Monroe v. Medtronic, Inc.

• Citation: 511 F.Supp.3d 26
• Decision Date: 06 January 2021
• Docket Number: Civil Action No. 20-10144-NMG
• Parties: Quanita MONROE, Plaintiff, v. MEDTRONIC, INC. et al., Defendants.
• Court: U.S. District Court — District of Massachusetts

511 F.Supp.3d 26

Quanita MONROE, Plaintiff,

v.MEDTRONIC, INC. et al., Defendants.

Civil Action No. 20-10144-NMG

United States District Court, D. Massachusetts.

Signed January 6, 2021

Nicholas Rocco Farnolo, Napoli Shkolnik PLLC, Melville, NY, for Plaintiff.

Jessica C. Wilson, DLA Piper Us LLP, Boston, MA, for Defendants.

MEMORANDUM & ORDER

GORTON, United States District Judge

Plaintiff Quanita Monroe ("plaintiff" or "Monroe") alleges that Medtronic, Inc. ("Medtronic"), its subsidiaries Covidien LP and Covidien U.S. Holdings, Inc. (collectively, "Covidien") and numerous unknown individuals involved in the manufacturing and distribution process (collectively, with Medtronic and Covidien, "defendants") are liable for her severe internal injuries caused by a medical mesh product implanted during hernia repair surgery. Pending before the Court is defendants’ motion to dismiss plaintiff's complaint.

I. Factual Background

Medtronic is a medical device manufacturer based in Ireland with a United States principal place of business in Minnesota. In 2015, Medtronic acquired each of the medical device companies that comprise Covidien, both of which are incorporated in Delaware and have their principal places of business in Massachusetts.

Covidien manufactures several different kinds of hernia mesh, including a polyester surgical mesh known as Parietex Composite ("PCO") mesh. PCO mesh is a two-sided composite mesh which, like other such meshes, is used to add support to muscular walls and prevent the recurrence of hernias. It has a protective absorbable collagen barrier to prevent tissue attachment on one side and a polyester textile on the other side.

Defendants allegedly secured approval to market PCO mesh from the U.S. Food and Drug Administration ("FDA") pursuant to a section of the Food, Drug and Cosmetic Act ("FDCA") that applies to devices found to be "substantially equivalent" in design and function to a device already legally on the market. 21 U.S.C. § 360c(f) and (i). That process, plaintiff avers, allowed defendants to forego pre-market clinical studies and research intended to ensure the safety of the product.

Monroe, a resident of Nebraska, alleges that she underwent surgery to repair an inguinal hernia in May, 2013, during which PCO mesh manufactured by defendants was implanted. She alleges that she suffered from chronic abdominal pain in the months following the surgery and that she underwent corrective surgery on an unrecalled date to remove or revise part of the implanted mesh.

In January, 2017, Monroe claims she went to the emergency room complaining of severe abdominal pain. Exploratory surgery purportedly revealed that the PCO mesh had eroded into her small intestine, requiring the immediate removal of the mesh and a portion of her bowel.

Plaintiff contends that, as a result of defendants’ negligent conduct in the manufacturing and distribution of PCO mesh, she has suffered severe and permanent injuries.

II. Procedural Background

Plaintiff filed her original complaint in this Court on January 23, 2020, alleging jurisdiction based upon diversity of citizenship. She amended her complaint first in February, 2020, and then again in April, 2020. In her second amended complaint ("the complaint"), plaintiff alleges 11 counts against the defendants: negligence (Count I); strict liability for defective design (Count II); strict liability for defective manufacturing (Count III); strict liability for failure to warn (Count IV); violations of 15 U.S.C. § 2301 et seq. and Neb. Rev. Stat. § 59-1602 et seq. (Count V); unjust enrichment (Count VI); fraudulent concealment (Count VII); negligent misrepresentation (Count VIII); negligence per se in violation of 21 U.S.C. § 33l(e) and 21 C.F.R. § 806.10(a)(1) (Count IX); vicarious liability (Count X); and punitive damages (Count XI).

Defendants filed their motion to dismiss plaintiff's complaint pursuant to Fed. R. Civ. P. 12(b)(6) and 9(b) on May 11, 2020. Pursuant to a joint motion of the parties, the case was stayed in June, 2020, pending a decision of the Judicial Panel on Multidistrict Litigation ("JPML") as to whether to consolidate the case with 11 other pending federal actions related to Covidien's hernia mesh products. In August, 2020, the JPML declined to consolidate the cases for coordinated pretrial treatment and defendants subsequently moved to lift the stay and renew their motion to dismiss. This Court lifted the stay in September, 2020, and plaintiff thereafter timely opposed the motion to dismiss.

III. Motion to Dismiss

A. Legal Standard

To survive a motion to dismiss, a claim must contain sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). In considering the merits of a motion to dismiss, the Court may only look to the facts alleged in the pleadings, documents attached as exhibits or incorporated by reference and matters of which judicial notice can be taken. Nollet v. Justices of Trial Court of Mass., 83 F. Supp. 2d 204, 208 (D. Mass. 2000), aff'd, 248 F.3d 1127 (1st Cir. 2000).

Furthermore, the Court must accept all factual allegations in the claim as true and draw all reasonable inferences in the claimant's favor. Langadinos v. Am. Airlines, Inc., 199 F.3d 68, 69 (1st Cir. 2000). If the facts in the claim are sufficient to state a cause of action, a motion to dismiss must be denied. See Nollet, 83 F. Supp. 2d at 208.

Although a court must accept as true all the factual allegations in a claim, that doctrine is not applicable to legal conclusions. Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Threadbare recitals of legal elements which are supported by mere conclusory statements do not suffice to state a cause of action. Id.

B. Application

1. Choice of Law

As a preliminary matter, this Court must determine what law applies to plaintiff's claims. In diversity actions, a federal court must apply the law that would be applied under the choice of law rules of the forum state. Levin v. Dalva Bros., 459 F.3d 68, 73 (1st Cir. 2006). In Massachusetts, courts apply a "functional approach" to choice of law that is "explicitly guided by the Restatement (Second) of Conflict of Laws (1971)." Id. at 74. Under that approach, tort claims are governed by the law of the state where the injury occurred unless another state has a more significant relationship to the underlying cause of action. Watkins v. Omni Life Sci., Inc., 692 F. Supp. 2d 170, 174 (D. Mass. 2010).

The parties conclude that Nebraska law should apply to plaintiff's claim and this Court agrees. The implantation of the mesh and the subsequent injuries and treatment appear to have occurred in Nebraska, where plaintiff also resides. The only state with any other significant connection to the case is Massachusetts, where Covidien has its principal place of business, but the cause of action is clearly more closely related to Nebraska than Massachusetts. Although choice of law analysis may be premature at the motion-to-dismiss stage in some circumstances, here the parties are in agreement and the facts are sufficiently clear that delay in making such a determination "would serve no useful purpose."

Foisie v. Worcester Polytechnic Inst., 967 F.3d 27, 42 (1st Cir. 2020). Therefore, this Court will apply Nebraska law.

2. Strict Liability (Counts II, III and IV)

a. Design Defect

To state a claim of strict liability for a design defect under Nebraska law, a plaintiff must show that

(1) the defendant placed the product on the market for use and knew, or in the exercise of reasonable care should have known, that the product would be used without inspection for defects; (2) the product was in a defective condition when it was placed on the market and left the defendant's possession; (3) the defect is the proximate or a proximately contributing cause of the plaintiff's injury sustained while the product was being used in a way and for the general purpose for which it was designed and intended; (4) the defect, if existent, rendered the product unreasonably dangerous and unsafe for its intended use; and (5) the plaintiff's damages were a direct and proximate result of the alleged defect.

Vallejo v. Amgen, Inc., 2014 WL 4922901, at *7, 2014 U.S. Dist. LEXIS 138455, at *18 (D. Neb. 2014). To satisfy the fourth element, a plaintiff must allege facts showing that the product was

dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.

Id. at *7, 2014 U.S. Dist. LEXIS 138455 at *18-19 (quoting Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 569, 618 N.W.2d 827 (2000) ).

Defendants contend that they are entitled to dismissal of Monroe's design defect claim because 1) her allegations that the PCO mesh was unreasonably dangerous or defectively designed are conclusory and 2) she does not explain how an alleged defect in the PCO mesh caused her injuries.

Liberally construing Monroe's complaint, this Court concludes that she has proffered facts sufficient to state a strict liability design defect claim. Monroe satisfies the first element because she alleged that defendants placed the PCO mesh on the market and knew that it would be used without inspection. She also satisfies the second element by alleging that the PCO mesh was defective when placed on the market because the absorbable collagen barrier and unsealed edges fail to protect against damage caused by the mesh's polyester textile component.

With respect to the fourth element, Monroe alleged that the defects of PCO mesh rendered it unreasonably dangerous and that the PCO mesh products are "considerably more harmful and inadequate than other meshes or methods for hernia repair." To support such a claim, plaintiff alleges that the PCO mesh causes a severe inflammatory response even when properly implanted....