Engren v. Johnson & Johnson, Inc.

SHERI A. ENGREN v. JOHNSON & JOHNSON, INC., and ETHICON, INC.

Civil Action No. 21-10333-RGS

United States District Court, D. Massachusetts

September 17, 2021

MEMORANDUM AND ORDER ON DEFENDANTS' MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

RICHARD G. STEARNS UNITED STATES DISTRICT JUDGE

As treatment for certain abdominal and pelvic conditions plaintiff Sheri A. Engren had implanted a polypropylene pelvic mesh designed, manufactured, and sold by defendants Johnson & Johnson, Inc., and Ethicon, Inc. By way of her Second Amended Complaint (SAC), Engren claims that the mesh was defective and unexpectedly eroded within five years exacerbating her conditions. Defendants move to dismiss for failure to state a claim upon which relief may be granted. See Fed. R. Civ. P. 12(b)(6). For the reasons to be explained, the court will deny the motion in part and allow it in part.

BACKGROUND

Engren had been diagnosed with severe stress incontinence and cystocele.^[1] SAC ¶ 18. On September 26, 2013 Engren “underwent a procedure involving a pubovaginal sling using Prolene mesh, transvaginal bilateral repair using Prolene mesh, transvaginal anterior colporrhaphy using autologous tissue, and a cystoscopy using GYNECARE GYNEMESH™ PS” (Gynemesh PS). Id. Defendants manufacture, advertise, promote, and sell Gynemesh PS - a polypropylene^[2] mesh product that is marketed and sold as a treatment for pelvic organ prolapse and stress incontinence. Id. ¶¶ 14-18. Engren underwent a revision surgery on March 22, 2018, at which time she was informed that she had suffered “eroded vaginal mesh and a recurrence of urinary urge incontinence.” Id. ¶ 18. Engren complains that since the revision surgery, she has suffered from stress incontinence, severe bladder spasms, and general abdominal discomfort. Id.

Engren filed this diversity suit on February 6, 2021. She asserts claims for defects in manufacturing, design, and warnings (Count I-III); negligence (Count IV); breach of warranty (Count V); negligent misrepresentation (Count VI); and violation of Massachusetts's Consumer Protection Act, Mass. Gen. Laws ch. 93A (Count VII).

DISCUSSION

“The sole inquiry under Rule 12(b)(6) is whether, construing the well-pleaded facts of the complaint in the light most favorable to the plaintiffs, the complaint states a claim for which relief can be granted.” Ocasio-Hernandez v Fortuno-Burset, 640 F.3d 1, 7 (1st Cir. 2011). In most circumstances, the plaintiff need not demonstrate a “heightened fact pleading of specifics, ” but rather must present “only enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Accordingly, facts that are “merely consistent with” a defendant's liability are inadequate. Id. Further, the recitation of the elements of a claim, “supported by mere conclusory statements, ” is insufficient to establish facial plausibility. Id.

Count I - Manufacturing Defect

Defendants contend, and the court agrees, that Engren's manufacturing defect claim fails because she does not allege a specific deviation or flaw in the manufacturing process. Under Massachusetts law, a manufacturing defect occurs where “a particular product[, ] rather than a line of products, is alleged to be defective because of negligence in the manufacturing process.” Smith v. Ariens Co., 375 Mass. 620, 626 (1978). Thus, “to establish a manufacturing defect, a plaintiff must demonstrate that there is a ‘deviation from the design [that] rendered the product unreasonably dangerous and therefore unfit for its ordinary purposes.'” Burnham v. Wyeth Labs., Inc., 348 F.Supp.3d 109, 112 (D. Mass. 2018), quoting Back v. Wickes Corp., 375 Mass. 633, 641 (1978).

Here, the SAC asserts that “[o]ne or more of the defects in the [Gynemesh PS] implanted in [Engren] are a result of improper or incorrect manufacturing processes.” SAC ¶ 94. Without identifying a particular flaw or deviation, Engren's conclusory statement that the product was improperly manufactured does not state a plausible claim for relief.^[3] See Iqbal, 556 U.S. at 678; see also, e.g., Taupier v. Davol, Inc., 490 F.Supp.3d 430, 440 n.6 (D. Mass. 2020) (dismissing manufacturing defect claim because the complaint was “devoid of allegations that the . . . mesh patch was manufactured in a manner that differed from its intended design”).

Count II - Design Defect

In Engren's view, defendants' defective design of Gynemesh PS led to mesh erosion that necessitated the revision surgery to remove the mesh and left Engren with intractable abdominal discomfort. SAC ¶¶ 101-107. Defendants argue that Engren has failed to plead facts that plausibly link her claimed injuries to any alleged defective design.

Manufacturers have “the duty to design [their] product[s] so that [they are] reasonably fit for the purpose for which [they were] made.” Ariens Co., 375 Mass. at 623. “For a product to be defective, it must be ‘made according to an unreasonably dangerous design' and does not meet a consumer's reasonable expectation as to its safety.'” Niedner v. Ortho-McNeil Pharm., Inc., 90 Mass.App.Ct. 306, 312 (2016), quoting Everett v. Bucky Warren, Inc., 376 Mass. 280, 290 (1978). To sketch a design defect, a plaintiff must demonstrate “(1) the manufacturer's failure to exercise a reasonable degree of care under the circumstances; (2) proximate causation; and (3) injury and/or loss.” Geshke v. Crocs, Inc., 889 F.Supp.2d 253, 261 (D. Mass. 2012), citing Ulwick v. DeChristopher, 411 Mass. 401, 408 (1991).^[4]

Engren has pled sufficient facts to state a design defect claim. In the SAC, Engren avers that in 2008 - five years before her Gynemesh PS implant - the U.S. Food and Drug Administration (FDA) issued a Public Health Notification to transvaginal mesh manufacturers, including defendants, that there had been over 1, 000 complaints of adverse events related to pelvic mesh products. SAC ¶ 30. In 2011 - two years before her procedure - the FDA issued a further “Safety Communication” that it had “conducted an updated analysis of adverse effects reported to the FDA and complications reported in the scientific literature and concluded that surgical mesh used in transvaginal repair of [p]elvic [o]rgan [p]rolapse was an area of ‘continuing serious concern.'” Id. ¶ 31. The FDA determined that the incidence of serious complications was “not rare” and that “[m]any of the[se] serious complications required medical and surgical treatment and hospitalization.” Id. Additionally, the FDA stated that there was no clear evidence that the use of surgical mesh for transvaginal repair of pelvic organ prolapse is “more effective than traditional non mesh repair of pelvic organ prolapse.” Id. ¶ 32. In December of 2011, the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) likewise released a joint committee opinion identifying physical changes to the mesh inside the body as a serious complication, highlighting “increasing reports of vaginal pain associated with changes that can occur with mesh (contraction, retraction, or shrinkage) that result in taut sections of mesh, ” and remarking that “[s]ome of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.” Id. ¶ 34.

In light of the well-known reports of serious complications, one can reasonably infer that at the time of Engren's implant, defendants' design of Gynemesh PS was “unreasonably dangerous.”^[5] Bucky Warren, Inc., 376 Mass. at 290. These public health messages also provided defendants with sufficient notice of the defect such that defendants failed “to exercise a reasonable degree of care under the circumstances.” Geshke, 889 F.Supp.2d at 261. Viewed against the FDA's conclusion that polypropylene surgical mesh may not be more effective “than traditional non mesh repair of pelvic organ prolapse, ” SAC ¶ 32, Engren's suggestions of possible alternative designs - such as sutures, an autologous fascia lata and an autologous fascia sling, an allograft sling, and a sling with less polypropylene - are adequate to survive a motion to dismiss.

Engren has also pled sufficient facts that, taken as true, establish defendants' defective design of Gynemesh PS as the proximate cause of her injuries. Engren's allegation - that mesh erosion required a removal surgery and caused incontinence, bladder spasms, and abdominal discomfort, see SAC ¶ 18 - is consistent with the ACOG and AUGS joint committee opinion that mesh erosion, or “contraction, ” is a documented serious complication that in many cases requires “surgical intervention” and causes chronic pain and discomfort. Id. ¶ 34. Engren also notes that medical and scientific studies have concluded that mesh erosion and contraction are causally related to the polypropylene mesh products themselves and “do not implicate errors related to the implementation of the devices.” Id. ¶¶ 53-54. Taken together, Engren's claim crosses the dividing line from “merely consistent” to “plausible.” Iqbal, 556 U.S. at 678.

Count III - Failure to Warn

Defendants maintain that because the SAC does not describe or disclose the content of any instructions or warnings that were given or should have been given by defendants to Engren's healthcare providers, Engren fails to establish that defendants' warnings were inadequate. The court agrees.

Under Massachusetts law, “a manufacturer can be found liable to a user of the product if the user is injured [because of] the failure of...