Friday, November 02, 2012

Off-Label Use And The Medical Standard Of Care


One of our posts earlier this week made the statement “Off-label use can be, in many circumstances, the standard of care.”  We didn’t cite anything for that proposition in that post, since its focus was elsewhere.  Later, one of us received an email from a reader (we assume on the other side – around 50 of our 924 Google subscribers are our opponents in court) noting that this statement didn’t have any support.

The implication, we suppose, was that it didn’t have any.  Well, that’s just not true, but apparently we have been remiss.  We haven’t addressed this point specifically in our five years online.  That changes today.  With a physician’s right to engage in off-label use under attack again, as exemplified by the absurd, overreaching, and downright dangerous (to the health of every person in the country) legal theory discussed in that post, it behooves us to put our citations where our mouths are – on the blog.

So here goes.

First of all, the general legality and value of off-label uses as part of medical practice is no longer in serious dispute.  That was settled by the Supreme Court in Buckman Co. v. Plaintiffs Legal Committee:  “[O]ff-label use is generally accepted” in medicine, and under the law, “[p]hysicians may prescribe drugs and devices for off-label uses.”  531 U.S. 341, 351 & n.5 (2001).  Numerous other courts have likewise confirmed the overall value and ubiquity of off-label use.  “Prescription drugs frequently have therapeutic uses other than their FDA-approved indications.”  In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 239 (3d Cir. 2012).  “[T]he fact that the FDA has not approved labeling of a drug for a particular use does not necessarily bear on those uses of the drug that are established within the medical and scientific community as medically appropriate.”  Weaver v. Reagen, 886 F.2d 194, 198 (8th Cir. 1989).  “The decision to prescribe such ‘off-label usage’ . . . is regarded as a professional judgment for the healthcare provider to make.”  Nightingale Home Healthcare, Inc. v. Anodyne Therapy, LLC, 589 F.3d 881, 884 (7th Cir. 2009) (applying Illinois law).  “[T]he lack of FDA approval of a drug or device for a particular use does not imply that using the drug or device for that use is either disapproved or improper.”  Richardson v. Miller, 44 S.W.3d 1, 12 (Tenn. App. 2000), appeal denied (Tenn. March 12, 2001).  Off-label use is “acceptable, and sometimes essential, clinical practice,” and is “an integral part of the modern practice of medicine.”  Id. at 13, 14.  “[O]ff-label use of many medical devices and drugs is an accepted medical practice.”  United States ex rel. George v. Boston Scientific Corp., ___ F. Supp.2d ___, 2012 WL 1038633, at *1 (S.D. Tex. March 27, 2012).  “Off-label prescribing of drugs is both legal and ethical.”  Bailey v. Wyeth, Inc., 37 A.3d 549, 576 (N.J. Super. Law Div. 2008), aff’d, 28 A.3d 1245 (N.J. Super. App. Div. 2011) (on the basis of lower court opinion), certif. denied, 48 A.3d 355 (N.J. 2012).  “[O]ff-label usage is not illegal or even disfavored under federal law.  Rather, it is an accepted and indeed valuable part of the practice of medicine.”  Riley v. Cordis Corp., 625 F. Supp.2d 769, 784 (D. Minn. 2009).  “[O]ff-label uses are presently an accepted aspect of a physician’s prescribing regimen.”  Washington Legal Foundation v. Friedman, 13 F. Supp.2d 51, 56 (D.D.C. 1998), vacated in part as moot, 202 F.3d 331 (D.C. Cir. 2000).

Even Judge Jack Weinstein, whom nobody can claim is any sort of pushover for pharmaceutical companies or for the defense bar generally, is in emphatic agreement on the value of off-label use:

It is generally agreed that off-label prescribing can benefit both individual patients and patient populations as clinical experience leads to the formation of hypotheses to be tested in structured clinical trials. . . .  The lack of an indication in the label should not be an issue, however, in the concerned physician’s managing of patients and prescribing a medication “off-label.”  Physicians and the community recognize that many drugs effective for a condition may not be labeled for that condition and may not have a strong body of evidence for or against their use.  When considering off-label prescribing, physicians depend on the patient-specific evidence they have available to them.

In re Zyprexa Products Liability Litigation, 253 F.R.D. 69, 112 (E.D.N.Y. 2008) (citations omitted) (Weinstein, J.), rev’d in part on other grounds, 620 F.3d 121 (2d Cir. 2010).

But what about standard of care?  Well, off-label use, as such, sure isn’t any sort of violation of the standard of care.  Not that plaintiffs haven’t tried that before.  But they haven’t done very well asserting off-label use as some sort of per se medical malpractice.  Such claims have failed, and rather miserably:

[T]he Court cannot agree with plaintiffs’ suggestion that an off-label prescription alone may violate [the prescriber’s] duty of care.  Off-label use is legal and generally accepted.  The federal Food, Drug and Cosmetic Act expressly disclaims any intent to regulate the practice of medicine. . . .  Plaintiffs have cited no case, and the Court is aware of none, suggesting off-label prescriptions breach any physician’s duty of care in Oklahoma.  These claims are utterly without basis in fact or law.

Wilhoit v. Boehringer Ingelheim Pharmaceuticals, Inc., 2009 WL 702007, at *3-4 (D. Minn. March 13, 2009) (citations omitted) (nominally applying Oklahoma law).

New uses for drugs are often discovered after FDA approves the package inserts that explain a drug’s approved uses.  Congress would have created havoc in the practice of medicine had it required physicians to follow the expensive and time-consuming procedure of obtaining FDA approval before putting drugs to new uses.

United States v. Algon Chemical, Inc., 879 F.2d 1154, 1163 (3d Cir. 1989).

As for the converse proposition – off-label use representing the medical standard of care – numerous cases, in a wide variety of contexts, have held that this or that off-label use was the standard of care.  We’ve blogged about one of them before, Layzer v. Leavitt, 770 F. Supp.2d 579 (S.D.N.Y. 2011).  Layzer involved Medicare coverage of an off-label use in a recurrent context, a rare disease where no on-label treatment existed because the tiny size of the market did not justify the cost of undertaking the sorts of studies the FDA requires to support a labeled indication.

Medicare denied coverage, because the particular off-label use didn’t fall within the government’s cubbyholes; it was neither on-label nor did it appear in of the specific compendia of compensable off-label uses.  The court held, as a matter of law, that the government’s position (including a regulation) about what was “medically accepted” was invalid.  770 F. Supp. At 587.  The compendia were simply examples, not limitations on how “medical acceptance” was determined..  Id.  The court credited forceful testimony by the plaintiffs’ physician that this use was required by the applicable standard of care:

[The prescriber] has warned that the medicine “is essential for my patient.  There is no substitute at this time.  Furthermore, if the medicine is stopped, even temporarily, it is likely that the remaining tumors will grow quickly and she will suffer grave consequences.  Other physicians have echoed the conclusion. . . .  Peer-reviewed medical literature has also recognized the unique and effective capacity of [this off-label use].

770 F. Supp.2d at 582.  Thus, under the standard in Layzer, any off-label use that a physician asserts is essential to patient care – and which has some support in outside literature – is medically accepted.

Quite a few other cases have reached similar holdings.  In an appeal from a medical disciplinary proceeding, the Missouri Supreme Court stated that “[t]here are many off-label uses of medicines that are generally accepted by the medical profession.”  State Board v. McDonagh, 123 S.W.3d 146, 162 (Mo. 2003).  The Pennsylvania Supreme Court, in refusing to add regulatory issues to informed consent, recognized that an off-label use “was considered to be the standard of care by the surgical community.”  Southard v. Temple University Hospital, 781 A.2d 101, 104 (Pa. 2001).  And here are a few more below the state supreme court level:

  • Gajewsky v. Ning, 997 So.2d 567, 570-71 (La. App. 2008) (affirming defense verdict in malpractice case based on testimony that off-label use was standard of care), writ denied, 998 So.2d 723 (La. 2009).
  • Sita v. Long Island Jewish-Hillside Medical Center, 803 N.Y.S.2d 112, 114 (N.Y. App. Div. 2005) (recognizing that an off-label use “was considered the standard of care in the medical community”).
  • King v. Danek Medical, Inc., 37 S.W.3d 429, 458 (Tenn. App. 2000) (finding that an off-label use was “recognized by the FDA as being the nationwide standard of care”).
  • Bailey, 37 A.3d at 558 (prescription drug product liability action; “[f]ollowing the accepted medical standard of care, physicians frequently prescribe drugs for off-label or unapproved uses”).
  • In re Zyprexa Products Liability Litigation, 671 F. Supp.2d 397, 415 (E.D.N.Y. 2009) (“[s]ome off-label uses of a prescription drug may be medically necessary”) (Judge Weinstein again).
  • In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *17 (D.N.J. July 10, 2009) (“[the d]rugs were as effective and sometimes more effective than available alternatives for treating many off-label conditions”).
  • United States v. Caronia, 576 F. Supp.2d 385, 393 (E.D.N.Y. 2008) (prosecution for off-label promotion; “[i]t is generally recognized (even by the FDA) that off-label prescriptions can constitute a medically recognized standard of care”), appeal perpetually pending, No. 09-5006 (2d Cir.).
  • Association of American Physicians & Surgeons, Inc. v. FDA, 226 F. Supp.2d 204, 206 (D.D.C. 2002) (administrative challenge to regulation; “[o]ff-label use of pharmaceuticals appears to be ‘generally accepted’ in the medical community”).
  • Conger v. Danek Medical, Inc., 27 F. Supp.2d 717, 720 (N.D. Tex. 1998) (“off-label use is appropriate, rational, and accepted medical practice and can be of great value”).
  • Baron v. Pfizer, Inc., 2006 WL 1623052, at *3 (N.Y. Sup. May 2, 2006) (off-label use “is widespread in the medical community, and often is essential to giving patients optimal medical care”) (in table at 820 N.Y.S.2d 841) (citation and quotation marks omitted), aff’d, 840 N.Y.S.2d 445, 448 (N.Y. App. Div. 2007) (“off-label use is a widespread and accepted medical practice”).

Finally, take a look at the current edition of the PDR:  Off-label is be within the medical standard of care:  “[A]ccepted medical practice includes drug use that is not reflected in approved drug labeling.”  PDR at “Forward” (66th ed. 2012).

Thus, just because we don’t always cite the support for statements we make in the blog, don’t assume we don’t have it – especially when the topic is off-label use.

5 comments:

esther said...
This comment has been removed by a blog administrator.
bmartinmd.com said...

This is (once again) a complete non-issue. Medical practice guidelines are chock-a-block with recommendations for care that have no input from the FDA whatsoever. If the dissenter wants evidence from the medical literature on non-FDA-approved standards (or recommendations) for care, he/she should expect a freakin' tsunami.

Adam mark said...

Excellent information provide for us about the Medical Standard Of Care ....................
Thanks for sharing
Medical Litigation

Tye Lawson said...

Some claim about 80% of Rx's are 'off label'. Proven results for the best thought out Tx

unapproved by the FDA. ie 'Zyprexa' "-trading sanity for tardive dyskinesia"

Bexis said...

Medical treatment is almost always a tradeoff. That's why prescription drugs require a prescription. They have risks, and they have benefits. Unfortunately, almost all anti-psychotics have a risk of TD - but the risk posed by the first-generation drugs that the atypicals such as Zyprexa replaced were much worse. So, yes, there can be a tradeoff, and if the physician makes it with knowledge of the risks and benefits, then it's not a legitimate basis for a lawsuit. Product liability is not free health insurance.

- Bexis