Insufficient Pre-Market Screening Allegedly Causes Pelvic Medical Device Failure

Court: United States District Court for the Southern District of West Virginia, Charleston Division
Jurisdiction: Federal
Case Name: Winebarger v. Boston Sci. Corp.
Citation: 2015 U.S. Dist. LEXIS 53892

Facts

This Multi-District Litigation involved the use of transvaginal surgical mesh to treat pelvic organ prolapse and urinary stress incontinence. In this particular case, the Uphold Vaginal Support System, a plastic device developed by the defendant for the prevention of prolapse, was surgically implanted in the patient. The plaintiff underwent surgery, after which she filed a suit alleging that she had suffered multiple complications and injuries as a result of the Uphold implant. The plaintiff’s husband also made a claim for the loss of consortium.

The Medical Device Expert Witness

The plaintiff’s medical device expert witness was a scientific and regulatory specialist providing advice, direction, and product development support to biopharmaceutical/pharmaceutical and medical device manufacturers in the fields of strategic planning, pre-clinical research, clinical trials, design and performance, and administrative matters affecting the FDA. The expert had significant knowledge and experience regarding the testing requirements of medical devices, the design and quality of drug labeling, and the protocols required to conform with regulatory and industry standards, including those laid down by the FDA.

In this case, the medical device expert gave four opinions: (1) the defendant did not carry out appropriate screening of its products prior to putting them on the market, (2) the products were not appropriately labeled, (3) physicians could not agree to the surgical implantation of the products due to misbranding, and (4) the defendant did not comply with the post-market diligence standard of care for these items. The medical device expert witness relied on a 2006 French National Authority for Health, Global Harmonization Task Force guideline documents and National Institute for Health and Care Excellence to form her opinions.

Discussion

The defendant argued that the plaintiff’s medical device expert’s experience as a scientist and specialist on the production of medical products did not qualify her as an authority on the safety and efficacy of mesh products, as she tried to do in her professional study. The defendant argued that because the research the expert focused on laid out guidelines rather than criteria, they could not serve as a reliable basis for her views.

The defendant also sought to compare Global Harmonization Task Force (GHTF) requirements with FDA regulations and claims that, like FDA regulations, the inclusion of GHTF standards to regulatory intent, context and emphasis could confuse and deceive the jury. The defendant argued that none of the findings reflected the medical device expert’s opinion that the defendant should have done pre-market clinical trials. The defendant argued that to the degree that her opinions on consumer labeling apply to the divergence of the defendant from the labeling provisions of the Food, Drug, and Cosmetic Act, they must be excluded. The defendant also sought to exclude her opinion on their inability to manage and minimize the risks associated with the product as it was based on adverse events submitted to the FDA’s Manufacturer and User Facility Device Experience website.

The court noted that the lack of a medical degree on the medical device expert’s curriculum vitae did not call into question her 42+ years of demonstrated knowledge and experience with medical devices. The court further noted that, if it permitted the defendant to convey to the jury that its device complied with FDA regulations, the jury would then perceive the device with the approval of the federal government. Such a view of the drug was wrong as per the court, considering that the item was sold through the 510(k) system of the FDA, which in no sense signifies the official approval of the device.

Held

The court denied the defendant’s pre-market testing objection as it went to the weight of the testimony. The court excluded the medical device expert’s opinion on product labeling as it amounted to legal conclusions. Her opinion on risk minimization was also excluded because the FDA’s Manufacturer and User Facility Device Experience (MAUDE) website was not a reliable source that manufacturers or users of medical devices relied on.

The defendant’s motion to exclude testimony from the plaintiff’s medical device expert witness testimony was granted in part and denied in part.

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