United States District Court, N.D. Alabama, Southern Division
OWEN BOWDRE CHIEF UNITED STATES DISTRICT JUDGE
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
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.
reasons discussed below, the court will GRANT
Boehringer's motion to dismiss.
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.
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.
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.
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,
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.
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.
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.
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.
McGee is one such Type-II diabetic. In January 2015,
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 ...