Wolicki–gables v. Arrow Int'l Inc.

Decision Date08 March 2011
Docket NumberNo. 09–14342.,09–14342.
Citation634 F.3d 1296
PartiesLinda WOLICKI–GABLES, Robert Gables, her husband, Plaintiffs–Appellants,v.ARROW INTERNATIONAL, INC., Codman & Shurtleff, Inc., Johnson & Johnson, Greg Nelson, Defendants–Appellees.
CourtU.S. Court of Appeals — Eleventh Circuit

634 F.3d 1296
22 Fla.
L. Weekly Fed. C 1871

Linda WOLICKI–GABLES, Robert Gables, her husband, Plaintiffs–Appellants,
ARROW INTERNATIONAL, INC., Codman & Shurtleff, Inc., Johnson & Johnson, Greg Nelson, Defendants–Appellees.

No. 09–14342.

United States Court of Appeals, Eleventh Circuit.

March 8, 2011.

[634 F.3d 1297]

T. Patton Youngblood, Jr., T. Patton Youngblood, Jr., P.A., Tampa, FL, for Plaintiffs–Appellants.Kristin Ann Norse, Stuart C. Markman, Kynes, Markman & Felman, PA, Joseph H. Lang, Jr., Edward W. Gerecke, Carlton Fields, P.A., Charles D. Bavol, Melissa DeAnn Krepps, Bavol Judge, P.A., Nancy Jean Stewig, Broad & Cassel, Tampa, FL, for Defendants–Appellees.Appeal from the United States District Court for the Middle District of Florida.Before EDMONDSON, HILL and ALARCÓN,* Circuit Judges.ALARCÓN, Circuit Judge:

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.


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 “premarket

[634 F.3d 1298]

approval.” 21 U.S.C. § 360c(a)(1)(C)(ii)(II).1

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 Wolicki–Gables'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.


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

[634 F.3d 1299]

liability, and loss of consortium against the Appellees. On January 22, 2008, Codman and Johnson & Johnson filed a notice of removal to the Middle District of Florida based on diversity jurisdiction pursuant to 28 U.S.C. § 1332. Arrow and Nelson consented to the removal. The Gableses filed an amended complaint in the District Court on July 7, 2008. They alleged seventeen counts against the Appellees.

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.” (Plaintiff's 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 connector 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., 641 F.Supp.2d 1270 (M.D.Fla.2009), the District Court determined that each claim was “expressly preempted”2 or was “derivative of”3 a preempted claim. The District Court also articulated three alternative bases on which Appellees were entitled to summary judgment on several of the...

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    ...because they are not pleaded with sufficient detail, relying heavily on our decision in Wolicki-Gables [v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011). . . . [U]nlike the plaintiff in Wolicki-Gables [plaintiff] is a pro se litigant whose pleadings are held to a less stringent ......
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