DECISION AND ORDER
Plаintiff, Kathlene Penich Garross, brings this diversity suit against defendants (collectively “Medtronic”) alleging numerous tort claims stemming from her spinal surgery. Specifically, plaintiff alleges that Medtronic violated state law by promoting an off-label use of a Class III medical device regulated by the Food and Drug Administration (“FDA”). Medtronic moves to dismiss the complaint on several grounds primarily that plaintiffs claims are expressly and impliedly preempted by federal law.
I. Background
The Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., amended the Food, Drug and Cosmetic Act (“FDCA”), establishing several levels of federal • oversight of medical devices. Class III devices receive the most oversight and require premarket approval by the FDA. Riegel v. Medtronic, Inc.,
In 2002, the FDA granted premarket approval for Medtronic’s Infuse bone graft/lt-cage lumbar tapered fusion device (“cоmbination device”), a Class III device designed to treat degenerative disc disease which affects the spine. The device has two components: (1) a spinal fusion cage and (2) a bone graft component, which includes a genetically-engineered human protein and a sponge-like carrier or scaffold for the protein that is placed inside the cage. .The FDA’s premаrket approval specified that the combination device could be used in the lumbar spine (L4-S1) via an anterior, or abdominal, approach, which was the intended use Medtronic supplied in its premarket approval application. The FDA has never approved use of the combination device in other parts of the body or in any other type of procedurе. Further, it has never approved use of the bone graft component separate from the cage component. In fact, the FDA-approved labeling states that “[t]hese components must be used as a system. The InFUSE Bone Graft component must not be used without the LT-Cage Lumbar Tapered Fusion Device component.” Defs.’ Br. in Supp. Ex. 3, at 2 (ECF No. 16-3). The label goes on to explain that “[t]he safety and effectiveness of the InFUSE Bone Graft cоmponent with other spinal implants, implanted at locations other than the lower lumbar spine, or used in surgical techniques other than anterior open or anterior laproscopic approaches have not been established. When degenerative disc disease was treated by a posterior lumbar interbody fusion procedure with cylindrical threaded cages, pоsterior bone formation was observed in some instances.” Id. at 5.
In 2008, plaintiff had spinal surgery. Her surgeon implanted the Infuse bone graft component without the cage component at the L1-L2 vertebrae using a posterior approach. This was an “off-label” use of the device for several reasons: it involved only one component rather than the combination device as a whоle, it was implanted in the spine at a different location than that approved, and it relied on a posterior rather than an anterior approach. Since her 2008 surgery, plaintiff alleges that she has experienced “exuberant bone growth,” causing pain and requiring additional surgeries, which she attributes to the off-label surgery. Compl. at 4 (ECF No. 1).
Despite the label warnings and the limited nature of the premarket approval, plaintiff alleges that Medtronic promoted the type of off-label use used in her surgery, namely use of the bone graft component via a posterior approach, in violation of federal law. Specifically, she alleges that Medtronic paid opinion leaders in the medical community to promote riskier off-label uses of the bone graft component and to hide and downplay the risks of these off-label uses, discouraged publication of adverse events resulting from these off-label uses, and failed to report adverse events related to off-label uses to the FDA. She further alleges that these violations of federal law caused her injuries and constitute evidence of various state law torts such as fraudulent misrepresentation, fraud in the inducement, constructive fraud, strict products liability — failure to warn, strict products liability — design defect, breach of express and implied warranty, negligence, and negligent misrepresentation.
II. Discussion
A. Preemption
The FDCA expressly preempts any state or local requirement relating to med
“The Supreme Court ... has made clear that section 360k protects a medical device manufacturer from liability to the extent that it has complied with federal law, but it does not extend protection from liability where the claim is based on a violation of federal law.” Bausch v. Stryker Corp.,
In addition to express preemption, plaintiffs state law claims must survive implied preemption, a doctrine under which state law claims arising “solely from the violation оf [federal] requirements” are impliedly preempted. Buckman Co. v. Plaintiffs’ Legal Comm.,
First, I consider whether federal requirements applicable to the device exist.. Premarket approval of Class III devices impose federal “requirements” within
Each of plaintiff’s claims is based on an alleged underlying violation of federal law. First, her fraudulent misrepresentation and fraud' in the inducement claims are based on Medtronic’s alleged promotion of off-label uses of the bone graft component, including misrepresenting the risks of such off-label uses to the medical community. While the FDCA does not regulate a doсtor’s off-label use of a device, see Buckman,
Seсond, plaintiffs negligence, negligent misrepresentation, strict liability— failure to warn, fraud, and constructive fraud claims are based on Medtronic’s alleged failure to report adverse events to the FDA and to submit a supplemental application seeking approval of the off-label use it was promoting. Class III medical device manufacturers are required to report adversе events to the FDA, 21 C.F.R. § 803.50, investigate serious adverse events and submit follow-up reports, 21 C.F.R. § 803.56, and submit a supplemental application for approval of additional uses of a medical device. 21 C.F.R. § 814.39 (listing “new indications for use of the device” as a change requiring supplemental FDA approval). Plaintiff may rely on these alleged violations as evidence that Medtronic violated a statе common law duty to warn patients of the risks of the off-label use. Plaintiff does not claim that state law imposes an additional require
Third, plaintiffs strict liability— design defect claim is based on Medtronic’s alleged promotion of off-label use, failure to investigate and report adverse events,. and failure to seek supplemental FDA approval of that off-label use. Plaintiff argues that Medtronic’s device was defectively designed for the use Medtronic promoted, and that Medtronic’s alleged violations of federal law in failing to seek supplemental FDA approval and promoting off-label use, despite knowledge of adverse effects, is evidence supporting her design defect claim. Again, the state law on which plaintiff relies does not impose a requirement different from or in addition to federal requirements; it merely creates a state law remedy.
Thus, none of plaintiffs state law claims are expressly preempted.
Nor are plaintiffs claims impliedly preempted. This is so because none of them arise solely from a violation of federal law; rather, each arises from an independent, well-recognized duty owed under state law. See Buckman,
B. Other Arguments for Dismissal
Medtronic makes several additional arguments, first that plaintiffs claims are time-barred by the applicable three year statute of limitations. See Wis. Stat. §§ 893.04, 893.54. In Wisconsin, claims begin to accrue “once a person either discovers the injury or in the exercise of reasonable diligence should have discovered the injury.” Claypool v. Levin,
Generally, a statute of limitations bar is an affirmative defense, and it is “irregular” to dismiss a claim as untimely on a motion to dismiss. Hollander v. Brown,
Here, plaintiffs complaint alleges that she “did not known[sie] and could not have known by the exercise of reasonable diligence, until September 11, 2012” of her injuries. Compl., at 15 (ECF No. 1). This is enough to survive defendant’s motion to dismiss. When plaintiff should have discovered her injuries is a fact question best determined after discovery.
Second, Medtronic argues that plaintiffs failure to warn and negligence claims fail as a matter of law. It contends that under the learned intermediary doctrine, its duty to warn runs to the surgeon and not the pаtient, and that under the sophisticated user doctrine, it has “no duty to warn members of a trade or profession about dangers generally known to the trade or profession.” Haase v. Badger Mining Corp.,
Third, Medtronic argues that plaintiff fails to adequately plead failure to warn, negligence, design defect, and failurе to report adverse events. To survive, plaintiffs complaint must “state a claim to relief that is plausible on its face,” Bell Atl. Corp. v. Twombly,
Fourth, Medtronic argues that plaintiff fails to plead fraud with particularity as required by Fed.R.Civ.P. 9(b). Rule 9(b) requires a plaintiff to plead “the who, what, when, where, and how” of the allegedly fraudulent act. Wigod v. Wells Fargo Bank, N.A.,
Finally, plaintiffs allege that Medtronic breached express and implied warranties, and Medtronic moves to dismiss these claims on a variety of grounds. Plaintiff failеd to respond to Medtronic’s arguments. Failure to respond to an argument
C. Request for Judicial Notice
Finally plaintiff requests that I take judicial notice of several medical journal articles, a U.S. Senаte staff report, hearing transcripts and filings from other cases, the FDA-approved labeling for the Infuse combination device, and letters from Senators to Medtronic. Medtronic asks me to take judicial notice of the FDA-approved labeling but objects to my taking judicial notice of the articles, staff report, and Senator letters and to accepting the factual findings in any case materials. I may take judicial notice of publicly-available documents when the contents are “not subject to reasonable dispute” and are “capable'of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed. R.Evid. 201(b). Neither party disputes the accuracy of the FDA-approved labеling, and the document is publicly available on the FDA’s website. See Funk v. Stryker Corp.,
III. Conclusion
THEREFORE, IT IS ORDERED that defendants’ motion to dismiss (EOF Nо. 15) is GRANTED in part and DENIED in part.
(a) The motion is GRANTED as to plaintiffs breach of express and implied warranty claims;
(b) The motion is DENIED as to all other claims.
Notes
. Medtronic cites U.S. v. Caronia,
. Medtronic’s alleged off-label promotion of its Infuse device has been the subject of litigation throughout the country, and some courts have concluded that claims similar to those asserted here are expressly and/or impliedly рreempted. I do not find these cases persuasive. Moreover, I am bound by Seventh Circuit case law stating that "[t]he idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive.” Bausch,