Martin v. Medtronic, Inc.

MICHAEL MARTIN, Plaintiff, v. MEDTRONIC, INC., et al., Defendants.

No. 1:15-cv-00994-DAD-MJS

UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA

February 24, 2017

ORDER GRANTING DEFENDANTS' MOTION TO DISMISS

(Doc. No. 25)

This matter came before the court on May 3, 2016, for hearing of defendants' motion to dismiss plaintiff's claims pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. Attorneys Philip C. Bourdette and Gale D. Pearson appeared on behalf of plaintiff Michael Martin, and attorneys Stephen J. Mackey and Rami N. Fakhouri appeared on behalf of defendants Medtronic, Inc., Medtronic Puerto Rico Operations, Co., and Medtronic Logistics, LLC (collectively "Medtronic"). Having considered the briefing of the parties and their oral arguments, for the reasons stated below, the court will grant defendants' motion to dismiss while also granting plaintiff leave to amend.

FACTUAL BACKGROUND

In his complaint plaintiff alleges as follows. In 2004, plaintiff was diagnosed with Lumbar Spondylosis and Lumbar Degenerative Disc Disease. (Doc. No. 18 at 3, ¶ 14.) After several years of taking medication for his condition, plaintiff was referred by his doctor for a pain pump trial. (Id.) He was admitted for the first trial of intrathecal opioid on January 17, 2008, and underwent a second trial on January 31, 2008. (Id. at 3-4, ¶¶ 14-15.) On February 4, 2008, plaintiff was implanted with medical devices for administering medication, the Medtronic Synchromed II Implantable Infusion System ("SynchroMed Device"), model # 8637-20, pump serial # NGP315748H, and the 8709SC Catheter, serial # N132467011. (Id. at 4-5, ¶¶ 15, 21.)

The SynchroMed Device is a programmable drug infusion system implanted in the human body for drug delivery. (Id. at 8, ¶ 31.) It is comprised of an infusion pump connected to a flexible catheter, which stores and delivers medication into a patient's spinal canal. (Id.) The device is manufactured by defendants, who received premarket approval ("PMA") from the U.S. Food and Drug Administration ("FDA") to market the SynchroMed Device in March 1988, and who later received supplemental PMA to market the device for use with the medications taken by plaintiff. (Id. at 2-3, 8-9, ¶¶ 2-10, 31-34.)

In November of 2008, plaintiff began experiencing health complications. (Id. at 4, ¶ 16.) These complications included "severe hot flashes [that] then progressed to abdominal cramping, nausea, severe malaise, fatigue, and blurred vision." (Id.) Plaintiff sought medical attention for these complications, but his physician was unable to identify their causes. (Id.)

In 2010, plaintiff's doctors removed the morphine from his medical pump, replacing it with another substance, "Hydromorphone (Dilaudid) or Fentanyl." (Id. at 5, ¶ 18.) Following the replacement, plaintiff began suffering from symptoms "like a withdrawal/overdose cycle." (Id.)

On July 12, 2013, plaintiff underwent a pump replacement procedure. (Id. at 5, ¶ 20.) The new implanted pump was a SynchroMed® II, model # 8637-20, pump serial # NGP385091H, and the new catheter was model # 8578 connection, serial # H880266403. (Id. at 5, ¶ 21.) During the procedure, the operating doctor discovered disintegration of the prior connector, noting broken pieces around the connector site of the pump, and slight leakage of fluids around the connection site. (Id. at 6, ¶ 23.) The doctor postulated that the leakage would have caused the medication in the pump to flow into the scar pocket where the pump was located, allowing medication to build up in the scar pocket for short periods without entering plaintiff's system, causing withdrawal symptoms, and then allowing fluid to leak periodically into plaintiff'ssystem in larger quantities than intended, causing him to experience the symptoms of an overdose. (Id.) Plaintiff alleges that he suffered "serious and permanent personal injuries" as a result of defects in the SynchroMed devices. (Id. at 7, ¶ 27.)

Beyond the specific defect in Martin's own device, plaintiff alleges that defendants have "shown a pattern of delayed responses to known safety issues concerning the SynchroMed II Implantable Infusion System." (Id. at 7, ¶ 27.) In his FAC, plaintiff cites a series of FDA Warning Letters from 2006, 2007, 2009, and 2012, all regarding defendants' device. (Id. at 15-22, ¶¶ 52, 55, 58, 59, 63). The FAC also notes that the FDA had inspected defendants' manufacturing facilities in 2006, 2007, 2011, 2012, and 2013, and had issued "Form 483" reports after each inspection session revealing potential violations of federal regulations discovered during the visit. (Id. at 26, ¶ 79.) According to plaintiff, defendants have issued over fifty recalls since 2004 relating to SynchroMed devices. (Id. at 23, ¶ 69.) Plaintiff suggests that defendants were also aware of an August 2011 recall issued by the FDA for the SynchroMed II Device due to "the potential for reduced battery performance that can lead to sudden loss of therapy." (Id. at 6, ¶ 25.) Plaintiff claims that, in May 2013, Medtronic issued a letter to customers implanted with SynchroMed II Devices that noted a redesign and suggested that certain models, including the one implanted in plaintiff, were to be removed from the market. (Id. at 6, ¶ 26.) Plaintiff alleges, however, that he did not receive any such letter. (Id.)

In 2015, the United States Department of Justice filed a complaint against Medtronic in the United States District Court for the District of Minnesota on behalf of the United States of America, alleging violations of federal law with respect to Medtronic's manufacturing practices for the Device. (Id. at 25-27, ¶¶ 77-84.) On April 27, 2015, that court issued a Consent Decree of Permanent Injunction against Medtronic, preventing the manufacture and distribution of Medtronic's Device. (Id. at 27, ¶ 85.)

PROCEDURAL BACKGROUND

Plaintiff Michael Martin initiated this action against the Medtronic defendants on June 29, 2014. (Doc. No. 2.) Plaintiff filed his First Amended Complaint ("FAC") on December 14, 2015. (Doc. No. 18.)

In his FAC, plaintiff presents eight causes of action, bringing claims for: (i) strict liability premised on a manufacturing defect, (Id. at 28-31, ¶¶ 87-101); (ii) negligence based on a failure to warn, (Id. at 31-34, ¶¶ 102-116); (iii) breach of express warranty, (Id. at 34-35, ¶¶ 117-22); (iv) breach of implied warranty, (Id. at 36-37, ¶¶ 123-29); (v) fraud based on intentional or negligent misrepresentation and concealment, (Id. at 37-38, ¶¶ 130-34); (vi) negligent failure to instruct and train medical providers, (Id. at 39-41, ¶¶ 135-39); (vii) violation of California's Unfair Competition Law ("UCL"), California Business & Professionals Code § 17200, (Id. at 40-41, ¶¶ 140-46); (viii) and violation of Minnesota consumer protection statutes, (Id. at 42-45, ¶¶ 147-69).

On January 13, 2016, defendants filed a motion to dismiss plaintiff's FAC. (Doc. No. 25.) Plaintiff filed his opposition on April 18, 2016. (Doc. No. 36.) Defendants filed their reply on April 26, 2016. (Doc. No. 37.) Following the hearing on defendants' motion to dismiss, both parties have filed notices of supplemental authority in support of their respective arguments. (Doc. Nos. 45-48.)

STANDARDS

The purpose of a motion to dismiss pursuant to Rule 12(b)(6) is to test the legal sufficiency of the complaint. N. Star Int'l v. Ariz. Corp. Comm'n, 720 F.2d 578, 581 (9th Cir. 1983). "Dismissal can be based on the lack of a cognizable legal theory or the absence of sufficient facts alleged under a cognizable legal theory." Balistreri v. Pacifica Police Dep't, 901 F.2d 696, 699 (9th Cir. 1990). A claim for relief must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Though Rule 8(a) does not require detailed factual allegations, a plaintiff is required to allege "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); Ashcroft v. Iqbal, 556 U.S. 662, 677-78 (2009). "A claim has facial plausibility when the pleaded factual content allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 556 U.S. at 678.

In determining whether a complaint states a claim on which relief may be granted, the court accepts as true the allegations in the complaint and construes the allegations in the lightmost favorable to the plaintiff. Hishon v. King & Spalding, 467 U.S. 69, 73 (1984); Novak v. United States, 795 F.3d 1012, 1017 (9th Cir. 2015). It is inappropriate to assume that the plaintiff "can prove facts that it has not alleged or that the defendants have violated the . . . laws in ways that have not been alleged." Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 526 (1983).

A district court should provide leave to amend upon granting a motion to dismiss unless it is clear that the complaint could not be saved by any amendment. Mueller v. Auker, 700 F.3d 1180, 1191 (9th Cir. 2012) (citing Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir. 2008)). Leave to amend is properly denied, however, if amendment would be futile. Thinket Ink Information Resources, In. v. Sun Microsystems, Inc., 368 F.3d 1053, 1061 (9th Cir. 2004).

ANALYSIS

Defendants advance three arguments in moving to dismiss plaintiff's FAC. (Doc. No. 25-1.) First, defendants contend that plaintiff's claims are preempted by the Medical Device Amendment ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA"). (Id. at 13-16.) Second, defendants argue that, to the extent his claims are not preempted, plaintiff has not satisfied federal pleading standards for claims concerning manufacturing defects, failure to warn, failure to train, breach of express and implied warranty, and fraud. (Id. at 22-24.) Third, defendants assert that there are state law grounds for...