Products Liability Law Daily No new trial needed in pelvic sling case
Monday, March 26, 2018

No new trial needed in pelvic sling case

By Georgia D. Koutouzos, J.D.

A woman who had received a $55,000 compensatory damages award after a jury found in her favor on a negligent misrepresentation claim against the manufacturer of an allegedly defective implantable pelvic sling device was not entitled to a new trial on either damages or on all issues, an Illinois federal court determined, also denying the sling maker’s motion for judgment as a matter of law. Despite the patient’s insistence that there was no doubt she had sustained an injury that produced pain and suffering, the fact that her physical complaints had been memorialized in voluminous medical records did not transform them into objective evidence, the court explained, ruling that the jury had been free to determine that the testimony regarding her pain was not credible (Springer v. Ethicon, Inc., March 23, 2018, Kennelly, M.).

A patient who had been surgically implanted with a Gynecare TVT Obturator System (TVT-O)—a type of mid-urethral sling manufactured by Ethicon, Inc. designed to be implanted in the pelvic area to treat stress urinary incontinence in women—allegedly suffered pelvic pain, urinary problems, and painful sexual intercourse because of the device. She filed suit against the manufacturer and, eventually, its parent company, Johnson & Johnson, Inc. (collectively, "Ethicon"), alleging claims of negligence, strict liability, and breach of warranty (the negligence and strict liability claims were both brought under theories of failure to warn and defective design).

The case was tried to a jury, which found in favor of the device maker on the negligence and strict liability claims but found in the patient’s favor on her claim of negligent misrepresentation. The jury awarded the patient $55,000 in compensatory damages, all of which was allocated to "[t]he reasonable expense of necessary medical care, treatment, and services received"; no punitive damages were awarded, nor were any damages for past or future pain and suffering or damages for loss of a normal life. Following the verdict, Ethicon filed a renewed motion for judgment as a matter of law on the patient’s claims, and she moved for a new trial on damages or, in the alternative, a new trial on all issues.

Verdict inconsistency. Noting that the jury had returned a verdict favoring the manufacturer on the patient’s negligence and strict liability claims, Ethicon contended that in reaching that verdict the jury necessarily found either that the TVT-O Instructions for Use (IFU) were adequate or that any inadequacy in the instructions had not caused the patient’s injury. As such, any alleged misrepresentation in the IFU could not support a verdict in favor of the patient with respect to the negligent misrepresentation claim, the company argued.

Ethicon’s stance seemed to assume that a verdict in favor of the patient on the negligent misrepresentation claim would be inconsistent with verdicts in favor of the manufacturer on the negligence and strict liability claims, the court observed, disagreeing with that position. In contrast with the strict liability and negligence jury instructions, the negligent misrepresentation instruction made no mention of inadequate warnings; instead, the negligent misrepresentation claim depended on proof of an "inaccurate or false statement of material fact to prescribing physicians regarding the safety and reasonable fitness" of the product. As such, the jury could have found that the IFU contained an inaccurate or false statement of material fact.

Furthermore, notwithstanding the company’s arguments to the contrary, it was not the case that, in returning a verdict for Ethicon on negligence and strict liability, the jury necessarily found that every statement in the IFU was either true or did not cause injury to the patient. Consequently, the manufacturer’s motion for judgment as a matter of law was denied.

Pain and suffering damages. The patient argued that a new trial on damages was warranted considering the jury’s award of $0 for pain and suffering. Specifically, she maintained that she had requested damages for three types of injuries: (1) recurrent urinary tract and bladder infections, (2) pelvic pain, and (3) painful sexual intercourse. In that regard, she asserted that, by finding in her favor on the negligent misrepresentation claim and awarding damages for medical expenses, the jury necessarily found that these injuries were caused by the TVT-O. She further argued that, although Ethicon had disputed that the TVT-O caused her injuries, it did not dispute the existence or extent of her injuries. In light of the above, she contended that there was no doubt that she had sustained an injury that produced pain and suffering.

With respect to the patient’s evidence of pain and suffering, however, the court found that although her medical records were replete with references to her complaints of pain and tenderness in the pelvic area, those complaints were subjective. The fact that they had been memorialized in a great number of medical records did not transform them into objective evidence. And, because complaints of pain are primarily subjective, the jury was free to determine that the patient’s testimony regarding her pain was not credible. Ergo, it could not be concluded that the jury’s damages award was necessarily inconsistent, that it bore no reasonable relationship to the loss suffered, or that the jury ignored a proven element of damages in awarding the patient damages for her medical expenses but nothing for pain and suffering. Therefore, a new trial was not warranted on that basis, the court advised.

Exclusion of recall evidence. The patient also argued that the court erred in having excluded evidence that Ethicon’s competitors had removed their own mid-urethral sling devices from the market due to complications associated with the slings. According to the patient, evidence of the other sling recalls was relevant to the issue of proximate cause because it undermined studies referring to pelvic mesh as the "gold standard" treatment for stress urinary incontinence.

However, the patient presented no argument regarding why the products that were recalled are comparable to the TVT-O, nor did she demonstrate that the questionable relevance of this evidence outweighed the danger that the jury would be misled into thinking that the competing slings that were removed from the market were fair comparators to the TVT-O. Accordingly, it was not error to have excluded that evidence under the relevant evidentiary standards, the court held.

Jury instructions. Lastly, the patient argued that the court erred in denying her proposed jury instruction for a negligence claim based on a "failure to test" theory in addition to failure to warn and defective design theories (the proposed instruction was denied on the basis that there was no viable support for a "failure to test" negligence claim independent of a defective design or failure to warn claim). However, the patient had not been precluded from arguing her failure to test theory; rather, she had been permitted to argue the point as part and parcel of her negligence claim

With that in mind, it was difficult to see how she had been prejudiced, the court said, concluding that it was not error to deny the patient's proposal to include a "failure to test" line item in the jury instructions for negligence. Accordingly, the patient’s motion for a new trial was denied and, because a new trial was unwarranted on any issues, no further evaluation was necessary on whether the requirements for a new trial on the damages issue had been met.

The case is No. 17 C 3930.

Attorneys: Elise Anne Waisbren (Phillips Law Offices LLC) for Thomas E. Springer. Christy D. Jones (Butler Snow O'Mara Stevens & Cannada, PLLC) and Erica M. James (Tucker Ellis LLP) for Ethicon, Inc. and Johnson & Johnson.

Companies: Ethicon, Inc.; Johnson & Johnson

MainStory: TopStory WarningsNews DesignManufacturingNews MedicalDevicesNews IllinoisNews

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