While We’re Waiting on Bartlett, Some New Preemption Challenges to Consider

By Kurt R. Karst –      

As folks in the generic drug industry patiently await the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-142), a design defect generic drug preemption case (see our previous post here), we thought we would whet the preemption appetite with two new petitions to the Supreme Court and an interesting state court decision.

Novartis Pharmaceuticals Corp. v. Fussman (Docket No. 12-1339).  In a petition for a writ of certiorari filed earlier this month, Novartis Pharmaceuticals Corporation (“NPC”) is appealing a February 2013 decision (unpublished) from the U.S. Court of Appeals for the Fourth Circuit involving NPS drugs AREDIA (pamidronate disodium) and ZOMETA (zoledronic acid). 

The Fourth Circuit, in affirming a district court’s denial of NPC’s motion for judgment as a matter of law on preemption theory, rejected NPS’s attempt to “carve out a niche in existing precedent” by arguing that Wyeth v. Levine, 555 U.S. 555 (2009), in which the Supreme Court held that a state-law tort action against a brand-name drug manufacturer for failure-to-warn is not preempted, “is inapplicable because it does not expressly reference punitive damages.”  NPS had argued that the FDC Act preempts the recovery of punitive damages because “(1) the purpose of punitive damages is to punish and deter, something the FDA has ‘ample power’ to accomplish through enforcement of labeling requirements and (2) allowing the punishment of FDA-approved conduct is improper.”  According to NPS, Wyeth concerned only compensatory damages.

The questions NPS presents in the case are:

1. Whether the FDA’s exclusive authority to punish violations of federal law governing the lawful marketing of prescription drugs preempts state tort law which allows the imposition of punitive damages to punish the same activity.

2. Whether a punitive damages award imposed in connection with the marketing of an FDA-approved drug impermissibly penalizes a drug manufacturer under state law for the exercise of its federal right to market the prescription drug.

3. Whether the Fourth Circuit below erred in basing its holding solely on [Wyeth], which does not address punitive damages.

NPS argues in its petition, among other things, that:

There was no award of punitive damages in [Wyeth] and, accordingly, no occasion for the Court to consider the separate preemption issue arising from such an award.  In its holding, however, the Court noted that state tort law claims “serve a distinct compensatory function.”  The Court also explained that in enacting the FDCA “Congress did not provide a federal remedy for consumers harmed by unsafe or ineffective drugs.”  By sharp contrast, the FDCA provides a wide variety of federal remedies by which the FDA may punish drug companies for alleged misconduct, and it provides a means for private individuals to raise such allegations through pubic citizen’s petitions. [(Internal citation omitted)]

That last sentence and some other related discussion in the petition about petitioning FDA caught our attention.  Although private individuals can certainly raise allegations in a citizen petition, just last year, FDA denied a citizen petition (Docket No. FDA-2012-P-0431) requesting that the Agency take enforcement action against a particular company.  According to FDA, “[r]equests for the Agency to initiate enforcement actions are not within the scope of FDA’s citizen petition procedures.”  Indeed, FDA’s regulation at 21 C.F.R. § 10.30(k) concerning citizen petitions states the regulation “does not apply to the referral of a matter to a United States attorney for the initiation of court enforcement action and related correspondence, or to requests, suggestions, and recommendations made informally in routine correspondence received by FDA. . . .”

Medtronic, Inc. v. Stengel (Docket No. 12-1351).  In a petition for a writ of certiorari that came out last week, Medtronic, Inc. (“Medtronic”) is appealing a January 2013 en banc decision from the U.S. Court of Appeals for the Ninth Circuit involving Medtronic’s Class III medical device, SynchroMed Pump & Infusion System and claims that the company was negligent under Arizona law because it allegedly violated requirements under the FDC Act to report adverse event information.

The Ninth Circuit held that respondents’ negligence claim was not impliedly preempted under the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), “because it was based on duties imposed by Arizona common law and was not brought exclusively under federal law.”  The Ninth Circuit further held that respondents’ negligence claim was not expressly preempted under the Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and under the FDC Act, “because the court deemed the state-law duties of reasonable care on which respondents relied to be “parallel[ ]” to the federal duty to report information to the FDA.”  In Buckman, the Supreme Court ruled that federal law impliedly preempted state “fraud-on-the-FDA” claims.  In Riegel, the Court found express preemption for devices subject to premarket approval based on express statutory language.

According to Medtronic:

The Ninth Circuit’s decision in this case deepens two direct and acknowledged circuit splits concerning the preemptive effect of the Medical Device Amendments (“MDA”) to the [FDC Act].  It also directly contravenes, and effectively nullifies, this Court’s holdings in [Buckman] and [Riegel]. . . .  Congress granted exclusive enforcement authority to the FDA so that it could establish a uniform federal regulatory framework and strike a balance that both promotes safety and ensures that the development of innovative devices is not “stifled by unnecessary restrictions.”  Private enforcement, in contrast, would jeopardize the public health by permitting lay juries to second-guess the FDA’s expert regulatory judgment.  Those jury trials would enmesh federal regulators in litigation as fact witnesses needed to prove what the agency would have done differently in the absence of alleged MDA violations, and interfere with the FDA’s carefully calibrated enforcement decisions. 

The question presented by Medtronic in its petition is “whether the MDA preempts a state-law claim alleging that a medical device manufacturer violated a duty under federal law to report adverse-event information to the FDA.”

Krelic v. Mutual Pharmaceuticals Co., Case No. GD-08-024513 (Pa. C.P. Allegheny Co. Apr.11, 2013).  Our friends over at Drug and Device Law Blog recently posted on an interesting from Pennsylvania (Allegheny County) Judge R. Stanton Wettick, Jr. rejecting a novel argment raised by the plaintiffs against preemption under the Supreme Court’s decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011).  In Mensing, the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers, because it is impossible for generic drug manufacturers to comply with both federal and state duties to warn.

The argument raised by plaintiffs in this case concerning prednisone is that the “different manufacturers exception” at FDC Act 505(j)(2)(A)(v) (and further discussed in FDA’s regulations at 21 C.F.R. §314.94(a)(8)(iv)) to the requirement that ANDA sponsors have the same labeling as the Reference Listed Drug (“RLD”) relied on for approval was somehow not covered by the Court’s Mensing decision.  (You can access the briefs in the case here by entering the case number above.)  Our friends at Drug and Device Law Blog characterized the exception as applying to “mundane things, such as corporate name, and inactive ingredients.”  We take some exception to that characterization.  Indeed, the statutory and regulatory exception from the same labeling requirement is the basis for our popular Labeling Carve-Out Citizen Petition Scorecard.  In any case, the court refused to accept the argument, saying that the exception “does not permit different labeling as to safety and efficacy.”

This is not the first time a Pennsylvania state court has rejected an attempt to avoid Mensing.  As we previously reported (here and here), several courts, including the Philadelphia Court of Common Pleas, have rejected the so-called “RLD Theory of Liability.”  Under that theory, FDA’s regulations impose new or additional responsibilities on an ANDA sponsor whose drug product is unilaterally designated by FDA as an RLD in the Orange Book when the brand-name NDA RLD is no longer marketed.