Justia Medical Malpractice Opinion Summaries

Articles Posted in Products Liability
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A surgeon and his clinic sought a writ from the Court of Appeal directing the trial court to vacate its order allowing the survivors of a patient who died from a surgical procedure to amend their complaint to assert a claim for punitive damages. The Court of Appeal determined the evidence of the misconduct of the surgeon and the employees of his clinic that the survivors submitted with their motion for leave to amend, if believed by the trier of fact, might well support an award of punitive damages. Nevertheless, because the survivors did not move to amend within the time mandated by statute, the Court granted the requested relief. View "Divino Plastic Surgery, Inc. v. Superior Court" on Justia Law

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Smith’s hip resurfacing implant consists of a metal ball that covers the top of the femur and a cup that fits inside the hip socket. When a surgeon puts these ball-and-cup surfaces in the joint, the polished metal surfaces are supposed to allow smoother movement than the damaged bone or cartilage they replace. Gall, who had hip resurfacing surgery for his left hip, recovered and became physically active. Years later, convinced his implant was unsatisfactory, Gall sued Smith.Gall argued that Smith failed to properly warn Gall’s surgeon, Dr. Hernandez, about the risks of using Smith’s product. The trial court granted Smith summary judgment because Hernandez independently knew these risks and whether Smith gave Hernandez redundant warnings did not matter. Gall also argued that Smith’s product was defective. The trial court granted summary judgment because Gall did not show anything was wrong with his implant. Gall did show Smith’s quality control procedures once failed to satisfy regulatory authorities, but the court concluded this fact did not imply the parts Gall received were defective. The court of appeal affirmed. Gall’s claims share the same causation element and Gall did not establish causation. View "Gall v. Smith & Nephew, Inc." on Justia Law

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In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law

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Bard manufactures a surgical patch, consisting of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall. Bard recalled several versions of the patch in 2005-2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient’s intestines. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera. Before the recall, Bowersock underwent hernia repair surgery, involving a Bard patch. Roughly one year later, she died of complications arising from an abdominal-wall abscess. Her estate sued. Unlike defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs. Plaintiff's expert tried to present a new theory of causation: the patch had “buckled,” forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. The court excluded that testimony, finding the “buckling” theory not sufficiently reliable. The Seventh Circuit affirmed summary judgment for the defense. The novel theory of causation was not peer-reviewed, professionally presented, consistent with Bowersock’s medical records or autopsy, or substantiated by other cases. View "Robinson v. Davol, Inc." on Justia Law

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Dalton’s doctor implanted Teva’s Intrauterine Device (IUD) in her uterus for long-term birth control. Dalton became dissatisfied with the IUD and asked her doctor to remove it. The doctor did so by grasping its strings with a forceps and pulling the IUD down. A piece broke off either before or during the removal and lodged in her uterus. Dalton’s doctor advised that removing the remaining portion of the IUD would require a hysterectomy. Dalton sued Teva, asserting “strict liability,” “strict products liability failure to warn,” and “manufacturer’s defect.” Dalton failed to timely disclose any expert witness and serve the expert witness report required by FRCP 26(a)(2). The district court granted Teva summary judgment. The Seventh Circuit affirmed. Claims under the Indiana Products Liability Act, which governs all consumer actions against a manufacturer for physical harm caused by a product, require proof that the injury was proximately caused by whatever defect or breach of duty underlies the claim. The Act requires expert testimony when an issue “is not within the understanding of a lay person.” Dalton did not establish how a lay juror faced with a broken IUD could identify the cause of the break—maybe the IUD was damaged after coming into the possession of the physician, maybe human error resulted in damage during implantation or removal. This case is far removed from situations in which a causation issue is so obvious that a plaintiff may forgo expert testimony. View "Dalton v. Teva North America" on Justia Law

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Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

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Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

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In this case, a manufacturer sold a surgical device to a hospital, which credentialed some of its physicians to perform surgery with the device. The manufacturer's warnings regarding that device were at the heart of this case: whether the manufacturer owed a duty to warn the hospital that purchased the device. The manufacturer argued that since it warned the physician who performed the surgery, it had no duty to warn any other party. The Supreme Court disagreed because the doctor was often not the product purchaser. The Court found that the WPLA required manufacturers to warn purchasers about their dangerous medical devices. “Hospitals need these warnings to credential the operating physicians and to provide optimal care for patients. In this case, the trial court did not instruct the jury that the manufacturer had a duty to warn the hospital that purchased the device. Consequently, we find that the trial court erred.” View "Taylor v. Intuitive Surgical Inc." on Justia Law

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This matter arose from Whitney Engler's use of a medical device, the Polar Care 500, that was manufactured by Breg, Inc. (Breg) and prescribed by David Chao, M.D. Engler suffered injuries as a result of her use of the Polar Care 500, and she brought various tort claims against Chao, his medical group Oasis MSO, Inc. (Oasis), and Breg, among others. The jury made findings of malice, oppression, or fraud as to each defendant on at least one claim. In the punitive damages phase of trial, the jury awarded $500,000 against Chao and $7 million against Breg. The jury declined to award any punitive damages against Oasis. Breg, Chao, Oasis, and Virginia Bigler-Engler, as administrator of Engler's estate, appeal. After careful consideration of the parties' arguments on appeal of the outcome of the trial, the Court of Appeals reversed the judgment in part, concluding the jury's verdict as to several claims was not supported by the evidence, including Engler's intentional concealment claim against Breg and her strict products liability claim against Oasis. In light of this reversal of Engler's intentional concealment claim against Breg, the jury's punitive damages award against Breg had to be reversed too. The Court also concluded the jury's award of noneconomic compensatory damages and the jury's award of punitive damages as to Chao were excessive. Those awards were reversed the case remanded for a new trial unless Bigler-Engler accepted reductions in those awards to $1,300,000 and $150,000 respectively. In all other respects, the judgment was affirmed. View "Bigler-Engler v. Breg, Inc." on Justia Law

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In 2001, BioEnterics obtained FDA approval for the Lap-Band, “designed to induce weight loss in severely obese patients by limiting food consumption" by creation of a small gastric pouch. The FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a postapproval study. BioEnterics's brochure states that surgeons planning laparoscopic placement must have specific experience, participate in a training program authorized by BioEnterics, be observed by “qualified personnel” during their first placements, have the equipment and experience necessary to complete the procedure via laparotomy if required, and report on their personal experiences using the device. In 2003, plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver; Lap-Band tubing became entangled with her small intestine. During surgery to remove the Lap-Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock, resulting in brain damage. More than nine years later, plaintiff filed suit. The court of appeal affirmed dismissal of her claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. View "Glennen v. Allergan, Inc." on Justia Law