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Transvaginal Mesh Verdict $3.31Million; FDA Postsurgery Regulatory Action Admitted


Pelvic organ prolapse occurs when a woman has weak vaginal walls that allow adjoining organs, 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 pelvic organ prolapse. 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.

 

In this case, the defendant medical device company manufactured and sold polypropylene transvaginal mesh kits to treat women with pelvic organ prolapse.

 

A woman sought medical care for urinary incontinence she experienced while participating in sports. She was also diagnosed with mild pelvic prolapse of the bladder and rectum. As a remedy, her gynecologist recommended surgical insertion of a mesh sling for the incontinence and surgical repair with two of the manufacturer’s mesh kits, anterior and posterior, for the prolapse. The gynecologist performed the procedures on the woman.

 

Postsurgery, the woman experienced complications. She could not urinate, had to self-catheterize, and was in pain. During the nine months after the initial surgery, the woman underwent five surgeries to attempt to resolve the complications. After a sixth surgery, another gynecologist discovered that the mesh had eroded (moved) into the woman’s rectum. She then underwent a seventh and eighth surgery to address the erosion. The woman continued to experience excruciating pain due to nerve damage and pain during sexual intercourse. She also lost control of her bowels.

 

The woman and her husband filed a complaint for negligence, strict product liability, negligent misrepresentation, and fraud against the gynecologist and the manufacturer of the transvaginal mesh kits. The action was bifurcated with the trial on the causes of action against the gynecologist to follow the trial on the causes of action against the manufacturer.

 

When the Superior Court of Kern County heard the in limine motions two months before trial, it barred evidence of postsurgery regulatory actions, including the FDA's 2008 and 2011 public health notices and 2012 letter requesting clinical trials.

 

During its opening statement, while the in limine ruling excluding the FDA regulatory actions was in place, the manufacturer explained to the jury that the manufacturer’s transvaginal mesh was cleared and then stated:

 

“Now, once the FDA does that and says you may sell, is that the end of it? The answer is a very definitive no. And that is that the FDA is monitoring and regulating these products throughout and they always do that. And so one of the things that is required by regulation [is] complaint handling so if anyone has a complaint or has an outcome if the company finds out it has to be reported to the FDA and there are certain rules and regulations about that, the complaints and the trending and tracking of those complaints would go to the departmental heads, the management review to keep an eye on to see is there anything out of the usual here or is this the incident rate about what we see for other product.”

 

During trial, the court reversed its pretrial ruling and allowed the couple to present evidence of the FDA's public health notices and 2012 letter. The manufacturer moved for a mistrial, which the trial court denied. Alternatively, the manufacturer requested a six-week continuance so it could recall certain witnesses. The trial court denied this motion as well. At trial, the manufacturer repeatedly and emphatically explained that the transvaginal mesh kit was taken off the market only because it had become obsolete.

 

The trial court directed a verdict on manufacturing defect, fraud and breach of warranty, but denied the motion on negligence and failure to warn. The jury returned a special verdict finding that the manufacturer was not liable for failure to warn. However, the jury found the manufacturer was negligent and that its negligence was a substantial factor in the woman's harm. The jury awarded her $5 million in damages and awarded her husband $500,000 for loss of consortium. The jury found the obstetrician's negligence was not a substantial factor in causing the couple’s harm, but assigned 40 percent fault to the obstetrician. Based on this finding, the trial court reduced the couple’s noneconomic damages by 40 percent and entered judgment for $3.31 million for the woman and $300,000 for her husband.

 

The California Court of Appeal for the Fifth District affirmed. The court held that the negligence theories were properly submitted to the jury; substantial evidence supported the negligence verdict; the trial court did not err in admitting the FDA's postsurgery regulatory actions; the trial court did not abuse its discretion when it changed its in limine ruling, admitted that evidence mid-trial, and denied the manufacturer’s request for a continuance; the couple was estopped from asserting that the trial court erred by failing to instruct the jury on medical professional negligence to support the apportionment; and the appellate court could not set aside the trial court’s apportionment of fault despite the ambiguous special verdict.

 

The trial court properly submitted the negligence theories to the jury. The trial court did not err in submitting the question of whether the manufacturer was liable for negligently designing the transvaginal mesh kit to the jury. The jury was properly instructed on general negligence and the need to determine whether the manufacturer used the amount of care in designing the product that a reasonably careful medical device manufacturer would use. The theory that the manufacturer undertook to train physicians and thus had a duty to use due care in carrying out such training was properly submitted to the jury. The directed verdict on the fraud cause of action did not preclude a negligence finding based on negligent misrepresentation. Therefore, the trial court did not err in submitting the negligent misrepresentation cause of action to the jury.

 

Substantial evidence supported the negligence verdict. The jury was presented with three negligence theories and returned a verdict without specifying which theory it relied on. Accordingly, the verdict would be sustained if any one theory is supported by substantial evidence and is unaffected by error. The negligent design claim was supported by substantial evidence. To be negligent, a product designer must fail to use the amount of care in designing the product that a reasonably careful designer would use in similar circumstances. The couple’s expert testified as to the differences between the manufacturer’s transvaginal mesh kit and other manufacturer's products and explained why the manufacturer’s transvaginal mesh kit design was more likely to injure the patient. From this evidence, the jury could decide whether the manufacturer acted as a reasonably careful medical device manufacturer when it designed the transvaginal mesh kit. Since only one theory was necessary to sustain the negligence verdict, the court did not determine whether the negligent training and negligent misrepresentation claims were supported by the record.

 

The trial court did not err in admitting the FDA's postsurgery regulatory actions because they were relevant, their admission did not violate the rule excluding evidence of subsequent remedial measures, and their probative value outweighed any risk of undue prejudice. The postsurgery regulatory actions were admitted as they were found relevant. During its opening statement, the manufacturer caused the FDA's postsurgery regulatory actions to become relevant when it intimated that the FDA had continued to monitor and regulate transvaginal mesh and had taken no action. Thus, the regulatory evidence became relevant to disabuse the jury of the notion introduced by the manufacturer that the FDA was closely monitoring transvaginal mesh kits and had found no cause for concern about their safety. The rule excluding evidence of subsequent remedial or precautionary measures did not apply because the postsurgery actions were taken by a third party, the FDA. Since imposition of liability was not sought against the person taking the remedial action, the policy consideration of not wanting to discourage persons from taking remedial action that might prevent further injury was absent. It was within the trial court’s discretion to exclude evidence if its probative value was substantially outweighed by the probability that it will create a substantial danger of undue prejudice, of confusing the issues, or of misleading the jury. The trial court's admission of the FDA regulatory actions was not so arbitrary, capricious or patently absurd that it resulted in a manifest miscarriage of justice. Although before trial the jurors might not have understood the different FDA actions, during trial various witnesses explained what the FDA's actions meant. Further, the jury was made aware that the FDA did not find the manufacturer’s transvaginal mesh to be defective and that the 2012 letter was sent to all transvaginal mesh manufacturers. Thus, the jury was able to evaluate the FDA regulatory actions in context.

 

The trial court did not abuse its discretion when it changed its in limine ruling, admitted that evidence mid-trial, and denied the manufacturer’s request for a continuance. In limine rulings are tentative and the trial court retains discretion to make different rulings as the evidence unfolds. The manufacturer's opening statement caused the FDA regulatory action to become relevant and the court warned the manufacturer shortly thereafter that its remarks had changed the situation. Moreover, the parties had fully explored this evidence during discovery. It was not a situation where the plaintiff was attempting to bring in new facts or theories of liability during the trial. Under these circumstances, the trial court's mid-trial ruling on the admissibility of the FDA regulatory action evidence was not arbitrary, capricious or patently absurd. Similarly, the trial court's denial of the manufacturer's motion to continue the trial for six weeks was not arbitrary or capricious. Because the trial was well underway, a lengthy continuance would have been unreasonably disruptive. Further, the manufacturer was able to use deposition testimony for the witnesses who had become unavailable for recall.

 

The couple was estopped from asserting that the trial court erred by failing to instruct the jury on medical professional negligence to support the apportionment. The jury was instructed on the basic standard of care. However, despite the jury being asked to determine whether a medical professional was negligent, the jury was not instructed on the medical standard of care. The medical standard of care was more specific than the general standard of care and, unlike general negligence, required expert testimony. Accordingly, it was more difficult to prove a defendant fell below the medical standard of care than it was to prove a defendant fell below the general standard of care. The court reasoned that it was in the couple’s best interest for the jury to find that the gynecologist was not at fault. Thus, it was in the couple’s best interest for the jury to be instructed on and apply the more specific standard of care. Nevertheless, the couple acquiesced in the giving of incomplete instructions on the gynecologist’s fault. This put the couple in a “win win” position. By acquiescing to the absence of an instruction on the medical standard of care, the couple could wait and see what the jury did and then, if the jury found the gynecologist was partially at fault, argue that the finding could not stand because the jury was not instructed on the medical standard of care. The court concluded that, under those circumstances, the couple was estopped from asserting this instructional error on appeal.

 

The appellate court could not set aside the trial court’s apportionment of fault despite the ambiguous special verdict. The jury needed to find that the gynecologist's negligence was a substantial factor before it could apportion fault to the gynecologist. The jury answered “no” to the question “Was [the gynecologist]'s negligence a substantial factor in causing [the woman]'s harm?” In response to a separate question the jury apportioned 40 percent fault to the gynecologist. There was an inconsistency between these two answers. The appellate court was not permitted to choose between inconsistent answers.

 

The California Court of Appeal for the Fifth District affirmed the trial court’s entry of judgment on a jury verdict in favor of the couple.

 

See: Scott v. C.R. Bard, Inc., 2014 WL 6475366 (Cal.App. 5 Dist., November 19, 2014) (not designated for publication).

 

 

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