By now it’s common knowledge that a compounding pharmacy in Massachusetts delivered tainted preservative free methyl-prednisolone to a number of hospitals / clinics. The taint was a fungus. And morbidity and mortality have climbed.
Why did doctors/ facilities even order from a compounding pharmacy? Two reasons: First, the typical preservatives used to suppress fungus can wreak havoc if the injection accidentally strays into the spinal sac (CSF). So, preservative-free is, in principle, a good idea as it is impossible to know with certainty the injection is in the epidural space. There are ways to be quite sure – but not completely sure.
Next, preservative-free methyl-prednisolone was in short supply. Major manufacturers had exited the space.
Lawsuits have been initiated against New England Compounding Center alleging product liability, pharmacy malpractice, general negligence, breach of warranties, and more.
Most recently, two New Jersey lawsuits have targeted an orthopaedic clinic and two doctors – alleging negligence and violation of product liability laws. For attorneys prosecuting these cases, they assume that there will not be enough assets or insurance to cover claims for affected patients. New England Compounding Center will likely have to file for bankruptcy if its assets cannot cover the load. And, whether the Compounding Center has adequate insurance to defend and cover claims, who knows? Doubtful. So, attorneys will likely broaden their pool of defendants.
Typically, it’s difficult to prevail against a physician in a product liability claim if the doctor didn’t manufacture the defective product. The questions that will be probed: Did the doctor still use the product after the recall? Did the doctor timely notify patients at risk once aware of the problem? Would a reasonably reasonable practitioner use such a pharmacy for the specific prescription?
“The flood gates are going to open,” D’Amore (a medical malpractice lawyer at the Cochran Firm in Washington, D.C.) predicted. “You’re going to get people suing everyone.”
State laws and the courts have traditionally protected health care providers from product-liability claims, he said. A medical malpractice suit would also have to show that providers acted both negligently and outside the norms of professional standards, D’Amore added.
That might be cold comfort to doctors who are sued, yet prevail over time.