Heart Valve Firm, Plaintiffs Battle Under Tons of Paper : Litigation: Shiley now faces at least 61 more complaints, and its attorneys, under court order, are digging through a warehouse full of documents to supply opposing lawyers.

Adding further mass to what attorneys call the largest product-liability case to ever hit Orange County, a Miami law firm has filed suit on behalf of 61 people nationwide who claim emotional distress as a result of being implanted with potentially faulty Shiley heart valves.

Their claim is expected to be merged with another consolidated lawsuit by about 430 other patients who received the Bjork-Shiley Convexo-Concave Heart Valve manufactured by Shiley Inc. of Irvine.

The new consolidated suit, filed last week, alleges that Shiley and its parent, Pfizer Inc., conspired to hide potential defects in the valve. Shiley denies this, and argues that patients who have been implanted with a life-saving device that has not failed have no grounds to sue.

Fractures of the defective heart valves are blamed for about 250 deaths. But the defect has also prompted hundreds of lawsuits from the estimated 55,000 patients who have Shiley valves that are still functioning, but who also must live with the anxiety of knowing that the devices could suddenly fail.

The first case, of a woman named Judy Khan who was implanted with the valve in the early 1980s, is expected to come to trial before Orange County Superior Court Judge William F. Rylaarsdam next summer.

Meanwhile, the 4-year-old legal battle over the “pre-fracture stress” patients has generated a paper chase of monstrous proportions.

To accommodate the massive process of discovery, Shiley built a warehouse in Irvine in 1988 where it deposited about 10 million documents dealing with every aspect of the manufacture, sale and regulatory approval of the heart valves, according to attorney Joseph L. Dunn of Robins, Kaplan, Miller & Ceresi in Newport Beach, which represents about 350 of the plaintiffs.

The company then invited the plaintiffs’ lawyers to come and find the paperwork they needed, Dunn said. At a court hearing in December, the plaintiffs argued that Shiley was drowning them in paper, and argued that the burden was on Shiley to produce the relevant documents.

The court sided with the plaintiffs, finding that “the defendants have created a haystack and told the plaintiffs to go find the needle,” according to Dunn.

Now, a battery of Shiley lawyers are combing through the vast archives searching for relevant documents, while in an adjacent conference room, an opposing army of about eight to 10 patients’ lawyers, clerks, paralegals and microfilmers wait to receive them, Dunn said.

“As their army of attorneys produce the documents, our army of microfilmers microfilm the documents,” Dunn said. “That’s been going on now for about six weeks, and will continue about through the end of the year.”

Meanwhile, the lawyers continue to tussle over which documents must be produced.

Among other things, Dunn charged, Shiley has refused to produce documents relating to an employee identified only as No. 2835, who was believed to be involved in the manufacture of faulty valves. After an investigation, Shiley announced that the real employee 2835 had left the company before the valves in question were ever made, and that it did not know who had been using that employee number.

Earlier this year, a Los Angeles judge refused to certify a class-action lawsuit filed by the Miami law firm, Robles & Gonzales, on the ground that any damage or emotional distress would vary too much from patient to patient to be litigated en masse.

The firm then filed a class-action suit in a Florida state court on behalf of Shiley patients who live in Florida, according to Robles & Gonzales attorney Joel Magolnick. That suit is still pending.

The Orange County suit includes 61 patients and about 45 of their spouses, Magolnick said. Two of the plaintiffs were part of the federal court suit in Los Angeles; the others are entering the court system for the first time, he said.

Shiley spokesman Bob Fauteaux said the suit is “essentially the same kind of claim that has been made by Robles & Gonzalez before,” and one that has been rejected by other courts.

“There isn’t the basis for a claim, and we’ll defend against a claim,” he said. Fauteaux declined to discuss other details of the litigation.