Posted on 12/04/2007 3:28:51 PM PST by ShadowDancer
Quaids Sue Maker Of Blood Thinner
Actor's Twins Given Accidental Massive Dose
POSTED: 4:53 pm EST December 4, 2007
UPDATED: 5:21 pm EST December 4, 2007
LOS ANGELES -- Dennis Quaid and his wife sued the makers of heparin Tuesday after their newborn twins were inadvertently given massive doses of the blood thinner at a hospital.
The product liability lawsuit, filed in Chicago, seeks more than $50,000 in damages. It claims that Baxter Healthcare Corp., based in Deerfield, Ill., was negligent in packaging different doses of the product in similar vials with blue backgrounds.
The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital last year.
The lawsuit was first reported by CelebTV.com, which obtained the court documents.
A call to Baxter Healthcare Corp. seeking comment wasn't immediately returned.
The Quaids' children, Thomas Boone and Zoe Grace, and a third patient were at Cedars-Sinai Medical Center on Nov. 18 when they were mistakenly given vials of heparin that were 1,000 times stronger than the usual dosage.
The twins were home Tuesday and "appear to be doing well," said Susan E. Loggans, the Chicago attorney who filed the lawsuit. "The Quads are a religious family, and they really believe the prayers of the public saved their kids."
"Apparently, they're going to be fine now," she said but declined to otherwise comment on the children's medical conditions.
"The point of this case is to save other children from this fate. They're not looking for money," Loggans said of the lawsuit.
The Quaids didn't sue Cedars-Sinai, which acknowledged after the news broke that a "preventable error" had resulted in three patients receiving vials containing 10,000 units per milliliter of heparin instead of vials with a concentration of 10 units per milliliter.
The patients were receiving intravenous medications and the heparin was used to flush the catheters to prevent clotting.
Two of the patients needed a drug that reverses the effects of heparin, the hospital said at the time.
The hospital issued an apology to the patients' families, and said it would take "all steps" to prevent a recurrence.
The heparin was "unreasonably dangerous" as it was packaged and sold because both the small and large dosage vials had labels with blue backgrounds when the vials "should have been completely distinguishable (by) size and shape," the lawsuit argued.
A similar dosage error killed three premature infants at an Indianapolis hospital last year. Three others survived overdoses.
In February, Baxter Healthcare Corp. sent a letter warning health care workers to carefully read labels on the heparin packages to avoid a mix-up.
But the lawsuit by Quaid and his wife, Kimberly, argues that the company didn't do enough.
The company failed to recall the large-dosage vials after the infant deaths and repackage the drug, the lawsuit contends.
It said the manufacturer also should have issued an "urgent" warning to health care providers that required them to educate nurses and others about the problems and implement safety procedures.
So they aren't suing the people that actually made the "preventable error" but instead are suing the manufacturer for not doing more to prevent third parties from making preventable errors.
Based on what I’ve read about this case, I think the Quaids have legitimate beef with the manufacturer regarding the packaging. I think they also have a claim against the hospital, as its employee should have caught the different dosage before giving the heparin to the babies. Even though the Quaids didn’t sue the hospital, it will almost certainly be brought into the suit by the manufacturer.
It boggles the mind....
It would be far more reasonable for them to sue the hospital, then for the hospital to go after the manufacturer. I think their lawyer looked around and concluded that the manufacturer has the deeper pocket.
This certainly doesn’t seem to be a deep pockets issue, they’re only suing for $50,000.
Just over $50,000? I'm surprised anyone would sue for that little in a medical liability case. I bet Baxter would spend many times that amount defending against this suit. Perhaps the Quaids are more interested in getting the manufaturer to change its practices.
As a practical matter, I don’t think makes much difference. If they only sue one party, that party will bring any other parties in to spread the exposure around. The pleadings will look a little different, but the net result will be the same.
That makes sense. It’s not like it’s a large sum for either party.
I’d been looking for more information on this. I’m pleased that the babies have recovered.
They gave the babies the adult dose.
“What is probably also in the suit but not mentioned is a request for an injunction forcing the manufacturer to change its labeling to prevent future incidents and recall product already in the market stream. From what I see, the Quaids are doing a public service, but that doesn’t stop the knees from jerking here at FR.
You're right. The Quaids are doing a public service, and this situation must be corrected before more babies die.
What's a "wife"?
Who the parents or the Maker?
Crapola. The situation won't be corrected by changing the color of the label - fer gosh sakes, the label was clear about the strength of the dose. The only way to correct the situation is to fire the responsible individuals from the hospital, and hire replacements who can read simple English and follow directions. What's next after the labels are in different colors - a defense that the nurse "forgot" which color represented which dose, or a claim that color-blindness prevented them from recognising which was which? And don't tell me that's far-fetched - to a lawyer, such a claim would be "reasonable," and their job would be to convince a jury of idiots to agree.
I do believe the employees who did this bear the responsibility. If they don’t get fired, something should be done.
To a movie star, $50,000 is probably just pocket change and more of about the principle that the packaging does need to be changed. The two are too similar and could have resulted in someone’s death.
They gave the babies several orders of magnitude more than you are supposed to give any person. They gave them the “cleaning solution” version of the drug, IIRC.
Actually, spesking as a retired nurse, I agree with the Quaids.
Heparin is not a child/adult dose difference, it’s used in different doses for different reasons.
ALL heparin I ever used was in extremely similar little glass vials, and it used to give me gray hair, checking and double checking to make sure I was using the right dose, particularly for an IV flush.
Seriously, the vials are horrifyingly similar. Maybe someone can find it on line and post pictures. When you’re working in a cramped med room, prepping maybe a dozen meds for a patient, pushed for time with lights going off all over the place, without having eaten anything all day, on your last hour of a 12 hour shift, checking the six rights on every last thing you give, trust me, it can get hairy.
Making the vials VERY different would seem to be a simple safety measure.
The heparin vials are almost identical. They need to be changed for the safety of ALL patients.
I agree. The vials are far too similar.
That seems to be their only motivation. And they're right.
Not suing the responsible parties...
Also, the error could have occurred in the pharmacy, by the tech who packed the med carts, or the person labeling patient med trays etc. And YES! These suckers look too much alike. I can see someone, assuming that person a picked the right drug and person b labeled it correctly giving the med.
I am guessing that the Quaids are showing empathy for the nurses who made a regrettable mistake. But the environment was made ripe for this mistake to occur. Seems as though the Quaids are being very decent here.
By their suit of 'more than' they are probably placing the suit in the major class.
The actual figure will be much more than $50k.
I don't know the legal jargon.
Can’t sue a California hospital in a Chicago court. Their claim against the hospital also requires that they give the hospital and doctors notice of the suit before it is actually filed. Finally, the case against the hospital is limited to $250,000 in general damages, no such limit as to the manufacturer.
Nope, gotta disagree. Nobody should ever be held liable, especially via a lawsuit. You roll the dice in this life, and if somebody’s negligence screws you over, that’s just tough luck.
The point is that any step to lessen the possibility of a bad outcome sounds, in and of itself, supremely reasonable...but tie all these baby steps together and the result is crazy. What happens when every single one of those thousands of drugs have unique containers, unique colors...will you remember what every one signifies? Nope - and then you'll resort to what should be done in the first place - read the label. Sorry you get tired, or frazzled, or rushed - every professional, and many non-professionals, are in the same boat. Will the mechanic, after the accident due to the wrong brake pads he installed, sue the manufacturer to say that different sizes and types of brake pads all deserve specially-designed packaging? If you think that wouldn't happen...well, I'd bet a considerable amount of money that I'm right.
The last thing I would have expected on Free Republic is encounters with the "There Oughta Be A Law" crowd, who think that a law, or a lawsuit, is the solution to any and every conceivable problem.
It certainly appears to me that the packaging is the root cause of this problem. It’s easy to blame human error, but in the vast majority of situations there’s a deeper problem within the process.
A simple analogy...suppose traffic accidents occur at a rate of 1:5000 vehicles transiting an intersection. Yet at one particular intersection, the rate is demonstrated to be 1:500. Are all the drivers at fault here, or is it more likely there's a design flaw in the intersection itself?
I rarely root for the plaintiff in high profile product liability cases, but making near identical vials, with dosages that are 1,000 orders of magnitude stronger, looks a whole lot like an ammo manufacturer making near identical inert training rounds and magnum hollowpoint rounds.
Yeah, folks ought to read the tiny letters on the rim of the casing that tell them if the rounds go bang, but it is not only forseeable, but certain, that some folks are gonna get them mixed up. A mix up like will get innocent people killed. That is why inert training rounds are very different in color and weight from magnum hollowpoints. These vials ought to be very different different too.
Don't give me your smug attitude. I quit nursing. There is NO REASON to make those vials so similar. It's one of those things every floor nurse knows from day one, it's still the cause of problems. They should just make one of them RED, for the safety of the patients.
FYI, good nurses like me quit. No reason to be under that much stress, and have people like you around, too. I don't need it, there are easier ways to make a decent living. People like me, who really gave a shit, get abused by the hospital patient/nurse ratio.
PS, Reading labels is one of the things I did ALL FREAKING DAY, no matter how many times I read them before. It's part of nursing, you do it because it's protocol.
Changing the vials is GOOD from a public policy and litigation standpoint. *sheesh, some people know it all.*
Thanks, najida. In real life, the vials can be quite a bit smaller, too.
I hope they lose...
Well, if this lawsuit forces the manufacturer to do more to recall the meds w/ confusing packaging AND to issue urgent warnings to med staff, then it’s a good thing.
I’ve seen the vials. I also know how med carts/tray are packed and labeled. It’s way too too easy a mistake to make.
And damn easy to fix.
I’m sorry, I side with the Quaids. The manufacturer should (reasonably)have forseen the opportunity for confusion and had distinct and unmistakably different markings.
“So they aren’t suing the people that actually made the “preventable error” but instead are suing the manufacturer for not doing more to prevent third parties from making preventable errors.”
Doesn’t make sense to me....but who has the money?
So adequate heparin will not be available for procedures that require full heparinization? That will make going on a perfusion pump a lot of fun.
I have never heard of a heparin shortage. If you know of one, please tell me.
I haven’t heard of one either unless they recall the large dosage.
Heparin is used so often that a simple change in the color of the labels would get into the stream within a week, without recalling anything.
False analogy, as there is evidence that changing the timing of a traffic light - or cutting down the bush obscuring the stop sign :-) - will make transiting that intersection safer. I.e., the principle is established in the law, AND there is sound science backing up the principle.
The Quaids’ asserted claim falls under the rubrics established under, for example, the Restatement of Torts. However, rather than alleging that the labeling was itself inadequate, they seek to interpose a new type of claim, relating to packaging design (and specifically, color). So they are seeking a new type of claim. This is much more than a small correction to a small problem. It is instead a humongous correction to a small problem...and a “correction” that itself opens doors to much more extensive litigation claims for every sort of product imaginable. I can’t believe how many people are not lifting their eyes from the specific issue to what it means as a legal principle. And history shows that once that legal genie is out of the bottle, virtually nothing can rein it in.
The lawyer is asking for a recall of the larger dosage. That could equal a temporary shortage for Cardiac surgery.
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