Thomas v. Ethicon, Inc., Civil Action GLR-20-3729

CourtUnited States District Courts. 4th Circuit. United States District Court (Maryland)
Writing for the CourtGeorge L. Russell, III United States District Judge.
Docket NumberCivil Action GLR-20-3729
PartiesCATHERINE THOMAS, et al., Plaintiffs, v. ETHICON, INC., et al., Defendants.
Decision Date28 December 2021

CATHERINE THOMAS, et al., Plaintiffs,

ETHICON, INC., et al., Defendants.

Civil Action No. GLR-20-3729

United States District Court, D. Maryland

December 28, 2021


George L. Russell, III United States District Judge.

THIS MATTER is before the Court on Defendants Ethicon, Inc. and Johnson & Johnson's (collectively, “Defendants” or “Ethicon”) Motion for Partial Dismissal of Plaintiffs' First Amended Complaint (ECF No. 11) and Motion to Sever Plaintiffs' Claims (ECF No. 3). The Motions are ripe for disposition, and no hearing is necessary. See Local Rule 105.6 (D.Md. 2021). For the reasons outlined below, the Court will grant in part and deny in part Ethicon's Motion for Partial Dismissal and will deny the Motion to Sever.[1]


A. Ms. Thomas and Ms. Shiflett's Treatment and Injuries

Plaintiffs Catherine Thomas (“Ms. Thomas”) and Patricia Shiflett (“Ms. Shiflett”) (collectively, “Injured Plaintiffs”) suffered from stress urinary incontinence and sought


surgical intervention to help treat it in the 2000s. They each received mesh implants that were developed and manufactured by Ethicon and designed to assist them with their conditions. (First Am. Compl. ¶¶ 2, 6, 10-11, 17). Over time, however, the materials used in the implants reacted negatively with their bodies, causing them to endure painful complications that eventually required them to undergo “revision procedures.” (Id. ¶ 99, 102).

The specific allegations regarding Injured Plaintiffs' treatment and injuries in the First Amended Complaint are scant. On April 21, 2003, Dr. George Mamo surgically implanted Ms. Shiflett with an Ethicon Gynecare TVT product (“TVT”) in Baltimore, Maryland. (Id. ¶ 6). The implant caused her to suffer from “pelvic pain, chronic inflammation, urgency, frequency, nocturia, dysuria, dyspareunia, difficulty and incomplete voiding, urinary tract infections, and worsening incontinence.” (Id. ¶¶ 6-7). A few years later, on January 12, 2007, Dr. Parvez Shah implanted Ms. Thomas with an Ethicon TVT-Secur pelvic mesh product (“TVT-S”) in Laurel, Maryland. (Id. ¶ 2). Ms. Thomas later suffered from complications causing “erosion, mixed incontinence, nocturia, difficulty and incomplete voiding, dyspareunia, and pelvic pain.” (Id. ¶ 3).

Ms. Thomas and Ms. Shiflett allege that they each had to undergo unspecified “revision procedures” because of defects in Defendants' TVT and TVT-S products. (Id. ¶ 102). They do not state what the procedures were or when they were performed. Injured Plaintiffs allege that they suffered from injuries and related damages.


B. Surgical Mesh Generally

Injured Plaintiffs provide far more detail about the use of surgical mesh generally than their own experiences with it. Surgical mesh products have been used to repair abdominal hernias since the 1950s. (Id. ¶ 26). In the 1970s, gynecologists began using mesh products designed for treating hernias to repair prolapsed organs. (Id.). By the 1990s, doctors used surgical mesh in the treatment of pelvic organ prolapse and stress urinary incontinence. (Id.).

Defendants' surgical mesh products, the TVT and TVT-S specifically, have been used to treat stress urinary incontinence. (Id. ¶ 27). The products are designed to repair weakened or damaged tissue. (Id. ¶ 28). During the surgical treatment for stress urinary incontinence, TVT or TVT-S mesh is permanently implanted in the patient to help support the weakened vaginal wall. (Id.). Most TVT or TVT-S products are made of “non-absorbable, synthetic, monofilament polypropylene mesh and/or collagen.” (Id.).

Plaintiffs allege that “the scientific evidence shows that this TVT-S and TVT mesh material is biologically incompatible with human tissue.” (Id. ¶ 30). The TVT-S and TVT mesh produces an immune response in “a large subset of the population” treated with the products. (Id.). This immune response, described as a “host defense response, ” can be severe and causes the polypropylene mesh, as well as some pelvic tissue, to degrade. (Id. ¶¶ 30-31). This degradation, in turn, “can contribute to the formation of severe adverse reactions.” (Id.). The mesh can also cause “chronic inflammation of the pelvic tissue, shrinkage or contraction of the mesh leading to nerve entrapment, further inflammation, chronic infectious response and chronic pain.” (Id. ¶ 31). As a result of the body's response


to the mesh products, women can experience “new-onset” symptoms, including pain during sex, urinary dysfunction, vaginal shortening and deformation, and other “adverse reactions.” (Id.). Injured Plaintiffs allege that Ethicon was “aware or had actual knowledge” of these risks and misrepresented or failed to inform them about the risks. (Id.).

The collagen contained in TVT and TVT-S products is also dangerous. (Id. ¶ 32). Collagen can cause “hyper-inflammatory responses, ” which in turn can create problems with chronic pain and fibrotic reaction. (Id. ¶¶ 32, 84). When the products “disintegrate” while in the pelvis, the collagen can cause “adverse tissue reactions” which are “causally related to infection.” (Id. ¶ 32). The collagen causes the body's tissues to “harden” in harmful ways. (Id.).

On October 20, 2008, the Food and Drug Administration (“FDA”) issued a Public Health Notification outlining over 1, 000 complaints it had received over a three-year period regarding the TVT and TVT-S products. (Id. ¶ 41). Injured Plaintiffs assert that the FDA's Manufacturer and User Facility Device Experience (“MAUDE”) database indicates that Ethicon's pelvic mesh products were the subject of the 2008 notification. (Id. ¶ 42).

On July 13, 2011, the FDA issued a warning about complications associated with the TVT and TVT-S products, including those manufactured, marketed, and distributed by Ethicon. (Id. ¶ 43). The warning stated that “serious complications” related to the use of surgical mesh for treatment of pelvic organ prolapse, a distinct condition from stress urinary incontinence, “are not rare.” (Id.). Around that time, the FDA received “increased reports of complications” associated with pelvic mesh products used to treat stress urinary incontinence, including TVT and TVT-S products. (Id.). The FDA explained: “Mesh


contraction (shrinkage) is a previously unidentified risk of transvaginal [pelvic organ prolapse] repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA . . . . Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.” (Id. ¶ 44). Plaintiffs allege that the mesh used in the TVT and TVT-S products is similar to the mesh used for pelvic organ prolapse repair described by the FDA as subject to mesh contraction, or shrinkage. (Id.).[3]

The FDA published a paper called “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse” around the same time as its safety notification described above. (Id. ¶ 46). The paper cited peer-reviewed literature indicating that mesh used in pelvic organ prolapse repair procedures could lead to complications “not experienced by patients who undergo traditional surgery without mesh.” (Id.). The FDA indicated that there were “serious safety and effectiveness concerns” regarding the surgical mesh used in pelvic organ prolapse procedures. (Id. ¶ 48). Plaintiffs assert that the mesh used in Defendants' products “is the same mesh” used in pelvic organ prolapse treatment and cautioned by the FDA. (Id.).


Other groups have argued that the risks presented by surgical mesh are unreasonable. On August 25, 2011, Public Citizen, a consumer advocacy group, submitted a petition to the FDA requesting a ban on the use of TVT-S and TVT products in pelvic repair procedures. (Id. ¶ 49). The group argued that the products should be recalled because they present serious risks to patients. (Id.). Additionally, in December 2011, the American College of Obstetricians and Gynecologists and the American Urogynecologic Society raised concerns about the use of pelvic mesh:

There are increasing reports of vaginal pain associated with changes that can occur with mesh (contraction, retraction, or shrinkage) that result in taut sections of mesh . . . . Some of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.

(Id. ¶ 50). The groups recommended that pelvic mesh only be used “for high-risk individuals in whom the benefit of mesh placement may justify the risk.” (Id. ¶ 51). Again, Plaintiffs assert that the mesh used in pelvic organ prolapse repair and complained about by these organizations is the same mesh used in Defendants' TVT and TVT-S products. (Id.). Injured Plaintiffs contend that Defendants knew that the pelvic mesh products they produced and marketed for stress urinary incontinence carried the same risks as the pelvic mesh used to treat pelvic organ prolapse. (Id. ¶ 52).

On April 16, 2019, the FDA ordered all transvaginal pelvic organ prolapse device manufacturers, including Defendants, to stop selling pelvic organ prolapse products. (Id. ¶ 55). Because Plaintiffs contend that the mesh used to treat stress urinary incontinence is the same as the mesh used for pelvic organ prolapse, they assert that Defendants “knew or


should have known” about the risk that the TVT and TVT-S products created for patients. (Id. ¶ 56).

C. Procedural History

On December 23, 2020, Ms. Thomas and Ms. Shiflett, along with their respective husbands, Richard Thomas and Ray Shiflett, filed suit against Ethicon. (ECF No. 1). On March 12, 2021, Ethicon filed a Motion to Sever Plaintiffs' Claims (ECF No. 3) and a Motion to Dismiss the Complaint (ECF No. 4). On March 17, 2021, Plaintiffs filed their First Amended Complaint, mooting Defendants' Motion to Dismiss. (ECF No. 7)...

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