Opinion ID: 1911822
Heading Depth: 1
Heading Rank: 8

Heading: Negligent Treatment and Manufacturer-Instruction Exception

Text: The Thones next argue that expert testimony is unnecessary to set the standard of care for their claims that appellees were negligent in treating and diagnosing Collette's complications. The Thones contend that compliance with an instruction manual supplied by BioEnterics, the alleged manufacturer of Collette's gastric band, is itself the proper standard of care for diagnosing and treating complications related to the band. In making this argument, the Thones invoke what might, for the sake of convenience, be called the manufacturer-instruction exception to expert testimony. On the theory that reasonable physicians do not deviate from instructions supplied by the manufacturers of drugs or devices, a number of courts hold that even without expert testimony indicating whether the instructions set the standard of care, a physician's failure to follow those instructions is prima facie evidence of negligence. [17] A minority of courts reject the idea that a manufacturer's instruction constitutes prima facie evidence of the standard of care. Instead, these courts hold that when unaccompanied by expert testimony, a manufacturer's instructions provide only `some evidence' of the standard. [18] Because the Thones cannot avoid summary judgment unless they make out a prima facie case of medical malpractice, [19] the difference between these two views is significant in this case. We need not choose between these views here, however, because we conclude that the BioEnterics manual is not sufficient to trigger the manufacturer-instruction exception. Our conclusion is predicated on the fact that cases applying the manufacturer-instruction exception involved either a physician's alleged failure to follow instructions for the use of drugs [20] or a medical attendant's failure to follow specific operating instructions for basic medical instruments such as an electrosurgical mole remover, [21] a heating pad, [22] and a wound stapler. [23] In contrast, the Thones' allegations  and the instructions in the BioEnterics manual  primarily relate to diagnosing and treating complications involving the gastric band. The Louisiana Court of Appeal was presented with a similar situation in Vinson v. Salmon. [24] There, a burn victim claimed that compliance with an article in a medical journal describing the proper treatment for burns was the standard of care under a Louisiana case applying the manufacturer-instruction exception. The court disagreed: The Terrebonne [25] case involved the specific timing of a drug dosage. In contrast, the present matter involves more complex medical issues, including the appropriateness of the diagnosis and treatment provided by [the treating physician]. Thus, the cited case is not persuasive support of plaintiff's position. [26] Like the Louisiana Court of Appeal, we recognize that treating and diagnosing a patient involves a multitude of variables and extrinsic considerations which make such activities highly complex. This suggests that a physician's decisions regarding treatment and diagnosis should not be scrutinized according to a rigid set of black-letter instructions. We therefore conclude that without expert testimony, the BioEnterics manual has no bearing on the standard of care governing appellees' decisions about how to diagnose and treat Thone's ailments. The Thones also rely on the manufacturer-instruction exception for their claim that appellees were negligent in failing to convey the BioEnterics manual's warnings about the dangers of using nonsteroidal anti-inflammatory drugs (NSAIDs) after the band was installed. The manual specifically indicates that such drugs ought to be used with caution because they can increase the risk that the stomach lining around the device will erode. Collette was using a prescription anti-inflammatory when she had the device installed and claims appellees knew this yet never warned her about the dangers of such use. However, the rationale behind the manufacturer-instruction exception is that a reasonable physician would not violate a manufacturer's specific instructions when using a drug or device. Even if we were to agree that the manufacturer-instruction exception should apply in the context of patient counseling, we note that the BioEnterics manual does not specifically instruct physicians to warn patients about the risks of combining NSAIDs with gastric bands. In fact, the manual does not even instruct physicians to discontinue use of such medications; it simply advises that they be used cautiously. As a result, no reasonable argument can be made that appellees violated an explicit instruction in the BioEnterics manual by not advising Collette of the dangers of continuing to use NSAIDs. In sum, the lack of expert testimony does not preclude the Thones from proving the standard of care with respect to their claim that appellees were negligent in waiting 5 days to treat Collette. Pursuant to the common-knowledge exception, a layperson can infer that a reasonable physician would not wait 5 days before rendering aid to a patient in Collette's condition. However, the BioEnterics manual does not trigger the manufacturer-instruction exception in this case. As such, the lack of expert testimony proves fatal to the Thones' claims that appellees committed negligence by deviating from the instructions set forth in the BioEnterics manual when attending to Collette's ailments. We therefore turn to a discussion of the other two elements of a prima facie case of medical malpractice as they relate to the Thones' delay-of-treatment claim.