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Mitchell v. Sandoz, Inc.

United States District Court, W.D. Kentucky, Paducah Division

September 18, 2014

SANDOZ INC., Defendant.


THOMAS B. RUSSELL, Senior District Judge.

This matter is before the Court upon Defendant Sandoz Inc.'s Motion to Dismiss for failure to state a claim. (Docket No. 11). Plaintiff Cindy Mitchell has responded, (Docket No. 14) and Defendant Sandoz, Inc. has replied. (Docket No. 15). This matter is now fully briefed and ripe for adjudication. For the following reasons, Defendant's Motion to Dismiss is GRANTED.


Plaintiff Cindy Mitchell, proceeding pro se, alleges that after taking "lovenox (generic) enoxaparin shots" from February of 2013 through September of 2013, she suffered a gastrointestinal bleed. (Docket No. 1). Mitchell alleges that the drug caused the bleeding and that the drug is "dangerous." ( Id. ). Additionally, she states that "the only side effect that [she] was suppose to be made aware of was abnormal bruising." (Docket No. 14).

Mitchell was hospitalized from September 16, 2013 until September 21, 2013. Her medical records indicate that she was admitted for "abdominal pain, nausea, vomiting, elevated and rising white blood cell counts" and that she was diagnosed with a gastrointestinal bleed, among other medical conditions. (Docket No. 6). Mitchell seeks compensation and that enoxaparin sodium shots be "taken off the shelf." (Docket No. 1). The Court construes Mitchell's complaint as alleging a failure to warn and a design defect claim under the Products Liability Act of Kentucky ("PLA"). (Ky. Rev. Stat. § 411.300).

Enoxaparin sodium is a prescription injection and is the generic bioequivalent of the drug Lovenox. (Docket No. 11). Defendant Sandoz Inc. ("Sandoz") is a generic drug manufacturer that manufactured and distributed enoxaparin sodium shots. Sandoz now moves to dismiss all the claims alleged against it based on federal preemption.


The Federal Rules of Civil Procedure require that pleadings, including complaints, contain a "short plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). A defendant may move to dismiss a claim or case because the complaint fails to "state a claim upon which relief can be granted." Fed.R.Civ.P. 12(b). When considering a Rule 12(b)(6) motion to dismiss, the court must presume all of the factual allegations in the complaint are true and draw all reasonable inferences in favor of the nonmoving party. Total Benefits Planning Agency, Inc., 552 F.3d 430, 434 (6th Cir. 2008) (citing Great Lakes Steel v. Deggendorf, 716 F.2d 1101, 1105 (6th Cir. 1983)). "The court need not, however, accept unwarranted factual inferences." Id. (citing Morgan v. Church's Fried Chicken, 829 F.2d 10, 12 (6th Cir. 1987)).

Even though a "complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citations omitted). Instead, the plaintiff's "[f]actual allegations must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in fact)." Id. (citations omitted). A complaint should contain enough facts "to state a claim to relief that is plausible on its face." Id. at 570. A claim becomes plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (citing Twombly, 550 U.S. at 556). If, from the well-pleaded facts, the court cannot "infer more than the mere possibility of misconduct, the complaint has alleged-but has not show[n]'-that the pleader is entitled to relief.'" Id. at 1950 (citing Fed.R.Civ.P. 8(a)(2)). "Only a complaint that states a plausible claim for relief survives a motion to dismiss." Id.

In addition, federal courts hold pro se pleadings to a less stringent standard than formal pleadings drafted by lawyers. Haines v. Kerner, 404 U.S. 519, 520-21 (1972); Jourdan v. Jabe, 951 F.2d 108, 110 (6th Cir. 1991). However, "[o]ur duty to be less stringent' with pro se complaints does not require us to conjure up unpled allegations." McDonald v. Hall, 610 F.2d 16, 19 (1st Cir. 1979) (citation omitted). Accordingly, this Court is not required "to explore exhaustively all potential claims of a pro se plaintiff, " as this would "transform the district court from its legitimate advisory role to the improper role of an advocate seeking out the strongest arguments and most successful strategies for a party." Beaudett v. City of Hampton, 775 F.2d 1274, 1278 (4th Cir. 1985). Only well-pled factual allegations contained in the complaint and amended complaint are considered on motions to dismiss pursuant to Fed.R.Civ.P. 12(b)(6). See Weiner v. Klais & Co., Inc., 108 F.3d 86, 89 (6th Cir. 1997).


The Court construes Mitchell's complaint as alleging both a failure to warn and a design defect claim under the Kentucky PLA. Ky. Rev. Stat. § 411.300. Kentucky defines a products liability action as any lawsuit alleging "personal injury, death or property damage... from the manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, testing, listing, certifying, warning, instructing, marketing, advertising, packaging or labeling of any product." Id.. The PLA applies to all claims for damages arising from the use of products, irrespective of legal theory. Monsanto Co. v. Reed, 950 S.W.2d 811, 814 (Ky. 1997).

In its Motion to Dismiss, Sandoz states that all claims alleged against it must be dismissed based on federal preemption. Docket No. 11. Sandoz argues that the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., conflicts with the PLA, making it impossible for the manufacturer of a generic drug to comply with both state and federal law. Thus, the ...

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