Law

How obsessed are we, you ask?  Well, when (courtesy of Mealey's; we probably wouldn't have seen the case at all otherwise) we read McCormack v. Hiedeman, ___ F.3d ___, 2012 WL 3932735 (9th Cir. Sept. 11, 2012), we didn't think about pro-life. pro-choice, or even preliminary injunctions.


No, we thought about FDCA preemption.

You see, going all the way back to McDermott v. Wisconsin, 228 U.S. 115 (1913), essentially the first FDCA successful preemption case ever, it has been established that a product, labeled in compliance with FDA regulations (although in 1913, it wasn't the FDA yet), and traveling in interstate commerce, cannot be excluded by state law.  In McDermott the Court recognized the preemption of a state statute that prohibited any product – including products labeled in accordance with the FDCA – unless they carried a state-specific label that was inconsistent with federal law.  The Supreme Court barred the state from prohibiting importation and sale of the federally-approved product:

If truly labeled within the meaning of the [predecessor of the FDCA], his goods are immune from seizure. . . . [T]he Wisconsin statute provides that they shall bear the label required by the state law and none other. . . . . In others words, it is essential to a legal exercise of possession of and traffic in such goods under the state law that labels which presumably meet with the requirements of the Federal law, and for the determination of the correctness of which Congress has provided efficient means, shall be removed from the packages before the first sale by the importer. . . . Conceding to the state the authority to make regulations consistent with the Federal law for the further protection of its citizens against impure and misbranded food and drugs, we think to permit such regulation as is embodied in this statute is to permit a state to discredit and burden legitimate Federal regulations of interstate commerce, to destroy rights arising out of the Federal statute which have accrued both to the government and the shipper, and to impair the effect of a Federal law which has been enacted under the Constitutional power of Congress over the subject.

* * * *

. . .The legislative means provided in the Federal law for its own enforcement may not be thwarted by state legislation having a direct effect to impair the efficient exercise of such means. For the reasons stated, the statute of Wisconsin, in forbidding all labels other than the one it prescribed, is invalid.

288 U.S. 133-34, 137.

So what happened in McCormack?  The state of Idaho passed a "fetal pain" statute limiting abortions to the first 20 weeks of pregnancy.  Apparently an ordinary termination was beyond this particular plaintiff's means.  2012 WL 3932735, at *1.  However, plaintiff "learned that medications inducing abortions had been approved for use in the U.S. and could be purchased over the internet."  Id.  That's exactly what she did.  Somehow, the opinion doesn't give details, the plaintiff "ingest[ed] one or more medications she reasonably believed to have been prescribed by a health care provider practicing outside" the state.  Id., see id. (plaintiff "reiterated that the medications were prescribed by a physician").  These unidentified medications – prescribed by a physician – induced an abortion/miscarriage.  Id.

That abortion, however, was illegal under state law, and plaintiff was threatened with prosecution for using the drugs, albeit as prescribed, in that fashion.  Id. at *2-3.

The rest of the McCormack opinion is devoted to constitutional arguments concerning state restrictions on abortions.  That's not germane to this blog.  But one other aspect of the decision caught our eye:

In addressing [defendant's] argument, the district court stated that, [plaintiff] "clarified at oral argument that the FDA-approved medication she procured through the internet was prescribed by a physician." . . . The district court's findings of fact, namely that [plaintiff] received from a physician FDA-approved medication used to induce an abortion, were not clearly erroneous. These facts were offered in both [plaintiff's] declaration and her complaint. [Plaintiff] stated in her declaration that the medication was "approved for use in the United States". . . . In her complaint, [plaintiff] stated that "physicians providing abortion services in the United States often prescribe medications approved by the U.S. Federal Drug Agency ("FDA") to cause women to abort their pregnancies medically, i.e., non-surgically.". . . . Here, prosecuting attorney [defendant] did not offer any controverted affidavits as to whether the pills were obtained from a physician over the internet or whether they were FDA-approved.

McCormack, 2012 WL 3932735, at *9 (our emphasis added; other emphasis removed).

Thus, as far as we can tell, in McCormack the plaintiff was threatened with state prosecution for using an FDA-approved (and presumably duly labeled) prescription drug in accordance with a physician's prescription.  In other words, the state was seeking to ban the use of an FDA-approved prescription drug.  We don't know for sure whether the use is on- or off-label, but we don't think that matters much since the Supreme Court has held that "off-label" usage . . . for some other purpose than that for which [the product] has been approved by the FDA is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine."  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350 (2001) (citation omitted).

Now, we don't doubt that all states can regulate physicians, and thus can regulate the ability of physicians to prescribe off-label.  Thus we have no preemption-related quarrel with Planned Parenthood of Cincinnati Region v. Strickland, 531 F.3d 406 (6th Cir. 2008), allowing a state to do precisely that in the abortion context.  However, the state in McCormack didn't do that – it didn't go after the physician, but rather after the purchaser/user of the drug  – who according to the (rather limited) facts, took the drug as prescribed.  As a conceptual matter that's hard to distinguish that from what the First Circuit did in Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012) – hold that a plaintiff can prevail on a purported state-law duty that the defendant drug manufacturer must remove its properly labeled, FDA-approved product from the market altogether in that state.

Practically every other court to consider that issue – in the common-law context – has held that removal from the market claims are preempted.  States simply can't prohibit the marketing and use of FDA-approved drugs.  See, e.g., Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012) (rejecting "failure-to-withdraw" argument); Mensing v. Wyeth, Inc., 658 F. 3d 867, 867 (8th Cir. 2011) (vacating earlier opinion to the extent that it embraced the "failure-to-withdraw" theory); Moore v. Mylan, Inc., 840 F. Supp.2d 1337, 1352 n.14 (N.D. Ga. 2012) ("any such state law duty [to cease marketing a drug] would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce"); Jacobsen v. Wyeth, LLC, 2012 WL 3575293, at *9 (E.D. La. Aug. 20, 2012) ("If state law could require a generic drug manufacturer to wholly withdraw from the market based on the unreasonable danger of the product (which is all a successful failure to withdraw from the market claim could be), it necessarily must repudiate the label approved by the FDA"); Strayhorn v. Wyeth Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3261377, at *16 (W.D. Tenn. Aug. 8, 2012) (holding failure to withdraw claims "invalid" and preempted); Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697, at *9 (E.D. La. July 20, 2012) ("[t]o require a generic manufacturer to remove a drug from the market would repudiate the label approved by the FDA"); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 2457825, at *1 (E.D. Ky. June 22, 2012) (refusing to follow Bartlett and rejecting "failure-to-withdraw" theory); Johnson v. Teva Pharmaceuticals USA, Inc., 2012 WL 1866839, at *5 (W.D. La. May 21, 2012) (rejecting "failure to withdraw argument"); Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817, at *6 (S.D. Tex. April 30, 2012) (a state law requirement that the drug be completely withdrawn from the market, based solely on a theory that the federally mandated label was inadequate, would also impermissibly conflict with federal law and be preempted"); Fulgenzi v. PLIVA, Inc., ___ F. Supp.2d ___, 2012 WL 1110009, at *7 n.5 (N.D. Ohio March 31, 2012) ( "failure-to-withdraw" theory preempted); Metz v. Wyeth, ___ F. Supp.2d ___, 2012 WL 1058870, at *4 (M.D. Fla. March 28, 2012) (removal from market claim preempted); Cooper v. Wyeth, Inc., 2012 WL 733846, at *6 (M.D. La. March 6, 2012) ("[i]f state law could require a generic drug manufacturer to wholly withdraw from the market based on the unreasonable danger of the product (which is all a successful failure to withdraw from the market claim could be), it necessarily must repudiate the label approved by the FDA"); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, at *2-3 (E.D. Ky. March 5, 2012) ("that [defendants] should have simply stopped selling [the drug] is an oversimplified solution"); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. March 2, 2012) (rejecting "failure-to-withdraw" theory); Moretti v. PLIVA, Inc., 2012 WL 628502, at *5-6 (D. Nev. Feb. 27, 2012) (liability for "continued distribution" held preempted); Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012) (allegation that defendant "could have simply stopped selling the product" held preempted); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *5 (S.D. Ga. Jan. 19, 2012) ("Finding that state law prohibits [defendant] from doing what federal law explicitly requires [defendant] to do would be tantamount to conferring supremacy upon the state law"); Fullington v. PLIVA, Inc., 2011 WL 6153608, at *6 (E.D. Ark. Dec. 12, 2011) (removal from market claim preempted); Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011) ("no state law duty that would compel generic manufacturers to stop production of a drug" could "exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce"); In re Reglan Litigation, 2012 WL 1613329 (N.J. Super. Law Div. May 4, 2012) ("conflict between state and federal law would be much more pronounced if the state courts upheld a decision that an FDA-approved drug should not have been on the market").

Since federal power to permit the marketing – and thus the purchase and use – of FDA-approved prescription drugs is necessarily supreme over state power to prohibit such marketing and use, as the above precedent abundantly holds, then the state source of power is irrelevant.  State legislation purporting to ban the marketing of an FDA-approved product (what the Supreme Court held preempted in McDermott back in 1913) is just as preempted as a tort claim ostensibly raising a common-law duty to do the same thing.

Thus, when we see the state in McCormack threaten to prosecute the user of an FDA approved drug for a prescribed use of that drug (not diverting the drug to some non-prescribed purpose, which would not raise any preemption question), we have to say "hold on."  Interstate commerce in prescription drugs, once they're approved by the FDA, can't be prohibited by state law.  States can regulate physicians all they want, but once they go beyond that to the sale and prescribed use of FDA-approved drugs, well, we think there's a bit of a Supremacy Clause problem there.



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Posted By Bexis to Drug and Device Law at 9/28/2012 12:00:00 PM

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