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News: The male patient fell from a ladder and suffered multiple non-displaced rib fractures, among other injuries. He was admitted to a hospital. While there, he experienced severe chest pain, despite receiving oral pain medication. The physicians requested a consult from a thoracic surgeon who performs a procedure known as the "On-Q procedure." That procedure involves insertion of a catheter to provide continuous analgesic to surrounding tissue and nerves, thus relieving pain associated with the rib fracture. The surgeon discussed the procedure with the patient. However, the surgeon failed to advise the patient that the surgeon had a financial interest in the procedure based on a contract with the On-Q’s manufacturer, and the surgeon never gave the patient the option to receive an epidural rather than undergo the On-Q procedure. The patient underwent the procedure, but he suffered from complications that required significant additional time in the hospital and several more surgeries. The patient brought suit against the surgeon and hospital, and he claimed that both parties were negligent. The defendants denied any wrongdoing. The jury found both liable and awarded $4.4 million in damages.
Background: The patient was an otherwise healthy adult who fell from a ladder in December 2009. He suffered multiple non-displaced rib fractures as well as other injuries, and he sought treatment at a nearby hospital. The patient suffered from severe chest pain despite having received an oral pain medication. The physicians requested a consult from a thoracic surgeon associated with the hospital who performs a special pain-relief procedure known as the "On-Q procedure." This procedure involves the insertion of a 5 inch long catheter, which contains several holes, under the patient’s skin and over the ribs using a metal tunneling device. After the catheter is in place, a liquid analgesic runs through it and soaks the surrounding tissue and nerves. This process allows for continuous distribution of the analgesic and allows relief from pain associated with the rib fracture. The On-Q procedure has not been approved by the Food and Drug Administration (FDA) and is thus an "off-label" use on the On-Q catheter.
During the consult, the surgeon discussed the procedure with the patient, including the aim of pain relief and risks of bleeding, infection, and injury to adjacent organs or tissues. The surgeon also discussed alternatives. During trial, he testified that he normally informed patients that epidural anesthesia was a very effective alternative, but it was not an option because it has risks and limitations. The patient was not given the choice of having epidural anesthesia. Furthermore, the surgeon failed to disclose his own personal financial interest in the On-Q procedure. Two years prior, the surgeon entered into a contract with the On-Q’s manufacturer to give presentations and promote the procedure. The surgeon performance of the procedure increased significantly, and he received approval from the hospital to study the procedure. The patient agreed to and underwent the procedure, but difficulties quickly followed. The day after insertion, the patient inadvertently removed the catheters, which necessitated the insertion of two new catheters. One of these subsequent catheters became displaced and perforated the patient’s internal organs, and the patient underwent several surgeries to remove the catheter and repair the organ damage.
The patient brought suit against the surgeon and hospital. He alleged multiple bases for negligence. One was that he claimed the surgeon failed to obtain informed consent and negligently performed the procedure. He claimed that the hospital was liable because the surgeon was its agent, along with the hospital’s negligent management of the surgeon’s On-Q study and negligent "expedited review" of the surgeon’s application to conduct the study. Following an eight-day trial, the jury returned a verdict for the plaintiff and awarded $3.75 million in damages to the plaintiff plus $650,000 to the plaintiff’s wife for loss of consortium. The jury found the surgeon and hospital liable, and it apportioned 65% liability to the surgeon and 35% to the hospital. Upon appeal, the state’s supreme court affirmed the judgment.
What this means to you: Several important issues arise from this case, which is consistent with the number of bases upon which the plaintiff alleged negligence. The first claim addressed by the court, and one of great importance to all physicians and hospitals, was the lack of informed consent. In general, physicians must fully inform their patients about the risks involved in any proposed procedure or treatment and possible alternatives to the procedure. Different jurisdictions might articulate the rule slightly differently, but the overall theme is the same: Physicians who fail to disclose important information to patients who are deciding about procedures may be found negligent for that failure. In this case, Delaware had a statute defining "informed consent" that required the healthcare provider to inform the patient in a "reasonably comprehensible to general lay understanding" of information regarding the nature and risks, as well as alternatives, to the treatment that a reasonable patient would consider "material" to the decision. This provision of course leaves room for debate regarding whether something is "material," but physicians and hospitals can err on the side of caution and prevent any debate by informing patients in the first place. The court here found that the failure to inform about alternatives and the surgeon’s relationship with the manufacturer were relevant. The court found that this information was particularly relevant because, since the surgeon was earning money from the On-Q procedure, he had a "strong incentive to play down the risks of the On-Q procedure and play up the problems with alternative treatments." It is important to note that this law does not preclude physicians and hospitals from having a financial interest in treatments or procedures, but if such is the case, patients must be informed of this fact to satisfy informed consent.
Physicians often can be seduced by private companies to use their product or drug on patients without ensuring that these are FDA-approved to treat the issue at hand or that, if not, the hospital medical staff and/or pharmacy leaders have approved the off-label use. Any time a product or drug is used in a study, regardless of by whom, the hospital or regional institutional review board has absolute oversight. A physician or principal investigator may ask for an expedited approval from the institutional review board (IRB), but it should not be approved if it involves a device or drug not FDA-approved for use on a patient. Hospital IRBs should not be pressured by physicians to push through expedited approvals. Finally, any patient or subject participating must be asked to sign an IRB-approved informed consent form, which by law requires that all elements of informed consent be present along with additional elements related to being part of a research study. This process is above and beyond the usual informed consent a patient is given for more routine procedures, and it can go a long way toward protecting physicians and hospitals involved in disputes regarding informed consent should the issue arise later. Without going through appropriate research study protocols, there exists the possibility of kickback law violations as well.
Another important issue raised by this case is the different treatment that expert witnesses and fact witnesses receive by courts. Expert witnesses play an extremely important role for plaintiffs and defense in medical malpractice cases, as the knowledge required is typically beyond that which a layperson knows. Such scientific, technical, or otherwise specialized knowledge may be presented only by expert witnesses who have been qualified as such by the court prior to giving their expert opinion. This qualification process can be quite involved and include days of hearings to determine the expert’s qualifications and reliability, so the complete scope goes beyond the purview of this article. However, of importance here is the fact that the trial court did not allow the defense’s "fact witnesses" to opine on the fact that the procedure was "experimental" in nature, while it allowed the plaintiff’s expert witnesses to testify about this fact as they possessed "specialized knowledge about what treatments for rib fracture pain were generally accepted in the medical community and what treatments were not." Choosing experts thus plays a critical role in litigation because if the court finds your "experts" are not properly qualified, this decision can be a death knell for your case without the experts’ required testimony regarding medical subject matters.
Supreme Court of Delaware, DE. Case No. N11C-06-092 MJB. Aug. 7,