Some lawyers in the East Coast and West Coast – you know who you are – tend to be dismissive of decisions from the middle of the country, referred to with disdain as “flyover country.” In our experience, the assumptions of the superiority of the coastal courts and the inferiority of landlocked courts are unwarranted. Courts on the coasts can and do get it wrong. If you want proof, just take a look at Conte, from a California appellate court, which is so wrong it has its own category on our blog. Or look at our many posts on decisions from the coastal state of New Jersey, at one time a judicial hellhole, although recent New Jersey decisions have been better. And courts in the middle of the country often get it exactly right. A good example is Tortorelli v. Mercy Health Center, Inc., 2010 Okla. Civ. App. LEXIS 84 (Okla. Civ. App. June 4, 2010), which was decided in June but only recently released for publication.
The plaintiff had surgery to remove a bone tumor from her leg. To repair the leg bone, her doctor used a tibial nail, a bolt, bone cement, and Dynagraft allograft bone putty. “Allograft” means it was made from another person’s tissues, specifically demineralized bone tissue obtained from an accredited tissue bank. Putty made from ground up human bones probably is better for bone repair than Spackle.
Plaintiff had pain and swelling after the surgery and eventually was diagnosed with reflex sympathetic dystrophy disease as a result of an allergic reaction to the bone putty. She brought a medical malpractice claim against her doctors and product liability claims against IsoTis, which made the bone putty. The trial judge dismissed the product liability claims on summary judgment, and the jury ruled in favor of the medical malpractice defendants.
On appeal, plaintiff argued that the warnings were inadequate. But the warnings specifically advised about the possibility of an antigenic reaction to bone putty, and the treating doctor said that she was aware of this risk. So plaintiff seized upon a statement in the package insert that “[t]he reaction of the body to any allograft is not completely understood.” Plaintiff tried to create a factual issue by presenting the testimony of a biomedical research scientist that those reactions are understood at a cellular level and offering statements from the treating doctor about her own understanding. The court properly concluded that this issue was “a red herring,” as “[t]he material fact at issue was whether the proximate cause of Plaintiff’s injury, here an antigenic reaction to the bone putty, was a risk disclosed to Dr. Smith. It was.” 2010 Okla. Civ. App. LEXIS 84 at **18.
Plaintiff then tried to argue that the defendant should have done more testing, without which the product supposedly was unreasonably dangerous, and that the treating doctor did not understand everything about the putty. The court saw through this nonsense:
This argument demonstrates a misconception about the learned intermediary doctrine. A major underlying assumption of the learned intermediary doctrine is that a product has properties rendering it dangerous so as to require a doctor’s prescription or order for its use. Argument about the particulars of the manufacturing process are not relevant when applying the learned intermediary doctrine. IsoTis’s duty as a manufacturer under this doctrine was not to provide an in-depth education to trained physicians in the underlying biochemistry in bone putty production but to identify and warn of risks.
Id. at **18-19.
We commend the Oklahoma Court of Civil Appeals for its clear-eyed focus on what’s really at issue. For any product, there is an endless amount of information that is not included the label, from the country of origin of each ingredient to the color of the machines used to make it. A manufacturer’s duty is not to tell learned intermediaries every known fact about the product or how to practice medicine, but only to warn about significant risks posed by the product. A plaintiff cannot recover if the manufacturer provided sufficient information about the risk that proximately caused the plaintiff’s injury. When that happens, as the court found it did in Tortorelli, the case is properly thrown out on summary judgment. Id. at **19.