Robert Gables and Linda Wolicki-Gables appeal from the District Court’s grant of summary judgment in favor of Arrow International (“Arrow”), Codman & Shurtleff (“Codman”), Johnson & Johnson, and Greg Nelson (collectively “Appellees”). The Gableses contend that the state law claims they brought against Appellees are not preempted by the Medical Device Amendments of 1976 (“MDA”). The Gableses also assert that the District Court erred in determining that she was not entitled to a presumption that the catheter connector for the Arrow pump implanted in Linda Wolicki-Gables was defective because it was destroyed by the manufacturer. We affirm because we conclude that the Gableses’ claims are preempted, and the District Court did not err in determining that they were not entitled to a presumption that the catheter connector was defective.
I
A
During much of the 1990s, Linda Wolicki-Gables (“Wolicki-Gables”) endured pain and physical limitations from two back injuries. On April 30, 2002, Brian James, Wolicki-Gables’s doctor, implanted an Arrow pump system in her back to manage her pain. This pump system works by allowing the continuous delivery of pain medication into the intraspinal space to eliminate the peaks and valleys often experienced with traditional oral drug therapy. It also allows the doctor to inject a separate bolus (a single, large quantity) of medication directly into the intraspinal space. The system includes three components: a pump that releases pain medication, an intrathecal catheter through which the medicine is delivered into the spinal canal, and a metal connector that links the pump catheter to the intrathecal catheter. As with all inherently risky “Class III” medical devices on the market, the pump system had been approved by the Food and Drug Administration (“FDA”) in a process called “premark
Venture Medical Devices, founded by Greg Nelson, distributed the pump for Arrow. In 2002, Codman, a subsidiary of Johnson & Johnson, acquired Arrow’s pump division and assumed the distribution contract between Arrow and Venture. Nelson became a Codman employee in July 2003. In August 2002, at WolickiGables’s request, Dr. James performed a dye injection test to assess whether the Arrow pump was working properly. Dr. James observed the dye spreading appropriately in the intraspinal space and saw no leaks in the system. On July 10, 2003, Dr. James performed a second test and found that the dye was not spreading appropriately. He hypothesized that the bolus feature of the pump was malfunctioning.
On July 15, 2003, Dr. James removed the Arrow pump, cut the pump catheter, and tested the bolus feature of the pump, which operated properly. Dr. James then removed the connector and sent a bolus through the intrathecal catheter, confirming that it too was functioning correctly. Having found nothing wrong, Dr. James replaced the connector between the pump and intrathecal catheters and reimplanted the pump into Wolicki-Gables. Nelson, who was present during the procedure, provided Dr. James with the new connector. Dr. James concluded in his postoperative report that the catheter “obviously had crimped.”
Mr. Gables testified that Nelson approached him after the surgery and said he would return the catheter connector removed from Wolicki-Gables’s back to the manufacturer. Mr. Gables also testified that Nelson later told him that the manufacturer had destroyed the catheter connector.
On July 29, 2003, Wolicki-Gables was taken to the hospital complaining of paralysis in her legs. After undergoing extensive testing, she was discharged with a diagnosis of transverse myelitis, the irritation or inflammation of the spinal cord. The neurologist who treated Wolicki-Gables during her hospitalization noted that there was no evidence of infection.
After she left the hospital, Wolicki-Gables entered HealthSouth, a rehabilitation facility. A few days later, HealthSouth noticed a purulent discharge around Wolicki-Gables’s incision site and transferred her back to the hospital. Dr. Raymon Priewe removed the entire pump system. Dr. Priewe’s postoperative note stated that there was “no pus in pump pocket or dorsal spine, only superficial skin.” Aside from a “superficial” infection at the incision site, the only other sign of bacteria was found in a culture taken from the incision site. Wolicki-Gables was discharged nine days after her readmission to the hospital with a diagnosis of suspected transverse myelitis. She has since lost her ability to walk and has become a partial paraplegic.
B
On July 24, 2007, the Gableses filed an action in the Florida State Circuit Court in Sarasota County alleging state law claims for product liability, negligence, vicarious
On July 24, 2008, Appellees filed two separate motions to dismiss the action pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. On December 10, 2008, the District Court granted in part and denied in part Appellees’ motions. It dismissed three of the Gableses’ negligence claims for failure to state a claim upon which relief can be granted. On March 12, 2009, the parties stipulated to the dismissal of a claim for vicarious liability as to Arrow and Nelson, and a claim for loss of consortium.
On March 12, 2009, Arrow filed a motion for summary judgment. It asserted that the Gableses’ twelve remaining claims were preempted by the MDA. On March 12, 2010, Codman, Johnson & Johnson and Nelson filed their own motions for summary judgment and partial summary judgment and, on March 13, 2010, joined Arrow’s motion for summary judgment.
The Gableses opposed the motions, arguing that the District Court should apply a presumption against preemption because Nelson participated in “off label” use of the Arrow pump and its parts, which constitutes “performing a procedure for which there was no provision within the Instructions for Use.” (Plaintiffs Response to Defendants’ Motion for Summary Judgment at 16-17.) They asserted that Nelson should have advised Dr. James against replacement of only the catheter connect or and should have recommended replacement of the entire pump. They also maintained that Nelson’s failure to do so constituted violation of the PMA requirements for the pain pump. Further, the Gableses contended that the District Court should grant them a presumption that the destroyed catheter connector was defective.
The Gableses also moved for partial summary judgment based on their assertion that Codman, Johnson & Johnson, and Nelson were distributors of the Arrow pump.
In its July 22, 2009 order,
Wolicki-Gables v. Arrow Int’l, Inc.,
The Gableses have timely appealed. This Court has jurisdiction pursuant to 28 U.S.C. § 1291.
II
The Gableses contend that the District Court erred in concluding that their
We review a District Court’s summary judgment ruling
de novo. Brooks v. Cnty. Comm’n of Jefferson Cnty.,
A
“[T]he MDA expressly pre-empts only state requirements different from, or in addition to, any requirement applicable ... to the device under federal law, § 360k(a)(l) .... ”
Riegel v. Medtronic, Inc.,
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.
21 U.S.C. § 360k(a).
In
Riegel,
the Supreme Court held that the MDA preemption clause does not apply to a parallel claim.
Id.
at 330,
State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to the requirements imposed by federal law.” § 360k(a)(l). Thus, § 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.
Id.
(citing
Medtronic, Inc. v. Lohr,
The Seventh Circuit explained the parallel claim principle as follows:
In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under § 360k(a), the plaintiff must show that the requirements are “genuinely equivalent.” State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law.
McMullen v. Medtronic, Inc.,
The Supreme Court established a two-pronged test in
Riegel
for deciding whether state claims are preempted.
The Court noted in
Riegel
that, in accordance with it’s holding in
Medtronic, Inc., v. Lohr,
In this matter, the District Court explained at length the Florida state laws concerning (1) strict liability for manufacturing and design defect and failure to warn, and (2) concerning liability for negligent design, manufacture and assembly. Wolicki-Gables,
In reviewing the District Court’s decision, we must first consider whether the Gableses have demonstrated that they have alleged a parallel claim.
Riegel,
The Gableses alleged in their complaint that Arrow, Codman and Johnson & Johnson:
(a) fail[ed] to reasonably design the implantable drug delivery system in a manner which would have prevented injury to those like LINDA WOLICKIGABLES;
(b) fail[ed] to reasonably manufacture the implantable drug delivery systems in a reasonable manner; [and]
(c) fail[ed] to reasonably provide adequate warnings regarding the defective and unreasonably dangerous implantable drug delivery system, having actual or constructive knowledge of the hazards associated with the product.
(Complaint at 12-13, 16, 20.
4
) These allegations do not “set forth any specific problem, or failure to comply with any FDA
B
The Gableses also contend that the District Court erred in concluding that they are not “entitled to an inference that a defect existed within the pain pump.” (Appellants’ Opening Br. at 19.) They argue that they are entitled to such an inference because the malfunctioning connector was destroyed. In support of this argument, they rely on
Cassisi
In
Cassisi
the Florida Court of Appeal held that the evidence presented by the plaintiff was sufficient to create an inference “that the malfunction itself ... is evidence of the product’s defective condition at both the time of the injury and at the time of the sale.”
In
Worsham v. A.H. Robins Co.,
Cassisi is inapplicable because the Gableses have failed to demonstrate that a defect in the Arrow pump “most probably” caused her injuries and not some other malfunction or obstruction. Their experts, Dr. Michael Meriweather and Edward Reese, Ph.D., 5 testified that though the catheter connector could have malfunctioned, they were unable to exclude alternate possible causes for a connector to fail, such as an idiosyncratic complication with the patient, natural bodily rejection, or clogging. (District Court Order at 13-14, 43^44.) The District Court did not err in concluding that they were not entitled to a presumption that the Arrow pump was defectively manufactured.
Ill
Because the Gableses’ claims are preempted, we do not address Arrow’s assertion that private actions brought for violations of the FDA regulations are barred pursuant to 21 U.S.C. § 337(a). Under 21 U.S.C. § 337(a), “[e]xcept as provided in subsection (b) [regarding actions brought by States], all such proceedings for the enforcement, or to restrain violations, of [the MDA] shall be by and in the name of the United States.”
Similarly, because the claims are preempted, we also need not address the Gableses’ contention that the District Court erred in finding that they failed to present sufficient evidence of an agency
Conclusion
The Gableses have failed to allege a parallel claim in their complaint. Therefore their claims are preempted by the MDA. Further, they have not demonstrated that they are entitled to a presumption that the destroyed catheter connector was. defective. Accordingly, the District Court’s grant of summary judgment is AFFIRMED.
Notes
. Section 360c(a)(l)(C)(i-ii) of volume 21 of the United States Code reads as follows:
[A Class III device is a] device which because it cannot be classified [under a less stringent classification], and is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury, is to be subject ... to premarket approval to provide reasonable assurance of its safety and effectiveness.
. Id. at 1285, 1286, 1288, 1290, 1295, 1296.
. Id. at 1288, 1290, 1291, 1296.
. The same claim is repeated against each of the three Appellees.
. Dr. Meriweather is the Gableses' medical expert and Dr. Reese is their regulatory expert.