Dennis Quaid Gives Congress An Earful

Actor Advocates Lawsuits Against Pharmaceutical Companies Over Medication Errors

(CBS/AP)  Actor Dennis Quaid told Congress on Wednesday of a harrowing, near-fatal drug mix-up 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.

Committee Chairman Henry Waxman, D-Calif., said that if manufacturers face no liability, all the financial incentives will point them in the wrong direction and that abusive practices will multiply.

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.

"It was the scariest, most frightening day that I think either of us have ever been through, to come face to face with your little kids who - so young in that kinda situation," Quaid told "60 Minutes" correspondent Steve Kroft in a March interview.

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.

But Calif. Congressman Brian Bilbray told Quaid there's another side to the argument - that suing drug companies can also lead to tragedy, reports CBS News correspondent Chip Reid.

Two decades ago Bilbray's pregnant wife needed a drug that had been taken off the market because of a lawsuit.

"I will go to my grave believing that my child is dead because he was denied the product that he desperately needed in his first trimester," Bilbray said.

It's not just Congress that's wrestling with the question of when consumers can sue drug companies, reports Reid. Later this year, the issue will go before the Supreme Court.

[fuzzybear9]

Hello Medical Poreffionals and Pharmecutical Companies

what we should point out here is that simple clear plain labeling is one of the most needed requirement of a pharmecutical company.

rather than point fingers at people and blame an innocent Nurse, and simply disregard Mr. Quaids grief.

I suggest new procedure high doses above 1000 mg be printed in Red, with dosage in upper Right
those below 1000 mg printed in blue, in lower left.

then Tired patient worn, PTA MoM Nurses with kids to pick up after work, at the soccer game won`t confuse the dosage.

sincerely Fuzzy

[sjc_1]

When Bill Clinton was President, they quoted a statistic that 90,000 people lost their lives every year do to medical mistakes.

There are protocols that can be put into place that would reduce the number of health care mistakes. Instead to doing what is right, some want to cap the malpractice awards. This is like saying that we could do better, but we would rather escape any accountability for our actions.

[dinkydog1]

Hey, I''''ve got an idea. Why don''''t we double our income tax to pay for socialized medicine. Then the homeless and democrats won''''t have to work for their medical insurance? Then the drugs will all be cheaper due mostly to higher death rates in waiting lines for surgery. Of course, if you''''re on the government payroll you go to the head of the line.

------------------------------------------------------
Posted by maxify55 at 07:18 AM : May 15, 2008

.............

The homeless, old, poor and retired already have what you call socialized medicine, it''s called medicare and medicaid. With the exception of the retired they don''t pay anything. We have the highest cost and the lowest rated health care of any other country in the industrialized world who all have nationalized health care. Progress is always being halted by those who continue these silly stories about socialism, doubling income tax and people dieing in line waiting for health care.

[usbrit-2009]

In the Quaid case I really don''t think that Baxter can be held responsible for the misreading of a label. Nurse, doctor, hospital, all possible, Baxter no. Now in the case of the contamminated Heparin that has killed numerous people this year (I don''t think it''s thousands) Baxter does have liability. Their (so far unnamed by the FDA) Chinese suppliers screwed up, but the buck stops with the US company distributing the drug.

[hwy71so]

So, what if there weren''t medicines or medical professionals to administer to these? We should just sue them all out the door and tend to our own ailments...

[libh8er]

At the end of the day, it''s still an RN or similar who selected the wrong bottle or administered the wrong dosage. I don''t see where suing the drug maker is the remedy here.

If you think it''s bad now, wait till healthcare eventually becomes socialized. Get ready for that 7000 number to increase by a factor of 10!

[samrensho]

What, hold drug companies responsible??? Absolute heresy. GOP will NEVER go for something that radical. Think of all those bribes, err "donations" still to come. What''s 7000 people a year. They were sick anyway.

[drinuk]

Until we start throwing Big Pharma CEO''s in jail along with their incestuous friends in the FDA the better our health and care will be. Sadly there are too many people in high places taking their dollars and favours and maybe we should make it a Capital offence, the penalty being Death, after all, they are killing thousands with impunity

[drinuk]

Until we start throwing Big Pharma CEO''s in jail along with their incestuous friends in the FDA the better our health and care will be. Sadly there are too many people in high places taking their dollars and favours and maybe we should make it a Capital offence, the penalty being Death, after all, they are killing thousands with impunity

[rosescent]

the problem isnt with president bush that remark is so stupid the problem is with the one who made the mistake and just so you will know this was going on a long time before president bush was elected hospitals doctors nurses drug companies make mistakes thanks to so many lawsuits for stupid reasons we are left with poor care very few qualified nurses now doctors fees are out of sight because of insurance premiums this damage was all done before president bush

While big business and corporations runs this country instead of the everyday person, we are in trouble.

We need to ensure that America is handed back to the people and taken out of the hands of corrupt politicians who sell out our freedoms for their own profit.

...government of the people, by the people, for the people...

[lini5]

Most people are not aware that medical negligence is now the number 1 cause of death in this country.Barbara Starfield Johns Hopkins study showes negligence in hospitals was #3 cause of death, factor in Out patient #1.FDA use doctors to test drugs & devices that are paid consultants for the drug & device co,They work for them ,conflict of interest.The fda recalled Heaprin in Feb 2008 after thousands of deaths, The drug co would still have on market. If the public is not allowed to sue doctors ,drug co device makers , check Medtronic story,we have no recorse, we are completly at there mercy.# 1 money spent lobbyiest is medical & drug they are buying the politicians.This is one of the most horrible thing that has happened in our country .People need to wake up. Drugs & devices that are unsafe are costing hundreds of thousands of lives each year ,All for the all mighty dollar.We need to stop this NOW.Do the research get involved it may save your life .

[cyberus-2009]

So since nobody from the pharmacy on up checked what was in the syringe was the proper drug and dosage .. its the drug companies fault?
As much as I despise the big pharma corps this ranks up there with suing McDonalds because they didn''t tell warn people that the hot coffee is hot and suing a lawn mower manufacturer because the lawn mower allowed you to turn it sideways and stick your hand into the moving blade.

[fxy77]

What about malepractice lawsuits, shouldn''t docters be held accountable if they don''t do the surgical procedure right? What if the patient doesn''t find out about the problem until maybe two years later, I think no docter should get away with wrong doing given that it effects the patients life or could even cause death because of the "good docter''s mistake". The law is saying if people don''t file a suit within a time period after surgery, then regardless of the docter''s fault the docter gets away the fault! Not fair,not right at all!

[it_oldtimer]

You can NEVER trust ANY corporation to put the interests of it''s customers - or the general public - ahead of it''s own financial interests or it''s obligation to produce profits for it''s stockholders.

It really is just as simple as that.

The courts are our ONLY real remedy and protection. Put your trust in the courts, not in the companies.

Put the interests of the PEOPLE ahead of the interests of businesses and PROFITS.

[marymary4868]

right on Dennis, go get em

[misssuzq]

FINALLY!

Besides Michael J. Fox, a celebrity that is doing great things for Parkinson''s Disease, Dennis Quaid and his wife are trying to save numerous lives around the world and because they are selfless and not putting themselves on a pedestal, they will succeed.

This makes much more sense than trying to raise awareness in a country that millions of Americans just cannot sink their teeth into.

[lf1952]

The fact that Heparin mixtures are all packaged nearly identically, but with widely varying concentrations is something known to health care providers, and has been known for decades.

The labels are clearly marked with the concentration, in addition to different colored bands.

There is no excuse for administering the wrong product. Nursing procedures generally require the label be read twice (before drawing into the syringe and before administration) and compared to the order.

While it would be nice to have each bottle a different shape or size, this is nothing new and was simple negligence on the part of the person who administered it.

That said, one would hope that Baxter would have already changed their bottles to make error less likely - it''s called human engineering.

The only reason to sue Baxter is to go to the "deep pocket". Based on the facts as reported in this article, the company was not negligent. The professional(s), and probably the hospital (as it would be very rare to ever use 10,000u/cc Heparin in a child, so why was it there) were negligent. The manufacturer complied with Federal Law, and sold a well known, safe and critically important drug, if administered correctly IAW the approved package insert.

[hermitdave]

Good luck with your effort Dennis. But as long as we live in a one party country controlled by big business greed, with total managed news, the drug companies will win.

[upisup]

Big.. pulsating.. pimples stick''n out''a it.. microphone.