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.
  • 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.

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

    • 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"

  • 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