Novak v. Mentor Worldwide LLC
Novak v. Mentor Worldwide LLC
Opinion of the Court
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 Mentor's motion.
PROCEDURAL BACKGROUND
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-md-2004-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
*88No. 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.
FACTUAL BACKGROUND
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 ").
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.
*89It 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.
LEGAL STANDARD
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. ,
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 ,
DISCUSSION
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 claims.
I. Whether Counts I-VI and IX are Time-Barred under Maine's Statute of Limitations
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. ,
*90Under the general rule in Maine, a cause of action accrues "at the time a judicially cognizable injury is sustained." Dugan v. Martel ,
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 and slumber.
Myrick v. James ,
On rare occasions, Maine courts apply a "discovery rule" exception to the general date-of-injury rule.
[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 *91investigation that would be destructive of the fiduciary relationship.
Nevin v. Union Tr. Co. ,
The Law Court has also acknowledged the continuing tort doctrine, which provides plaintiffs with another possible refuge from the harshness of the date-of-injury 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. ,
Here, Mentor asserts that Maine's six-year limitations period applies to bar Ms. Novak's claims for negligence, defective design, manufacturing defects, failure-to-warn, breach of implied warranties, breach *92of 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.
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.
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.
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.
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.
II. 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.
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 injury." Pottle v. Up-Right, Inc. ,
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.
"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. ,
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 to other slings." Pl.'s Resp. 7-8.
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 would have altered his decision to go ahead with Ms. Novak's ObTape surgery. See generally Bhatta Dep. Tr.
*97Ms. 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. ,
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 her failure-to-warn claims. Merriam ,
CONCLUSION
For the reasons stated above, the Court GRANTS the Defendant's motion for summary judgment.
SO ORDERED.
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 :
Vaginal Erosion
Urethral Erosion
Infection
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) ).
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 medical malpractice. Choroszy v. Tso ,
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").
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. ,
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 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 ,
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,
Wilcox is inapposite. Unlike the Wilcox plaintiffs, Ms. Novak underwent only one, readily-identifiable 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 ,
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. ,
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.
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 ,
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 ,
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. ,
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. ,
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.
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 ,
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.
Reference
- Full Case Name
- Janice NOVAK v. MENTOR WORLDWIDE LLC
- Cited By
- 4 cases
- Status
- Published