On Record About Off-Label Usages
A Few Legal Basics on the Off-Label Use of Drugs, Medical Devices, and Medical Systems in New York and New Jersey
A doctor’s patients are not guinea pigs on whom new, novel, or experimental treatments are to be undertaken with regularity and impunity. However, it is widely recognized and accepted that many potential avenues for treating patients involve the use of prescription medications, medical devices, and medical systems beyond what they were approved for by the Food and Drug Administration, i.e., “off-label.” See, e.g., Sita v. Long Island Jewish-Hillside Med. Ctr., 22 A.D.3d 743 (2d Dep’t 2005) (holding that although the marketing and promotion for certain medical system was not FDA approved for the purpose for which it was used, it did not prevent a physician from using it in an “off-label” manner); Blazoski v. Cook, 787 A.2d 910, 918 (N.J. Super. Ct., App. Div. 2002). So what should a New York or New Jersey practitioner know about the potential legal and regulatory implications of engaging in the off-label usage of medications, medical devices, and medical systems? A few basics follow.
Mere Off-Label Usage is not, in and of Itself, Malpractice in New York or New Jersey
The use of a given medication, device, or system in an “off-label” manner may nonetheless be considered the standard of care in the medical community. Sita, 22 A.D.3d at 743-44. Indeed, it is expressly recognized in New Jersey that “the Physician’s Desk Reference…approved by the FDA, does not in itself establish a medical standard of care, in part because ‘[s]uch an approach…would be inconsistent with the FDA’s position that physicians are not bound by PDR recommendations.” Blazoski, 787 A.2d at 919 (internal citation omitted). Moreover, “physicians have the right, exercising reasonable medical judgment, to use [drugs, devices, and systems] for off-label purposes that are not FDA approved, provided that the FDA has approved the [same] for some other purpose.” Id. at 920. Accordingly, while off-label uses themselves do not give rise to a malpractice claim, “a physician who engages in off-label uses has the responsibility to be well informed about the [drug, device, or system], and base the decision to use it on sound medical evidence[.]” Id. (quoting Femrite v. Abbott Northwestern Hosp., 568 N.W.2d 535, 542 (Minn. Ct. App. 1997) (internal citation omitted)). New Jersey further expressly recognizes the importance of the off-label use of prescription drugs, as reflected in N.J.S.A. 26:1A-36.9 (“Findings, declarations, ‘off-label drugs’”), “by stating that to require all appropriate uses of a drug to undergo approval by the FDA may deny patients the ability to obtain medically effective treatment.” Blazoski, 787 A.D.2d at 922, Note 4.
New York recognizes that “[t]he FDA cannot establish the standard of care for the practice of medicine and the use of medical devices for purposes other than those for which they have been approved, i.e., ‘off-label’ uses.” Brown v. Speaker, 2007 N.Y. Slip Op. 31069U (S. Ct. New York Cty. 2007) (citing 21 U.S.C. § 396; Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 350 (2001)) (further noting that “[t]he standard of care is one established by the profession itself”). Accordingly, “[a] different standard of care is not implicit in Education Law § 6527(4)(e), which permits ‘[t]he physician’s use of whatever medical care, conventional or unconventional, which effectively treats human disease, pain, injury, deformity or physical condition,’ or in a patient’s acceptance of non-conventional therapies, which, by itself, does not constitute an express assumption of risk.” Gray v. Gonzalez, 290 A.D.2d 292, 293 (1st Dep’t 2002) (internal citations omitted). The bottom line is that “[t]he standard for proving negligence in a malpractice case is whether the treatment deviates from accepted medical standards.” Charell v. Gonzalez, 660 N.Y.S.2d 1997 (S. Ct. New York Cty. 1997). Thus, if a doctor cannot live up to his or her responsibility in accordance with the applicable standard of care, that is when liability for malpractice can be found whether a given injury arises from an off-label usage or not. See also, e.g., Baron v. Pfizer, Inc., 42 A.D.2d 627, 629 (3d Dep’t 2007) (finding that a plaintiff’s claim that “off-label prescription of Neurontin was potentially dangerous…asserts a claim that is merely speculative”).
New York’s Express Assumption of Risk Defense
It is recognized in New York that “”[e]xpress assumption [of risk], which … preclude[s] any recovery, result[s] from agreement in advance that defendant need not use reasonable care for the benefit of plaintiff and would not be liable for the consequence of conduct that would otherwise be negligent.” Arbegast v. Board of Educ., 65 N.Y.2d 161, 169, 490 N.Y.S.2d 751, 757, 480 N.E.2d 365, 371 (1985). “Express assumption of risk is a total bar to recovery.” Boyle v. Revici, 961 F.2d 1060, 1063 (2d Cir. 1992) (quoting Arbegast, 65 N.Y.2d at 169). Accordingly, in the event that a physician is sued for medical malpractice in connection with an off-label usage, an affirmative defense of the express assumption of risk is available in the event that the accused can document that the express risks, benefits, and alternatives of a given off-label usage were discussed with a patient who then agreed to go forward with same despite the fact that the usage might fall outside of accepted medical standards.
New Jersey Has Rejected Product Liability Claims for Mere Off-Label Usages of Medical Devices
The United States District Court for the District of New Jersey recently reiterated the Garden State’s disallowance of utilizing a products liability claim for the off-label use of a medical device “as a second attempt at a negligence claim against a physician, without having to demonstrate the standard of care.” Mendez v. Shah, Civil Action No. 13-1585 (NLH/JS) (D. N.J. March 3, 2016) (quoting Seavey v. Globus Med., Inc., No. 11-2240, 2014 WL 1876957 (D. N.J. March 11, 2014)). The Seavey court, as adopted by the Mendez court, went on to state that:
“To allow such a cause of action to proceed would be to dispense with the expert testimony requirement for both medical negligence and informed consent claims by allowing an analogous claim to proceed in the guise of a product liability cause of action. Further, the [New Jersey Products Liability Act] is a strict liability statute…To allow a product liability claim against a surgeon to proceed past summary judgment based on off-label usage would allow litigants to hold physicians strictly liable for harm resulting from any off-label use of a device, which would be in contravention of established New Jersey law.” 2014 WL 1876957, at *19 (citing Blazoski, 787 A.2d 910 (App. Div. 2002)).
Accordingly, New Jersey plaintiffs are largely unable to assert products liability claims as part of a larger medical malpractice lawsuit unless it can be separately alleged that the product itself that was used in an off-label manner was defective.
Medicaid and Off-Label Usages
Under federal law, “[w]hether a drug is FDA-approved for a particular use will largely determine whether a prescription for that use of the drug will be reimbursed under the federal Medicaid program.” United States v. Parke-Davis, 147 F. Supp.2d 39, 44 (D. Mass. 2001). “Reimbursement under Medicaid is, in most circumstances, available only for ‘covered outpatient drugs,’” which do not include drugs that are ‘used for a medical indication which is not a medically accepted indication’ unless included in a specified drug summary, in accordance with 42 U.S.C. § 1396. Id. at 45 (internal citations omitted). In the absence of any such summary, a prescription for the off-label use of a drug is not eligible for Medicaid reimbursement. Id. Therefore, the submission of an off-label prescription for reimbursement can constitute a false claim under the False Claims Act, 31 U.S.C. § 3729(a). Id. at 50.
Based on the above-summarized law, which by no means constitutes an exhaustive treatment on the topic, it is plain that New York and New Jersey regard the off-label usage of medications, devices, and systems as an accepted practice in the medical community subject to compliance with all applicable standards of care. Be cautioned, however, that to the extent that a given off-label usage has not been sufficiently researched, documented, or otherwise tested, a physician would be best advised to find another, more globally accepted, way to treat his or her patients. A standard of care in the medical community simply is not established by the undertakings of just a few outlying physicians who are effectively using their patients as guinea pigs.
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