Which Law For Meningitis Tainted Shots: Medical Malpractice or Product Liability?

The devastation caused by the outbreak of meningitis in spinal injections for back pain continues to grow, with the CDC reporting yesterday that the death toll has grown to 23 patients, and nationwide there have been more than 300 reported cases of infection. The FDA continues to recommend:

Patients who believe they received an injection or other product that was shippedby NECC on or after May 21, 2012 should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms.

Unsurprisingly, numerous lawsuits have already been filed, many of them disturbingly filed by lawyers representing patients who have not been diagnosed with meningitis. I’m disappointed, but not surprised: any lawyer filing one of these cases for a patient who has not been diagnosed with an infectious disease that can be connected to the tainted shots is just looking to get their name in the newspaper. This sort of grandstanding by lawyers trying to market themselves only lowers the public’s opinion of what we do as personal injury lawyers – it’s an honorable profession, where we spend most for days helping hurt people hold corporations accountable for their recklessness and greed, as permitted by our laws – and causes the public, the courts, and the legislators to doubt the allegations brought by the real victims of this tragedy.

I mentioned legislators because they may yet have a role to play in the legal fallout from the meningitis outbreak. Put simply, there is absolutely no way that the New England Compounding Center, the compounding pharmacy that was the source of the outbreak, has adequate financial resources or liability insurance to compensate even a fraction of the victims here. Each one of those 23 (so far) wrongful death claims represents millions of dollars in compensable damages. For the patients who survived, even a comparatively brief fight with meningitis could be valued by a jury in the hundreds of thousands of dollars once all the economic and non-economic damages are added up.

Many of these patients, potentially most of the patients, were not seriously ill, but were in fact still ambulatory and still working their jobs. Thus, the lost wages alone from over 300 people – and the total will probably be much higher in the end – rendered sick and hospitalized for a few days could amount to tens of millions of dollars. In short, NECC is worse than just bankrupt: it will inevitably be liquidated and its insurance coverage will be totally exhausted long before any victims negotiate or receive reasonable settlements.

Faced with that challenge, lawyers for meningitis victims have already started looking to other potential defendants. Reuters has an article up today discussing how “the success of the suits [against doctors and pain clinics who injected the tainted steroid shots] could hinge on whether judges decide the injections are subject to product liability or medical malpractice laws.”

In a medical malpractice lawsuit, the plaintiff needs to show that the nurse, doctor, or clinic acted negligently, sometimes described as “breaching the standard of care” or “acting unreasonably in light of the standards of the profession.” In the meningitis cases, the plaintiffs would have to show, for example:

• that the pain clinic should have done a better job investigating NECC,
• that the doctor should have recognized the risk of tainted injections and should have taken preventative measures, or
• that the pain clinic unreasonably failed to warn the patients that a serious infection was a risk of the procedure.

Proving that type of negligence might be very difficult to do: negligence is usually proven by showing what others in the profession normally do, and in the orthopedic, pain, and back treatment world, doctors often purchase their solutions from a licensed compounding pharmacy and then don’t bother to do anything else to ensure their patients’ safety.

In contrast, in product liability lawsuits, the plaintiff sometimes doesn’t have to show any sort of negligence by the defendant, they just have to show that the product was “unreasonably dangerous.” That means the plaintiff doesn’t have to prove any particular act of wrongdoing by the clinic, they just have to show that the product should not have been sold as it was. This outbreak, and the inevitable liquidation of NECC, demonstrate exactly why this sort of “strict liability” without fault was enacted in the first place: to ensure the availability of reasonable compensation in the event that one or more defendants were insolvent while others who profited from me deadly activity still had adequate insurance coverage to help cover the losses.

In my humble opinion, one critical issue that’s going to come out of the next weeks to resolve the malpractice-versus-products issue is: did the doctors charge a premium for the steroid injections? As in, did the mark up the cost of the shot itself, apart from the service of providing the shot? If so, then I would argue that the doctors and clinics were serving as sellers of the product rather than physicians performing a healthcare service, and so they should be subject to product liability law, not medical malpractice law, when it comes to determining their responsibility for the tainted shots. In short, if you’re not willing to take the responsibility as the seller of a product, then you should bill patients as if you are a seller.

But in the end it may not matter. Unfortunately, over the past three decades courts and legislatures have started chipping away at this sort of “strict liability,” trying to eliminate “strict liability” entirely and replacing it with another form of negligence. Recently the Third Circuit (the federal appellate court that oversees federal courts in Pennsylvania, New Jersey, and Delaware), predicted that the Supreme Court of Pennsylvania would, in the future, follow a new type of product liability law that eliminates “strict liability” and replaces it with a standard that makes it harder for the users of dangerous products to recover compensation by focusing the case on the “reasonableness” of the defendant’s conduct, rather than focusing the case on the danger of the product itself.

For over fifty years, the drug injury lawyers of The Beasley Firm have helped patients injured by defective products, and have obtained over $2 billion in settlements and jury verdicts. We can help you understand your legal rights and options. Please feel free to contact us to learn more about how our pharmaceutical error attorneys can help you.