Off-Label Use And The Medical Standard Of Care

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One of our posts earlier this week made the statement “Off-label use can be, in manycircumstances, the standard of care.”  Wedidn’t cite anything for that proposition in that post, since its focus waselsewhere.  Later, one of us received anemail from a reader (we assume on the other side – around 50 of our 924 Googlesubscribers are our opponents in court) noting that this statement didn’t haveany support.
The implication, we suppose, was that it didn’thave any.  Well, that’s just not true,but apparently we have been remiss.  Wehaven’t addressed this point specifically in our five years online.  That changes today.  With a physician’s right to engage inoff-label use under attack again, as exemplified by the absurd, overreaching,and downright dangerous (to the health of every person in the country) legaltheory discussed in that post, it behooves us to put our citations where ourmouths are – on the blog.
So here goes.
First of all, the general legality and value ofoff-label uses as part of medical practice is no longer in seriousdispute.  That was settled by the SupremeCourt in Buckman Co. v. Plaintiffs Legal Committee:  “[O]ff-label use is generally accepted” inmedicine, and under the law, “[p]hysicians may prescribe drugs and devices foroff-label uses.”  531 U.S. 341, 351 &n.5 (2001).  Numerous other courts have likewiseconfirmed the overall value and ubiquity of off-label use.  “Prescription drugs frequently havetherapeutic uses other than their FDA-approved indications.”  In re Schering Plough Corp. Intron/TemodarConsumer Class Action, 678 F.3d 235, 239 (3d Cir. 2012).  “[T]he fact that the FDA has not approvedlabeling of a drug for a particular use does not necessarily bear on those usesof the drug that are established within the medical and scientific community asmedically appropriate.”  Weaver v.Reagen, 886 F.2d 194, 198 (8th Cir. 1989). “The decision to prescribe such ‘off-label usage’ . . . isregarded as a professional judgment for the healthcare provider to make.”  Nightingale Home Healthcare, Inc. v. AnodyneTherapy, LLC, 589 F.3d 881, 884 (7th Cir. 2009) (applying Illinoislaw).  “[T]he lack of FDA approval of adrug or device for a particular use does not imply that using the drug ordevice 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 sometimesessential, clinical practice,” and is “an integral part of the modern practiceof medicine.”  Id. at 13, 14.  “[O]ff-label use of many medical devices anddrugs is an accepted medical practice.”  UnitedStates ex rel. George v. Boston Scientific Corp., ___ F. Supp.2d ___, 2012WL 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 notillegal or even disfavored under federal law. Rather, it is an accepted and indeed valuable part of the practice ofmedicine.”  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’sprescribing regimen.”  WashingtonLegal Foundation v. Friedman, 13 F. Supp.2d 51, 56 (D.D.C. 1998), vacatedin part as moot, 202 F.3d 331 (D.C. Cir. 2000).
Even Judge Jack Weinstein, whom nobody can claimis any sort of pushover for pharmaceutical companies or for the defense bargenerally, is in emphatic agreement on the value of off-label use:
It is generally agreed that off-label prescribingcan benefit both individual patients and patient populations as clinicalexperience leads to the formation of hypotheses to be tested in structuredclinical 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 thecommunity recognize that many drugs effective for a condition may not belabeled for that condition and may not have a strong body of evidence for oragainst their use.  When consideringoff-label prescribing, physicians depend on the patient-specific evidence theyhave available to them.
In re Zyprexa Products Liability Litigation, 253F.R.D. 69, 112 (E.D.N.Y. 2008) (citations omitted) (Weinstein, J.), rev’d inpart 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 anysort of violation of the standard of care. Not that plaintiffs haven’t tried that before.  But they haven’t done very well assertingoff-label use as some sort of per se medical malpractice.  Such claims have failed, and rather miserably:
[T]he Court cannot agree with plaintiffs’ suggestionthat an off-label prescription alone may violate [the prescriber’s] duty ofcare.  Off-label use is legal andgenerally accepted.  The federal Food,Drug and Cosmetic Act expressly disclaims any intent to regulate the practiceof medicine. . . . Plaintiffs have cited no case, and the Court is aware of none,suggesting off-label prescriptions breach any physician’s duty of care inOklahoma.  These claims are utterlywithout 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 FDAapproves the package inserts that explain a drug’s approved uses.  Congress would have created havoc in thepractice of medicine had it required physicians to follow the expensive andtime-consuming procedure of obtaining FDA approval before putting drugs to newuses.
United States v. Algon Chemical, Inc., 879 F.2d1154, 1163 (3d Cir. 1989).
As for the converse proposition – off-label userepresenting the medical standard of care – numerous cases, in a wide varietyof contexts, have held that this or that off-label use was the standard ofcare.  We’ve blogged about one of them before, Layzer v. Leavitt, 770 F. Supp.2d 579 (S.D.N.Y.2011).  Layzer involved Medicarecoverage of an off-label use in a recurrent context, a rare disease where noon-label treatment existed because the tiny size of the market did not justifythe cost of undertaking the sorts of studies the FDA requires to support a labeledindication.
Medicare denied coverage, because the particularoff-label use didn’t fall within the government’s cubbyholes; it was neitheron-label nor did it appear in of the specific compendia of compensableoff-label uses.  The court held, as amatter of law, that the government’s position (including a regulation) aboutwhat was “medically accepted” was invalid. 770 F. Supp. At 587.  Thecompendia were simply examples, not limitations on how “medical acceptance” wasdetermined..  Id.  The court credited forceful testimony by theplaintiffs’ physician that this use was required by the applicable standard ofcare:
[The prescriber] has warned that the medicine“is essential for my patient.  There isno substitute at this time.  Furthermore,if the medicine is stopped, even temporarily, it is likely that the remainingtumors will grow quickly and she will suffer grave consequences.  Other physicians have echoed theconclusion. . . .  Peer-reviewedmedical literature has also recognized the unique and effective capacity of [thisoff-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 – andwhich has some support in outside literature – is medically accepted.
Quite a few other cases have reached similarholdings.  In an appeal from a medicaldisciplinary proceeding, the Missouri Supreme Court stated that “[t]here aremany off-label uses of medicines that are generally accepted by the medicalprofession.”  State Board v. McDonagh,123 S.W.3d 146, 162 (Mo. 2003).  The Pennsylvania SupremeCourt, in refusing to add regulatory issues to informed consent, recognizedthat an off-label use “was considered to be the standard of care by thesurgical community.”  Southard v.Temple University Hospital, 781 A.2d 101, 104 (Pa. 2001). And here are a few more below the statesupreme 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 thePDR:  Off-label is be within the medicalstandard of care:  “[A]ccepted medicalpractice 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 supportfor statements we make in the blog, don’t assume we don’t have it – especiallywhen the topic is off-label use.