California Court of Appeals, Second District, Fifth Division
APPEAL from a judgment of the Superior Court of Los Angeles County, No. SC112290 Cesar C. Sarmiento, Judge.
Law Offices of Martin N. Buchanan, Martin N. Buchanan; Girardi & Keese and James G. O’Callahan for Plaintiff and Appellant.
Mayer Brown LLP, Andrew E. Tauber, Scott M. Noveck; Reed Smith LLP, Michael K. Brown, James C. Martin and Lisa M. Baird for Defendants and Respondents.
Plaintiff and appellant John Coleman sued defendants and respondents Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, Medtronic), alleging he suffered painful complications after a spinal surgery in which Infuse, Medtronic’s federally-approved bone fusion medical device, was used in an “off-label” manner. Coleman’s seven causes of action are generally based upon allegations that Medtronic defectively manufactured Infuse, promoted off-label uses of Infuse without adequately warning of the associated risks, and failed to take available steps to warn Coleman of the risks of such uses. The trial court sustained Medtronic’s demurrer to Coleman’s third amended complaint without leave to amend on the grounds that each cause of action was preempted by federal law. We conclude that Coleman may allege causes of action for negligence and strict liability in a manner that avoids federal preemption but has waived any claim of error with respect to the remaining causes of action. We therefore affirm in part, reverse in part, and remand to the trial court for further proceedings.
FACTUAL AND PROCEDURAL BACKGROUND
Medtronic manufactures and sells Infuse, a medical device used in surgery to strengthen the spines of individuals with degenerated vertebral discs. Infuse consists of an absorbable collagen sponge, rhBMP-2 (a manufactured version of a protein found in small quantities in the human body), and a titanium threaded fusion cage. During surgery, the doctor infuses the collagen sponge with liquid rhBMP-2 and inserts the sponge into the cage to both stabilize the spine and maintain spacing between the vertebrae during the fusion process.
Under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), as amended by the Medical Device Amendments of 1976 (MDA), the Federal Drug Administration (FDA) granted Infuse premarket approval for use in certain types of spinal fusion surgeries, including Anterior Lumbar Interbody Fusion (Anterior Fusion), where the surgical incision is on the patient’s abdomen. Posterior Lumbar Interbody Fusion (Posterior Fusion) is an alternate form of spinal fusion surgery that approaches the spine through an incision in the patient’s back. Posterior Fusion is considered an off-label use of Infuse because the FDA has only approved Infuse for use in Anterior Fusion.
Coleman’s third amended complaint alleges Medtronic promoted the off-label use of Infuse while downplaying the risk of complications, violating both state and federal laws. Medtronic sponsored a clinical trial in 1999 to explore the use of Infuse in Posterior Fusion but halted the trial because early results showed unwanted and uncontrolled bone growth in more than 70 percent of patients. Between 1998 and 2011, Medtronic entered into consulting and royalty agreements with “Key Opinion Leaders” who were physicians touting Infuse through presentations and medical journal articles. Studies funded by Medtronic omitted discussion of bone growth in the spinal canal as an adverse event and instead reported no adverse events. Medtronic, however, was aware that adverse events or complications had been reported in between 20 and 70 percent of cases where Infuse was used in Posterior Fusion. Medtronic also provided information and instructions for off-label surgeries by placing sales personnel in hospital operating rooms. Medtronic’s promotional activities increased the use of Infuse in Posterior Fusion. At the same time, various investigations by media, the Department of Justice, and the Congress raised questions about the safety of Infuse and about payments from Medtronic to physicians.
In April 2009, Coleman underwent Posterior Fusion surgery of his L3–L5 vertebrae. His surgeon used Infuse in an off-label manner. Coleman began suffering numbness and pain after the surgery. CT scans showed the collagen sponge had leaked rhBMP-2 and unwanted bone growth had encased the nerves in Coleman’s spine.
In April 2011, Coleman filed suit against Medtronic. The trial court sustained Medtronic’s demurrers to Coleman’s complaint and first amended complaint with leave to amend. Medtronic filed a demurrer to Coleman’s second amended complaint. Coleman’s opposition to the demurrer attached a third amended complaint. On April 12, 2012, the court sustained the demurrer to the second amended complaint but found the proposed third amended complaint sufficient, with the exception of Coleman’s manufacturing defect claim. The court ordered Coleman to file a third amended complaint without the manufacturing defect claim and ordered Medtronic to file an answer.
Four days later, a three-judge panel of the Ninth Circuit Court of Appeals held that a state law negligence cause of action based on a failure to report adverse information about an FDA-approved medical device as required by federal regulations was preempted by federal law. (Stengel v. Medtronic, Inc. (9th Cir. 2012) 676 F.3d 1159 (Stengel I).) Based on the decision in Stengel I, Medtronic demurred to Coleman’s third amended complaint. The trial court sustained Medtronic’s demurrer without leave to amend on June 13, 2012.
On July 25, 2012, the Ninth Circuit agreed to rehear Stengel I en banc. (Stengel v. Medtronic, Inc. (9th Cir. 2012) 686 F.3d 1121 (Stengel II).) On August 27, 2012, Coleman filed a timely notice of appeal. On January 10, 2013, the Ninth Circuit issued a unanimous 11-judge en banc decision holding that the plaintiff’s state law negligence claims for failure to warn were not preempted by federal law. (Stengel v. Medtronic, Inc. (9th Cir. 2013) 704 F.3d 1224 (Stengel III).)
Medtronic petitioned the United States Supreme Court for a writ of certiorari in Stengel III on May 10, 2013. On October 7, 2013, the Supreme Court issued an order stating: “The Solicitor General is invited to file a brief in this case expressing the views of the United States.” (Medtronic, Inc. v. Stengel (Oct. 7, 2013, No. 12-1351) __ U.S. ___ [134 S.Ct. 375].)
In his timely appeal, Coleman contends his failure to warn, negligence, and manufacturing defect claims are not preempted because they are based on state law duties that parallel requirements under federal law. Medtronic contends that Coleman’s state law claims cannot survive preemption, and to the extent they do, they are inadequately pleaded.
A. Standard of Review
“We apply a de novo standard of review because this case was resolved on demurrer (McCall v. PacifiCare of Cal., Inc. (2001) 25 Cal.4th 412, 415) and because federal preemption presents a pure question of law (Spielholz v. Superior Court (2001) 86 Cal.App.4th 1366, 1371).” (In re Farm Raised Salmon Cases (2008) 42 Cal.4th 1077, 1089, fn. 10 (Farm Raised Salmon).) “In ruling on a demurrer, the ‘allegations [of the complaint] must be liberally construed, with a view to substantial justice between the parties.’ (Code Civ. Proc., § 452; see Rickley v. Goodfriend (2013) 212 Cal.App.4th 1136, 1141-1142 [court must liberally construe complaint, and draw all reasonable inferences in favor of its allegations].)” (Teva Pharmaceuticals USA, Inc. v. Superior Court (2013) 217 Cal.App.4th 96, 102.)
B. Federal Regulation of Class III Medical Devices
The MDA “imposed a regime of detailed federal oversight” including a “rigorous regime of premarket approval” for Class III medical devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316-317 (Riegel).) Before the FDA will grant premarket approval to a Class III medical device, it must be reasonably assured of the device’s safety and effectiveness. (21 U.S.C. § 360e(d).) The premarket approval process is very involved, and applicants, usually the device manufacturers, must meet many requirements both before and after the FDA grants premarket approval. (Riegel, supra, at pp. 318-319.) The agency must “weigh any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.” (§ 360c(a)(2)(C).) The FDA also reviews the device’s proposed labeling as part of the premarket approval process, evaluating safety and effectiveness under the conditions of use set forth on the label (§ 360c(a)(2)(B)), and determining that the proposed labeling is neither false nor misleading (§ 360e(d)(1)(A)). After this review process, the FDA decides whether to grant or deny premarket approval to a given device. (§ 360e(d).)
After premarket approval, applicants must report “adverse events” to the FDA. These are incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred. (21 C.F.R. § 803.50(a).) Applicants must also report new clinical investigations or scientific studies concerning the device of which the applicant knows or reasonably should have known. (Id., § 814.84(b)(2).) The FDA may withdraw premarket approval based on newly reported data or existing information; it must withdraw approval ...