Eleanor FULGENZI, Plaintiff-Appellant, v. PLIVA, INC., Defendant-Appellee.
No. 12-3504.
United States Court of Appeals, Sixth Circuit.
March 13, 2013
Rehearing and Rehearing En Banc Denied May 13, 2013.
I do not share the majority‘s apparent sense of chafing under the constraints that follow from taking seriously these concerns. To the contrary, I believe the rigors of the categorical approach to be both principled and workable. Taylor made clear that a standard approach to classifying past convictions is essential to fair and uniform federal sentencing. Taylor, 495 U.S. at 601-02, 110 S.Ct. 2143; see, e.g., Perez-Gonzalez v. Holder, 667 F.3d 622, 629 (5th Cir.2012) (Jones, C.J., dissenting) (noting “the benefit of ‘lenity’ inhering in the categorical approach” and acknowledging that it is appropriate “for the law, guided by the due process clause and the rule of lenity, to give a criminal defendant the benefit of the categorical approach for purposes of enhanced sentencing“). Once again, I find myself in agreement with Judge Wilkinson, writing for the Fourth Circuit in Rangel-Castaneda, who observed:
It may be that, although a consensus-based analysis ultimately aids the defendant in the case at bar, the approach can cut both ways. To wit, if the majority of states subscribes to a broad definition of an offense enumerated in a federal sentencing enhancement, a defendant convicted in one of those jurisdictions might not be able to avoid the enhancement by pointing to a minority view defining the offense more narrowly. Be that as it may, our task is to apply the Taylor decision in a neutral manner.
Rangel-Castaneda, 709 F.3d at 379, 2013 WL 829149, at *5. With all due respect to my colleagues, it is not our place to eschew faithful application of the disciplined analysis required by precedent merely because some may become “skeptical” when it produces results favorable to criminal defendants.
IV
For the foregoing reasons, I would vacate Rodriguez‘s sentence and remand for resentencing. Because the court today reaches a contrary result, I respectfully dissent.
Before: BOGGS and WHITE, Circuit Judges; and McCALLA, District Judge.**
OPINION
BOGGS, Circuit Judge.
This case involves a state tort suit brought by Eleanor Fulgenzi against the generic-drug manufacturer PLIVA, Inc., for failure to adequately warn of the risks
I
A
For three months starting in September 2004 and for over a year from 2006 to 2007, Eleanor Fulgenzi was prescribed the generic drug metoclopramide, sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. She now alleges that taking the drug caused her to develop tardive dyskinesia, an often irreversible neurological disorder that causes involuntary movements, especially of the lower face.
Metoclopramide was first approved by the Food and Drug Administration (FDA) in 1980; five years later generic manufacturers also began to produce the drug. Over time, evidence has mounted that long-term use of metoclopramide poses a substantial risk of causing tardive dyskinesia, among other serious side effects. Initially, the only disclaimer on the labeling of Reglan was: “Therapy longer than 12 weeks has not been evaluated and cannot be recommended.” In July 2004, however, the FDA approved a labeling change proposed by Schwarz Pharma, the manufacturer of Reglan, which stated in bold-face type: ”Therapy should not exceed 12 weeks in duration.” The new warning appeared twice, as the first line in both the “Indications and Usage” and “Dosage and Administration” sections of the label. The earlier disclaimer, however, was not replaced, and remained in the dosage section for gastroesophageal reflux disease. Apparently, PLIVA never updated its metoclopramide labeling to include the new warning, nor communicated the change to any physicians. In February 2009, the FDA went further and ordered a “black-box warning“—the strongest form of warning the FDA requires—indicating the serious risk of developing tardive dyskinesia. The warning urged avoiding treatment longer than 12 weeks “in all but rare cases where therapeutic benefit is thought to outweigh the risk of tardive dyskinesia.”
B
Under federal law, all prescription drugs require approval of the FDA before they can be marketed. The Food, Drug, and Cosmetic Act (FDCA),
After initial approval of a drug, branded-drug companies may seek modification of their labeling1 in two ways: first, through a “Prior Approval Supplement,” which requires submission to and approval by the FDA prior to distribution of the product, and applies to most labeling and other changes with “potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product,”
The rules apply differently to generic-drug manufacturers. Generic-drug manufacturers must maintain labeling consistent with their branded counterpart, or else the FDA may withdraw approval.
C
On July 30, 2009, Eleanor Fulgenzi filed suit against PLIVA, Inc., and several other pharmaceutical manufacturers, for failure to warn of the risk of developing tardive dyskinesia, among other related claims. Since all of Fulgenzi‘s prescriptions were filled with generic metoclopramide, and since PLIVA was the largest generic manufacturer of metoclopramide, the district court dismissed the other manufacturers, leaving PLIVA as the sole defendant. After the Supreme Court‘s decision in Mensing narrowed the scope for state failure-to-warn claims against generic drug manufacturers, Fulgenzi was given leave to amend her complaint. In her Second Amended Complaint, Fulgenzi alleged that PLIVA‘s failure to include the updated 2004 warn-
PLIVA filed a motion to dismiss, which the district court granted in March 2012. The district court reasoned that “regardless of how Plaintiff attempts to cast these claims, they are at the core, failure-to-warn claims that are clearly preempted by Mensing.” In addition, the court found that Fulgenzi‘s allegations failed to state a claim under Ohio law, since there is no private cause of action for violations of FDA regulations. The district court also relied on the implicit holding of Smith v. Wyeth, 657 F.3d 420 (6th Cir.2011), finding no exception to preemption for a state-law warning claim based on failure to comply with FDA regulations. Fulgenzi now appeals her product-liability claims, contesting the district court‘s dismissal of her allegations based on the 2004 failure to update.
II
In determining the viability of state tort claims against drug manufacturers, we are guided by two recent decisions of the Supreme Court. In a 2009 opinion authored by Justice Stevens, the Supreme Court held that failure-to-warn claims against branded-drug manufacturers were not preempted by federal law, because 1) “it is not impossible for [a branded-drug manufacturer] to comply with its state and federal law obligations” and 2) state “common-law claims do not stand as an obstacle to the accomplishment of Congress’ purposes in the FDCA.” Wyeth, 555 U.S. at 581, 129 S.Ct. 1187. In finding no impossibility preemption, the Court found that because the “changes being effected” (CBE) process allowed branded-drug manufacturers to strengthen warnings without prior approval of the FDA, compliance with both federal and state duties was not impossible. Id. at 568, 129 S.Ct. 1187. The Court did not find it significant that the FDA has authority to reject unilateral labeling changes made pursuant to the CBE process, finding it “difficult to accept” that the FDA would not have permitted a change to a stronger warning. Id. at 570, 129 S.Ct. 1187. Without “clear evidence that the FDA would not have approved a change,” the Court was unwilling to find impossibility. Id. at 571, 129 S.Ct. 1187. The Court also denied “purposes and objectives” preemption, finding that the absence of an express preemption provision “coupled with [Congress‘] certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.” Id. at 575, 129 S.Ct. 1187. The Court noted that while Congress did include an express preemption provision for medical devices,
In 2011, the Court issued another preemption decision, with Justice Thomas—who had concurred in Wyeth—writing the majority opinion that held failure-to-warn suits preempted against generic drug manufacturers. Mensing, 131 S.Ct. 2567. The Court reviewed the regulations relevant to generic drug manufacturers, finding that because generic manufacturers have a duty of sameness, they cannot use the CBE process to strengthen their labels
After Mensing, some suits against generic-drug manufacturers were summarily dismissed, while other courts permitted certain claims to go forward. Compare Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 186-187 (5th Cir.2012) (design-defect claims preempted) and In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 2012 WL 718618, at *4 n. 8 (E.D.Ky., Mar. 5, 2012) (failure-to-update claims preempted), with Bartlett v. Mutual Pharm. Co., 678 F.3d 30, 37-38 (1st Cir.), cert. granted, 133 S.Ct. 694, 184 L.Ed.2d 496 (2012) (design-defect claims not preempted) and Fisher v. Pelstring, 817 F.Supp.2d 791, 805 (D.S.C. 2011) (failure-to-update claims not preempted). The Sixth Circuit has dismissed one such case, explaining that “[t]he Supreme Court held unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug‘s label, thus barring the plaintiffs’ state-law tort claims.” Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir.2011). Although the Smith plaintiffs did raise the same arguments that Fulgenzi does here, they were raised only on supplemental briefing and, from the court‘s opinion, it does not appear that they were considered. As a result, we are not controlled by Smith and are faced with a question of first impression. Since none of the foregoing authorities are dispositive, we proceed to conduct a preemption analysis in accord with the principles of Wyeth and Mensing.
III
A
We review the question of whether a federal statute preempts state law de novo. State Farm Bank v. Reardon, 539 F.3d 336, 340 (6th Cir.2008). The
Courts will find impossibility preemption where it is “impossible for a private party to comply with both state and federal requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995). This analysis can become difficult when applied to the regulatory context—overlapping federal duties, ex-post and ex-ante agency approval, and ambiguous regulations make the question of whether a party is acting in accord with federal policies uncertain. In the wake of Wyeth and Mensing, however, the application of impossibility preemption principles has become clearer. Mensing explains that the key question is “whether the private party could independently” comply with its state duty—without relying on the prior exercise of federal-agency discretion. Mensing, 131 S.Ct. at 2579, 2580-81. Wyeth, by contrast, holds that there is no impossibility as long as the approval comes after the independent action of the private party (especially where denial is speculative and unlikely). Wyeth, 555 U.S. at 573, 129 S.Ct. 1187. In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, see Mensing, 131 S.Ct. at 2575, but it had a federal duty to do so,
We note at this point that Fulgenzi‘s claims survive only to the extent PLIVA‘s actions were permitted by federal law. She cannot claim that PLIVA should have included an aggressive black-box warning; any such allegations are preempted under Mensing. Instead, she is left to argue only that PLIVA‘s warning was inadequate to the extent that it did not include the language contained in the updated Reglan label from 2004. This leaves her with a weaker case than if she were suing a branded-drug manufacturer, but that is the statutory scheme provided to us by
B
We turn next to whether state tort suits against generic-drug manufacturers would frustrate the “purposes and objectives” of Congress, and thus warrant preemption. Hines, 312 U.S. at 67, 61 S.Ct. 399. Arguments have been made that state tort suits against generic-drug manufacturers should be preempted by the FDCA. See Wyeth, 555 U.S. at 609, 129 S.Ct. 1187 (Alito, J., dissenting) (“Where the FDA determines, in accordance with its statutory mandate, that a drug is on balance ‘safe,’ our conflict pre-emption cases prohibit any State from countermanding that determination.“). The FDA must strike a balance between safety and ensuring access to life-saving drugs. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001); cf. Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000). The FDA is an expert body, and better placed to set drug policy than state legislatures, much less state juries in after-the-fact verdicts. Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); but see Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984). Nevertheless, the reasoning of the Wyeth majority all but closes off this line of argument. Wyeth, 555 U.S. at 573-75, 581, 129 S.Ct. 1187 (“In short, Wyeth has not persuaded us that failure-to-warn claims like Levine‘s obstruct the federal regulation of drug labeling.“). The Court concluded that at the time of the FDCA‘s passage, Congress had evidently determined that “state rights of action provided appropriate relief for injured customers.” Id. at 574, 129 S.Ct. 1187. In addition, the Court found that 70 years of Congressional failure to enact an express preemption provision for prescription drugs—despite the enactment of an express provision for medical devices—to be “powerful evidence” that Congress did not intend to preempt state remedies. Id. at 574-75, 129 S.Ct. 1187.
One might argue that while Wyeth‘s purposes-and-objectives analysis may control for branded drugs, the Hatch-Waxman Act sets forth different policies with respect to generic drugs. The most easily identifiable policy is promotion of generic drugs, and the attendant reduction in costs. See Congressional Budget Office, How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry (July 1998) (identifying Hatch-Waxman Act as major factor in dramatic rise in sales of generic drugs and the resulting savings). Permitting state tort actions to go forward against generic-drug manufacturers, the argument goes, would increase costs and reduce usage. However, the Mensing dissenters plausibly observed that the inability to sue for inadequate warnings may actually reduce consumer demand. Mensing, 131 S.Ct. at 2593. This is an empirical question, and we should not affirmatively answer on the basis of mere speculation about Congressional purposes. Cf. Wyeth, 555 U.S. at 587-88, 129 S.Ct. 1187 (Thomas, J., concurring) (criticizing the “freewheeling judicial inquiry” of purposes-and-objectives preemption).
It is enough to resolve the question here that nothing in the text or structure of the Hatch-Waxman Act evidences an intent to achieve such savings at the cost of safety, effectiveness, or consumer protection. Instead, the abbreviated approval process created by the Act is premised on the duty of sameness, which ensures that generic drugs are of the same safety and effectiveness as their branded counterparts. Since 1962, the FDCA has required that all new drugs—both generic and branded—be shown safe and effective before being mar-
IV
A
Although PLIVA‘s violation of its federal duty of sameness defeats its impossibility-preemption arguments, the result of this violation does raise concerns that Fulgenzi is simply attempting to enforce a federal-law violation through state litigation. Where, as here, the statute specifically excludes a private cause of action,
even premised on violation of federal law, but rather on an independent state duty. The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption. The federal duty of sameness is not “a critical element” in Fulgenzi‘s case. Buckman, 531 U.S. at 353, 121 S.Ct. 1012. Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law. Her suit instead relies upon the adequacy of the warnings and the causation of her injuries. The theory of her case would work equally well against a branded-drug manufacturer, or a generic-drug manufacturer whose branded counterpart had not updated its warning (of course, under Mensing the second case would be preempted under an impossibility theory). Fulgenzi‘s claim, therefore, is not preempted under Buckman.
B
PLIVA makes a similar argument that Fulgenzi has failed to state a claim under Ohio law, since “Ohio law does not require the manufacturer of a generic drug product to update its labeling to match the branded equivalent.” Appellee Br. at 28. This misstates Fulgenzi‘s claim. PLIVA‘s violation of the federal duty of sameness is essential to her case—but only to avoid preemption under Mensing. On the merits, whether PLIVA has violated its federal duties is irrelevant to the adequacy of its warnings. A jury need not know about the duty of sameness at all to determine whether the warning label used by PLIVA in 2004 and 2006 was inadequate, and whether the failure to include the updated warning was a proximate cause of Fulgenzi‘s injuries.5
PLIVA also tries to argue that there is no such thing as a “failure-to-inadequately-warn” claim under Ohio law. Appellee Br. at 30. To start, Fulgenzi‘s complaint does not have to be read as asserting such a claim. While her allegation that any warning short of the FDA‘s 2009 “black-box” warning was unreasonable is preempted, she is free to argue in the alternative that any label lacking Reglan‘s 2004 updated warning was inadequate. Further, there is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately. In a failure-to-warn case, the plaintiff must show that “[t]he manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided.”
Thus Fulgenzi does not fail to properly state a claim. Fulgenzi alleges that PLIVA‘s use of the old warning (“Therapy longer than 12 weeks has not been evaluated and cannot be recommended.“) instead of adding the updated one (”Therapy should not exceed 12 weeks in duration.“) was unreasonable, and the proximate cause of her injuries. At the motion-to-dismiss stage, it is sufficiently plausible that the use of a neutral warning disavowing approval instead of a bold-faced warning affirmatively discouraging long-term use proximately caused Fulgenzi‘s injury. Whether in fact these allegations are true is a matter for further proceedings.
C
There is one final point to emphasize. Although Fulgenzi‘s claims are not preempted, they must pass through the “narrow gap” between Mensing and Buckman, and will be constrained as a result. Cf. In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010). The arguments she makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles. Under Mensing, Fulgenzi‘s claims are viable only to the extent PLIVA‘s actions were permitted by federal law. Thus she must argue that PLIVA should have included the language contained in the updated Reglan label by soon after July 2004, and that the failure to include that language proximately caused her injuries.
On the facts of this case, Buckman does not necessitate similar narrowing of Fulgenzi‘s claims. Buckman only applies where a link in the causal chain or element of the claim is premised on a federal-law violation and not in all circumstances. See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir.2004) (fraud exception to state-law immunity for FDA-approved drugs not preempted, as long as the FDA itself determined that fraud occurred); see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1234 (9th Cir.2013) (en banc) (claim premised on failure to warn the FDA not preempted). Here, as discussed supra Part IV.A, the federal duty of sameness is not essential to Fulgenzi‘s claim. Thus there is no “partial” preemption, unlike in Mensing.
Nevertheless, the logic of Buckman would encourage exclusion of evidence of federal-law violations where possible. See Bouchard v. Am. Home Prods. Corp., 213 F.Supp.2d 802, 811-12 (N.D.Ohio 2002) (excluding evidence of fraud on the FDA if offered only to show FDA was misled, and also to prevent confusion of the jury as to the nature of the claims). Unless federal law bears on the state duty of care, evidence of such law is inadmissible. If such evidence is relevant, however, Buckman is no bar to its admission. Thus courts have found that, as long as authorized by state law, negligence per se suits premised on violation of federal law could go forward. See Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436, 442 (6th Cir.2010) (negligence per se claim for failure to follow federal “Good Manufacturing Practices” not preempted); see also Hughes v. Boston Scientific Corp., 631 F.3d 762, 771-72 (5th Cir.2011) (negligence per se claim for failure to warn not preempted). Although federal-law violations here are not as relevant as they would be in a negligence per se case, references to federal law will inevitably arise. To avoid Mensing preemption, Fulgenzi must use the language of the 2004 FDA-approved label in her proximate-cause argument, not (or not merely) the fact of the failure to update. Federal standards are also likely to arise in determining the ade-
V
For the foregoing reasons, the decision of the district court with respect to Fulgenzi‘s failure-to-warn claim is REVERSED and REMANDED.
BOGGS
CIRCUIT JUDGE