Articles Posted in Medical Device Liability

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A problem has developed with the St. Jude implanted heart device: A wire or lead that connects a defibrillator to a patient’s heart has been failing, often with fatal results. The lead, a model called Riata, has been used by more than 128,000 patients worldwide.
The electrical wires within the Riata lead have been known to break through the insulation, causing shocks in some patients and other more serious injuries. More important, the Riata wire failure does not react to the need for a lifesaving jolt to keep a failing heart beating.
St. Jude stopped selling the Riata product in late 2010. In December 2011, The U.S. Food and Drug Administration (FDA) announced the voluntary physician recall of the Riata and Riata Silicone Defibrillation Leads as a Class I Recall. This means that the FDA believed there was potential risk of serious injury or patient death caused by the devices’ malfunction.
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In following the U.S. Supreme Court’s decisions in Daimlar AG v. Bauman, 134 S. Ct. 746 (2014) and BNSF Railway Company v. Tyrrleo, 137 S. Ct. 1549 (2017) and the Missouri Court’s earlier opinion in State ex rel. Norfolk S. Ry. Co. v. Dolan, 512 S.W. 3d 41 (Mo. En Banc 227), the Missouri Supreme Court has dismissed claims filed in the City of St. Louis by nonresident plaintiffs against Bayer Corp. and several subsidiaries for lack of personal jurisdiction.

The plaintiffs in this case had initiated an action against Bayer in St. Louis City Circuit Court to recover damages for personal injuries they allegedly experienced from their use of Essure, a medical device that Bayer manufactures and distributes. The case named 92 plaintiffs, but only seven were Missouri residents. The remaining 85 plaintiffs are not Missouri residents and do not allege they used Essure in Missouri or that they were injured in the state.

None of the Bayer defendants is incorporated in or has a principal place of business in Missouri; thus, these defendants are not “at home” in Missouri.
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The U.S. Supreme Court has prevented 592 nonresidents from joining 86 California residents in suing Bristol-Myers Squibb in California state court for personal injury allegedly caused by Plavix, a blood thinner. At the state level, the California Supreme Court concluded that the Due Process Clause of the 14th Amendment did not bar the out-of-state residents from suing the corporation, BMS, in state court.

In the vigorous dissent written by Justice Sonia M. Sotomayor, the U.S. Supreme Court reversed. Justice Samuel A. Alito Jr.’s majority opinion explained, “The nonresidents were not prescribed Plavix in California, did not purchase Plavix in California, did not ingest Plavix in California and were not injured by Plavix in California.

The mere fact that other plaintiffs were prescribed, obtained and ingested Plavix in California – and allegedly sustained the same injuries as did the nonresidents – does not allow the state to assert specific jurisdiction over the nonresidents’ claims.”
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According to the report of this Illinois Appellate Court (1st District) decision, new ground is being broken in a lawsuit brought by Senayda Norabuena against Medtronic Inc. The suit, which was first dismissed on motion, involved the use of a Medtronic medical device implanted in a spinal fusion surgery.

The appeals panel for the 1st District held that the lawsuit, brought by Norabuena and her husband, against Medtronic involved parallel state law claims that are not pre-empted by federal law.

The justices found the plaintiffs’ pleadings were insufficient and ordered Cook County Circuit Court Judge John P. Callahan Jr. to grant them leave to file an amended complaint.
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In a split decision, the Kentucky Supreme Court has allowed a medical malpractice lawsuit to proceed against the defendant, a surgeon, who was alleged to have chosen not to inform a patient, the plaintiff, of a risk associated with a device implantation procedure. The trial judge dismissed the case for lack of a medical expert to support the plaintiff’s case.

In a 4-3 decision, the Kentucky Supreme Court agreed with the intermediate appellate court that overturned the trial court’s directed verdict. The claim brought by Jacqulyn G. Harrington had been dismissed. In her suit, Harrington had alleged that Dr. Alex Argotte chose not to warn her that the device, called an inferior vena cava (IVC) filter, which was designed to prevent blood clots, could break apart and become lodged in her lungs.

The trial judge threw out the case shortly after Harrington’s lawyer made an opening statement at trial saying that they were not going to call an expert witness because only “common sense” was required to determine whether Harrington had been properly informed of the risks of the procedure.
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This case concerned the first of over 500 cases regarding the Wright Medical Conserve “metal-on-metal” hip replacement device designed and manufactured by the defendant. The plaintiff filed a products liability suit alleging, among other things, that the defendant was liable for design defects based on strict liability and negligence.

On appeal, the defendant challenged the entry of a $2,100,000 judgment. The court rejected the defendant’s argument that the district court erred in ordering the jury to continue deliberations after the jury had already begun to deliver its verdict.

In this case, upon recognizing the inconsistency in the jury verdict, the district court immediately halted publication of the verdict and instructed the jury that an error had been made; the district court acted in a neutral and non-biased manner in acknowledging and addressing the inconsistent verdict; and the district court also recharged the jury.
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In this case, a manufacturer, Intuitive Surgical Inc., sold a surgical device, the robotic surgical system, to a hospital, Harrison Medical Center, which credentialed some of its physicians to perform surgery with the device. The surgical device is a robotic surgery tool called the “da Vinci System.”

At the trial, an expert urologist for Josette Taylor, the wife of Fred E. Taylor who died four years after undergoing a failed prostatectomy surgery by the robotic device, opined that the surgeons must be credentialed in order to use the da Vinci System. The doctor testified that the da Vinci robotic surgical system is one of the most complex devices used in surgical procedures.

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.
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In a recent Journal of the American Medical Association Surgery (JAMA Surgery) article, the safety concerns of the use of the transvaginal mesh in pelvic organ prolapse (POP) repair has been noted by the U.S. Food and Drug Administration (FDA).The recent article by two physicians was published in the Journal of the American Medical Association Surgery edition published online on Nov. 30, 2016.

The article highlights studies that reveal the incidences and timing of complications related to the use of the transvaginal mesh organ prolapse repair, the amount of vaginal mesh used with mesh erosions and repeated surgery after pelvic organ prolapse repair and urinary incontinence surgery. The study is discussed expertly in the JAMA article by the authors, physicians Bhumy A. Davé, M.D., a female pelvic medicine & reconstructive surgeon associated with Northwestern Medicine, and Anne-Marie Boller, M.A., M.D., FACRS, a colon and rectal surgeon also with the Northwestern Medical Group in Chicago.

The article points out that the recent transvaginal mesh study focused on the clinically important mesh complications (those that require an intervention as opposed to asymptomatic erosions) and it references a statewide database, which minimizes under reporting that occurs when patients change doctors secondary to complications.
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A city of St. Louis Circuit Court jury found that Johnson & Johnson’s well-known white powder, Baby Powder and Shower to Shower and other products containing talcum, were the cause of the ovarian cancer and death of an Alabama woman. The Shower to Shower product line was sold by Johnson & Johnson in 2012. For decades, these products have been depicted in advertisements as beneficial for women and children.

The civil lawsuit was brought by Jackie Fox of Birmingham, Ala., which was part of a larger claim involving 60 other injured individuals. Fox’s claim was brought by her son who took over the case after his mother passed away in October 2015 at the age of 62. She died 2 years after her diagnosis of ovarian cancer. Fox underwent painful chemotherapy and radiation therapies in the effort to control her cancer.

It was alleged and proved in the lawsuit that Fox used the talcum powder as a bathroom staple for years. The jury deliberated for five hours after a 3-week trial. It was the first such case among more than 1,200 nationally that are still pending against Johnson & Johnson.

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In a recent New York Times article, it was reported that Johnson & Johnson and Bayer, the makers of the anticlotting drug Xarelto, were complicit in staying silent in what is claimed to be an effort to protect the drug from criticism over its safety. Xarelto is sold in the U.S. by Johnson & Johnson and overseas by Bayer. Sales in the U.S. in 2015 were nearly $2 billion. Xarelto is said to be the best seller in a new category of drugs used to break up blood clots.

The claim of deception comes from what was a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University that omitted laboratory data about Xarelto. Xarelto is widely used as a replacement to Warfarin, which is an older blood thinner. Johnson & Johnson and Bayer hired the Duke Clinical Research Institute to run a 3-year clinical trial involving more than 14,000 patients that led to Xarelto’s approval by federal regulators.

Those research results have come under scrutiny since Sept. 20, 2015, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.

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