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Judge Strikes Merck Witness' Testimony
AP/Yahoo ^ | 10/7/05 | BONNIE PFISTER, Associated Press Writer

Posted on 10/07/2005 11:08:17 AM PDT by Jaded

ATLANTIC CITY, N.J. - The judge in the second Vioxx product liability trial delivered a stunning blow to Merck & Co. Friday when she struck the testimony of its first defense witness from the record.

With the jury outside, Superior Court Judge Carol Higbee said she felt misled and sickened upon rereading the transcript of Thursday's testimony by a Merck researcher who said studies by the company in the late 1990s showed the pain reliever would not cause heart damage.

Higbee struck the testimony of Merck researcher Dr. Briggs Morrison from the record because she said he was not an expert on the studies he had told the jury about Thursday, nor did Merck give the court sufficient notice about what he would discuss.

"I felt sick last night, and I realized how I got sucked into this. I feel that the court was misled repeatedly with this testimony," Higbee told attorneys Friday morning.

Morrison was Merck's opening witness in the three-week trial over whether Vioxx caused the 2001 heart attack of Boise, Idaho, postal worker Frederick "Mike" Humeston. Merck in August lost its first product liability case in Texas over the death of another Vioxx user, and 5,000 similar lawsuits are pending.

Merck voluntarily pulled the drug from the market a year ago after its own study found that more than 18 months of Vioxx use could double the risk of heart attack and stroke.

(Excerpt) Read more at news.yahoo.com ...


TOPICS: Culture/Society; News/Current Events
KEYWORDS: lawsuitlottery; merck; pharmaceuticals; ruling; vioxx

1 posted on 10/07/2005 11:08:21 AM PDT by Jaded
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To: Jaded
We need to shut down all the "evil" drug companies so we can "die with dignity".

In the future if you're ill, don't call a doctor, call a lawyer, they can protect you much better than the "evil ones".

2 posted on 10/07/2005 11:18:11 AM PDT by Mister Baredog (("It dawned on me that I was present at the birth of a political jihad."))
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To: Jaded

Know what makes me sick?  Some guy who claims Vioxx gave him a heart attack because he took it that morning.  There's no evidence at all that Vioxx increases risk of heart attack unless you've taken it for 18 months and this fraud was on it for 3 months.

"Ladies and gentelmen of the jury, I propose the following:  Vioxx + Heart Attack = Cha-CHING!  You honor, where can I pick up my check?"

Owl_Eagle

(If what I just wrote makes you sad or angry,

 it was probably sarcasm)

3 posted on 10/07/2005 11:21:19 AM PDT by End Times Sentinel (In Memory of my Dear Friend Henry Lee II)
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To: Jaded

Click on the link and scope out the judge. Her appearance does not inspire confidence in Blind Justice. This judge can see the dinner table.


4 posted on 10/07/2005 11:21:33 AM PDT by Pearls Before Swine (Is /sarc really needed?)
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To: Mister Baredog

In the future if you're ill, don't call a doctor, call a lawyer, they can protect you much better than the "evil ones".

I don't agree with mega lawsuit settlements. However...

If a pharmaceutical company still markets a drug that it knows to damage patients, it's still okay in your book?

That appears to be what Merck did, it just wanted to keep making the $2.5 billion annual profits on Vioxx sales and patient's health be damned.


5 posted on 10/07/2005 11:24:34 AM PDT by BlackRain (Trust, but verify. - Ronald Reagan)
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To: BlackRain

I'm not sure that you will find a modern drug that will not harm some patient. Have you read the disclaimers and the notes that come with the drugs? Enough to make you sick, I tell you...


6 posted on 10/07/2005 11:35:46 AM PDT by battlecry
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To: BlackRain

The Cleveland Clinic, one of the better respected group of chest cutters out there where trying to warn of the risks of this drug 5 years ago. Merck fought them all the way, can't feel too sorry for them.


7 posted on 10/07/2005 11:40:54 AM PDT by krshnbrn
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To: BlackRain
Your living with the illusion that drugs are safe.

Even aspirin has side effects which can be deadly to some.

Your logic is flawed.

This is another field day for lawyers.

The lawyers will try to make Merck responsible for EVERY ailment they can that any consumer of Vioxx suffered.

It's the TORT system that will kill more people than imaginable. Are you a lawyer, just curious?

8 posted on 10/07/2005 11:47:53 AM PDT by Mister Baredog ((Conservatives don't want judicial "litmus tests", UNLESS they supply the test that is))
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To: BlackRain
If a pharmaceutical company still markets a drug that it knows to damage patients, it's still okay in your book?

I suppose you'd get rid of prednisone then? It does serious damage: loss of eyesight, thinning bones, weight increase, diabetes. Those are only what it gave me, not the total list. However, I would not have taken it if the benefits had not (at first) been better than not taking it.

Does this excuse any company from hiding side effects? No, it does not. If you keep to the 'no damage' rule, we'll have precious few things on the pharmacy shelf.

The issue is not drugs with damage, it's uninformed consent. The claim is that while Merck knew about possible damage, the doctors prescribing Vioxx did not nor did the patients taking Vioxx. Had everyone known about the possible damage, there would be no case here.

9 posted on 10/07/2005 11:56:12 AM PDT by slowhandluke (It's hard work to be cynical enough in this age)
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To: BlackRain
By your logic , Bayer should remove all aspirin tablets from the market -- the fact is , far more people die every year due to untoward side effects of aspirin therapy such as GI bleeding than ever died or were harmed by Vioxx.

The question a prescriber of any medication should ask: does the benefit of the drug outweigh the risk for potential harm ?

Having prescribed Vioxx hundreds if not thousands of times, I can tell you that I rest easy that even with what we know today, the folks for whom I prescribed the drug were treated with a drug whose benefits outweighed the risk associated with treatment.

10 posted on 10/07/2005 12:03:23 PM PDT by BartMan1 (...)
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To: Jaded
I have no idea whether, in this particular case, Merck did wrong or not.

But yes, the pop-culture willingness to blame Big Pharm is troubling. Why, don't you know? that all big drug companies routinely lie, cheat, bribe, steal and murder, to increase their profits?


11 posted on 10/07/2005 12:10:14 PM PDT by pogo101
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To: BartMan1

"By your logic , Bayer should remove all aspirin tablets from the market -- the fact is , far more people die every year due to untoward side effects of aspirin therapy such as GI bleeding than ever died or were harmed by Vioxx."


You are missing the point completely.

Merck HID the findings that it's product was dangerous. Most drug makers let you know what the side effects are and some get a black box warning. That way your doctor and you can decide if the medicine is worth the risks posed.

However, you are stating that it is okay for Merck to HIDE the fact it's own research revealed their product was dangerous to patients. The public was uniformed.

And no, I am not a lawyer and I am in the healthcare field.


12 posted on 10/07/2005 2:08:31 PM PDT by BlackRain (Trust, but verify. - Ronald Reagan)
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To: BlackRain

"Having prescribed Vioxx hundreds if not thousands of times, I can tell you that I rest easy that even with what we know today,"

That's funny.

I remember when patients were getting Phen-Phen. It was 'safe' as well, remember.

I warned my patients and the doc's that did not listen had nice malpractice cases.


13 posted on 10/07/2005 2:12:06 PM PDT by BlackRain (Trust, but verify. - Ronald Reagan)
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To: BlackRain

West Palm Beach Doctor Files Vioxx Lawsuit Against Merck
Source: PR Newswire
Published: February 10, 2005

A West Palm Beach doctor and his wife filed a lawsuit Thursday against Merck & Co. and company sales representative Angie Henderson, claiming he developed heart damage as a result of taking the arthritis drug Vioxx.

Dr. Robert Plasko contends he suffered heart damage, rendering him permanently disabled, as a result of taking Vioxx. Dr. Plasko is now disabled, and was forced to give up his medical practice of 16 years, according to the complaint.

The lawsuit, filed in Palm Beach County Circuit Court, West Palm Beach, Florida by attorneys Keen and Reiter, alleges that Merck knew as early as 2000 that Vioxx was unsafe, yet did not withdraw it from the market until September 30, 2004, after a study found that it increases a patients’ risk of heart attack and stroke.

Dr. Plasko states that as a consumer and a physician, he was misled by Merck and its sales staff, and that he hopes this litigation will serve as a means to prevent such corrupt activity from happening again in the future.





Doctors Sue Merck Over Vioxx Animal Tests

Merck Relied on Animal Experiments Showing Vioxx
to Be "Safe," While Ignoring Critical Human Data

WASHINGTON—In a lawsuit filed this week, the Physicians Committee for Responsible Medicine (PCRM) alleges that Merck & Co. wrongfully relied on tests showing Vioxx was safe in animals while ignoring mounting evidence that the drug is dangerous to humans. Vioxx, a best-selling painkiller, was pulled off the market last fall, after the APPROVE clinical trial showed cardiac risk to humans. This is believed to be the first time a U.S. pharmaceutical company has been sued specifically for relying on animal tests.

“Merck endangered public health by relying on inapplicable animal tests rather than relevant and available human data,” says Dan Kinburn, PCRM associate general counsel. The injured plaintiff, Nancy Tufford, a PCRM member from Minnesota, is seeking $1 million in damages because she developed congestive heart failure while taking Vioxx.

The lawsuit charges that Merck was well aware of the limitations of animal testing—that animal studies are often inconsistent, species-dependent, and not useful in predicting drug safety or efficacy in humans. At least nine of 11 mice and rat studies, for example, showed COX-2 drugs to be beneficial for animal hearts. The suit accuses Merck of using these and other inapplicable animal data to justify keeping Vioxx on the market. It also states that Merck knew of more effective safety assessment methods, such as postmarket surveillance of patient reactions, in vitro tests using human cells and tissues, and computer modeling, but failed to employ these methods.

At a news conference held in Washington, D.C., today, Dallas-based cardiologist and PCRM consultant John J. Pippin, M.D., F.A.C.C., shared the results of his research into the Vioxx tragedy, including a new “smoking gun.” Dr. Pippin presented data from an unpublished study on African green monkeys that Merck used as additional evidence of Vioxx’s supposed safety.

“Animal tests clearly show Vioxx to be safe, but these tests simply do not apply to humans,” Dr. Pippin said. “Merck was wrong to rely on data from mice, rats, and African green monkeys when faced with compelling evidence that human patients are at risk,” says Dr. Pippin. “Ultimately, Merck’s reliance on scientifically flawed animal tests led to human injury and death.”

Muhammad Mamdani, PharmD, M.A., M.P.H., senior scientist and leader of the Drug Research Group at the Institute for Clinical Evaluative Sciences in Toronto, Ontario, also participated in the news conference. Dr. Mamdani, the lead author of a recent human-based study in The Lancet that links Vioxx to congestive heart failure, has stated that studies with mice and monkeys are not always predictive of a drug’s effect in human patients.

Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, especially good nutrition. PCRM also conducts clinical research studies, opposes unethical human experimentation, and promotes alternatives to animal research.


14 posted on 10/07/2005 2:15:49 PM PDT by BlackRain (Trust, but verify. - Ronald Reagan)
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To: BlackRain
Merck HID the findings that it's product was dangerous. Most drug makers let you know what the side effects are and some get a black box warning. That way your doctor and you can decide if the medicine is worth the risks posed.

You are wrong -- Merck did not NOT hide the evidence of possible heart effects -- in particular , a suggestion in the phase three trials of the drug that the treatment group may have had a higher incidence of heart attacks than the placebo group. The information was discussed in an open forum of experts, including cardiologists and rheumatologists at an FDA convened meeting prior to the drugs approval. The committee, after duly considering the evidence , felt that Vioxx represented an additional anti-inflammatory med for physicians which had the unique benefit of a lower GI bleeding rate, and on balance, if it in fact had a tendency to increase the risk of heart disease, the lower risk of GI bleeding outweighed that risk in certain ppatients.

The trouble with the phase three trial was that it was relatively short term, as I recall 3 months, which is standard for the industry. The increase in heart attacks in the treatment group did not meet standards of statistical significance. But the information was made widely availble , including in the package insert, and I can tell you was widely discussed amongst physicians who used the drugs ( at least in the group I circulate in ).

What next happened is that Merck launched a large long term trial of the drug designed to test its efficacy in the prevention of colorectal polyps and cancer. It was during this trial that the number of heart attacks and strokes reached unacceptable levels, but the numbers only began to go up at the two year treatment mark. Merck stopped the trial, notified the study investigators, and made a public announcement.

I think it is important that you and others know these facts , because to accuse Merck of a coverup is a calumny -- this company as far as I can tell operated above board, and went the extra mile to make all players aware of the risks of this drug.

15 posted on 10/08/2005 7:21:39 AM PDT by BartMan1 (...)
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To: Owl_Eagle

"Ladies and gentelmen of the jury, I propose the following: Vioxx + Heart Attack = Cha-CHING! You honor, where can I pick up my check?"

Dear Eagle, I took it and ended up in the emergency room. I didn't sue.


16 posted on 10/08/2005 7:28:12 AM PDT by dljordan
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To: BartMan1

"You are wrong -- Merck did not NOT hide the evidence of possible heart effects"

Really? Explain this!

At least 38,000 Americans are believed to have died from taking the pain pill Vioxx before it was withdrawn from the market.

Dr. Eric Topol, a Cleveland Clinic cardiologist, said that researchers outside of Merck had been making the link between Vioxx and cardiovascular problems for years, but Merck always maintained that those studies weren't conclusive.

1) Merck company documents show that the drug maker was in the process of beginning a major cardiovascular study of the drug in 2002, and suddenly dropped the project just before it was set to start.

2) It has emerged that the Merck was aware for years that Vioxx might be dangerous. Now, new documents obtained by NPR suggest that even as Merck was making Vioxx into a bestseller, the company was putting pressure on independent doctors. The company's apparent aim: to keep them from discussing evidence of Vioxx's potential safety problems. The documents show that Merck exerted pressure not only on individual doctors, but also on several of the nation's top medical schools.

http://www.npr.org/templates/story/story.php?storyId=4696609


17 posted on 10/08/2005 9:26:21 AM PDT by BlackRain (Trust, but verify. - Ronald Reagan)
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