STEVEN L. McCORMICK, ET UX.
MEDTRONIC, INC., ET AL
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Argued by: George S. Tolley, III (Dugan, Babij & Tolley, LLC of Timonium, MD) Bijan Esfandiari (Baum, Hedlund, Aristei & Goldman PC of Los Angeles, CA) (Cara J. Luther, Baum, Hedlund, Aristei & Goldman, PC of Washington, D.C.) on the brief for Appellant.
Argued by: Lindsay S. Goldberg (Laura S. Colton, Hogan, Lovells, U.S. LLP of Baltimore, MD) Andrew E. Tauber (Scott M. Noveck, Mayer, Brown, LLP of Washington, D.C.) all on the brief for Appellee.
Meredith, Berger, Arthur, JJ. Opinion by Arthur, J.
[219 Md.App. 496]
This case principally concerns the extent to which federal law expressly or impliedly preempts state common-law and statutory claims for personal injuries that resulted from the so-called " off-label" promotion of a medical device.
Relying on one of the first of what are now numerous federal district court decisions concerning the specific device at issue in this case, the Circuit Court for Montgomery County ruled that federal law preempted all of the plaintiffs' claims, except those for fraud. The court then ruled that the plaintiffs had failed to plead fraud with particularity. Consequently, the court dismissed the claims against the manufacturer with prejudice.
We shall hold that federal law does not expressly or impliedly preempt the plaintiffs' claims concerning misrepresentations or express warranties that the manufacturer may have made in voluntary communications with the public or with members of the medical profession. We shall also hold that the plaintiffs failed to plead common-law fraud with particularity, but that the circuit court, on remand, should allow them an opportunity to replead. We shall affirm the circuit court in all other respects.
Appellants present two questions for our review, which we have rephrased as follows:
I. Did the trial court err in holding that all of the appellants' causes of action (except those for fraud) are expressly and impliedly preempted by federal law?
II. Did the trial court err in holding that appellants had failed to plead fraud with particularity?
[219 Md.App. 497] As stated above, we shall affirm in part and reverse in part on the preemption issues. On the issue of pleading fraud with particularity, we shall affirm, but shall direct the circuit court to afford leave to amend on remand.
Factual and Procedural History
This is one of numerous cases nationwide concerning the Infuse Bone Graft device, a medical device that is manufactured and marketed by defendant Medtronic, Inc.
In 2007, plaintiff Steven McCormick underwent spinal-fusion surgery, in which his surgeon, defendant Michael K. Rosner, M.D., implanted the Infuse device in an " off-label" manner -- i.e., in a manner other than the one " for which it has been approved by the FDA." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Mr. McCormick claims to have suffered serious complications, including excessive bone growth, which allegedly necessitated a second surgery and has left him disabled. He attributes his condition to what he characterizes as Medtronic's " illegal" promotion of off-label uses of the device, including alleged misrepresentations concerning the risks of the off-label uses.
B. The Infuse Device
As approved by the FDA in 2002, the Infuse device consists of three components: a genetically-engineered version of a naturally-occurring protein that stimulates bone growth; a collagen sponge; and a cage or hollow cylinder that holds the
vertebrae in place and directs the development of bone growth.
In surgery employing the device, the genetically-engineered protein is applied to the sponge, which acts as a carrier and scaffold for the protein. The surgeon implants the protein-infused sponge and the cage into the spine, where the protein evidently spurs the bone growth necessary to achieve the fusion. The device thus appears to have been intended to [219 Md.App. 498] replace or supplant the conventional method of performing spinal-fusion surgery, which involves harvesting bone (either from the patient's hip or from a cadaver) and implanting the harvested bone in the patient's spine.
C. FDA Approval
The McCormicks allege that the majority of spinal-fusion procedures, including those that are used to treat nerve compression, are performed by means of a " posterior approach" through the back. The McCormicks further allege that even before the FDA approved the Infuse device in 2002, Medtronic knew, from clinical trials, that when the surgeons employed a posterior approach, the use of the genetically-engineered protein led to undesired or " heterotopic" bone growth. According to the McCormicks, an FDA advisory panel admonished Medtronic to guard against the use of the device in procedures other than an " anterior approach," by which the surgeon approaches the spine from the front of the body, through an incision in the abdomen. One panel member allegedly observed that because the cage is difficult to implant in a posterior approach, the use of the cage would prevent most surgeons from employing the posterior approach.
When the FDA approved the Infuse device, it required the labeling to warn that the device may be used only via the anterior approach. In addition, the approved labeling warns that the product " must not be used" without the cage.
D. Off-Label Marketing
The McCormicks' complaint is replete with allegations that, after obtaining FDA approval of the Infuse device, Medtronic engaged in an extensive and (they allege) illegal effort to promote the off-label use of the device, apparently by means of a posterior approach without the required cage. The McCormicks specifically allege that Medtronic promoted the off-label use of the Infuse device by giving financial incentives to physicians, by providing physicians with information from consultants and " key opinion leaders" whom Medtronic had targeted and paid, and by placing Medtronic sales representatives [219 Md.App. 499] in operating rooms when surgeons were performing surgeries in which they employed the off-label, anterior approach.
The McCormicks allege that, as a result of Medtronic's off-label promotion of the Infuse device, sales of the device exceeded $900 million in 2010, of which more than 85 percent resulted from off-label procedures.
E. The Spine Journal
The McCormicks' complaint prominently mentions the July 2011 edition of a medical
periodical, The Spine Journal, which, they say, devoted an entire issue to articles concerning the Infuse device. The complaint alleges that the journal articles discussed Medtronic's failure to accurately report the adverse side-effects that occurred in the clinical trials of the device; Medtronic's failure to disclose that many of the authors who studied and promoted the device had conflicts of interest because of their significant financial ties to Medtronic (having received a median range of payments of between $12 million and $16 million per study); and Medtronic's downplaying of the risks associated with the device (including the stimulation of excessive bone growth) while overemphasizing its advantages over conventional procedures (such as bone grafts).
F. The Disclosure of Increased Risks of Cancer
The McCormicks also allege that a November 2011 study showed that a high-dosage use of the Infuse device, which, they say, occurs in some off-label procedures, can result in a nearly four-fold increased risk of cancer. They go on to allege [219 Md.App. 500] that, according to the study's lead researcher, the genetically-engineered protein in the Infuse device is a cancer-promoting substance. The McCormicks claim that Medtronic knew of the alleged risks of cancer, but failed to inform the public or the medical community of them.
G. Mr. McCormick's Unsuccessful Surgery
On July 27, 2007, well before the allegations about the Infuse device became public, Mr. McCormick himself underwent spinal-fusion surgery to relieve his complaints of persistent back pain. His surgeon, Dr. Rosner, took a posterior approach (rather than the approved anterior approach), and he used a Medtronic cage that the FDA had not approved for use with an Infuse bone graft. Additionally, the McCormicks appear to allege that the surgeon used an inappropriate amount of the genetically-engineered protein component of the device. According to the McCormicks' complaint, at least one Medtronic sales representative -- defendant Vincent Profitt -- was present in the operating room during Mr. McCormick's surgery.
The McCormicks allege that the surgery did not succeed in relieving Mr. McCormick's complaints. As a consequence, the McCormicks allege, Mr. McCormick was unable to continue to work and was forced to go on permanent disability in October 2008. They claim that in the spring of 2010 Mr. McCormick's physicians discovered that he suffered from neural foraminal stenosis, or narrowing of the cervical disc space, at the site where the Infuse device had been implanted. Eventually, in September 2010, Mr. McCormick underwent revision surgery to remove the " bony overgrowth" and inflammation that had allegedly resulted from the earlier surgery in 2007. The McCormicks allege that in the revision surgery Mr. McCormick's surgeon was forced to chisel away the excess bone-growth that, they say, the Infuse product had caused.
According to the McCormicks, Mr. McCormick learned in August 2011 that he had two nodules in his lungs that he must monitor to ensure that they do not become cancerous. The [219 Md.App. 501] McCormicks contend that Mr. McCormick's exposure to the Infuse product significantly increases the risk that the nodules will become cancerous.
H. The Complaint
On the basis of these essential allegations, Mr. McCormick asserted a series of claims against Medtronic, a Medtronic subsidiary, the Medtronic sales representative who was in the operating room during his
surgery (collectively, " Medtronic" ), and Dr. Rosner.
As against Medtronic, Mr. McCormick asserted claims for negligence (Count II), strict products liability (Count III), breach of warranty (Count IV), fraud (Count V), negligence per se (Count VI), and violations of the Consumer Protection Act (Count VII). As against the surgeon, Dr. Rosner, McCormick asserted a claim for failure to obtain informed consent (Count VIII). Finally, Mr. McCormick and his wife asserted a joint claim for loss of consortium (Count IX).
I. The Proceedings in the Circuit Court
Medtronic moved to dismiss the McCormicks' complaint on several grounds, including federal preemption and the failure to allege fraud with particularity. Dr. Rosner also moved to dismiss the complaint, arguing that the McCormicks had failed to comply with their obligation to submit their claim to the Health Care Alternative Dispute Resolution Office before filing suit. See Md. Code (1974, 2013 Repl. Vol.) § 3-2A-04(a)(1)(i) of the Courts and Judicial Proceedings Article. [219 Md.App. 502] Meanwhile, Mr. McCormick voluntarily dismissed the claim that alleged negligence per se.
After a hearing, the circuit court dismissed the claims against Medtronic, relying exclusively on Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206 (W.D. Ok. 2013), one of the first reported cases to consider the extent to which federal law preempts state-law claims concerning the Infuse device. Rather than dismiss the claims against Dr. Rosner, however, the court stayed the proceedings to permit the McCormicks to file the claim in the Health Care Alternative Dispute Resolution Office.
In response, the McCormicks initially asked the court to allow them to appeal the order as to Dr. Rosner under the collateral order doctrine, " a very narrow exception to the final judgment rule." See, e.g., Nnoli v. Nnoli, 389 Md. 315, 329, 884 A.2d 1215 (2011). After the court complied with their request, however, the McCormicks dismissed ...