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A Philadelphia jury issued a defense verdict to a doctor sued after a needle he was using for a bone biopsy broke off in the plaintiff’s back, requiring an additional surgery to remove it.

The defense win came in a case where the plaintiff claimed the manufacturer’s warning clearly notes the needle at issue should not be used to penetrate bone.

According to court papers in DeZago v. CareFusion, plaintiff Melanie DeZago went to the Eastern Regional Medical Center of Cancer Treatment Centers of America for a biopsy of a lesion on her lumbar spine. DeZago had previously been treated for breast cancer and the lesion on the spine was thought to possibly be metastasized to her spine.

On May 14, 2010, DeZago went in for the biopsy procedure, which was performed by defendant interventional radiologist Dr. Aalpen Patel. Patel first tried to perform the biopsy with a 17-gauge “guiding” needle covering an 18-gauge biopsy needle. He had trouble inserting the needle because of what Patel described as “dense bone,” according to defense court documents in the case.

Despite several attempts, Patel could not perform the biopsy with the initial needle, so he switched to a 20-gauge biopsy needle that was still covered by a 17-gauge guiding needle. Patel didn’t initially get an adequate sample, so he inserted another biopsy needle through the guiding needle to retrieve a better sample. When he removed the needle, Patel realized part of the guiding needle remained in DeZago, according to defense papers.

Patel testified that in an attempt to drive the needle into the bone, the needle “‘must have buckled in its midpoint,’” according to court documents.

Patel obtained permission from DeZago’s family to immediately go in for surgery to remove the needle. The portion of the needle was removed intact from the soft tissues of her left back, according to court documents. DeZago underwent another biopsy about a week later and it showed the cancer had metastasized to her back, the defense said in court papers, which said DeZago’s cancer is now in total remission.

“Though she claims ongoing pain complaints from her procedure with Dr. Patel, Dr. Patel vehemently denies she has any residual problems,” Patel’s attorneys at Obermayer Rebmann Maxwell & Hippel said in a pretrial memorandum. “There are numerous documents which have been produced in this case, which clearly demonstrate that Mrs. DeZago is not a credible witness regarding her ongoing pain complaints.”

DeZago had sued Patel, Cancer Treatment Centers of America and CareFusion Corp., the manufacturer of the needle at issue, according to the complaint. Aside from the surgery required to remove the needle, DeZago said her damages included a scar on her back and chronic pain in her lumbar region, according to her pretrial memorandum. DeZago said she has been placed on permanent restrictions, including no repetitive bending at the waist, no repetitive stooping, no kneeling, crawling or climbing, and no repetitive overhead lifting, according to court documents.

DeZago also cited the need for future medical care to the tune of $7,000 to $10,000 a year and a diagnosis of an “adjustment disorder with depressed and anxious mood.”

Gary M. Samms of Obermayer Rebmann led Patel’s defense team along with Jacqueline S. Roe. Samms said the plaintiffs settled before trial with CareFusion, but Samms had the company sit through the trial so the jury could understand there may be others responsible for the plaintiff’s injuries. Cancer Treatment Centers of America was dismissed from the case on agreement of all parties, Samms said. Patel was not an employee of CTCA but, rather, was an employee of a private radiology group that covered CTCA.

DeZago argued at trial that Patel used the wrong needle in performing the biopsy, Samms said. He said the plaintiff argued the manufacturer’s instructions for the needle say it is not intended for bone, but only soft-tissue use.

Samms said his biggest concern was that a Philadelphia jury would look at the fact that a needle was left in someone and that the manufacturer said not to use it for such a procedure. Samms said his client’s position was that it was an acceptable use of the needle given there are many medical instruments, particularly in interventional radiology, that are used for “off-label uses.”

“It’s the physicians that set the standards in the medical community, not the manufacturers,” Samms said he argued. He said, in talking to the jury foreperson after the trial, the jury seemed to understand and accept that argument.

The demand, according to DeZago’s pretrial memorandum, was $2 million.

According to Samms, the last demand from DeZago was $750,000. Samms said his client offered a $5,000 to $40,000 high-low arbitration that was denied. He said there was no other high-low agreement in the case.

The trial opened April 4 and was given to the jury April 11. After about five hours of deliberation, the 12-member jury returned a verdict in favor of Patel. Philadelphia Court of Common Pleas Judge Annette Rizzo presided over the case.

DeZago called retired physician Michael Bettmann as an expert witness on liability; psychologist Wolfram Rieger of the University of Pennsylvania as an expert witness on DeZago’s mental anguish; and Dr. William C. Murphy of Smart Rehabilitation in Media, Pa., as an expert on DeZago’s future care needs.

Patel’s expert witnesses were Abington Memorial Hospital head of interventional radiology Dr. Paul O’Moore as to liability and neurologist Dr. George H. Dooneief of Abington Health Physicians as to the likelihood of DeZago still having any pain four years later.

Thomas F. Sacchetta of Sacchetta & Baldino represented DeZago. He was not available for comment by press time.

Gina Passarella can be contacted at 215-557-2494 or at gpassarella@alm.com. Follow her on Twitter @GPassarellaTLI.