Off-Label Use of Drugs and Devices: Defending the Physician

Physicians who wish to minimize their potential liability for off-label prescriptions of drugs and devices have several tools they may use to position themselves favorably in the event of future litigation. Using these “best practices” will go a long way in helping their defense.

Insulating the Physician from Liability

First, physicians should recognize that they have a general obligation to stay abreast of the latest developments in their field through regular review of relevant medical literature and continuing medical education. In addition, “physicians prescribing a drug or device off-label have a responsibility to be well-informed about the [particular] drug or device.” Richardson, 44 S.W. 3d at 15. To the extent the physician learns of potential off-label uses through his or her review of literature or attendance at seminars and conferences, retaining the specific materials about that off-label use will be helpful to show that the decision to use the drug or device in an off-label manner was supported by authoritative studies and the experience of other practitioners. See Bax Global Inc. v. Brenneman, 2007 Ohio 695 (Ohio Ct. App. 2007) (finding that use of a spinal implant at a location for which it was not specifically approved in the United States was not experimental, because there was literature related to use in Europe to support the safety and effectiveness of the off-label use.)

In addition, where the physician can point to patient-specific reasons for opting to employ a drug or device in an off-label manner, such evidence will be powerfully persuasive to judge and jury. If the approved treatment options would carry a higher morbidity or mortality risk or be more difficult or painful for the particular patient than the unapproved use, or if the patient has experienced success with a similar treatment in the past, this information should be charted by the physician. Charting these sorts of considerations and discussing them with the patient when deciding what treatment to attempt will help the physician demonstrate in future litigation that there were unique patient circumstances that justified the decision to employ the off-label use, based upon what was known at the time.

Physicians may also protect themselves through the careful charting of informed consent counseling discussions. Charting should include detailed documentation of the reasons relayed to the patient why he or she is a good candidate for the off-label use, such as similarity in presentation or history to a patient who had a good outcome with the use in the past, or the patient's inability to tolerate or respond to approved treatment options. Having such information clearly documented in the medical records before the off-label use occurs will bolster the physician's case that his or her medical judgment to use the drug or device off-label was appropriate under the circumstances. Ideally, charting should include not only patient-specific factors that led to the choice of the off-label use, but documentation of the discussions with the patient about the proposed use, including any patient questions; documentation of the medical literature; opinions of colleagues; or other bases for the physician's judgment that the off-label use is safe to attempt in this patient.

Finally, while there is no legal requirement to do so in most states, a physician may choose to inform a patient that a proposed treatment is not approved by the FDA. At the same time, the physician may inform the patient of the reasons why the physician believes he or she is an appropriate candidate and the data or information the physician has that indicates this treatment could be safe and effective despite its lack of FDA approval. Choosing to provide such information to the patient before she consents to the procedure and charting it in the medical records will ensure the patient cannot later argue that had she known the drug or device was not approved for the manner utilized, she would never have consented to its use. However, this approach may not be practical in all circumstances, such as the use of drugs or devices in emergent situations or where the patient is incapacitated, or situations where a physician is adjusting a particular dosage or drug combination numerous times in a search for the right option for a particular patient.

Defending Malpractice Claims Premised on
Off-Label Uses

Physicians should know, first and foremost, that the mere fact that they used a drug or device in an off-label manner does not establish a legal presumption that the physician was negligent per se, or failed to comport with the applicable standard of care. While many patients and even some uninformed plaintiffs' attorneys may believe that off-label treatment equals an airtight case of malpractice, they are incorrect; and as we have demonstrated the issue is often far more complex. There are numerous tools that physicians defending malpractice claims premised on off-label uses have at their disposal to defeat such arguments.

First, as noted above, most states do not recognize a duty to inform a patient that a drug or device is not approved prior to prescribing that drug or device. See Section IV, supra. An early dispositive motion on the grounds of absence of duty may be successful in jurisdictions with strong appellate law establishing this point. Even where no such law exists, the defense should consider making this an issue of first impression given the strong weight of case law in other courts.

In addition, counsel for the physician should consider arguing that the FDA-approved labeling for the drug or device should not be admissible at trial in any manner whatsoever ' or, at minimum, should not be admissible for the purpose of establishing the standard of care. The plaintiff undoubtedly will seek to admit the FDA-approved labeling into evidence, likely through the Physician's Desk Reference (“PDR”), and thereby attempt to establish that the drug or device should only have been used in strict accordance with the limitations described in the labeling. “Virtually every court addressing this question has concluded that the drug's labeling and PDR reference are relevant to the standard of care issue.” Richardson v. Miller, 44 S.W.3d at 15. However, most courts have also held that the labeling or PDR entry for a drug or device is only admissible where the plaintiff introduces expert testimony regarding the standard of care for use of that drug or device. Id. Filing motions to exclude the plaintiff's expert witnesses may permit the physician defendant to keep the label out of the case entirely, if the plaintiff cannot put forth any competent expert to testify as to the standard of care for use of the drug or device at issue.

Even where the plaintiff meets the burden of putting forth expert testimony about the standard of care for use of the drug or device, the physician should attempt to keep the approved labeling out of the case. The physician should argue that the labeling is not relevant to determining the applicable standard of care, and that admitting the labeling into evidence may pose a substantial risk of jury prejudice and confusion. Mark Hermann and Parson Bownas, Keeping the Label out of the Case, Northwestern L. Rev. Colloquy (2009) (http://colloquy.law.northwestern.edu/main/author-bownas-pearson). Because the standard of care changes more rapidly than the approved indications for a particular drug or device, and because the PDR and numerous federal regulations state that FDA-approved labeling is not meant to establish the standard of care, physician defendants have a strong argument that the standard of care can be determined by the jury without reference to the labeling at all. Id. In addition, as demonstrated by the lack of awareness among the general public as to the frequency of off-label uses, it is very easy for jurors to mistakenly believe that lack of approval of a particular use is definitive evidence of negligence. Id.; see also Section II, supra.

Where the malpractice claim has been included in a lawsuit alleging product liability against the drug or device manufacturer for failure to warn, the physician may be tempted to argue that, if only he or she had been warned by the manufacturer not to attempt the specific off-label use, the alleged harm could have been prevented. This instinctual response will generally prove unhelpful to both the physician and the manufacturer. The physician cannot abdicate his responsibility for the decision in his medical judgment to utilize the product in an off-label manner, or his responsibility to fully educate himself regarding the risks and benefits of that use before deciding to employ it in a patient. Careful documentation of the reasons why the physician chose the off-label use for each specific patient, and documentation of the information and evidence supporting his belief in the safety and effectiveness of the off-label use, will be more effective in bolstering the medical judgment employed.

Conclusion

The rate of off-label uses of drugs and devices continues to climb, and the approval process for drugs and devices continues to become evermore cumbersome, expensive and lengthy. Thus, to some extent. increasing litigation involving off-label uses is inevitable and unavoidable. However, most courts continue to recognize the merits of allowing physicians to have off-label uses of approved drugs and devices as weapons in their arsenal of treatment, and continue to reject most legal challenges to the decision to prescribe off-label. Physicians who carefully document their reasons for employing particular off-label uses and of their counseling of patients regarding the risks associated with each off-label prescription will have strong evidence in their favor in the event litigation does unfortunately occur.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder with Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by the National Law Journal as one of “The 50 Most Influential Women Lawyers in America” and “Top 40 Under 40.” Sara K. Thompson is of counsel with Greenberg Traurig, LLP and focuses her practice on pharmaceutical and medical device products liability litigation, as well as medical malpractice litigation.

Physicians who wish to minimize their potential liability for off-label prescriptions of drugs and devices have several tools they may use to position themselves favorably in the event of future litigation. Using these “best practices” will go a long way in helping their defense.

Insulating the Physician from Liability

First, physicians should recognize that they have a general obligation to stay abreast of the latest developments in their field through regular review of relevant medical literature and continuing medical education. In addition, “physicians prescribing a drug or device off-label have a responsibility to be well-informed about the [particular] drug or device.” Richardson, 44 S.W. 3d at 15. To the extent the physician learns of potential off-label uses through his or her review of literature or attendance at seminars and conferences, retaining the specific materials about that off-label use will be helpful to show that the decision to use the drug or device in an off-label manner was supported by authoritative studies and the experience of other practitioners. See Bax Global Inc. v. Brenneman , 2007 Ohio 695 (Ohio Ct. App. 2007) (finding that use of a spinal implant at a location for which it was not specifically approved in the United States was not experimental, because there was literature related to use in Europe to support the safety and effectiveness of the off-label use.)

In addition, where the physician can point to patient-specific reasons for opting to employ a drug or device in an off-label manner, such evidence will be powerfully persuasive to judge and jury. If the approved treatment options would carry a higher morbidity or mortality risk or be more difficult or painful for the particular patient than the unapproved use, or if the patient has experienced success with a similar treatment in the past, this information should be charted by the physician. Charting these sorts of considerations and discussing them with the patient when deciding what treatment to attempt will help the physician demonstrate in future litigation that there were unique patient circumstances that justified the decision to employ the off-label use, based upon what was known at the time.

Physicians may also protect themselves through the careful charting of informed consent counseling discussions. Charting should include detailed documentation of the reasons relayed to the patient why he or she is a good candidate for the off-label use, such as similarity in presentation or history to a patient who had a good outcome with the use in the past, or the patient's inability to tolerate or respond to approved treatment options. Having such information clearly documented in the medical records before the off-label use occurs will bolster the physician's case that his or her medical judgment to use the drug or device off-label was appropriate under the circumstances. Ideally, charting should include not only patient-specific factors that led to the choice of the off-label use, but documentation of the discussions with the patient about the proposed use, including any patient questions; documentation of the medical literature; opinions of colleagues; or other bases for the physician's judgment that the off-label use is safe to attempt in this patient.

Finally, while there is no legal requirement to do so in most states, a physician may choose to inform a patient that a proposed treatment is not approved by the FDA. At the same time, the physician may inform the patient of the reasons why the physician believes he or she is an appropriate candidate and the data or information the physician has that indicates this treatment could be safe and effective despite its lack of FDA approval. Choosing to provide such information to the patient before she consents to the procedure and charting it in the medical records will ensure the patient cannot later argue that had she known the drug or device was not approved for the manner utilized, she would never have consented to its use. However, this approach may not be practical in all circumstances, such as the use of drugs or devices in emergent situations or where the patient is incapacitated, or situations where a physician is adjusting a particular dosage or drug combination numerous times in a search for the right option for a particular patient.

Defending Malpractice Claims Premised on
Off-Label Uses

Physicians should know, first and foremost, that the mere fact that they used a drug or device in an off-label manner does not establish a legal presumption that the physician was negligent per se, or failed to comport with the applicable standard of care. While many patients and even some uninformed plaintiffs' attorneys may believe that off-label treatment equals an airtight case of malpractice, they are incorrect; and as we have demonstrated the issue is often far more complex. There are numerous tools that physicians defending malpractice claims premised on off-label uses have at their disposal to defeat such arguments.

First, as noted above, most states do not recognize a duty to inform a patient that a drug or device is not approved prior to prescribing that drug or device. See Section IV, supra. An early dispositive motion on the grounds of absence of duty may be successful in jurisdictions with strong appellate law establishing this point. Even where no such law exists, the defense should consider making this an issue of first impression given the strong weight of case law in other courts.

In addition, counsel for the physician should consider arguing that the FDA-approved labeling for the drug or device should not be admissible at trial in any manner whatsoever ' or, at minimum, should not be admissible for the purpose of establishing the standard of care. The plaintiff undoubtedly will seek to admit the FDA-approved labeling into evidence, likely through the Physician's Desk Reference (“PDR”), and thereby attempt to establish that the drug or device should only have been used in strict accordance with the limitations described in the labeling. “Virtually every court addressing this question has concluded that the drug's labeling and PDR reference are relevant to the standard of care issue.” Richardson v. Miller , 44 S.W.3d at 15. However, most courts have also held that the labeling or PDR entry for a drug or device is only admissible where the plaintiff introduces expert testimony regarding the standard of care for use of that drug or device. Id. Filing motions to exclude the plaintiff's expert witnesses may permit the physician defendant to keep the label out of the case entirely, if the plaintiff cannot put forth any competent expert to testify as to the standard of care for use of the drug or device at issue.

Even where the plaintiff meets the burden of putting forth expert testimony about the standard of care for use of the drug or device, the physician should attempt to keep the approved labeling out of the case. The physician should argue that the labeling is not relevant to determining the applicable standard of care, and that admitting the labeling into evidence may pose a substantial risk of jury prejudice and confusion. Mark Hermann and Parson Bownas, Keeping the Label out of the Case, Northwestern L. Rev. Colloquy (2009) (http://colloquy.law.northwestern.edu/main/author-bownas-pearson). Because the standard of care changes more rapidly than the approved indications for a particular drug or device, and because the PDR and numerous federal regulations state that FDA-approved labeling is not meant to establish the standard of care, physician defendants have a strong argument that the standard of care can be determined by the jury without reference to the labeling at all. Id. In addition, as demonstrated by the lack of awareness among the general public as to the frequency of off-label uses, it is very easy for jurors to mistakenly believe that lack of approval of a particular use is definitive evidence of negligence. Id.; see also Section II, supra.

Where the malpractice claim has been included in a lawsuit alleging product liability against the drug or device manufacturer for failure to warn, the physician may be tempted to argue that, if only he or she had been warned by the manufacturer not to attempt the specific off-label use, the alleged harm could have been prevented. This instinctual response will generally prove unhelpful to both the physician and the manufacturer. The physician cannot abdicate his responsibility for the decision in his medical judgment to utilize the product in an off-label manner, or his responsibility to fully educate himself regarding the risks and benefits of that use before deciding to employ it in a patient. Careful documentation of the reasons why the physician chose the off-label use for each specific patient, and documentation of the information and evidence supporting his belief in the safety and effectiveness of the off-label use, will be more effective in bolstering the medical judgment employed.

Conclusion

The rate of off-label uses of drugs and devices continues to climb, and the approval process for drugs and devices continues to become evermore cumbersome, expensive and lengthy. Thus, to some extent. increasing litigation involving off-label uses is inevitable and unavoidable. However, most courts continue to recognize the merits of allowing physicians to have off-label uses of approved drugs and devices as weapons in their arsenal of treatment, and continue to reject most legal challenges to the decision to prescribe off-label. Physicians who carefully document their reasons for employing particular off-label uses and of their counseling of patients regarding the risks associated with each off-label prescription will have strong evidence in their favor in the event litigation does unfortunately occur.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder with Greenberg Traurig, LLP. She focuses on litigation and trial work for the pharmaceutical and medical device industries, products liability, and medical malpractice. She has been recognized by the National Law Journal as one of “The 50 Most Influential Women Lawyers in America” and “Top 40 Under 40.” Sara K. Thompson is of counsel with Greenberg Traurig, LLP and focuses her practice on pharmaceutical and medical device products liability litigation, as well as medical malpractice litigation.