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.

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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.

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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.

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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.

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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 resulted in a permanent vegetative state or death, noneconomic damages were capped at $1 million. In cases not involving death or permanent vegetative state, the patient injured by medical negligence could be awarded up to $1 million, if the trial court determined that a manifest injustice would occur unless increased noneconomic damages were awarded, based on the special circumstances of the case, and a finding that the noneconomic harm sustained by the injured patient was particularly severe.

In striking down the damages caps, the Florida Supreme Court affirmed the decision of the Fourth District Court of Appeals in North Broward Hospital District v. Kalitan. The Broward County lawsuit was filed after dental assistant Susan Kalitan underwent carpal-tunnel syndrome surgery and suffered a perforated esophagus during the anesthesia process. A jury awarded $4 million in non-economic damages. The amount of the award was reduced by approximately $2 million based on the damages caps in the statute.

The 4th District Court of Appeals ruled that the damage caps were unconstitutional, noting the Supreme Court’s 2014 decision in Estate of McCall v. United States, finding that the caps in section 766.118 are unconstitutional in wrongful-death malpractice cases. The McCall Court found that the statute “arbitrarily diminished noneconomic damage awards based on the number of survivors and lacked a rational relationship to addressing the medical malpractice crisis.”

Based on the plurality opinion in McCall finding that there is no evidence of a continuing medical malpractice insurance crisis justifying the arbitrary application of the statutory cap in wrongful death cases, the Court reached the same conclusion with regard to the application of caps in medical negligence cases. The Court found that the statutory caps in section 766.118 “unreasonably and arbitrarily limit recovery of those most grievously injured by medical negligence.”

The Court concluded that “because there is no evidence of a continuing medical malpractice insurance crisis justifying the arbitrary and invidious discrimination between medical malpractice victims, there is no rational relationship between the personal injury noneconomic damage caps in section 766.118 and alleviating this purported crisis.”

Therefore, the Court held that the caps on personal injury noneconomic damages provided in section 766.118 violate the Equal Protection Clause of the Florida Constitution.

The four-member majority included Chief Justice Jorge Labarga and Justices Barbara J. Pariente, R. Fred Lewis and Peggy A. Quince.

Justice Ricky Polston dissented, joined by Justices Charles T. Canady and C. Alan Lawson, arguing that “It is the Legislature’s task to decide whether a medical malpractice crisis exists, whether a medical malpractice crisis has abated, and whether the Florida statutes should be amended accordingly.’’

While some states continue to impose damages caps, Pennsylvania does not impose caps on damages in personal injury cases unless the case is brought against a Commonwealth agency. In fact, damages caps are otherwise unconstitutional under the Constitution of the Commonwealth of Pennsylvania.