By Jeffrey H. Brochin, J.D.
Under Indiana’s Product Liability Act (IPLA) a reasonable jury could conclude that Prolift® created risks beyond the expectations of ordinary pelvic-floor surgeons.
A federal appeals court has affirmed the judgment of the trial court that awarded $10 million in compensatory damages and $10 million in punitive damages (after remittitur) to a patient who was implanted with Johnson and Johnson’s Ethicon Prolift® pelvic floor mesh and who subsequently suffered pain which was deemed to be permanent. The trial court acted properly in excluding evidence as to the FDA’s Section 510(k) approval, and the jury reasonably found the device to be "unreasonably dangerous" under Indiana law (Kaiser v. Johnson & Johnson and Ethicon, Inc., January 14, 2020, Sykes, CJ).
Implantation of mesh. In January, 2009, a 60 year old Indiana patient who suffered from severe pelvic floor prolapse, was implanted with a Prolift® vaginal mesh manufactured by Johnson & Johnson’s Ethicon division (Ethicon). By September, 2011 she was experiencing severe pain, bladder spasms, and pain during intercourse. Her doctor determined that mesh contraction was the cause of the conditions, and he undertook revision surgery to remove the mesh. However, because tissue had grown into the mesh, it could not be completely removed, and he informed her that the painful complications she was experiencing were likely permanent.
Marketing of device without premarket approval. Ethicon first started marketing Prolift® in 2005 without submitting anypremarket notification to the FDA, reasoning that the device didn’t depart materially from a transvaginal mesh product that the agency had previously cleared. Ethicon did not submit a 510(k) premarket notification for Prolift® until 2007 when the FDA demanded one, and Ethicon then asserted that its mesh was substantially equivalent to three other devices, and had the same technological characteristics as the predicate devices.
The FDA cleared Prolift® based on that submission, however, the agency did indicate by letter that the cited "predicates" were a group of surgical meshes that the FDA classified in a 1988 rulemaking, and that when it promulgated that rule, the FDA cautioned that the "surgical mesh has not been implanted in a sufficient number of patients by a sufficient number of medical practitioners to provide adequate evidence on the long-term biocompatibility of these devices."
In 2011 after numerous consumer and professional complaints about complications from transvaginal mesh devices, the FDA ordered Ethicon and other transvaginal mesh manufacturers to submit plans for post-market studies of the devices. When the FDA rejected Ethicon’s plan for Prolift® in 2012, Ethicon discontinued the device.
Evidence of FDA clearance excluded. The patient originally sued Ethicon in the Southern District of West Virginia, the venue of a 28,000-case multidistrict litigation (MDL) against Ethicon, and the parties agreed that Indiana law applied. The MDL judge construed two counts in the complaint as alleging design-defect and failure-to-warn claims under the IPLA, and rejected Ethicon’s argument that the federal regulatory scheme preempted Indiana law. Furthermore, the MDL judge granted the patient’s motion to exclude evidence related to the FDA’s clearance of Prolift®, reasoning that the § 510(k) process was only minimally probative of safety and that introducing evidence about the regulatory process posed a significant risk of jury confusion.
The judge further ruled that Prolift® did not qualify as "state of the art" under Indiana law, which blocked Ethicon from relying on a rebuttable presumption that the device was not defective.
‘Unreasonably dangerous’ standard. Ethicon argued that the evidence failed to establish that Prolift® was defective and unreasonably dangerous as required for liability under the IPLA. The appeals court noted that "defectiveness" focuses on the product itself, and that a product is defective if it is in a condition not contemplated by reasonable persons among those considered expected users or consumers of the product; and, it is deemed "unreasonably dangerous" when used in reasonably expectable ways.
No federal preemption. Ethicon also argued that the state requirements conflicted with the federal requirements and that therefore federal preemption should bar the state law action. However, the court found that nothing in the 510(k) regulatory scheme prevented Ethicon from complying with the IPLA’s standard of care before seeking 510(k) clearance for Prolift®. The 510(k) process did not require Prolift® to take any particular form for any particular reason, rather, the 510(k) process simply inquired whether the device was substantially equivalent to an approved device or otherwise met the MDA’s broad standards for Class I or II devices. Accordingly, federal law did not stop Ethicon from satisfying its state-law duties regarding Prolift®’s design beforeit filed its premarket notification seeking substantial-equivalence clearance.
No reason to disturb jury findings. Under the above noted standard of risk applicable to those who were considered expected users of Prolift®, the appeals court ruled that under that understanding of Indiana law, a reasonable jury could conclude that Prolift® created risks beyond the expectations of ordinary pelvic-floor surgeons. The record included testimony from the patient’s surgeon that "none of the surgeons originally implanting the Prolift® probably were quite as appraised of all the possible risks and some of the subsequent problems" associated with the device. He was not aware that Prolift® was impossible to remove safely in some patients, making its complications permanent. In addition, an expert witness for the patient testified that he "did not know of the risks that were associated with the Prolift® device; and once he found out about them, he stopped using it."
The court cited precedent whereby the issue of whether a manufacturer has discharged its duties is always a question for the trier of fact and that the principle applies with equal force to the learned-intermediary doctrine. Whether Ethicon breached its duty to warn was a question for the jury, and the appeals court found no reason to disturb its determination on that element of the claim.
Similarly, based on the record of known issues disclosed within the company, as well as post-marketing revelations, the appeals court found that even under the heightened burden of proof, on the instant record a reasonable jury could find that Ethicon acted recklessly when releasing Prolift® and crafting its warnings, and it was reasonable for the jury to determine that Prolift® was unreasonably dangerous.
Based on the forgoing, the appeals court affirmed the trial court judgment.
The case is No.: 18-2944.
Attorneys: Timothy Jackson (Wexler Wallace LLP) for Barbara Kaiser. Lisa Schiavo Blatt (Williams & Connolly LLP) for Johnson & Johnson. Stephen D. Brody (O'Melveny & Myers LLP) for Ethicon, Inc.
Companies: Johnson & Johnson; Ethicon, Inc.
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