Consumers v. Corporate Giants

Corporations try to manipulate federal law to minimize liability when their products cause harm. Public Citizen is working to hold these companies accountable.

By Joe Newman

When actor Dennis Quaid and his wife Kimberly brought their newborn twins to the hospital to treat staph infections in 2007, they never expected that Thomas Boone and Zoë Grace would be fighting for their lives before the night was over.

As the Quaids watched, a nurse gave the twins a blood thinner meant to help keep their intravenous lines open. No one in the room knew that she had just mistakenly given them 1,000 times the amount of medicine they should have received.

Because of a confusing set of labels and the similar size of the bottles, the nurse gave the children an adult dose of Heparin, an anti-coagulant drug, instead of Hep-Lock, a product made for infants.

Baxter Healthcare Corp., the manufacturer of both drugs, was aware of this problem. In 2006, the confusion over the blue-labeled bottles had caused the death of three infants at a hospital in Indianapolis. After the deaths, Baxter apparently understood that the labels were confusing and changed the labels on the Heparin bottles, but did not recall or relabel the drugs already on the market. The drug with the confusing label remained on hospital shelves and was injected into the Quaid twins. They barely survived – and only after suffering massive bleeding and terrible pain. The Quaids are now suing Baxter because of the inadequate labeling. Public Citizen is part of the Quaids’ legal team.

But the drug company is claiming that the Quaids’ suit should be dismissed because the drug was approved for marketing by the federal government. In recent years, drug and medical device manufacturers have been trying to use similar claims to block Americans’ access to the court system.

Now, Congress wants to investigate these efforts to block court access. Dennis Quaid – the star of dozens of movies, including “The Day After Tomorrow,” “Everybody’s All-America” and “The Big Easy” – came to Washington, D.C., in May to testify before Congress about the mistakes that harmed the twins.

“My family blessedly survived a huge drug error, triggered by the misconduct of a drug manufacturer,” Quaid said in his testimony. “Others are not so fortunate. If they are denied access to our courts, they will have no compensation for their injuries, and society will lose one of the most effective incentives for safer drugs.”

Accompanying Quaid to the hearing before the U.S. House of Representatives’ Committee on Oversight and Government Reform on May 14 were Brian Wolfman, director of the Public Citizen Litigation Group, and Allison Zieve, a Public Citizen attorney. Wolfman and Zieve are both experts on pre-emption, the legal argument supported by the Bush administration and drug and medical device manufacturers that contends lawsuits concerning their defective and mislabeled products are pre-empted because the federal government has approved the products for marketing.

Drug companies claim that Food and Drug Administration (FDA) approval cuts off Americans’ access to the courts – no matter how negligently the companies design their products or whether they warn doctors about product hazards or even withhold critical information from the FDA and the public.

The issue isn’t just about allowing victims and their families to receive compensation for their injuries; it’s also about holding drug and medical device manufacturers accountable and ensuring that they will produce the safest products possible.

The FDA has a spotty record when it comes to keeping bad products off the market. Often, it is years before some problems with drugs or devices are discovered.

When Congress passed the Food, Drug and Cosmetic Act in 1938, it never meant to give appointed bureaucrats at the FDA the right to protect drug companies from liability, Public Citizen’s Wolfman said.

“Allowing drug companies to claim pre-emption from lawsuits not only denies Americans access to the court system but it also removes an important incentive for drug and medical device makers to produce the safest products possible,” Wolfman said. “The best way to protect consumers is to allow legal remedies to work in tandem with federal regulation.”

Public Citizen is urging lawmakers to pass legislation introduced June 26 by Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.) that would re-establish the rights of patients who are injured by defective or inadequately labeled medical devices to seek compensation for their injuries from the device makers. This bill would restore the original intent of the medical device laws enacted in 1976 and overturn a February 2008 decision of the Supreme Court, which held that federal marketing approval shields device makers from liability to patients. The House bill is H.R. 6381; a similar Senate bill is expected soon.

At the hearing, Quaid urged lawmakers to protect patients’ rights to sue drug makers for injuries caused by their products.

“I believe if pre-emption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats,” Quaid said.

Joe Newman is a press officer in Public Citizen’s communications office.