A fungal meningitis outbreak which has caused 19 fatalities and afflicted 400 people in 19 states has been linked to contaminated steroid injections. Victims and their families have begun filing lawsuits against the clinics and doctors who administered the contaminated steroid shots. The success or failure of the lawsuits could depend on whether judges decide that the cases are sound in medical malpractice or strict product liability.
New England Compounding Center (NECC), the drug compounding pharmacy that produced and sold the tainted shots, already faces numerous lawsuits. But the company is fairly small, and those infected with meningitis are now suing larger targets.
In New Jersey, two doctors and orthopedic clinics that provided the steroid injections have been sued. Legal experts predict more cases will follow in that state and others.
If courts define the injections as products, doctors and clinics could be sued for product liability. But if the administration of the injections is deemed to be a service, plaintiffs would likely have to prove negligence under medical malpractice laws—a much more difficult task.
Plaintiffs’ lawyers may look to clients’ medical bills to determine whether they have a case under strict product liability laws. If a bill lists the steroid and its administration as separate line items, an argument can be made that the drug was a product sold. This argument would be less sound if patients were billed only for the injection.
In some states, doctors cannot be sued under strict liability standards. In others, caps are imposed on damages for such claims. NECC’s tainted injections have infected patients in 19 states. Because laws vary across those states, the outcomes of lawsuits against doctors and clinics are likely to vary as well. Some plaintiffs may even file claims both for malpractice and for product liability in the hopes that at least one holds up.
Distributors of NECC’s products may also find themselves named in lawsuits.
Another possible target is the State of Massachusetts, which regulates drug compounders like NECC within the state, but legal experts say the legal standards necessary to sue the state are difficult to meet.
The federal government will likely not face any lawsuits. The agency is under scrutiny because it had cited NECC for regulatory violations as recently as 2006, but the FDA’s authority to regulate drug compounders is quite limited.
Paul Greenberg is a Chicago medical malpractice lawyer and Chicago medical malpractice attorney with Briskman Briskman & Greenberg. To learn more call 1.877.595.4878 or visit http://www.briskmanandbriskman.com/.