Products Liability Law Daily Design defect claim survived trans vaginal surgical mesh manufacturers’ summary judgment motion
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Friday, August 28, 2020

Design defect claim survived trans vaginal surgical mesh manufacturers’ summary judgment motion

By Leah S. Poniatowski, J.D.

Patient did not need to present testimony linking feasible alternative design to patient specifically, but her belated request to substitute experts was not harmless to manufacturers.

A products liability-based lawsuit against the manufacturers of trans vaginal surgical mesh survived a summary judgment challenge on the issue of design defect, a federal district court in South Carolina ruled, holding that there was no requirement that the patient present a feasible alternative design connected to her specifically. The court also ruled on the patient’s motion to substitute an expert, ruling that it was untimely and would not be harmless to the manufacturers. In lieu of automatically excluding the testimony as her request triggered sanctions, the court allowed her to present testimony of a timely-identified expert (Gardner v. Ethicon, Inc., August 27, 2020, Lydon, S.).

A patient purportedly injured after having a Profit device and TVT-SECUR implanted in order to remedy her pelvic organ prolapse and stress urinary incontinence filed a products liability-based lawsuit against the manufacturers, Ethicon, Inc., and Johnson & Johnson. Her case joined the multi district litigation against Ethicon in 2013, and was remanded in March 2020. Ethicon and Johnson & Johnson filed the present motion for summary judgment in June 2020. At the same time, the patient also filed a motion to substitute an expert witness.

Design defect. The court addressed the manufacturers’ motion for summary judgment first, holding that under South Carolina’s seminal case on application of the risk-utility test when evaluating design defects, summary judgment in favor of the manufacturers was not appropriate. The patient asserted negligence and strict liability design defect claims in her lawsuit. In order to prevail on her claim, under applicable law, she is required to demonstrate that: (1) she was injured by the product; (2) that the product, at the time of the accident, was in essentially the same condition as when it left the hands of the manufacturer; and (3) the injury occurred because the product was in a defective condition unreasonably dangerous to the user.

In Branham v. Ford Motor Co., 701 S.E.2d 5, 13 (S.C. 2010), the South Carolina Supreme Court held that plaintiffs must present evidence of a reasonable alternative design in order to satisfy the third element, adding that "in design defect cases the risk-utility test provides the best means for analyzing whether a product is designed defectively." Under this test, the plaintiff must show that a design flaw existed in the product and how the alternative design would have prevented the product from being unreasonably dangerous. Failing this, the defendant becomes entitled to judgment as a matter of law.

In the present case, the manufacturers argued that the patient did not have any case-specific expert opinion of a safer design of the devices, and the patient did not dispute that her expert did not proffer case-specific evidence. However, the patient asserted that the general liability experts provided opinions on a less-dangerous feasible design alternative for individuals such as the patient. The court held that, under Branham, the manufacturers were incorrect that the patient needed to link the reasonable alternative design to her specific injuries. Subsequent case law applying Branham established that only "some evidence" of an alternative design is necessary, because, according to the court in the present case, "the risk-utility test relates to the defectiveness of the design—not causation."

Expert witness substitution. In the patient’s motion before the court, she requested permission to substitute an expert witness pursuant to federal evidentiary rules. She alternatively pleaded that if the court does not find she has good cause for the substitution, that the court not apply the automatic exclusion rule to bar her expert’s report and testimony. The court stated that identifying the expert at this stage was "unquestionably too late," as it occurred two years after the deadline established by the MDL.

At the end of the hearing, the court did not find good cause for the expert substitution, which would trigger the automatic exclusion rule. However, there are two exceptions to the sanctions rule—if the failure to disclose was: substantially justified or harmless. The court already determined that the patient did not meet the "substantial justification" exception. The court turned to the applicable five-factor test to determine if the patient’s late disclosure was harmless, focusing on the first four factors. Although the patient asserted that: (1) there would be no surprise to the manufacturers because they had possession of the proposed expert’s report two years before the deadline; (2) the surprise is easily cured by allowing the manufacturers to substitute an expert; (3) it would not disrupt the trial because it is not on the eve of trial; and (4) she would be without a key expert to provide causation testimony.

The court explained that the same attorneys and the same expert were involved in a similar situation in a parallel MDL case, but that its analysis of harmlessness must focus on the present case only. The manufacturers argued at the hearing that the patient was trying to change experts for strategic reasons, and that they chose their experts based on the patient’s designations in the MDL, and that the patient’s attorneys continue to lack candor with the court. However, the court determined that these arguments "only tangentially relate to surprise and ability to cure," i.e., the first two factors. The court observed that both parties appear to agree that the case would proceed to trial as scheduled, and that the evidence is "crucially important" to the patient’s case.

The court concluded that allowing the new witness testimony would not be harmless to the manufacturers. It would require the manufacturers to have to make eve-of-trial decisions in addition to undermining the goal and purpose of the MDL pretrial proceedings.

Sanctions. The court agreed that the automatic sanction under the federal rules would be too harsh as it would leave the patient without a general causation expert. Accordingly, the court permitted a timely-identified expert witness to testify at trial.

The case is No. C/A No. 4:20-cv-00067-SAL.

Attorneys: James Edward Bell, III (Bell Legal Group) for Jennifer Gardner. Robert E. Sumner, IV (Butler Snow LLP) for Ethicon Inc. Daniel R. Higginbotham (Thomas Combs & Spann, PLLC) for Johnson & Johnson.

Companies: Ethicon Inc.; Johnson & Johnson

MainStory: TopStory DesignManufacturingNews CausationNews ExpertEvidenceNews MedicalDevicesNews SouthCarolinaNews

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