Quaid Testifies of Peril to Newborn Twins
WASHINGTON - Actor Dennis Quaid told Congress on Wednesday of a harrowing, near-fatal drug mixup in which his newborn twins were administered 1,000 times the normal dose of a blood thinner.
The actor said his family’s brush with tragedy underscores the need to hold pharmaceutical companies accountable through lawsuits, a remedy that is becoming increasingly problematic for injured consumers.
Some 7,000 Americans die every year from medication errors.
At issue before the House Reform and Government Oversight Committee is a move by regulators at the Food and Drug Administration to step into lawsuits on the side of defendant drug companies.
In court, the drug companies argue that federal regulation should pre-empt the filing of lawsuits under state law, a matter that will come before the Supreme Court later this year in a case from Vermont.
The Quaid family is suing drug maker Baxter Healthcare Corp., which is seeking dismissal of the lawsuit on federal pre-emption grounds that the FDA approved the labeling.
“Like many Americans, I believed that a big problem in our country was frivolous lawsuits,” Quaid testified. “But now I know that the courts are often the only path to justice.”
Quaid said that if all lawsuits are pre-empted, “it will basically make us uninformed and uncompensated lab rats.”
The committee’s ranking Republican, Rep. Tom Davis of Virginia, sympathized with Quaid, saying that if this had happened to the Davis family, “I’d be suing everybody in sight.” Apart from Quaid’s case, Davis called for balance between total pre-emption and unrestrained litigation.
Quaid told the committee his family’s life-altering story began in November 2007 when twins Thomas and Zoe, at the time 12 days old, developed a staph infection and had to be hospitalized.
The children were mistakenly administered the wrong version of the drug heparin, due to two concentrations of the drug being bottled with similar labels and size. When rotated slightly as they often are when stored, the light blue 10-unit bottle and the 10,000-unit dark blue bottle are virtually indistinguishable, Quaid told the panel.
The actor asked whether consumers’ rights to sue under state law should be blocked just because the FDA approves the drug and its labeling and packaging.
The actor said that under the approach favored by business and the federal government, the FDA handed the drug maker “a get-out-of-jail-free card” when the regulatory agency allowed heparin onto the market.
The Quaids’ children recovered, though “we don’t know what the longer-term effects will be,” said Quaid.
© 2008 Associated Press
Huh…blaming it on the ole label, which is the FDA’s fault. Something similar happened many years ago in Michigan (http://everything2.com/index.pl?node_id=1774247) where a chemical company had poor labeling and PBB was introduced into the Michigan food chain. The chemical company wasn’t held accountable either.
Also Baxter has a problem relating to one of their suppliers (in China) where a Heparin ingredient was contaminated. The product (blood thinner) was recalled.
Places like Baxter (who actually is a very good company) must be held accountable. Too often companies agree, but they feel they can handle it by themselves. For those of you in the working world, I’m sure you’ve seen too many times where a company is operating on a tightened budget, with too few staff to perform their jobs adequately. Also places like Baxter rely on the FDA for compliance. Problem is, even the FDA has fallen on tight financial times.
Who pays the price? We do.
HOW COME THEY NEVER GIVE ME TOO MUCH HYDROCODONE?..OR VALIUM..HEY..WHEN IS THE TECHNOLOGY GOING TO ALLOW COMMON DREAMS TO SEND A VALIUM THROUGH YOUR PRINTER? CAUSE I NEED ONE EVERY TIME I READ THESE HEADLINES..SERIOUSLY…
When will hospitals and drug and equipment manufacturers learn that it is ALWAYS better (and better for the bottom line) to accept responsibility for preventing errors from recurring? Anyone who has worked in a medical setting knows that flawed designs and protocols often come to light for the first time when an error occurs. If errors are acknowledged, and a real effort is made to understand how they occurred and prevent them in the future, people are less likely to sue in cases where the error didn’t result in lasting harm.
I recall a case in our local childrens’ hospital in which a clinical fellow mistakenly injected a young girl with highly treatable leukemia her chemo drugs intrathecally (directly into her spinal canal) instead of IV, killing her.
The hospital immediately acknowledged the error and began a thorough review of every step the fellow took leading up to it, finding a “perfect storm” of poor package design, poor design of the drug storage system on the child’s unit, poor design of the meds tray, and inadequate protocols to reduce the potential impact of poor design. They then shared all of that information, along with new procedures to prevent a recurrence and a heartfelt apology, with the child’s family, which declined to sue, reasoning that the hospital had already satisfied whatever demands they might have made at court. Unfortunately, the fellow, by all accounts a highly gifted clinician, was so shattered by the incident that he considered leaving medicine altogether, then switched from clinical to research work.
As important as it is for responsible parties to acknowledge error when it occurs, if the US wants to reduce medical lawsuits (and the size of awards), the single most effective way to do it is to adopt universal single-payer, publicly-financed health insurance.
It is difficult to see how anyone could swallow the tripe that if FDA approved the drug then the Big Pharma are immune to prosecution since the drug trials are ghost written by the drug companies themselves, http://www.naturalnews.com/023074.html. Now if we could sue the FDA then that is a different story. But someone needs to be held accountable when so many drugs are being prescribed with very little research into the combined effects of so many drugs in the system.
Hello Dennis. Glad you’ve finally woken up.
FDA = ‘Federal Disinformation Agency’ Run By and For big business at the cost of YOUR safety.
Mr. Quaid, Justice isn’t to be found in taking some money away from a corporation.
Justice would be a large dose of heparin for all the careless people who arranged the injection. Care-less.
The Chuck Pendleton machine. Zero defects.
Name the movie for free fudge for life.
If anyone believes that only 7,000 people die every year from medication errors - then I’ve got a lovely bridge in Brooklyn for you… I think you need to add more zeroes…
Hell, I’ve been to ER nearly every year because of ‘medication errors’ - and they weren’t my fault. The drug companies do a snow job on the doctors, and even the pharmacists have a hard time ferreting out the truth… it’s worse than you think, especially among the elderly. (I’ve been both a VA and senior advocate, and found errors in medical protocols all the time.)