Pfizer wins big Celebrex ruling
In what appears to be one of the most important “gate-keeping” rulings ever rendered in a mass-tort case, the federal judge presiding over 3,000 personal injury lawsuits against Pfizer (PFE) has barred plaintiffs’ experts from testifying that Celebrex can cause increased risk of heart failure and stroke at what Pfizer says is the drug’s most commonly administered dosage, 200 milligrams per day. The ruling is here..
Judge Charles Breyer of San Francisco — U.S. Supreme Court Justice Stephen Breyer’s brother — rejected, however, Pfizer’s more audacious request for him to also bar such testimony relating to 400 mg/day dosages, which were commonly prescribed for rheumatoid arthritis. Pfizer conceded that 800 mg/day dosages would cause increased risk.
Celebrex is the only Cox-2 inhibitor class of painkiller still sold in the United States; Merck’s (MRK) Vioxx was pulled in September 2004 due to concerns with increased cardiovascular risk, while Pfizer’s Bextra was pulled in April 2005 due to a melange of safety reasons, including cardiovascular risk.
Two leading plaintiffs lawyers in the litigation told the Wall Street Journal last night, see here, that the ruling would affect only about one-third of the cases. (That sounds optimistically low. Merck, for instance, has claimed that, as of September 30, 2007, more than 5,500 “plaintiff groups” who sued over Vioxx had either had their suits dismissed or had voluntarily withdrawn them, and that 20 suits were withdrawn or dismissed after they were actually set for trial; in many of these cases the plaintiffs were having difficulty proving that they had ever taken Vioxx.)
Pfizer’s national liaison counsel in the case (and its national coordinating counsel for all Bextra/Celebrex litigation) is Amy Schulman of DLA Piper. She was not immediately available for comment.
Judge Breyer had held three-days of hearings in San Francisco in October, hearing testimony from four plaintiffs experts and one defense expert. Only two of the plaintiffs experts opined that 200 mg/day could cause increased cardiovascular risk, and Judge Breyer’s caustically found that their views lacked sufficient scientific basis to even allow a jury to consider them.
“Dr. [Neil] Doherty, a clinical physician with no relevant research experience and who developed his opinion for the purpose of testifying,” Breyer wrote, “bases his opinion on a study that he fundamentally misunderstood, is counter to the great weight of the evidence, and, by his own admission, does not make biological sense. . . . Dr. [Maryilyn] Rymer’s . . . opinion is also not good science. She ignores all the evidence that contradicts her litigation-created conclusion and instead bases her opinion on the same cherry-picked study as Dr. Doherty, even though that study suffers from the exact same limitations that caused her to reject other studies that do not support her conclusion. She also relies on an unpublished, non-peer reviewed study that does not disclose its design or confidence intervals.”
At the same time, Judge Breyer rejected Pfizer’s long-shot attempt to score a nearly total knock-out punch by excluding testimony that 400 milligrams/day increased risk. Pfizer’s claim in this regard had been contradicted on its face by the so-called APC study, “a large, long-term, randomized, placebo-controlled, double-blind, multi-center clinical trial that was halted after 33 months [in December 2004] because it demonstrated a statistically significant risk of heart attack, stroke, and heart failure at 400 mg/d.” (The increased risk had been 260%. At 800 milligrams a day, the increased risk was 340%.)
Although Judge Breyer’s ruling does not apply to cases filed in state court, New York State supreme court justice Shirley Werner Kornreich, who presides over hundreds of cases there, where Pfizer is headquartered, sat in with Judge Breyer at the October hearings in San Francisco. It’s not clear yet how she will rule.
For coverage in a pharmaceutical journalist’s blog, see here, and for coverage by a pharmaceutical industry defense lawyer’s blog, see here.
Just to add a little balance to the argument, I am one of the 200mg victims of what most of you seem to dismiss as ‘trying to scam the drug companies’.
I was a perfectly healthy mid-50’s man with no history of any heart/arterial problems, normal blood pressure and cholesterol. My family history was that of most living well into 80’s or 90’s. I began taking 200mg Celebrex to releive back pain from an accident. After 15 months I suffered a heart attack and was stented. One month later I suffered stent blockage and another heart attack, requiring bypass surgery. Three months later I suffered blockage of my right illiac artery requiring a stent. Three months later I suffered another blockage of my right illiac requiring another stent. Four months later I suffered additional blockage of my right illiac and left femoral arteries and both hypogastric arteries requiring massive arterial bypass surgery of both illiac arteries and left femoral artery. This resulted in total impotence and because of reduced blood flow limits my walking ability to about 100 yards, inability to engage in any physical sports activity and total impotence. Shortly after this my doctor took me off Celebrex and suffered no blockages since that time.
So no, I am not trying to scam Phizer. I have now been totally disabled for five years thanks to them and my personal life and physical abilities have been taken from me because of about two years of taking these frankenstein’s pills.
It is tragic that a single judge can destroy any hope of those like myself being able to have my day in court to present my case.
For those who seem to always blame the patients, I hope you never have to see someone you love not know you or themselves because of a stroke. Drug Company’s are suppost to have smart people working for them not people who cover up for them. Lawyers are greedy but so are drug companies.
The drug cos. are not always to blame for the medicines they invent to help people. Sometimes you have to look at the Doc’s who prescribe the medicine or should I say give their patients free samples in order for them to keep coming back so they can charge medicare and the insurance cos. for each visit.
Scott is absolutely right about Shirley and her husband’s false claims. I am sure that her husband suffered from one or more conditions that contributed to having heart trouble.
I do not like when people that don’t think choose to blame others when they misuse pharmaceutical products. Lawsuits do not lead to better medicine. They only lead to increased costs of business. The next time someone I know tries to join a class-action suit against a pharmaceutical company, I am going to explain why they are wrong. Their lawsuit will only make the lawyers rich and will continue to drive the costs of medicine through thr roof. Is a few hundred dollars really going to make a plaintiff in a class-action lawsuit feel any better? The pharmaceutical companies could be using the money wasted on lawsuits to create new medicines to help people!
Response to Shirley’s post: Let me guess…your husband has no history of heart disease in his family, he had absolutely no personal history of high blood pressure, no history of coronary artery disease, he wasn’t diabetic, he wasn’t overweight, he wasn’t taking any other medications, and he didn’t live a sedentary lifestyle. He took Celebrex at the prescribed dosage, and he had his coronary event within months of taking Celebrex.
Right? Of course not… just another american looking to play the lottery system with the best odds, odds you can’t pass up– the lottery known as our personal injury court system. Hey…you never know!
My husband was fine until they put him on cellebrex and at 55 he almost died and needed a stent.
Thank goodness that Pfizer was victorious here.
It deeply angers me that people who take drugs choose to shirk responsibility and instead sue the pharmaceutical companies. Many of those that took Celebrex and other Cox-2 inhibitors were irresponsible people and did not follow the recommendations of their doctors or pharmacists. These people overdosed on the medicine but then tried to sue because it may have made them sick.
I really believe that many Americans need to take an IQ test before using drug products because many do not follow directions or take precautionary measures to ensure that they will not get sick in the first place.
Pfizer and all other pharmaceutical companies are in the business of making medicines that will help humans to live better lives. These companies are not trying to hurt anyone or cause suffering. They are trying to relieve pain and discomfort. Those individuals that choose to sue a pharmaceutical company should be barred from purchasing or using and other product that company manufacturers. This would eliminate 90% of the suits brought against the pharmaceutical companies. This would force people to think twice before not following directions. Those that blame others for their own actions will never take responsibility.
From the experence that i have recently had with lawyers the word integrity is not one that they are even knowlegeable of the meaning
Lawyers are officers of the court and are supposed to have a high standard of integrity. I have the answer-greed.
If they can’t prove their client ever took the drug-why are they wasting the court’s time-answer is “billable hours”.
I don’t know the answer to that Peter. I really don’t.
>> . . . in many of these cases the plaintiffs were having difficulty proving that they had ever taken Vioxx.
It’s not the main point of the post, but I gotta know. In a world where a lawyer is an officer of the court and presumably has to adhere to a high standard of integrity, how does this happen???
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This blog is about legal issues that matter to business people, and it's geared for nonlawyers and lawyers alike. Roger Parloff is Fortune magazine's senior editor (legal affairs). He practiced law for five years in Manhattan before becoming a full-time journalist.
what happens to people that suffered with their digestive tract, with pain,nausea,diarrhea ,and finally ,miocardial infarction to the point of causing their death.does this not matter at all,after being on 200 mgs. to possibly 400 mgs. of celebrex per day,at times ,for a period of 19 months..sounds kind of serious to someone like myself,if not to judge breyer.have all other symptoms beside heart attack or stroke, been thrown out of the window and ruled irrelevant?