After the sudden deaths of five people following the placement of inflated silicone balloons in their stomachs to treat obesity, the Food and Drug Administration sent a letter to health care providers on August 10, 2017, warning of potential risks associated with the intragastric balloons. All five reported deaths happened within one month of the procedure, with three of the five people dying one to three days after the procedure. The agency said two more death reports happened within the same time frame and may be related to complications from the balloon treatment. The agency has not yet determined whether any of the deaths were directly related to either the devices or the insertion procedures.
Potential Risks of Intragastric Balloons
One risk is over-inflation. Overinflation may occur when the intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. Overinflation symptoms include abdominal swelling, severe abdominal pain, breathing problems, and vomiting. Acute pancreatitis is a separate type of risk, caused when the balloons compress other gastrointestinal structures. Symptoms include back and abdominal pain.
Both types of complications can happen within days of the procedure and may require doctors to remove the devices.
A recent New Jersey case addressed a statute of limitations issue pertaining to claims arising from a physician’s disclosure of a patient’s HIV-positive status to a third party without his consent.
Plaintiff was a patient of the defendant physician, a board-certified nephrologist. He was being treated for acute kidney failure. During an emergency consultation in plaintiff’s private hospital room, defendant discussed his medical condition and disclosed plaintiff’s HIV-positive status in the presence of a third party without plaintiff’s consent.
According to the Centers for Disease Control and Prevention (CDC), 83.6 percent of adults and 93 percent of children had contact with a health care professional in 2015. Hospital visits numbered 125.7 million while physician office visits numbered 922.6 million.
While the vast majority of medical procedures go smoothly, errors do occur and cause injury to patients. Surgery errors are the most common basis for an inpatient medical malpractice claim. As for outpatients, errors in diagnosis are the most common basis for a claim.
If a person suspects medical malpractice due to an adverse outcome from a medical diagnosis or procedure, he or she may decide to reach out to the physician, medical care provider, or hospital for some explanation or recourse. As a recent case illustrates, that may NOT be the best course of action to take.
Generally, after an examination for a medical problem, a doctor will sit down with a patient and explain what the issue is and offer treatment advice and alternatives. Often, the patient goes home afterward and then and can’t remember exactly what the doctor said. Was it ice, then heat – or heat, then ice? Do you take the new prescription before or after eating? How long should you wait before resuming normal activity? What were the risks and benefits of each treatment option?
What did the Doctor Say?
Anxiety, confusion, or the medical issue itself may affect a person’s ability to remember and understand what transpired during a doctor’s appointment. This is especially true if the medical condition being discussed is complex and/or many treatment options are offered.
Patients may turn to recording their conversations during doctor visits, either to listen to the recording later to clarify what was said or to share with family members who can help them make an informed healthcare decision.
What Does the Law Say About Recording Doctors? Wiretapping Statutes
Researchers from The Dartmouth Institute for Health Policy and Clinical Practice’s Open Recordings Project recently published an article in the Journal of the American Medical Association (JAMA) that discusses the legality of recording medical visits as well as other related issues.
State wiretapping statutes apply when patients’ conversations with physicians are recorded. The key factor in state wiretapping laws involves consent – that is which parties to the conversation need to consent to the recording. In states where all parties need to consent, recordings made without such consent violate the law. In states where only one party needs to consent, a patient can record a conversation with a doctor during an appointment without the doctor’s consent.
Pennsylvania requires the consent of all parties to the conversation before recording. In Pennsylvania, the patient needs the doctor’s consent before recording a conversation taking place during an appointment.
New Jersey requires only the consent of one party to the conversation. In New Jersey, a patient can record conversations during his or her appointment without the doctor’s consent.
The Health Insurance Portability and Accountability Act does not apply to recordings made by patients unless they provide that recording to a health care plan or health care practitioner.
Guidelines for Patients Recording Doctor Visits
Because patients are recording their doctor visits more frequently with technology such as smart phones, one of the Open Recordings Project authors, Glyn Elwyn, M.D., stated that it may be time for medical professionals to develop guidelines to protect confidentiality and privacy. Clear guidelines would promote responsible, positive use of open recordings. Guidelines could also address issues such as sharing recordings on social media or with other healthcare providers.
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.
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.
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.
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.
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.
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.