Products Liability Law Daily Partial summary judgment upheld in vaginal mesh implant case against Johnson & Johnson subsidiary
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Monday, October 19, 2020

Partial summary judgment upheld in vaginal mesh implant case against Johnson & Johnson subsidiary

By Joshua Frumkin, J.D.

Ethicon, Inc. will be allowed to assert a statute of limitations defense.

In an action arising from injuries allegedly caused by a vaginal mesh implant manufactured by Ethicon, Inc., an Iowa federal court affirmed its earlier grant of partial summary judgment to the manufacturer. Specifically, the court rejected the patient's request to reconsider its earlier grant of summary judgment on her design defect and failure to warn claims, and granted the manufacturer leave to file a supplemental motion for summary judgment on a critical statute of limitations issue (Kelly v. Ethicon, Inc., October 16, 2020, Williams, C.).

In March 2004, the patient received a tension-free vaginal tape mesh implant manufactured by Ethicon, Inc., a subsidiary of Johnson & Johnson (collectively, the manufacturers or J&J). The patient received the implant to stabilize her prolapsed bladder. She testified that she did not remember receiving any materials about the implant before her surgery and did not know who manufactured the implant. She claimed that her physician failed to inform her of the potential risks posed by the implant. She alleged that, as a result of her implant, she suffered from numerous severe ailments.

The patient filed suit against the manufacturers in February 2014. In August 2019, J&J moved for partial summary judgment on 14 of the patient's 17 claims. In August 2020, the court granted in part and denied in part J&J's motion [see Products Liability Law Daily’s August 11, 2020 analysis]. The patient then brought a motion to reconsider and amend the court's previous grant of summary judgment on five grounds: (1) her strict liability design defect claim was not subsumed by her negligent design defect claim; (2) the learned intermediary doctrine did not apply to her negligent failure to warn claim, or exceptions applied; (3) her negligent misrepresentation claim should be allowed because J&J allegedly made fraudulent misrepresentations; (4) she had sufficiently stated her fraud claims; and (5) her husband was entitled to some relief for his loss of consortium. J&J also brought a motion for leave to file a supplemental motion for summary judgment on the statute of limitations, and argued that the statute of limitations on all claims may have expired over a decade ago.

Strict liability design defect. The court denied as moot the patient's argument that her design defect claim did not merge with her negligent design claim. The court previously granted summary judgment on this claim due to the patient's failure to oppose it. Here, the patient argued that her claim should be reinstated as factually supported by expert testimony sufficient to rebut summary judgment. The Iowa Supreme Court previously held that negligent design defect claims and strict liability design defect claims were not meaningfully distinct and, therefore, should be merged into a single design defect claim. In this case, the court opined that if it did permit the patient to withdraw her abandonment of the claim and reinstate it, the strict liability claim would necessarily merge with the extant negligent design defect claim under Iowa law. The court noted that it had not granted summary judgment on the negligent design defect claim.

Negligent failure to warn. The court also denied the patient's request to amend the summary judgment ruling on her negligent failure to warn claim. The court previously granted summary judgment on this claim based on the learned intermediary doctrine: the patient failed to show that different warnings would have changed her physician's decision to use the implant or his warnings to her. The patient argued that the learned intermediary doctrine did not apply, or that exceptions to the doctrine applied. This doctrine shifts an implantable medical device manufacturer's obligation to warn from the patient to the patient's attending physician. Here, the patient failed to cite a single case contrary to the court's prior ruling, which held that this case involved a medical device, that the patient's physician was a learned intermediary, and that the patient could not establish proximate causation between the alleged inadequacy of J&J's warnings and her injury. As such, the doctrine applied. The court also rebuffed the patient's argument that her physician wasn't a learned intermediary because he did not know about the implant's risks; while a physician's prior knowledge of a device's risks can prevent a manufacturer from being liable, a lack of physician knowledge does not preclude the application of the doctrine.

Finally, the court rejected the patient's argument that J&J violated its post-sale duty to warn. Under Iowa law, sellers have a post-sale duty to warn if: (1) they knew that a product posed a substantial risk of harm; (2) the persons to be warned can be identified and reasonably be assumed to be unaware of the risk; (3) a warning can be communicated; and (4) the risk of harm is sufficient to justify the burden of providing a warning. The court initially noted that the patient had never raised this issue previously, which itself would justify denial; regardless, the court dismissed it on the merits. The court held that the learned intermediary doctrine stood in the way of causation, and so prevented the patient from prevailing.

Negligent misrepresentation and fraud claims. The patient argued that the court should reinstate her negligent misrepresentation claim, which the court previously dismissed due to a lack of supporting evidence. The court rejected the patient's argument that she may subsequently recollect receiving J&J's warnings and instructions—which she asserted were false and misleading and contained fraudulent information—in time for trial. The court had previously granted summary judgment on her negligent misrepresentation claim because she had testified that she did not remember reading or relying on any J&J material in selecting the implant. The court refused to engage with her conjecture that she might later remember having read those documents. Further, the court dismissed as unbelievable the idea that she might suddenly remember reading and relying on warnings from 16 years ago or that a jury would reasonably rely on that testimony. Because there was no evidence that the patient or her physician had read and relied upon J&J's warnings, the court denied her motion.

Loss of consortium. The patient also argued that her husband's loss of consortium claim survived summary judgment and that the court should reconsider it. However, the court's prior order stated that this claim had not been at issue and remained viable. The court thus denied the patient's motion as moot.

Statute of limitations defense. Finally, after briefly reviewing the procedural history of the case, the court granted J&J's motion for leave to file a summary judgment motion on a heretofore unmentioned statute of limitations defense. The statute of limitations on personal injury claims in Iowa is two years from when the injured person first becomes aware of facts that would prompt a reasonably prudent person to begin seeking information about the injury's cause. In granting J&J's earlier motion for partial summary judgment, this court held that the patient began experiencing many, if not all, of her symptoms within a few months of the implant. Because she received the implant in March 2004, the statute of limitations would have expired in 2006—eight years before she brought the suit. J&J requested that the court rule on this narrow, critical issue before trial for the sake of judicial efficiency. The court agreed, even though J&J should have raised this issue earlier and had no good cause for its delay. The court noted that this issue had the potential to be dispositive on all of the patient's claims. While this court was dubious of allowing such a dispositive motion to be filed a year after the case was filed, the court recognized that the parties would need to address this issue anyway. No date for trial had yet been scheduled and, the court reasoned, permitting a summary judgment motion to be filed on the issue would not backtrack litigation. On the contrary, it might resolve the entire case and save everyone both time and money. Thus, the court elected to exercise its discretion to permit J&J to file a motion for summary judgment on the statute of limitations issue.

The case is No. 20-CV-2036-CJW-MAR.

Attorneys: Andrew J. Feldman (Flint Law Firm, LLC) for Susan Kelly. Nancy J. Penner (Shuttleworth & Ingersoll, P.L.C.) for Ethicon, Inc. and Johnson & Johnson.

Companies: Ethicon, Inc.; Johnson & Johnson

MainStory: TopStory WarningsNews MedicalDevicesNews DesignManufacturingNews SofLReposeNews GCNNews DefensesLiabilityNews IowaNews

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