The actor and his wife sued the heparin maker after their newborn twins were inadvertently given massive doses of the blood thinner at a hospital, the
Associated Press reports.
The product liability lawsuit seeks more than $50,000 in damages and claims Baxter Healthcare 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 seeking comment wasn't immediately returned, the AP writes.
The Quaids' two children 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 Quaids are a religious family, and they really believe the prayers of the public saved their kids. Apparently, they're going to be fine now," Sue Loggans, their attorney, tells the AP, while declining 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."
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 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.
14 Comments
Well first of all i'd like to say that i'm glad the Quaid twin's are doing well, which is what's most important, and 2nd here is a family that is'nt sueing someone for money,because they don't need it, i'm sure they have been made aware of a problem like so many of us and this is the way to address it, bring it out and make other's aware, I would'nt be surprised if we hear more on this subject from the Quaid's.......
Packaging of drugs, especially in hospital use, is SO critical. When you are giving hundreds of different drugs in a day, a vial of similar size, font on the label, and color have to be different enough to be recognized at a glance. Even the most conscientious nurse is human and can make mistakes. I'm not dismissing the nursing liability here, but a simple change by the manufacturer could prevent this. This heparin problem has been around for a while. Hopefully, this tragedy will result in long overdue changes in the packaging.
So why not go ahead and sue the FDA too since they have to approve labeling? I don't think going after Baxter was the right thing. The hospital staff should remove that lump from their rear called their head. Put blame where blame is due.
Phil,
The Quaid's actions are honorable, The hospital has apologized, and now its time for this Company to use common sense and just change the label. Again,.. a litlle common sense goes a long way in preventing tragedy.
I agree with "Phil". This is a frivolous, publicity-seeking, "rebel (liberal?) without a cause" lawsuit against the manufacturer. All packaging/labeling is approved by the FDA. Every clinician, be they physician, nurse, pharmacist, is or should be aware of the different concentrations of heparin that are commonly used, and it is on THEM to make sure that the right one is used for the right purpose. Heparin is used SAFELY in tens of thousands of patients every day here in the US, and though there are human errors such as this, the overall rate is low given the very large denominator. Bottom line: the nurse, physician, or pharmacist who drew up the syringe is at fault. Period. Before you crucify me, I have 10+ years experience in the critical care setting and have administered heparin to thousands of patients without one single error such as this.
Dr.R,
I have administered heparin to my daughter via a Pic Line, it was pre packaged and clearly marked, so why shouldnt it be clearly marked in a hospital.
Publicity-seeking, in this case, thats a good thing.The Company should be embarrassed, there is no excuse for not taking a common sense approach.
Huh,
Lisa - it is not as if the hospitals only have to give 3 things via IV and nothing else. If every vial had a different look/feel to it, no one would know where to look for the vital information. These vials are made to look like marketing pieces - they are generic vials that have the vital information only and are small. Baxter sells heparin for about $.20/vial, a sterile product in plastic/glass packaging. Think they are making a ton of $$$ off this and putting it into the look of their vials?
This was a hospital mistake as the 10,000u/ml heparin should not have been stored with the standard heparin flush supplies. This should have been a pharmacy order item that is separate from the 10 and 100 u vials. Also they sell prepackaged flushes already in syringes. But these are more expensive so not used as much.
Not everything can be blamed on a company. There are thousands of vials in a hospital, they can't all look different. Plus they are barcoded and if the hospital had employed bar code readers this would not have happened.
So let's go over hospital mistakes:
1) poor employee 2) poor system that allowed the 2 heparins to be on the floor 3)lack of use of more expensive, but less accident prone prefilled syringes. 4)lack of using a proven error reducer - bar code readers (expensive)
And Baxter's mistake-
They literally sell 10,000 different vials of IV meds and a few happen to look similar.
Quit blaming everything in the world on pharma companies. And try to have some bit of knowledge before you speak out.
The company should not be embarrassed as you point out - it was a personal mistake and a hospital system mistake all done to save $$$.
Dr. Remulac is a great example - when you have a properly trained person who actually is paying attention and knows a life is potentially on the line this doesn't happen. Or barcode scanners could have saved the day.
OK, I feel better.
my mistake - they are NOT made to look like marketing pieces. The vials are small and contain only vital information.
That word is kind of important.
Todd,
Mistake, I was ready to hit you on that one.
The pre Packaged flushes already in Syringes is what I had used for my daughter. As a non medical professional, it made my life easier and brought my anxiety level down. I commend the Company for providing this type of clearly pre packaged product. As a Parent, the expense of the drug is meaningless.
High Volume of a setting, more of a reason to have clearlymarked packaging..
sorry, this was a hospital error. Cedar's-Sinai and other hospitals were aware of the possibility of confusion and the labels are different enough that even a non-professional would notice there is a difference between the vials. To sue the manufacturer when the hospital admitted to the error and has not so much as implied they received mis-labeled product seems a bit much (especially since the stated grounds for not suing the hospital is because the staff was nice and apologetic).
Ol Cranky,
Nothing is Preventing Baxter from being a responsible and caring company, if placing clearer labels on their products that will prevent another tragedy-- Just do it, they will be a better company for it..
There's enough blame to go around..
There are alot of systems to blame for this one. But since it's been a problem for a long time, who doesn't matter who as much as fix it!! Heparin is not the only drug with this dilemma. Generics are a problem in this area also. We use to have Hydroxyzine(Vistaril) and Hydralazine(antihypertensive) in identical vials(same colors, same size). BIG potential for a problem.
Oh, don't get me wrong - Baxter should change the labels to make the difference more obvious, I'm just not sure the error didn't occur because someone just didn't bother to look at the label.
A better, more productive, solution to suing the manufacturer would be to use the opportunity to publicize the need to support fast-tracking pedigree efforts and tracking through bar coding.
To begin with, I would like to thank you for your extremely informative post. I would also like to say, like the previous commentators, that I am glad the twins are safe. Before reading your post, I wasn't entirely sure who was held responsible for this catastrophe and now I know that it was mostly the manufacturers of the drug. I agree with the fact that identical drug vials with different concentrations is dangerous for people working in a fast paced scenario, like a hospital. Moreover, the fact that Baxter did not recall its product even before the Quaid case, when three children were killed by the same calamitous error, is unfathomable. While I am sincerely relieved that the Quaid twins will be fine, it disgusts me that the prior deaths were not as well publicized. Do you think there would have been any change at all if these twins were not related to a celebrity? I found in my research that 1.5 Americans are affected by medication errors every year. I can't believe this wasn't a top news story before the celebrity scandal. On the other hand, I wonder if this is a problem of hospital accountability as well. As you mentioned in your post, the manufacturers did send a warning to hospitals describing their mistake with the vials telling them to be overly cautious. This obviously was not enough; but shouldn't all hospital procedures be meticulously careful when it comes to children? Overall, I would just like to thank you for your post because it gave me some more insight on a very intriguing, vital subject in the medical world. I hope that, for the sake of millions of children being treated every day, hospitals and medicine manufacturers make an aggressive effort to improve upon and diminish these horrific blunders.