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Posts Tagged ‘11th Circuit’

11th Circuit Does Not Mesh Around and Upholds $27M Judgment

Posted on: November 13th, 2017

By Samantha Skolnick

In a recent decision by the U.S. Court of Appeals for the Eleventh Circuit, the Court upheld almost $27 million in judgments against Boston Scientific Corporation (BSC). The consolidated cases stemmed from women who claimed to have had complications from their surgeries using BSC’s Pinnacle Pelvic Floor Repair Kit to correct pelvic organ prolapse. The complications included exposure of pieces of mesh requiring further surgical procedures, loss of vaginal sensitivity, pelvic pain and pressure, incontinence and painful intercourse.

After a jury trial in 2014, each woman was awarded more than $6 million dollars. On appeal, the Eleventh Circuit held that the district court exercised the appropriate amount of discretion when it consolidated the actions and when it disallowed certain FDA evidence. The FDA evidence was related to the regulatory scheme and clearance of the Pinnacle for sale pursuant to the 510 (k) “substantial equivalence” process. The Court excluded this evidence under Fed. R. Evid. 402 and 403 on the basis that it was irrelevant and prejudicial. In so doing, the Court found that positive completion of the Section 510(k) process was immaterial to the product’s safety. The Court cited to the district court’s explanation that “[i]f 510(k) does not go to a product’s safety and efficacy — the very subjects of the plaintiffs’ products liability claims — then evidence of BSC’s with 510(k) has no relevance to the state law claims in this case.” The Court found that the concern with prejudice and confusion substantially outweighed the probative value of the evidence, which separated from any clear showing of safety review for the device or a device of a similar nature was minimal. The evidence had diminished probative value because 510(k) “operate[s] to exempt devices from rigorous safety review procedures.”

The key take away: the Federal Rules of Evidence and the ever-present 403 balancing test must always be in the back of your mind, especially in products liability cases.  An entire case can fall apart at the stitches (or sutures) when evidence is deemed inadmissible when the probative value does not outweigh the prejudice.

If you have any questions or would like more information, please contact Samantha Skolnick at [email protected]

SCOTUS Affirms FMG Victory In First-Of-Its-Kind 11th Circuit Flash Bang Case

Posted on: October 10th, 2017

By: Wayne S. Melnick and A. Ali Sabzevari

Previously, we blogged on a first-of-its-kind summary judgment obtained by Freeman Mathis & Gary in a Section 1983 case involving allegations of excessive force based on the police’s use of “Flash Bang.”  The case was appealed to the 11th Circuit Court of Appeals and that court affirmed the lower court opinion finding this case of first impression was the first in the circuit to address Flash Bang usage; and as such, the officer was entitled to the qualified immunity granted by the district court because there was no clearly established law on point.

In a one-line order issued earlier this month, the United States Supreme Court denied plaintiff’s petition for certiorari thereby locking in the 11th Circuit victory as controlling precedent. Because the 11th Circuit provided a bright line test for future Flash Bang use, it is imperative that all practitioners defending law enforcement officers who deploy Flash Bangs (as well as those officers themselves) be familiar with the rules provided by the court going forward.

If you would like a copy of the 11th Circuit opinion or more information, please contact either Wayne Melnick at [email protected] or Ali Sabzevari at [email protected].