[CERTIFIED FOR PARTIAL PUBLICATION[*]]
APPEAL from a judgment of the Superior Court of Kern County, No. CV-266034 William D. Palmer, Judge.
[Copyrighted Material Omitted]
[Copyrighted Material Omitted]
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Law Offices of Eugene R. Lorenz, Eugene R. Lorenz; and Elaine Houghton for Plaintiffs and Appellants.
Reed Smith, Michael K. Brown, Raymond A. Cardozo, Eric J. Buhr, Kevin G. Lohman and Anne M. Grignon for Defendant and Appellant.
LEVY, Acting P.J.
Defendant C.R. Bard, Inc. (Bard) manufactured and sold polypropylene mesh kits to treat women with pelvic organ prolapse. Bard’s product was surgically implanted in plaintiff Christine Scott. Christine Scott suffered serious complications and filed the underlying lawsuit against Bard for personal injuries. Plaintiff Roy Scott, Christine Scott’s husband, sought damages for loss of consortium.
The jury found Bard was negligent and awarded the Scotts $5.5 million in damages. The jury also found that Christine Scott’s surgeon, a nonparty, was 40 percent at fault and the trial court reduced the award accordingly.
On appeal, Bard contends the three negligence theories submitted to the jury were erroneous as a matter of law. Bard alternatively argues that the verdict is not supported by substantial evidence. Bard additionally asserts it was denied a fair trial due to the admission of evidence of postsurgery events, attorney misconduct and juror misconduct. In their appeal, the Scotts argue that the apportionment of fault to Christine Scott’s surgeon cannot stand because it was based on incorrect jury instructions.
The negligence theories were properly submitted to the jury and the negligence finding is supported by substantial evidence. Further, Bard was not denied a fair trial. The Scotts acquiesced in the giving of incomplete jury instructions on the surgeon’s fault when it was in their best interest for the jury to be properly instructed on that issue. Thus, the Scotts are estopped from asserting this instructional error on appeal. Accordingly, the judgment is affirmed.
1. Pelvic organ prolapse.
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. This condition can cause organ dysfunction, such as incontinence, pelvic pressure and pain. Pelvic organ prolapse can significantly impact a woman’s quality of life and, in severe cases, cause a woman to become physically disabled.
If noninvasive treatments, such as exercises, are not effective, there are various surgical options for pelvic organ prolapse. For example, repairs can be done using the patient’s own tissue. However, because poor tissue causes the problem, the procedure using that tissue has a high failure rate over time.
Another repair 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. At issue here are two such transvaginal mesh kits sold by Bard.
2. Bard’s development and sale of the Avaulta products.
In 2005, Sofradim, a French company, developed “Ugytex Dual Knit Mesh” to repair pelvic organ prolapse. Ugytex is a polypropylene mesh that has a soft center section with stronger sections on the side. Bard and Sofradim entered into an agreement for Bard to sell Ugytex in the United States under the name Avaulta.
Thereafter, Bard developed its own transvaginal mesh kit called “Avaulta Solo.” This design is different from the Sofradim product. Avaulta Solo has a soft knit center graft with four stronger knit arms that are pulled back out through the body to anchor the graft in place. The kit also includes a large curved needle called a trocar that is used to snare and guide the mesh.
In 2007, Bard started selling “Avaulta Plus.” The only difference between Avaulta Solo and Avaulta Plus is that Avaulta Plus has a collagen layer on the center portion of the mesh. These products were sold by prescription.
The Food and Drug Administration (FDA) regulates transvaginal mesh as a medical device. Before placing the Avaulta products on the market, Bard obtained a pre-market clearance from the FDA. A clearance means the FDA has determined that the device is substantially similar to a device that is
already on the market. Avaulta Solo and Avaulta Plus were cleared on the ground that they were substantially equivalent to the Sofradim product, Ugytex/Avaulta. In contrast, FDA approval means the FDA has determined that the product is safe and effective.
In developing Avaulta Plus, Bard performed functional, mechanical, biological, quality and biocompatibility tests. As part of the testing, pieces of mesh were placed in rats, rabbits and sheep. However, the stiffer mesh arms were not implanted in the animals. The product was also tested on cadavers.
3. Bard’s physician training program.
As part of marketing its products, Bard offered physicians training through its MDU Physician Education Continuum. The education options included large classes, smaller regional labs, and surgery observations.
In February 2007, Christine Scott’s gynecologist, Dr. Tillaikarasi Kannappan, attended a one day session relating to Avaulta taught by Dr. Susan Tate, a urogynecologist. The session included a power point presentation and a cadaver lab. During the cadaver lab, Dr. Kannappan was shown the proper technique for implanting Avaulta but was not instructed on either removing mesh or diagnosing when mesh should be removed. According to Dr. Kannappan, she was told there could be complications but that they were minimal. Dr. Kannappan recalled being told Avaulta could cause minimal erosion but that the problem could be dealt with as an outpatient procedure in the office by trimming the mesh. Dr. Kannappan’s overall impression was that Avaulta was very safe to use and was a superior product. She was not informed that Avaulta should not be used in sexually active women or for a mild prolapse. Dr. Kannappan was provided with the Avaulta instructions for use and a DVD showing another doctor’s implant technique.
4. Christine Scott’s surgeries and complications.
Christine Scott 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, Dr. Kannappan recommended surgical insertion of a mesh sling for the incontinence and surgical repair with two Avaulta Plus mesh kits, anterior and posterior, for the prolapse.
In January 2008, Dr. Kannappan performed surgery on Christine Scott and implanted the Avaulta Plus anterior and posterior mesh and a mesh sling. Avaulta Plus was not on the market when Dr. Kannappan attended the Bard training session in 2007. But, about a week before Christine Scott’s surgery,
Dr. Kannappan watched a DVD on the surgical technique for Avaulta Plus. However, Dr. Kannappan did not read the instructions for use.
Postsurgery, Christine Scott experienced complications. She could not urinate, had to self-catheterize, and was in pain. Dr. Kannappan operated again in February 2008 but this did not resolve the urination problem. Dr. Gregory Klis, Dr. Kannappan’s colleague at the same practice, performed a third surgery on Christine Scott in May 2008 and a fourth surgery in July 2008. Christine Scott developed an infection and in November 2008, Dr. Klis conducted a fifth surgery to irrigate an abscess.
Dr. Klis referred Christine Scott to UCLA (University of California at Los Angeles) urogynecologist Dr. Christopher Tarnay. Dr. Tarnay conducted a sixth surgery to extrude more mesh and release mesh tension. Thereafter, Dr. Tarnay discovered that the mesh had eroded into Christine Scott’s rectal area. Erosion occurs when the mesh does not stay in place but rather goes into a different space. Christine Scott then underwent her seventh and eighth surgeries performed by Dr. Tarnay and Dr. James Yoo, a colorectal surgeon.
Christine Scott is often in excruciating pain due to nerve damage, has pain during sexual intercourse, and has lost control of her bowels.
5. The FDA’s public health notifications and requests for postmarket studies.
In October 2008, after Christine Scott’s surgery, the FDA issued a public health notification to health care practitioners. This notification discussed risks of transvaginal mesh procedures and recommended physicians “‘[o]btain specialized training for each mesh placement technique, ’” and “‘[b]e vigilant for potential adverse events from the mesh, especially erosion and infection.’” The notification also suggested warning patients that the implantation of surgical mesh is permanent and that some complications associated with mesh may require additional surgery that may or may not correct the complication.
The FDA issued a second public health notification in July 2011. This notification repeated what was in the October 2008 public health notification and added that serious complications associated with transvaginal mesh surgeries are not rare.
In January 2012, the FDA wrote letters to approximately 30 manufacturers, including Bard, requesting that they conduct postmarket clinical studies or collect clinical data for transvaginal mesh. Bard responded that it would like to take the Avaulta product off the market. According to Bard, removing
Avaulta Plus from the market was purely a business decision based on the market having moved to the next generation of products. Bard did not decide to stop selling Avaulta Plus because of any concern with the safety and efficacy of the product.
6. The underlying litigation.
In January 2009, Christine Scott and her husband, Roy Scott, filed a complaint for negligence, strict product liability, negligent misrepresentation and fraud against Bard, Dr. Kannappan, and Dr. Klis. The Scotts dismissed the action as to Dr. Klis. The action was bifurcated with the trial on the causes of action against Dr. Kannappan to follow the trial on the causes of action against Bard.
The trial court heard motions in limine two months before trial. One of the trial court’s rulings barred evidence of postsurgery regulatory actions, including the FDA’s 2008 and 2011 public health notices and 2012 letter requesting clinical trials. Nevertheless, the trial court advised the parties that with the in limine motions they “are not pouring any concrete” and that the rulings would “remain in place until and if something changes in the evidence.”
During trial, the court reversed its pretrial ruling and allowed the Scotts to present evidence of the FDA’s public health notices and 2012 letter. Bard moved for a mistrial, which the trial court denied. Alternatively, Bard requested a six-week continuance so it could recall certain witnesses. The trial court denied this motion as well.
Bard moved for a directed verdict on all claims. 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 Bard was not liable for failure to warn. However, the jury found Bard was negligent and that its negligence was a substantial factor in Christine Scott’s harm. The jury awarded Christine Scott $5 million in damages and awarded Roy Scott $500, 000 for loss of consortium. The jury found Dr. Kannappan’s negligence was not a substantial factor in causing the Scotts’ harm but assigned 40 percent fault to her. Based on this finding, the trial court reduced the Scotts’ noneconomic damages by 40 percent and entered judgment for $3.31 million for Christine Scott and $300, 000 for Roy Scott.
Bard moved for judgment notwithstanding the verdict and for a new trial. Bard argued it was denied a fair trial because the trial court reversed its in limine ruling on the FDA’s regulatory actions, the Scotts’ counsel engaged in
continuous misconduct, and one juror committed multiple acts of misconduct. The trial court denied these motions.
1. Bard’s appeal.
Bard contends the trial court submitted erroneous negligence theories to the jury. Further, Bard argues, none of these theories are supported by substantial evidence. Bard additionally asserts the trial was tainted by evidence of postsurgery events, attorney misconduct and juror misconduct. We address the attorney ...