Victims of a deadly U.S. meningitis outbreak are starting to sue the physicians and clinics that administered tainted steroid shots, and the success of the suits could hinge on whether judges decide the injections are subject to product liability or medical malpractice laws.
The drug-mixing pharmacy linked to the outbreak, the New England Compounding Center, already faces lawsuits related to the shots, as do its executives. But because the Massachusetts company is relatively small, patients exposed to meningitis are beginning to sue more well-insured defendants.
Plaintiffs have sued at least two physicians and orthopedic clinics in New Jersey that provided the injections, and legal experts predict similar cases against other doctors and clinics.
Such lawsuits, however, may hinge on whether courts define the tainted injections as products that were sold. In that case, hospitals and doctors could be sued for product liability and held responsible regardless of intent to harm. These strict standards are part of most state product liability laws.
However, if courts define an injection as a service, plaintiffs likely would face the tougher task of showing negligence under medical malpractice laws.
"The question will be whether the doctor or hospital failed to investigate the competence and safety of the steroids, and you'll have to put some flesh on those bones," said personal injury lawyer Fred Thompson of law firm Motley Rice.
Motley Rice plans to sue NECC on behalf of meningitis plaintiffs in the next several days, said another attorney at the firm, Don Migliori. The lawsuits may expand over time to include other defendants, he said.
In the New Jersey case, plaintiffs accused the physicians of negligence, but sought to invoke strict liability for the clinics, meaning the facility could be held liable for selling a defective product even without knowing of a defect.
One of the clinics, Professional Pain Management Associates in Vineland, New Jersey, declined to comment, while the other clinics and doctors named as defendants were not immediately available to comment.
To build a case under the legal standard of strict product liability, plaintiffs' lawyers may look at clients' medical bills, said New York personal injury lawyer David Jaroslawicz, who said he is not yet involved in any lawsuits linked to the meningitis outbreak.
If a bill shows separate prices for the injection and the steroid, a plaintiff could argue that the steroid was a product sold. That argument may be harder if doctors only bill for the service or do not itemize, Jaroslawicz said.
Twenty-three people have died and nearly 300 have been infected in the meningitis outbreak. Health regulators estimate as many as 14,000 people were exposed to the steroids, which were used as pain medications.
NECC, the compounding pharmacy, has been sued by patients in states including Michigan, Minnesota and Tennessee. A company representative did not respond to a request for comment on the litigation.
In one Massachusetts case, plaintiffs have tried to go after NECC's executives, seeking a court order to freeze the assets of company owners Barry and Lisa Cadden and Greg Conigliaro.
Product-liability claims against doctors or hospitals are not always allowed. In some states, doctors are protected from strict liability standards, and some states impose caps on damages for such claims, said Charles Joern, a Chicago lawyer who defends companies in product liability lawsuits.
"That's going to play a role in determining where claims are filed," Joern said.
Indeed, the issue of damages is central to personal injury litigation, and limits on damages can deter litigation.
Compensatory damages, which cover a plaintiff's financial loss, are often modest. But plaintiffs usually seek punitive damages, designed to punish wrongdoers, which can be much higher.
In practice, punitive damages can be difficult to win, except in extreme cases.
"In New York, for example, unless a doctor comes in the room drunk and cuts off the wrong leg, it's hard," said Jaroslawicz. "Most doctors, if they make a mistake, it's an honest mistake."
Because lawsuits are likely to be filed in multiple states, outcomes could vary. Plaintiffs may file claims for both product liability and malpractice, in hopes one or both stick, said Andrew Meyer, a personal injury lawyer at Massachusetts law firm Lubin & Meyer, which has been looking into potential cases on behalf of meningitis plaintiffs.
Hospitals and doctors may not be the only defendants. Everyone in the supply chain, from suppliers to compounders to distributors, could face litigation, Meyer said.
One entity unlikely to be sued is the federal government, said Motley Rice's Migliori.
"You can point the finger and say these steroids should have been regulated better -- that's the big controversy," he said. "But you can't say the government in this case failed to carry out a duty."
While the U.S. Food and Drug Administration has limited authority to regulate pharmacies such as NECC, it has been under scrutiny because it had flagged violations at the company as recently as 2006.
There is some precedent for successfully suing the government over faulty products, but only when the government played a key role in letting those products into the market, such as through negligent testing or regulation, Migliori explained.
Lawsuits could target the Massachusetts state government, which had regulatory responsibility over NECC, but legal standards may be too rigorous for plaintiffs to overcome, Meyer said.
"You can always make a claim, but the difficulties associated with suing any government, federal or state, are enormous," he said.