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
Plaintiff Bethani Lee brings this action for the death of her mother, Jonee Adair Lee-Livingston.
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.
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, ___ U.S. at ___, 129 S.Ct. at 1949. A pleading
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, ___ 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, ___ 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.
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 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.
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
This does not mean, however, that the Plaintiff's negligent misrepresentation and breach of warranty claims must be dismissed in their entirety. This is because the Plaintiff does not base these claims entirely on the failure to provide accurate or sufficient information to her mother. Rather, for example, the Plaintiff alleges in her negligent misrepresentation claim that the Defendants "failed to communicate to the FDA, Decedent, physicians, distributors, pharmacists, and/or the general public that the use of this drug could cause serious injury and/or death." (Doc. 1, at 9). While the learned intermediary doctrine clearly would bar any negligent misrepresentation claims based upon a failure "to communicate to" the Plaintiff's mother, the Defendants' motion and the Parties' briefs do not address whether the Plaintiff can state a claim based upon negligent misrepresentations to others,
In sum, the Court agrees that the Plaintiff cannot base her negligent misrepresentation claim or her breach of warranty claims on the alleged failure of the Defendants to provide accurate or sufficient information regarding the use of MFTS patches to the Plaintiff's mother. However, these claims cannot be dismissed in their entirety, at this point, because they are not entirely based upon the failure to provide accurate or sufficient information to the Plaintiff's mother.
The Defendants also argue the Plaintiff cannot prevail on any breach of warranty claims because Ms. Lee-Livingston was not in privity of contract with them. Many states have eliminated the requirement of vertical privity,
Once privity is established, a plaintiff may bring claims for breach of the implied warranties of merchantability and fitness for a particular purpose. Jones, 142 Ga.App. at 842, 237 S.E.2d at 406 (reversing summary judgment on implied warranty claim because privity existed and implied warranties were not expressly excluded); Chrysler Corp. v. Wilson Plumbing Co., Inc., 132 Ga.App. 435, 437, 208 S.E.2d 321, 323-24 (1974) ("While ordinarily under [O.C.G.A. § 11]-2-314 there is no implied warranty existing between a manufacturer and an ultimate consumer, this is due to the fact that no privity of contract exists between the two. However, where an automobile manufacturer, through its authorized dealer issues to a purchaser of one of its automobiles from such dealer admittedly as a part of the sale a warranty by the manufacturer running to the purchaser, privity exists and [section 11]-2-314 becomes operative.").
The Court recognizes that many Georgia cases can be read to suggest a no exception rule that an ultimate consumer cannot sue a manufacturer for breach of warranty when a middleman stands between the consumer and manufacturer. Generally, these cases can be traced to Stewart v. Gainesville Glass Co., Inc., 131 Ga.App. 747, 206 S.E.2d 857 (1974)—the first case to cite Schmitt, which clearly recognized that the ultimate consumer could, in limited circumstances, sue a manufacturer for breach of warranty. In Gainesville Glass, Judge Eberhardt, writing for the majority, cited Schmitt for the proposition that a subsequent consumer cannot recover on the warranty made to the initial consumer. 131 Ga.App. at 751, 206 S.E.2d at 859.
131 Ga.App. at 753, 206 S.E.2d at 860-61. However, that is not quite what Judge Pannell said, or at least that is not a full statement of what Judge Pannell said. Schmitt makes three things clear: (1) Georgia law requires privity of contract; (2) subsequent consumers may not recover on the warranty to the initial consumer because there is no privity of contract; and (3) it is possible for the ultimate consumer to establish privity of contract if the manufacturer extends an express warranty to her.
Here, the Plaintiff brings express warranty, implied warranty of fitness for a particular purpose, and implied warranty of merchantability claims. With regard to the express warranty claim, the Plaintiff claims "the Mylan Defendants made affirmations of fact or promises regarding the safety and effectiveness of the Lee-Livingston Patch (including the safe, time-released delivery of fentanyl), which became part of the basis of the bargain."
Accordingly, there is no need to address the Plaintiff's argument that Georgia's third-party beneficiary statute, O.C.G.A. § 11-2-318, allows ultimate consumers to enforce the protections of a manufacturer's warranties.
The Defendants' Motion to Dismiss the Plaintiff's Complaint in its entirety on the grounds that it fails to plead her claims with sufficient detail is