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?

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.

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

As reported by philly.com, New Jersey Department of Health investigators have released a preliminary report finding that that the Osteo Relief Institute Jersey Shore in Wall Township deviated from multiple infection control guidelines issued by the Centers for Disease Prevention and Control.

The report indicates that the clinic’s disregard of accepted hygiene practices likely caused 40 patients to develop septic arthritis of the knee following injections to treat knee pain. The clinic was closed in March but reopened two weeks later. The clinic treated up to 85 patients a day at the time of the infection outbreak, according to the report.

One physician at the clinic told health department investigators she did not wash her hands between procedures. Most troubling was the report’s finding that single-use vials were reused on multiple patients and leftover needles were put in the trash instead of in approved medical waste containers.

Lawsuits have been filed on behalf of several of the affected patients.

The Pennsylvania Superior Court will reconsider its ruling that attorney-client privilege does not apply to an email from a hospital’s attorney to its public relations firm.

The discovery dispute in the case involved a document generated by outside counsel pertaining to a public announcement planned by the hospital. The announcement would name two doctors who were identified from the results of a cardiology services audit as having performed unnecessary cardiac stent procedures. The hospital claimed that the audit indicated that the blockages in the patients at issue were so minimal that stents were not medically appropriate.

Continue Reading Pennsylvania Court to Reconsider Denial of Attorney-Client Privilege for Email to Consultant