Company Sold Heart Catheter That It Knew Was Flawed

AT LEAST TWO DEATHS are blamed on a company that prosecutors say acted with greed and deception. The medical-device manufacturer has agreed to plead guilty to 391 criminal counts and pay $61 million.

LAMAR, Mo. - When Eunice Beavers checked into Oak Hill Hospital, her family was told not to worry. Odds against a problem were "1,000 to 1," her daughters recall being reassured.

In fact, the odds were against her.

Beavers was about to be treated with a faulty heart catheter. It malfunctioned inside the artery leading to her heart, shutting off the flow of blood, sending her into cardiac arrest and ending her life.

The company that made the device, C.R. Bard Inc., had known about problems with the product for 10 months before Beavers died Dec. 28, 1988. Bard employees had noticed it even before the catheter was put on the market, according to sweeping criminal charges the U.S. attorney in Boston filed against Bard in October.

Despite knowing the dangers, Bard sold the catheters and collected the profits. The company concealed the problem from the Food and Drug Administration. It kept selling them even after failures began to mount. It left doctors in the dark. And it ignored the human cost that would be paid by patients like Eunice Beavers.

The real story behind Beavers' death - as well as a story of Bard's greed and deception - emerges from an 85-page document that federal prosecutors filed Oct. 15.

The story also takes shape from interviews with Beavers' family and federal officials familiar with the case, from lawsuits involving the company, and from government documents obtained through the Freedom of Information Act.

Bard, of Murray Hill, N.J., one of the world's largest medical device companies, has agreed to plead guilty to 391 counts of conspiracy, mail fraud, lying to regulators and shipping "adulterated products" for human experimentation.

It will pay a $61 million fine, by far the largest settlement of criminal health-care fraud charges in U.S. history. The figure was reached by adding up the sales of all Bard products involved in the schemes.

"I don't think you can explain this kind of behavior," said William Reilly, a Bard lawyer. "We have acknowledged illegal behavior, and that kind of behavior is indefensible. It will not be tolerated by Bard now or in the future."

Bard chairman and chief executive George Maloney and five former executives were indicted separately. They have pleaded innocent and face trial.

Each is charged with 200 to 300 counts, and each count carries a maximum penalty of 5 to 20 years in prison and a $250,000 fine.

The indictments link Bard's products to two deaths and a massive heart attack, as well as nearly two-dozen cases in which emergency open-heart surgery was required. A federal official close to the investigation said that "in all likelihood there were quite a few more deaths" that never came to light.

Until last week, something else had not come to light. Until they received a phone call from a reporter, Beavers' survivors believed that the vibrant 76-year-old matriarch had died unexpectedly of natural causes during the procedure.

During nearly five years of questions, suspicions and investigations of Bard by federal authorities, no one had bothered to tell the family what went wrong that day.

`We didn't expect her to die'

"All I know, all they told us, is her heart just stopped beating and they couldn't get her revived," daughter Helen Wilson said, fighting tears. "We didn't expect her to die. The procedure was supposed to be minor."

The charges, and the questions surrounding Beavers' death, can be traced to Bard's USCI division, with plants in Haverhill and Billerica, Mass.

USCI makes heart catheters, devices that are used to open blockages in the arteries leading to the heart. Blocked arteries can cause strokes and heart attacks.

Heart catheters, 4 1/2-foot-long tubes the thickness of cooked spaghetti, are inserted through a vein in the arm or groin, then threaded through the body to arteries, often those near the heart.

Most have a tiny balloon that is temporarily inflated to press down on the plaque that blocks arteries. The balloon is then supposed to deflate, and the catheter is removed.

The procedure, called angioplasty, has become so popular that 400,000 are performed each year, making it a $900 million industry.

Bard's USCI division was an early leader, enjoying a virtual monopoly in the United States from 1980, when the catheters were introduced, through 1985. But other companies began selling catheters with new features that appealed to doctors. Bard's share of the market was cut in half by 1988.

From 1987 to 1990 Bard officials ignored or disobeyed federal regulations that are supposed to protect the public from unscrupulous manufacturers and faulty products, the government alleged.

That meant systematically lying to the government about malfunctioning devices, changing the design of catheters without approval, lying about where catheters were being made, failing to recall outmoded catheters, misleading doctors - and therefore, patients - about problems, and assorted other schemes outlined by federal prosecutors and FDA investigators.

FDA Commissioner David Kessler said Bard, in effect, was "using unsuspecting patients as guinea pigs and operating rooms as laboratories for unapproved products."

But Bard's approach, like some of its products, would soon begin to backfire.

In November 1988, Beavers suffered a mild heart attack. Dr. John Cox, a cardiologist, thought it would be best to clear out the blockages that prevented blood from flowing to Beavers' heart.

On Dec. 27, Cox made the case to Beavers and her family for performing a balloon angioplasty.

What Beavers didn't know was that the firm had lied to the FDA to market the device that Cox would be using, called the Miniprofile catheter.

Bard workers had found flaws

As outlined in documents filed by prosecutors, Bard employees discovered in February 1988, 10 months before Beavers' surgery, that the balloon on the catheter "could fail to deflate in human coronary arteries." A catheter balloon that refuses to deflate can cause exactly the kind of blockage the procedure is supposed to eliminate.

But rather than scrap the catheter or tell the FDA, as required by law, Bard sought the agency's approval for the device. By June, the company was selling it nationwide. Almost immediately, doctors began complaining that the devices failed to deflate. From July through November 1988, Bard received at least 28 such complaints.

Secretly, Bard employees began redesigning the catheter. By the middle of November 1988, the company decided to begin selling the newly designed catheter, without telling the FDA and without recalling the faulty ones already sold.

One of those catheters had been shipped to the office of Dr. John Cox. Last month Cox described how Beavers' routine procedure quickly became a life-and-death struggle. After he inserted the catheter into Beavers' coronary artery and inflated the balloon, "the device did not deflate as it was supposed to," he said.

Beavers died so quickly that there was no time for emergency open-heart surgery, Cox said.

Although he realized the catheter had failed, Cox said he was not entirely sure of its role in Beavers' death. So he simply told the family her heart stopped during the procedure and that there was no way to save her.

The criminal charges prove that the authorities picked up the ball. But the indictment does not name Beavers, the hospital or the doctors involved; it does mention the date of her death and the type of catheter involved.

Although the company has agreed to admit guilt on all the charges, Reilly, the Bard lawyer, said that "none of the information provided to date leads Bard to conclude that a Bard product" was responsible for Beavers' or any other death. Bard catheters now approved

Bard's USCI division still makes heart catheters, all of which the FDA has approved.

Bard has shaken up the management of its USCI division. It regained FDA approval to reintroduce angioplasty products in 1991.

Now when the $990 million company talks about its future, it pays lip service to the heart catheter business but quickly mentions the potential of other products, such as its collagen implant for urinary incontinence.

"Our business is manufacturing lifesaving devices," said Reilly, the company spokesman. "It may sound cute, but it's not. We have manufactured lots of products that have saved countless lives, and that's what we focus on."