Justia Medical Malpractice Opinion Summaries

Articles Posted in Products Liability
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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

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After all defendants to the original complaint filed responsive pleadings in Mary Meeks’s medical malpractice suit, Meeks obtained leave of court and filed a first amended complaint, adding as a defendant the manufacturer of a medical device, Hologic, Inc. A doctor performed an outpatient diagnostic hysteroscopy and an endometrial ablation on Meeks at the Northwest Regional Medical Center in Clarksdale using a Novasure medical device manufactured and sold by Hologic to treat Meeks’s menorrhagia. Meeks did not serve the first amended complaint on Hologic but instead filed a second amended complaint without leave of court or permission from all defendants. Hologic filed a motion to dismiss, arguing that Meeks’s claims against Hologic were federally preempted and that Meeks’s claims additionally were barred by the statute of limitations. Because Meeks failed to obtain leave of court or permission from the defendants to file the second complaint, and because the first was never served on Hologic, the Supreme Court found that the statute of limitations had expired against Hologic and that the trial court properly granted Hologic’s motion to dismiss. View "Mary Meeks v. Hologic, Inc." on Justia Law

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Plaintiff filed suit against Bard, manufacturer and seller of polypropylene mesh kits, for personal injuries, and plaintiff's husband sought damages for loss of consortium. A jury found Bard was negligent and awarded $5.5 million in damages. The jury also found that plaintiff's surgeon, a nonparty, was 40 percent at fault and the trial court reduced the award accordingly. The court concluded that the jury was properly instructed on the theory of negligent design, negligent training, and negligent misrepresentation; substantial evidence supported the negligence verdict; and Bard was not denied a fair trial. The court rejected plaintiffs' argument that it was necessary to instruct the jury on medical professional negligence to support the apportionment and, because the jury was not so instructed, the trial court erred in reducing the damages. Plaintiffs acquiesced in the giving of incomplete jury instructions on the surgeon's fault when it was in their best interest for the jury to be properly instructed on that issue. Consequently, plaintiffs are estopped from asserting this instructional error on appeal. The court affirmed the judgment. View "Scott v. C.R. Bard, Inc." on Justia Law

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Hardin suffered complete blindness and permanent, severe and painful scarring after she took Lamotrigine, the generic form of the medication Lamictal. Hardin sued the prescribing physician, the manufacturer, the store where she bought the prescription (Safeway), WKH, which produced the drug information pamphlet (monograph), and PDX, a software provider that distributes drug information to pharmacy customers. Unlike physician package inserts and patient medication guides, which are FDA-mandated, WKH monographs are not regulated or reviewed by the FDA, but are produced as part of a self-regulating action plan required under 110 Stat. 1593. The WKH monograph was the only information received by Hardin when she first filled her prescription for Lamictal. The abbreviated warning used by Safeway and provided to Hardin omitted the “Black Box” warning: “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. Hardin says that had she been provided this warning, she would not have taken the medication. WKH moved to strike Hardin’s claims against it under Code of Civil Procedure section 425.16, the “anti-SLAPP” (Strategic Lawsuit Against Public Participation ) statute.. The trial court ruled that WKH’s production of drug monographs was protected speech concerning a public issue or an issue of public interest and that Hardin had no probability of prevailing because she could not establish that WKH owed her any duty. The court denied PDX’s motion to strike, finding that the activity underlying PDX’s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings instead of the full eight-section version that included those warnings. The court of appeal affirmed. View "Hardin v. PDX, Inc." on Justia Law

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In the late 1990s, people who had taken the prescription diet-drug combination Fen-Phen began suing Wyeth, claiming that the drugs caused valvular heart disease. A 2000 settlement included creation of the Fen-Phen Settlement Trust to compensate class members who had sustained heart damage. Claims required medical evidence. Attorneys who represented certain claimants retained Tai, a board-certified Level 2-qualified cardiologist, to read tests and prepare reports. Tai read 12,000 tests and asserted that he was owed $2 million dollars for his services. Tai later acknowledged that in about 10% of the cases, he dictated reports consistent with the technicians’ reports despite knowing that the measurements were wrong, and that he had his technician and office manager review about 1,000 of the tests because he did not have enough time to do the work. A review of the forms Tai submitted found that, in a substantial number of cases, the measurements were clearly incorrect and were actually inconsistent with a human adult heart. Tai was convicted of mail and wire fraud, 18 U.S.C. 1341 and 1343, was sentenced to 72 months’ imprisonment, and was ordered to pay restitution of $4,579,663 and a fine of $15,000. The Third Circuit rejected arguments that the court erred by implicitly shifting the burden of proof in its “willful blindness” jury instruction and applying upward adjustments under the advisory Sentencing Guidelines for abuse of a position of trust and use of a special skill, but remanded for factual findings concerning whether Tai supervised a criminally culpable subordinate, as required for an aggravated role enhancement. View "United States v. Tai" on Justia Law

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Plaintiffs brought two separate actions alleging that Hazel Smart died as a result of a defective catheter used in her dialysis treatment at Greater Waterbury Gambro HealthCare. The trial court consolidated the two actions, which brought claims sounding in negligence, medical malpractice, loss of consortium, and products liability. During pretrial proceedings, the trial court imposed monetary sanctions on Plaintiffs for failure to comply with a discovery order. Plaintiffs appealed. The appellate court dismissed the appeal for lack of subject matter jurisdiction, finding that the trial court's discovery order was not an appealable final judgment. The Supreme Court affirmed, holding that the appellate court properly dismissed the appeal, as the trial court's order did not constitute an appealable final judgment. View "Incardona v. Roer" on Justia Law

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Plaintiff-Appellant Brian C. Howard, M.D. received a knee replacement manufactured by Defendant Sulzer Orthopedics, Inc. The implant failed and had to be removed allegedly because it did not bond to Howard's bone. Howard asserted that the implant was unsuccessful because Sulzer left oily residue on the implant in violation of federal regulations. The United States Court of Appeals for the Tenth Circuit certified a single question to the Oklahoma Supreme Court. The Court in turn reformulated the question as one of first impression: "[w]hether 21 U.S.C. 337 of the Federal Food, Drug, and Cosmetic Act (FDCA), [which provides] that all violations of the Act shall be prosecuted in the name of the United States, prohibits Oklahoma from recognizing a claim for negligence per se based on violation of a federal regulation under the Medical Device Amendments (MDA) to the FDCA?" Howard asserted that Oklahoma law would allow a claim for negligence per se to proceed based on the violation of a federal regulation, and that such a position was supported by a recent opinion promulgated by the Oklahoma Court. Sulzer argued that federal regulations are not the type of law which should give rise to negligence per se claims. The manufacturer also insisted that recognizing such a claim would contravene legislative intent where no clear standard of conduct is outlined. The Oklahoma Supreme Court was not persuaded by Sulzer's arguments and answered the single reformulated first impression question, "no." View "Howard v. Zimmer, Inc." on Justia Law

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India Graves, a six-month-old girl, died while being monitored by one of CAS Medical Systems' products. India's parents, Kareem and Tara Graves, subsequently filed a products liability lawsuit against CAS, contending the monitor was defectively designed and failed to alert them when India's heart rate and breathing slowed. The circuit court granted CAS's motion to exclude all of the Graves' expert witnesses and accordingly granted CAS summary judgment. The Graves appealed. Upon review, the Supreme Court concluded that the circuit court did not abuse its discretion in excluding the testimony of the Graves' computer experts. While the court did err in excluding one doctor's testimony, the Graves were still left with no expert opinions regarding any defects in the monitor. In the absence of this evidence, CAS was entitled to summary judgment. Accordingly the Court affirmed the circuit court. View "Graves v. CAS Medical Systems" on Justia Law