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

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

Connie Thacker (Plaintiff) received two surgical mesh devices, Prolift and TVT-Secur, as implants on May 8, 2009. Both devices were manufactured by Ethicon, Inc. and were designed to treat pelvic organ prolapse and stress urinary incontinence in women. Later, Thacker sued, alleging damages resulting from the use of these devices and identified Bruce Rosenzweig as her “Case-Specific Urogynecologist.”

Ethicon moved to exclude Rosenzweig’s opinion that it did not adequately furnish Thacker’s implanting physician, Dr. James Guiler, with necessary information about Prolift and TVT-Secur. Ethicon also also aimed to bar Rosenzweig from presenting any opinions regarding general causation.

Urogynecology Expert Witness

Dr. Bruce Alan Rosenzweig, an Assistant Professor of Obstetrics and Gynecology at Rush University Medical Center and an Attending Physician of Obstetrics and Gynecology at Rush Presbyterian St. Luke Hospital. He earned his M.D. from the University of Michigan. Following medical school, he completed an Obstetrics and Gynecology Residency at Michael Reese Hospital. He pursued a one-year pelvic surgery fellowship at the State University of New York, and subsequently attended a two-year Urogynecology and Urodynamic fellowship at UCLA Harbor General Hospital. Throughout his career, Rosenzweig has performed over a thousand pelvic floor surgical procedures and utilized various synthetic pelvic mesh products. He has conducted over 350 surgeries addressing complications related to synthetic mesh. Rosenzweig possesses expertise and knowledge in the field of the pelvic floor and its reactions to materials and devices. Additionally, he has contributed to the field by inventing and designing products for gynecological applications.

Discussion by the Court

Regarding the Defendants’ motion to exclude Rosenzweig’s opinion on whether the Defendants provided sufficient information to Guiler about Prolift and TVT-Secur, the Defendants highlighted specific statements in Rosenzweig’s report. Rosenzweig, based on his examination of Thacker’s medical records, experience, education, and a review of depositions, internal Ethicon documents, and medical literature, expressed two key opinions with a reasonable degree of medical certainty:

  1. Thacker couldn’t make a fully informed medical decision about TVT-S and Prolift mesh implantation because Ethicon did not fully disclose the risks and complications in the Instructions for Use (IFUs), both early and late. The lack of complete disclosure by Ethicon meant that Thacker, and surgeons, including her implanting surgeon, were unaware of these risks. Despite Ethicon having information about these risks before the devices’ launch, it was not fully disclosed. Consequently, Thacker’s implanting surgeon couldn’t convey this information to her for proper consent regarding the risks associated with TVT-S and Prolift devices. This resulted in Thacker being unable to make a fully informed decision about the implantation, and, with a reasonable degree of medical certainty, she suffered injuries that were not disclosed by Ethicon. The inadequate disclosure of these risks was considered a substantial factor and/or cause of Thacker’s injuries.
  1. Thacker’s implanting surgeon, Guiler, couldn’t furnish the necessary and required information to Thacker for informed consent. This inability stemmed from Ethicon’s failure to fully disclose and evaluate the essential information before the launch of the medical devices.

The Defendants objected to Rosenzweig’s opinions solely on the basis that he should not be allowed to testify regarding Guiler’s state of mind. The objection contended that Rosenzweig lacked insight or expertise into the specific knowledge or state of mind of Guiler. It was emphasized in the objection that there was no challenge to Rosenzweig’s qualifications to express opinions on whether Ethicon adequately disclosed the risks and complications of its products.

The Court concurred with the Defendants that Rosenzweig should not be allowed to testify about Guiler’s knowledge or state of mind. It was noted that the Plaintiff intended to call Guiler as a witness at the trial, allowing him to testify about his own knowledge and state of mind. The Court clarified that the portion of Rosenzweig’s report in question did not express an opinion on Guiler’s knowledge or state of mind. Instead, it focused on whether Ethicon adequately disclosed the risks and complications of its products to physicians, including Guiler. Rosenzweig’s opinion that Ethicon did not disclose adequately and, consequently, physicians couldn’t adequately inform patients, was deemed permissible. The Court stated that any inconsistency between Rosenzweig’s testimony on Ethicon’s disclosure to Guiler and Guiler’s own testimony could be addressed through cross-examination.

Regarding Rosenzweig’s opinion on general causation, Ethicon contended that Plaintiff Thacker had not identified Rosenzweig as an expert on general causation. Consequently, Ethicon argued that the Court should bar Rosenzweig from providing testimony on this particular topic.

The Court rejected the motion, asserting that the Defendants had not provided sufficient evidence to support their claim that Thacker did not appropriately designate Rosenzweig as an expert on general causation.

This case was initially filed in the United States District Court for the Eastern District of Kentucky, but on July 31, 2012, it was transferred to the Southern District of West Virginia as part of a multidistrict litigation (“MDL”) titled In re: Ethicon, Inc. Pelvic Repair Systems Product Liability Litigation. The MDL Court organized cases into different “Waves,” and Thacker’s case was assigned to “Wave 4”. The pretrial order for Wave 4 mandated that the Plaintiff disclose experts by January 17, 2017, Defendants disclose experts by February 15, 2017, and Daubert motions be filed by April 13, 2017. Additionally, the pretrial order imposed a limit of a maximum of five experts for each side in each case.

In adherence to the pretrial order issued by the MDL Court, on January 17, 2017, the Plaintiffs’ counsel in the MDL provided defense counsel with a designation and disclosure of general expert witnesses. The disclosure comprised a list of 25 “general retained experts,” which included 13 urogynecologists. Rosenzweig, also a urogynecologist, was among the experts identified in the disclosure.

The Defendants contended that the expert disclosure made on January 17, 2017, in the MDL did not fulfill the Plaintiff’s responsibility to designate Rosenzweig as a general causation expert in her specific case. They argued that the disclosure could not have outlined the general causation experts Thacker intended to call, as it included 25 doctors, exceeding the MDL Court’s limit of five retained experts per case. According to the Defendants, the Plaintiff Steering Committee (“PSC”) in the MDL identified all general causation experts to be retained across all Wave 4 cases with the January 17, 2017 expert disclosure. Defendants asserted that each individual Plaintiff was then obligated to serve a separate disclosure, specifying the general causation experts retained for their particular case.

The Defendants did not refer to any order from the MDL Court explicitly outlining the procedure they argued for. The only order highlighted by the Defendants was the Pretrial Order for the Wave 4 cases, which mandated that Plaintiffs disclose their experts by January 17, 2017.

In instances where the MDL Court issued additional orders concerning Plaintiffs’ expert disclosures, it remains uncertain if such orders would have been applicable to Thacker’s case. This uncertainty arises because, on June 28, 2017, the MDL Court placed Thacker’s case on the “inactive docket” following counsel’s notification of an agreed-upon settlement model. Concurrently, the MDL Court extended all discovery deadlines for Thacker’s case. Thacker’s case remained on the inactive docket within the MDL Court until it was later remanded to the United States District Court for the Eastern District of Kentucky.

The Defendants failed to provide sufficient evidence to support their claim that Thacker did not appropriately designate Rosenzweig as a general causation expert in accordance with the MDL Court’s requirements. Concerning the disclosure of general causation experts in this Court, the Judge issued the scheduling order. This order established deadlines for Thacker and the Defendants to submit “case-specific expert witness reports” and for the Defendants to “designate general causation experts and testimony developed and existing in” the MDL. However, no deadline was set for Thacker to designate general causation experts. The reason for this omission is unclear, and it is possible that the Judge determined Thacker had already identified general causation experts in the MDL as per that Court’s established procedure. Nevertheless, Thacker did not miss any deadline set by this Court for designating general causation experts.

Consequently, the Court allowed Rosenzweig to testify as a general causation expert on behalf of Thacker.

Defendants argued that due to Thacker’s failure to designate Rosenzweig as a general causation expert after the case was remanded, they refrained from filing a Daubert motion challenging the substance of Rosenzweig’s general causation opinions. Although the Defendants had previously filed a motion in the MDL Court to exclude Rosenzweig’s general causation testimony, it seems this issue was addressed during the period when Thacker’s case was on the inactive docket in the MDL. The MDL Court explicitly stated that its Daubert ruling did not apply to Thacker’s case. Consequently, the Court granted the Defendants 30 days to submit a Daubert motion challenging Rosenzweig’s testimony on general causation, adhering to the response and reply times outlined in the Local Rules.

The Court rejected any vague request by the Defendants to exclude the general causation opinion of any expert not specifically identified by name in their motion. The Court deemed such a request too ambiguous to address and, accordingly, denied it.


1) Defendants’ motion in limine to exclude improper testimony from Plaintiff’s expert Bruce Rosenzweig was denied.

2) Defendants were granted permission to file a motion challenging the substance of Rosenzweig’s general causation opinion. This motion must be filed within 30 days of the entry date of the order, and the response and reply times are to be in accordance with the Local Rules.

The Court has not arrived on an outcome for this case since the remaining issues involved in this case still await resolution. 

Key Takeaways

The Court’s rulings on expert testimony in this case centered on Dr. Rosenzweig’s opinions regarding the adequacy of information provided by Ethicon to both the plaintiff, Thacker, and her implanting surgeon, Dr. Guiler. The Court agreed with the Defendants that Rosenzweig should not testify about Guiler’s state of mind, emphasizing that the focus should remain on Ethicon’s disclosure practices rather than the individual surgeon’s awareness. While permitting Rosenzweig to opine on Ethicon’s inadequate disclosure and its impact on physicians, including Guiler, the Court stressed that any inconsistencies could be addressed through cross-examination during the trial.

In terms of general causation, the Defendants sought to exclude Rosenzweig’s testimony, arguing that Thacker had not properly identified him as a general causation expert. The Court rejected this motion, citing insufficient evidence from the Defendants. The case’s transfer to a multidistrict litigation (MDL) setting added complexity, with the Defendants challenging the adequacy of Thacker’s expert designation during the MDL proceedings. Despite the Defendants’ contentions regarding the MDL Court’s procedure for expert disclosures, the Court found no evidence to support their claim and allowed Rosenzweig to testify as a general causation expert.

Case Caption: Thacker V. Ethicon, Inc. Et Al

Docket Number: 5:20cv50

Court: United States District Court, Kentucky Eastern

Citation: 2024 U.S. Dist. LEXIS 4379

Order Date: January 09, 2024


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