Randy Warstler, Plaintiff, v. Medtronic, Inc., et al., Defendants.
Case No. 3:16CV00385
IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO WESTERN DIVISION
02/28/17
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
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),
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.
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.”
In addition to the restrictions on post-PMA changes, FDA regulations subject manufacturers to reporting requirements.
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 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
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 that the pleader is entitled to relief.”
To survive a motion to dismiss under
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).
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, 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 (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).
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 (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 device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
Congress intended
While “[t]he Supreme Court has interpreted
Simply put, “‘state tort suits that allege, as the basis of their claim, that the approved FDA requirements have not been met are not preempted.” In re Sulzer Hip Prosthesis & Knee Prosthesis Liab. Litig., 455 F. Supp. 2d 709, 718 (N.D. Ohio 2006) (quoting Martin v. Medtronic, Inc., 254 F.3d 573, 583 (5th Cir. 2001)).
I note, however, that “[a]rmed with the Supreme Court‘s ruling in Reigel, courts have held that ‘[p]arallel claims must be specifically stated in the initial pleadings. A plaintiff must allege that ‘[t]he defendant violated a particular federal specification referring to the device at issue.‘‘” Schmidt v. Boston Scientific Corp., 2016 WL 1274824, *3 (N.D. Ohio) (quoting Wolicki-Gables v. Arrow Intern., Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (quoting Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 589 (E.D.N.Y. 2009))) (emphasis added); see also Wolicki-Gables, supra, 634 F.3d at 1301 (“‘To properly allege parallel claims, the complaint must set forth facts’ pointing to specific PMA
Accordingly, I apply a two-part test to determine whether plaintiff‘s state law claims are preempted. See, e.g., Wolicki-Gables, supra, 634 F.3d at 1300-01; In re Medtronic, Inc., Spring Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp. 3d 619, 623-24 (W.D. Mich. 2015).
First, “[I] must determine whether the Federal Government has established requirements applicable to [the device at issue]” Riegel, supra, 552 U.S. at 321. If so, then I must determine whether the state law claims impose “requirements with respect to the device that are ‘different from, or in addition to’ the federal ones, and that relate to safety and effectiveness.” Id. at 321-22 (quoting
If these conditions apply, then
The device at issue understandably meets the first inquiry: the PMA provides the framework for regulating the SynchroMed II as a Class III medical device. The Court in Riegel specifically held that “[p]remarket approval . . . imposes [federal] ‘requirements‘” as that term is used in
As discussed above, SynchroMed II originally received PMA in 1988, allowing entry into the market, and received subsequent approval via more than 200 supplemental applications. The FDA‘s evaluation that led to PMA was specific to SynchroMed II, requiring the device to be manufactured with “almost no deviations from the specifications in its approval application.” Id.
Thus, the FDA‘s PMA established federal requirements applicable to SynchroMed II.
2. Warstler Bases His Claims on Ohio Requirements “Different From, or In Addition To” Federal Requirements and That Relate to Safety and Effectiveness4
Because the FDA‘s grant of PMA to SynchroMed II established federal requirements, plaintiff can proceed with his state law claims only if the state law requirements on which he bases his claims parallel (i.e., are not “different from, or in addition to“) the FDA-imposed requirements.
a. Count One: Manufacturing Defect
Plaintiff raises a manufacturing defect claim against defendant, arguing defendant is strictly liable for any manufacturing defects in its SynchroMed II device.
Because plaintiff fails to assert facts suggesting defendant deviated from any specific FDA-prescribed manufacturing requirement, I conclude that
Plaintiff does not allege that the actual manufacture of the SynchroMed II device he received deviated from the FDA‘s requirements relating to production of the device. See, e.g., Aaron, supra, 2016 WL 5242957 at *9. Therefore, “‘to prevail on this claim, Plaintiff[] would need to establish that the [SynchroMed II device] should have been designed in a manner different than that approved by the FDA.‘” Id. (quoting Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1040 (D. Haw. 2014) (emphasis in original)).
The Supreme Court in Riegel clearly foreclosed any such claim, holding that
In Aaron, the court reached the same conclusion with respect to a design defect claim, holding it was “‘the exact type of claim that is expressly preempted under
This is precisely what plaintiff‘s manufacturing defect claim improperly seeks to do.
First, there is no allegation that defendant did not produce plaintiff‘s SynchroMed II device according to FDA specifications per the PMA. Thus, allowing plaintiff to proceed with his manufacturing defect claim effectively results in a holding that an FDA-approved manufacturing process could nevertheless be legally insufficient and expose defendant to liability. As the court in Aaron concluded, this decision would “enchroach[] on federal regulatory authority that
Further, I disagree with plaintiff‘s attempt to avoid preemption by alleging violations of Good Manufacturing Practices (GMP).5
In Howard, supra, 382 F. App‘x at 440, the Sixth Circuit rejected the defendant-manufacturer‘s argument that the GMP at issue was unenforceable as a basis for plaintiff‘s negligence per se claim. In reaching this conclusion and allowing plaintiff to proceed on this state law claim, the Sixth Circuit emphasized the fact that the plaintiff identified a specific GMP that he believed defendant violated. The court emphasized that “the particular GMP that [plaintiff] cites is not so vague as to be incapable of enforcement.” Id.
First, unlike the plaintiff in Howard, plaintiff alleges generally that “Medtronic violated the federal manufacturing regulations and Current Good Manufacturing Practices (CGMPs) with regards to the SynchroMed® II Device.” (Doc. 1, ¶46). To evidence these alleged GMP violations, plaintiff references FDA inspection notices, warning letters, and recalls of certain component parts. Despite these references, plaintiff fails to identify a GMP that “is not so vague as to be incapable of enforcement.” Howard, supra, 382 F. App‘x at 440.
Even assuming plaintiff properly identifies a specific GMP that defendant allegedly violated, he asserts no facts linking an alleged GMP violation, recall, or FDA regulatory action to the injuries he claims that the specific device implanted in his body in 2013 caused. See e.g., Frere v. Medtronic, Inc., 2016 WL 1533524, *6 (C.D. Cal.) (dismissing complaint based on similar GMP allegations because plaintiff included “only conclusory allegations that the purported irregularities or failure to warn caused [the plaintiff‘s] injuries“); Anderson v. Boston Scientific Corp., 2013 WL 632379, *2 (S.D. Ohio) (“[T]he complaint contains no factual allegations that can support a plausible inference of causation.“); Anthony v. Stryker Corp., 2010 WL 1387790, *4 (N.D. Ohio) (dismissing complaint because the plaintiff “did not plead any facts that would lead this court to plausibly infer that [the manufacturer‘s] noncompliance with FDA regulations led to his injury“).
Accordingly,
Plaintiff also alleges that defendant is liable for plaintiff‘s injuries due to defendant‘s failure to warn of SynchroMed II‘s dangers.
I conclude, again, that
First, to the extent plaintiff alleges Ohio law required defendant to provide any warning other than or beyond that which the FDA required as part of its PMA, I look no further than the statutory language:
Second, plaintiff argues that he premises his failure to warn claim on defendant‘s failure “to monitor the product after pre-market approval and to discover and report to the FDA any complaints about the product‘s performance and any adverse health consequences of which it became aware and that are or may be attributable to the product.” (Doc. 13, at 11). Specifically, plaintiff argues defendant had a duty to warn “patients, their doctors, the medical community, and the FDA of the device‘s risks and dangers.” (Id.). I disagree.
Section
Unlike the FDA‘s adverse event reporting requirement, Ohio law imposes no duty to report adverse events to the FDA. Simply put, the federal reporting duty is not “equal to, or substantially
As a result, plaintiff‘s allegation that defendant failed to satisfy a duty to warn does not state a parallel claim.
Further, I note that a manufacturer‘s mandatory adverse event report to the FDA does not function as a warning. While the FDA “may disclose” adverse event reports to the public, it has no obligation to do so.
Accordingly,
Count Three alleges that defendant breached express warranties that SynchroMed II “was safe, effective, fit and proper for the intended or prescribed use and foreseeable uses.” (Doc. 1, ¶92).
Count Four alleges that defendant breached implied warranties that SynchroMed II “was of merchantable quality, was manufactured, packaged, or labeled in accord with FDA regulations, complied with applicable FDA regulations and approved specifications, was safe, effective, and fit for use for the ordinary purpose for which it was intended.” (Id. ¶99).
In other words, plaintiff‘s breach of warranty claims challenge the safety and effectiveness of SynchroMed II, as warranted by defendant.
To succeed on these claims, a jury would need to find that SynchroMed II “was not safe and effective” as labeled. See, e.g,. Gavin v. Medtronic, Inc., 2013 WL 3791612, at *15-16 (E.D. La.); Hafer, supra, 99 F. Supp. 3d at 863-64; Caplinger, supra, 921 F. Supp. 2d at 1222; Lawrence v. Medtronic, Inc., 2013 WL 4008821, at *5 (D. Minn.).
Such a finding, however, would directly conflict with the FDA‘s initial PMA and its numerous supplements for SynchroMed II and the basis for its actions: namely, that “there is a ‘reasonable assurance’ of the device‘s ‘safety and effectiveness.‘” Riegel, supra, 552 U.S. at 318 (quoting
Simply put, plaintiff bases his breach of warranty claims on the safety or effectiveness of SynchroMed II and thereby seeks ultimately to hold defendant liable for violating requirements “different from, or in addition to” those the federal government has imposed.6
Accordingly,
In his misrepresentation claims, plaintiff alleges that defendant represented to him and to his medical providers that SynchroMed II was safe and effective despite having knowledge that the device was defective and dangerous.
Like plaintiff‘s breach of warranty claims, his misrepresentation claims also require a finding that SynchroMed II was unsafe or ineffective despite the FDA‘s PMA, which the FDA based primarily on its determination that the device was safe and effective. In other words, for these claims to prevail, a jury must make findings contrary to the FDA‘s PMA finding of safety and effectiveness. Such a finding would ultimately hold defendant liable for violating requirements “different from, or in addition to” those the federal government had established.
Also, there is nothing in either count alleging a violation of PMA requirements, further foreclosing any parallel claim argument.
Accordingly,
e. Count Six: Negligence
Finally, plaintiff brings a negligence claim, alleging defendant breached its duty to manufacture, label, market, distribute, supply, and sell products in such a way as to avoid harm to users. This breach, according to plaintiff, directly and proximately caused his injuries.
To dispose of this claim, I need look no further than the Supreme Court‘s opinion in Riegel, in which the Court held the plaintiff‘s negligence claim was preempted. 552 U.S. at 330; see also Lohr, supra, 518 U.S. at 503-05 (Breyer, J., concurring in part and concurring in judgment).
The same is true here. The FDA‘s PMA established the federal requirements with which defendant had to comply in manufacturing, labeling, marketing, distributing, supplying, and selling SynchroMed II. Imposing Ohio or common law negligence doctrine and a corresponding reasonableness standard would create duties that are “different from, or in addition to” the federal requirements applicable to SynchroMed II and would “disrupt the federal scheme” in that the FDA already evaluated SynchroMed II‘s safety and effectiveness and granted PMA. Id.
Accordingly,
B. Implied Preemption
Defendant argues, in the alternative, that even if
In addition to
Because I already concluded that the FDCA expressly preempts plaintiff‘s claims, I decline to address whether the Act impliedly preempts his claims as well.
Conclusion
Plaintiff asserts only state law claims. I conclude that the Medical Device Amendment‘s express preemption provision,
It is, therefore,
ORDERED THAT: defendant‘s motion to dismiss (Doc. 6) be, and the same hereby is, granted.
So ordered.
/s/ James G. Carr
Sr. U.S. District Judge