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Winter is coming – and with it comes snow, sleet, and freezing rain. In the Philadelphia area, the average yearly snowfall is 22.4 inches.

Winter driving is dangerous. According to the Federal Highway Administration, more than 116,000 Americans are injured and over 1,300 are killed on snowy, slushy, or icy pavement every winter. Pennsylvania is one of the top five deadliest states for wintertime car accidents, often caused, at least in part, by poor visibility and road conditions. Be careful out there!

Another hazard, a preventable hazard, is also part of winter driving. While viewed by many as a harmless prank, PennDot cautions against throwing snowballs at cars due to the risk of causing an accident. A snowball thrown at a car can break a car’s windshield or cause a car accident by distracting the driver or causing the driver to swerve into adjacent or oncoming vehicles, or even pedestrians.

Continue Reading Don’t Throw Snowballs (or Rocks) at Cars!

The FDA has issued a safety alert to consumers involving several dietary supplements including Rhino 7, Papa Zen, Fifty Shades, and Grande X. The safety alert warns consumers that the products may include undeclared active prescription drug ingredients.

The products are labeled as a dietary supplement and each is packaged as a blister pack capsule. Product names and lot numbers are available in the FDA’s safety alert here.

Voluntary Recall of Dietary Supplements

Gadget Island, Inc. is voluntarily recalling the dietary supplements at the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients – sildenafil, desmethyl carbodenafil, and tadalafil.

Continue Reading FDA Issues Warning About Dietary Supplements Containing Active Drug Ingredients

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.

Continue Reading FDA Issues Warning Letter Concerning Stomach Balloons Used to Treat Obesity

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.

Continue Reading What You Should and Shouldn’t Do if You Suspect Medical Malpractice

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