TIGERT v. RANBAXY PHARMACEUTICALS, INC. et al
Filing
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OPINION. Signed by Judge Robert B. Kugler on 12/18/2012. (drw)
NOT FOR PUBLICATION
(Doc. No. 30)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
CAMDEN VICINAGE
___________________________________
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Plaintiff,
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v.
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RANBAXY PHARMACEUTICALS, INC :
et. al.,
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Defendants.
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___________________________________ :
BRITTANI TIGERT,
Civil No. 12-00154 (RBK/JS)
OPINION
KUGLER, United States District Judge:
This matter comes before the Court on the motion of Medicis Pharmaceutical
Corporation (“Defendant”) for judgment on the Second Amended Complaint of Brittani Tigert
(“Plaintiff’), pursuant to Federal Rule of Civil Procedure 12(c). Plaintiff allegedly suffered
serious liver damage after taking the prescription drug Solodyn®. Plaintiff now contends that
Defendant failed to adequately warn consumers of Solodyn’s dangers, seeking damages under
either a strict products liability or negligence theory of liability. Defendant asserts its
presumptive non-liability under Texas law, which undisputedly applies to this case. Defendant
further notes that both the Fifth Circuit Court of Appeals and several Texas district courts have
held that the immunity exception Plaintiff seeks to invoke is preempted by federal law. Despite
Defendant’s request that the Court defer to the Fifth Circuit’s ruling, the Court finds that the
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presumption against preemption obtains in this case. Accordingly, Defendant’s motion for
judgment on the pleadings is DENIED.
I.
BACKGROUND
Plaintiff, a 21 year old college student, was prescribed Solodyn® (“Solodyn”) to treat her
acne. Compl. ¶7.3. Defendant manufactures, markets, and distributes Solodyn. Id. at ¶6.3.
After allegedly filling six prescriptions for the drug, Plaintiff suffered serious liver damage and
experienced liver failure. Id. at ¶7.5. Plaintiff claims that when she was originally prescribed
Solodyn, the drug’s packaging insert “grossly understated the risks associated” with Solodyn. Id.
at ¶8.6. The actual label on the drug, however, was approved by the Food and Drug
Administration (“FDA”) and featured FDA-approved warnings. See Id. at ¶8.6. Plaintiff
continues to receive treatment for her condition and claims that her use of Solodyn caused
permanent injuries. Id. at ¶7.4.
Plaintiff now seeks damages, under either strict products liability or a negligence theory
of liability, for Defendant’s alleged failure to warn consumers and medical care professionals of
the potential dangers of Solodyn. Plaintiff initially also brought common law claims for
misrepresentation of facts, breach of implied warranty, and fraudulent concealment, but later
stipulated to their dismissal.
Defendant files the present motion asserting its immunity as a matter of law. Under
Texas law, defendants in “failure to warn” products liability actions are afforded a rebuttable
presumption of non-liability when “the warnings or information that accompanied the product in
its distribution were those approved by the United States Food and Drug Administration.” Tex.
Civ. Prac. & Rem. Code §82.007(a)(1). This presumption may be rebutted by establishing that
“the defendant, before or after pre-market approval. . .withheld from or misrepresented to the
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United States Food and Drug Administration required information that was material and relevant
to the performance of the product and was causally related to the claimant’s injury.”
§82.007(b)(1). Defendants raise §82.007(a)(1) as an affirmative defense and contend that the
§82.007(b)(1) exception is preempted by federal law according to the Supreme Court’s decision
in Buckman Co. v Plaintiff’s Legal Comm., 531 U.S. 341 (2001). Plaintiff urges this Court to
adopt an alternative interpretation of both the Texas statute and recent case law and find no
preemption.
II.
LEGAL STANDARD
Under Fed. R. Civ. P. 12(c), a court will grant judgment on the pleadings if, on the basis
of the pleadings, no material issue of fact remains and the movant is entitled to judgment as a
matter of law. See Fed. R. Civ. P. 12(c); DiCarlo v. St. Mary Hosp., 530 F.3d 255, 259 (3d Cir.
2008). In reviewing 12(c) motions, the court must accept the nonmoving party’s well-pleaded
factual allegations as true and construe those allegations in the light most favorable to the
nonmoving party. See DiCarlo, at 262-63. The court “may grant such a motion only where ‘it
appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which
would entitle him to relief.’” Carino v. Stefan, 376 F.3d 156, 159 (3d Cir. 2004) (quoting Conley
v. Gibson, 355 U.S. 41, 45-46 (1957)).
III.
DISCUSSION
Plaintiff’s ability to overcome Defendants’ presumptive non-liability hinges on whether this
Court will follow the Fifth Circuit decision in Lofton v. McNiel Consumer & Specialty
Pharmaceuticals that §82.007(b)(1) is preempted, or adopt the position of the Second Circuit and
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determine that it is not. 1 See Lofton, 672 F.3d 372 (5th Cir. 2012); see Desiano v. WarnerLambert & Co., 467 F.3d 85 (2d Cir. 2006). Defendant encourages the Court to defer to the
Fifth Circuit’s interpretation of Buckman, citing the general principle that, where possible, courts
should interpret the law to avoid circuit conflicts. See Def.’s Reply Br. Further Supp. Mot. J.
Pleadings (“Def.’s Reply Br.”) at 3-4. Defendant further notes that the Court should defer to the
Fifth Circuit because it is the regional circuit court. Id. at 4.
As a preliminary matter, this Court is not bound by the Fifth Circuit’s interpretation of
federal law. See e.g. Desiano, 467 F.3d at 90-91 (stating the court was not obligated to defer to a
foreign circuit’s views on federal law); see also Colby v. J.C. Penny Co., Inc., 811 F.2d 1119,
1123 (7th Cir. 1987) (noting that neither circuit nor district courts are required to give automatic
deference to the decisions of other courts of appeals). Moreover, whatever duty the Court may
have had to avoid a circuit conflict is now irrelevant, as a split of authority already exists among
courts who have addressed this issue. See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir.
2004) (holding that Michigan statute containing an immunity exception was preempted by
federal law); accord Lofton, 672 F.3d at 381 (§82.007(b)(1) preempted by federal law absent the
FDA’s prior finding of fraud). But see Desiano, 467 F.3d at 98 (concluding that the Michigan
immunity exception is not prohibited through preemption); accord Yocham v. Novarties
Pharmaceuticals Corp., 736 F.Supp.2d 875 (D.N.J. 2010) (holding that §82.007(b)(1) not
preempted by federal law). Therefore, this Court will evaluate the question of federal
preemption independently, declining to automatically defer to the Fifth Circuit’s interpretation.
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Neither party challenges the applicability of Texas law to this dispute. See Pl. Second Amend. Compl. at 18;
Def.’s Mot. J. Pleadings at 1. As such, a choice of law analysis is unnecessary.
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The Lofton Decision
The Fifth Circuit faced a substantially similar question to the one now before this Court in
Lofton. The plaintiffs sued a drug manufacturer for the manufacturer’s alleged failure to warn
consumers of the risk of severe autoimmune allergic reactions to Motrin®. Lofton, 672 F.3d at
374. The drug manufacturer moved for summary judgment, asserting the Texas presumption of
non-liability. Id. The plaintiffs attempted to overcome the presumption by arguing, pursuant to
§82.007(b)(1), that the drug manufacturer had withheld or misrepresented material information
to the FDA, but the district court found that federal law preempted the state statute. Id. at 375.
On appeal, the Fifth Circuit affirmed the district court’s ruling. Id. at 381.
In the absence of directly on point precedent from either the United States or Texas Supreme
Court, the Fifth Circuit searched for guidance in relevant Supreme Court decisions and the
conflicting decisions of two circuit courts. At the time, the Supreme Court had held that
traditional products liability claims were not preempted merely because a drug’s warning label
was approved by the FDA, See Wyeth v. Levine, 555 U.S. 555 (2009), but that fraud on the
agency claims, in which liability attached “solely by virtue of the FDCA disclosure
requirements,” were preempted by federal law. See Buckman Co. v Plaintiff’s Legal Comm.,
531 U.S. 341 (2001). The Lofton court first questioned whether the Texas statute fit more
appropriately within the Buckman framework or was shielded from preemption altogether under
Wyeth. Lofton, 672 F.3d 375-77. After deciding that the Buckman framework applied, the court
then evaluated competing interpretations of the Supreme Court’s decision. Id. at 377.
Both the Second and Sixth Circuit had encountered the question of Buckman preemption
with a similar Michigan immunity exception 2 and reached divergent conclusions. The Sixth
2 The Michigan statute stated in relevant part:
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Circuit determined that the exception was impliedly preempted by Buckman, because the statute
“inevitably conflict[ed] with the FDA’s responsibility to police fraud consistently with the
Agency’s judgment and objectives.” Garcia, 385 F.3d at 965 (quoting Buckman, 531 U.S. at
350). Noting the applicability of concerns about judicial interference with the FDA cited in
Buckman, the Sixth Circuit found that the Michigan statute was not sufficiently distinct from a
fraud on the agency claim to merit differential treatment. Id. at 965-66. Consequently, the court
held that unless the FDA itself had already found fraud, plaintiffs could not attempt to overcome
the presumption of non-liability by invoking the “fraud-on-the-FDA” statutory exception. Id. at
967.
The Second Circuit, however, subscribed to a narrower interpretation of Buckman, holding
that the Michigan statute was not preempted. See Desiano, 467 F.3d at 98. The court first found
that the “presumption against preemption,” which did not apply in Buckman, attached to the
plaintiff’s claims because they fell within the legislature’s power to regulate matters of health
and safety, “a sphere in which the presumption against preemption. . . stands at its strongest.” Id.
at 94. The court also noted that the plaintiffs were not pursuing “fraud-on-the-FDA” claims, but
rather were “asserting claims that sound in traditional state tort law.” 3 Id. The court further
“(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or
unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy
by the United States food and drug administration, and the drug and its labeling were in compliance with the United
States food and drug administration's approval at the time the drug left the control of the manufacturer or seller. . .
This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any
of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration
information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic
act, and the drug would not have been approved, or the United States food and drug administration would
have withdrawn approval for the drug if the information were accurately submitted.” Mich. Comp. Laws
Ann. § 600.2946 (5)(citations omitted).
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The Second Circuit also importantly noted that the position of no preemption aligned with the pharmaceutical
industries’ position articulated during oral argument in Buckman. The pharmaceutical industry stressed the unusual
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distinguished the matter before them from Buckman because proof of fraud against the FDA was
not an actual element of the plaintiffs claim, but rather would become germane “only if a
defendant company chooses to assert an affirmative defense made available by the Michigan
legislature.” 4 Id. at 96 (emphasis in original). Noting that “common law liability cannot be
easily displaced in our federal system,” the court found that the Michigan statute did not
“implicate the same concerns that animated the Supreme Court’s decision in Buckman” and was
consequently not preempted. Id. at 97.
The Fifth Circuit evaluated each court’s rationale and found the Second Circuit’s
interpretation unpersuasive. See Lofton, 672 F.3d at 379. Skirting the question of whether the
presumption against preemption applied, the court reached the conclusion that “because
§82.007(b)(1) requires a Texas plaintiff to prove fraud-on-the-FDA to recover for failure to
warn, this requirement invokes federal law supremacy according to Buckman.” Id. The court
rejected the Second Circuit’s distinction between fraud on the agency as a predicate to recovery
and the fraud on the agency cause of action, asserting that the distinction fails “when the statute
at issue conditions recovery on ‘establishing’ what amounts to fraud on the agency.” Id. at 380.
The court adopted the Sixth Circuit’s ruling on this basis, finding that “the threat of imposing
state liability on a drug manufacturer for defrauding the FDA intrude[d] on the competency of
the FDA and its relationship with regulated entities.” Id.
nature of the claims asserted by the plaintiffs and stated that “this is a very unusual form of State law product
liability action. The plaintiffs don’t claim that these devices were in any way defective. There’s no claim here of
manufacturing defect. There’s no claim here of design defect. The plaintiffs also don’t claim that the surgeon who
used these devices did anything wrong. There’s no claim of medical malpractice.” Desiano, 467 F.3d at 95 (quoting
Oral Argument Transcript, Buckman, 531 U.S. 341 (2000)(No. 98-1768)).
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The Court is not persuaded by this argument or by the Second Circuit’s assertion that “only when proof of fraud is
by itself sufficient to impose liability-and indeed is the sole basis of liability (as it was in Buckman)-does the
incentive to flood the FDA appreciably escalate.” Desiano, 467 F.3d at 97 (emphasis in original). This is a
“distinction without a difference.” Yocham, 736 F.Supp.2d at 888. As a practical matter, the concerns of flooding
the FDA remain whether fraud on the agency is an essential element of the plaintiff’s claim, or a procedural hurdle
to overcome the presumption of non-liability. Nevertheless, the Court finds that the statute is not preempted.
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Reconsidering Lofton
The Fifth Circuit emphasized the dangers recognized in Buckman and their potential
realization if plaintiffs were permitted to invoke §82.007(b)(1) to overcome defendants’
presumptive non-liability. Unfortunately, the court highlighted certain portions of the Buckman
opinion to the exclusion of others. The Supreme Court indeed cautioned that state law fraud-onthe-agency claims incentivized applicants “to submit a deluge of information that the
Administration neither wants nor needs, resulting in additional burdens on the FDA’s evaluation
of an application.” Buckman, 531 U.S. at 351. This was not, however, the primary rationale
motivating the decision.
The Supreme Court reached concerns of burdening the FDA only after determining that the
presumption against preemption did not obtain in Buckman. The court contrasted fraud on the
agency claims, which existed “solely by virtue of the FDCA disclosure requirements,” from
traditional state tort law claims, which implicated “federalism concerns and the historic primacy
of state regulation of matters of health and public safety.” Id. at 347-48, 353. The court further
distinguished the claims in Buckman from traditional state tort law claims by noting that fraud
on the agency claims served solely as a mechanism for policing the FDA. This mechanism was
not only duplicative, as the FDA “has at its disposal a variety of enforcement options that allow
it to make a measured response to suspected fraud upon the Administration,” but also potentially
troublesome as it could impose “additional burdens” on the FDA. See Id. at 349-51. This
distinction is crucial because unlike traditional state tort law claims in which the plaintiffs must
still establish the elements of a tort, thus regulating the interaction between the defendant and
plaintiff, fraud on the agency claims regulated only the “defendant’s interaction with a federal
agency.” Yocham, 736 F.Supp.2d at 887. The Fifth Circuit overlooked these critical differences
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when it failed to recognize the applicability of the presumption against preemption and expanded
Buckman preemption to §82.007(b)(1).
While this Court finds persuasive Defendant’s argument that similar concerns of judicial
oversight of the FDA manifest with §82.007(b)(1), these concerns were not the decisive factors
in the Supreme Court preempting fraud on the agency claims. The court reached concerns of
interference only after first finding that fraud on the agency claims presented a unique
circumstance in which the traditional presumption against preemption of state law did not apply.
Such is not the case here. As such, the Supreme Court’s narrow ruling in Buckman is unstable
ground on which to rest a finding of preemption. Therefore, the Court finds that §82.007(b)(1) is
not preempted by federal law.
Sufficiency of Plaintiff’s Second Amended Complaint
Defendant alternatively argues that if the Court declines to follow Lofton, the Court must
still grant the motion for judgment on the pleadings because Plaintiff does not allege fraud with
sufficient particularity pursuant to Federal Rule of Civil Procedure 9(b). 5 Fed. R. Civ. Proc. R.
9(b) (2006). This argument was raised for the first time in Defendant’s reply brief. In both the
Answer and brief in support of the motion for judgment on the pleadings, Defendant contends
that Plaintiff failed to allege fraud with particularity only with respect to the misrepresentation,
breach of implied warranty, and fraudulent concealment claims, all of which were voluntarily
dismissed. See Def.’s Answer ¶¶ 10.1-12.10; see also Def.’s Mot. J. Pleadings at 12.
Consequently, the Court will decline to consider this argument. See U.S. v. Boggi, 74 F.3d 470,
478 (3d Cir. 1996) (Court of appeal would not consider arguments raised in a reply brief so that
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Defendant also implies, without any supporting law, that Plaintiff’s stipulation to dismissal of the
misrepresentation and fraudulent concealment claims precludes her from invoking the statutory exceptions to
Defendant’s presumptive non-liability. The Court finds this argument unpersuasive.
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appellees are not prejudiced by the lack of opportunity to respond); see also Stern v. Halligan,
158 F.3d 729, 731 n.3 (3d Cir. 1998) (“A party cannot raise issues for the first time in a reply
brief.”); see also D’alessandro v. Bugler Tobacco Co., 2007 WL 130798 (D.N.J. Jan. 12, 2007)
(stating that a moving party may not raise new issues in a reply brief because “no sur-reply is
permitted, so the opponent has no opportunity to address the new defense.”)
IV.
CONCLUSION
For the foregoing reasons, Defendant’s motion for judgment on the pleadings pursuant to
Federal Rule of Civil Procedure 12(c), is DENIED. An accompanying order shall issue today.
Dated: 12/18/2012
/s/ Robert B. Kugler
ROBERT B. KUGLER
United States District Judge
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