William Cooper v. Smith & Nephew, Incorporated

259 F.3d 194, 56 Fed. R. Serv. 1001, 2001 U.S. App. LEXIS 15408
CourtCourt of Appeals for the Fourth Circuit
DecidedJuly 9, 2001
Docket00-2556
StatusPublished
Cited by4 cases

This text of 259 F.3d 194 (William Cooper v. Smith & Nephew, Incorporated) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
William Cooper v. Smith & Nephew, Incorporated, 259 F.3d 194, 56 Fed. R. Serv. 1001, 2001 U.S. App. LEXIS 15408 (4th Cir. 2001).

Opinion

259 F.3d 194 (4th Cir. 2001)

WILLIAM COOPER, Plaintiff-Appellant,
v.
SMITH & NEPHEW, INCORPORATED, Defendant-Appellee,
and
SMITH & NEPHEW RICHARDS, INCORPORATED; ABRAHAM ROGOZINSKI; CHAIM ROGOZINSKI; JAMES WALT SIMMONS; AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS; NORTH AMERICAN SPINE SOCIETY; SCOLIOSIS RESEARCH SOCIETY; ACROMED CORPORATION, CHARTER NUMBER 614043; ACROMED CORPORATION,CHARTER NUMBER 816942; ACROMED INCORPORATED, CHARTER NUMBER 811415; ACROMED INCORPORATED, CHARTER NUMBER 816943; ACROMED HOLDING CORPORATION, CHARTER NUMBER 811416; ACE MEDICAL COMPANY; ADVANCED SPINE FIXATION SYSTEMS, INCORPORATED; CROSS MEDICAL PRODUCTS; DEPUY-MOTECH, INCORPORATED; SYNTHES; SYNTHES, INCORPORATED; SYNTHES NORTH AMERICA, INCORPORATED; SYNTHES A.G. CHUR; DANEK MEDICAL, INCORPORATED; SOFAMOR, INCORPORATED; SOFAMOR-DANEK GROUP, INCORPORATED; SOFAMOR, S.N.C.; YOUNGWOOD MEDICAL SPECIALTIES, INCORPORATED, formerly known as Stuart Medical Specialty, Incorporated, formerly known as National Medical Specialty, Incorporated; ZIMMER, INCORPORATED, Defendants.

No. 00-2556

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

Argued: May 9, 2001
Decided: July 9, 2001

Appeal from the United States District Court for the District of Maryland, at Baltimore. J. Frederick Motz, Chief District Judge.

(CA-97-2578-JFM)[Copyrighted Material Omitted]

COUNSEL ARGUED: Frederick Steven Longer, LEVIN, FISHBEIN, SEDRAN & BERMAN, Philadelphia, Pennsylvania, for Appellant. Terri Steinhaus Reiskin, HOGAN & HARTSON, L.L.P., Washington, D.C., for Appellee. ON BRIEF: Arnold Levin, Scott Levensten, LEVIN, FISHBEIN, SEDRAN & BERMAN, Philadelphia, Pennsylvania; Steven M. Pavsner, JOSEPH, GREENWALD & LAAKE, Greenbelt, Maryland, for Appellant. James B. Irwin, David O'Quinn, IRWIN, FRITCHIE, URQUHART & MOORE, L.L.C., New Orleans, Louisiana, for Appellee.

Before WILKINSON, Chief Judge, NIEMEYER, Circuit Judge, and Arthur L. ALARCON, Senior Circuit Judge of the United States Court of Appeals for the Ninth Circuit, sitting by designation.

Affirmed by published opinion. Chief Judge Wilkinson wrote the opinion, in which Judge Niemeyer and Senior Judge Alarcon joined.

OPINION

WILKINSON, Chief Judge:

This case is one of several thousand involving the promotion, sale, and use of pedicle screw fixation devices to treat spinal injuries. Appellant William Cooper brought this lawsuit against Smith & Nephew, Inc., claiming that its defective device was responsible for his failed back surgeries and the accompanying deleterious side effects. The district court dismissed Cooper's claims after determining that Cooper had no admissible medical evidence indicating that Smith & Nephew's device was the proximate cause of his injuries. Because the district court did not abuse its discretion in excluding the testimony of Cooper's expert on medical causation, we affirm the judgment.

I.

A.

Appellee Smith & Nephew, Inc., ("S&N;"), manufactures the Rogozinski Spinal Rod System. The Rogozinski System is a medical device consisting of connectors, rods, bone screws, and hooks. Orthopedic surgeons use the Rogozinski System to aid them in performing spinal fusion surgeries. This type of surgery stabilizes the spine by fusing two or more vertebrae together into a single bone. The Rogozinski System is used to promote a successful fusion between vertebrae by providing stability for the spine.

Since June 25, 1990, the FDA has cleared the Rogozinski System for sale for some spinal applications. Prior to the initiation of this lawsuit, the Rogozinski System had not been approved for pedicle fixation. The pedicles are two pieces of bone on each side of the spinal vertebrae. Pedicle fixation is the process by which bone screws are inserted through the pedicles in order to provide increased spinal stability, thereby promoting fusion.

Once the FDA has cleared a device for introduction into the stream of commerce, physicians may use the device in any manner they determine to be best for the patient, regardless of whether the FDA has approved the device for this usage. This practice by physicians is known as "off-label" usage. See Buckman Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012, 1018 (2001). Although the FDA had not approved the Rogozinski System for pedicle fixation prior to 1998, many physicians engaged in the off-label usage of the Rogozinski System for this purpose. Indeed in 1998, the FDA adjusted its assessment of devices capable of lumbar pedicle screw fixation, stating that "FDA believes that there is reasonable assurance that pedicle screw spinal systems are safe and effective for certain intended uses." See 63 Fed. Reg. 40,025, 40,035-36 (July 27, 1998).

B.

On January 28, 1990, appellant William Cooper slipped on a patch of ice, resulting in lower back and leg pain. An MRI performed on Cooper in March 1990 revealed herniated disks between lumbar vertebrae positions 3 and 4 ("L3-L4"), 4 and 5 ("L4-L5"), and lumbar position 5 ("L5") and sacral region 1 ("S1"). The MRI also revealed a compression of the L4 nerve root sheath. Cooper subsequently underwent two procedures in order to alleviate his pain. The hospital records from these surgeries revealed that Cooper had smoked one pack of cigarettes per day for 25 years.

Following his second surgery, Cooper experienced worsening pain in his lower back and legs. After further diagnosis, an orthopedic surgeon, James Murphy, M.D., determined that there was instability in Cooper's lumbar spine. On June 19, 1991, Dr. Murphy performed spinal fusion surgery on Cooper, inserting the Rogozinski System between the L3-L4, L4-L5, and L5-S1 vertebrae. The goal of the surgery was to obtain a fusion at all three levels of vertebrae.

Following this surgery, Cooper continued to experience back and leg pain. By May 1992, Dr. Murphy believed that there likely was a nonunion at all three levels of vertebrae. Subsequent X rays revealed that the right S1 pedicle screw appeared to have loosened. During this time, Dr. Murphy continued to urge Cooper to stop smoking.

On October 15, 1992, a second fusion surgery on Cooper revealed that fusion had indeed occurred at L3-L4 and L4-L5. Dr. Murphy removed the pedicle screws from these levels. The surgery also revealed, however, that there was a nonunion at the L5-S1 level. Dr. Murphy attempted to refuse L5-S1, using the same bone screws, but attaching new rods and cross-links. After this surgery, Cooper continued to experience pain. An X ray taken on June 15, 1993, revealed that a screw had cracked on the left side of S1. In addition, a fusion failed to occur at L5-S1 following the second surgery. In preparation for yet another surgery, Dr. Murphy wrote in Cooper's medical records: "I think the most important function if we are going to reoperate on [Cooper] is that he stop smoking because that is going to really have a great deal of effect on the success or failure of the procedure."

In February 1995, Dr. Murphy performed a final surgery on Cooper, in which he attempted to fuse L5-S1. Dr. Murphy also removed the broken screw at left S1, and inserted new Rogozinski screws and rods at L4 and S1.

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Bluebook (online)
259 F.3d 194, 56 Fed. R. Serv. 1001, 2001 U.S. App. LEXIS 15408, Counsel Stack Legal Research, https://law.counselstack.com/opinion/william-cooper-v-smith-nephew-incorporated-ca4-2001.