Navy doctors left surgical instrument inside Maryland woman

Two lawsuits seek millions

March 30, 2011|By Tricia Bishop, The Baltimore Sun

Seventeen months after one set of Navy surgeons performed an elective hysterectomy on a Maryland woman, another set had to operate — this time to remove the surgical instrument left behind.

Patient Kimberly E. Williams has filed two federal negligence lawsuits seeking millions from the United States and the makers of the disposable Gyrus Forceps, a portion of which broke off in her belly while doctors at the Portsmouth Naval Medical Center in Virginia were removing her uterus in February 2008.

The U.S. government claims its physicians are not responsible for the mishap, because the forceps were faulty and the piece that came off was too small to even "notice it was missing." And the company, which recalled the instrument in January 2010, says it doesn't yet know enough about the case to take or deflect the blame.

Williams, who lives at Fort Meade in Anne Arundel County, is the only one who seems to have realized that something wasn't quite right about the operation that day.

She says that she repeatedly visited the general surgery clinic in Portsmouth afterward, complaining of pain and pressure but that "her symptoms were not investigated nor diagnosed," according to court documents. It wasn't until she went to an emergency room at the National Naval Medical Center in Bethesda in July 2009, describing "unbearable abdominal pain, nausea, and near-fainting" that the blunder was discovered.

"Upon investigation of those symptoms by CT scan, it was noted that a foreign object was in Mrs. Williams' pelvis," states the $2 million negligence lawsuit she filed against the United States. "A 'curved metallic foreign body' measuring 3.5 x 0.4 x 0.3 cm with three plastic prongs" was removed from her abdomen.

Williams says she has since been hospitalized several times, "undergone painful procedures to investigate and treat her symptoms" and grown fearful of the medical community, according to the suit, which was filed in Virginia last year and transferred to Baltimore's U.S. District Court this month.

Williams, who is 37, according to public records, declined to comment, as did her lawyer.

It's unclear what connection she has to the military. Negligence claims against the United States are typically barred when the injured party is an active military member, though lawsuits can be filed on behalf of civilians.

For example, a 20-year-old Marine awaiting chemotherapy at the Portsmouth hospital was mistakenly killed there in December after being given a drug overdose, and his family has no legal recourse because of the young man's military status. But the government has settled claims on behalf of non-military patients injured at the naval medical center.

In January, the U.S. Justice Department agreed to pay $2.3 million to settle allegations that the naval hospital's inadequate care led to neurological damage in an infant, identified only as K.H. in the lawsuit filed on her behalf, delivered there by emergency cesarean section. And last year, the government agreed to a $450,000 settlement with the family of a woman — the wife of a retired naval officer — who died at the Naval Medical Center while undergoing surgery to remove a boil.

The government indicated early on that it would settle this case as well, "instead of trying it" according to court documents filed March 1. But that changed quickly, a federal attorney said, after she "saw the actual objects: specifically how small the [broken piece] was, and how difficult it was to notice it was missing on the forceps."

"I understood now how a surgeon would not notice after surgery that this small piece had become detached from the forceps, especially since the forceps is a disposable instrument," wrote Assistant U.S. Attorney Virginia Van Valkenburg.

Williams didn't learn that the object left inside her came from the forceps until September 2010, when the defendants admitted that it was the "shim" portion of the instrument, which had been recalled from the market by Gyrus ACMI Corp. early last year, according to U.S. Food and Drug Administration records.

"The metal shim between the jaws may detach during the procedure and fall into the surgical field. The detached shim may be undetected and be left behind in the patient. This circumstance could subsequently cause complications," the company, owned by Japan-based Olympus Corp., explained in a recall notice.

By the time Williams found out, the two-year statute of limitations for filing a product-liability suit against the company had expired in Virginia. So in February, she filed a $12 million suit against Gyrus and its related entities in Maryland's U.S. District Court, where the time limit is longer.

She also asked to transfer the case against the government here as well, after originally filing it Virginia where the surgery occurred. The request was granted March 14.

"In this case, the Court finds that the interest of justice outweighs the possible inconvenience that transferring the case might cause the Defendant and its witnesses," Virginia's U.S. District Court Judge Robert G. Doumar wrote in a 7-page order and opinion.

Gyrus has filed a motion to dismiss three of the six counts against it in Williams' lawsuit, claiming that Virginia law applies in the case and that the state doesn't allow such "strict liability" counts.

The company also filed an answer to the remaining three counts, which have to do with negligence and warranty breaches, listing 17 possible defenses, including misuse of the product. Its Baltimore-based attorney did return a message seeking comment.

No schedule has been set for either case, which could be combined into one now that they're in the same venue, Doumar noted.

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