Legal Brief: No liability found against Smith & Nephew in Rogozinski spinal rod system lawsuit

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Theresa Fitzgerald had a long history of back problems dating back to 1970 when, at the age of 19, she was diagnosed with defects in the configuration of her lumbar spine.

In December 1970, Fitzgerald had the first of six lumbar spine surgeries, an interlaminal exploration and for aminotony at the L4 level of her spine. However, that surgery did not relieve her symptoms (generalized back pain, which radiated into both legs). Therefore, a second surgery ensued in July 1971, another for aminotony, accompanied by an attempted fusion at the L4-L5 and L5-S1 levels of the spine. According to Fitzgerald, the second surgery was successful and her back pain subsided.

By 1988, however, Fitzgerald began to again experience low back pain, accompanied by bladder problems, constipation and numbness in both legs. A CAT scan revealed developmental abnormalities and degenerative changes at the L4-L5 and L5-S1 levels of Fitzgerald's spine. Fitzgerald fell in 1989 and she began thereafter to suffer neck pains.

In January 1990, Fitzgerald reported pain and tingling in her arms. Later in the month, she reported numbness and pain over the entire left side of her body. A CT scan revealed that Fitzgerald's brain was normal, but it also disclosed disc difficulties. Later, Fitzgerald was diagnosed with cervical disc disease and, in October 1990, underwent fusion surgery on her neck. About five weeks later, she began to complain of frequent urination and again reported discomfort in both legs.

Subsequently, in February 1991, Fitzgerald continued to report bladder problems as well as tingling in her legs. Additionally, she continued to complain of lower back pain for which no objective cause was uncovered, notwithstanding extensive testing. In May 1991, Dr. Tolner, Fitzgerald's treating physician, cataloged her reports of leg and back pain for the three preceding years, observed that those reports were unsupported by objective neurological findings and confessed still to be "quite at a loss to explain this patient's symptoms." Hence, Dr. Tolner referred Fitzgerald to Dr. Randy Davis, an orthopedic surgeon.

Shortly thereafter, but also in May 1991, Dr. Davis examined Fitzgerald, reviewed her medical history, and reached the conclusion that Fitzgerald likely had a nonunion of the spine at L4-L5 or a pseudarthrosis there. Dr. Davis recommended rehabilitation therapy and advised Fitzgerald that, if the rehabilitation therapy was unsuccessful, she might consider surgery to explore the fusion that had been accomplished in 1991, a surgical procedure to which Dr. Davis ascribed a 40% chance of improving Fitzgerald's situation and a 10% chance of making it worse. At about the same time, Fitzgerald consulted Dr. Barry who also recommended physical therapy.

Fitzgerald, however, reported that physical therapy made her worse. She complained that she could not walk without pain and determined to proceed with surgery. After consulting again with Dr. Davis, who emphasized that he was pessimistic about the benefit of surgery, Fitzgerald elected to proceed with the surgical alternative and, on August 1, 1991, Dr. Davis and Tolner performed Fitzgerald's next surgery, this time a revision lumbar laminectomy with extended foraminotomies and an L4-L5 fusion. They also implanted a bone growth stimulator to assist the process of fusion.

Fitzgerald initially reported significant improvement, and she was discharged from neurological care in December 1991. However, in February 1992, she had surgery to remove the bone growth stimulator.

A month later, in March 1992, Fitzgerald again complained that the back pain had returned and that it significantly limited her activities. Dr. Davis expressed the opinion that she might have pseudarthrosis, but advised against further surgery because it would involve the use of plates and screws to stabilize her spine. Fitzgerald returned to Dr. Davis in September 1992, reporting that she could no longer live with her severe and debilitating pain and that she wanted once again to consider surgical options. In November 1992, Fitzgerald told Dr. Barry that she wanted to have surgery but that she did not want to return to Dr. Davis because she had lost good communication with him.

Dr. Barry informed Fitzgerald, as had Dr. Davis sometime before, that further relief would require implanting the Rogozinski System. Dr. Barry's records reflect that he informed Fitzgerald that there was "significant risk of damage to nerve roots from placement of pedicle screws possibly requiring the need to go back and remove the screws." Dr. Barry also recorded that Fitzgerald "understands that even with the instrumentation there was no guarantee that the fusion would take and that the instrumentation itself would not hold up without a solid fusion."

Fitzgerald's next surgery, implantation of the Rogozinski System, was performed on January 21, 1993 to fuse the spine at the L4-L5 level.

Immediately after that surgery, Fitzgerald reported improvement. On a follow-up visit in May 1993, she had no back or leg pain, and she reportedly was "very pleased" with the result of the surgery.. That circumstance did not last long, and, by July 1993, Fitzgerald complained of "some bizarre symptoms in her arms and legs" as well as headaches, weakness, short term memory loss, and difficulty judging distances.

Dr. Barry examined Fitzgerald in September 1993 and observed, through x-rays, that there was a solid fusion at L4-L5 "with no change in the excellent position of the fixation hardware." Like Fitzgerald's family doctor, Dr. Barry thought that perhaps her difficulties were psychiatric or psychological in origin and suggested exploring that alternative for treatment.

In May 1994, another doctor diagnosed Fitzgerald with fibromyalgia, a form of nonarticular rheumatism which is said to cause pain or stiffness in the lower back, neck, shoulders, arms, hands, knees, thighs, legs and feet.

Later in 1994, Dr. Hennessy, a neurosurgeon, suggested that the Rogozinski System could be related to Fitzgerald's recurring back pain and asked whether she wanted to remove it. Although Fitzgerald refused to proceed with that course in 1994, she did have the Rogozinksi System removed on August 8, 1996 after she had learned about pending lawsuits involving the use of bone screws.

Dr. James Murphy performed the explant of the Rogozinski System and confirmed that, at the time, there was a solid fusion of L4-L5. For a brief period after explantation of the Rogozinski System occurred, Fitzgerald experienced relief. However, by October 1996, she again complained of "constant excruciating pain," of numbness and weakness, cervical pain. She reported that her level of activity had significantly decreased. Her complaints of cervical pain persisted into December 1997, at which time she also reported suffering from neck, arm and posterior iliac spine pain and twitching and numbness in both legs. In April 1998, nearly two years after explanation of the Rogozinski System, Fitzgerald still complained of headaches, neck and arm pain, "chronic pain with her back and [was] severely limited in her activities."

Fitzgerald filed a lawsuit on October 10, 1996 against, among others, Smith & Nephew, Incorporated, the manufacturer of the Rogozinski Spinal Rod System.

Her case was heard by the United States District Court For The District Of Maryland which ruled in favor of Smith & Nephew. Fitzgerald appealed to the United States Court Of Appeals For The Fourth Circuit which, on June 12, 2001, upheld the district court ruling.

Source: Fitzgerald v. Smith & Nephew, Inc., 2001 U.S. App. LEXIS 12853 (United States Court Of Appeals For The Fourth Circuit) (June 12, 2001)

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