TAINTED DRUGS A recent court ruling could mean more costly lawsuits for facilities that give patients faulty medications or defective medical devices.

Usually when a patient receives a defective medication or medical device during a procedure, the facility and provider are sued for medical malpractice, while the manufacturer or vendor typically faces a harsher product liability claim. But a new ruling out of Connecticut suggests that facilities that charge patients for various medications, implants and devices could be on the hook for additional pricey litigation should the product fail.

Contaminated meds
In this case, a patient underwent a spinal procedure at a Connecticut hospital. During the surgery, the hospital injected the patient with preservative-free betamethasone, which they had purchased from the New England Compounding Center, the compounding facility at the center of the 2012 meningitis outbreak that sickened more than 800 individuals and resulted in the deaths of 64. The medication was contaminated.

After receiving the tainted injection, the patient suffered from several unnamed complications. The patient then sued the hospital for both strict product liability and medical malpractice. The hospital challenged the suit, saying that the patient's claims sounded only in medical malpractice, and because she did not include the correct expert support for her malpractice claim, the suit should be dismissed.

However, the court ruled that while the malpractice claims could not proceed without the proper expert support, the product liability claim could continue. In it, the patient argued that the hospital, acting as a seller of the medication, sold her a defective product without revealing the information about the risks associated with it. Additionally, the court found that the hospital's pricing of the medication did not involve the patient's diagnosis or treatment, further strengthening the patient's product liability claim. The case is now pending trial.

How this could impact you
Any facility that provides medication or medical devices to patients should pay attention to this case. When a product malfunctions during the course of medical treatment, a patient can usually sue for products liability and medical malpractice under the law. After the suit is filed, the court determines the entity that's ultimately responsible for the injury — typically the manufacturer, designer or vendor for selling a defective product, or the provider for giving poor care to the patient.

Generally, it is preferable for healthcare facilities to be sued for medical malpractice and not product liability, since malpractice suits come with strict burdens that patients often don't or can't meet, resulting in a dismissal of the suit. In this case, that happened with the malpractice claims the patient brought against the hospital; however, it still got hit with the product liability claim, which comes with lower burdens for the plaintiff and potentially higher financial penalties for the defendant. There are a few reasons why that occurred.

The court found that the hospital acted in a product seller role. Since the patient was charged for the medication separately from the service it was used for — the spine surgery — it opened itself up to the product liability suit. Another example would be if a hospital's chargemaster showed that it charged patients $25 for 2 pills of acetaminophen. If an uninsured patient is then charged for those 2 pills separately from any specific medical care, and the pills are tainted and cause harm, the hospital could be on the hook.

ANESTHESIA LAWSUITS
Mixed Malpractice News For Anesthesia Providers

SUIT SHIFT Outpatient anesthesia-related malpractice claims are now outpacing inpatient claims, a new study has found.

While overall malpractice claims related to anesthesia care are declining, the proportion of outpatient claims has increased in comparison to inpatient ones, says Richard J. Kelly, MD, JD, MPH, FCLM, clinical associate professor of anesthesiology and perioperative care at the University of California Irvine School of Medicine.

Dr. Kelly recently completed a study looking at the rate of anesthesia-related malpractice claims between 2005 and 2013 (osmag.net/FX6Ybo). In it, outpatient and inpatient payment reports decreased during that time by 24% and 45% respectively, though outpatient payments as a percentage of all payments increased from 19% in 2005 to 25% in 2013. Dr. Kelly says he believes the increase is due largely to the growth of the outpatient surgery arena, and that all providers should be paying close attention to anesthesia safety to help reduce their risk.

'The incidence of both inpatient and outpatient malpractice claims declined overall during the study period,' says Dr. Kelly. 'But, the inpatient claims came down much more than outpatient claims.'

— Kendal Gapinski

Avoid these types of situations as much as possible. Steer clear of acting as the retailer or middleman between the manufacturer and the patient. It's all too common for a facility to purchase a product from a manufacturer, raise the price and charge patients for it independently of the overall care provision. Instead, for instances where a medical device or medication is given to the patient as part of another service — for example, an injection administered as part of the spine surgery — it's best to bundle the device or medication's cost with that of the overall service.

Finally, it's also a good idea to stay abreast of any news about device or medication malfunctions. In this case, the patient also claimed that the hospital, in its role of selling the medication to the patient, should have known that there were problems with compounding centers — especially with the New England Compounding Center — since the FDA had issued a warning about them shortly before her surgery. This further bolstered her product liability suit. You can easily avoid this by closely following any device recalls or FDA warnings, and taking appropriate action. OSM