Mesh Medical Device News Desk, February 13, 2018~ Boston Scientific has lost its latest effort to overturn an $18.5 million loss by four plaintiffs at trial over its Obtryx pelvic mesh.
The Tyree case (here) consolidated four products liability cases against Boston Scientific (BSC) and was heard in November 2014 in the pelvic mesh multidistrict litigation currently underway.
The trial involved Jacquelyn Tyree, Carol Campbell, Jeanie Blankenship and Chris Rene Wilson. They were awarded damages ranging from $3.25 million to $4.25 million.
All were implanted with the Obtryx pelvic mesh, a ribbon of polypropylene (PP) plastic mesh placed under the urethra. All of the women had their surgery in West Virginia.
In 2015 Boston Scientific attempted to have the jury decision overturned.
The latest appeal was heard in December and decided February 7th (here) and written by Judge Wilkinson of the U.S. District Court of Appeals, of the 4th Circuit.
It states the evidence supported the jury finding that BSC negligently designed the device and failed to provide adequate warning. The appeals court also rejected the BSC argument against consolidation and upheld the punitive damages.
Among the plaintiffs, the first woman, implanted in 2011, experienced dyspareunia (painful sex). It was discovered her Obtryx pelvic mesh had eroded and portions of it were excised.
Plaintiff two was implanted in 2009. Her Obtryx pelvic mesh was “released” in 2012 since she could not urinate.
Plaintiff three had her Obtryx pelvic mesh implanted in 2010 and had a so called “sling-release procedure” in 2013 because her urethra had narrowed.
Plaintiff four was implanted in 2010 and experienced chronic pain and dyspareunia.
Originally consolidated into eleven cases for trials, six were dismissed and one was removed from consolidation, leaving the four cases. BSC wanted them tried separately, but that motion was denied.
BSC then tried to remove the evidence related to the MSDS (material safety data sheet) but that was denied. The district court did grant the plaintiffs’ motion to exclude evidence about the FDA’s 510(k) clearance process.
The trial in Charleston, WV took eleven days. The jury awarded compensatory damages of $250,000 to each of the four women and punitive damages of $1,000,000 each including future compensatory damages of $3 million to the first and second plaintiff, $3.5 million to the third and $4 million to the fourth.
Since then, BSC has reached settlements (presumably for less money) with two of the plaintiffs, while BSC proceeded with appeals in the two remaining cases.
BSC claimed the court abused its discretion by consolidating the cases in the first place, then allowing the MSDS evidence and excluding the process within the FDA which allows these medical devices on the market. BSC also challenged the punitive damage awards asserting erroneous jury instructions.
Trials can be consolidated under the Federal Rules of Civil Procedure 42(a), which says that actions that involve a common question of law or fact may be joined for a hearing or a trial. Consolidations also preserve time and resources and avoids conflicting rulings that could take place in individual actions.
The jury was reminded these are four separate claims and should be treated as such
In this case, all four plaintiffs were diagnosed with stress urinary incontinence (SUI) before being implanted with the Obtryx. All of the implants took place in West Virginia. In each case, the plaintiffs asserted design defect and a failure to warn under West Virginia law.
Because of the similarities they could share some she same expert witnesses and evidence.
APPEAL BY BSC
But Boston Scientific said that prejudice existed since the evidence presented only applied to some of the plaintiffs, not others.
BSC complained that omitting the clearance process by the FDA, the 510(k) regulation, omitted relevant information. Federal rules allow evidence to be omitted if it is unfairly prejudicial, confuses the issues, misleads the jury, or wastes time.
Judge Goodwin decided that the 510(k) evidence was of questionable relevance and was “inadmissible because of its potential to confuse the issues and mislead the jury.”
BSC wanted to show that meeting the criteria for FDA clearance was reasonable, which would have required experts and time to explore the FDA standard.
Discussion of the 510(k) process was also omitted in Cisson v. C.R. Bard Inc and in the Huskey v. Ethicon case.
BSC said the individual awards could imply jury confusion, but Judge Goodwin said it was not known what happened in the jury room and the separate awards indicates the jury considered the cases individually.
A product is made by the manufacturer with instructions on its use.
Those are the standards for use and they should be “reasonably safe” for its intended use. When they are not, it is a design defect.
The plaintiffs showed the design was defective because of the use of Marlex polypropylene and the difficulty removing the Obtryx after implantation.
BSC argued that the evidence was insufficient because the plaintiffs’ lawyers did not establish a specific design flaw and did not provide any evidence there was a safer, alternative design.
But there was discussion during the trial of a safer alternative, when Obtryx was compared to another BSC device, there was no difference in cure rates but more groin pain among the women implanted with Obtryx.
At the time of the Tyree trial, there was a question whether West Virginia’s design defect claims required evidence of a safer design. The state’s law now requires evidence of a reasonable alternative design. (See Nease v. Ford Motor Co., 848 F.3d 219,234 (4th Cir. 2017))
FAILURE TO WARN
BSC says that the plaintiffs did not prove through expert testimony that the directions for use were inadequate, proof of a failure-to-warn.
Judge Goodwin said the Morningstar decision in the West Virginia Supreme Court of Appeals does not establish that expert testimony is required to establish a failure-to-warn claim. Instead, the jury heard evidence regarding the risks of Obtryx and risks that were not included in the directions for use.
“A jury could reasonably conclude based on this evidence that the Obtryx’s instructions were inadequate,” ~ Judge Wilkinson, 4th Circuit US Court of Appeals.
BSC claimed that the instructions to the jury on punitive damages used the wrong standard and should have been governed by a “clear-and-convincing-evidence” standard.
Judge Goodwin instructed the jury that they should apply the “preponderance-of-the evidence” standard, citing that the West Virginia Supreme Court of Appeals has affirmed such decisions.
A statute was later passed by the West Virginia legislature that a plaintiff establishes “by clear and convincing evidence” but it was not in effect at the time of the Tryee trial.
The appeals court decision, affirms the judgments of the district court.
The same week as the Tyree case, Judge Goodwin was presiding over the first Boston Scientific bellwether trial in Miami.
It too had four plaintiffs – Eghnayem, Dortes, Nunez and Betancourt – who were all implanted with the Boston Scientific Pinnacle Pelvic Floor Repair Kit.
On November 13, 2014, the jury returned a collective award of $26.7 million to the four women. Mesh News Desk was in the courtroom for this Miami trial. See coverage here.
Pinnacle was removed from the market in May 2011, under an Immediate Recall by the FDA because the device “may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”
Obtryx II, an update to Obtryx, a pelvic mesh device to treat stress urinary incontinence, is still being marketed by Boston Scientific, along with three other mid-urethral sings made by Boston Scientific.
Boston Scientific also sells four meshes made for pelvic floor repair. ###