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An orthopedic surgeon who claims he was hit with a slew of lawsuits for using pedicle bone screws in spinal fusion operations cannot sue the manufacturers of the devices under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law because he was not the direct purchaser, a federal appeals court has ruled. In Balderston v. Medtronic Sofamor Danek Inc., a unanimous three-judge panel of the 3rd U.S. Circuit Court of Appeals upheld a June 2001 decision by U.S. District Judge R. Barclay Surrick, of the Eastern District of Pennsylvania, that rejected the doctor’s theory that he should be allowed to sue under the CPL as the “purchasing agent” for his patients. Third Circuit Judge Anthony J. Scirica found that Surrick was also correct in holding that the CPL claim was doubly barred because even if the surgeon had made a purchase, it would have been for a business purpose, and not for “personal, family or household use” as the law requires. In the suit, Dr. Richard A. Balderston, a prominent Philadelphia orthopedic surgeon, claimed that the conduct of two manufacturers of the devices — Medtronic Sofamor Danek (MSD) and Acromed Corp. — caused him to be named a defendant in 34 medical malpractice lawsuits. Attorneys Paul R. Rosen, David Picker, Nancy Abrams and Michael C. Wagner of Philadelphia-based Spector Gadon & Rosen filed the suit in the Philadelphia Court of Common Pleas, but it was later removed to federal court by Acromed’s lawyer, Louis A. Bov� of Philadelphia’s Bodell, Bov�, Grace & Van Horn. According to the suit, Balderston is a graduate of Yale University and the University of Pennsylvania School of Medicine who went on to a fellowship in spinal deformities in the Twin Cities Scoliosis Center at the University of Minnesota. From 1983 through 1997, Balderston was a practicing orthopedic surgeon at the Pennsylvania Hospital. He was also affiliated with the University of Pennsylvania from 1983 to 1986 and with Jefferson University Hospital between 1986 and 1997. Since 1990, Balderston has limited his practice primarily to spinal surgery, the suit said. Beginning in 1985, he began studying the use of pedicle screws in spinal fusion surgeries as part of the Spinal Fixation Study Group, a research group formed under the leadership of chief of orthopedic surgery Dr. Charles Edwards at the University of Maryland, to determine whether the use of screws through the pedicle to help fixate the spine was safe and effective. Through test procedures that included implanting pedicle screws as part of a spinal fixation system in cadaver spines and plastic spines, Balderston, in agreement with the Spinal Fixation Study Group, determined that the future use of pedicle screws in spinal fusion surgery would be safe and effective. The suit said the manufacturers knew that Balderston and other orthopedic surgeons had determined that the future use of pedicle screws in spinal fusion surgery would be safe and beneficial to the patient and that they would persuade the FDA to eventually approve the use of pedicle screws in spinal fusion surgery. In about 1986, sales representatives of defendants Acromed and MSD began to market their pedicle screws to doctors for use in spinal fusion surgeries, the suit said. But the suit said both manufacturers “knew that the pedicle screws they marketed to plaintiff for personal use by his patients and to other physicians were not yet approved by the FDA for use in spinal fusion surgery.” As a result, the suit said, the manufacturers “knew or should have known that, because of the universal practice in the medical profession that medical devices marketed for a specific purpose which have not obtained FDA approval may only be offered for sale as part of a clinical trial, plaintiff would reasonably assume that the pedicle screws marketed to him by Acromed’s and MSD’s sales representatives were approved by the FDA for use in spine fusion surgery.” Because the manufacturers are in the business of marketing and selling exclusively to doctors, the suit said, “they knew that the doctors to whom they marketed their products would rely on defendants to obtain the FDA approval prior to marketing or selling the pedicle screw, and that they had a duty to obtain informed consent from their patients prior to performing surgical procedures.” Balderston claimed the manufacturers also knew that if he and other doctors had known that the FDA approval had not been obtained, they would have a duty to disclose that information to their patients and would therefore delay the purchase of the product for their patients. “Based on this knowledge and not wanting to delay their sales, defendants adopted marketing schemes designed to encourage plaintiff and other orthopedic surgeons to designate defendants’ pedicle screws for their patients’ personal use in spinal fusion surgeries knowing the plaintiff would accept the screws for use because they believed they were safe and that plaintiff would naturally assume defendants had obtained FDA approval for the sale of that product for use in spinal fusion surgery prior to their marketing of the product,” the suit alleged. The manufacturers therefore “adopted and carried out a scheme to increase their market share and sales” pending the expected approval by the FDA “by deceptively marketing the products to plaintiff for the personal use of [his] patients and misrepresenting the approval status of those products by concealing the material information regarding the FDA status of their pedicle screws from plaintiff and his patients until they could obtain FDA approval,” the suit said. To do so, the suit said, the manufacturers published sales literature and conducted seminars nationally on the use of their pedicle screws in spinal fusion surgery. Balderston claimed that by withholding the true FDA status of their pedicle screws from him, the manufacturers prevented him from obtaining truly informed consent and deceived him and his patients “into believing the consent the patients gave for the spinal fusion surgery was informed.” Named in 34 lawsuits between 1994 and 1997, Balderston claimed his reputation has suffered and that his practice has been significantly reduced. He complained that the lawsuits forced him to provide uncompensated trial and deposition testimony. His suit sought more than $50,000 in damages, trebled under the CPL, plus attorney fees. Surrick dismissed the suit after finding that the CPL’s private right of action “is expressly limited to persons who purchase or lease goods or services.” Now the 3rd Circuit has ruled that Surrick was right and that Balderston’s claims are not cognizable. “Dr. Balderston is not a ‘purchaser’ under the CPL. Therefore, he has no standing to sue,” Scirica wrote in an opinion joined by Senior Judge Morton I. Greenberg of the 3rd Circuit and visiting Senior Judge Myron H. Bright of the 8th Circuit. Medtronic Sofamor Danek was represented in the appeal by attorney Philip H. Liebowitz of Philadelphia-based Pepper Hamilton. Arguing the case for both manufacturers was attorney Mark Herrman of Jones Day Reavis & Pogue of Cleveland, who was joined on the Acromed brief by Jones Day attorney John Q. Lewis, and Bov� of Bodell Bov�, who had handled the case at the district court.

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