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Phelps v. Wyeth, Inc.

United States District Court, D. Oregon

April 2, 2013


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For Betty Phelps, Delbert Phelps, Plaintiffs: Daniel J. McGlynn, LEAD ATTORNEY, PRO HAC VICE, McGlynn Glisson & Mouton, LLP, Baton Rogue, LA; Leslie W. O'Leary, Michael L. Williams, Thomas B. Powers, LEAD ATTORNEYS, Steven B. Seal, Williams Love O'Leary & Powers, PC, Beaverton, OR; Terrence Joseph Donahue, Jr., LEAD ATTORNEY, PRO HAC VICE, McGlynn Glisson & Mouton, Baton Rogue, LA; William B. Curtis, LEAD ATTORNEY, PRO HAC VICE, Curtis Law Group, Dallas, TX.

For Pliva USA, Inc., Defendant: Joseph P. Thomas, Tiffany Reece Clark, LEAD ATTORNEYS, PRO HAC VICE, Ulmer & Berne LLP, Cincinnati, OH; Rex A. Littrell, LEAD ATTORNEY, PRO HAC VICE, Ulmer & Berne LLP, Columbus, OH; Susan E Watts, LEAD ATTORNEY, Kennedy Watts Arellano & Ricks, LLP, Portland, OR.

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Ann Aiken, United States District Judge.

Plaintiffs bring this action alleging Betty Phelps was injured after ingesting a generic version of the prescription drug metoclopramide manufactured by Pliva from 2004 through 2007. Specifically, plaintiffs alleged that Pliva was negligent by failing to adequately warn Mrs. Phelps of the dangers of using metoclopramide and by failing to update its product label in 2003 and 2004 to match the warning on the brand-name product. In 2012, Judge Coffin found that plaintiffs' failure to adequately warn claim against Pliva was preempted by PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), and recommended that the undersigned dismiss that claim. (Doc. 260). In April 2012, I adopted Judge Coffin's findings and recommendations and dismissed plaintiffs' failure to warn claim. Remaining is plaintiff's failure to update claim against Pliva. (Doc. 296).

In July 2012, Pliva filed the instant motion for summary judgment on plaintiffs' failure to update claim, arguing that plaintiffs' claim is preempted by federal law and not recognized under Oregon law. (Doc. 301). After oral argument and briefing on the issue, Judge Coffin issued a Findings and Recommendation (F& R) that I deny Pliva's motion for summary judgment. (Doc. 344). Pliva objected to the F& R. (Doc. 347). For the reasons stated below, I adopt Judge Coffin's F& R and deny Pliva's motion for summary judgment.


When a party objects to a magistrate judge's F& R regarding a dispositive motion, the district court must make a de novo determination of that portion of the magistrate judge's report. Fed.R.Civ.P. 72(b) (3); see 28 U.S.C. § 636(b) (1) (C); McDonnell Douglas Corp. v. Commodore Bus. Machs., Inc., 656 F.2d 1309, 1313 (9th Cir. 1981). For non-dispositive motions, the magistrate's findings are reviewed for

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clear error. Fed.R.Civ.P. 72(a); Henry v. Gill Indus., Inc., 983 F.2d 943, 946 (9th Cir. 1993). Defendant filed timely objections to Judge Coffin's findings. I give de novo review of the defendant's objections to the F& R regarding defendant's motion for summary judgment.

Summary judgment is appropriate if " the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). In order to grant summary judgment, there must be no genuine issue of material fact. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The movant has the initial burden of establishing that no genuine issue of material fact exists or that a material fact essential to the nonmovant's claim is missing. Celotex Corp. v. Catrett, 477 U.S. 317, 322-24, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Summary judgment is also appropriate where federal law preempts a plaintiff's state law claims. See e.g., Bank of Am. v. City & Cnty. of S.F., 309 F.3d 551, 556 (9th Cir. 2002).

Once the movant has met its burden, the burden shifts to the nonmovant to produce specific evidence to establish a genuine issue of material fact or to establish the existence of all facts material to the claim. Celotex, 477 U.S. at 322-24; see also Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991); Nissan Fire & Marine Ins. Co., Ltd., v. Fritz Cos., Inc., 210 F.3d 1099, 1105 (9th Cir. 2000).


The following facts are undisputed. Metoclopramide is a prescription drug available in both name-brand and generic forms. Defendant Pliva, at all times relevant to this action, produced a generic form of metoclopramide. Mrs. Phelps was prescribed, and ingested, metoclopramide tablets from November 2002 to at least August 2009. Mrs. Phelps alleges that she developed a movement disorder called tardive dyskinesia during that time. Further, she alleges that her use of metoclopramide caused her to develop this disorder. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a generic drug manufacturer's package inserts must match the package inserts of its name-brand counterpart. 21 U.S.C. § 301 et seq. During 2003 and 2004, Pliva's metoclopramide package inserts did not match the package inserts of its name-brand counterpart. Plaintiffs allege that Pliva's negligent failure to update its labeling injured Mrs. Phelps.

Pliva argues that plaintiffs' failure to update claim is preempted under Mensing and the FDCA, or alternatively, is not cognizable under Oregon law. Pliva also objects to Judge Coffin's findings regarding causation, Oregon's product liability presumption, and punitive damages.


A. Mensing Does Not Require Dismissal of Plaintiffs' Failure to Update Claim

Pliva argues that Judge Coffin has misconstrued the Supreme Court's holding in PLIVA, Inc. v. Mensing. 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) and objects to the finding that plaintiffs' claim is not preempted. In his findings, Judge Coffin states that under Mensing, a generic manufacturer could not be liable for a failure to warn so long as it complied with the FDA regulations that require generic manufacturers to update its warnings to match those contained in the name-brand equivalents. (Doc. 344 at 2). Nonetheless, because Pliva allegedly failed to update its warnings in accordance with FDA regulations, Judge Coffin found that Pliva could be liable for that failure notwithstanding Mensing. Pliva argues that this interpretation inserts an exception into Mensing that is inconsistent with the Court's holding that any state-law failure

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to warn claim is preempted. (Doc. 347 at 8-9).

Under the FDCA, generic drug manufacturers " have an ongoing federal duty of 'sameness'" regarding their warning labels. Mensing, 131 S.Ct. at 2575. This duty of sameness requires that generic drug labeling match the equivalent name-brand drug's labeling. 21 U.S.C. § 355(j) (2) (A) (v). Furthermore, the FDCA prohibits generic manufacturers from issuing additional or different warnings on their products. Mensing, 131 S.Ct. at 2576. In light of these rules, the Supreme Court held that state-law failure to warn claims against generic manufacturers were preempted.

In Mensing, the plaintiffs argued that state law required generic drug manufacturers to provide a stronger warning than the name-brand label, and that they failed to do so despite the known risk that metoclopramide can cause tardive dyskinesia. Id. at 2573. The Court explained that where it is impossible for a party to comply with both state and federal law, a conflict between the two exists, and state law must give way to federal law. Id. at 2577. Because it was impossible under the FDCA for the generic manufacturers to unilaterally strengthen their labels to conform to the state law requirements, the Court held that the plaintiffs' state-law failure to warn claims were preempted. Id. at 2577-78. (finding preemption because " [i]t was not lawful under federal law for the Manufacturers to do what state law required of them." ) Pliva argues that the same rationale applies here because the Court did not exclude failure to update claims from its holding.

I conclude that Judge Coffin's interpretation of Mensing is consistent with that case and hold that plaintiffs' failure to update claim is not preempted under Mensing. While it is true that the Supreme Court in Mensing did not carve out an exception for failure to update claims, the absence of a specific exception does not warrant the conclusion that such claims are preempted under Mensing. This is especially true considering the factual differences between a failure to warn claim and plaintiffs' failure to update claim. The crux of the Court's decision in Mensing rested on the fact that the plaintiffs claimed that state law required generic manufacturers to provide stronger labels than were permitted by federal law. As the Court pointed out, this was impossible for the generic manufacturers given the federal requirement that generic labels match name-brand labels. Id. at 2577-78. Plaintiffs' failure to update claim in this case, however, poses no such impossibility problem. Unlike the failure to warn claim in Mensing, plaintiffs do not claim that Pliva was required to use a different or stronger warning label; they merely claim that, under Oregon law, Pliva was negligent by failing to update its label to match the name-brand label - a requirement that is consistent with the FDCA. Thus, because plaintiffs' state-law claim does not make it impossible for Pliva to comply with federal law, no conflict exists and preemption is not warranted.[1]

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Pliva nonetheless argues that the Supreme Court held that plaintiffs' failure to update claim was preempted in Mensing, because the Court knew that at least one of the generic manufacturers in that case had failed to update its label, and yet the Court did not limit its holding to exclude those kinds of claims. Pliva claims that during the Mensing case, the Court was aware that Pliva may not have made the label change in 2003 and 2004 because Pliva's counsel wrote a letter to the Court's clerk mentioning that fact. (Doc. 347 at 9). According to Pliva, if the Supreme Court thought a failure to update claim was cognizable, it would have said so in Mensing.

I agree with Judge Coffin and conclude that Pliva's argument is inconsistent with Supreme Court precedent. The Supreme Court has a long-standing rule that if the Court has " never squarely addressed the issue . . . [the Court is] free to address the issue on the merits." Brecht v. Abrahamson, 507 U.S. 619, 631, 113 S.Ct. 1710, 123 L.Ed.2d 353 (1993). Indeed, " [q]uestions which merely lurk in the record, neither brought to the attention of the court nor ruled upon, are not to be considered as having been so decided as to constitute precedents." Webster v. Fall, 266 U.S. 507, 511, 45 S.Ct. 148, 69 L.Ed. 411 (1925). Thus, an issue not " raised in briefs or argument nor discussed in the opinion of the Court. . . . is not a binding precedent on [that] point." U.S. v. L.A. Tucker Truck Lines, Inc., 344 U.S. 33, 38, 73 S.Ct. 67, 97 L.Ed. 54 (1952).

Under this rule, Pliva's argument fails, and the precedential power of Supreme Court rulings demands such a result. Were it possible for a party to expand the scope of a Supreme Court ruling by merely sending a letter, the Court's decisions could be subject to unwarranted, unconsidered expansion. Accordingly, because the Court in Mensing did not address the failure to update claim expressly in its decision, I refuse to find that it did so impliedly through its silence.

Nonetheless, Pliva argues that the Sixth and Eighth Circuits have held that plaintiffs' failure to update claim is preempted by Mensing. First, Pliva contends that in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), the Sixth Circuit's denial of a plaintiffs' petition for rehearing constituted a rejection of failure to update claims under Mensing because the plaintiffs raised the failure to update issue in their petition and the court nonetheless denied their petition. (Doc. 347 at 10-11). The Smith court's decision, however, did not mention anything about a failure to update claim, and referred only to the plaintiffs' failure to warn claim. Smith, 657 F.3d at 423 (holding that the plaintiffs' state-law failure to warn claims were preempted by Mensing because " [t]he Supreme Court held unequivocally . . . 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" ).

Next, Pliva maintains that the Eighth Circuit's decision to deny supplemental briefing after the Supreme Court remanded the Mensing v. Wyeth case back to the court demonstrates that Mensing preempts such claims. Mensing v. Wyeth, Inc., 658 F.3d 867, 2011 WL 4636653 (8th Cir. 2011). Pliva reasons that because the Supreme Court remanded the case to the Eighth Circuit with instructions to conduct " further proceedings consistent with [the Court's] opinion", the Eighth Circuit's denial of supplemental briefing on the failure to update

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issue is evidence that Mensing did require preemption of failure to update claims. Mensing, 131 S.Ct. at 2582.

I reject these arguments for two reasons. First, neither court specifically addressed the failure to update theory in their decisions. Thus, while the issue may have lurked in the record, it was not decided by the court. Additionally, a court's decision to grant or deny rehearing or supplemental briefing does not necessarily indicate a substantive decision on issues proposed to be argued in that additional briefing or petition. Second, even assuming arguendo that the Sixth and Eighth Circuits did decide that failure to update claims are preempted, those circuits' decisions are not binding precedent on this court. Thus for the reasons stated above, I find that Judge ...

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