Bostic v. Ethicon Inc.

• Decision Date: 30 March 2022
• Docket Number: Civil Action 20-6533
• Court: U.S. District Court — Eastern District of Pennsylvania
• Parties: LAVONIA BOSTIC v. ETHICON INC. AND JOHNSON & JOHNSON

LAVONIA BOSTIC
v.
ETHICON INC. AND JOHNSON & JOHNSON

Civil Action No. 20-6533

United States District Court, E.D. Pennsylvania

March 30, 2022

MEMORANDUM

JOHN R. PADOVA, J.

Plaintiff Lavonia Bostic filed this action against Defendants Ethicon Inc. and Johnson & Johnson, alleging that she suffered injuries after being implanted with the Gynecare TVT pelvic mesh product that was manufactured, sold, and distributed by Defendants. Defendants have moved to dismiss her First Amended Complaint (“Complaint”). For the following reasons, the Motion to Dismiss is granted in part and withdrawn in part.

I. FACTUAL BACKGROUND

The Complaint alleges the following facts. Bostic was implanted with the Ethicon Gynecare TVT pelvic mesh product (the “TVT product”) to treat stress urinary incontinence (“SUI”) by Dr. Carmen J. Sultana (“Plaintiff's implanting physician”) at Thomas Jefferson University Hospital in Philadelphia.^[1] (Comp. ¶¶ 2, 52.) The TVT product, like most pelvic mesh products, is made from polypropylene mesh, which is a type of plastic. (Id. ¶¶ 3, 13, 15.) Plaintiff developed complications from the TVT product, which include “mesh complications necessitating a revision procedure, sling dysfunction, mesh contracture and shrinkage, urinary hesitancy,

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difficulty voiding or urinary retention, mixed urinary incontinence, chronic pelvic pain, dyspareunia, a vaginal bulge, and stress and anxiety. (Id. ¶ 4.) Ethicon, Inc. is part of a business unit of Johnson & Johnson that designed, promoted, marketed, distributed, and sold the TVT product. (Id. ¶ 5.)

Surgical mesh is a medical device that is used to repair weakened or damaged tissue. (Id. ¶ 13.) “It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.” (Id.) Gynecologists began using surgical mesh products for the surgical repair of prolapsed organs in the 1970s. (Id. ¶ 11.) In the 1990s, gynecologists began to use surgical mesh to treat pelvic organ prolapse (“POP”) and SUI. (Id.) Defendants manufacture the TVT product, which is a Class II medical device, for women who suffer from SUI “as a result of the weakening [of] or damage caused to the walls of the vagina.” (Id. ¶¶ 12, 14.) To treat SUI, surgical mesh is used to reinforce the weakened vaginal wall and support the urethra. (Id. ¶ 13.) The TVT product is marketed as a way to correct SUI with a “minimally invasive procedure” that causes “minimal local reactions, minimal tissue trauma and minimal pain.” (Id. ¶ 12.)

Polypropylene mesh is biologically incompatible with human tissue. (Id. ¶ 15.) A large number of the people who are inserted with the TVT product experience “host defense response” in which their “‘pelvic tissue[] promotes degradation of the polypropylene mesh and the pelvic tissue, and causes 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. ¶ 16.) The “host defense response” can also cause “painful sexual relations, significant urinary dysfunction, vaginal shortening and anatomic deformation, and can contribute to adverse reactions to the mesh.” (Id.) In addition, TVT products which contain collagen cause “hyper-inflammatory responses leading to problems including chronic pain and fibrotic reaction.” (Id. ¶ 17.)

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Defendants' TVT products which contain collagen disintegrate after implantation causing adverse tissue reactions and infection. (Id.) Moreover, cross linked collagen hardens body tissues. (Id.) In addition, insertion of the TVT product in the female body “creates a non-anatomic condition in the pelvis leading to chronic pain and functional disabilities.” (Id. ¶ 18.)

The FDA approved the marketing of the TVT product for use in the treatment of SUI in 1997 under the 510(k) approval process. (Id. ¶ 19.) The 510(k) approval process, “provides for marketing of a medical device if the device is deemed ‘substantially equivalent' to other predicate devices marketed before May 28, 1976.” (Id.) The 510(k) approval process does not require a formal review for safety or efficacy and no such review was conducted with respect to the TVT product. (Id.)

Defendants marketed the TVT product to the medical community and to patients “as a safe, effective, reliable medical device; implanted by safe and effective, minimally invasive surgical techniques for the treatment of medical conditions, including [SUI], and as safer and more effective as compared to the traditional products and procedures for treatment, and other competing pelvic mesh products.” (Id. ¶ 21.) Defendants sold the TVT product to the medical community and to patients “through carefully planned, multifaceted marketing campaigns and strategies, ” including aggressive marketing to health care providers at medical conferences, hospitals, and private offices, using cash and non-cash benefits to health care providers. (Id. ¶ 22.) Defendants also marketed the TVT product through documents, patient brochures, and websites, which exaggerated and created “misleading expectations as to the safety and utility of the TVT product.” (Id. ¶ 23.) Defendants also engaged in direct-to-consumer marketing for the TVT product. (Id.)

On October 20, 2008, the FDA issued a Public Health Notification that described more than 1000 adverse events that had been reported over the previous three-year period related to

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pelvic mesh products, including Defendants' TVT product. (Id. ¶¶ 26-27.) On July 13, 2011, the FDA issued a Safety Communication warning of serious complications from pelvic mesh products, including the TVT product. (Id. ¶ 28.) The FDA stated that “‘serious complications associated with surgical mesh for transvaginal repair of POP are not rare.'” (Id.) The Safety Communication warning also noted that “‘[m]esh contraction (shrinkage) is a previously unidentified risk of transvaginal POP 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. ¶ 29 (alteration in original).) The Safety Communication also indicated that the benefits of using pelvic mesh products could be outweighed by the risks of using those products: “‘it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risks.'” (Id. ¶ 30.)

At the same time that it released the Safety Communication, the FDA released a White Paper titled “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.” (Id. ¶ 31.) The White Paper noted that “‘[p]atients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.'” (Id. (alteration in original).) The White Paper also stated that the FDA “‘has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risks.'” (Id. ¶ 32.) The White Paper also noted that the mesh products “are associated with serious adverse events” and that “POP can be treated successfully without mesh.” (Id. ¶ 33.) The White Paper

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further stated “that the FDA ‘ha[d] identified serious safety and effectiveness concerns over the use of surgical mesh for transvaginal repair of pelvic organ prolapse.'” (Id.)

On August 25, 2011, Public Citizen petitioned the FDA for a ban on the use of the TVT product in pelvic repair procedures. (Id. ¶ 34.) In December 2011, a joint committee of the American College of Obstetricians and Gynecologists (“ACOG”) and the American Urogynecologic Society (“AUGS”) “identified physical and mechanical changes to the TVT transvaginal mesh inside the body as a serious complication associated with transvaginal mesh” that could cause contraction, retraction, or shrinkage and require surgical repair; the joint committee also noted that some of the pain caused by the condition “appears to be intractable.” (Id. ¶ 35.) The ACOG/AUGS Joint Committee also recommended that “‘[p]elvic organ prolapse vaginal mesh repair . . . be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk.'” (Id. ¶ 36 (first alteration in original).) “In January 2012, the FDA recognized the risk to women and mandated additional studies to further investigate these risks.” (Id. ¶ 39.) “On April 16, 2019, the FDA ordered all transvaginal POP device manufacturers, including Defendants, to stop selling and distributing these products immediately.” (Id. ¶ 40.) The FDA had “concluded that these products do not have a reasonable assurance of safety and effectiveness.” (Id.)

Defendants marketed the TVT product as a safe medical device even though they knew that “the product was not safe for its intended purposes” and that it would and did cause serious medical problems and catastrophic injuries. (Id. ¶ 53.) Defendants hid the magnitude and frequency of these problems from physicians. (Id.) Defendants intentionally misrepresented and concealed facts regarding the defective nature of the TVT product from Plaintiff and her physicians so that they would request and purchase the TVT product, and Plaintiff and her implainting

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physician justifiably relied on Defendants' misrepresentations to Plaintiff's detriment. (Id. ¶¶ 54-55.) Plaintiff and her physicians were not aware of the facts about the TVT product and, if they had been, they would not have relied on Defendants' representations about the safety and efficacy of the TVT product or used the TVT product to treat Plaintiff's SUI. (Id. ¶ 56.) Defendants made misrepresentations about the TVT...