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Jeff Krawitz is a Shareholder and member of Stark & Stark’s Accident & Personal Injury Group.

Heart surgery patients failed to prove that they were injured after Intuitive Surgical Inc.’s da Vinci surgical robot left metal fragments in their brains, said the Eleventh Circuit in upholding a District Court decision dismissing their case. The plaintiffs alleged that MRIs showed that metal fragments discharged from the robot’s surgical instruments, entered their bloodstreams and ended up in their brains. The complaint in Gabriel Fernando Nassar Cure v. Intuitive Surgical Inc. asserted that Intuitive designed, manufactured, marketed, and sold defective medical instruments that were used during surgeries at hospitals across the country.

In dismissing the case, the district court cited to Boyd v. Orkin Exterminating Co. The district court found that the injuries allegedly caused when Intuitive’s da Vinci surgical robot inadvertently sent bits of metal debris into the brains of patients were speculative, similar to injuries claimed due to toxic chemical exposure. The patients, however, argued the injury is similar to foreign object claims where objects left in the body constitute an injury. The plaintiffs asserted that their injuries are not speculative and that Intuitive designed and manufactured a defective instrument or instruments which caused them injury by improperly shedding metal fragments into their bodies during surgery. The patients alleged they have suffered physical, neurological, and mental impairments as a result of the metal shavings left in their brains following surgery.


Continue Reading Surgical Robots Left Behind Metal Fragments in Heart Patients’ Brains

On August 4, 2017, the Federal Motor Carrier Safety Administration (FMCSA) and the Federal Railroad Administration (FRA) announced the withdrawal of their advance notice of proposed rulemaking (ANPRM) which would have required railroads and trucking companies to test employees for obstructive sleep apnea. This is one of many withdrawals of proposed safety regulations by the Trump administration.

The ANPRM was jointly issued in March 2016 as the first step for the agencies to consider whether to propose requirements concerning obstructive sleep apnea for commercial vehicle drivers and rail workers in safety sensitive positions. Based on the potential severity of obstructive sleep apnea-related transportation incidents and crashes, the ANPRM sought information from interested parties regarding obstructive sleep apnea to better inform the agencies’ decision on whether to take regulatory action.


Continue Reading Sleep Apnea Rule for Truckers and Train Engineers Withdrawn

Many people are taking advantage of technology to monitor their health and vital signs. But should you monitor your heart with a smartphone? Is this technology approved or regulated by the U.S. Food & Drug Administration? Entering the market in increasing numbers are heart-monitoring apps that are intended to be used as medical devices, which – unlike fitness trackers – must be approved by the FDA. Some are designed for home use, while others are for health care providers.

Digital health technology has revolutionized health care, empowering consumers to make better-informed decisions about their health. The U.S. Food & Drug Administration (FDA) is reevaluating its oversight of digital health technology. The FDA seeks to ensure patients’ timely access to high-quality, safe, and effective digital health products.


Continue Reading Should You Check Your Heart Rate With Your Smartphone?

In 2015, prompted by outbreaks of antibiotic-resistant infections linked to duodenoscopes, the FDA issued a Safety Communication, indicating that the complex design of duodenoscopes may impede effective reprocessing. From January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) involving approximately 135 patients relating to possible microbial transmission from reprocessed duodenoscopes. Duodenoscopes are used to visualize the duodenum and upper digestive tract, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Reprocessing involves a detailed, multistep process to clean and disinfect or sterilize the reusable devices.

The FDA reports that more than 500,000 Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using duodenoscopes are performed in the United States each year. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The complex design of duodenoscopes improves the efficiency and effectiveness of ERCP. However, that design creates challenges for cleaning and disinfection because some parts of the scopes may be difficult to access. Residual body fluids and organic debris may remain in crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.


Continue Reading Voluntary Recall of Duodenoscope Issued Due to Infection Risk

The Wisconsin Court of Appeals recently joined courts in Florida, Illinois, New Hampshire, and Washington in finding that caps on noneconomic medical malpractice damages are unconstitutional.

The appeals court found that Wisconsin’s cap on noneconomic medical malpractice damages always reduces noneconomic damages only for the class of the most severely injured victims who have been awarded damages exceeding the cap. Yet, the cap always allows full damages to the less severely injured malpractice victims. The court therefore concluded that the cap denies equal protection to that class of malpractice victims whose noneconomic damages are determined by the factfinder to be in excess of the cap. The court therefore concluded the statutory cap is facially unconstitutional.


Continue Reading Are Medical Malpractice Damages Caps Unconstitutional?

Endo Pharmaceutical’s recent decision to halt sales of Opana ER (oxymorphone hydrochloride) quickly followed the U.S. Food and Drug Administration’s (FDA) request that it remove the abuse-linked opioid pain medication from the market. This is the first time the agency sought to remove a currently marketed opioid pain medication from sale due to the public health crisis of opioid abuse.

In 2015, more than 33,000 people died from opioid overdoses, according to the Centers for Disease Control. Almost half of the deaths involved a prescription medication.


Continue Reading Sales of Opioid Pain Medication Halted After FDA Request

The Supreme Court of Florida held that the state’s statutory caps on personal injury noneconomic damages in medical negligence actions violate the Equal Protection Clause of the Florida Constitution. The statute, section 766.118, set noneconomic damages caps of $500,000 per claimant in personal injury or wrongful death actions arising from medical negligence. If the negligence

Access to a nurse’s personnel file became a key issue in a recent PA medical malpractice wrongful death and survival action. In Snyder v. DeCesare, the Court of Common Pleas of Lackawanna County considered whether plaintiffs were entitled to disclosure of the personnel file of defendant Heather Shingler, RN. Plaintiffs alleged that their unborn child died in utero due to negligent fetal monitoring by the nurse, who was subsequently terminated from her employment with defendant Moses Taylor Hospital.

Plaintiffs sought a court order to compel production of the nurse’s personnel file, alleging a nexus between her termination of employment and her alleged negligent fetal monitoring. Defendants claimed there was no connection between the two events. Also, Nurse Shingler denied that her termination was related to the facts alleged in this case.


Continue Reading Hospital Must Disclose Fired Nurse’s Personnel File in PA Medical Malpractice Case

On March 10, 2017, the Accreditation Council for Graduate Medical Education (ACGME) announced that first-year doctors will be allowed to work 24-hour shifts in hospitals starting July 1, 2017. The cap that has limited shifts to 16 consecutive hours of patient care since 2011 will be lifted. The 80-hours-per-week cap remains in place.

Balancing the logistics of physician training with the safety and needs of patients has been the subject of controversy and debate for decades. According to a recent article in the New England Journal of Medicine, the debate centers on the concern that longer hours mean less sleep and sleep-deprived residents might make errors. However, that is countered by other concerns about shorter work hours resulting in more patient hand-offs that could affect patient care.


Continue Reading Residents’ Return to 24-Hour Shifts Rekindles Controversy Over Patient Care

The Pennsylvania Supreme Court will hear an appeal from the dismissal of a wrongful death lawsuit brought by the widow of Derek Valentino, a triathlete who drowned in a 2010 event organized by Philadelphia Triathlete LLC. The Court will determine whether the wrongful death claims brought by Mr. Valentino’s widow against Philadelphia Triathlete are barred by the liability waiver signed by him.

As part of the registration process for the triathlon, Mr. Valentino paid a fee and electronically executed the liability waiver assuming all risks of participating in the event. The swimming portion of the competition occurred in the Schuylkill River. Mr. Valentino entered the river on the morning of the event; his body was discovered in the river the following day.

In her wrongful death suit, Mr. Valentino’s widow claimed that Philadelphia Triathlete was grossly negligent and reckless. She maintained that the event organizers “failed to inspect or maintain the event course, failed to warn of or remove dangerous conditions, failed to properly plan or organize the event, failed to follow safety standards, and failed to properly train employees.”


Continue Reading Pennsylvania Justices to Review Waiver of Liability in Triathlete Wrongful Death Case