Bacterial Infections Prompt Two Lawsuits Against Hospital and Medical Device Manufacturer

Two lawsuits have been filed against York Hospital and LivaNova, the manufacturer of a medical device that was linked to a series of bacterial infections throughout southcentral Pennsylvania. Both suits are making defective design and failure-to-warn claims, among others, against LivaNova and negligence claims against both LivaNova and York Hospital.

The lawsuits come about eight months after York Hospital, owned by WellSpan Health, announced it was notifying approximately 1300 patients who had open heart surgery between October 1, 2011 and July 24, 2015, that they may have been exposed to nontuberculous mycobacteria (NTM). Five York Hospital patients have died; three others have been diagnosed with NTM. In July 2014, LivaNova sent an “Important Information” letter to hospitals noting that its own investigations had found that some devices were contaminated and warned that without proper cleaning, disinfection and maintenance the NTM bacteria “can multiply” in a heater-cooler device. The medical device – a Sorin 3T Heater-Cooler System — is used during surgery to control a patient’s body temperature. Due to a defect in the heater-cooler device, NTM could develop in the machines, and then become “aerosolized” by the device and could enter a patient’s body. The infection is slow moving and patients who contracted NTM could take months or even years to develop symptoms.

A lawsuit on behalf of a 62-year-old business man alleges that LivaNova not only designed a device that “prevented it from being reliably and consistently cleaned, disinfected, and maintained”, but that LivaNova knew or should have known of the association of the device and NTM infections.

The man had open heart surgery at York Hospital in December 2014. The suit states that he endured subsequent months of fever and fatigue. In June 2015, a bone marrow biopsy and blood test showed he tested positive for NTM. He began an anti-NTM therapy the next day, but his symptoms worsened. He was admitted to York Hospital for congestive heart failure, and subsequently died on Nov. 7, 2015, roughly two weeks after he was notified by the hospital that he had the bacterial infection. The lawsuit also alleges that York Hospital was negligent in its maintenance and cleaning of the device and in failing to earlier warn exposed patients of their risk of NTM infections. “This tragedy should have been avoided but for design flaws and human error,” said attorney Tom Kline.

The second lawsuit was filed by a patient who had open heart surgery at York Hospital in March 2015. After the surgery, the man was doing well but by August he became increasingly tired, suffered a loss of appetite and often spent days just lying in bed. By September, his symptoms worsened to include fever, chills and vomiting. He was in and out of the hospital in October; his blood cultures tested negative and he was diagnosed with dehydration. Even after receiving the letter in late October informing him of the risk if NTM, no specialists suspected contamination when he was admitted on Nov. 20, 2015, for “persistent leukopenia,” or reduction in white blood cells, according to the complaint. A week later, the patient learned he tested positive for NTM and was started on antibiotic therapy, which the complaint states has serious side effects, including vision and hearing loss that have already begun to manifest. The lawsuit argues that as a “direct and proximate result” of the defendants, the plaintiff suffered chronic illness, severe pain and suffering and a loss of income.

These lawsuits may be the first of many more to come. In addition to York Hospital, the Milton Hershey Medical Center has also notified 2,300 patients after at least two died from NTM infections. Similar cases have been investigated in other states, including South Carolina and Iowa.

While many states have made it difficult for medical malpractice victims to receive just compensation for their injuries and loss, Pennsylvania does not impose a cap on compensatory or non-economic damages. If a person is injured or dies due to medical negligence, then that person or the family can recover whatever compensation is awarded by the jury or judge. However, unless a doctor intentionally harms a patient, punitive damages cannot exceed 200 percent of compensatory damages. In addition, 25 percent of all punitive damages awarded to a patient must go into a special fund known as the MCARE Fund. This fund serves to pay patients whose claims exceed the healthcare provider’s malpractice insurance coverage. Pennsylvania also has a “periodic payments rule” which states that any future damage award — medical bills, lost wages, and other damages expected to be incurred in the future — greater than $100,000 must be paid in installments. Other damage caps in medical malpractice cases depend on the defendant. If the defendant is a state-run hospital, the liability is limited to $250,000 per injured party or a total of $1,000,000 for any single incident.

Although Pennsylvania is more “plaintiff friendly”, any attempt to take power away from a jury is an attempt to take power from citizens. Tort reform, damage caps, medical liability reform — of any kind– restricts a victim’s access to justice. They are essentially an effort to curb personal injury and medical malpractice claims and payouts to victims, trampling on our 7th Amendment rights. If there are limited or no consequences for bad behavior, bad behavior will continue; corporations and insurance companies will continue to put profits over safety.

All victims deserve the right to tell their story; to exercise their right to trial by jury under the Seventh Amendment. No one should have to bear the financial burden that resulted from a medical mistake. It is time every state puts the decisions back in the hands of those who hear the facts, circumstances, and evidence of each case — the juries.

The average citizen isn’t aware that tort reform laws can severely hinder seeking justice until it affects them personally. By then, it’s too late. We must all pay more attention to the issues and what our elected officials are doing about them. If these officials are acting in a manner contrary to the interests of the average citizen, they need to be voted out. Only you, the voter, has the power to make that happen.

Lawsuit Financial will continue to speak out against all forms of tort reform, caps on damages, judicial legislation of certain types of claims, and anti-justice politics in America. For further information on these issues, contact Injury Board, your local association for justice or the American Association for Justice. Together, perhaps we can, once again, live in a country that supports liberty and justice for all.

Mark Bello is the CEO and General Counsel of Lawsuit Financial Corporation, a pro-justice lawsuit funding company.