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Dennis Quaid Sues Drug Company

12/4/2007 5:19 PM PST BY TMZ STAFF

Actor Dennis Quaid and wife Kimberly Buffington have filed suit against Baxter Healthcare Corp., the makers of the drug Heparin.
Click to read the lawsuit!
The couple's newborn twins Zoe Grace and Thomas Boone were mistakenly given a massive overdose of the anti-coagulant drug last month while hospitalized at Cedars-Sinai Medical Center in L.A. The Quaid's attorney says the twins "were very critical for a while," but appear to have recovered and "everything looks good." They filed suit because they want to prevent this from happening to any other children, Loggans said. The suit claims the Baxter is liable and negligent because the packaging of the 10 unit vial of Heparin looks almost exactly as the 10,000-units-per-milliliter vial of the drug.

Three children died in Indiana from a similar mix-up with the drug.

We're told that the Quaids have not sued Cedars ... yet. Just yesterday, Baxter issued a news release outlining the company's new "drug safety initiative" that promises to change the labeling of Heparin vials.

Cedars-Sinai released the following statement:

Cedars-Sinai Medical Center today announced a series of changes it has made in its medication policies and protocols since November 19, as well as immediate additional training of all nursing and pharmacy staff, as the medical center completed its preliminary investigation into a November 18 medication error involving three patients who erroneously received the wrong concentration of heparin (a medication used to prevent blood clotting) to flush their IV catheters.

The medical center's investigation found that preventable errors made by pharmacy and nursing staff caused the wrong concentration of heparin to be used.

A pharmacy technician failed to follow hospital policy of having another pharmacy technician verify the medication and concentration prior to removing it from main pharmacy inventory. As a result, the technician mistakenly retrieved a higher concentration of heparin (10,000 units per milliliter) instead of the lower-concentration heparin (10 units per milliliter) used for flushing IV catheters.

The higher concentration heparin was delivered to the satellite pharmacy that serves the pediatrics unit. A second pharmacy technician, working in the satellite pharmacy, did not verify the concentration of the delivery from the main pharmacy, as required by hospital policy.

As a result, the higher-concentration heparin was placed in a location in the pediatrics unit where the lower-concentration heparin is kept. The nurses who subsequently administered the heparin to the patients also did not follow hospital policy of verifying the correct medication and dose prior to flushing the intravenous site.

The error was identified later that day by Cedars-Sinai staff, who immediately performed blood tests on the patients to measure blood clotting function. In one of the three patients, the clotting tests returned quickly to normal. The other two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore blood clotting function to normal. Additional medical tests and clinical evaluation conducted on the two patients found no adverse effects from the heparin or from the temporary abnormal clotting function.

"Although this was a rare event, and attributable to human error, it is also an important opportunity for the entire institution to explore any and all ways we can further improve medication safety," said Michael L. Langberg, M.D., chief medical officer at Cedars-Sinai Medical Center.

"On behalf of the medical center, I extend my deepest apologies to the families who were affected by this situation, and we will continue to work with them on any concerns or questions they may have. This was a preventable error, involving a failure to follow our standard policies and procedures, and there is no excuse for that to occur at Cedars-Sinai," Langberg said.

"Cedars-Sinai's reputation as a quality and safety leader nationally is due in large part to an organizational culture of continually improving our systems to minimize any chance of human error. Immediately following this incident we began additional focused education on medication safety to augment our regular training, and have implemented additional procedures and protocols for our pharmacy and nursing staff," Langberg said.

Among the actions Cedars-Sinai has taken in response to the incident:


► High-concentration heparin (10,000 units per milliliter) has been further sequestered in all pharmacies.

► Only saline will be used for peripheral IV catheter flush on all pediatric patient-care units. (It was already the practice on adult patient-care units to use only saline for peripheral IV catheter flush.)

► In addition to the existing policy of having designated high-alert medications (such as heparin) checked by two pharmacy staff prior to the medications leaving the main pharmacy, and then checked again by pharmacy staff in the satellite pharmacy, a new step requires a second check by pharmacy staff in the satellite pharmacy before they place high-alert medications in stock on a patient-care unit.

► In addition to these checks on designated high-alert medications by pharmacy staff, nurses will continue the existing policy of separately verifying medication and dose prior to giving high-alert medications to the patient.

► The existing ongoing training for pharmacy and nursing staff on medication safety policies and protocols has been augmented with immediate focused education on high-alert medications, begun Nov. 20, to reinforce the hospital's high-alert medication safety policies and protocols:

Starting on the evening shift of November 20:

● All nurses (approximately 1800) were re-trained on high-alert medication policies and practices, and were required to pass a written test on the material before they could resume caring for any patients.

● All pharmacy staff (approximately 200) were re-trained on high-alert medication policies and practices.

► The individuals involved in this incident were immediately relieved of duty pending investigation, and appropriate disciplinary actions are being taken.

Langberg said that Cedars-Sinai is also continuing to cooperate with regulatory agencies investigating the incident, and that Cedars-Sinai would make additional changes in policies and protocols if indicated by the regulatory agencies or any additional findings by Cedars-Sinai.

212 COMMENTS

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1.

Rhi    

Freaking whiners...The Quaids have a lot of money they don't need to sue anyone but regardless of that I hope they lose because it's not the Drug Company's fault people can't damn well read a label on something. The bottles clearly state what the medication is. There is nothing similar to them really especially when one says 10 and the other 10,000...

if anyone should be sued it should be the nurses who administered the drug to the infants and these nurses should lose their jobs and their licenses. For a nurse to say "I can't remember if I read the bottle" is just plain amazing. Stupid asses...

2374 days ago
2.

pimp    

First bitches!!!

The bottles are different enough for me.

Sue the hospital or the nurse

or the Nurse school.....they are more at fault

2411 days ago
3.

Pam Green    

Good.......

2411 days ago
4.

two cents    

I agree with #1. They're putting the blame in the wrong place. It was human error, not the manufacturers.

Still, I'm glad their babies pulled through this ok. =)

2411 days ago
5.

ME    

He must need the money. When was the last time he actually was in a movie.

2411 days ago
6.

truthfully yours    

Sounds like a good idea to make the manufacturer relabel the product. I am sure the Quaids aren't doing it for the money, but to get something done. The fact this error has happened elsewhere shows that action is needed, and quick.

2411 days ago
7.

ME    

This loser should've sued the hospital.

2411 days ago
8.

Amy    

That's ridiculous. It's the hospital's fault (or nurse that administered the drug) not the drug manufacturer's fault.

2411 days ago
9.

furfeather    

This is NOT the drug company's fault, this is the fault of nurses who didn't do the simple job of double checking before you shoot somebody up with something. This is COMMON practice to double check and they didn't.

2411 days ago
10.

averagejoe    

He should be suing the person who administered the injection. He/she didn't read the bottle carefully (was probably in a hurry or just careless) as well as the hospital for not following standard procedure with their employees.

2411 days ago
11.

Nikki    

This isn't about the money! It's about what happend to those poor babies. I would sue too. I wouldn't want another baby to go through what his children have been put through. I would sue the hospital as well. I wouldn't sue the drug company. The nurse is the one that made the mistake.

2411 days ago
12.

itsmerose    

I agree with Pimp. The bottles even have different colored lids. Fault lies with the hospital & staff. Glad the babies will be ok.

2411 days ago
13.

Mary New York    

The blame is absolutely being put in the wrong place.
Someone administering medication SHOULD absolutely be the one held accountable.
Those bottles were not that similar. Trained staff should be to blame.

2411 days ago
14.

Over It    

Yeah, they look pretty different to me, but then again, I actually looked at the freakin' bottles. Isn't that the job of the hospital employees. Holding the drug company responsible makes no sense to me. Why do people get so litigious and blame everybody? Oh, yeah, money hungry.

2411 days ago
15.

Amy    

God People... he is suing the party that his lawyer (obviously after much consideration and research) is telling him to sue. And I am guessing the lawyers know a little more about this then you.
And yes- someone needs to pay huge this. i can't even imagine...

2411 days ago
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