We’ve already blogged twice about the patently meritless U.S. ex rel. Watson v. King-Vassel False Claims Act case. In the first post, we pointed out that the apparent premise of King-Vassel lawsuit appeared to be that all prescriptions of drugs for off-label use was ipso facto a "false claim." That was hardly surprising, since as the opinion we were discussing, United States v. King-Vassel, 2012 WL 5272486 (E.D. Wis. Oct. 23, 2012), pointed out that litigation was "solicit[ed] through the efforts of entities opposed to all use of what purported psychotropic drugs:
The relator . . . secured the cooperation of [a patient of the defendant’s] in bringing this suit after meeting an attorney through the International Society for Ethical Psychology and Psychiatry, and doing further research into bringing a qui tam claim through the website PsychRights.org. After researching qui tam false claims actions, [relator] placed an ad in a [local] newspaper soliciting minor Medicaid patients who had received certain medications.
Id. at *1. We were reasonably pleased at the dismissal of the suit, but not particularly impressed, since the dismissal wasn’t based on the suit’s erroneous equation of off-label prescription with "false claims," but rather on the plaintiff not having a Medicaid legal expert.
Our second King-Vassel post discussed the Seventh Circuit reversing district court and holding that the district court’s expert-based rationale was improper because plaintiff hadn’t been given sufficient notice of it and in any event experts on issues of law aren’t required. United States v. King-Vassel, 728 F.3d 708, 712-16 (7th Cir. 2013). Because the District Court had gone off on a tangent, the Seventh Circuit let the suit’s improper legal foundation – that off-label use = a false claim – slide. The court held that evidence of a physician’s knowledge that an off-label prescription would be reimbursed by Medicare was enough to support the complaint’s allegations of "knowing" conduct. Id. at 713.
That post pointed out that: (1) nothing in the Seventh Circuit opinion approved the suit’s false underlying legal premise, (2) the appellate court all but invited defendant to try again to dismiss the case, 728 F.3d at 717, and (3) the Seventh Circuit agreed with the District Court’s sanctions and condemnation of the manner in which this suit was initiated as "borderline fraudulent" except "we might remove the word ‘borderline.’" Id.
In that regard we also noted that plaintiff's counsel on the appeal was also "the attorney in the Zyprexa litigation when there was an issue regarding violation of a court confidentiality order." We’ll let the Zyprexa Judge, Hon. Jack Weinstein, explain:
[A reporter] provided [plaintiff’s expert] with the name of an Alaska attorney, James Gottstein, unconnected to the instant litigation, who might be willing to employ a pretense to subpoena the documents and help disseminate them in violation of the protective order. To carry out the scheme for obtaining and disseminating the protected documents, Gottstein intervened in a state case in Alaska wholly unrelated to Zyprexa. In that case, he then subpoenaed from [the expert] confidential documents he knew to be under the protective order which bore no relevance to the Alaska litigation. The subpoenaed documents were sent by [the expert] to Gottstein pursuant to an expedited amended subpoena about which [defendant] was deliberately kept in the dark so that it would be unable to make a timely objection. Gottstein immediately sent the confidential documents on to [the reporter] and others. None of the three . . . sought a lifting or modification of the protective order.
In re Zyprexa Injunction, 474 F. Supp. 2d 385, 392 (E.D.N.Y. 2007), aff’d sub nom. Eli Lilly & Co. v. Gottstein, 617 F.3d 186, 190 (2d Cir. 2010) (similar discussion of these events). Since the latest King Vassel opinion, like Zyprexa, also involves confidential information subject to a protective order, counsel’s prior conduct in Zyprexa seems even more pertinent now.
Unfortunately, the third time in King-Vassel is not the charm either. On remand from the Seventh Circuit, the plaintiff pursued a fishing expedition through the medical records of other, non-party patients of the defendant doctor for "eight years" looking for other off-label prescriptions written by the same doctor. United States v. King-Vassel, 2013 WL 5946362, at *2 (E.D. Wis. Nov. 5, 2013) (plaintiff "is requesting records from unnamed medical records custodians to analyze numerous volumes covering an eight year span of time") ("King-Vassel III").
Incredibly, the court allowed it. Refusing once again to address the erroneous premise of the entire lawsuit – that off-label use = false claims – the court let plaintiff go rummaging through the confidential medical records of who knows how many non-parties. The excuse? It wasn’t the right time to "cut plaintiffs off at the knees":
[T]his order does not settle any law that will be applied at trial. [Defendant’s] brief opposing [the] motion for a HIPAA order rehashes her arguments regarding whether off-label prescriptions are per se false claims. That is irrelevant to the question. . . . Without more evidence and argument . . . the Court is not prepared to rule on that issue at this juncture. But it will not cut [plaintiff's] case off at the knees at this point, either.
Id. at *2. We find it appalling that such sensitive discovery was allowed despite: (1) the Seventh Circuit signing on to the "fraudulent" description of how plaintiff previously obtained medical records in this case, and (2) plaintiff's counsel being previously sanctioned in Zyprexa for deliberately violating another protective order involving confidential documents in other litigation also related to the off-label use of drugs. The court didn’t even impose a bond against the possibility of that something else might happen.
The court did, however, deny the plaintiff’s further request to dragoon the defendant into serving, in effect, as plaintiff’s expert. The defendant was not required to go through prescriptions and identify off-label uses were found in the compendia by which the government judges eligibility for reinbursement. King-Vassel III, 2013 WL 5946362, at *4-5. Note: these "compendia" matter because the government itself recognizes that many off-label uses need to be covered by its programs, and relevant statutes provide coverage for such uses that have medical support, such as in certain compendia. See generally Layzer v. Leavitt, 770 F. Supp.2d 579, 584-86 (S.D.N.Y. March 7, 2011) (discussing this issue in detail).
Well, with all due respect to the district court (probably gunshy, and not at all happy, after being reversed by the Seventh Circuit) it is well past time to cut this plaintiff "off at the knees." We’ve blogged twice in recent weeks about discovery abuse and the need to change the discovery rules to get rid of, once and for all, the overbroad "reasonably calculated" standard that allows this sort of discovery abuse. Third parties should not be subject – without their knowledge or consent – to having their personal medical records rummaged through in litigation that has no legal or medical basis. There’s no hint, in any of the three decisions in this litigation that we’ve read, that the drugs in question were not of therapeutic value to any patients for whom they were prescribed off-label.
In King-Vassel the cart needs to be put back after the horse. There should be no discovery, let alone extensive, intrusive and virtually unprecedented discovery of third-party medical records, in litigation that utterly fails to state a claim. First, the King-Vassel litigation is a misapplication of the FCA:
The False Claims Act, even in its broadest application, was never intended to be used as a back-door regulatory regime to restrict practices that the relevant federal and state agencies have chosen not to prohibit through their regulatory authority.
United States ex rel. Polansky v. Pfizer, Inc., 914 F. Supp.2d 259, 266 (E.D.N.Y. 2012) (rejecting FCA claims attacking off-label use). We have never heard of any court accepting proposition that "off-label prescriptions are per se false claims," 2013 WL 5946362, at *2, in any FCA context.
Most fundamentally, the prescription of drugs/devices for off-label use is a physician’s prerogative, is extremely commonplace, and is 100% legal. These propositions have been recognized by courts at every level, from the United States Supreme Court on down. "[O]ff-label use is generally accepted" and under the law, "[p]hysicians may prescribe drugs and devices for off-label uses." Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 351 & n.5 (2001). "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).
Once FDA-approved, prescription drugs can be prescribed by doctors for both FDA-approved and -unapproved uses; the FDA generally does not regulate how physicians use approved drugs . . . . [C]ourts and the FDA have recognized the propriety and potential public value of unapproved or off-label drug use.
United States v. Caronia, 703 F.3d 149, 153 (2d Cir. 2012) (citations omitted). "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). "[I]t is standard medical practice in the United States for physicians to prescribe FDA-approved drugs in dosages and for medical indications that were not specifically approved − or even contemplated − by the FDA." Planned Parenthood of Southwestern Ohio Region v. DeWine, 696 F.3d 490, 496 (6th Cir. 2012) (citation and quotation marks omitted). "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).
Thus, off-label use "is well known, and not illegal." Pyott v. Louisiana Municipal Police Employees’' Retirement System, 74 A.3d 612, 614 (Del. 2013).
The practice of providing approved medications using regimens different from that described in the medication’s final printed label is known as an "off-label use," or an "evidence-based regimen." The FDA has stated that evidence-based regimens are common, permissible, and can be required by good medical practice.
Cline v. Oklahoma Coalition for Reproductive Justice, ___ P.3d ___, 2013 WL 5799863, at *3 (Okla. Oct. 29, 2013). "[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.
"After the FDA approves a drug for use, and absent any state regulation to the contrary, doctors may prescribe that drug for indications, in dosages, and following treatment protocols different than those expressly approved by the FDA." McCormack v. Hiedeman, 900 F. Supp.2d 1128, 1137 (D. Idaho 2013). "[A] manufacturer’s label is not proscriptive, and does not prohibit use for a longer period, or in any other manner not described in the labeling." Holtshouser v. United States, 2013 WL 1855775, at *8 (D. Mont. May 1, 2013). "[O]ff-label use of many medical devices and drugs is an accepted medical practice." United States ex rel. George v. Boston Scientific Corp., 864 F. Supp.2d 597, 599 (S.D. Tex. 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). "[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). Judge Weinstein agreed, in the aforementioned Zyprexa litigation:
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) (record citations omitted), rev’d in part on other grounds, 620 F.3d 121 (2d Cir. 2010).
Even the FDA agrees, as we recently pointed out (see our post here):
The FD & C Act does not, however, limit the manner in which a physician may use an approved drug. Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such "unapproved" or, more precisely, "unlabeled" uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.
The term "unapproved uses" is, to some extent, misleading. It includes a variety of situations ranging from unstudied to thoroughly investigated drug uses. Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigation.
Cline, 2013 WL 5799863, at *5 (quoting and following FDA Drug Bulletin 12:4-5 (1982), and 59 Fed.Reg. 59,820, 59,821 (FDA Nov. 18, 1994)).
Further, many cases have recognized that off-label use can be, and often is, the medical standard of care. "Up to date, clinically appropriate medical practice at times requires the use of pharmaceuticals for ‘off-label’ indications." Memorandum of the AMA House of Delegates, Resolution 820, Off-Label Use of Pharmaceuticals (Sept. 21, 2005). That means that in some instances (at least theoretically), it could be malpractice not to treat particular patients and conditions off label. "There 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) (concurring opinion); see Southard v. Temple University Hospital, 781 A.2d 101, 104 (Pa. 2001) (recognizing that an off-label use "was considered to be the standard of care by the surgical community"); Gajewsky v. Ning, 997 So.2d 567, 570-71 (La. App. 2008) (testimony that off-label use was standard of care supported defense verdict in malpractice case), 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 (Tenn. App. 2000) (recognizing that an off-label use was "recognized by the FDA as being the nationwide standard of care"); Bailey, 37 A.3d at 558 (product liability action; "[f]ollowing the accepted medical standard of care, physicians frequently prescribe drugs for off-label or unapproved uses"); 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"); McCormack, 900 F. Supp.2d at 1137 ("[t]he medical community recognizes off-label, non-FDA-approved alternatives"); Henricks v. Pickaway Correctional Inst., 2013 WL 4804983, at *7 (S.D. Ohio Sept. 9, 2013) (failure to fill off-label prescription could constitute "deliberate indifference" under Eighth Amendment); 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"); 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"); 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").
The current edition of the Physician’s Desk Reference, widely consulted by doctors, echoes these same points. First, off-label use is legal. "Once a product has been approved for marketing, a physician may choose to prescribe it for uses or in treatment regimens or patient population that are not included in the approved labeling." PDR at "Forward" (67th ed. 2013). Second, off-label can be within the medical standard of care: "[A]ccepted medical practice includes drug use that is not reflected in approved drug labeling." Id.
We have, in many other contexts, condemned the misuse of the law for extralegal purposes, whether attempted by "food fascist" plaintiffs or by judges practicing the "judicial triumphalism" in cy pres class actions. We do so again here. We view King-Vassel is an illegitimate attempt to hijack the False Claims Act as a vehicle for conducting a political vendetta against legal off-label use of legal psychoactive drugs. It’s erroneous law, bad policy, and worse medicine.