IN RE: ETHICON PHYSIOMESH FLEXIBLE COMPOSITE HERNIA MESH PRODUCTS LIABILITY LITIGATION (2024)

ORDER

THIS MATTER is before the Court on Defendants’ Motion for Summary Judgment [Dkt. 8], Plaintiff's Response in Opposition [Dkt. 9],¹ and Defendants’ Reply in Support [Dkt. 10]. Having considered the record and applicable legal authorities, the Court enters the following Order.

BACKGROUND

Plaintiff Tracey Hallac's case, like all those in the MDL, is a product liability action brought against Defendant Ethicon and its parent company, Defendant Johnson & Johnson, arising from the implantation of Ethicon's PHYSIOMESH Flexible Composite Mesh (“Physiomesh”), a synthetic polypropylene-based mesh indicated for the repair of Plaintiff's hernia defects. Ms. Hallac alleges that the Physiomesh caused her injuries.

Ms. Hallac was implanted with Physiomesh in New York on July 22, 2013, to repair a ventral incisional hernia. [Defendants’ Statement of Undisputed Material Facts (“DSMF”), ¶ 1; Plaintiff's Response to DSMF, ¶ 1; Plaintiff's Fact Sheet (“PFS”) at 11].

When asked to “[i]dentify the date (or approximate date) when [she] first experienced symptoms of the alleged injuries [Plaintiff] claim resulted from the Physiomesh product, the date (or approximate date) when [she] first saw a health care provider for each of the injuries, and the name, address and specialty of the healthcare provider(s),” Plaintiff responded under penalty of perjury:

In approximately 2017/2018, I began to experience pain and abdominal swelling. I later noted a ball size area on one side of my abdomen. In Fall 2019, I saw Ajay Panchal, MD, 350 Alberta Drive, Amherst, NY14226 who advised me that I had received a recalled mesh which had rolled up and was on one side of my torso and had a reoccurrence of my hernia.

[DSMF, ¶ 2; Pl. Resp. DSMF, ¶ 2; PFS at 15].²

On November 20, 2019, Dr. Ajay Panchal removed the Physiomesh. [DSMF, ¶ 3; Pl. Resp. DSMF, ¶ 3; PFS at 14].

Plaintiff filed suit on March 17, 2023. [DSMF, ¶ 4; Pl. Resp. DSMF, ¶ 4; Dkt. 1-1, Exhibit A]. Plaintiff initially filed in the Supreme Court of the State of New York, Erie County. [Dkt. 1-1, New York State Case Number 803595/2023]. Ms. Hallac initiated four causes of action against Defendants based upon theories of negligence, breach of express warranty, breach of implied warranty, and strict products liability. She also requested punitive damages.

On July 27, 2023, Defendants removed Plaintiff's case to the U.S. District Court for the Western District of New York, Buffalo Division. [Dkt. 1]. On August 8, 2023, Plaintiff's case was transferred to the Northern District of Georgia by the Judicial Panel on Multidistrict Litigation's Conditional Transfer Order as a tag-along case within MDL 2782. [Dkt. 3].

Defendants now move for summary judgment and contend that Plaintiff's claims are time-barred by New York's statute of limitations for personal injury and breach of warranty.³ Defendants seek dismissal with prejudice.

LEGAL STANDARD

The standard for summary judgment is well-established. Federal Rule of Civil Procedure 56 requires that summary judgment be granted “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” “The moving party bears ‘the initial responsibility of informing the ․ court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact.’ ” Hickson Corp. v. N. Crossarm Co., 357 F.3d 1256, 1259 (11th Cir. 2004) (quoting Celotex Corp. v. Catrett, 106 S. Ct. 2548, 2553 (1986)). Where the moving party makes such a showing, the burden shifts to the non-movant, who must go beyond the pleadings and present affirmative evidence to show that a genuine issue of material fact does exist. Anderson v. Liberty Lobby, Inc., 106 S. Ct. 2505, 2514 (1986).

The applicable substantive law identifies which facts are material. Id. at 2510. A fact is not material if a dispute over that fact will not affect the outcome of the case under the governing law. Id. An issue is genuine when the evidence is such that a reasonable jury could return a verdict in favor of the non-moving party. Id. at 2510–11.

In resolving a motion for summary judgment, the court will “consider the record and draw all reasonable inferences in the light most favorable to the non-moving party.” Blue v. Lopez, 901 F.3d 1352, 1357 (11th Cir. 2018). But the court is bound only to draw those inferences which are reasonable. “Where the records taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial.” Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir. 1997) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 106 S. Ct. 1348, 1356 (1986)). “If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.” Anderson, 106 S. Ct. at 2511 (citations omitted); see also Matsushita, 106 S. Ct. at 1356 (once the moving party has met its burden under Rule 56(a), the non-moving party “must do more than simply show there is some metaphysical doubt as to the material facts”).

The Court now turns to the merits of Defendants’ motion.

DISCUSSION

As an initial matter, the Court applies New York law because the transferor court is the U.S. District Court for the Western District of New York and because the State of New York is “the jurisdiction having the greatest interest in resolving” Plaintiff's substantive claims.⁴ [Dkt. 8-2 at 3-5 (listing cases, inter alia, In re Conagra Peanut Butter Prod. Liab. Litig., 2015 WL 847430, at *2 (N.D. Ga. Feb. 26, 2015))]. Ms. Hallac alleges that she has been a New York citizen and resident at all times, that she was implanted with Physiomesh in New York, that she sustained her alleged injuries in New York, and that she underwent a revision surgery and received all other relevant medical care in New York. See Paesano v. Ethicon, 2022 WL 846899, at *4 (S.D.N.Y. Mar. 22, 2022); see also Baker v. Skyler Corp., 770 F. App'x 12, 14 (2d Cir. 2019).

I. Tort Claims

Plaintiff asserts claims against Defendants for negligence (Count I) and strict liability (Count IV). With respect to Counts I and IV, Defendants argue that, pursuant to New York Civil Practice Law and Rules (“CPLR”) § 214, Plaintiff's claims are subject to a three-year statute of limitations from accrual. Plaintiff suggests that there are exceptions to the CPLR that apply on these facts. The statute of limitations issue turns upon when determination of Plaintiff's injury occurred such that claim accrual began. Plaintiff argues that the “when” is a matter to be decided by a jury.

Under New York law, “the general limitations period for personal injury torts, including personal injury ․, based on negligence, [or] strict liability ․ is three years measured from date of the injury.” Paesano, 2022 WL 846899, at *4 (citations omitted). New York does not apply a discovery rule.⁵ The cause of action accrues, and the statute of limitations begins to run, at the time of injury, “even if the plaintiff is unaware that he or she has a cause of action” at that time. Id. (citation omitted). “The rationale is that the injury puts the putative plaintiff on inquiry notice and, therefore, charges him or her with responsibility for investigating, within the limitations period, all potential claims and all potential defendants.” Id. (citation omitted).

“In cases involving the malfunction of medical devices ‘implanted or inserted into the human body,’ the statute of limitations ‘runs from the date of the injury resulting from the malfunction.’ ” Paesano, 2022 WL 846899, at *4 (quoting Baker, 770 F. App'x at 14)). “Accordingly, the ‘[t]hree year limitations period runs from the date when plaintiff first noticed symptoms, rather than when a physician first diagnosed those symptoms.’ ” Id. (quoting Galletta v. Stryker Corp., 283 F.Supp.2d 914, 917 (S.D.N.Y. 2003)); accord Perciballi v. Ethicon, Inc., 2021 WL 810339, at *4 (E.D.N.Y. Mar. 3, 2021), aff'd, No. 21-901, 2022 WL 3147781 (2d Cir. Aug. 8, 2022).

Pursuant to these authorities, Defendants argue that Plaintiff's own PSF [Dkt. 8-1] establishes that her tort claims began to accrue when she first began experiencing symptoms in 2017/2018.⁶ [Dkt. 8-2 – Def. Mem. In Supp.].⁷ The Court agrees.

Plaintiff argues instead that CPLR § 214-c, an exception, governs. Plaintiff contends that her cause of action did not accrue until she began receiving treatment for a hernia recurrence in the Fall of 2019.⁸ In support, Plaintiff cites Wetherill v. Eli Lilly, 89 N.Y.2d 506 (1997),⁹ as “the pinnacle case pertaining to the analysis and application of CPLR [§] 214-c.” [Pl. Resp. at 4]. Subsection (2) of CPLR § 214-c reads:

Notwithstanding the provisions of section 214, the three year period within which an action to recover damages for personal injury or injury to property caused by the latent effects of exposure to any substance or combination of substances, in any form, upon or within the body or upon or within property must be commenced shall be computed from the date of discovery of the injury by the plaintiff or from the date when through the exercise of reasonable diligence such injury should have been discovered by the plaintiff, whichever is earlier.

CPLR § 214-c (emphases added). For purposes of § 214-c, the term “exposure” includes implantation. CPLR § 214-c(1).¹⁰

In Wetherill, the court was asked to decide “whether an ‘injury’ is discovered within the meaning of CPLR [§] 214-c(2) when the symptoms become apparent or instead when the connection between those symptoms and the injured's exposure to a toxic substance is recognized.” Id. at 509. The court held that the statute of limitations begins to run “when the injured party discovers the primary condition on which the case is based.” Id. (emphases added). In contrast to “the primary condition on which the case is based[,]” the Wetherill court went on to recognize that “there may be situations in which the claimant may experience early symptoms that are too isolated or inconsequential to trigger the running of the Statute of Limitations under CPLR [§] 214-c(2)[,]” a fact-intensive inquiry. Id. at 514 n.4. Ms. Hallac contends that, under the teachings of Wetherill, her symptoms in 2017/2018 were too inconsequential and would not have constituted a discovery of the injury.¹¹

Defendants argue that Wetherill has no application here in that § 214-c was enacted to address injuries stemming from latent exposure to a substance. [Def. Reply at 3-6]. Significantly, Ms. Hallac does not contend “that [she] was exposed to a toxic substance or latent disease from the implant” or “that [she] developed a condition or contracted a disease” as a result of her Physiomesh implant. Baker, 2018 WL 1440311, at *6. The Court, therefore, finds that Section 214-c(2), referred to as “the toxic tort exception,” does not save Plaintiff's case from the statute of limitations bar. Perciballi, 2021 WL 810339, at *5 n.11 (parties agreed that the “toxic tort exception” to CPLR § 214 did not apply).

Both Paesano and Perciballi, the primary cases relied upon by Defendants, were pelvic mesh implant cases, i.e., medical device cases. As such, they are more analogous to the facts here than those in Wetherill.¹² As noted, Plaintiff contends that, even under these cases, the symptoms of the plaintiffs in Paesano and Perciballi were more profound than her symptoms of abdominal pain and swelling. Plaintiff argues, through counsel, that her medical records do not support Defendants’ suggestion that her symptoms in 2017/2018 were indicative of the primary injury for purposes of statute of limitations analysis.¹³ However, Plaintiff's PSF and Plaintiff's proffered expert report of Francisco J. Rodriguez, M.D., [Dkt. 9-1 – Dr. Rodriguez Report] date Plaintiff's abdominal symptoms back to at least 2017/2018. In fact, Dr. Rodriguez's review of Plaintiff's medical records indicates that Plaintiff reported “having constant pain in the hernia repair area” as early as September 13, 2013. [Dr. Rodriguez Report at 7]. Dr. Rodriguez also notes that Plaintiff reported occasional complaints of left sided pain and suprapubic pain to her primary physician from 2015 to 2018. [Id.]. Plaintiff's complaints of abdominal pain and regular follow-up visits to explore and investigate these symptoms are sufficient to put her on notice of injury under New York law. See Galetta, 283 F.Supp.2d at 916-17; and see, e.g., Gaillard v. Bayer Corp., 986 F. Supp. 2d 241, 242–43, 248 (E.D.N.Y. 2013) (dismissing plaintiff's claims as time-barred; and explaining that “[s]erious symptoms ․, which were also sufficient to require medical attention and an attempted diagnosis, are significant enough to trigger the statute of limitations period under New York law”).

Plaintiff erroneously focuses on discovery of the hernia defect that resulted in the revision surgery in November 2019 as opposed to the symptoms that triggered the statute of limitations under § 214. “The three year limitations period runs from the date when plaintiff first noticed symptoms rather than when a physician first diagnosed those symptoms, so the significant date is when plaintiff began experiencing symptoms ․” Galetta, 283 F.Supp.2d at 916-17 (citing, inter alia, Wetherill, 89 N.Y.2d at 515). Simply put, under New York law, the diagnosis of Plaintiff's hernia recurrence is not the trigger for commencing the three year statute of limitations. As harsh as it may seem, this rule is unaltered even where there are multiple potential causes for symptoms and even in the case of misdiagnosis.¹⁴

In sum, while it may be true that the record does not conclusively demonstrate Plaintiff's discovery of the hernia defect itself until 2019, discovery of the defect or diagnosis of hernia recurrence is not what New York's statute of limitations requires. CPLR § 214. As explained herein, the Court finds that Plaintiff's symptoms of abdominal pain and swelling dating back to 2017/2018 are sufficient to trigger the three year statute of limitations.

For this reason, the Court will grant Defendants’ Motion for Summary Judgment as to Counts I and IV.

II. Breach of Warranty Claims

Plaintiff also asserts claims alleging breach of express warranty (Count II) and breach of an implied warranty (Count III). Defendants contend that Plaintiff's warranty claims are also barred by the statute of limitations.

New York law imposes a four year limitations period on warranty claims. N.Y. U.C.C. § 2-725(1); Heller v. U.S. Suzuki Motor Corp., 64 N.Y.2d 407, 410 (1985). “A cause of action accrues when the breach occurs, regardless of the aggrieved party's lack of knowledge of the breach. A breach of warranty occurs when tender of delivery is made, except that where a warranty explicitly extends to future performance of the goods and discovery of the breach must await the time of such performance the cause of action accrues when the breach is or should have been discovered.” § 2-725(2); Heller, 64 N.Y.2d at 410.

“A cause of action against a manufacturer accrues on the date [it] tenders delivery of the product [to its purchaser], not on the date that some third party sells it to plaintiff.” Heller, 64 N.Y.2d at 411 (citations omitted); see also Solorio v. Asplundh Tree Expert Co., 2009 WL 755362, at *5 n.10 (S.D.N.Y. Mar. 23, 2009) (“statute of limitations for a breach of warranty claim, whether implied or express, begins to run at the time the product is placed in the stream of commerce or at the time of the original sale of the good by the manufacturer, regardless of when the injury was sustained”) (citing § 2-725(1)).

In this case, Defendants assert that Plaintiff's breach of warranty claims accrued no later than July 22, 2013, when she was implanted with Physiomesh. See, e.g., Scism v. Ethicon, Inc., 2020 WL 1245349, at *7 (N.D.N.Y. Mar. 16, 2020); Galetta, 238 F.Supp.2d at 916 (“no question that the breach of warranty claim is time barred” where polyethylene implant had to have been delivered to the hospital where the operation was performed prior to the date of operation, which triggered four year statute of limitations). Plaintiff did not file suit until 2023 -- approximately ten years later.

In an attempt to toll or enlarge the four year limitations period, Plaintiff contends that “Defendants’ warranties extended to future performance of the [Physiomesh] and ․ the accrual date is extended to when the breach of warranty was discovered or should have been discovered.” [Pl. Resp. in Opp'n at 13]. As argued in Reply, the future performance exception is “narrowly construed.” Rochester-Genesee Reg'l Trans. Auth. v. Cummins Inc., 2010 WL 2998768, at *3 (W.D.N.Y. July 28, 2010); and see Standard All Indus., Inc. v. Black Clawson Co., 587 F.2d 813, 820 (6th Cir. 1978) (explaining that a “specific reference to a future time in the warranty” must be identified and that, as a result of harsh construction, “most express warranties cannot meet the test”).

Defendants persuasively argue that Plaintiff failed to meet her burden to establish the existence of any express warranty for future performance.¹⁵ [Reply at 8-11 (listing cases)]. And see, e.g., M/S Shiraz Impex v. Beech-Nut Nutrition Corp., 715 F. Supp. 1230, 1234 (S.D.N.Y. 1989) (plaintiff's burden to produce evidence of warranty seeking to invoke and recover on). Plaintiff, who did not file any Statement of Additional Facts as permitted by LR 56.1(B)(2)(b), NDGA, failed to identify any express or implied warranty or cite to any specific language she contends amounted to an express warranty. See, generally, WCA Holdings III, LLC v. Panasonic Avionics Corp., 2023 WL 8434776, at *3 n.14 (S.D.N.Y. Dec. 5, 2023) (explicit extension of warranty required to establish warranty for future performance). Plaintiff likewise failed to produce evidence of her reliance. See Schwata v. Super Millwork, Inc., 2011 WL 5027163, at *2 (N.Y. Sup. Ct. 2011) (“express warranty provided by defendants did not guarantee future performance of the windows and doors for a specified time and, therefore, did not toll the four-year statute of limitations until discovery of the claimed defect”). Although Ms. Hallac was not deposed, Plaintiff failed to produce an affidavit or declaration speaking to her reliance. Defendants point to Plaintiff's representation in her Verified PSF that she did not recall receiving or reviewing any informational materials or warranties prior to implantation of the Physiomesh. [PSF at 11].

Plaintiff's counsel argues that, given its intended use and purpose, “the contention could be made that the Defendants in their promotion of the product, expressly warranted [Physiomesh's] future performance after implantation.” [Resp. in Opp'n, at 13 (citing Imperia v. Marvin Windows of New York, Inc., 747 N.Y.S.2d 35 (2nd Dept. 2002))]. This contention is insufficient to overcome summary judgment.

The Court finds Plaintiff's filing of suit on March 17, 2023, over nine years from the date Physiomesh was implanted, exceeds the applicable four-year statute of limitations (as extended 228 days by the New York Governor). The Court, therefore, finds as a matter of law that Plaintiff's breach of warranty claims are precluded pursuant to § 2-725, and Defendants’ Motion is due to be granted on Counts II and III.

CONCLUSION

For the foregoing reasons, the Court finds that Defendants’ Motion for Summary Judgment is due to be granted on all of Plaintiff's claims.

Accordingly, it is ORDERED that Defendants’ Motion for Summary Judgment [Dkt. 8] is GRANTED.

SO ORDERED this 9th day of April, 2024.

FOOTNOTES

1.   Plaintiff's Response brief appears to contain a typographical error on page one and refers to “Plaintiff Fannie Matter” rather than Tracey Hallac.

2.   Defendants clarify that Physiomesh was voluntarily withdrawn from the market as opposed to being “recalled.”

3.   Defendants argue that Plaintiff's tort claims accrued no later than 2018 (more than 3 years and 228 days before she filed suit) and her breach of warranty claims accrued no later than July 22, 2013 (more than 4 years and 228 days before she filed suit).

4.   The parties also apply New York law.

5.   Defendants point out that New York law on this issue, which is obviously less favorable to plaintiffs, is unlike many other states. [Def. Mem. In Supp., at 5].

6.   It is undisputed that, during the COVID pandemic, the Governor of New York tolled the three-year statute of limitations applicable to Plaintiff's tort claims (Counts I and IV) and the four-year statute of limitations applicable to Plaintiff's breach of warranty claims (Counts II and III) for 228 days.

7.   Apparently, Plaintiff has not been deposed. One of Plaintiff's arguments in opposition to summary judgment is that discovery has not concluded.

8.   As noted above, Plaintiff underwent her second surgery and removal of the Physiomesh on November 20, 2019.

9.   The full citation is Matter of New York Cnty. DES Litig. (Wetherill v. Eli Lilly & Co.), 89 N.Y.2d 506 (1997).

10.   The relationship between exposure by way of an implant is explained in Baker v. Porex Corp., 2018 WL 1440311 (E.D.N.Y. Mar. 22, 2018), where the court held that § 214-c(2) did not apply where plaintiff did not contend “that he was exposed to a toxic substance or latent disease from the implant” or “that he developed a condition or contracted a disease because of his implant.” Id., at *6 (exception is inapplicable to this case because it only “covers exposure to toxic substances from implantation of the substance”), aff'd sub nom. Baker v. Stryker Corp., 770 F. App'x 12 (2d Cir. 2019) (citations omitted). Rather, the court observed that plaintiff alleged in a sworn statement, and the evidence established, that his implant was ill-fitting and caused his injury the day it was implanted. Id. (citations omitted).

11.   The injuries in Wetherill were deemed sufficient to place plaintiff on notice of a claim and trigger injury discovery where plaintiff experienced miscarriages, a misshapen uterus, and an incompetent cervix. Id. at 514. The court held that it was not necessary that plaintiff learn of the cause of the reproductive issues she was experiencing before the statute of limitations could run. Id. at 514-15. The court did not accept plaintiff's position that the statute of limitations could not have begun until plaintiff had some notice years after her reproductive problems that she may have been exposed to a toxic substance in utero. Id.

12.   To be clear, even under Wetherill, the cause of the primary condition (or a diagnosis) need not be known for the statute of limitations to begin to run. 89 N.Y.2d at 514 (“the only reasonable inference is that when the Legislature used the phrase ‘discovery of the injury’ it meant discovery of the physical condition and not ․ the more complex concept of discovery of both the condition and the nonorganic etiology of that condition”).

13.   Defendants note that Plaintiff does not proffer an affidavit or declaration speaking to her state of mind or impressions shared by her providers at the time she first experienced abdominal pain and swelling.

14.   Prior to the Physiomesh implant, Plaintiff underwent a laparoscopic hand assisted partial left nephrectomy for removal of a renal cell carcinoma that required a 4 cm to 6 cm incision on the left side of her lower abdomen. [Dr. Rodriguez Report at 6].

15.   Plaintiff cannot rely on an implied warranty theory to salvage a breach of warranty claim based upon future performance. See VVA Phase III, LLC v. Hilti, Inc., 2022 WL 20467126, at *5 (N.D. N.Y. Sept. 2, 2022) (stating that the “future performance exception does not extend to breaches of implied warranty because an implied warranty, by definition, cannot contain an explicit guarantee”); and see Rouviere v. Howmedica Osteonics Corp., 645 F. Supp. 3d 157, 176 (S.D.N.Y. 2022) (“Implied warranty claims ․ are not subject to tolling under U.C.C. § 2-725(2)”).

RICHARD W. STORY, United States District Judge