MEMORANDUM OPINION
In this diversity action, Plaintiff Lirlene Gardley-Starks asserts numerous causes of action under Mississippi law, arguing that her ingestion of the prescription drug metoclopramide caused her to develop a neurological disorder known as tardive dyskinesia. Before the Court is a Motion for Summary Judgment [81] filed by Defendant Schwarz Pharma, Inc., and a Motion for Partial Summary Judgment [83]
FACTS & PROCEDURAL HISTORY
Metoclopramide is a prescription drug approved by the FDA for short term treatment of gastroesophageal reflux disease and diabetic gastroparesis. The FDA approved metoclopramide in 1980 under the brand name Reglan. In 1985, generic drug manufacturers began producing metoclopramide. Brand name Reglan was
Long term use of metoclopramide can cause a serious and permanent neurological condition known as tardive dyskinesia. In 1985, the drug’s label was modified to warn that “tardive dyskinesia ... may develop in patients treated with metoclopramide,” and the drug’s package insert added that “[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended.” In 2003, another labeling change was approved regarding metoclopramide use in geriatric patients. In 2004, the label was again changed to add that “[tjherapy should not exceed 12 weeks in duration.” In 2009, the FDA ordered a boxed warning on metoclopramide — its strongest — which states: “Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.... Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.” Plaintiff alleges that Defendant PLIVA, a generic manufacturer, never updated its product labeling to reflect the 2003 and 2004 changes.
Between 2002 and 2008, Plaintiff was prescribed metoclopramide to treat her acid reflux, ulcers, and heartburn. Plaintiff alleges that her prescribing doctor relied upon information published in the package inserts for the drug and/or information published in the Physicians’ Desk Reference (PDR). Plaintiff alleges that as a result of her long-term use of metoclopramide, she developed tardive dyskinesia. Plaintiff commenced the instant suit on August 9, 2010.
On February 28, 2011, this Court held a case management conference and stayed the case pending the United Supreme Court’s decision in PLIVA, Inc. v. Mensing, - U.S. -,
On August 3, 2011, the Court lifted the stay to allow limited discovery regarding the issue of product identification. That discovery revealed that Plaintiff ingested generic metoclopramide manufactured by ESI Lederle, Northstar, PLIVA, and Purepac; however, there is no evidence that Plaintiff ever ingested brand name Reglan.
Thereafter, Defendants filed dispositive motions. The Brand Defendants argued that they were entitled to summary judgment due to the fact that Plaintiff never ingested brand name Reglan. The Generic Defendants sought judgment on the pleadings, asserting that Plaintiffs claims were preempted in light of Mensing. In response, Plaintiff filed a motion for leave to file an amended complaint, which was granted. On April 12, 2012, Plaintiff filed her first, amended complaint, alleging that:
This case involves Defendants’ failure to warn physicians that use of metoclopramide should not exceed 12 weeks in duration ... their sale of a defective product, their breach of express and implied warranties, and their negligence in continuing to market and sell Reglan/metoclopramide without complying with federal and state laws designed to protect consumers and in spite of theirknowledge that numerous physicians were engaging in dangerous prescribing practices likely to result in injury to those who consumed the drug.
Plaintiff asserts the following claims under Mississippi law: (1) negligence, (2) strict liability, (3) breach of warranties, (4) misrepresentation, fraud, and suppression of evidence, and (5) gross negligence.
DISCUSSION
I. Brand Defendants
The Brand Defendants argue that, because it is undisputed that the Plaintiff never ingested their product (brand name Reglan), they are entitled to summary judgment. The Court agrees.
A. Summary Judgment Standard
“The court shall grant summary judgment 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). “An issue of material fact is genuine if a reasonable jury could return a verdict for the nonmovant.” Agnew v. Wash. Mut. Fin. Group, LLC,
“A party asserting that a fact cannot be or is genuinely disputed must support the assertion by: (A) citing to particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations (including those made for purposes of the motion only), admissions, interrogatory answers, or other materials; or (B) showing that the materials cited do not establish the absence or presence of a genuine dispute, or that an adverse party cannot produce admissible evidence to support the fact.” Fed. R. Civ. P. 56(c)(1). “Conclusional allegations and denials, speculation, improbable inferences, unsubstantiated assertions, and legalistic argumentation do not adequately substitute for specific facts showing a genuine issue for trial.” Oliver v. Scott,
The Court is not to weigh the evidence or engage in credibility determinations. Anderson,
B. Analysis
The Brand Defendants argue that no matter how Plaintiff labels her claims, they are ultimately products liability claims, and because it is undisputed that Plaintiff never ingested a Brand Defendant product, her claims fail as a matter of law. Plaintiff responds that it is immaterial whether Plaintiff actually ingested name brand Reglan. Instead, she contends that her injury is due to her physician’s reliance on false and misleading information disseminated by the Brand Defendants. Plaintiff asserts that she may still pursue claims against the Brand Defendants sounding in common law negligence and misrepresentation.
The Mississippi Products Liability Act (“MPLA”) provides in pertinent part, that:
(a) The manufacturer or seller of the product shall not be liable if the claimant does not prove by the preponderance of the evidence that at the time the product left the control of the manufacturer or seller:
(i)1. The product was defective because it deviated in a material way from the manufacturer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications, or
2.The product was defective because it failed to contain adequate warnings or instructions, or
3. The product was designed in a defective manner, or
4. The product breached an express warranty or failed to conform to express factual representations upon which the claimant justifiably relied in electing to use the product; and
(ii) The defective condition rendered the product unreasonably dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought.
Miss.Code Ann. § 11-1-63. “Numerous district courts have recognized that the MPLA subsumes common law negligence and misrepresentation claims based on a defective product.” Lashley v. Pfizer, Inc.,
Plaintiff cites the case of Lawson v. Honeywell Int’l, Inc.,
On appeal, the Mississippi Supreme Court determined that the MPLA applied only to “manufacturers” and “sellers,” and that an entity which merely designed a product was neither. Id. at 1029-30. Accordingly, the court held that the MPLA did not preclude a common law claim for negligent design against the non-manufacturing, non-selling designer of the seat-belt buckle. Id. at 1030. However, as the Brand Defendants point out, they are manufacturers and sellers of metoclopramide, just not the particular metoclopramide that injured the plaintiff. The court in Lawson was careful to limit its holding to non-manufacturing, non-selling designers of a product, and the Plaintiff has presented no authority applying Lawson in such an expansive manner as she suggests. The Court finds that Lawson is inapplicable to the present case and provides no support for a negligence or misrepresentation claim against a Brand Name manufacturer for an injury caused by the use of a competitors’ generic product.
Although the Mississippi Supreme Court has not yet addressed this issue, two federal courts applying Mississippi law post-Lawson have dismissed similar claims brought against the manufacturers of brand name drugs by users of their generic equivalents. First, in In re Darvocet, Darvon & Propoxyphene Prods. Liab. Litig., a consolidated multi-district litigation (“MDL”) products liability action, thirty-five plaintiffs from numerous states, including Mississippi, brought claims related to their ingestion of the drug propoxyphene against Xanodyne Pharmaceuticals, Inc., the manufacturer of Darvocet (the name brand version of propoxyphene).
Second, in an almost identical action, the United States District Court for the Southern District of Mississippi granted a mo
The Court finds the reasoning of these cases persuasive. Moreover, the holdings of these cases are in line with the overwhelming majority of courts to consider the issue. See, e.g., Smith v. Wyeth, Inc.,
The Court concludes that Mississippi law, consistent with the vast majority of courts to consider this issue, would not recognize a cause of action — however styled — against a brand manufacturer for injuries caused by use of its competitors’ generic product. Accordingly, the Court GRANTS the Brand Defendants’ respective Motions for Summary Judgment and Partial Summary Judgment.
II. Generic Defendants
The Generic Defendants have filed a Motion to Dismiss pursuant to Rule 12(b)(6), arguing that all of Plaintiffs claims are preempted in light Mensing or otherwise fail to state a claim. The Court agrees.
A. Motion to Dismiss Standard
Under Rule 12(b)(6), the “court accepts ‘all well-pleaded facts as true, viewing them in the light most favorable to the plaintiff.’ ” Martin K. Eby Constr. Co. v. Dallas Area Rapid Transit,
The Supreme Court’s decision in Iqbal provides a framework for examining the sufficiency of a complaint. First, the district court may “begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth.” Id. 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.
B. Discussion
Under federal law, generic and brand-name manufacturers of drugs have different drug labeling duties. Mensing,
Brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by medical practitioners, pharmacists, or nurses, containing drug information supplied by the manufacturer, packer, or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor.
21 C.F.R. § 202.1(l)(2) (2012).
In Mensing, several plaintiffs asserted state tort claims against drug manufacturers for their alleged failure to provide adequate warning labels for generic metoclopramide.
If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking [the plaintiffs’] allegations as true, state law imposed on the Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels____Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.
Id. at 2578.
The Generic Defendants seek dismissal on the grounds that Mensing held that claims such as those pursued by the Plaintiff are now preempted by federal law. Indeed, the majority of courts have continued to hold that state law tort claims asserted against generic drug manufacturers, no matter how styled, are ultimately based on a failure-to-warn and therefore preempted under Mensing. See e.g. Strayhorn v. Wyeth Pharm. Inc.,
Nonetheless, the Plaintiff responds that the Mensing should be interpreted narrowly, and argues that “[w]hat was not
considered in Mensing was the extent to which a generic manufacturer could be held liable for selling an unreasonably dangerous product, for accompanying its product with false information about potential risks associated with metoclopramide, and for concealing important safety information from the FDA, consumers, and the medical community.”
Unfortunately for the Plaintiffs, the Fifth Circuit recently left no doubt regarding the broad reach of Mensing in the recent opinion of Demahy v. Schwarz Pharma, Inc.,
In her brief, Demahy also, like the Plaintiff here, asserted that Mensing did not apply to claims that a “manufacturer distributed a misbranded drug with a label containing false information, that Actavis had failed to communicate the warnings appearing in the label for the brand-name drug, and that it had failed to use reasonable care in providing its warnings,” as well claims for “the introduction into interstate commerce of a misbranded drug” and the failure of Actavis to “communicate information that was ‘consistent with and not contrary to’ the information appearing in the approved labeling for the drug through numerous available means.” Brief of Plaintiff-Appellant Julie Demahy at 26-27, Id., (No. 11-31073).
The Fifth Circuit affirmed the district court, finding that “it is true that the mandate addressed only her failure to warn claims ... because Demahy’s only remaining claims had been characterized by the district court, this Court, and Supreme Court as failure-to-warn claims.” Id. The Fifth Circuit went on to state that “even if we were to find that these claims survived the mandate, or if we were to accept Demahy’s assertion that the mandate was ‘erroneous,’ ... we would still affirm the district court insofar the claims are, at base, failure-to-warn claims, which would be preempted in light of Mensing.” Id. at 186.
Similarly, here, no matter how Plaintiff styles her theories of recovery, her claims ultimately relate to the Generic Defendants’ alleged failure to warn about the side effect of metoclopramide. Therefore, all theories will be analyzed together under the umbrella of a failure to warn claim under Mississippi law. Swayze v. McNeil Labs., Inc.,
is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates sufficient information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to an ordinary consumer who purchases the product; or in the case of a prescription drug, medical device or other product that is intended to be used only under the supervision of a physician or other licensed professional person, taking into account the characteristics of, and the ordinary knowledge common to, a physician or other licensed professional who prescribes the drug, device or other product.
§ 11—1—63(c)(ii).
The Court finds that Plaintiffs claims against the Generic Manufacturers are subject to preemption or otherwise unavailing. None of Plaintiffs other theories discussed below persuade the court otherwise.
1. Failure-to-withdraw Theory
Plaintiff argues that Mensing did not address “the ability of a plaintiff to assert liability against a generic drug manufacturer for continuing to market and distribute its drug, despite the fact that it is misbranded.” This theory was embraced by the Eighth Circuit in its original Mensing opinion which was later reversed by the Supreme Court. See Mensing v. Wyeth, Inc.,
2. Failure to Communicate to Warnings
Plaintiff next asserts that the Generic Defendants may held liable for failing to communicate the 2003 and 2004 labeling changes to Physicians and consumers through the use of “Dear Doctor” letters or by other methods. Plaintiffs argue that Mensing only held that generic manufacturers could not send “Dear Doctor” letter that contained new or additional warnings, and the Court did not consider whether a generic manufacturer could use such letters or other methods to apprise health care professionals of information appearing in approved labeling. However, the Mensing decision itself forecloses this argument:
A Dear Doctor letter that contained substantial new warning information would not be consistent with the drug’s approved labeling. Moreover, if generic drug manufacturers, but not the brand-name manufacturer, sent such letters, that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly “misleading.” ... Accordingly, we conclude that federal law did not permit the Manufacturers to issue additional warnings through Dear Doctor letters.
Mensing,
The Court finds, consistent with the majority of other courts to consider this issue, that any claims stemming from the generic defendants alleged failure to communicate additional warnings through some method other than their package inserts are preempted. Demahy II,
3. Failure to Conduct post-marketing surveillance and reporting
Plaintiffs also allege that the Generic Defendants violated federal law by “failing] to perform post-marketing surveillance for their drugs, to ensure the accuracy of statements appearing in their package insert, to review all adverse drug event information, and to report important information relating to the safety of their products.” These types of claims have been repeatedly rejected as being preempted in light of Mensing. As recently explained by another court in this district:
To the extent any investigation, testing, or marketing surveillance would have revealed the dangers of the drug, that knowledge would have been helpful only to the extent it was communicated through labeling — which would not have made any difference as long as the Generic Defendants were following the FDA’s labeling regulations. The Generic Defendants could not have unilaterally improved the labeling of the drug any further even if they had wanted to. Thus, the Court holds that all of the Plaintiffs’ claims against the Generic Defendants are preempted under federal law.
Truddle v. Wyeth LLC,
4. Failure to Update Label
Finally, Plaintiff alleges that PLIVA never updated its label to incorporate the 2003 and 2004 changes. The Generic Defendants respond that Plaintiffs claims regarding PLIVA’s failure to implement the labeling changes represent impermissible attempts to enforce the FDA regulations. See 21 U.S.C. § 337(a); Buchman Co. v. Plaintiffs’ Legal Comm.,
However, this issue was raised before the Supreme Court in Mensing, as well as the Eight Circuit following remand, but neither court carved out an exception for cases when the generic drug’s label is not updated to match the brand label. Del Valle v. PLIVA Inc.,
In light of this lack of clear precedent, several district courts have allowed such claims to proceed. See e.g. Lyman v. Pfizer, Inc.,
However, other courts have reached the opposite conclusion. See e.g. Strayhorn,
The Court finds that, even if Plaintiffs claims related to PLIVA’s failure to update its label are not preempted, Plaintiff nonetheless fails to state a claim upon which relief may be granted. Specifically, Plaintiffs First Amended Complaint fails to plausibly allege causation between PLIVA’s failure to update its label and Plaintiffs injuries. Mississippi adheres to the “learned intermediary” doctrine, which holds in part “ ‘that where prescription drugs are concerned, a manufacturer’s duty to warn only extends to physicians and not to laymen.’ ” Lashley,
Plaintiff fails to allege that her physician ever relied on PLIVA’s labeling when prescribing metoclopramide. Instead, Plaintiff alleges that her physician relied
5. Defective Design
Finally, to the extent Plaintiff is pursuing a design defect against the Generic Defendants, the Court finds that such claims are also preempted. The “duty of sameness” requires a generic drug to be bioequivalent to its name-brand counterpart. Therefore, “a generic manufacturer cannot alter the design of a drug without violating federal law and this duty of sameness.” Jacobsen,
CONCLUSION
For all of the reasons set forth above: Defendant Schwarz Pharma Inc.’s Motion for Summary Judgment [81] is GRANTED;
Defendants Pfizer, Inc. and Wyeth, Inc.’s Motion for Partial Summary Judgment [83] is GRANTED; and The Generic Defendants’ Motion to Dismiss [111] is GRANTED.
Notes
. Plaintiff asserts claims against Wyeth arising from her alleged use of metoclopramide manufactured by ESI Lederle Inc., a former division of American Home Products Corporation which was later acquired by Wyeth. Wyeth’s motion relates only to "Plaintiff's claims asserted against Wyeth on the basis that it is somehow liable for harm allegedly caused by other manufacturers’ generic metoclopramide” and does not extend to claims resulting from Plaintiff's alleged use of metoclopramide manufactured by ESI Lederle, Inc.
. Pfizer acquired Wyeth in 2009 and is sued in its capacity as Wyeth’s parent corporation.
. Plaintiff's response in opposition fails to address her claims for strict liability and breach of warranty. Accordingly, the Court deems those claims to be abandoned against the Brand Defendants. See Sanders v. Sailormen, Inc.,
. The Brand Defendants have cited sixty-six decisions applying the law of twenty-three different jurisdictions holding that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product. See Docket [82], [102], [116]. Only two decisions have adopted the Plaintiff’s theory of liability: the California intermediate Court of Appeals in Conte v. Wyeth, Inc.,
. As stated above, Mensing dealt with conflict or impossibility preemption. Plaintiffs argument that the preemption analysis in this case is or should be governed by various decisions of the United States Supreme Court and the Fifth Circuit Court of Appeals involving express preemption such as Cipollone v. Liggett Group, Inc., 505 U.S. 504,