Wolicki-Gables v. Doctors Same Day Surgery Ctr., Ltd.

Decision Date15 February 2017
Docket NumberCase No. 2D15–2495
Citation216 So.3d 665
Parties Linda WOLICKI–GABLES and Robert Gables, her husband, Appellants, v. DOCTORS SAME DAY SURGERY CENTER, LTD., d/b/a Doctors Same Day Surgery Center, Appellee.
CourtFlorida District Court of Appeals

T. Patton Youngblood, Jr. of the Youngblood Law Firm, St. Petersburg, for Appellants.

Joshua P. Welsh of Bush Ross, P.A., Tampa, for Appellee.

LaROSE, Judge.

Linda Wolicki–Gables and her husband, Robert Gables, appeal the trial court's final summary judgment in favor of Doctors Same Day Surgery Center, Ltd. (the Surgery Center). The Gableses brought a third-party spoliation lawsuit against the Surgery Center. They asserted that if the Surgery Center had kept an allegedly defective pain-pump connector removed from Mrs. Wolicki–Gables, the Gableses could have maintained a civil action against Arrow International, Inc., on one of two grounds: (1) a first-party spoliation suit; or (2) a "parallel claim" for negligent design and/or manufacture under Florida law. We have jurisdiction. See Fla. R. App. P. 9.030(b)(1)(A). Because any potential state law claim for negligent design or manufacture against Arrow is preempted by federal law, and because the Gableses cannot assert a "parallel claim" against Arrow under Florida law, we are compelled to affirm.


Mrs. Wolicki–Gables suffered from back and neck pain. To alleviate the condition, Dr. James of the Surgery Center implanted a "pain pump system" into Mrs. Wolicki–Gables in the spring of 2002. The system consisted of: (1) an infusion pump to hold and release pain medication; (2) an intrathecal catheter that delivered the medication into Mrs. Wolicki–Gables's spinal canal; and (3) a connector that linked these two components. Arrow manufactured all three components, which are Class III medical devices approved through the Premarket Approval Process (PMA) of the Food and Drug Administration (FDA). See Medical Device Amendments of 1976 (MDA) 5121 U.S.C. § 360e (2012); 21 C.F.R. §§ 814.1 –.126.

Unfortunately, Mrs. Wolicki–Gables's pain persisted. In response, Dr. James increased the dosage of the medication being dispensed from the pump in the summer of 2002. Mrs. Wolicki–Gables experienced no relief. About a year later, Dr. James performed a dye injection test to assess whether the pain pump system was operating properly. He concluded that the pain medication was not being directed through the intrathecal catheter into Mrs. Wolicki–Gables's spine; rather, it leaked from the injection site and dripped down Mrs. Wolicki–Gables's sides. Dr. James scheduled Mrs. Wolicki–Gables for surgery and contacted an Arrow representative, Greg Nelson.

On July 15, 2003, Mrs. Wolicki–Gables arrived at the Surgery Center for the operation. She signed an Informed Consent to Treat and Disclose Information form. She handwrote on the form, "we want old pump." She also noted on the form that she did not want technical support personnel, which would include Mr. Nelson, present during the surgery.

Dr. James proceeded with the surgery, during which Mr. Nelson was present. Dr. James removed the pain pump system and determined that the most likely cause of the malfunction was the connector between the pump and the intrathecal catheter. Dr. James replaced the connector and reinserted the pain pump system into Mrs. Wolicki–Gables's body. Dr. James confirmed that the pain pump system was operating properly.

Following the surgery, Mr. Nelson approached Mr. Gables in the waiting room to explain that the connector had been replaced. Mr. Gables asked for the old connector. Mr. Nelson refused, stating that he had to take it to Arrow for testing. Mrs. Wolicki–Gables claims that she also made a similar request to Dr. James later that same day. He, too, stated that the connector had to go to Arrow.

When released from the Surgery Center, Mrs. Wolicki–Gables had no apparent complications. At a postoperative follow-up on July 17, 2003, she presented no signs of infection and the pain pump system was working properly. Sadly, twelve days later, Mrs. Wolicki–Gables was rushed to the hospital where she was diagnosed with transverse myelitis—inflammation of the spinal cord. Several days later, the hospital released her. She returned three days later when her incision site became infected. The hospital again diagnosed Mrs. Wolicki–Gables with transverse myelitis, and added an infected pain pump to her diagnosis. Mrs. Wolick–Gables underwent another surgery where the pain pump system was permanently removed. During her convalescence from this third procedure, Mr. Gables contacted Mr. Nelson to obtain the old connector removed in the second surgery. Mr. Gables learned that Arrow tested the connector, found no defect, and destroyed it in accordance with company policy. The Gableses then sued Arrow in state court.

The Gableses asserted numerous claims against Arrow, including strict liability and negligence claims. Arrow removed the case to federal district court based on diversity jurisdiction. See 28 U.S.C. § 1332 (2011). Ultimately, the federal district court granted summary judgment to Arrow, concluding that their claims were expressly preempted by the Medical Devices Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA). Wolicki–Gables v. Arrow Int'l, Inc. , 641 F.Supp.2d 1270, 1296 (M.D. Fla. 2009), aff'd , 634 F.3d 1296, 1303 (11th Cir. 2011). The federal district court also granted summary judgment in favor of Mr. Nelson on the Gableses' claims of negligence and loss of consortium. Wolicki–Gables , 641 F.Supp.2d at 1292–96. The federal district court also concluded that they failed to demonstrate any causal relation between her injuries and the loss of the connector. Id. at 1295. Importantly, experts in the federal case were not impeded from offering meaningful testimony because the connector was unavailable. Id. at 1281.

Undeterred, and convinced that they would have prevailed against Arrow if they had the old connector, the Gableses sued the Surgery Center in state court, asserting a third-party spoliation claim. A third-party spoliation claim arises when "a person or an entity, though not a party to the underlying action causing the plaintiff's injuries or damages, lost, misplaced, or destroyed evidence critical to that action." Martino v. Wal–Mart Stores, Inc. , 908 So.2d 342, 345 n.2 (Fla. 2005). In such a case, the plaintiff attempts to recover from the third party "the loss of a probable expectancy of recovery against the first-party torfeasor."Id. (citing Humana Worker's Comp. Servs. v. Home Emergency Servs., Inc. , 842 So.2d 778, 781 (Fla. 2003) ). The Gableses alleged that but for the Surgery Center allowing Mr. Nelson to take the old connector, they could have proceeded successfully against Arrow on (1) a first-party spoliation claim, or (2) a negligent design/manufacture theory. The trial court granted summary judgment to the Surgery Center. The trial court found that neither a first-party spoliation claim nor a permissible "parallel claim" against Arrow for negligent design/manufacture existed under Florida law. This appeal followed.


The Gableses argue that the trial court erred in concluding that they could not assert a "parallel claim" against Arrow under Florida law for negligent manufacture based on a violation of MDA regulations related to Class III medical devices. We write to explain why the trial court committed no error on this point. As to the first-party spoliation claim, we affirm without further discussion. See Martino , 908 So.2d at 347.

a. Express and Implied Preemption Statutes

We begin our "parallel claim" analysis by noting that the MDA bars virtually all state-based claims for allegedly defective Class III medical devices. Two statutes are relevant. 21 U.S.C. § 360k(a) provides that

[N]o 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.

This section expressly preempts any state requirement or other obligation that is "different from, or in addition to, any requirement applicable [under the MDA] to the device," related to the "safety or effectiveness of the device." Id.

The second statute, 21 U.S.C. § 337(a), provides that "all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." Section 337(a) impliedly preempts any action "for the enforcement, or to restrain violations," of the MDA in any name other than that of the United States. Thus, enforcement of MDA requirements, in the first instance, is left to the federal government.

In tandem, §§ 360k(a) and 337(a) make it exceedingly difficult for a plaintiff to maintain negligence claims for allegedly defective medical devices that entered commerce through the PMA approval process. Often, state law claims, such as claims for negligent manufacture, are broad in scope and are expressly preempted by § 360k(a). This was the conclusion reached by the federal district court in the Gableses' initial lawsuit against Arrow. Wolicki–Gables , 641 F.Supp.2d at 1288. But, when a plaintiff attempts to assert a claim specifically based on a violation of the MDA, the claim is impliedly preempted by § 337(a), which leaves enforcement of the MDA to the United States.

The PMA approval process does not swallow the entire universe of potential state law claims. Under our federal system, states may enact laws which create a private cause of action for "failure to comply with the federal standards which were established [for a medical device] through the PMA process." Wolicki–Gables , 641 F.Supp.2d at 1284 (citing ...

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