Lee v. Mylan, Inc.

• Citation: 806 F.Supp.2d 1320
• Decision Date: 15 April 2011
• Docket Number: Civil Action No. 5:10–CV–361 (MTT).
• Parties: Bethani LEE, as Personal Representative of the Estate of Jonee Adair Lee–Livingston, Plaintiff, v. MYLAN INC., et al., Defendants.
• Court: U.S. District Court — Middle District of Georgia

806 F.Supp.2d 1320

Bethani LEE, as Personal Representative of the Estate of Jonee Adair Lee–Livingston, Plaintiff,

v.MYLAN INC., et al., Defendants.

Civil Action No. 5:10–CV–361 (MTT).

United States District Court, M.D. Georgia, Macon Division.

April 15, 2011.

Alex Simanovsky, Atlanta, GA, for Plaintiff.

Angela M. Spivey, McGuirewoods LLP, Atlanta, GA, Brett C. Shear, Clem C. Trischler, Pittsburgh, PA, for Defendants.

ORDER

MARC T. TREADWELL, District Judge.

This matter is before the Court on the Defendants' Motion to Dismiss (the “Motion”) (Doc. 4). For the following reasons, the Motion is GRANTED in part and DENIED in part.

I. FACTUAL BACKGROUND

Plaintiff Bethani Lee brings this action for the death of her mother, Jonee Adair Lee–Livingston.¹ On October 2, 2008, Ms. Lee–Livingston's doctor prescribed for her 25 mcg/hr Mylan fentanyl transdermal system (“MFTS”) patches manufactured by the Defendants. On October 12, 2008, Ms. Lee–Livingston died, according to a medical examination, of fentanyl toxicity.

MFTS patches have been approved by the Federal Drug Administration and can only be obtained by prescription. MFTS patches, used to relieve pain, come in 25, 50, 75, and 100 mcg/hr dosages. MFTS patches are applied directly to the skin and release fentanyl into a patient's blood stream.

The Plaintiff claims that numerous patients, including her mother, have received lethal doses of fentanyl from using the MFTS patches as prescribed and that the Defendants knew or should have known the drug could cause serious injury and/or death. In short, the Plaintiff claims that her mother died because the MFTS patches released lethal doses of fentanyl.

The Plaintiff brings this action against the Defendants for strict liability (Counts I–III); negligence (Count IV); negligent misrepresentation (Count V); breach of implied warranty of fitness for a particular purpose (Count VI); breach of implied warranty of merchantability (Count VII); and breach of express warranty (Count VIII). The Defendants argue that all claims should be dismissed. Specifically, they allege the Plaintiff failed to plead her claims with sufficient detail, the learned intermediary doctrine bars the negligent misrepresentation and breach of warranty claims, and lack of privity of contract bars the breach of warranty claims.

II. DISCUSSION

A. Sufficiency of Pleadings

To avoid dismissal pursuant to Fed.R.Civ.P. 12(b)(6), “a complaint must contain specific factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). The Federal Rules employ a notice pleading standard, which requires that the complaint contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). The complaint must contain “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at ––––, 129 S.Ct. at 1949. A pleading containing mere “labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955. Rather, the complaint must “give the defendant fair notice of what the claim is and the grounds upon which it rests.” Id. (citation omitted).

The Defendants argue that this action should be dismissed pursuant to Twombly and Iqbal because the Plaintiff “merely ... provid [ed] conclusory averments that recite the bare elements of a cause of action.” (Doc. 4, at 3). However, it is clear the Plaintiff has alleged sufficient facts to put the Defendants on notice of her claims and the grounds upon which they rest. With regard to claims based upon a defective product, according to the Complaint, on October 2, 2008, Ms. Lee–Livingston's doctor prescribed for her 25 mcg/hr MFTS patches. Ten days later, she died of fentanyl toxicity. These facts allow the Court to draw the reasonable inference that the Defendants are liable for the misconduct alleged. With regard to claims based upon a failure to communicate, the Plaintiff alleges the Defendants knew or had reason to know of the dangers associated with the MFTS patches. With regard to claims based upon affirmations of fact or promises, the Plaintiff claims the Defendants represented the MFTS patches were safe and effective.

Moreover, the claims cannot be dismissed pursuant to Twombly and Iqbal because there is no “ ‘obvious alternative explanation.’ ” Iqbal, 556 U.S. at ––––, 129 S.Ct. at 1951–52 (quoting Twombly, 550 U.S. at 567, 127 S.Ct. 1955). The Court in Twombly attributed the defendants' actions to lawful, free-market conduct, and not a conspiracy. Also, the Court in Iqbal believed arrests of Arab Muslims were “likely lawful and justified by [the Director of the FBI's] nondiscriminatory intent to detain aliens who were illegally present in the United States and who had potential connections to those who committed terrorist acts.” Iqbal, 556 U.S. at ––––, 129 S.Ct. at 1951. Here, the Plaintiff's mother died of fentanyl toxicity ten days after she began using a patch manufactured by the Defendants that contained fentanyl. There is no obvious alternative explanation of how fentanyl entered Ms. Lee–Livingston's blood stream. Thus, the allegation that some defect in the MFTS patches caused Ms. Lee–Livingston's death is a plausible conclusion.

Accordingly, because the Complaint gives the Defendants fair notice of what her claims are and the grounds upon which they rest, her claims cannot be dismissed pursuant to Twombly and Iqbal.

B. Learned Intermediary Doctrine

A more difficult issue is whether the learned intermediary doctrine bars the Plaintiff's negligent misrepresentation and breach of warranty claims. Generally, a manufacturer is responsible for failing to warn an end user of the known risks or hazards of its products. However, pursuant to Georgia's learned intermediary doctrine, a prescription drug manufacturer “ ‘does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient's doctor, who acts as a learned intermediary between the patient and the manufacturer.’ ” Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir.2010) (quoting McCombs v. Synthes (U.S.A.), 277 Ga. 252, 253, 587 S.E.2d 594, 595 (2003)). The rationale behind the doctrine is that the patient's doctor is in a better position than the manufacturer to warn the patient of potential dangers. McCombs, 277 Ga. at 253, 587 S.E.2d at 595.

To prevail on a negligent misrepresentation claim, a plaintiff must show “ ‘(1) the defendant's negligent supply of false information to foreseeable persons, known or unknown; (2) such persons' reasonable reliance upon that false information; and (3) economic injury proximately resulting from such reliance.’ ” Marquis Towers, Inc. v. Highland Group, 265 Ga.App. 343, 346, 593 S.E.2d 903, 906 (2004) (quoting Hardaway Co. v. Parsons, Brinckerhoff, Quade & Douglas, Inc., 267 Ga. 424, 426, 479 S.E.2d 727, 729 (1997)). The Plaintiff also brings three claims for breach of warranties, one express and two implied. An express warranty is created by any affirmation of fact or promise made by the seller to the buyer which relates to the goods, description of the goods, or sample or model that is made a part of the basis of the bargain. O.C.G.A. § 11–2–313(1). O.C.G.A. § 11–2–314 creates an implied warranty that goods will be merchantable if the seller is a merchant. O.C.G.A. § 11–2–315 creates an implied warranty of fitness for a particular purpose if the seller has reason to know the particular purpose for which the goods are required and if the buyer has relied on the seller's skill or judgment to select the goods.

The Defendants place much emphasis on the reliance elements, or what they say are the reliance elements, of the Plaintiff's negligent misrepresentation and breach of warranty claims. They argue that the Plaintiff's mother could not have reasonably relied on any representations made by them because the learned intermediary doctrine legally precludes such reliance. The Plaintiff primarily argues that in order to invoke the learned intermediary doctrine, a defendant must first prove that its warning to the doctor was adequate.²

Neither argument quite hits the mark. The learned intermediary doctrine bars any claim based upon an alleged failure to warn the patient. Although the doctrine recognizes the manufacturer's duty to warn the learned intermediary, it clearly eliminates any duty on the part of the manufacturer to warn a patient. The doctrine does not accomplish its goal by precluding reliance; it simply eliminates any duty to warn patients.

Further, the doctrine is not limited to failure to warn claims. It encompasses any claim based upon the failure of the manufacturer to provide the patient with correct or necessary information concerning the use of the product. See, e.g., Catlett v. Wyeth, Inc., 379 F.Supp.2d 1374, 1381 (M.D.Ga.2004) (“It is clear that Georgia courts would find the ‘learned intermediary rule’ encompasses any fraud, fraudulent concealment, misrepresentation, failure to warn or breach of warranty claims related to the sale and use of prescription drugs.”). By definition, a negligent misrepresentation claim, to the extent it is based upon misrepresentations to the patient, is based upon information imparted or not imparted to the patient. Similarly, to the extent a breach of warranty claim is based upon inadequate labeling or any failure on the part of the manufacturer to provide information to the patient, rather than to her doctor, it almost certainly falls within the scope of the learned intermediary doctrine. Incidentally, and although not argued by the Defendants, the same reasoning applies to the Plaintiff's...