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McGee v. Boehringer Ingelheim Pharmaceuticals, Inc.

United States District Court, N.D. Alabama, Southern Division

March 20, 2018

PHILLIP McGEE, SR., Plaintiff,



         Plaintiff Phillip McGee brings this products-liability suit against Boehringer Ingelheim Pharmaceuticals, Inc.; he alleges that “Jardiance, ” a prescription drug manufactured and sold by Boehringer, caused him to go into diabetic ketoacidosis (“DKA”). Mr. McGee, a Type-II diabetic, asserts, essentially, that Boehringer failed to adequately warn him that Jardiance presented a known risk of DKA.

         The matter comes before the court on Boehringer's motion to dismiss Mr. McGee's First Amended Complaint under Fed.R.Civ.P. 12(b)(6). (Doc. 24). Boehringer contends that federal law preempts Mr. McGee's claims and that the complaint fails to provide a sufficient factual basis to state a claim for relief.

         For the reasons discussed below, the court will GRANT Boehringer's motion to dismiss.

         First, the court will GRANT Boehringer's motion to the extent Mr. McGee attempts to raise a claim that Boehringer should have told the FDA about Jardiance's DKA risk during the drug's approval process. Federal laws and regulations preempt such a claim, and the court will DISMISS any such claim WITH PREJUDICE.

         Second, the court will GRANT Boehringer's motion to dismiss as to Mr. McGee's claim that Boehringer should have updated Jardiance's label to warn about DKA after the FDA approved Jardiance and before Mr. McGee's injuries. In the complaint, Mr. McGee fails to allege whether the body of relevant newly-available information increased during this specific time period. The court will therefore DISMISS Mr. McGee's failure-to-warn claims for this time period WITHOUT PREJUDICE.

         Finally, Boehringer raises several other arguments in favor of dismissal. It argues that the learned intermediary doctrine bars Mr. McGee's failure-to-warn claims and that the complaint merely contains legal conclusions without factual underpinnings. Because the court will dismiss Mr. McGee's complaint without prejudice on the preemption issue, the court need not address these arguments at this time. As to these arguments, Boehringer's motion to dismiss is MOOT.


         A Rule 12(b)(6) motion to dismiss attacks the legal sufficiency of the complaint. Generally, the Federal Rules of Civil Procedure require only that the complaint provide “‘a short and plain statement of the claim' that will give the defendant fair notice of what the plaintiff's claim is and the grounds upon which it rests.” Conley v. Gibson, 355 U.S. 41, 47 (1957) (quoting Fed.R.Civ.P. 8(a)). A plaintiff must provide the grounds of his entitlement, but Rule 8 generally does not require “detailed factual allegations.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley, 355 U.S. at 47). It does, however, “demand[ ] more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal 556 U.S. 662, 678 (2009). Pleadings that contain nothing more than “a formulaic recitation of the elements of a cause of action” do not meet Rule 8 standards nor do pleadings suffice that are based merely upon “labels or conclusions” or “naked assertions” without supporting factual allegations. Twombly, 550 U.S. at 555, 557.

         The Supreme Court explained that “[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.'” Iqbal, 556 U.S. at 678 (quoting and explaining its decision in Twombly, 550 U.S. at 570). To be plausible on its face, the claim must contain enough facts that “allow[ ] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678.


         Boehringer sells Jardiance as a prescription drug designed to treat Type-II diabetes. Jardiance belongs to a class of drugs known as “SGLT-2 inhibitors” that, working properly, lowers patients' blood-glucose levels. The FDA approved Jardiance for use in treating Type-II diabetes on August 1, 2014. At that time, the FDA-approved label for Jardiance did not include warnings about DKA, a medical condition that rarely occurs in Type-II diabetics.

         The FDA has a publicly-available database known as the Adverse Event Reporting System (“FAERS”). Beginning in March 2013, FAERS recorded “adverse events” in which Type-II diabetics on SGLT-2 inhibitors were hospitalized after going into DKA.

         Mr. McGee is one such Type-II diabetic. In January 2015, [1] a doctor prescribed Jardiance to Mr. McGee as a treatment for his diabetes. On January 17, Mr. McGee went into DKA. Mr. McGee remained hospitalized until January 21. Mr. McGee had taken Jardiance from the time his doctor prescribed it until his hospitalization. Mr. McGee asserts that he ...

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