Biomedical Engineering Expert’s Testimony on Product Warnings Admitted

Posted on July 22, 2025 by Expert Witness Profiler

Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.

Defendants filed a motion to exclude or limit certain opinions and testimony of Plaintiff Thacker’s expert, Anne H. Wilson, MBA.

Biomedical Engineering Expert Witness

Anne Holland Wilson is a biomedical engineer and quality assurance consultant, holding certifications as a Quality Auditor and Quality Engineer.

She received a Bachelor of Science in Biomedical Engineering from Vanderbilt University in 1985, and a Master of Business Administration from the University of Colorado in 1991.

Want to know more about the challenges Anne Wilson has faced? Get the full details with our Challenge Study report.

Discussion by the Court

Wilson has been designated as an expert in the field of compliance with quality and risk management standards. She is expected to testify that Ethicon failed to meet the “industry standards” for design control processes and risk management.

Reliability of Wilson’s Testimony

The Defendants argued that Wilson’s methodology is insufficient because she (1) should have conducted an audit of Ethicon’s systems; (2) failed to consider applicable U.S. standards while inappropriately basing her “industry standards” testimony on inapplicable European standards; and (3) failed to review all relevant case materials in reaching her conclusions.

Failure to Audit

The Defendants did not explain, or offer any authority to explain, how conducting an audit is the only reliable methodology available for reviewing the processes Wilson has been asked to review. To the contrary, the Court held that the methodology Wilson used to arrive at her opinions, which involved reviewing Ethicon’s design and risk control documents and evaluating them within the framework of industry standards, was plainly based on “sufficient facts,” and “reliable principles and methods.”

As Wilson explained in her report, her role in this case involves “addressing the design control and risk management processes of Ethicon.”

Failure to Review Appropriate Industry Standards

The Defendants argued that (1) Wilson should not have consulted standards set by the International Organization for Standardization; and (2) she should have consulted applicable FDA regulations in offering testimony on Ethicon’s compliance with “industry standards.”

To begin with, no party disputes that particular FDA regulations make up a portion of the universe of “industry standards” for design control and risk management processes in the medical device manufacturing industry.

The Defendants argued that the standards set by the International Organization for Standardization (which are referred to as “ISOs”), however, are not a part of that same universe. However, Wilson’s report stated the opposite— explaining that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems at the time Ethicon developed the at-issue devices. She also explained during her deposition that applicable ISOs and FDA regulations are very similar.

It should be noted that the Defendants failed to offer any evidence or authority stating that ISOs are irrelevant to medical device manufacturers in the United States. Moreover, Wilson’s failure to consider applicable FDA regulations during her review of this case did not render her testimony unreliable. Basically, Wilson plainly opined that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems. Because ISOs provided “appropriate validation” for her testimony on Ethicon’s compliance with industry standards, the Court found Wilson’s “industry standards” testimony reliable.

While Wilson’s testimony may be offered to help define the contours of the duty of care for her common law negligence claim (and for other relevant purposes), such testimony shall not equate compliance or non-compliance with satisfaction or dereliction of the duty of care.

Failure to Review all Case Materials

The Defendants first contended that Wilson inappropriately offered “medical opinions” throughout her report. The Defendants did not specify which of Wilson’s opinions are “medical opinions” but rather just cited a page range of Wilson’s report which they argued is “replete” with such opinions.

Without more specific objections, the Court declined to conduct a line-by-line analysis of the page range cited to determine which of Wilson’s opinions are medical opinions. However, the Court did agree that medical opinions are beyond the scope of Wilson’s qualifications and should be excluded.

The Defendants finally argued that Wilson’s testimony regarding Ethicon’s Instructions for Use (“IFU”) on the TVT-S device should be excluded. Specifically, the Defendants argued that Wilson is unqualified to offer testimony on IFUs. Wilson is expected to testify that Ethicon’s failure to adequately address certain risks in the TVT-S’s IFU was “a violation of industry practices and international standards.”

The parties seemed to agree that issues with IFUs relate to risk assessment in the general sense. And the Defendants did not challenge Wilson’s qualifications to testify as an expert on risk assessment. Accordingly, it was apparent to the Court that testimony concerning IFUs directly relates to Wilson’s area of expertise.

As such, the Court found that Wilson’s familiarity with risk assessment processes in the medical device manufacturing context provides her with sufficient knowledge on IFUs to assist the trier of fact to at least some degree. Wilson is therefore qualified to offer opinions regarding product warnings as a fundamental part of the risk management process in the medical device industry.

Held

The Court granted in part and denied in part the Defendants’ motion to exclude or limit the testimony of Plaintiff Connie Thacker’s expert, Anne Wilson, MBA.

Key Takeaway:

The Court recognizes that just because Wilson is an expert in one area “does not ipso facto qualify her to testify as an expert in all related areas.” But ultimately, Rule 702 takes a liberal approach to expert witness qualification in that the degree of ‘knowledge, skill, experience, training, or education’ sufficient to qualify an expert witness is only that necessary to ensure that the witness’s testimony ‘assist’ the trier of fact to any degree.

Please refer to the blog previously published about this case:

Urogynecology Expert Witness Testimony about inadequate risk disclosure admitted in medical device product liability action

Obstetrics and Gynecology Expert’s Testimony on Mesh Porosity and Stiffness Admitted

Urogynecology Expert’s Opinion on Continuum of Care Admitted

Obstetrics and Gynecology Expert’s Opinion Regarding the Common Knowledge of Pelvic Surgeons Admitted