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?

A recent study by a team of vehicle experts at the U.S. Department of Transportation’s Volpe Center found that pedestrian crash avoidance/mitigation (PCAM) systems can potentially reduce up to 5,000 vehicle-pedestrian crashes and 810 fatal vehicle-pedestrian crashes each year. Even if a crash is unavoidable, PCAM systems may reduce the resulting number of injured pedestrians by lowering the speed of the vehicle prior to impact.

It only takes a momentary distraction to cause a motor vehicle/pedestrian collision. That distraction may be on the part of the driver of the vehicle or the pedestrian, or a combination of the two. A driver may be distracted by children in the car or a ringing cell phone, or by changing the music that is playing. A pedestrian may be looking at his or her cell phone, talking to others, or even reading while walking. But whatever the cause or causes, the pedestrian is by far the most likely to be injured or killed as a result of the impact.

Continue Reading Do Pedestrian Detection Systems in Cars Save Lives?

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?

In Pennsylvania, a medical malpractice lawsuit must be filed in the county where the alleged malpractice occurred.

The Superior Court in Pennsylvania recently reversed a trial court decision in a medical malpractice case that transferred venue from Philadelphia County to Berks County, sending the case back to Philadelphia County.

The case involved a premature infant who was being treated in the neonatal intensive care unit in a Berks County hospital. The infant underwent a transthoracic echocardiogram in Berks County, which was interpreted by a pediatric cardiologist working in a hospital in Philadelphia County. The Philadelphia cardiologist wrote a report of her findings, including her diagnosis and treatment plan. The diagnosis of the Philadelphia doctor was pulmonary hypertension requiring immediate treatment or intervention, which was to be forwarded to plaintiff’s treating providers in Berks County.

Continue Reading Venue Returned to County Where Failure to Communicate Medical Test Results Occurred

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

A physician cannot perform a surgery or other medical procedure on a patient without first obtaining the patient’s informed consent. Informed consent means that the patient was advised of the risks, benefits, and alternatives to the procedure and, knowing these, made the decision to undergo the procedure. A physician can be legally liable where he or she fails to obtain a patient’s informed consent before performing a medical procedure.

In a recent medical malpractice action, the Pennsylvania Supreme Court held that a physician’s duty to provide information to a patient sufficient to obtain her informed consent is non-delegable. Thus, conversations between the patient and members of the physician’s staff will not suffice. The duty to obtain a patient’s informed consent for a major medical procedure belongs to the physician, who must inform the patient about the risks, benefits, likelihood of success, and alternatives.

Continue Reading Can a Doctor Delegate Duty to Obtain Informed Consent to Staff Member?

Most people are aware that a dog owner can be sued if his dog bites you. But what if a dog runs up to you, jumps on you, and knocks you down, causing injury? That scenario highlights the difference between injuries from dog bites and injuries that occur from a dog attack or confrontation.

Pennsylvania law treats dog attacks differently depending on whether the dog is a “dangerous dog” and whether the bite caused severe injury or death. A “dangerous dog” is defined as one that has:

  1. Inflicted severe injury on a human being without provocation on public or private property.
  2. Killed or inflicted severe injury on a domestic animal, dog, or cat without provocation while off the owner’s property.
  3. Attacked a human being without provocation.
  4. Been used in the commission of a crime.

And the dog has either or both of the following:

  1. A history of attacking human beings and/or domestic animals, dogs, or cats without provocation.
  2. A propensity to attack human beings and/or domestic animals, dogs, or cats without provocation.

Continue Reading Knocked Down and Injured by a Dog – Now What?