Lashley v. Pfizer, Inc.

• Decision Date: 21 February 2014
• Docket Number: 12–41148.,Nos. 12–60861,s. 12–60861
• Citation: 750 F.3d 470
• Parties: Walter LASHLEY, Plaintiff–Appellant, v. PFIZER, INC.; Wyeth, Inc.; Schwarz Pharma, Inc.; Watson Pharma, Inc.; Watson Laboratories, Inc.;, Defendants–Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

750 F.3d 470

Walter LASHLEY, Plaintiff–Appellant,

v.PFIZER, INC.; Wyeth, Inc.; Schwarz Pharma, Inc.; Watson Pharma, Inc.; Watson Laboratories, Inc.;, Defendants–Appellees.

Nos. 12–60861, 12–41148.

United States Court of Appeals, Fifth Circuit.

Feb. 21, 2014.

Terrence J. Donahue, Jr., Esq., Daniel J. McGlynn, McGlynn Glisson & Mouton, Baton Rouge, LA, William B. Curtis, Curtis Law Group, Dallas, TX, Gerald Joseph Diaz, Jr., Diaz Law Firm, P.L.L.C., Madison, MS, for Plaintiff–Appellant.

Kevin Christopher Newsom, Esq., Lindsey C. Boney, Esq., Attorney, Bradley Arant Boult Cummings, L.L.P., Birmingham, AL, Walter Thomas Johnson, Leigh Davis Vernon and Steve Orlansky, Watkins & Eager, P.L.L.C., Jackson, MS, Henninger Simons Bullock, Andrew Jonathan Calica, Attorney, Mayer Brown, L.L.P., New York, NY, Joseph Paul Thomas, Linda E. Maichl, Esq., Jeffrey Francis Peck, Attorney, Ulmer & Berne, L.L.P., Cincinnati, OH, Rex Allen Littrell, Ulmer & Berne, L.L.P., Columbus, OH, Ronald G. Peresich, Esq., Page, Mannino, Peresich & Mcdermott, P.L.L.C., Biloxi, MS, Michael Andrew Walsh, Sr., Esq., Attorney, Strasburger

& Price, L.L.P., Dallas, TX, Richard Anthony Oetheimer, Esq., Goodwin Procter, L.L.P., Boston, MA, William F. Sheehan, Esq., Attorney, Goodwin Procter, L.L.P., Washington D.C., Michael G. Terry, Hartline Dacus Barger Dreyer, L.L.P., Corpus Christi, Kannon K. Shanmugam, Williams & Connolly, L.L.P., Washington D.C., for Defendants–Appellees.

Appeals from the United States District Courts for the Southern District of Mississippi and the Southern District of Texas, USDC Nos. 1:09–cv–00749 and 1:11–cv–000113.

Before STEWART, Chief Judge, and HIGGINBOTHAM, Circuit Judge.^*

PER CURIAM:

These appeals arise out of claims against both generic and brand-name manufacturers for injuries related to use of the drug metoclopramide (brandname Reglan). Because the pertinent facts and legal issues of these cases are nearly identical, we consolidate them for disposition.

In case No. 12–60861, Lashley v. Pfizer, et al., Appellant Walter Lashley (“Lashley”) appeals the Southern District of Mississippi's grant of Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc.'s (“Watson generic defendants”) motion to dismiss, as well as its grant of summary judgment in favor of defendants Pfizer, Inc.; Wyeth, Inc.; and Schwarz Pharma, Inc. (“Pfizer brand defendants”). Lashley's claims against the Watson generic defendants were based upon their sale and distribution of metoclopramide to Lashley. His claims against the Pfizer brand defendants were based on allegedly false and misleading representations they made to the medical community.

In case No. 12–41148, Del Valle v. Teva Pharm.,et al., Appellant Maria Del Valle (“Del Valle”) similarly appeals the Southern District of Texas's grant of Qualitest Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; PLIVA, Inc.; and Vintage Pharmaceuticals, LLC's (“Teva generic defendants”) ¹ motion to dismiss and its grant of Schwarz Pharma, Inc. and Wyeth, Inc.'s (“Schwarz brand defendants”) ² motion for summary judgment. Del Valle alleged that the Teva generic defendants were liable for damages she experienced as a result of her ingestion of metoclopramide manufactured by these defendants. Her claims against the Schwarz brand defendants were based on alleged misrepresentations they made to the medical community.

For the reasons stated herein, we AFFIRM the district courts' rulings in both cases.

I. Facts

Lashley took generic metoclopramide from 2002 until late 2006. In 2004, brand defendant Schwarz submitted a label update for Reglan adding that “[t]herapy with Reglan tablets should not exceed 12 weeks in duration,” which the FDA approved. Not all generic manufacturers modified their labels to conform with the newly approved warnings at that time. Lashley developed the movement disorders tardive dyskinesia and akathisia as a result of taking the drug and brought suit in October 2009. As noted above, he sued the Watson generic defendants based on their sale and distribution of the drug and sued the Pfizer brand defendants for misrepresentations made to the medical community. He brought claims against all defendants under theories including negligence, gross negligence, strict liability, breach of warranty as to merchantability, breach of warranty as to fitness for a particular purpose, misrepresentation, fraud, and suppression of evidence.

Del Valle took generic metoclopramide from 2004 to February 2011. Like Lashley, she developed tardive dyskinesia and akathisia as a result of taking the drug. She brought suit in June of 2011. She sued the Teva generic defendants based on their manufacture and distribution of metoclopramide, under theories of negligence, gross negligence, misrepresentation, fraud, suppression of evidence, strict liability, breach of warranty as to merchantability, breach of warranty as to fitness for a particular purpose, and deceptive trade practices. She brought the same claims against the Schwarz brand defendants for their role in the promotion and manufacture of the drug, with the exception of deceptive trade practices.

The courts below in both cases dismissed the claims against the generic manufacturers, finding them to be either preempted under PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (holding failure-to-warn claims against generic manufacturers of Reglan preempted) or deficient for failure to state a claim on which relief could be granted. SeeFed.R.Civ.P. 12. All the claims against the generic manufacturers were treated as variations of a failure-to-warn claim. See Morris v. PLIVA, Inc., 713 F.3d 774, 778 & n. 6 (5th Cir.2013) (per curiam) (“Appellants next argue that the generic defendants failed to test and inspect the product according to federal law ... [A]ny ‘useful’ reporting—at least from the standpoint of those injured—would ostensibly consist of some sort of warning.”).³ The district courts granted summary judgment in favor of brand manufacturers in both cases below, on the grounds that neither Lashley nor Del Valle ever ingested their product, Reglan. These appeals timely followed.

II. Claims Against Generic Manufacturers

Appellants argue that the lower courts erred in dismissing their claims against generic manufacturers as preempted under Mensing.⁴ We review grants of Rule 12(b)(6) motions to dismiss de novo. Highland Capital Mgmt. LP v. Bank of Am., Nat'l Ass'n, 698 F.3d 202, 205 (5th Cir.2012). Judgments on the pleadings are also reviewed de novo; Rule 12(c) motions are governed by the same standard as Rule 12(b)(6) motions. ⁵Jebaco, Inc. v. Harrah's Operating Co., 587 F.3d 314, 318 (5th Cir.2009). The fundamental question is whether the plaintiff states a claim on which relief may be granted.

In order to place their claims outside the ambit of Mensing, both Lashley and Del Valle argue for a very narrow interpretation of that case. Their arguments are unavailing. The Court in Mensing held that federal law demands “generic drug labels be the same at all times as the corresponding brand-name labels.” 131 S.Ct. at 2578. This duty of sameness is overlaid with the agency's pronouncement that “Dear Doctor” letters (or other forms of warning) from a generic manufacturer constitute labeling. Because of this, potential state law duties requiring generic manufacturers to act unilaterally concerning any consumer warnings are preempted. Id. at 2580–81. At their core, all Lashley and Del Valle's claims against the generic manufacturers turn on the adequacy of labeling and related information, and can thus be construed as failure-to-warn claims. As such, we find them to be preempted under Mensing.

Appellants argue that not all failure-to-warn claims run afoul of Mensing, such as those alleging that generic manufacturers could have taken steps that would not require them to differ their labeling from that of the reference listed drug (“RLD”) for metoclopramide, Reglan.⁶ The duty of sameness, they contend, would not be violated by generic manufacturers communicating information consistent with the brand-name labeling. Under this theory, generic manufacturers would be liable for failing to convey FDA-approved warnings; for example, they could have circulated “promotional labeling”-type communications warning of the dangers of metoclopramide use after twelve weeks. According to the complaints, the generic manufacturers should have made consumers aware of the risks associated with metoclopramide and, by not doing so, negligently or fraudulently caused injuries. This Court addressed an almost identical argument in Morris v. PLIVA, Inc., and rejected such failure-to-warn claims in light of Mensing.⁷ In Morris, we wrote:

Mensing forecloses such claims because failure to “communicate” extends beyond just a label change. To avoid liability, the manufacturer must take affirmative steps to alert consumers, doctors, or pharmacists of changes in the drug label. Because the duty of sameness prohibits the generic manufacturers from taking such action unilaterally, they are dependent on brand-names taking the lead. [ Mensing, 131 S.Ct.] at 2576 (“[I]f generic drug manufacturers, but not the brand-name manufacturer, sent [additional warnings such as ‘Dear Doctor’ letters], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly ‘misleading.’ ”). Under federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not whether the proposed warning to be disseminated contains substantially similar information as the label. Because no brand-name manufacturer sent a warning based on the 2004 label change, the generic manufacturers were not at liberty to do so. As Mensing concluded, preemption is thus triggered since it would be impossible for PLIVA to comply with both the state law duty to warn and the federal law duty of sameness.

713 F.3d at 777 (second ...