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holding that drug defect claims must be alleged at the manufacturer of the allegedly defective drug
Summary of this case from Camejo v. Angelini Pharma Inc.Opinion
Civil Action No. 10–cv–00110–AW.
2012-01-27
Shirley GROSS, Plaintiff, v. PFIZER, INC., et al., Defendants.
Daniel J. McGlynn, Terrence Joseph Donahue, Jr., McGlynn Glisson and Mouton, Baton Rouge, LA, Robert K. Jenner, Janet Jenner and Suggs LLC, Baltimore, MD, William Burton Curtis, Curtis Law Group, Dallas, TX, for Plaintiff. Thomas Peter Bernier, Segal McCambridge Singer and Mahoney Ltd., Michelle Noorani, Whiteford Taylor and Preston LLP, Baltimore, MD, Linda E. Maichl, Thomas G. McIntosh, Ulmer and Berne LLP, Cincinnati, OH, Rex A. Littrell, Ulmer Berne LLP, Columbus, OH, Michelle Jacquelyn Marzullo, Jennifer E. Cameron, Michael Thomas Hamilton, Marks O'Neill O'Brien and Courtney PC, Towson, MD, Jonathan I. Price, Nilda M. Tulla–Isidro, Goodwin Procter LLP, New York, NY, Richard A. Oetheimer, Goodwin Procter LLP, Boston, MA, for Defendants.
Daniel J. McGlynn, Terrence Joseph Donahue, Jr., McGlynn Glisson and Mouton, Baton Rouge, LA, Robert K. Jenner, Janet Jenner and Suggs LLC, Baltimore, MD, William Burton Curtis, Curtis Law Group, Dallas, TX, for Plaintiff. Thomas Peter Bernier, Segal McCambridge Singer and Mahoney Ltd., Michelle Noorani, Whiteford Taylor and Preston LLP, Baltimore, MD, Linda E. Maichl, Thomas G. McIntosh, Ulmer and Berne LLP, Cincinnati, OH, Rex A. Littrell, Ulmer Berne LLP, Columbus, OH, Michelle Jacquelyn Marzullo, Jennifer E. Cameron, Michael Thomas Hamilton, Marks O'Neill O'Brien and Courtney PC, Towson, MD, Jonathan I. Price, Nilda M. Tulla–Isidro, Goodwin Procter LLP, New York, NY, Richard A. Oetheimer, Goodwin Procter LLP, Boston, MA, for Defendants.
MEMORANDUM OPINION
ALEXANDER WILLIAMS, JR., District Judge.
Pending before the Court is Defendant Pliva USA, Inc. (“PLIVA”)'s motion for judgment on the pleadings pursuant to Rule 12 of the Federal Rules of Civil Procedure. See Doc. No. 83. The Court has reviewed the motions and all supporting documents and finds no hearing is necessary. See Md. Loc. R. 105.6 (D. Md. 2010). For the reasons articulated below, the Court grants Defendant's motion.
I. FACTUAL & PROCEDURAL BACKGROUND
Plaintiff filed this action as a result of injuries she suffered from ingesting the prescription drug metoclopramide. Plaintiff stipulates that the drugs she consumed are a generic form of metoclopramide manufactured by Defendant PLIVA, and that she did not ingest any metoclopramide product manufactured by Pfizer, Wyeth or Schwarz. See Doc. No. 54. Plaintiff nonetheless filed suit against Defendants Pfizer, Wyeth, and Schwarz, who manufactured the brand-name form of metoclopramide, on theories of negligence, breach of warranty, strict product liability, and misrepresentation. The Court dismissed Plaintiff's claims against the brand-name manufacturers because Maryland law only allows drug defect claims to proceed against the manufacturer whose drug allegedly caused the injury; in this case, the generic manufacturer PLIVA. See Doc. No. 63.
On April 7, 2011, the Court stayed proceedings against PLIVA pending the Supreme Court's decision in a collection of lawsuits addressing claims against generic manufacturers based on similar facts. On June 23, 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) ( reh'g denied ). In Mensing, the Supreme Court considered a state law tort claim based on the alleged failure of a manufacturer to provide adequate warning labels for generic metoclopramide. 131 S.Ct. at 2572. Under the Food and Drug Administration (“FDA”) regulations, generic drug manufactures are required to make their warning labels identical to those provided by the brand-name manufacturers. Id. at 2577. Because FDA regulations do not allow generic manufacturers to independently change or strengthen their product labeling, the Court found that it would be impossible for a generic manufacturer to comply with both federal law and state tort law. Id. at 2578. As a result, the Court held that the federal regulations preempt state law failure to warn claims, reversing decisions by the Fifth and Eighth Circuit Courts of Appeals which had found otherwise. Id.
After the Mensing decision, Plaintiff filed a motion in the instant action to alter or amend the Court's entry of final judgment in favor of brand-name manufacturer Defendants as well as a motion to lift stay. See Doc. Nos. 74, 76. The Court denied Plaintiff's motion to reconsider its judgment in favor of the brand-name manufacturers but granted her motion to lift stay for the limited purpose of allowing the parties to brief the Court on the impact of the Mensing decision. See Doc. No. 80. Accordingly, PLIVA filed the present motion for judgment on the pleadings. See Doc. No. 83. PLIVA argues that, after Mensing, Plaintiff's state-law claims against PLIVA are preempted. For the reasons discussed below, the Court agrees.
II. STANDARD OF REVIEW
A Rule 12 motion should be granted when, viewing the allegations in the complaint as true, including all inferences which may reasonably be drawn from the facts alleged, the complaint fails to state a claim upon which relief may be granted. See Brockington v. Boykins, 637 F.3d 503, 505–06 (4th Cir.2011). Although the court should accept as true all well-pleaded allegations and should view the complaint in a light most favorable to the plaintiff, the Court should not accept unsupported legal allegations, Revene v. Charles Cnty. Comm'rs, 882 F.2d 870, 873 (4th Cir.1989), “legal conclusion[s] couched as ... factual allegation[s],” Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986), or conclusory factual allegations devoid of any reference to actual events, United Black Firefighters of Norfolk v. Hirst, 604 F.2d 844, 847 (4th Cir.1979).
In resolving a motion to dismiss, the court should proceed in two steps. First, the court should determine which allegations in the complaint are factual allegations entitled to deference, and which are mere legal conclusions that receive no deference. See Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949–50, 173 L.Ed.2d 868 (2009). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Id. at 1949. Second, “[w]hen there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.” Id. at 1950.
III. ANALYSIS
The question before the Court is to what extent, if any, do Plaintiff's claims survive the Supreme Court's preemption ruling in Mensing. Mensing precludes consumer suits against generic manufacturers based on failure to warn claims. The Court in Mensing reasoned that generic manufacturers are unable to strengthen or change their warning labels under federal law, which requires that generic manufacturers make their warning labels identical to those provided by the brand manufacturer of the drug. 131 S.Ct. at 2578. The Court therefore found that federal law preempts state law tort claims attacking the sufficiency of the warning label on a generic drug. Id.
Defendant PLIVA argues that Mensing disposes of Plaintiff's state law tort claims, all of which are based on inadequate warnings. Plaintiff's claims attack the sufficiency of the warnings provided by PLIVA under state law. According to PLIVA, these are precisely the types of claims that Mensing held were preempted by federal law. However, Plaintiff contends that Mensing only preempted failure to warn claims involving the inadequacy of the warning PLIVA provided on its metoclopramide label, whereas Plaintiff has additionally alleged that: (1) PLIVA was negligent in selling its drug with a label that contained false information and lacked adequate instructions for use; (2) for failing to test and inspect its products; (3) for selling a product that was not fit for the purpose for which it was sold; (4) for concealing important safety information regarding its drugs; and (5) for placing an unreasonably dangerous product into the stream of commerce. While acknowledging “the unfortunate hand that federal drug regulation has dealt” Plaintiff as a consumer of a generic drug, id. at 2581, the Court finds that Mensing disposes of all these claims. The Court will proceed to address each of these allegations below. A. Negligence for Continuing to Sell Metoclopramide
While Plaintiff acknowledges that her claims relating to PLIVA's inadequate labeling of metoclopramide are preempted after Mensing, she contends that her claims attacking PLIVA's continued sale of metoclopramide remain. Specifically, Plaintiff argues she has surviving claims that PLIVA was negligent for continuing to sell metoclopramide with an inadequate label, for continuing to sell a product that was not fit for the purpose for which it was sold, and for continuing to place an unreasonably dangerous product into the stream of commerce.
As an initial matter, under Maryland law Plaintiff's product liability claims must be based on a design defect, a manufacturing defect, or a failure to warn. See Simpson v. Standard Container, 72 Md.App. 199, 527 A.2d 1337, 1339 (1987). Plaintiff has not stated a claim for a manufacturing defect, and this Court has found that “[d]esign defect claims are generally incompatible with actions concerning prescription medications because these medications are thought to be ‘unavoidably unsafe.’ ” King v. Pfizer Pharm. Co., Inc., No. RWT 11 cv00127, 2011 WL 3157305, at *2 (D.Md. Jul. 25, 2011) (citation omitted). Thus, by process of elimination Plaintiff's claims attacking PLIVA's continued sales of metoclopramide must relate to PLIVA's alleged failure to warn consumers and physicians about the dangers of the drug.
The very arguments Plaintiff contends survive Mensing were adopted by the Eighth Circuit in Mensing v. Wyeth, Inc., and later rejected by the Supreme Court in Mensing. Finding in favor of the Plaintiff-consumer in Wyeth, the Eighth Circuit reasoned that the “generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales.” Wyeth, 588 F.3d 603, 611 (8th Cir.2009).
The Supreme Court rejected this reasoning on appeal and denied a rehearing despite the contentions of Respondents that the Supreme Court had “overlook[ed] the fact that the Petitioners could have ‘independently’ complied with both state and federal law simply by suspending sales of generic metoclopramide with warnings that they knew or should have known where inadequate.” Respondents' Petition for Rehearing at 1, PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), Nos. 09–993, 09–1039, 09–1501, 2011 WL 2874547, at *1. Moreover, the Sixth Circuit considered the same argument in the plaintiff's supplemental brief to the court after the Mensing decision, and though it did not address it specifically, the court ruled that Mensing barred Plaintiff's state-law claims. See Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir.2011).
Accordingly, the Court finds unavailing Plaintiff's argument that PLIVA could have simply stopped manufacturing metoclopramide and thus avoided violating either federal or state law. The Court is aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce. Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce. See 21 U.S.C. § 301 et seq. For all these reasons, the Court finds that Plaintiff's negligence claims based on PLIVA's continued sale of metoclopramide fail under Mensing. B. Negligence for Concealing Important Safety Information
Plaintiff contends that its negligence claim based on PLIVA's alleged concealment of important safety information about metoclopramide survives Mensing. The Court disagrees. To the extent Plaintiff claims that PLIVA could have revealed safety information by adding to or changing the metoclopramide label, her claims are clearly preempted by Mensing. To the extent Plaintiff claims that PLIVA should have revealed information to the FDA regarding the dangers of metoclopramide, her claims are also preempted. The Court in Mensing addressed arguments that generic pharmaceutical companies had a duty to ask the FDA to add to or strengthen the labeling for metoclopramide. The Court found that “[t]he federal duty to ask the FDA for help in strengthening the corresponding brand-name label, assuming such a duty exists, does not change this [preemption] analysis.” 131 S.Ct. at 2578 (citing Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)). The Court additionally found that “federal law did not permit [generic drug] Manufacturers to issue additional warnings through Dear Doctor letters.” Id. at 2576 (citations and internal quotation marks omitted). Accordingly, Plaintiff's claims based on PLIVA's alleged concealment of safety information are preempted under Mensing. C. Negligence for Failing to Test and Inspect PLIVA's Products
Plaintiff contends that her allegation that PLIVA failed to test and inspect its products survives Mensing. The Court fails to see how these allegations are but a piece of Plaintiff's larger failure to warn claims. Accordingly, Mensing preempts these allegations as they relate to Plaintiff's failure to warn claims. D. Plaintiff's Request to Amend Complaint to Allege Additional Facts
Finally, Plaintiff requests the opportunity to amend her complaint to allege additional facts relating to PLIVA's failure to include important warnings added to the labeling for metoclopramide in 2004. Specifically, Plaintiff contends that PLIVA's metoclopramide label differed from the brand-name label, which in July 2004 added to the already-existing language: “Therapy longer than 12 weeks has not been evaluated and cannot be recommended,” the statement: “Therapy should not exceed 12 weeks in duration.”
However, Plaintiff does not claim that the alleged failure of PLIVA to update its label gives rise to any cause of action under Maryland law; nor is the Court aware of any such cause of action. Additionally, Plaintiff has consistently claimed that all warnings issued before 2009 relating to metoclopramide, including the brand-name warnings stating that “Therapy should not exceed 12 weeks in duration”, were inadequate. See Compl.
Moreover, the weight of authority suggests that such claims are unavailing after Mensing. Identical arguments were made by plaintiffs in supplemental briefings to the Sixth and Eighth Circuits, and both courts nevertheless dismissed the plaintiffs' claims based on preemption under Mensing. See Doc. No. 85 Ex. 1 at 5; Ex. 2 at 4. The issue was also brought to the Supreme Court's attention by PLIVA's counsel before oral arguments were held in Mensing. See Doc. No. 85 Ex. 5 (letter from PLIVA's counsel informing the Supreme Court that “at least some of PLIVA's post–2004 labels do not include th [e] change.”). Accordingly, the Court declines to allow Plaintiff to amend her complaint to allege additional facts relating to PLIVA's failure to implement the label change.
In dismissing Plaintiff's state-law tort claims against PLIVA, the Court joins a growing number of courts which, in the wake of Mensing, have dismissed similar lawsuits against generic drug manufacturers. See, e.g., Stevens v. Pliva, Inc., Civ. No. 6:10–0886, 2011 WL 6224569 (W.D.La. Nov. 15, 2011) (Doc. No. 85 Ex. G at 3–6) (dismissing failure to warn and design defect claims under Mensing); In re: Accutane Prod. Liab., MDL 1626, 2011 WL 6224546 (M.D Fla. Nov. 9, 2011) (Doc. No. 85 Ex. I) (dismissing claims that, inter alia, defendant-pharmacy sold a product that was not fit for the purposes intended and did not conduct a proper investigation, based on Mensing); Richardson v. Wyeth Inc., No. 10–0883, 2011 WL 5402184, at *2 (W.D.La. Oct. 20, 2011) (dismissing plaintiff's failure to warn claims under Mensing); Guarino v. Wyeth LLC, No. 8:10–cv–2885, 2011 WL 5358709 (M.D.Fla. Nov. 7, 2011) (Doc. No. 85 Ex. K at 5) (dismissing claims that generic manufacturer's label was “inaccurate, misleading, materially incomplete, false and otherwise inadequate” and that manufacturer failed to send Dear Doctor letters to prescribing physicians, under Mensing); Metz v. Wyeth, LLC, No. 8:10–CV–2658, 2011 WL 5024448, at *1 (M.D.Fla. Oct. 20, 2011); Morris v. Wyeth, Inc., No. 3:09–CV–854, 2011 WL 4973839, at *1 (W.D.La. Oct. 19, 2011) (dismissing plaintiff's claims against generic drug manufacturer for negligence, strict liability, breach of warranties, misrepresentation, fraud, and negligence per se, under Mensing).
Like the Court in Mensing, this Court “acknowledge[s] the unfortunate hand that federal drug regulation has dealt” Plaintiff as a consumer of generic metoclopramide. As Justice Sotomayor noted in her dissent,
[A] drug consumer's right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth [ v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009) ]. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue. 131 S.Ct. at 2592. Accordingly, federal drug regulations have foreclosed Plaintiff's means of seeking a judicial remedy in the instant action, and legislative action remains as the most appropriate means of redress at this juncture.
IV. CONCLUSION
For the foregoing reasons, the Court grants Defendant's motion for judgment on the pleadings. An Order will follow.
MEMORANDUM OPINION
Pending before the Court is Plaintiff Shirley Gross's motion to alter or amend the Court's November 22, 2011 Order granting Defendant PLIVA's motion for judgment on the pleadings. See Doc. No. 88. The Court has reviewed the motions and all supporting documents and finds no hearing is necessary. See Md. Loc. R. 105.6 (D.Md.2010). For the reasons articulated below, the Court DENIES Plaintiff's Motion.
I. FACTUAL & PROCEDURAL BACKGROUND
Plaintiff filed this action as a result of injuries she suffered from ingesting the prescription drug metoclopramide. Plaintiff stipulates that the drugs she consumed are a generic form of metoclopramide manufactured by Defendant PLIVA, and that she did not ingest any metoclopramide product manufactured by Pfizer, Wyeth or Schwarz. See Doc. No. 54. Plaintiff nonetheless filed suit against Defendants Pfizer, Wyeth, and Schwarz, who manufactured the brand-name form of metoclopramide, on theories of negligence, breach of warranty, strict product liability, and misrepresentation. The Court dismissed Plaintiff's claims against the brand-name manufacturers because Maryland law only allows drug defect claims to proceed against the manufacturer whose drug allegedly caused the injury; in this case, the generic manufacturer PLIVA. See Doc. No. 63.
On April 7, 2011, the Court stayed proceedings against PLIVA pending the Supreme Court's decision in a collection of lawsuits addressing claims against generic manufacturers based on similar facts. On June 23, 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 564 U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) ( reh'g denied ). In Mensing, the Supreme Court considered a state law tort claim based on the alleged failure of a manufacturer to provide adequate warning labels for generic metoclopramide. 131 S.Ct. at 2572. Under the Food and Drug Administration (“FDA”) regulations, generic drug manufactures are required to make their warning labels identical to those provided by the brand-name manufacturers. Id. at 2577. Because FDA regulations do not allow generic manufacturers to independently change or strengthen their product labeling, the Court found that it would be impossible for a generic manufacturer to comply with both federal law and state tort law. Id. at 2578. As a result, the Court held that the federal regulations preempt state law failure to warn claims, reversing decisions by the Fifth and Eighth Circuit Courts of Appeals which had found otherwise. Id.
After the Mensing decision, Plaintiff filed a motion in the instant action to alter or amend the Court's entry of final judgment in favor of brand-name manufacturer Defendants as well as a motion to lift stay. See Doc. Nos. 74, 76. The Court denied Plaintiff's motion to reconsider its judgment in favor of the brand-name manufacturers but granted her motion to lift stay for the limited purpose of allowing the parties to brief the Court on the impact of the Mensing decision. See Doc. No. 80. Subsequently, PLIVA filed a motion for judgment on the pleadings, contending that Plaintiff's state-law claims against PLIVA are preempted post- Mensing. The Court agreed and, on November 22, 2011, granted PLIVA's motion. On December 20, 2011, Plaintiff filed the present motion to alter or amend the Court's November 22, 2011 judgment, contending that reconsideration is necessary to correct errors of law and prevent manifest injustice. See Doc. No. 88.
II. STANDARD OF REVIEW
Under Rule 59(e), a Court can amend an earlier judgment: “(1) to accommodate an intervening change in controlling law; (2) to account for new evidence not available at trial; or (3) to correct a clear error of law or prevent manifest injustice.” Hutchinson v. Staton, 994 F.2d 1076, 1081 (4th Cir.1993). Reconsideration is, however, an extraordinary remedy. Pac. Ins. Co. v. Am. Nat'l Fire Ins. Co., 148 F.3d 396, 403 (4th Cir.1998).
III. ANALYSIS
Plaintiff seeks reconsideration of the Court's order granting PLIVA's motion for judgment on the pleadings, contending that she retains claims against PLIVA under theories of strict liability, negligence, breach of warranties, fraud, and misrepresentation post- Mensing and that new cases offer additional support for the viability of her claims. Plaintiff's arguments in support of her motion overwhelmingly constitute a rehash of prior arguments already considered and rejected by this Court. Additionally, Plaintiff's contention that “the vast majority of courts” are not dismissing similar claims across the country is belied by the case law. Most notably, the Sixth Circuit earlier this month denied a petition for a rehearing and rehearing en banc by plaintiffs who have made and continue to make substantially the same arguments as does Plaintiff in the instant action. See Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir.2011) petition for reh'g and reh'g en banc denied (6th Cir. Nov. 22, 2011) (Doc. No. 89 Ex. 3); Pls.'–Appellants' Supplemental Letter Br. Regarding Pliva, Inc. v. Mensing (Doc. No. 83 Ex. 9); Pls.'–Appellants' Pet. for Reh'g and Reh'g En Banc (Doc. No. 89 Ex. 8).
At the time of the Court's November 22, 2011 judgment, it noted the growing number of district courts dismissing similar lawsuits against generic drug manufacturers in the wake of Mensing. See Doc. No. 86 at 8–9 (citing district court cases). In the intervening two months, the number of courts dismissing similar suits under Mensing has only grown. See, e.g., Del Valle v. PLIVA, Inc., Civ. No. B: 11–113, 2011 WL 7168620 (S.D.Tex. Dec. 21, 2011) (Doc. No. 89 Ex. 2) (finding that plaintiff's “claims against the generic drug defendants, no matter how she casts them, are for failure to warn” and that “[v]irtually every district court in the country that has examined Reglan/metoclopramide claims, after Mensing, has concluded that the Supreme Court's decision mandates dismissal of claims against makers of generic drugs for failing to unilaterally include adequate warnings.”); Huck v. Trimark Physicians Grp., No. LAC018947 (Iowa Dist. Ct. Sac Cnty. Jan. 5, 2012) (Doc. No. 89 Ex. 4) (dismissing plaintiff's claims for breach of warranty, negligence, negligent misrepresentation, fraud, constructive fraud, and fraud by concealment, under Mensing); Guarino v. Wyeth LLC, No. 8:10–cv–02885–T–30TGW, 2012 WL 28810 (M.D.Fla. Jan. 5, 2012) (Doc. No. 89 Ex. 5) (denying plaintiff's motion for reconsideration on its claims against generic manufacturer for negligence, strict liability, breach of warranties, misrepresentation, fraud, and negligence per se, noting that “recently over twenty additional decisions have been entered dismissing materially identical claims in the face of the same or similar arguments Plaintiff presents in this case.”).
However, Plaintiff is correct in identifying a split in authority as to the viability of Plaintiff's claims based on PLIVA's failure to include a warning on its metoclopramide label that the brand-name manufacturer had added to its label in 2004. Pre–July 2004, the brand-name label and generic label both stated: “Therapy longer than 12 weeks has not been evaluated and cannot be recommended.” In July 2004, the brand-name label added to that already-existing language the statement: “Therapy should not exceed 12 weeks in duration.” PLIVA did not add this language to the label of the generic metoclopramide consumed by Plaintiff. Plaintiff argues that its claim based on the 2004 label change is not preempted because it does not require the generic manufacturer to send “substantial new warning information” or “additional warnings” but only requires that the generic manufacturer inform physicians and consumers of warnings consistent with and not contrary to information on the brand-name label.
A few courts have allowed similar claims based on the 2004 label change to proceed, finding that they are not preempted under Mensing. See, e.g., Fisher v. Pelstring, Civ. No. 4:09–cv–00252–TLW, 817 F.Supp.2d 791, 805, 2011 WL 4552464, at *3 (D.S.C. Sept. 30, 2011) (“The Court finds that this possible deviation in PLIVA's label for generic metoclopramide, which both parties indicate exists, is sufficient to conclude the plaintiffs' claims are not entirely preempted.”); Brasley–Thrash v. Teva Pharm. USA, Inc., Civ. No. 10–00031–KD–N, 2011 WL 4025734 (S.D.Ala. Sept. 12, 2011) (Doc. No. 88 Ex. 6 at 5) (“[A]t this time, the defendants have not convinced this Court that generic drug manufacturers must seek out the FDA's approval when sending a DHCP letter that simply reiterates warnings contained in the approved label.”).
The cases cited by Plaintiff have not been issued since the Court's November 22, 2011 opinion; nor do they change the Court's analysis of Plaintiff's claim. The Court did not dismiss Plaintiff's claim relating to the 2004 label change on the grounds of preemption, although there are strong arguments that such a claim is preempted, and the Sixth and Eighth Circuits have rejected nearly identical arguments by plaintiffs after Mensing. See, e.g., Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir.2011) petition for reh'g and reh'g en banc denied (6th Cir. Nov. 22, 2011) (Doc. No. 89 Ex. 3); Pls.'–Appellants' Pet. for Reh'g and Reh'g En Banc (Doc. No. 89 Ex. 8) (denying plaintiff's petition for rehearing and rehearing en banc despite Plaintiff's argument that “ Mensing did not address PLIVA's failure to implement the 2004 label change”, noting that “the issues raised in the petition were fully considered upon the original submission and decision of the cases.”)
Rather, the Court dismissed this claim in its November 22, 2011 opinion because Plaintiff's allegations relating to the 2004 label change failed to state a claim upon which relief can be granted. See Doc. No. 86 at 8 (“However, Plaintiff does not claim that the alleged failure of PLIVA to update its label gives rise to any cause of action under Maryland law....”). Within her Complaint and subsequent pleadings, Plaintiff has consistently alleged that all metoclopramide labels, including the brand-name label with the added language “[t]herapy should not exceed 12 weeks in duration”, were inadequate until an FDA labeling change in 2009. Plaintiff now contends that her injuries could have been avoided if PLIVA had given physicians and consumers this inadequate warning. As the court noted in Del Valle v. PLIVA when faced with the same claim, “[i]n essence, [plaintiff] is asking the Court to hold PLIVA and Teva responsible for not updating their labeling in 2004 to a label that [plaintiff] believes, and has pled, would still be inadequate.” Civ. No. B: 11–113, 2011 WL 7168620 (S.D.Tex. Dec. 21, 2011) (Doc. No. 89 Ex. 2 at 14). Given the irreconcilable inconsistency between what Plaintiff has pled and her present theory of relief (or lack thereof, as the Court noted in its prior opinion), dismissal of Plaintiff's claim relating to the 2004 label change is proper regardless of the district and circuit court split on the issue of whether Mensing preempts such claims.
Although the Court saw fit to clarify its rationale for rejecting Plaintiff's claim relating to the 2004 label change, the Court reiterates that Plaintiff has shown no error of law or change in controlling law that would give the Court pause to reconsider its judgment; indeed, portions of Plaintiff's most recent motion are taken nearly verbatim from her response to PLIVA's motion for judgment on the pleadings. The standard for Rule 59(e) motions is high. To justify reconsideration on the basis of manifest error, the prior decision cannot be “ ‘just maybe or probably wrong; it must ... strike us as wrong with the force of a five-week-old, unrefrigerated dead fish.’ ” TFWS, Inc. v. Franchot, 572 F.3d 186, 194 (4th Cir.2009) (quoting Bellsouth Telesensor v. Info. Sys. & Networks Corp., Nos. 92–2355, 92–2437, 1995 WL 520978 at *5 n. 6 (4th Cir. Sept. 5, 1995)). Plaintiff's motion does not meet this sniff test; her reiteration of arguments reveals a “mere disagreement” with the Court's decision and is insufficient grounds for such an extraordinary remedy. Hutchinson v. Staton, 994 F.2d 1076, 1082 (4th Cir.1993). Accordingly, the Court affirms its November 22, 2011 opinion in all respects.
IV. CONCLUSION
For the foregoing reasons, Plaintiff's motion for reconsideration under Federal Rule 59(e) is DENIED. A separate Order will follow.