As you know, TCJL is tracking legislation that explicitly creates a new private cause of action. But we are also on the lookout for bill that may implicitly create causes of action by imposing new or expanded legal duties. Nowhere is this more evident than in health care liability. We have already identified numerous bills that expand or may expand the liability exposure of physicians, hospitals, and other health care facilities and professionals. One such bill, SB 297 by Hall (R-Canton), caught our eye because it may inadvertently create a statutory basis for additional health care liability claims.
The bill proposes a statutory patient’s bill of rights to replace the current regulatory requirement embodied in 25 TAC § 133.42. Much of the bill simply codifies the rule’s requirements in statute. There are, however, some differences that may be problematic from a liability standpoint.
- The current rule provides that a patient has a right to “considerate and respectful care that accounts for the psychological, spiritual, and cultural variables that influence the perceptions of illness.” The proposed codification adds “without any bullying or shaming by hospital or medical staff.” This language appears to presume that such “bullying or shaming” occurs so regularly that the statute has name it. It’s hard to predict what legal effect this added language may have, but it does introduce a new fact issue into the equation of “considerate and respectful care.”
- The current rule does not say anything about a patient’s right to be treated by a physician of the patient’s choice, just that the patient has the right to collaborate with his or her physician in making decisions about the patient’s care. The bill specifies that the patient has the right to choose his or her physician “to the extent feasible.” This language would appear to authorize the patient’s choice to override a hospital’s policies and protocols regarding admitting and clinical privileges and create a heightened risk of liability exposure.
- The bill creates a new right to unrestricted visitation by at least one individual at any given time, even in a declared state of disaster. This one-size-fits-every-situation mandate has obvious liability implications, as well as raising safety questions for hospital staff and other patients.
- The bill creates a new patient right to use, “as prescribed by the patient’s physician of choice,” an FDA-approved drug for an off-label use or “a complementary or alternative medical treatment, regardless of the [FDA’s] approval of the treatment.” This strikes us as a liability disaster waiting to happen because it puts the hospital and staff in the impossible position of treating a patient with a seriously circumscribed power to exercise their own professional judgment about the best treatment options. They will also have to deal with the patient health consequences flowing from the use of “complementary or alternative medical treatments,” whatever those may be. How will a medical liability policy cover that type of situation? In addition to that, we wonder what the implications for pharmaceutical manufacturers the bill may have if hospital patients can take drugs for non-approved uses with few controls.
- The bill entitles a terminally ill patient to “access and use certain investigational drugs, biological products, and devices that are in clinical trials” in accordance with Chapter 489, Health and Safety Code. That statute makes a patient “eligible to access and use” such drugs, products, or devices,” but the bill appears to give the patient an absolute right to access and use them. Chapter 489 specifically states that it does not create a cause of action against a manufacturer or require a manufacturer to make available to the patient a drug, product, or device. Does the bill create a conflict between the two statutes? In other words, if a manufacturer has no duty to make an investigational drug available to an eligible patient, but the hospital’s duty is to provide such access, what happens if either the manufacturer declines to meet the patient’s request or the drug is unavailable for some other reason? Is the hospital liable? Is the manufacturer liable because the patient now has a statutory right of access to the drug?
- The bill establishes statutory administrative penalties that apply on a per violation per day basis.
There may be other unintended consequences of codification that we do not have the practical experience necessary to identify. It does seem to us that, at the very least, the bill should provide liability protections for hospitals and hospital staff in the event that an external agent not under the hospital’s control gets in the middle of the patient’s care. The bill should likewise provide that it does not create a cause of action against a hospital, hospital staff, or pharmaceutical manufacturer based on the violation of one or more of the duties imposed by the bill.
This bill offers a good example of a perfectly well-intentioned proposal that may nevertheless have potentially serious liability pitfalls. In the coming weeks and months, we will try to identify as many of these bills as we can. If you see something that we have missed or misread, please let us know.
