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Groups Tell 4th Circ. Bard Evidence Was Rightly Excluded
Jun 9, 2015 | Law360
By Sindhu Sundar
Two advocacy groups told the Fourth Circuit Monday that a federal program screening new medical devices only determines if they are similar enough to older devices and not if they're safe, arguing that a lower court rightly excluded certain evidence in a vaginal mesh trial C.R. Bard Inc. lost.
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Groups Tell 4th Circ. Bard Evidence Was Rightly Excluded
Jun 9, 2015 | Law360
By Sindhu Sundar
Two advocacy groups told the Fourth Circuit Monday that a federal program screening new medical devices only determines if they are similar enough to older devices and not if they're safe, arguing that a lower court rightly excluded certain evidence in a vaginal mesh trial C.R. Bard Inc. lost.
The public interest advocacy law firm Public Justice PC argued in an amicus brief that the U.S. Food and Drug Administration's 510(k) program, which requires medical device markers to alert the agency to new products they plan to market, only relates to their “substantial equivalence” to existing devices.
The brief comes in a dispute in which plaintiff Donna Cisson, who won a $2 million award from a West Virginia federal jury against Bard in August 2013, is challenging the device maker's argument that the lower court was wrong to exclude evidence relating to the 510(k) rule, which requires device makers to notify the agency 90 days before marketing a medical device.
The lower court had excluded evidence that the FDA had cleared through the 510(k) process Bard's “Avaulta Plus” pelvic repair mesh medical device, which Cisson claimed injured her. Public Justice and health research think tank National Center for Health Research, which jointly filed the brief, argued the older devices that the FDA uses as a gauge for substantial equivalence were themselves not approved on the basis of safety.
"Defendant and its supporting amici urge reversal, contending that the FDA’s 510(k) clearance is evidence that a device is safe," the groups said in their brief.
"Public Justice and NCHR believe that adoption of this position would unfairly disadvantage persons injured by this and the many other types of medical devices subject only to 510(k) clearance by allowing manufacturers to argue to juries that the FDA had found their devices to be safe at the time they caused an injury, when the FDA never in fact made any such determination," they argued.
Researchers at the National Center for Health Research have found that “substantial equivalence” finding was often vague and resulted in the approval of new products that were not necessarily as safe as the products they were found to be equivalent to, according to the brief.
The group's arguments echo those of Cisson, who earlier this month told the appeals court in a lengthy brief that Bard's challenge to the exclusion of that evidence amounts to a misunderstanding or a misrepresentation of what the 510(k) process evaluates. U.S. District Judge Joseph R. Goodwin, who presided over the trial, had also similarly told Bard that the process does not assess whether a device is safe and effective.
Public Justice and the National Center for Health Research are represented by Michael J. Quirk, Esther E. Berezofsky
and Joseph Alan Venti of Williams Cuker Berezofsky LLC.
Cisson is represented by Anthony J. Majestro of Powell & Majestro PLLC, Allison Van Laningham of Turning Point Litigation and Henry G. Garrard III and Josh B. Wages ofBlasingame Burch Garrard & Ashley PC.
Bard is represented by Lori G. Cohen, Brigid F. Cech Samole, Elliot H. Scherker Jay, Andrew Yagoda and Sean Jessee of Greenberg Traurig LLP.
The case is Cisson v. C. R. Bard Inc., case number 15-1102 in the U.S. Court of Appeals for the Fourth Circuit.
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