Warstler v. Medtronic, Inc.

238 F.Supp.3d 978

Randy WARSTLER, Plaintiff,

v.MEDTRONIC, INC., et al., Defendants.

Case No. 3:16CV00385

United States District Court, N.D. Ohio, Western Division.

Signed February 28, 2017

David W. Zoll, Carasusana B. Wall, James G. O'Brien, Michelle L. Kranz, Zoll & Kranz, Toledo, OH, for Plaintiff.

Joe W. Tomaselli, Jr., Goldman Ismail Tomaselli Brennan & Baum, Dallas, Tx, Rami N. Fakhouri, Goldman Ismail Tomaselli Brennan & Baum, Chicago, IL, for Defendants.

James G. Carr, Sr. U.S. District Judge

ORDER

This is a products liability action against defendant Medtronic, Inc. (Medtronic). Plaintiff alleges that the Medtronic-manufactured device implanted in his body was defective, causing him serious injuries. Plaintiff brings his claims pursuant to Ohio law.

Jurisdiction is proper under 28 U.S.C. § 1332.

Pending is defendant Medtronic's motion to dismiss for failure to state a claim. (Doc. 6). Plaintiff has filed a response (Doc. 13) to which defendant has replied. (Doc. 14).

For the reasons that follow, I grant defendant's motion.

Background

Defendant Medtronic manufactures many different devices, but at issue in this case is the SynchroMed® II Programmable Drug Infusion System (SynchroMed II).

SynchroMed II is a prescription medical device–specifically, a programmable drug infusion system implanted in the body for drug delivery. Each SynchroMed II includes an infusion pump, connected to a thin, flexible catheter, that enables storage and delivery of medicine.

Pursuant to the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360c et seq. —an amendment to the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. —SynchroMed II is a Class III medical device.¹

Under the FDCA and MDA, all medical devices, including SynchroMed II, are subject to Food and Drug Administration (FDA)–imposed regulations concerning design, manufacture, labeling, marketing, and sale. Specifically, as a Class III device, SynchroMed II—in its original form—was subject to the FDA's rigorous Premarket Approval Process (PMA), which, as its name suggests, requires prior FDA approval for a device to enter the market. § 360e

To receive PMA, manufacturers submit information about their device's proposed design, manufacture, and labeling. Based on these submissions and a comprehensive review, the FDA determines whether a device is suitable for the market, granting PMA only if there is "reasonable assurance" of the device's "safety and effectiveness." § 360e(d). This "safety and effectiveness" determination involves a risk-benefit analysis; the FDA "weig[hs] 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 either grants or denies PMA, § 360e(d)(1)(A) or, alternatively, places sale and distribution restrictions on the device as a condition to approval. § 360e(d)(1)(B)(ii).

PMA does not, however, allow manufacturers to then proceed without oversight. Rather, Class III device manufacturers must obtain FDA permission to make "any change to a device subject to an approved application...that affects safety or effectiveness." § 360e(d)(5)(A)(i). To make such a change, the manufacturer must submit for FDA approval an application for supplemental approval. Then, an evaluation similar to the initial application occurs. § 360e(d)(5)(A)(i)-(ii).

In addition to the restrictions on post–PMA changes, FDA regulations subject manufacturers to reporting requirements. § 360i. These include reporting new clinical investigations or scientific studies that the manufacturer knows of or reasonably should know of, 21 C.F.R. § 814.84(b)(2). In addition, the manufacturer must report incidents where the device either may have caused or contributed to death or serious injury or malfunctioned in such a way that would likely cause or contribute to death or serious injury if it happened again. § 803.50(a).

In this case, the FDA granted PMA to the original version of SynchroMed II, and the device entered the market in 1988.

SynchroMed II was approved for the following uses:

• The chronic epidural/intrathecal infusion of Infumorph (preservative-free ziconotide sterile solution) for the management of pain;

• The chronic intrathecal infusion of Baclofen (Lioresal ) for the management of severe spasticity; and

• The chronic intravascular infusion of floxuridine (FDUR) and methiotrexate for the treatment of primary or metastic cancer.

Since SynchroMed II's initial application and approval, the FDA has approved numerous supplements (i.e., changes) to the original device. One such supplement is plaintiff's Model 8637 SynchroMed II pump and Model 8590–1 SynchroMed mesh pouch, for which the FDA granted PMA on September 12, 2003. Like all Class III devices, SynchroMed II remains subject to FDA oversight.

Plaintiff's need for the allegedly defective device resulted from a boating accident in 1980, which caused neuropathy in his right leg. In 1998, physicians implanted an infusion pump in plaintiff to manage pain. In July 2013, plaintiff received a replacement SynchroMed II pump. At that time, physicians also inserted a mesh pouch as part of the SynchroMed II.

Plaintiff alleges this replacement pump was defective and caused the injuries for which he now seeks recovery.

Medtronic designed the replacement SynchroMed II pump to pump pain medication through a catheter into the spinal cavity. Plaintiff alleges that the replacement SynchroMed II allowed medication "to leak out of the pump into Plaintiff's abdominal cavity." (Doc. 1, ¶ 26). Plaintiff discovered the SynchroMed II pump's failure and the resulting leakage when doctors treated him on February 26, 2014.

The leakage led to an infection in the pump pocket site, necessitating several surgeries. Plaintiff asserts that a March, 2014 operative report stated he had an "[i]nfected mesh status post removal of the morphine pump and mechanical complication of the pump." (Id. ¶ 28). An April, 2014 report listed preoperative and postoperative diagnoses as "Failure of implanted medical device." (Id. ).

Plaintiff also asserts that the pain medication that leaked into his abdominal cavity injured his bowel and internal organs, causing damage to his left leg and the left side of his body. As noted above, the injury which initially required implantation of the SynchroMed II was in plaintiff's right leg; as a result of defendant's allegedly defective device, plaintiff's left leg is now damaged.

Finally, plaintiff asserts that the leaking medication caused the mesh pouch to dissolve, making the pouch and catheter wrap around his bowel and abdominal tissue and ultimately absorb the tissue. The tubing remains absorbed into the mesh, which remains wrapped around plaintiff's large bowel and left kidney. According to plaintiff, continued treatment of this condition requires loss of at least eight inches of his large bowel, eighteen inches of his small bowel, and his left kidney.

As a result of the damage caused by the alleged defect, plaintiff brought this products liability suit, asserting seven state law claims against defendant under Ohio law.²

According to defendants, MDA § 360k(a) expressly preempts plaintiff's state law claims, and MDA § 337(a) impliedly preempts any claims based in federal law.

Standard of Review

A complaint must contain a "short and plain statement of the claim showing the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2).

To survive a motion to dismiss under Rule 12(b)(6), the complaint "must contain sufficient factual matter, accepted as true, to state a claim that is plausible on its face." Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). "A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id.

In ruling on a motion to dismiss, I may consider "the Complaint and any exhibits attached thereto, public records, items appearing in the record of the case and exhibits attached to defendant's motion to dismiss so long as they are referred to in the Complaint and are central to the claims contained therein." Bassett v. Nat'l Collegiate Athletic Ass'n , 528 F.3d 426, 430 (6th Cir. 2008).

Discussion

There are three varieties, one express and two implied, of federal preemption. Bibbo v. Dean Witter Reynolds, Inc. , 151 F.3d 559, 562–63 (6th Cir. 1998) ; Casden v. Burns , 504 F.Supp.2d 272, 280 n.7 (N.D. Ohio 2007).

Express preemption arises when Congress "expresses a clear intent to pre-empt state law in the language of the statute." Bibbo, supra, 151 F.3d at 562.

"Field preemption"—one form of implied preemption—results when "Congress indicates an intent to occupy exclusively an entire field of regulation." Id. This may occur with "a federal regulatory scheme that is ‘so pervasive as to make reasonable the inference that [it] left no room for the States to supplement it.’ " Id. (citing Fidelity Fed. Savings and Loan Ass'n v. de la Cuesta , 458 U.S. 141, 153, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982) ).

"Conflict preemption"—the other form of implied preemption—occurs "either where it is impossible to comply with both federal and state law, or where state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress' as reflected in the language, structure and underlying goals of the federal statute at issue." Id. at 562–63 (quoting Fidelity Fed. Savings and Loan Ass'n, supra, 458 U.S. at 153, 102 S.Ct. 3014 ).

A. Express Preemption

Prior to the MDA's enactment, the states primarily governed medical devices. Medtronic, Inc v. Lohr , 518 U.S. 470, 475–76, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). This drastically changed with the MDA, due largely in part to the statute's express preemption provision, which states:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a

...