federal Rule of Civil
Procedure 56(e)(4) requiring Ms. Novak to supplement the record. (ECF No. 26.) After
Ms. Novak responded to that order, I permitted the parties to exchange brief
memoranda regarding Ms. Novak’s evidentiary submissions. Pl.’s Notice of Filling
(ECF No. 27); Mot. to File Under Seal Dep. Tr. of Dr. Krishna M. Bhatta (ECF No.
28); Def.’s Resp. to Pl.’s Notice of Filing (ECF No. 32) (“Def.’s Supp. Resp.”); Pl.’s
Reply to Def.’s Resp. to Notice of Filing (ECF No. 35) (“Pl.’s Supp. Reply”). I heard
oral argument on Mentor’s motion on February 2, 2018.
On November 10, 2004, Ms. Novak underwent surgery at Reddington Fairview
Hospital in Skowhegan, Maine to implant an ObTape. Def.’s Separate Statement of
Material Facts ¶ 1 (ECF No. 5-2) (“DSMF”). The ObTape was intended to treat Ms.
Novak’s stress urinary incontinence. DSMF ¶ 1. Ms. Novak’s surgeon, Dr. Krishna
Bhatta, has testified that he cannot recall any specific representations that Mentor
made to him regarding the ObTape sling, including any warnings regarding risks
specific to that device. Pl.’s Additional Facts ¶ 13 (ECF No. 6-1 at 7-9) (“PSMF”).1
However, Dr. Bhatta was aware at the time of Ms. Novak’s surgery that, as a general
matter, implanting a foreign object into a human abdomen is associated with risks
that include infection and abscess, erosion, pain during vaginal intercourse (in
medical parlance, dyspareunia), postoperative pain, bleeding, irritable bowel
symptoms, urgency, stress urinary incontinence, and vaginal or pelvic pain. DSMF
¶ 2. Dr. Bhatta warned Ms. Novak of these risks before he performed her ObTape
surgery. Bhatta Dep. Tr. 32 (ECF No. 28-2).
Mentor failed to include the language of any warning associated with the ObTape in its
statement of facts or exhibits. However, Mentor’s opening memorandum referred me to the following
finding by Judge Land in connection with the ObTape MDL:
Every ObTape package included a Product Insert Data Sheet (“PIDS”) which contained
the following statement regarding “Adverse Reactions”:
No undesirable effects that could be directly attributed to the polypropylene fibers
have been reported in the literature. As with all foreign bodies, the ObTape is likely
to trigger any existing infection, which can result in fistular formation and/or
expulsion of the device. The following events have been reported very rarely:
Patients should be monitored regularly after the device has been implanted.
No undesirable effects directly attributed to materials used in the Introducer
Needles have been reported in the literature.
Order at 4-5, No. 4:08-md-2004-CDL (M.D. Ga. Apr. 22, 2010) (ECF No. 241) (cited in Def.’s Mem in
Support of Mot. for Summ. J. 1 (ECF No. 5-1)).
Ms. Novak claims that she experienced several of these symptoms as a result
of her ObTape. DSMF ¶ 3. Shortly after her ObTape surgery, Ms. Novak began
experiencing lower abdominal pain. DSMF ¶ 4. Between eight months to one year
after the surgery—toward the end of 2005—Ms. Novak began experiencing pain
during sexual intercourse. DSMF ¶ 5; PSMF ¶ 4. And sometime before the end of
2006, Ms. Novak began to experience vaginal leaking and vaginal bleeding. DSMF
¶ 6; PSMF ¶ 5.
Within two years of her surgery—before the end of 2006—Ms. Novak went
back to Dr. Bhatta and told him that she was experiencing abdominal pain. PSMF
¶ 2. Dr. Bhatta did not know what was causing Ms. Novak’s pain and ordered several
tests. PSMF ¶ 2. Ms. Novak underwent one inconclusive round of testing but she did
not complete the tests because she found them embarrassing. See Novak Dep. Tr. 7-8
(ECF No. 7-1). Ultimately, Dr. Bhatta did not provide Ms. Novak with a diagnosis.
PSMF ¶¶ 2, 3. Ms. Novak later consulted her regular physician, Dr. Michael
MacDonald, who also did not offer an opinion on the cause of her abdominal pain.
PSMF ¶ 3.
It was not until 2013 that Ms. Novak first attributed her abdominal pain,
dyspareunia, and vaginal leaking and bleeding to the ObTape. PSMF ¶ 10. On April
24, 2014, Ms. Novak underwent surgery at Broward Outpatient Center in Pompano
Beach, Florida, during which Dr. Earle Pescatore removed part of her ObTape.
DSMF ¶ 7.
Summary judgment is appropriate when there is no genuine dispute of
material fact and the moving party is entitled to judgment as a matter of law. Fed.
R. Civ. P. 56(a). A dispute is genuine where a reasonable jury could resolve the point
in favor of either party. Oahn Nguyen Chung v. StudentCity.com, Inc., 854 F.3d 97,
101 (1st Cir. 2017). A fact is material where it could influence the outcome of the
litigation. Id. The moving party may establish that there is no genuine dispute of
material fact by “affirmatively produc[ing] evidence that negates an essential
element of the non-moving party’s claim,” or by “using ‘evidentiary materials already
on file . . . [to] demonstrate that the non-moving party will be unable to carry its
burden of persuasion at trial.’ ” Ocasio-Hernandez v. Fortuño-Burset, 777 F.3d 1, 4-5
(1st Cir. 2015) (citation omitted). This burden “may be discharged by ‘showing’—that
is, pointing out to the district court—that there is an absence of evidence to support
the nonmoving party’s case.” Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986).
On a motion for summary judgment, courts must construe the record in the
light most favorable to the non-movant and resolve all reasonable inferences in the
non-movant’s favor. Burns v. Johnson, 829 F.3d 1, 8 (1st Cir. 2016). Conversely,
“neither conclusory allegations, improbable inferences, and unsupported speculation,
nor brash conjecture coupled with earnest hope that something concrete will
materialize, is sufficient to block summary judgment.” J. Geils Band Emp. Benefit
Plan v. Smith Barney Shearson, Inc., 76 F.3d 1245, 1251 (1st Cir. 1996) (marks and
citations omitted); see also Griggs–Ryan v. Smith, 904 F.2d 112, 115 (1st Cir. 1990)
(“A genuine issue of material fact does not spring into being simply because a litigant
claims that one exists.”).
Mentor has moved for summary judgment on all of Ms. Novak’s claims,
advancing three principal arguments: 1) that Ms. Novak’s claims for negligence,
defective design, manufacturing defects, failure-to-warn, breach of implied
warranties, breach of express warranties, and negligent misrepresentation (Counts
I-VI, IX) are time-barred under Maine’s statute of limitations; 2) that Ms. Novak’s
“failure-to-warn” claims (part of Count I and Counts IV, VII-IX) fail because she has
not adduced evidence of causation, which is an essential element of those claims; and
3) that Ms. Novak’s fraudulent misrepresentation, fraudulent concealment, and
negligent misrepresentation claims (Counts VII-IX) fail because she has not provided
evidence that she suffered a pecuniary loss, which is an essential element of all three
Whether Counts I-VI and IX are Time-Barred under Maine’s Statute of
The parties do not dispute that Maine law applies to Ms. Novak’s claims. Def.’s
Mem. in Support of Mot. for Summ. J. 3 (ECF No. 5-1) (“Def.’s Mem.”); Pl.’s Opp’n to
Def.’s Mot. for Summ. J. 3-7 (ECF No. 6) (“Pl.’s Opp’n”). Under Maine’s limitations
statute, “[a]ll civil actions shall be commenced within 6 years after the cause of action
accrues and not afterwards.” 14 Me. Rev. Stat. § 752; see also Johnston v. Dow &
Coulombe, Inc., 686 A.2d 1064, 1065 n.1 (Me. 1996).
Under the general rule in Maine, a cause of action accrues “at the time a
judicially cognizable injury is sustained.” Dugan v. Martel, 588 A.2d 744, 746 (Me.
1991). In tort actions, the cause of action is said to accrue when “a wrongful act
produces an injury for which a potential plaintiff is entitled to seek judicial
vindication.” Id. Under this date-of-injury rule, “mere ignorance of a cause of action
does not prevent the statute of limitations from running.” Id.; see also Descoteau v.
Analogic Corp., 696 F. Supp. 2d 138, 140 (D. Me. 2010) (under Maine’s statute of
limitations, “[i]t is irrelevant whether the plaintiff is aware of his injury and/or the
extent of his damages”). While the rule may seem harsh, statutes of limitations
represent public policy decisions by state legislatures that balance several competing
interests. As the Law Court has explained:
First, parties injured by the actions of others must be afforded an
opportunity to pursue their meritorious claims and seek relief in the
courts. On the other hand, potential defendants are entitled to eventual
repose and to protection from being required to meet claims which could
have been addressed more effectively if asserted more promptly.
Difficulties in defending stale claims are caused by faded memories,
dead or otherwise unavailable witnesses, and lost or destroyed evidence.
Additionally, several courts have attributed to statutes of limitations
the function of filtering out those claims which are spurious,
inconsequential, and unfounded, because meritorious claims are not
usually allowed to remain neglected. The intended effect, then, of
statutes of limitations is to stimulate activity and to punish negligence
Myrick v. James, 444 A.2d 987, 994 (Me. 1982) (citations omitted) superseded by
statute on other grounds by P.L. 1985, ch. 804, §§ 13, 22 (effective Aug. 1, 1988)
(codified at 24 Me. Rev. Stat. § 2902 (2011)), as recognized in Choroszy v. Tso, 647
A.2d 803, 807 (Me. 1994); see also Erlich v. Ouellette, Labonte, Roberge & Allen, P.A.,
637 F.3d 32, 37 (1st Cir. 2011) (“Departures from Maine’s date-of-injury rule are rare.
They have involved careful balancing between competing interests of fairness and
repose, and the opinions have not always been unanimous.”).
On rare occasions, Maine courts apply a “discovery rule” exception to the
general date-of-injury rule.2 Under the discovery rule exception, a claim does not
accrue until the plaintiff discovers the defendant’s misconduct. The Law Court has
strictly limited the discovery rule’s application to “three discrete areas: legal
malpractice, foreign object and negligent diagnosis medical malpractice, and
asbestosis.” Johnston, 686 A.2d at 1066. When it has applied the discovery rule, the
Law Court has been moved by situations in which the plaintiff did not and could not
know of her injury. For example in Anderson v. Neil, the court adopted a discovery
rule exception in actions for negligent title search, a form of legal malpractice. 428
A.2d 1189, 1192 (Me. 1981). The Law Court has since described its holding in
Anderson as follows:
[A]pplication of the discovery rule is appropriate only when there exists
a fiduciary relationship between the plaintiff and defendant, the
plaintiff must rely on the defendant’s advice as a fiduciary, and the
cause of action was virtually undiscoverable absent an independent
investigation that would be destructive of the fiduciary relationship.
Nevin v. Union Tr. Co., 726 A.2d 694, 699 (Me. 1999). Likewise in Myrick v. James,
the Law Court found it appropriate to apply a discovery rule exception in foreign
object malpractice actions3 because a patient necessarily places complete trust in her
The Maine Legislature has also enacted laws that have applied the discovery rule to certain
limited causes of action, none of which are advanced here. See, e.g., 14 Me. Rev. Stat. § 751–E (2003)
(claims for damages based on profits of crime accrue when loss is discovered).
The Maine Legislature later codified the discovery rule for foreign object malpractice actions
and simultaneously foreclosed any further judicial expansion of the discovery rule in the area of
surgeon, and because “the presence of the foreign-object and thus the plaintiff’s
awareness of an act asserted to be negligent remained unknown and unknowable
until” after the statute of limitations period had run. 444 A.2d 987, 995 (Me. 1982).
The Law Court has also acknowledged the continuing tort doctrine, which
provides plaintiffs with another possible refuge from the harshness of the date-ofinjury rule. Courts have applied Maine’s continuing tort doctrine where “no single
incident in a chain of [tortious] activity can fairly or realistically be identified as the
cause of significant harm.” Frontier Commc’ns Corp. v. Barrett Paving Materials, Inc.,
631 F. Supp. 2d 110, 115 (D. Me. 2009) (quoting McLaughlin v. Superintending Sch.
Comm. of Lincolnville, 832 A.2d 782, 789 n.6 (Me. 2003)) (applying continuing tort
doctrine where complaint described a series of incidents spanning 20 years during
which contaminants were allegedly spilled onto the ground or into the river near a
rail yard). “In such cases, the breach of duty is regarded as a single continuing wrong
that terminates when the exposure to the harm terminates.” Id. (quoting
McLaughlin, 832 A.2d at 789 n.6). The Law Court has yet to apply the continuing tort
doctrine outside of an action involving a continuing trespass or nuisance. It has also
refused to apply the doctrine when the cause of a plaintiff’s injuries was a single act
of negligence. See Dugan, 588 A.2d at 745-46 (plaintiff’s claim was time-barred where
medical malpractice. Choroszy v. Tso, 647 A.2d 803, 807 (Me. 1994) (discussing history of 24 Me. Rev.
Stat. § 2902 (2003)).
Ms. Novak’s claims are not the same as claims for foreign object malpractice, which arise when
a doctor unintentionally leaves an object in a patient’s body. In fact, when Maine’s legislature codified
the discovery rule for foreign object malpractice actions they expressly excluded cases like Ms. Novak’s.
24 Me. Rev. Stat. § 2902 (foreign object malpractice discovery rule does not apply where “[an] object
[was] intentionally implanted or permitted to remain in the patient’s body as a part of the health care
or professional services”).
defendant’s negligent installation of insulation caused walls to rot and cellulose dust
to leak into home continuously and was not saved by the facts that harms were
continuing in nature or that plaintiff did not become aware of the scope of the injury
until later). In Dugan, the Law Court found that the ongoing nature of the harm did
not toll the statute of limitations because—unlike, for example, an action alleging a
pattern or practice of discriminatory behavior—the plaintiff’s injuries were caused
“only by [the defendant’s] single negligent installation job in October of 1981, not by
separate and discrete acts on his part occurring afterward.” Id. at 746; see also
Kelleher v. Boise Cascade Corp., 676 F. Supp. 22, 25 (D. Me. 1988) (claim time-barred
where plaintiff “had notice of his injuries immediately after his exposure to the
hazardous substance. . . . His right to seek recovery for that injury was not prejudiced
by his inability to determine the exact scope of his injuries.”).
Here, Mentor asserts that Maine’s six-year limitations period applies to bar
Ms. Novak’s claims for negligence, defective design, manufacturing defects, failureto-warn, breach of implied warranties, breach of express warranties, and negligent
misrepresentation. Def.’s Mem. 1. As Ms. Novak filed suit on January 14, 2016, those
claims are time-barred if they accrued before January 14, 2010. Def.’s Mem. 6-7.
Mentor claims that it is undisputed that Ms. Novak began to experience the same
symptoms that she has attributed to the ObTape—abdominal pain, vaginal bleeding,
vaginal leaking, and dyspareunia—no later than two years after her initial ObTape
surgery on November 11, 2004. PSMF ¶¶ 1, 4, 6, 8. Mentor argues that because Ms.
Novak therefore sustained an injury for which she could have sought judicial
vindication no later than November 11, 2006, that is the latest date on which her
claims could have accrued.
In response, Ms. Novak initially argued that Maine’s date-of-injury rule does
not apply to this action because the “Obtape was a condition . . . which caused
continuous harm to Ms. Novak for the entire time that the device remained
implanted.” Pl.’s Opp’n 5. She claimed that the ObTape’s presence in her body
therefore constituted a continuing tort and that the statute of limitations was tolled
until she had the ObTape removed in 2014. Pl.’s Opp’n 7.4 In her supplemental brief
Ms. Novak raised a new claim that a genuine dispute exists regarding when the
ObTape first caused her injuries. Pl.’s Supp. Reply 1. Ms. Novak asserts that Mentor
has produced no evidence that her symptoms in late 2006 were caused by the ObTape.
Pl.’s Supp. Reply 1. Although she complains of the same symptoms now, she argues,
essentially, that her early symptoms may have had a different cause.
Ms. Novak’s claim does not fall within the bounds of Maine’s continuing tort
doctrine. She has not alleged that Mentor took repeated wrongful actions that, in
aggregate or in unidentifiable part, ultimately caused her harm. Instead, she has
alleged that there was some finite act or set of acts (manufacture, design, inadequate
warning, or misrepresentation) that led to her injuries.5 This case aligns most closely
Ms. Novak relied in part on a pair of decisions by the Federal District Courts of Georgia, both
of which applied a version of the continuing tort doctrine followed under Georgia law. Pl.’s Opp’n 5-6
(citing Wheeler v. Novartis Pharm. Corp., 944 F. Supp. 2d 1344 (S.D. Ga. 2013); Carr v. Ethicon, No.
11 Civ. 2217, 2011 WL 4424457 (N.D. Ga. Sept. 20, 2011)). At oral argument, Ms. Novak’s counsel
conceded that Georgia applies a very different accrual rule from the rules applicable in Maine. These
cases are accordingly inapposite.
Ms. Novak also invokes the continuing treatment doctrine, which tolls the statute of
limitations for medical malpractice claims until the end of a physician/patient relationship. Pl.’s Opp’n
with Dugan,6 where the Law Court refused to apply the continuing tort doctrine
despite ongoing harm and found that the statute of limitations began to run when
cracks appeared in the siding and nails began to protrude three days after the
contractor finished the job. In this case, Ms. Novak first began to experience
symptoms of abdominal pain shortly after the operation in 2004, and pain during
sexual intercourse, vaginal leaking, and vaginal bleeding began all before the end of
2006. By that time, at the latest, the statute of limitations had begun to run.7
5-6. Similar to the continuing tort doctrine, the Law Court has found that the continuing treatment
doctrine may apply if a plaintiff’s claim “arises from two or more related acts or omissions by a single
health care provider or practitioner where each act or omission deviated from the applicable standard
of care and, to at least some demonstrable degree, proximately caused the harm complained of.” Baker
v. Farrand, 26 A.3d 806, 816 (Me. 2011). As discussed above, however, this case does not involve
repeated tortious actions that continued into the limitations period, and the continuing treatment
doctrine does not save Ms. Novak’s claims.
At oral argument, Ms. Novak’s counsel pressed the point that Dugan is distinguishable and
that the continuing tort doctrine should apply here because Ms. Novak’s ObTape degenerated over
time and Mentor can therefore point to no one, critical moment when Ms. Novak’s injury began.
Counsel directed my attention to Wilcox v. City of Portland, No. CV-06-444, 2008 WL 6630061 (Me.
Super. Ct. Sept. 10, 2008). In Wilcox, the plaintiffs claimed to have suffered various illnesses after
being exposed to airborne biotoxins in Portland’s former International Marine Terminal. Id. at 1. Most
of the plaintiffs had worked in the terminal for at least two days during the statute of limitations
period. Id. at 10. The court first found that it was not necessary to apply the continuing tort doctrine
to save those plaintiffs’ claims. The court noted that the defendant had not eliminated the possibility
that the plaintiffs’ exposures during the limitations period caused them additional medical harms. Id.
at 12. Therefore, the court considered the plaintiffs’ final day of exposure to be their date of injury
under Maine’s ordinary accrual rule. Id. After observing that the plaintiffs’ injuries during those final
exposures might well be negligible, the court went on to find that it would be appropriate to apply the
continuing tort doctrine to the case at bar, “where the harm is caused by the cumulative effect of the
mold conditions for which the [defendant] allegedly bears responsibility, where no single incident can
realistically be identified as the cause of significant harm, and where the result is a continuing wrong
that terminates when the exposure to the harm terminates.” Id. at 12 n.16.
Wilcox is inapposite. Unlike the Wilcox plaintiffs, Ms. Novak underwent only one, readilyidentifiable exposure to the ObTape (her surgery), and all of Mentor’s allegedly tortious conduct took
place before that point. Like the contractor-defendant and the plaintiff’s home in Dugan, Mentor’s
wrongful conduct may have caused the ObTape to deteriorate, which in turn may have caused injuries
over time. However, once those injuries had manifested, the fact that their full scope remained
unknown did not stop the statute of limitations from running. See Dugan, 588 A.2d at 746.
Ms. Novak’s argument that her early symptoms were “too isolated or inconsequential to trigger
the running of the Statute of Limitations,” Pl.’s Supp. Reply 4, is unavailing. The case on which Ms.
Novak relies for this proposition was decided under New York law and applied that state’s discovery
rule. See Grill v. Philip Morris USA, Inc., 653 F. Supp. 2d 481 (S.D.N.Y. 2009). As discussed above, no
The Plaintiff’s additional claim—raised in her supplemental briefing—that
there is a genuine dispute over whether her 2004–2006 symptoms were caused by the
OBTape also is without merit. Mentor has provided evidence that the ObTape caused
her early symptoms, and Ms. Novak has been unable to point to any contradictory
evidence that would establish a genuine dispute. As Mentor explained in its opening
brief, Def.’s Mem. 6, Ms. Novak’s own expert, Dr. Christopher Walker, reported that
Ms. Novak experienced bleeding, dyspareunia, and pelvic pain “[s]hortly after her
implant,” and that in his medical opinion Ms. Novak’s symptoms “are complications
of her ObTape implant.” Walker Report 3 (ECF No. 5-8). Dr. Walker’s report therefore
serves as evidence that the symptoms Ms. Novak experienced shortly after her
surgery were caused by her ObTape.8 The only evidence that Ms. Novak offers to
dispute her own expert’s opinion is the fact that neither Dr. Bhatta nor Dr.
similar rule applies here. To the contrary, under Maine law the statute of limitations begins to run
even if the plaintiff could only access nominal damages at the time of their initial injury. Rared
Manchester NH, LLC v. Rite Aid of N.H., Inc., 693 F.3d 48, 52 (1st Cir. 2012); see also Williams v. Ford
Motor Co., 342 A.2d 712, 716 (Me. 1975) (“[A] cause of action arises when a wrongful act is coupled
with an injury, no matter how slight.”).
Were there any doubt as to whether Dr. Walker’s report was addressing Ms. Novak’s early
symptoms, Ms. Novak’s own testimony would dispel it: Dr. Walker attributed Ms. Novak’s dyspareunia
to her ObTape even though Ms. Novak admittedly had not had sex for “eight [or] nine years” as of her
February 9, 2017 deposition. Novak Dep. Tr. 5 (ECF No. 5-5). Ms. Novak’s own testimony therefore
suggests that she first experienced symptoms that her own medical expert has specifically attributed
to the ObTape no later than February of 2009—well before the January 2010 accrual cutoff.
This evidence also differentiates this action from Sturgeon v. Marois Bros., on which Ms. Novak
relies. 511 A.2d 1065 (Me. 1986); see Pl.’s Supp. Reply 2. In that case, the only “evidence” that the same
negligent conduct had caused two injuries occurring years apart was the plaintiff’s belief that the two
events were related. 511 A.2d at 1066. Ms. Novak’s reliance on Townsend v. Chute Chem. Co., 691 A.2d
199 (Me. 1997), is similarly misplaced. Townsend reversed a trial court’s grant of judgment as a matter
of law to the defendant because, unlike Ms. Novak, the Townsend plaintiff had offered testimony about
the accrual date of her injury that contradicted other evidence in the record. Id. at 202.
MacDonald drew any connection between her symptoms and the ObTape when she
saw them in 2006. Pl.’s Supp. Reply 3.
The question before me is whether, on this evidence, a reasonable juror could
find that the symptoms Ms. Novak experienced before January 14, 2010 were caused
by something other than the ObTape.9 Even drawing all reasonable inferences in Ms.
Novak’s favor, I find that conclusion to be unsupported. There is no evidence that Dr.
Bhatta or Dr. MacDonald made any finding that contradicted Dr. Walker’s later
determination that Ms. Novak’s symptoms were caused by the ObTape. Instead, the
evidence shows that Dr. Bhatta’s initial testing on Ms. Novak was inconclusive, and
that she refused to return for further tests. See Novak Dep. Tr. 7-8 (ECF No. 7-1). As
to Dr. MacDonald, there is no evidence in the record regarding his treatment of Ms.
Novak beyond Ms. Novak’s testimony that she spoke to him about her lower
abdominal pain and that Dr. MacDonald prescribed Detrol to help with her vaginal
leaking. Novak Dep. Tr. 9. On this record, a jury could not infer that something other
than the ObTape caused Ms. Novak’s symptoms without engaging in complete
speculation. In such instances, summary judgment is appropriate. J. Geils Band
Emp. Benefit Plan, 76 F.3d at 1251.10
Ms. Novak argues that to succeed on its motion Mentor must establish a specific accrual date
as a matter of law. Pl.’s Supp. Reply 4. Ms. Novak cites no authority for this assertion and even a
cursory search of the caselaw reveals that Maine’s courts do not require such exactitude. See, e.g.,
Halliday v. Henry, 116 A.3d 1270, 1272 (Me. 2015) (granting summary judgment where the record
established that plaintiff’s claims accrued “no later than 2005”).
Ms. Novak has given me no reason to push against the boundaries of Maine’s statute of
limitations jurisprudence. Ms. Novak was informed of the possible risks of her implantation surgery.
When within two years she experienced symptoms similar to those of which she had been warned, Ms.
Novak went back to her surgeon. And when Ms. Novak’s surgeon told her that she would need to
undergo certain tests for a diagnosis, she refused additional testing. On these facts, Ms. Novak cannot
claim the “blameless ignorance” that has supported application of the discovery rule. See Myrick, 444
For the foregoing reasons, I find that Counts I-VI and IX of Ms. Novak’s
Complaint are barred by Maine’s statute of limitations, and I grant Mentor’s motion
for summary judgment on those counts.
Whether Ms. Novak Has Presented Evidence of Causation Sufficient
to Support her Failure-to-Warn Claims (Counts I, IV, VII-IX)
Mentor asserts that it is entitled to summary judgment on Ms. Novak’s claims
that are “premised on a failure to warn” because Ms. Novak has failed to develop any
evidence that Mentor’s failure to warn of the ObTape’s risks proximately caused Ms.
Novak’s injuries.11 Def.’s Mem. 7. Specifically, Mentor argues that Ms. Novak has no
evidence that an alternative warning or representation would have changed Dr.
Bhatta’s decision to use the ObTape to treat her. Def.’s Mem. 8.
To survive a motion for summary judgment on a failure-to-warn claim, a
plaintiff must show that an “inadequate warning proximately caused the plaintiff’s
A.2d at 995; see also Erlich, 637 F.3d at 37 (“Applying a discovery rule in these circumstances would
represent a significant step in expanding Maine law that we decline to take.”).
These include Ms. Novak’s strict liability failure-to-warn, fraudulent misrepresentation,
fraudulent concealment, and negligent misrepresentation claims, and a portion of her negligence
claim. Mentor’s motion treats this set of claims collectively, and Ms. Novak has not objected to this
characterization. Moreover this appears to be a reasonable reading of Ms. Novak’s theories of liability.
Count I, Ms. Novak’s negligence count, alleges in part that Mentor breached “a duty to Plaintiff to
adequately warn her and her treating physicians, of the risks associated with the Ob/Tape.” Compl.
¶ 24 (ECF No. 1). Count IV is a straightforward failure-to-warn claim. Compl. ¶¶ 44-56. Count VII—
Fraudulent Misrepresentation—alleges that Mentor falsely represented that the ObTape had been
tested and found to be safe for treatment of female urinary incontinence. Compl. ¶¶ 75-76. Count
VIII—Fraudulent Concealment—alleges that Mentor misrepresented that the ObTape was safe for its
intended use. Compl. ¶ 86. And Count IX—Negligent Misrepresentation—alleges that Mentor
negligently misrepresented the ObTape’s “high risk of unreasonable, dangerous side effects.” Compl.
¶ 98. In light of the foregoing, I have adopted the parties’ joint treatment of these counts as “predicated
on a failure to warn.” See Doe v. Solvay Pharm., Inc., 350 F. Supp. 2d 257, 262, 274 & nn.7, 12 (D. Me.
2004) (on defendant’s motion for summary judgment, considering plaintiff’s claims for deceptive trade
practices, failure to warn, and fraudulent misrepresentation collectively because those counts were
“premised on a failure to warn”), aff’d Doe v. Solvay Pharm., Inc., 153 F. App’x 1 (1st Cir. 2005).
injury.” Pottle v. Up-Right, Inc., 628 A.2d 672, 675 (Me. 1993). Under Maine law,
“[p]roximate cause is generally a question of fact for the jury, but the court has a duty
to direct a verdict for the defendant if the jury’s deliberation [would] rest only on
speculation or conjecture.” Merriam v. Wanger, 757 A.2d 778, 781 (Me. 2000); see also
Koken v. Black & Veatch Const., Inc., 426 F.3d 39, 49 (1st Cir. 2005) (applying Maine
law and granting summary judgment to the defendant on plaintiff’s failure-to-warn
claim because there was no evidence regarding the possible consequences of the
plaintiff’s proposed alternative warning).
In Merriam v. Wanger, a medical malpractice action, the Law Court vacated a
judgment in favor of the plaintiff because the court found that the plaintiff had failed
to present any evidence of proximate cause. 757 A.2d at 782. The court noted that
while the plaintiff’s experts had testified to the foreseeable risks caused by the
defendant doctor’s failure to properly diagnose the plaintiff, “neither expert testified
that [the plaintiff’s] damages would have been avoided had [the defendant] acted
properly, and neither was directly asked that question.” Id. The court further
explained that “[a]llowing a jury to infer causation on complex medical facts without
the aid of expert testimony on the subject and without some showing that Wanger’s
conduct was ‘more likely than not’ a cause of Merriam’s injury, stretches the jury’s
role beyond its capacity.” Id.
“It is generally accepted that in a case involving medical products prescribed
or used by a physician or trained medical personnel, the warning runs to the
physician not the patient.” Knowlton v. Deseret Med., Inc., 930 F.2d 116, 120 n.2 (1st
Cir. 1991). That is, a manufacturer fulfills its duty to warn a consumer of the dangers
inherent in a product when the manufacturer has adequately warned the consumer’s
physician. See Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992). The parties
agreed during oral argument that this “learned intermediary” rule applies here. 12
Where the learned intermediary rule applies, “to create a jury question, the evidence
must be of sufficient weight to establish . . . at least some reasonable likelihood that
an adequate warning would have prevented the plaintiff from receiving the [medical
product].” Doe v. Solvay Pharm., Inc., 350 F. Supp. 2d 257, 273 (D. Me. 2004) (quoting
Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992)).
The parties do not dispute that when Dr. Bhatta performed Ms. Novak’s
surgery, he was aware of various risks inherent in the implantation of any foreign
object into the human body. DSMF ¶ 2. Mentor argues that Ms. Novak’s claimed
injuries are simply the manifestation of those known risks, and that Ms. Novak has
no evidence that an additional warning would have altered Dr. Bhatta’s decision to
implant the ObTape.
Ms. Novak initially responded by asserting that Dr. Bhatta “may very well
have decided not to use the ObTape if he had been informed about the foreseeable
risks associated with the device, such as ObTape’s greater risk of erosion as compared
While the Law Court has yet to adopt the learned intermediary rule, the First Circuit has
repeatedly found that the Law Court would likely apply the rule in medical products liability actions.
E.g. Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir. 1995); Doe v. Solvay Pharm., Inc.,
153 F. App’x 1, 3 (1st Cir. 2005); see also Tardy v. Eli Lily & Co., CV–03–538, 2004 WL 1925536, *2
(Me. Super. Ct. 2004) (following an “ ‘overwhelming majority’ of jurisdictions” and applying the learned
to other slings.” Pl.’s Resp. 7-8.13 Ms. Novak’s unsupported assertion of fact and
speculation regarding what a witness might say at trial are, of course, not evidence.
I therefore permitted Ms. Novak an opportunity to submit evidence into the record to
support her otherwise bald assertion. In response, Ms. Novak produced a set of
academic articles that discuss the ObTape and Dr. Bhatta’s complete deposition
Even with this additional evidence, Ms. Novak has failed to establish a genuine
issue of fact regarding proximate cause. The articles that Ms. Novak has submitted
do suggest that the ObTape is associated with higher rates of certain complications
than other sling products, including vaginal erosion and impaired vaginal healing.
See, e.g., Pl.’s Notice of Filing 5 (ECF No. 27-3) (concluding that the ObTape “is
effective in curing or improving stress incontinence; however, a troubling incidence
of impaired vaginal healing and mesh extrusion has been recognized”). However, Ms.
Novak has offered no evidence whatsoever that this information would have changed
Dr. Bhatta’s decision to treat Ms. Novak using the ObTape. The information
presented in Ms. Novak’s supplemental exhibits is not so one-sided that a lay jury
could reasonably assume, without any further context, that it would have altered Dr.
Bhatta’s assessment of the ObTape’s risks. And Dr. Bhatta’s deposition transcript
reflects that Ms. Novak’s counsel failed to ask him whether additional information
Ms. Novak’s counsel advanced a different theory at oral argument, claiming that Dr. Bhatta
was not aware of a risk that the ObTape could degrade inside a patient’s body. This discussion of
degradation appears nowhere in Ms. Novak’s briefing on proximate cause. Moreover, counsel could
provide no record support for the proposition that if Dr. Bhatta had been made aware of the risk of
degradation, he would not have proceeded with Ms. Novak’s surgery.
would have altered his decision to go ahead with Ms. Novak’s ObTape surgery. See
generally Bhatta Dep. Tr.14
Ms. Novak’s counsel conceded at oral argument that there is a “paucity” of
evidence in the record to support the proposition that Dr. Bhatta would have changed
his decision to treat Ms. Novak using the ObTape if Mentor had warned him of
additional risks. Counsel further conceded that to put such evidence into the record,
they would need to submit an additional declaration or to question Dr. Bhatta at trial.
Neither route is available to Ms. Novak. While Ms. Novak might have presented an
additional declaration during summary judgment briefing, her counsel failed to do so
even after I offered them an opportunity to supplement the record and despite having
been on notice of this evidentiary gap since the day they received Mentor’s opening
brief. Nor is waiting until trial to develop evidence an option for a party faced with a
motion for summary judgment. See Celotex Corp., 477 U.S. at 322.
Absent any evidence of how Dr. Bhatta would have responded to an additional
or different warning, I find that Ms. Novak has failed to satisfy her burden to
establish that a genuine issue of material fact exists regarding proximate cause on
Contrary to Ms. Novak’s supposition, Pl.’s Opp’n 8, it was her burden to develop evidence
sufficient to make out her own claims. She cannot, therefore, avoid summary judgment by suggesting
that Mentor ought to have asked Mr. Bhatta this question instead. See Celotex Corp. v. Catrett, 477
U.S. 317, 322 (1986) (“The plain language of Rule 56(c) mandates the entry of summary judgment,
after adequate time for discovery and upon motion, against a party who fails to make a showing
sufficient to establish the existence of an element essential to that party’s case, and on which that
party will bear the burden of proof at trial.”); see also Beane v. Util. Trailer Mfg. Co., 934 F. Supp. 2d
871, 883 n.36 (W.D. La. 2013) (“[The plaintiff] bears the burden of proving the elements of her
[products liability] claim at trial. Thus, assertions that [the defendant’s] claims fail because it did not
ask about certain issues in a deposition improperly place the burden on [the defendant].”).
her failure-to-warn claims. Merriam, 757 A.2d at 782; Koken, 426 F.3d at 50. I
therefore grant Mentor’s motion for summary judgment on Counts VII-IX.15
For the reasons stated above, the Court GRANTS the Defendant’s motion for
/s/ Nancy Torresen
United States Chief District Judge
Dated this 14th day of February, 2018.
Mentor argues that Ms. Novak’s fraudulent misrepresentation, negligent misrepresentation,
and fraudulent concealment claims fail for the additional reason that she has not developed evidence
that she suffered a pecuniary loss. Def.’s Mem. 8. Because I find that summary judgment is appropriate
on those Counts for the reasons set out above, I need not address this additional argument.
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