Thursday, December 27, 2012
It’s no surprise that we don’t like. Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012). It topped the list of our least favorite decisions of 2012, and we have openly rooted for the Supreme Court first to take the appeal, and now that they have, to reverse.
There are, as we see it, four rock solid arguments for reversing Bartlett. Two of them broadly focus on the decision’s implications for the FDA’s authority over the marketing of prescription drugs. Two others focus more narrowly on the Hatch-Waxman amendments to the FDCA, which largely created the generic drug industry.
The first broad argument rejects Bartlett’s holding that that state-law re-weighing of the risks and benefits of an FDA-approved drug can peacefully coexist with the FDA’s drug approval function. "Yes" and "no" simply aren’t complementary. Instead a duty-to-withdraw claim strikes at the heart of the FDA’s power to determine what prescription drugs are properly sold in interstate commerce in the United States:
[A] state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce . . . 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.
Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011), reconsideration denied, 825 F. Supp.2d 661 (D. Md. 2012). "The 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." In re Reglan Litigation, 2012 WL 1613329 (N.J. Super. Law Div. May 4, 2012) Allowing such a claim "would be tantamount to conferring supremacy upon the state law." Jacobsen v. Wyeth, LLC, 2012 WL 3575293, at *9 (E.D. La. Aug. 20, 2012). Accord Eckhardt v. Qualitest Pharmaceuticals, Inc., 858 F. Supp.2d 792, 801 (S.D. Tex. 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 ("a state law requirement that the drug be completely withdrawn from the market, based solely on a theory that the federally mandated label was inadequate, would also impermissibly conflict with federal law"); Cooper v.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 . . . it necessarily must repudiate the label approved by the FDA"). See also Demahy v. Schwarz Pharma, Inc., ___ Fed. Appx. ___, 2012 WL 5261492, at *6 (5th Cir. Oct. 25, 2012) (dictum); Fulgenzi v. PLIVA, Inc., 867 F. Supp.2d 966, 9715 n.5 (N.D. Ohio 2012); Moretti v. Mutual Pharmaceutical Co., 852 F. Supp.2d 1114, 1118 (D. Minn. 2012); Pirello v. Qualitest Pharmaceuticals, Inc., 2012 WL 5363243, at *4 (M.D. La. Oct. 30, 2012); Strayhorn v. Wyeth Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3261377, at *16 (W.D. Tenn. Aug. 8, 2012); Aucoin v. Amneal Pharmaceuticals, LLC, 2012 WL 2990697, at *8-9 (E.D. La. July 20, 2012); Johnson v. Teva Pharmaceuticals USA, Inc., 2012 WL 1866839, at *5 (W.D. La. May 21, 2012); Metz v. Wyeth LLC, 872 F. Supp.2d 1335, ___, 2012 WL 1058870, at *4 (M.D. Fla. March 28, 2012); Bowman v. Wyeth, LLC, 2012 WL 684116, at *6 (D. Minn. March 2, 2012); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *5 (S.D. Ga. Jan. 19, 2012); In re Fosamax Litigation, 2011 WL 5903623, at *6 n.5 (D.N.J. Nov. 21, 2011); Fullington v. PLIVA, Inc., 2012 WL 1893749, at *6 (E.D. Ark. May 23, 2012). Cf. Mensing v. Wyeth, 658 F.3d 867 (8th Cir. 2011) (per curiam) (vacating prior order that had allowed a failure to withdraw claim post Mensing without explanation).
Id. (footnote omitted).
In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 2457825, at *1 (E.D. Ky. June 22, 2012) (citation omitted) ("Darvocet II"). Accord Frazier, 2012 WL 6641626, at *6 (refusing to follow Bartlett because "the logic of Mensing is applicable to design defect claims"); Strayhorn, 2012 WL 3261377, at *10 (agreeing with Darvocet II); Purvis, 2012 WL 5364392, at *4 (court "not persuaded" by Bartlett); Pirello, 2012 WL 5363243, at *4 n.3 (same); Lashley v. Pfizer, Inc., ___ F. Supp.2d ___, 2012 WL 2459148, at *9 (S.D. Miss. June 27, 2012) (finding Bartlett "unpersuasive and not a proper basis for relief").
The second broad argument is that Bartlett’s rationale that a "decision to make the drug and market it in [a state] is wholly [defendant’s] own," 678 F.3d at 38, is the same type of excuse that Mensing rejected when presented as a possibility of obtaining assistance from the FDA to change otherwise unchangeable warnings. See 131 S. Ct. at 2578-79. That excuse didn’t defeat impossibility preemption because it proves too much – it "would render conflict pre-emption largely meaningless." Id. at 2579. One could seek the aid of an agency, or even of Congress, to change practically anything:
We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it. . . . [I]t is also possible that the Manufacturers could have convinced the FDA to reinterpret its regulations [or] . . . to rewrite its generic drug regulations entirely or talked Congress into amending the Hatch–Waxman Amendments.
If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force.
The Bartlett argument that a manufacturer always has the option to leave the market entirely is similarly overexpansive. "[T]he idea that they should have simply stopped selling propoxyphene is an oversimplified solution that could apply anytime the issue of impossibility preemption arises: avoid a conflict between state and federal law by withdrawing from the regulated conduct altogether." In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 718618, at *3 (E.D. Ky. March 5, 2012) ("Darvocet I") (citing to Mensing). The virtually unlimited scope of this argument is illustrated by how plaintiffs, both before and since Bartlett, have indiscriminately brought failure-to-withdraw claims involving a bunch of generic drugs. See Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011) (metoclopramide – one of many such attempts); Aucoin, 2012 WL 2990697, at *8-9 (tramadol); Darvocet I, 2012 WL 718618, at *3 (propoxyphene); Coney, 2012 WL 170143, at *5 (phenytoin); Fosamax, 2011 WL 5903623, at *6 n.5 (alendronate).
The first of the narrower arguments is that the Supreme Court’s "sameness" rationale in Mensing is equally applicable to design as well as warning defect claims. The FDCA and FDA regulations require all generic drugs to be the same as branded drug as to which bioequivalence is being claimed. See 21 U.S.C. §355(j)(2)(A)(ii) ("active ingredients" must be the "same"; 21 C.F.R. §314.127(a)(3) (dissimilar "active ingredients" will cause rejection of application for approval of generic drugs). Thus, to market a generic drug, the manufacturer is "required to produce a drug that was equivalent to the brand-name drug and [is] not free to unilaterally pursue a safer alternative design in order to comply with state law." Eckhardt, 858 F. Supp.2d at 801. Therefore, "the ‘federal duty of sameness,’ also applies in the context of generic drug design, and federal law preempts state laws imposing a duty to change a drug's design on generic drug manufacturers." In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479, 484 (E.D.N.Y. 2012) (citation omitted). Accord Frazier v. Mylan, Inc., ___ F. Supp.2d ___, 2012 WL 6641626, at *5-6 (N.D. Ga. Dec. 18, 2012); Jacobsen, 2012 WL 3575293, at *9; In re Accutane Products Liability Litigation, 2012 WL 3194952, at *2-3 (M.D. Fla. Aug. 7, 2012); Aucoin, 2012 WL 2990697, at *8-9; Johnson, 2012 WL 1866839, at *4; Metz, 2012 WL 1058870, at *4; Darvocet I, 2012 WL 718618, at *2; Lyman v. Pfizer, Inc., 2012 WL 368675, at *4 (D. Vt. Feb. 3, 2012); Stevens v. Pliva, Inc., 2011 WL 6224569, at *2 (W.D. La. Nov. 15, 2011).
The second narrower argument sounds in purposes and objectives preemption (which Justice Thomas, the author of Mensing, doesn’t like). If ever there is a place for P&O preemption, however, Bartlett is the case. The express congressional purpose of the Hatch-Waxman amendments is to "make available more low cost generic drugs by establishing a generic drug approval procedure." H.R. Rep. No. 98-857, pt. 1, p. 14 (1984). Claims that would give state juries the power, in effect, to ban generic drugs right and left directly conflict with that congressional purpose. Darvocet I, 2012 WL 718618, at *2 (pointing out "the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public").
Thus, for all of these reasons, most courts even after Bartlett have disagreed with the First Circuit’s rationale and continued to find design defect/failure to withdraw claims preempted:
Having reviewed the Bartlett decision, the Court agrees with the Generic Defendants. In Bartlett, the First Circuit adopted the "failure-to-withdraw" argument previously rejected by this Court and others. This argument − which failed to persuade either the Supreme Court or the Eighth Circuit on remand in Mensing, and the Sixth Circuit in Smith v. Wyeth − is no more availing now. Moreover, the First Circuit offered little explanation for accepting it, noting simply that the Mensing opinion had not specifically addressed design-defect claims.