Cardioplegic Solution Lawsuit

Schmidt & Clark, LLP is No Longer Taking These Cases - If you feel that you may have a potential case, we urge you to contact another law firm adequately suited to handle your case.

The U.S. Food & Drug Administration (FDA) has expanded its investigation into a deadly nationwide fungal meningitis outbreak to include a cardioplegic solution processed by the New England Compounding Center (NECC). So far, the primary blame for the epidemic as been on methylprednisolone acetate, a widely-prescribed steroid medication believed to have caused at least 24 deaths and 317 illnesses around the country. However, after a patient who was treated with cardioplegic solution was diagnosed with the specific variety of fungal meningitis associated with the outbreak, the FDA’s investigation has expanded to include other drug products manufactured by NECC.

Fungal Meningitis Update 1/30/13: This week, a federal judge ruled that assets of the company at the center of last year’s unprecedented fungal meningitis outbreak will be frozen indefinitely. An emergency injunction was placed on the New England Compounding Center (NECC) after the owners were accused of funneling more than $21 million out of the company’s assets before filing for bankruptcy in December.

What’s the problem?

According to the FDA, a heart transplant patient who received cardioplegic solution manufactured by NECC became infected with Aspergillus fumigatus, one of two specific funguses thought to be responsible for the nationwide meningitis outbreak. The investigation of the patient is ongoing, and other theories regarding the source of the contamination have not been ruled out. The FDA will release additional information as it becomes available.

Cardioplegic solution is used during surgery to paralyze the heart so it does not become injured. The solution allows surgeons to operate on the heart with relative safety, as it maintains and supports the heart muscle despite the lack of blood flow. Cardioplegic solution lowers the metabolic rate of the heart, thereby preventing cell death while it is being operated on.

Health officials are bracing for a continuous influx of new cases of fungal meningitis in the coming weeks and months, due to the fact that the incubation period of the disease may be up to three months or even longer. Signs and symptoms of fungal meningitis may include:

  • headache
  • nausea
  • vomiting
  • stiff neck or neck pain
  • sleepiness
  • confusion
  • photophobia (sensitivity to light)
  • altered mental states

People who were given a steroid injection since July and are now experiencing any of these symptoms should seek immediate medical attention. If a conclusive diagnosis of fungal meningitis is made, the patient will likely be treated with intravenous anti-bacterial drugs, which must be administered by a doctor in a hospital setting.

Awards & recognition