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Wood v. Medtronic Xomed Inc.

United States District Court, D. New Hampshire

May 14, 2015

Celeste Wood and Thomas Wood
v.
Medtronic Xomed Inc.

ORDER Opinion No. 2015 DNH 099.

LANDYA McCAFFERTY, District Judge.

The plaintiff, Celeste Wood, suffers from a condition known as pseudotumor cerebri ("PC"), which results in elevated intracranial pressure. To alleviate her symptoms, Mrs. Wood has undergone several surgeries to implant devices known as "shunts, " which are designed to drain fluid away from her brain. During one of these surgeries, in 2009, Mrs. Wood's surgeon implanted a catheter manufactured by the defendant, Medtronic Xomed Inc. ("Medtronic"). Later, the catheter broke, and a piece became lodged in Mrs. Wood's heart. Subsequently, Mrs. Wood required surgery, and she endured a series of infections and an extended hospital stay.

Mrs. Wood and her husband, Thomas Wood, brought suit against two medical facilities at which Mrs. Wood was treated, several of her doctors, and Medtronic. The Woods have since dismissed all of the defendants with the exception of Medtronic, against which they assert claims for strict liability and loss of consortium. Medtronic has moved for summary judgment and the Woods have objected. The court held a hearing on Medtronic's motion on May 11, 2015. For the reasons that follow, the court denies the motion for summary judgment.

Background

I. Statement of Facts[1]

Mrs. Wood has suffered from PC since 1994. The disorder is characterized by intracranial hypertension, which results in headache and vision loss, among other symptoms. PC is often treated by using shunts to divert cerebrospinal fluid ("CSF") away from the brain to another part of the body. A shunt is typically comprised of a valve with an attached catheter on either end. One catheter is surgically placed near the brain to collect CSF, and the other is placed elsewhere in the body, often in the abdomen. The draining of CSF away from the brain acts to relieve the buildup of pressure within the skull.

Mrs. Wood first underwent surgery to implant a shunt system in 1998. Due to ongoing symptoms, the shunt system was modified in 2000. Mrs. Wood underwent a further surgery to modify the shunt system on June 4, 2009. The purpose of this surgery was to convert Mrs. Wood's existing shunt system to a so-called "ventricular-atrial shunt." To complete the procedure, Mrs. Wood's surgeon attached a catheter manufactured by Medtronic, and ran the catheter from the existing shunt to Mrs. Wood's right atrium, one of the chambers of the heart. This catheter was made of silicone, and was part of a batch of Medtronic catheters bearing the lot number C37608, and the reference number 43103.

Several months after the surgery, Mrs. Wood experienced further symptoms, and surgery was scheduled to examine the modified shunt system. This surgery occurred on March 4, 2010, and it determined that the newly-installed catheter had broken into two pieces. Mrs. Wood's surgeon removed a segment measuring approximately two centimeters, but he could not locate the remaining portion of the catheter.

Mrs. Wood was transferred to the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, where she underwent further surgery. During this procedure, her surgeons removed a 14-centimeter portion of the catheter, which, after breaking, had migrated through a valve in Mrs. Wood's heart from the right atrium to the right ventricle. Mrs. Wood underwent yet another surgery on March 18, 2010, to address ongoing problems related to the broken catheter.

After her release from Dartmouth-Hitchcock, Mrs. Wood developed an infection in the area of the surgical incisions. Combating the infection required two surgical procedures and an extensive antibiotics regimen. Ultimately, Mrs. Wood was hospitalized for a total of 28 days, and then suffered a series of severe rashes requiring extensive dermatological treatment.

II. The Summary Judgment Record

The Woods allege that the catheter was defectively manufactured and that Mrs. Wood suffered injury as a result. The parties have each offered evidence on these issues. The Woods proffer the testimony of two witnesses whom they seek to offer as experts: Dr. Richard Sutton, and Professor John G. Webster, Ph.D.

Dr. Sutton serves as Acting Chief of the Section of Infectious Diseases at the Veterans Affairs Connecticut Healthcare System. Dr. Sutton proposes to testify regarding the infection that Mrs. Wood developed following her surgeries. He does not, however, offer any testimony regarding the manner in which the catheter broke, or whether the catheter was defectively manufactured.

Professor Webster is not a medical doctor, but has a long background in engineering and fluid mechanics. Professor Webster began his career in the 1950s in the aerospace industry, and since 1967 has worked as a professor at the University of Wisconsin, where he studies and teaches in the field of medical devices and instrumentation. He is currently conducting funded research on the use of shunt systems to drain CSF.

Professor Webster proposes to testify regarding the manner in which the catheter malfunctioned. In Professor Webster's expert report, he concludes, without a great deal of elaboration, that the shunt system broke due to "excessive flexing." Separately, in a more detailed declaration, Professor Webster opines that "more probably than not, the subject catheter was defective... [and] could not withstand normal flexion stress and separated." See Decl. of John G. Webster, Ph.D. (doc. no. 69-4) ¶ 9.

The Woods have also offered in evidence a declaration by Mrs. Wood's surgeon, Dr. Joseph Phillips, who originally implanted the Medtronic catheter, and who discovered during the March 2010 exploratory surgery that the catheter had broken.[2] In relevant part, Dr. Phillips states that the catheter was not abnormally stretched during surgery, and that he is aware of one other incident involving a different patient in which a Medtronic catheter similarly malfunctioned. See Decl. of Joseph M. Phillips, M.D. (doc. no. 69-5) ¶¶ 4, 6.

Medtronic has offered two experts of its own: Dr. Michael Pollay and Dr. Joseph Polak. Both Drs. Pollay and Polak would testify regarding whether the catheter was defectively manufactured. Each concludes that a malfunction due to a manufacturing defect is highly improbable, and Dr. Polak suggests that a more likely cause of the break was an error by Mrs. Wood's surgeon in implanting the catheter.

In addition, Medtronic offers the declarations of four of its employees, each of whom concludes that a manufacturing defect was highly unlikely. Jeffrey Bertrand, a Principal Scientist in Product Development, suggests based on his assessment of the two broken ends of the catheter that it was manually torn or cut, and did not fail as a result of normal stretching or flexing. Another Principal Scientist in Product Development, Drew Amery, suggests that the catheter's silicone material was strong enough to withstand extreme stretching, and that therefore a manufacturing defect would have been highly unlikely to result in a malfunction. Jason McElroy, a Senior Principal Quality Engineer, states that the catheter was ...


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