Kapps v. Biosense Webster, Inc.

813 F.Supp.2d 1128

Donald KAPPS, M.D., Plaintiff,

v.BIOSENSE WEBSTER, INC., a Johnson & Johnson Company, and Ascent Healthcare Solutions, Inc., Defendants.

Case No. 09–CV–1039 (PJS/JSM).

United States District Court, D. Minnesota.

Sept. 27, 2011.

Tara D. Sutton and Kelly M. McLain, Robins, Kaplan, Miller & Ciresi L.L.P., for plaintiff.

Tracy J. Van Steenburgh and Dana M. Lenahan, Nilan Johnson Lewis PA, for defendant, Biosense Webster, Inc.

Blake W. Duerre, Lindsay G. Arthur, Jr., Beth A. Jenson Prouty, and Michelle M. Carter, Arthur, Chapman, Kettering, Smetak & Pikala, P.A., for defendant, Ascent Healthcare Solutions, Inc.

ORDER

PATRICK J. SCHILTZ, District Judge.

In this lawsuit, plaintiff Donald Kapps, M.D., seeks to recover for injuries he suffered after the tip of a catheter made by defendant Biosense Webster, Inc. (“Biosense”) and reprocessed by defendant Ascent Healthcare Solutions, Inc. (“Ascent”) ¹ broke off in his heart during a medical procedure at the Mayo Clinic. Kapps filed a motion for summary judgment, Biosense filed a motion for summary judgment, Ascent filed two motions for summary judgment, and the parties together filed the equivalent of eight motions to exclude expert testimony under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The Court heard arguments on these motions at a day-long hearing on March 17, 2011.

The Court ruled on many of the parties' motions from the bench. Specifically, the Court denied Kapps's motions for summary judgment and granted in part and denied in part Kapps's motions to exclude the testimony of various defense experts. The Court also granted in part and denied in part Ascent's motion to exclude the testimony of David G. Benditt, M.D., one of Kapps's expert witnesses. Those rulings were reduced to writing the following day. Order Mar. 18, 2011 [Docket No. 121].

The Court took under advisement the motions of Biosense and Ascent to exclude the testimony of Kapps's primary expert witness, Bruce H. Barkalow, Ph.D. The Court also took under advisement the motions of Biosense and Ascent for summary judgment. Biosense's and Ascent's motions raised a host of difficult issues—including legal issues on which there appears to be little helpful authority.

The Court now rules on Biosense's and Ascent's Daubert and summary-judgment motions. For the reasons that follow, the Court excludes Barkalow's testimony with respect to Biosense and grants summary judgment to Biosense. With respect to Ascent, the Court excludes Barkalow's testimony only to the extent that it relates to approval by the United States Food and Drug Administration (“FDA”) of Ascent's reprocessing procedures, and the Court grants in (small) part and denies in (large) part Ascent's motions for summary judgment.

The Court also denies Kapps's motion for leave to amend his complaint to add a claim for punitive damages. Kapps initially submitted his motion to Magistrate Judge Janie S. Mayeron, but in light of the pendency of the parties' Daubert and summary-judgment motions, Judge Mayeron referred the motion to the undersigned.

I. BACKGROUND

A. Facts

1. Kapps's Injuries ²

Kapps suffers from atrial fibrillation, a condition in which the heart's rhythm is fast and irregular.³ In June 2005, during a procedure at the Mayo Clinic to treat the condition, a Lasso catheter made by Biosense and reprocessed by Ascent was manipulated inside Kapps's heart by Dr. Ming Wong, a visiting fellow who was supervised by Dr. Douglas L. Packer. The Lasso catheter is a “mapping” catheter whose function is to measure the conductivity of areas within the heart before and after treatment of those areas with an ablation catheter. The Lasso takes its name from the circular open loop (or “lasso”) that forms the catheter's tip.

While Wong was manipulating the Lasso catheter inside the left atrium of Kapps's heart, the lasso portion of the catheter's tip flipped across the mitral valve into Kapps's left ventricle and became entrapped in the mitral valve and its supporting structures or “chordae.” Packer then took over for Wong and attempted to extricate the catheter by rotating it. The lasso portion snapped off and remained entangled in Kapps's mitral valve and chordae; Packer withdrew the rest of the catheter. Various other doctors assisted Packer in attempting to snare the detached loop with devices introduced through a catheter, and eventually they succeeded in removing the loop.

In the meantime, however, Kapps's blood pressure dropped, and he experienced bleeding into the pericardium (the sac surrounding the heart). His mitral valve was also damaged. To treat his pericardial bleeding and the damage to his mitral valve, Kapps underwent open-heart surgery, and his mitral valve was replaced with a porcine prosthesis. He has suffered various health problems as a result of the surgery.

2. The Lasso Catheter

The Lasso catheter is one of a number of different types of catheters made by Biosense. The loop or “lasso” portion that detached in Kapps's heart is basically a single length of nitinol wire. The length of wire has two parts, each of which is covered with a different material: (1) a straight portion that fits inside a lumen in the body of a catheter and that is covered with a plastic sheath; and (2) a curved open loop that projects out of the catheter body and that is covered with what is called a “spine cover.” (The spine cover exposes small individual conductive areas attached to electrical leads running along the nitinol wire.)

The open loop's circular shape is perpendicular to the straight portion. Thus, an assembled catheter looks like a lasso being twirled overhead by a cowboy: The curved open loop of the length of nitinol wire corresponds to the loop of the cowboy's lasso, and the catheter body (which contains the straight portion of the length of nitinol wire) corresponds to the rope in the cowboy's hand.

Roughly speaking, the tip of the Lasso catheter is assembled in two steps. In the first step, the lasso portion—which, as noted, begins as a single length of nitinol wire—is assembled separately from the catheter body. During this step, the spine cover and leads are attached to the open loop of nitinol wire, and the plastic sheath is glued to the straight portion of the wire. (A small area of wire remains exposed between the straight and curved portions of wire.) In the second step, the lasso portion is attached to the catheter body. During this step, polyurethane glue is applied to the (now mostly sheathed) straight portion of the lasso up to the base of the spine cover, and the straight portion is inserted within a lumen of the catheter body. The polyurethane glue forms a dome at the point where the loop exits the catheter body. Thus, the lasso portion is attached to the catheter body by the polyurethane dome and by the polyurethane glue that was applied along the straight portion of the lasso.

During Kapps's procedure, the entire lasso portion—including both the straight part and its sheath, and the loop and its spine cover—pulled cleanly out of the catheter body, leaving the polyurethane dome basically intact. The lasso portion was discarded sometime after Kapps's procedure and thus was not examined by any of the parties' experts. Instead, the experts examined only the catheter body and the polyurethane dome.

As noted, the catheter at issue in this case was made by Biosense. In the Instructions for Use (“IFU”) document that accompanies each Lasso catheter, Biosense warns that the catheter is “[f]or one single use only.” McLain Aff. [Docket No. 93] Ex. 18 at BW001109; id. at BW001110 (“The Biosense Webster LASSO Circular Mapping Catheter is intended for single patient use only.”). Biosense affixes a lot number to each Lasso catheter so that, if a problem arises with respect to a catheter, the circumstances surrounding the making of that catheter can be ascertained.

The catheter at issue in this case was sold by Biosense to the Mayo Clinic and used in a patient. Contrary to Biosense's instruction that the catheter should be used only once, the Mayo Clinic then shipped the used catheter to Ascent for reprocessing, so that the catheter could be used in a second patient. In general, when reprocessing a Lasso catheter, Ascent inspects the catheter, cleans and sterilizes it, and repackages it.

Ascent also takes some steps that go beyond simply inspecting and cleaning the used catheter. In this case, for example, Ascent eliminated the Biosense lot number and replaced it with an Ascent serial number. Barton–Varty Dep. at 121–23.⁴ Ascent also provided its own IFU—replacing Biosense's IFU—when it returned the reprocessed catheter to the Mayo Clinic. See McLain Aff. [Docket No. 93] Ex. 24. And finally, Ascent provided its own warranty—a warranty that guaranteed not just that the catheter had been properly cleaned, but that the catheter would work properly.

Specifically, the “warranty” section of Ascent's IFU said that the “Medical Facility” (here, the Mayo Clinic) “acknowledges that [Ascent] performs a service, and that Medical Facility retains the title and ownership of all medical instruments under this Agreement.” Id. at AHS002619. The warranty section then provided:

[Ascent] warrants the sterility of reprocessed medical instruments unless the packaging of the medical instrument has been damaged or opened. [Ascent] warrants the functionality of reprocessed medical instruments until such medical instruments have been used in one medical procedure. [Ascent] shall refund the cost of reprocessing any medical instrument that does not meet the total satisfaction of Medical Facility....

[Ascent] shall indemnify and hold harmless Medical Facility against all claims, demands and liability all sums for which Medical Facility shall become legally obligated to pay as damages caused by bodily injury to patients as a result of [Ascent's] performance of services under this...