Gomez v. St. Jude Medical Daig Div. Inc.
| Decision Date | 14 March 2006 |
| Docket Number | No. 04-30202.,04-30202. |
| Citation | 442 F.3d 919 |
| Parties | Danell GOMEZ and Martin Gomez, Plaintiffs-Appellants, v. ST. JUDE MEDICAL DAIG DIVISION INC., formerly known as Daig Corporation; Kensey-Nash Corporation; Tyco International; Wyeth, formerly known as American Home Products Corporation; Tyco Healthcare Group LP, formerly known as Kendall Company, Defendants-Appellees. |
| Court | U.S. Court of Appeals — Fifth Circuit |
Marie Riccio Wisner (argued), New Orleans, LA, Samuel A. Abady, Law Office of Samuel A. Abady & Associates, New York City, for Plaintiffs-Appellants.
Edward F. Fox (argued), Bassford Remele, Minneapolis, MN, Jerry L. Saporito, Jennifer Carmichael Babin, Saporito & Sledge, New Orleans, LA, J. Aron Allen, St. Jude Medical, Cardiology Div., Minnetonka, MN, for Defendants-Appellees.
Appeal from the United States District Court for the Eastern District of Louisiana.
Before KING and DAVIS, Circuit Judges, and ROSENTHAL, District Judge.*
In March 1999, Danell Gomez had a surgical catheterization to treat a blockage in an artery leading to her left arm. When the procedure was complete, the surgeon used a medical device known as an Angio-Seal to close the hole he had made in Gomez's femoral artery to access the blockage. The Angio-Seal deposits a small plug of collagen on the outside of the artery wall at the puncture site. The collagen plug quickly causes a clot that stops the bleeding. The Angio-Seal includes an "anchor" intended to keep any of the collagen from traveling to the inside of the artery, where it can cause a clot in the bloodstream. Gomez alleges that the Angio-Seal worked improperly in her case, allowing collagen to travel to the inside of her artery and cause a large blockage that had to be surgically removed. She attributes her subsequent nine surgeries and persistent leg pain and weakness to the defective Angio-Seal.
Gomez sued the manufacturer of the Angio-Seal under the Louisiana Product Liability Act, seeking actual and punitive damages. Gomez's husband joined in the suit seeking loss of consortium damages. The district judge granted summary judgment as to Gomez's state-law design and marketing claims on the basis of federal preemption. The parties tried the manufacturing defect claim to a jury. At the close of the evidence, the district judge granted defendants' motion for judgment as a matter of law under Rule 50(a) of the Federal Rules of Civil Procedure. Gomez appealed.
We affirm the preemption determination, reverse the Rule 50 order, and remand to the district court. The reasons are explained below.
In 1999, Danell Gomez, then forty-four years old, saw her doctor complaining about numbness and tingling in her left arm and hand. (Tr. at 399, 789). An arteriogram indicated a blockage in the right subclavian artery in Gomez's chest. Her doctor referred her to Dr. Christopher White, an interventional cardiologist —defined as one who "performs procedures such as angioplasties and stents"— at the Ochsner Clinic in New Orleans. (Tr. at 778).
Dr. White performed surgery to relieve the blockage and repair the artery. Dr. White followed a standard procedure and accessed the subclavian artery through the right femoral artery in the groin area, where the blood vessels are close to the skin. Dr. White inserted a catheter through the opening he made in the femoral artery, passed the catheter to the subclavian artery, and inserted a balloon to open the blockage. The balloon did not have the desired effect, requiring insertion of a stent, which was successful. Dr. White then withdrew the catheter and other equipment through the femoral artery, leaving an opening that had to be treated to stop the bleeding.
The evidence at trial described two common approaches to closing such an opening. One approach is to use manual compression, applying pressure to the puncture area until a clot forms and the bleeding stops. This approach can be uncomfortable for the patient because of the pressure and because the patient must stay still for a long period—six to eight hours—to avoid disrupting the clot. Complications such as prolonged bleeding and pseudoaneurysms can result. The other approach is to use one of the recently-developed puncture-closing devices, such as the Angio-Seal. The Angio-Seal operates by placing a small plug of collagen on the outside of the artery wall to close the puncture site. Other devices operate with a stitch or glue applied to the site. Dr. White and the Ochsner Clinic had been involved in clinical studies leading to the FDA's approval of the Angio-Seal and Dr. White preferred it to other puncture-closing devices and to manual compression. Dr. White testified that the use of closure devices like the Angio-Seal make the postoperation procedure easier, faster, and less expensive for both the doctor and patient. Because both closure devices and manual compression have approximately the same rate of complications—although the complications are different—one approach is not inherently more or less safe than the other.
The Angio-Seal consists of a guidewire, a carrier tube, a bypass tube, a bovine collagen plug, and a T-shaped biodegradable polymer anchor. The Angio-Seal specifications require that when the device is packaged for shipping, the T-shaped anchor must be in a vertical position within the bypass tube, neither extending beyond the end of the tube nor inserted deeply within it. The bypass tube protects the anchor from damage during shipping and during surgery. When the doctor inserts the Angio-Seal into the patient, the Angio-Seal anchor must pass through a silicon hemostasis valve, which prevents the patient's blood from flowing back through the artery opening during the surgery. When the Angio-Seal is inserted into a patient, the bypass tube—not the anchor— pushes open the hemostasis valve, the anchor is inserted into the artery, and the collagen plug is deposited on the outside of the artery wall.
During a surgery such as the one performed on Gomez, the surgeon enters the femoral artery through a catheter. When the doctor has completed the procedure and is ready to remove the catheter and close the entry wound using an Angio-Seal, the surgeon first inserts the guidewire through the catheter that is already inside the patient's femoral artery. The catheter is then removed. The surgeon then inserts the Angio-Seal device, using the bypass tube to push through and open the hemostasis valve before the anchor is released from the bypass tube. The anchor is supposed to swivel ninety degrees once it is out of the bypass tube, allowing the surgeon to pull the anchor flat, or flush, against the inner wall of the artery. The surgeon cannot see the anchor, but relies on the tension felt when the suture is pulled and the anchor is drawn perpendicular to, and flush against, the interior artery wall. The surgeon then tamps the collagen plug attached to the suture on the outer artery wall, causing rapid clotting at the puncture site. The anchor prevents the collagen from getting into the inner portion of the artery, the patient's bloodstream. If collagen enters the bloodstream, the intended benefit of the Angio-Seal —rapid clotting—can instead cause severe harm. Several medical witnesses testified that if collagen is introduced into a patient's bloodstream, significant complications can result. Dr. White, Gomez's treating doctor, described possible complications as including death, heart attack, stroke, bleeding, infection, limb loss, and "embolization," which he described as the "breaking off [of] bits and pieces of plaque in the artery [that] can go downstream and cause problems in toes and fingers and [cause] stroke as well." (Tr. at 787). All the witnesses agreed that humans have collagen in their bodies, but only in the outer artery walls, not inside the arteries.
Dr. White did not experience any problem in using the Angio-Seal on Gomez on March 12, 1999. The records show that the bleeding at the access puncture site stopped with "no complications." (Tr. at 792-93). After routine postsurgical monitoring showed no problems, Dr. White discharged Gomez.
Less than two days after her surgery, Gomez experienced extreme pain in her right leg. She returned to Dr. White approximately two weeks later, complaining of pain in the right groin and thigh when she walked. Dr. White arranged for an ultrasound, which showed a 70% narrowing of the artery at the point he had entered it for the surgery. Dr. White advised either an angioplasty or surgery to correct the narrowing. Dr. White testified at trial that he believed scarring from the collagen plug caused a clot on the outer femoral artery wall, which externally compressed and narrowed the artery. (Tr. at 856).
Gomez did not quickly obtain the treatment Dr. White recommended. Instead, she decided that she wanted a doctor closer to her home. She consulted Dr. Diana Gilmore, a cardiovascular surgeon, who referred her to Dr. Anthony Morales, an interventional cardiologist. Gomez's leg pain persisted during this period. On April 22, 1999, Dr. Morales performed an arteriogram, which indicated a 99% blockage in Gomez's right femoral artery. (Tr. at 404-06). Dr. Morales tried but failed to clear the blockage using a catheter. He testified that when he tried moving the catheter through the blockage he felt like he was "hitting concrete." He recommended surgery, which Dr. Gilmore performed on April 29, 1999.
Dr. Gilmore testified that she found a single embolus, or mass, inside Gomez's right femoral artery. She emphasized that the mass was not on the outside compressing the artery wall, as Dr. White opined, but inside the artery itself, in the area known as the luma. The mass was so large that it was pressing against the inside wall of the artery, known as the intima. (Tr. at 753-54). Dr. Jerry Hudson,...
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