Health Law Daily Negligence claims proceed in mesh suit, other claims fail
Thursday, October 17, 2019

Negligence claims proceed in mesh suit, other claims fail

By Donielle Tigay Stutland, J.D.

The court allowed negligence claims to continue in transvaginal mesh lawsuit against Boston Scientific; however, the court dismissed warranty and product liability claims.

A Texas district court granted in part and denied in part Boston Scientific Corporation’s (BSC) motion to dismiss a transvaginal mesh lawsuit. The injured patient underwent several surgeries during which products manufactured by BSC were implanted, and she alleged the devices caused several medical issues. BSC sought to dismiss the case based on a failure to state a claim. The court dismissed the counts related to product liability, breach of warranty and fraud, however, it found that the plaintiff may continue her suit based on the negligence claim (Fearrington v. Boston Scientific Corporation October 16, 2019, Lake, S.).

Factual background. BSC produced three devices at issue in the suit, the Obtryx® Transobturator Mid-Urethral Sling System, the Polyform® Synthetic Mesh, and the Advantage Fit® System. The plaintiff received two of the three devices in Florida in 2006, and the third device in Texas in 2017. The patient alleged that she sustained injuries because the pelvic mesh products warped and shrunk while inside of her. She also alleged that she was not warned of the risks, nor was the risk of injury justified. The complained alleged multiple theories of recovery, including products liability for marketing, manufacturing and design defects; breach of express and implied warranties; negligence; and fraud, fraudulent concealment, and negligent misrepresentation.

Products liability claims. The court dismissed the claims based on marketing defects, manufacturing defects and design defects due to vague pleadings. With respect to the marketing defect, the court found that Texas law, not Florida law, was controlling. Under Texas law, the learned intermediary doctrine applies, and the patient would need to show that the manufacturer did not adequately warn the physicians, and but for this failure, the patient would not have been injured by the device. The court found that the patient did not plead with specificity and her pleadings were simply a recitation of this doctrine.

In discussing the manufacturing defect argument, the court noted that while the patient argued that the products deformed while within her body, it was not sufficient to establish a manufacturing defect claim. She failed to show that the product was defective when it left BSC and that the defect caused her injuries. The court found that the patient did not give any detail as to how the design differed from intended design or specification, or how such a deviation actually caused the injury once in her body. The court indicated that the patient did not establish that a feasible design was available, nor did she provide enough facts to establish Florida, which has a different design defect test, controls. The court granted leave to amend these pleadings.

Warranties. The court found that patient did not plead sufficient facts to show that either an express or implied warranty was breached. First, the court agreed with the manufacturer that there were insufficient facts to show the breach of an express warranty. Again, the court looked at the learned intermediary doctrine and concluded that the plaintiff did not allege specific facts to show any specific communication to show an alleged warranty. With respect to the implied warranty claim, the court noted that her claim did not show privity of contract, as the device was not sold directly to the plaintiff.

Fraud and negligent misrepresentation. The court also dismissed claims relating to fraud and negligent misrepresentation. The complaint alleged that BSC’s sales and marketing claims were willfully deceiving; however, the patient provided no details as to any communications regarding the marketing campaign, where it originated, or who the recipients of the campaign were. These claims were also dismissed, with only the negligence claims remaining.

The case is Civil Action No. H-19-2366.

Attorneys: Larissa A. Davis (Bossier & Associates, PLLC) for Janet Fearrington. Amy R. Fiterman (Faegre Baker Daniels LLP) for Boston Scientific Corp.

Companies: Boston Scientific Corp.

MainStory: TopStory FDCActNews MDeviceNews PLDeviceNews

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