Products Liability Law Daily Wrap Up, PLEADINGS—MEDICAL DEVICES—M.D. Ga.: Lengthy recitals of alleged product defects failed to connect those deficiencies with patient’s own injuries, (May 1, 2024)

By Jeffrey H. Brochin, J.D.

The inherent issue with the patient’s shotgun pleadings was that they required the court and the manufacturer to cull through factual allegations, identify the claims, and then determine which allegations that appeared to be germane to her claims.

A federal district court in Georgia has granted the Motion to Dismiss filed by Johnson & Johnson (Manufacturer) in a products liability lawsuit brought by a patient who claimed she suffered injuries as a result of implantation with the Manufacturer’s TVT-O mesh (device or product). Despite numerous and lengthy allegations as to alleged defects, dangers, and risks to women in general from the device, the complaint failed to properly tie in those deficiencies with the Patient’s injuries, and was overall deemed to be an example of impermissible shotgun pleading (Pacheco v. Johnson & Johnson, April 16, 2024, Self, T.).

Problems following mesh implant. On June 18, 2010, the patient was implanted with the TVT-O pelvic mesh device to treat her SUI. Although the surgery went well, at some point after the implant, she began experiencing mesh erosion and exposed mesh, among other symptoms, that led her to needing corrective surgery. She filed suit against the manufacturer in 2017 claiming design defect, manufacturing defect, failure to warn, negligence, and gross negligence, as well as for breach of express warranty and implied warranty. Presently before the court was the Manufacturer’s Motion to Dismiss based on shotgun pleading and other grounds.

Federal Rules 8(a)(2) and 10(b). Federal Rules 8(a)(2) and 10(b) work together to serve at least two critical functions. First, these rules require that claims be presented discretely and succinctly so that the opposing party can understand what the complaint is claiming so as to be able to frame a responsive pleading. Second, they allow courts to determine which facts support which claims and whether the complaint has properly stated any claims upon which relief can be granted. Furthermore, Rule 8(a)(2) requires that a complaint contain a short and plain statement of the claim showing that the pleader is entitled to relief.

The Eleventh Circuit Court of Appeals has identified four types of “shotgun pleadings” that are characterized by: (1) multiple counts that each adopt the allegations of all preceding counts; (2) conclusory, vague, and immaterial facts that do not clearly connect to a particular cause of action; (3) failing to separate each cause of action or claim for relief into distinct counts; or (4) combining multiple claims against multiple defendants without specifying which defendant is responsible for which act. The unifying characteristic of all types of shotgun pleadings is that they fail to one degree or another to give the opposing party adequate notice of the claims against them and the grounds upon which each claim rests.

Shotgun pleadings. The manufacturer argued that the instant complaint matched the second and fourth types of shotgun pleading. The court therefore began its analysis based on those grounds. The complaint detailed numerous facts about the product and its risks, for example, under Count I (negligence), the complaint included a non-exhaustive list of 14 ways in which the product was “was unreasonably dangerous and defective,” but without explaining which of those dangers caused the patient’s injuries. In Count II (design defect), the complaint included another non-exhaustive list of nine ways in which the product was defective, but again did not specify which defects affected her. In Count IV (failure to warn), she alleged numerous risks that the manufacturer failed to warn the public about, but she did not say which of those risks ultimately manifested in her injuries.

Connecting facts to injuries. The court observed that the only place where patient discussed her own interaction with the TVT-O product and alleged injuries from it were in her “Common Facts” section before she attempted to detail her individual causes of action. The court noted that the only patient-specific facts in the “Common Facts” section were that (1) the patient received the implant in June 2010 in Athens, Georgia, (2) to treat her SUI (3) via a surgery without complication, (4) at some point after which, she suffered from numerous injuries, including mesh erosion and corrective surgery. Those four facts make up the vast majority, if not all, of the only facts specific to the patient throughout the entire complaint.

But what the court found most problematic was that it was unclear which “Common Facts” applied to which counts. The patient did not reference the “Common Facts” section, nor any of its numbered paragraphs, in her counts, nor did she incorporate the patient-specific facts in any of her counts. Accordingly, both the court and the Manufacturer were left wondering: which “Common Facts” apply to which counts? The court therefore concluded that the patient’s complaint amounted to an impermissible shotgun pleading and the complaint was dismissed (albeit with leave to amend) on that basis.

Breach of warranty claims. The manufacturer also argued that Count V (breach of express warranty) and Count VI (breach of implied warranty) should be dismissed as untimely under O.C.G.A. § 11-2A-506.8. Specifically, they argued that the patient was required to assert her breach of warranty claims within four years after she received the implant in 2010, and that because she did not file her initial action until 2017, her claims were therefore time-barred.

In response, the patient argued that in the Georgia statute that the manufacturer referenced, they ignored a crucial piece of that statute which provides an exception: “Where a warranty explicitly extends to future performance of the goods,” the cause of action doesn’t accrue until a patient discovers or should have discovered the breach. The court found that the patient was correct as to the exception applying to warranties that explicitly extend to future performance of the goods, and that her breach of express warranty claim could potentially survive the statute of limitations if her amended complaint would adequately plead that she filed her 2017 action within four years of discovering the defects. However, the manufacturer was correct as to her breach of implied warranty claim not falling under the Georgia statute’s exception and therefore that claim was dismissed as time-barred.

The case is No. 3:24-cv-00002-TES.

Attorneys: Andrew N. Faes (Wagstaff & Cartmell) for Yary Pacheco. S Eric Rumanek (Troutman Pepper Hamilton Sanders LLP) for Johnson & Johnson and Ethicon Inc.

Companies: Johnson & Johnson; Ethicon Inc.

Cases: CourtDecisions MedicalDevicesNews DesignManufacturingNews WarningsNews GeorgiaNews