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Transvaginal Mesh Plaintiffs’ Verdicts Affirmed; Failure to Warn


A woman suffered from pelvic organ prolapse (POP), which occurs when pelvic floor muscles become weak or dysfunctional and cease supporting the organs in the pelvic area, causing connective tissue attachments to stretch or break, and allowing the uterus, the bladder, and/or the rectum to drop into the vaginal canal.

 

If noninvasive treatments are not effective, there are various surgical options for POP. One option is to use polypropylene mesh to support the vagina. One way to implant this mesh is through an abdominal incision. Beginning around 2003, surgeons began using kits to implant the mesh transvaginally, i.e., through the vagina.

 

A company manufactured and sold polypropylene transvaginal mesh kits to treat women with pelvic organ prolapse. In 2007, the FDA cleared the manufacturer to sell a transvaginal mesh kit pursuant to its 510(k) process, which entailed finding that the transvaginal mesh kit was “substantially equivalent” to another device already available on the market.

 

The transvaginal mesh kit’s directions for use contained the following warnings:

 

Hysterectomy may be needed in the future; use of mesh may make future hysterectomies more difficult due to tissue in-growth and scarring.

In the event that infection presents post procedure, the entire mesh many have to be removed or revised.

Tissue responses to the implant could include local irritation at the wound site, vaginal erosion or exposure through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation, foreign body reaction, and inflammation. The occurrence of these responses may require removal or revision of the mesh.

 

The woman had a transvaginal mesh kit made by this manufacturer implanted to treat POP. In the months following the surgery, the woman began to experience bleeding and pain during intercourse, incontinence, and pelvic pain and pressure.

 

The woman visited a doctor for these problems. The doctor performed a pelvic exam that revealed that the woman had exposed mesh in the vagina. The doctor performed in-office surgery to trim the exposed mesh in an attempt to alleviate the woman’s symptoms. Unfortunately, this treatment did not resolve the woman’s problems.

 

Four years later, the woman visited another doctor and complained of similar symptoms. This doctor examined the woman, found another mesh exposure, and performed a second mesh-removal surgery. Since then, the woman’s pain largely subsided, but the woman lost vaginal sensitivity.

 

The woman sued the manufacturer of the transvaginal mesh. The woman’s complaint sought compensatory and punitive damages based on claims for negligent design defect, negligent failure to warn, strict-liability design defect, and strict-liability failure to warn.

 

The woman initially filed suit in the United States District Court for the Southern District of West Virginia as part of a transvaginal mesh multidistrict litigation (MDL). The woman’s suit was consolidated with three other similar suits and transferred to the United States District Court for the Southern District of Florida for trial. The consolidated plaintiffs all brought the same four claims under Florida law, arguing that the manufacturer was both negligent and strictly liable for the transvaginal mesh’s defective design, and both negligent and strictly liable for failing to warn of the resultant danger from the transvaginal mesh.

 

After discovery, the manufacturer moved the district court to sever the suits. The motion argued that the similarities in the plaintiffs’ suits did not predominate and that consolidation would lead to jury confusion and prejudice. It pointed out that each plaintiff had different complaints, different medical histories, and different treating doctors; was prescribed the transvaginal mesh kit at different times for different conditions; and claimed to suffer different injuries, after different lengths of exposure, resulting in different treatment courses. The district court denied the motion.

 

Prior to trial, the district court excluded all evidence relating to the FDA’s regulatory scheme and clearance of the transvaginal mesh kit for sale pursuant to the 510(k) “substantial equivalence” process. The district court reasoned that the evidence was irrelevant and any probative value was substantially outweighed by a danger of unfair prejudice, confusing the issues, misleading the jury, undue delay, or wasting time.

 

During the trial, the women presented evidence. The women presented graphic images and testimony regarding one patient’s removed mesh. Experts testified about two specific defects in the transvaginal mesh kit. First, the polypropylene material may experience oxidative degradation, which causes it to lose its physical and mechanical properties in a way that causes injury. Second, the crosshatched design of the mesh makes it very difficult, if not impossible, to remove if there is a problem with the mesh. The women also presented evidence post-dating some of the implantations of the transvaginal mesh kit in some of the women, including admissions from the manufacturer’s employees tending to show a general pattern of insufficient research for medical devices and information suggesting a high erosion rate for the transvaginal mesh.

 

After eight days of trial, the jury found for each of the women on all four claims, awarding more than six million dollars to each woman.

 

The Eleventh Circuit United States Court of Appeals affirmed. The court held that the district court did not abuse its discretion in consolidating the lawsuits; graphic images and testimony regarding one patient’s removed mesh was admissible; evidence post-dating some of the women’s implantation procedures, including admissions from the manufacturer’s employees tending to show a pattern of insufficient research for other medical devices and information suggesting a high erosion rate for the transvaginal mesh kit, was admissible; evidence regarding the manufacturer’s compliance with the FDA’s 510(k) review process was inadmissible; under Florida law, sufficient evidence supported the jury’s finding that the transvaginal mesh kit was defectively designed; under Florida law, sufficient evidence supported the jury’s finding that the manufacturer failed to adequately warn physicians of the dangers of the transvaginal mesh kit; and, under Florida law, the question of whether the woman was on notice of the possible invasion of legal rights by the manufacturer, as would cause the four-year limitations period on the products liability action to accrue, on the day after the surgery when the woman experienced urinary incontinence, was a question for the jury.

 

The district court did not abuse its discretion in consolidating the lawsuits. Although each woman’s proof of causation for injuries was different, all four women brought the same claims based largely on same facts, i.e., that the transvaginal mesh kit was unreasonably dangerous by design and that the manufacturer failed to include sufficient warnings with the transvaginal mesh kit to alert physicians to the danger. Generally, differences in causation are not enough, standing alone, to bar consolidation of products liability claims. Any danger of prejudice arising from consolidation was reduced because the district court explained the consolidated nature of the trial to the jury and expressly instructed the jury to consider each plaintiff’s claims separately. Most of the evidence presented by the women went toward the common claims among them: (1) whether the transvaginal mesh kit was a defective medical device, and (2) whether the transvaginal mesh kit’s warnings were sufficient. The only evidence that went to the individual claims came from the more-easily-distinguishable doctors who performed each woman’s implantation, and concerned comparatively straightforward issues: (1) whether the transvaginal mesh kit’s design caused that specific woman’s injuries, and (2) whether the lack of sufficient warnings influenced that specific doctor’s decision to implant the transvaginal mesh kit. Nearly identical or identical damages awards for different plaintiffs in consolidated actions, without more, is not sufficient evidence of juror confusion for purposes of determining whether a court abused its discretion in consolidating actions.

 

Graphic images and testimony regarding one patient’s removed mesh was admissible. Graphic medical photos and testimony, while potentially disturbing, might also be particularly helpful in allowing a jury to better understand a medical device and the allegedly related injuries. The very feature that made the images graphic, i.e., the tissue that was removed along with the mesh, was what made the images relevant to the women’s claim that the very nature of the transvaginal mesh kit’s design prevented removal of the mesh without removing tissue.

 

Evidence post-dating some of the women’s implantation procedures, including admissions from the manufacturer’s employees tending to show a pattern of insufficient research for other medical devices and information suggesting a high erosion rate for the transvaginal mesh kit, was admissible. A pattern of insufficient research might be probative as to whether the manufacturer generally designed products without due care. The transvaginal mesh kit’s high erosion rate was probative of whether the manufacturer was strictly liable for a defective product. This evidence could not be used to show the manufacturer’s knowledge of the risks associated with the transvaginal mesh kit for those women whose implantations predated the evidence. But when evidence is relevant for some purposes and not others, limiting instructions—not exclusion—are generally the best way to handle the issue. The manufacturer failed to request limiting instructions.

 

Evidence regarding the manufacturer’s compliance with the FDA’s 510(k) review process was inadmissible. Evidence regarding the manufacturer’s compliance with the FDA’s 510(k) review process was not probative of the transvaginal mesh kit’s safety. The FDA’s 510(k) review process does not address a product’s safety and efficacy, merely its similarity to another product. Compliance with the FDA’s 510(k) review process could not show that the manufacturer performed sufficient testing or complied with applicable safety regulations. Even if evidence regarding the manufacturer’s compliance with the FDA’s 510(k) review process was probative, the district court did not abuse its discretion when it excluded the evidence. The court agreed with the district court that admitting the evidence might have provoked the parties to engage in a time-consuming mini-trial on whether the manufacturer complied with FDA regulations. The apparent significance of federal regulatory schemes might have misled the jury into thinking that general federal regulatory compliance, not state tort liability, was the core issue. Risk of confusion for the jury substantially outweighed any probative value.

 

Under Florida law, sufficient evidence supported the jury’s finding that the transvaginal mesh kit was defectively designed. The women’s expert in the field of polymer science testified that the polypropylene material in the transvaginal mesh kit could experience oxidative degradation, which could cause it to lose its physical and mechanical properties in a way that causes injury. The women’s expert in the fields of obstetrics and gynecology opined that the crosshatched design of the mesh made it very difficult, if not impossible, to remove the transvaginal mesh kit if there was problem with the mesh. When taken together, these experts’ testimony provided a sufficient foundation for a reasonable jury to conclude that the design of the transvaginal mesh kit increased both the potential for degradation and the difficulty of removal.

 

Under Florida law, sufficient evidence supported the jury’s finding that the manufacturer failed to adequately warn physicians of the dangers of the transvaginal mesh kit. The women’s expert in the fields of obstetrics and gynecology testified that the transvaginal mesh kit’s directions for use failed to inform doctors that a patient may need multiple operative procedures to remove it and that removing portions of it resulted in part of the patient’s normal tissue being removed. This expert also testified that the manufacturer’s warnings did not explain that complications from the transvaginal mesh kit could be permanent, irreversible, and untreatable. The court found that, while the transvaginal mesh kit’s warnings may have been sufficient to notify doctors that multiple procedures might be needed to remove the mesh, the warnings did not even remotely suggest that removal might be impossible. The repeated warnings that removal might be necessary suggested just the opposite. The warnings also failed to notify doctors that removal of the mesh might require removal of healthy tissue as well. The closest the warnings came was by warning that “future hysterectomies [may be] more difficult due to tissue in-growth and scarring.” That warning was not so unambiguous that it would be unreasonable for a jury to hold the manufacturer liable for failure to warn. The woman’s physician who implanted the transvaginal mesh kit testified that had the physician known the risks of using the transvaginal mesh kit, the physician would have had concerns about using it and would have discussed those concerns with the woman. The court reasoned that the woman’s physician’s testimony did not point so overwhelmingly in favor of the manufacturer that no reasonable jury could find that the failure to warn proximately caused the woman’s injuries.

 

Under Florida law, the question of whether the woman was on notice of the possible invasion of legal rights by the manufacturer, as would cause the four-year limitations period on the woman’s products liability action to accrue, on the day after the surgery when the woman experienced urinary incontinence, was a question for the jury. The court found that the evidence was not clear. While the woman did exhibit one new symptom—urinary incontinence—the symptom could have been associated with a defect in the transvaginal mesh kit and was not so obviously unusual as to indisputably put the woman on notice about the woman’s claim. It was not “patently clear” or “obvious” that the woman’s incontinence was a sufficiently distinct symptom from what might be expected after vaginal surgery to put the woman on notice of the cause of action against the manufacturer. The woman could also have reasonably believed that the incontinence was related to the surgery itself rather than the transvaginal mesh kit. The court concluded that a jury could have reasonably concluded that the woman’s injury was not so distinct from conditions naturally to be expected from the woman’s post-surgical condition and so the timeliness of the woman’s action was properly a question of fact for the jury.

 

The Eleventh Circuit United States Court of Appeals affirmed the trial court’s entry of judgment on a jury verdict in favor of the women.

 

See: Eghnayem v. Boston Scientific Corporation, 2017 WL 4681345 (C.A.11 (Fla.), October 19, 2017) (not designated for publication).

 

See the Medical Law Perspectives Blog: First Appellate Decision on Merits Affirms Verdict for Plaintiffs’ Transvaginal Mesh Case

 

 

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