Medical devices' dark side

Those harmed want a way to sue manufacturers

Staff WriterJune 13, 2010 

  • In a 2008 decision called the Riegel v. Medtronic case, the U.S. Supreme Court ruled that people cannot sue medical device manufacturers in state courts using standards different from or in addition to the U.S. Food and Drug Administration's approval requirements.

    What does that mean? For certain complex devices that must undergo FDA scrutiny before they can be sold, the manufacturers are shielded from lawsuits if their products later turn out to have flaws.

    Who benefits? Device makers say patients benefit, because innovative products that save lives can be marketed sooner without fear of lengthy, expensive court battles from unforeseen problems. Patient advocates say the device makers benefit, foisting costs on individuals and insurance companies when faulty products cause injury.

    What's happening now? Congress could act to nullify the Supreme Court ruling and allow lawsuits under the Medical Device Safety Act, which was introduced last year in identical bills in the House and Senate. The bills remain in committees, but some action is anticipated this summer.

    Staff reports

Three years ago, John Cline's 87-year-old mother-in-law suffered a series of violent shocks to her heart when wires in an implanted defibrillator fritzed.

Since then, the Duke University facilities manager has waged a frustrating battle to seek at least some compensation for her harrowing experience, which included a frantic effort to shut off the defibrillator, a hospital stay and a procedure to implant a different device to keep her heart on pace.

His fight is one of thousands waged on legal and legislative fronts that patient advocates hope will gather momentum this summer. Their goal is to correct a 2008 ruling by the U.S. Supreme Court, which determined that people such as Cline's mother-in-law, Jewel Fore, have no right to sue medical device makers when their products cause harm.

The ruling covered only the most sophisticated devices that must pass safety tests for marketing approval from the U.S. Food and Drug Administration - life-saving tools such as heart pumps, artificial joints and implants.

Citing language in the 30-year-old law that created FDA oversight of medical devices, the high court said Congress shielded manufacturers from lawsuits because FDA approval meant the products were safe. Any lawsuits in state courts were then barred if they asserted the federal safety standards were somehow insufficient.

Thousands of lawsuits have since been thrown out, and others never got filed.

The result is that patients and their insurers must pay to correct problems if a hip joint fails or a balloon catheter bursts, rather than seek compensation from the manufacturers.

Patient advocates estimate Medicare will eventually pay $1 billion in federal tax dollars just to correct problems associated with the faulty defibrillator, a product made by Medtronic Inc. that was later recalled.

"The question is, who is going to pay when a patient is injured?" said Allison Zieve, a lawyer with the consumer advocacy group Public Citizen. Zieve argued the case before the Supreme Court that resulted in the 2008 ruling.

"Now the answer is, the patient pays, which also means Medicare and Medicaid, disability and Social Security insurance - everybody is paying now except the companies," Zieve said. "The idea that the costs would go away is not correct. There are unpaid bills, medical bills, lost wages, -those things still exist."

Manufacturers hailed the Supreme Court decision, and are fighting bills in Congress that aim to correct the ruling.

Device makers contend that the FDA's rigorous approval process for complex new devices adequately protects patient safety, while the threat of lawsuits would only inhibit innovation and keep needed interventions from the market.

"We think that's not in the interest of patients, not in the interest of innovation, and it minimizes the expert role the FDA plays as the regulator for this industry," said Rob Clark, spokesman for Medtronic.

Defibrillators

Among the largest groups now barred from suing are patients who, like Fore, had a faulty defibrillator. The device, the size of a cigarette pack, implanted in the chest, senses when the heart pumps too fast or slow, triggering a strong electrical shock that jolts the beats back to normal.

Problems with Medtronic's Sprint Fidelis brand defibrillator began to arise soon after it was introduced in 2004. Wires leading off the computerized device went directly into the heart, and these so-called leads were prone to break, causing the device to fire powerful shocks thatweren't needed.

One patient described the shocks as being kicked repeatedly by a mule.

Cline's mother-in-law was one of thousands injured by the Medtronic device. He said Fore's ordeal was prolonged because emergency workers and doctors had no way of knowing how to turn off the implanted device, and finally had to call the company directly.

It's still in her chest, although apparently deactivated, and she's now relying on a less sophisticated pacemaker.

Cline said Fore's health has declined precipitously since the incident, which occurred in 2007. The next year, just as the Cline family joined one of numerous lawsuits against Medtronic, the Supreme Court issued its ruling. Their case is now in limbo.

"She has been told you don't count, and that's infuriating," Cline said. "I can't tell you how angry that makes me."

Michael W. Patrick, a product liability lawyer in Chapel Hill, said the Supreme Court ruling was a huge setback for people like Cline and his mother-in-law.

He said thousands of cases were tossed out involving the defibrillator alone, and lawyers turned away many other potential clients.

"I don't know how many cases there were in North Carolina," Patrick said. "I got contacted by half a dozen to 12 people about it, for sure. Some were told by their doctors they had defective [wires]. That's sort of like being told you have a time bomb in your chest. And they're more hazardous to take out than to just leave. I also had been contacted by people who got shocked, and had them removed. I don't believe there's any recovery for that."

The Medtronic defibrillators were eventually pulled from the market, but not before about 150,000 had been implanted in patients in the United States.

Clark, the Medtronic spokesman, said the company has paid many patients for new devices, which cost between $20,000 and $30,000. But the company does not cover the doctor or hospital bills associated with removing old defibrillators or implanting new ones.

"I would say that's the role of insurance," he said, noting that all insurers, including taxpayer-funded Medicare and Medicaid, cover the revision procedures.

20 shocks

Soon after the Supreme Court decision, bills were drafted in Congress to clarify the wording justices relied on to bar lawsuits. The Medical Device Safety Act was introduced in both the House and Senate with dozens of sponsors, including North Carolina Sen. Kay Hagan, and representatives Brad Miller, Walter Jones and G.K. Butterfield.

Hagan said she was moved to support the bill by a constituent who called from Newton to relay his experience.

"He was jolted out of bed and rushed to the hospital," Hagan said. "He experienced 20 very painful shocks from a faulty defibrillator and had to have surgery to replace it.

"No one should be subjected to this unnecessary pain, but consumers currently have limited recourse if their medical device fails," Hagan said. "The Medical Device Safety Act would ensure consumers have the ability to seek appropriate compensation under state law."

Movement on the bill stalled, although hearings were held last year.

Christine Hines, a lobbyist for Public Citizen, said there may be efforts this summer to move the bills out of committee, now that the health care reform drive has passed.

And there is interest. Rep. David Price, through a spokesman, said he is following the bill closely even though he has not signed on as a sponsor.

"As an appropriator, Rep. Price has worked for years to ramp up FDA investments in better regulation and oversight to catch more of these problems early and ensure devices meet appropriate standards," spokesman Andrew High said.

Hines said patient advocates have a well-heeled foe in the medical device industry, which is fighting the bill.

"This argument they have is a little weak - that it will affect their innovation," Hines said. "What it will do is make products safer and hold them more accountable for their designs."

The advocacy group contends that the FDA's safety approval process for medical devices was never meant to be the sole means of uncovering the defects and risks of potential new products. During clinical trials, the devices are tested on a small number of patients, so flaws often aren't discovered until products have been approved and used in thousands of patients over time.

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