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A timeline for Vioxx litigation ..._Aug. 17, 2006: A state judge in New Jersey overturns Merck's victory in the Humeston case, saying evidence uncovered since the November verdict warranted a new trial. She found of particular note the revelation that Merck left some heart attack data out of its VIGOR report … _Aug. 17, 2006: A federal jury in New Orleans orders Merck to pay $51 million to Gerald Barnett, who began taking Vioxx in 2000, had a heart attack Sept. 6, 2002, and continued taking Vioxx until the week before it was withdrawn from the market … _Aug. 30, 2006: Federal judge orders a new trial on Barnett's damages, saying $50 million compensatory is "grossly excessive."…
8/3 Merck Wins California Vioxx Case:
Merck Wins First California VIOXX(R) Case … second time in the past month that plaintiffs were unsuccessful in their bid to blame their heart attack on their VIOXX use. … Jury in Los Angeles rejected the claims of a California man who blamed his 2001 heart attack on his intermittent, sporadic use of VIOXX … plaintiff was at high risk for a heart attack regardless of whether he was taking VIOXX …[ Merck Press Release ]
Editor's Note: Adds that Merck is resolved to try each case separately.
See Also> Similar Report From Wall Street Journal; $$$
See Also> Similar Report From AP/Yahoo
See Also> Similar Report From Reuters
8/2 Decision Expected Soon In California Vioxx Lawsuit
Jury Begins Deliberations In California Vioxx Trial … Plaintiffs' lawyer, Thomas Girardi of Los Angeles-based Girardi & Keese, devoted his closing remarks to arguing that Merck knew Vioxx was dangerous and that the company marketed the drug to the public anyway … Merck argued that Mr. Grossberg's previous artery blockage was the cause of his heart attack…[ Wall Street Journal; $$$; ANDREW SIMONS]
8/1 Vioxx: One Trial Begins One About To End;
both lawsuit patients had preexisting cardiac disease; one long-term Vioxx user, one sporadic Vioxx user:
Opening arguments begin in Vioxx trial … second federal plaintiff to claim that the painkiller Vioxx caused a heart attack was a fit retired FBI agent who watched his diet, exercised regularly … heart attack, followed by a 5-way bypass operation, on Sept. 6, 2002. He was 58 and had taken Vioxx for 31 months. He continued to take it until one week before Merck pulled it from the market .,..[ AP/BusinessWeek; JANET McCONNAUGHEY[
Jury hears closing arguments in California Vioxx trial … first Vioxx liability lawsuit to go to trial in … three prescriptions of 30 Vioxx pills each in the two years before his heart attack in September 2001…[ AP/Newsday; Alex Veiga]
Editor's Note: Above cited trial was 8th to be heard in the United States.
7/20 Vioxx Whistleblower claims he was target of smear campaign:
Lawyer : FDA, Merck collaborated to discredit Vioxx whistleblower … A federal health official worked with drug maker Merck to discredit a government whistleblower who publicized safety risks associated with the painkiller Vioxx, a lawmaker alleged Wednesday in seeking an investigation … [ Barre Montpelier Times]
7/14 Merck Celebrates Vioxx Lawsuit Victory
Latest Vioxx Win Justifies Merck Strategy … Merck & Co.'s victory Thursday in the latest Vioxx trial buttresses its strategy of fighting lawsuits over the withdrawn painkiller one by one, but with lawsuits mounting past 16,000, the company must broach a global settlement at some point, experts said Friday …[ AP][ AP/Newsday ]
7/13 Merck Looses NJ Vioxx Trial
Jurors Rule for Merck in N.J. Vioxx Case … Merck & Co. won a crucial legal victory on Thursday, when jurors decided that the drugmaker's Vioxx painkiller, now the subject of at least 16,000 product liability lawsuits, did not …[ MSN]7/11 Vioxx Trial Jury Gets Complex Legal Instructions
Vioxx trial jury instructions delay closing arguments … ATLANTIC CITY -- Closing arguments in the state's latest Vioxx trial, pitting drug maker Merck & Co. against a 68-year-old heart attack survivor, were delayed until today as lawyers on Monday continued to hash out specific instructions the jury will get before deliberations. .,..[ NJ.com]
7/10 Vioxx Lawsuit Heads To Conclusion
Closing arguments in NJ Vioxx trial now seen Tuesday
ATLANTIC CITY, N.J. (MarketWatch) -- Closing arguments are expected to get under way Tuesday morning in a trial in which a woman claims her use of Merck & Co.'s (MRK) Vioxx painkiller caused her 2004 heart attack.
Unlike previous Vioxx cases in New Jersey, the jury will get to decide whether Merck failed to warn consumers about Vioxx's cardiovascular risks in its advertising …[ Market Watch]
2/14 Merck Pleads - One At A Time:
Merck: Vioxx Cases Shouldn't Be Combined … Merck & Co. has filed a motion opposing a judge's plan to consolidate two Vioxx cases into one trial, saying their differing circumstances would make for a "Frankenstein's monster" of a case for jurors to consider …[ AP/Yahoo; John Curran]
2/8 Vioxx: Plaintiff Strategy Flip-Flop:
Slam Marketing 1st, Hit Science 2nd;
Lawyers Switch Tactics for Vioxx Retrial … working to convince jurors that manufacturer Merck & Co. ignored safety in favor of sales, rather than opening with medical testimony …[ AP/Yahoo; Janet Mcconnaughey]
2/7 Vioxx Retrial Begins; Elderly Overweight Heart Patient's Wife Says 1-month of Vioxx Pills triggered fatal event:
Jury seated in retrial of federal Vioxx case … Merck & Co. argued that Richard "Dicky" Irvin's heart attack was 30 years in the making, caused by a buildup of plaque in the blood vessels … [ AP/Newsday; JANET McCONNAUGHEY]
Vioxx Retrial Opens in New Orleans … Attorney Andy Birchfield told two parallel tales of Merck's actions and the Mr. Irvin's life. He said that the drug maker "played fast and loose with the science," misled the medical community …[ Wall Street Journal; $$$; HEATHER WON TESORIERO ]
2/6 Vioxx: Judge Blocks Plaintiff Expert From Testifying
Judge: Doctor Can't Testify in Vioxx Case ... Not Qualified to Testify
That Vioxx Caused Blood Clots ... no pharmacology training ... never
prescribed it, and got most of his knowledge about the drug in an
eight-hour review of medical articles ...[ AP/Yahoo; Janet
Mcconnaughey]
3/12 Vioxx Trial: Cardiologist Testifies
That Merck Distorted Data
Cardiologist testifies Merck withheld data … Topol, who left the Cleveland Clinic this year to join the faculty at Case Western Reserve University in Cleveland, has published 16 articles and editorials criticizing Merck's marketing of Vioxx. …[ Bloomberg/Boston Globe]
See Also> Similar Report From Reuters
3/12 Vioxx: Plaintiff Testifies: Obesity, Ditched Cholesterol Medicine, Vioxx Therapy Duration Sketchy
Vioxx plaintiff says had pre-heart attack ailments … been 20 to 30 pounds overweight, had an elevated cholesterol level for which he was prescribed medication, and a history of sleep apnea, which can deprive the body of oxygen… [ Reuters; John Hurdle]
Plaintiff takes stand in Vioxx trial … lost 22 pounds in the three months before the heart attack, suffered from sleep apnea and had been diagnosed with high cholesterol but only filled the prescription he was given for it once …[ AP/BusinessWeek; JOHN CURRAN]
3/8 Vioxx Plaintiff Lawyer Tries To Refocus Jury away from plaintiff's medical condition onto Merck sales & marketing:
Merck Exec. Acknowledges Market Pressure … Lanier said Merck's development and testing of the drug was dominated by marketing concerns … lived with heart disease risk factors but wasn't stricken until he began taking Vioxx … [ AP/MSN ]
Merck rushed Vioxx development, court told …hired its biggest-ever sales force, spent $1 million on a launch party at which containers of Vioxx were presented to guests on silver platters ...more free samples than for any previous product …[ Reeuters/MSN]
3/7 Vioxx Lawyers Face-off
Merck tried to hide Vioxx risk, attorney charges … repeatedly used a graphic of a man standing near the edge of a cliff, and claimed that Vioxx pushed users over the edge when combined with other cardiovascular risk factors such as age, weight and cholesterol… [ Reuters; Jon Hurdle]
See Also> Similar Report From AP/Yahoo
3/6 Vioxx Lawyer: He Won Once; Will He Do It Again?
Length of time using Vioxx seen key in Merck trial … Merck & Co. faces the lone lawyer who has beaten the company in one of these cases -- this time representing two long-term users of the painkiller who say it caused their heart attacks…. [ Reuters; Anna Driver]
3/2 Vioxx #6; Lawyers Begin Pre-Trial Hype
as 10-person jury is seated
Casino workers hold the cards in next Vioxx case; openings Monday … Cona, 59, of Cherry Hill, and John McDarby, 77, ... say it was Vioxx that caused them to be stricken … also contend that Merck failed to warn consumers about Vioxx risks it knew or should have known …[ AP/Newsday; Kevin Freking]
2/27 Chess Clocks To Limit Vioxx Testimony
Time Limits Planned for Next Vioxx Trial … will use tabletop clocks -- activated manually, each time one side or the other puts a witness on the stand … Judges move cases along, that's their function. But I've never heard of having to punch a clock. …[ AP/Yahoo; John Curran]
2/22 Long-Term Vioxx User Lawsuits coming up:
Merck long-term Vioxx users seen as next hurdle … first trial involving long-term Vioxx use comes up in New Jersey, in a trial expected to begin Feb. 27 involving two Vioxx users who took the drug for 25 months and 49 months… [ Reuters; Kim Dixon]
Editor's Note: Adds analyst comments regarding ramifications of prevailing in short-term versus long-term claims.
2/20 Merck Wins Another Vioxx Trial; heart disease patient who took Vioxx short term:
Merck Wins Retrial of First Federal Vioxx Lawsuit … too soon to say Merck has momentum ...Many people felt the Irvin case was a weak case to begin with. It was a short-term usage case…[ Bloomberg; Sophia Pearson]
See Also> Similar Report From AP/Newsday
2/6 Vioxx: Trials Delayed
Two U.S. Vioxx trials delayed as retrial looms … Diaz trial, originally set for March 13, will be rescheduled for a date in May, Jarrell said. The Borowicz trial has been rescheduled for June 12 from April 3 … [ Reuters ; Ransdell Pierson and Bill Berkrot]
1/27 Editor's Choice: Vioxx Trial From 30,000 Feet;
WSJ publishes the best Vioxx we've ever read in 2 years
Defending Multiple Vioxx Cases Is Costly Burden for Merck … So far, the company hasn't used the same trial team twice and appears to be still auditioning lawyers … no one expects all of the more than 9,200 Vioxx cases that have been filed against Merck to go to trial…[ Wall Street Journal; $$$; HEATHER WON TESORIERO ]
Editor's Note: Above report contains eloquent synopsis of the next 7 trials; start dates, venue, alleged injury ( heart attack, death, etc), how long the plaintiff took the pills.
Editor's Note: Adds medical history of latest plaintiff ( 20+ years of cardiac disease), plaintiff's glib opening statements, review of Merck legal strategy, prediction of Merck's final costs.
1/26 Vioxx Trial #4: He Said, She Said;
All Comes Down To "How Many Pills Did the Dead Guy Take?"
Lawyers Argue Cause of Death in Vioxx Case … seeking $1 billion in punitive damages … Garza's family says doctors gave him more than a month's supply, while Merck contends he only had a week's worth … [ AP/MSNBC ]
1/26 The Other Vioxx Trial; Judge Allows Into Evidence NEJM Emails that bolster Merck's defense;
Court Releases Journal's E-Mails on Vioxx … Curfman and managing editor Stephen Morrissey wrote, among other things, that the authors slanted their explanation of why people taking Vioxx had more heart attacks than people who took the other drug used in the test …[ AP/Yahoo; Janet Mcconnaughey]
1/11 Vioxx Plaintiff #4 Had Previous Heart Attack, 23-years of heart disease under belt:
Second Texas Vioxx trial slated for January … Garza had a 23-year history of cardiovascular disease and had suffered a prior heart attack. … one-week supply of Vioxx 25 milligram samples … one month before his death… [ Reuters ]
12/9 Vioxx Trial #3 Comes To Speedy End;
jury begins deliberation
Attorneys give closing arguments in federal Vioxx trial … Jurors began deliberating Thursday afternoon … whether Merck failed to warn Irvin's doctor about Vioxx risks, whether the painkiller was defective and whether Merck was negligence…[ AP/Newsday; ANGELA K. BROWN]
Texas jury gets federal Merck Vioxx case … The 53-year-old Florida man had taken the drug for less than a month… [ Reuters/Yahoo ]
Editor's Note: Adds that verdict of nine member jury must be unanimous.
12/8 Merck Science Exec Denies Wrongdoing Regarding Vioxx; Influential cardiologist claims chronic heart disease caused death
Executive denies Merck misled doctors about Vioxx risks … head of Baylor College of Medicine's pathology department, testified for the defense Wednesday that Irvin's sudden death was caused by plaque that ruptured in an artery …[ AP/Newsday ]
*************************************************
Here is a detailed explanation of the issues surrounding Vioxx written by a prominent injury attorney from New Your City:
By repeatedly vouching for the safety of its highly profitable NSAID painkiller, Vioxx (despite credible medical and scientific evidence it had in is possession to the contrary) the pharmaceutical giant, Merck & Co. ("Merck"), appears to have been disrespectful of the truth.
Merck's lack of candor, throughout this latest episode of a "miracle" drug gone bad, is an example of the process by which pharmaceutical manufacturers manipulated and exploit scientific data in order to market a prescription drug.
In our action against Merck, we shall endeavor to prove that the pharmaceutical industry in general and Merck in particular:
- Withhold or otherwise concealing critical research or clinical data from the public prior to securing FDA approval.
- Rush drugs to market before any long-term side effects can be identified or studied under controlled conditions.
- Spend enormous sums of money ($3.8 billion annually) on Direct to Consumer Advertising (DTC) that utilize everything from celebrity spokespersons to famous rock and roll songs from the 1960s and 1970s to encourage patients to demand specific drugs from their doctors without regard to the serious risks associated with those drugs.
- Engaging in damage control designed to minimize liability while maximizing profit retention.
Much has been written about the rush to market new drugs before they are adequately tested and well before their long-term effects are known.
We endeavor to prove that Vioxx, represents one of the most extreme cases of a drug which never should have been marketed.
The evidence to support this conclusion is extensive and compelling. Most experts familiar with the history of Vioxx from either a medical or business perspective were not surprised by Merck's sudden withdrawal of the drug from the market.
Merck marketing campaign goes full force despite data indicating COX-2's posed a cardiovascular risk:
Between January 2003 and June 2004, Merck & Co. spent almost $123.9 million dollars in DTC advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems.
Celebrities, like Olympic figure skating champion Dorothy Hammil, pitched the drug in carefully orchestrated commercials set to The Rascals' 1968 hit "Beautiful Morning."
This aggressive advertising campaign continued although Merck, the FDA, and many highly respected medical experts were aware that the drug was considerably more dangerous than the public knew or even suspected.
Merck refused to acknowledge the significant (heart-related) danger Vioxx posed. To the contrary, Merck was always committed to obtaining approval for wider applications for the drug.
On September 8, 2004, only three weeks before Vioxx was pulled from the market, the FDA approved the use of Vioxx in the treatment of rheumatoid arthritis in children as young as two.
Chronology of events shows the troubling sequence of events that was occurring while Vioxx generated sales in the billions of dollars for Merck:
November 23, 1998:
Merck submitted its New Drug Application (NDA) to the FDA.
April 20, 1999:
The Advisory Committee on Arthritis Drugs (FDA) met to review Vioxx.
May 20, 1999:
The FDA approved Vioxx for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis. (The original safety database included approximately 5,000 patients on Vioxx and did not, according to Merck, show an increased risk of heart attack or stroke).
October 8, 1999:
Merck updated the Vioxx package insert.
November 18, 1999:
A meeting of the Data and Safety Monitoring Board (DSMB) concerning the Vioxx/VIGOR study (in which all voting members of the committee were to be independent from Merck) took place at which the Board discussed its concerns over the "excess deaths and cardiovascular adverse experiences" that was observed in the group using Vioxx as compared to the patients who were taking Naproxen.
April 2000:
The FDA required Merck to add labeling information about a possible link to possible increased heart attack and stroke risk.
June 2000:
Information was presented at the European United League against Rheumatism, of which Merck is a member and corporate sponsor, which demonstrated a statistically significant increase in hypertension and myocardial infarction.
June 2000:
The VIGOR study (sponsored by Merck) was submitted to the FDA (VIGOR - Vioxx® Gastrointestinal Outcomes Research which is the same study that gave rise to the lengthy memorandum by Dr. Targum, referred to below). The study was primarily designed to look at side-effects such as stomach ulcers and bleeding. It showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking Naproxen.
February 8, 2001:
The VIGOR study was discussed at an FDA Arthritis Advisory Committee meeting. The Committee was specifically concerned with the unexpected findings of potential cardiovascular risks and myocardial infarctions associated with the use of Vioxx as opposed to the side effects (stomach ulcers and bleeding) that the VIGOR study was aimed at.
February 1, 2001:
Dr. Shari L. Targum, submitted a memorandum with respect to her review of the available data concerning Vioxx. Dr. Targum was a Medical Officer in the FDA's Division of Cardio-Renal Drug Products. The 37-page memorandum documented the serious cardiac events, myocardial infarctions, and related deaths for participants in the VIGOR study who had used Vioxx. She indicated that as early as November 18, 1999, the VIGOR Data and Safety Monitoring Board had discussed the "excess deaths and cardiovascular adverse experiences" in the group using Vioxx.
April 2001 Public Citizen advised the public not to use Vioxx because of potential heart-related risks. Merck continued to minimize this risk in its advertisements.
May 22, 2001:
Despite the mounting evidence of the association of Vioxx to strokes and heart attacks, Merck issued a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx", also claiming Vioxx has a "favorable cardiovascular safety profile"
June 16, 2001:
Merck issued another press release (released in Europe), entitled "Vioxx Similar to Placebo and Three (3) Widely Prescribed NSAIDs Regarding Cardiovascular Events".
July 11, 2001:
Merck again modified the package insert for Vioxx.
August 22, 2001:
A study published in the Journal of the American Medical Association (JAMA) by Drs. Mukherjee, Nissen, and Topol, researchers from the Cleveland Clinic, indicated that Vioxx was linked to a 200% increase in blood clots, heart attacks and strokes based on their review of previous clinical trials.
September 2001:
The American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke.
September 17, 2001:
The FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found:
"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."
The FDA demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses and found after a review of several of Merck's promotional conference calls and sales pitches, that the promotions by Merck "are false, lacking in fair balance, or otherwise in misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations," It also required Merck to send letters about the deception to the medical community.
November 2001:
Public Citizen publishes information concerning the FDA warning letter. At this time, Merck was also aware of increased risks of thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs, hypertension, and altered kidney function.
April 11, 2002:
The FDA instructed Merck to include in the package insert certain precautions based on results of the VIGOR studies. The possible link to high blood pressure and an increase in the risk of heart attacks were to be added.
April 11, 2002:
Merck announced that it had added rheumatoid arthritis to the list of approved uses for Vioxx.
August 2002:
Drs. Topol and Falk published an editorial in The Lancet encouraging further warnings and labeling regarding the cardiovascular effects of COX-2 inhibitors. Kaiser Permanente, the largest HMO in the United States, found the incidence of sudden cardiac death to be three times greater for Vioxx than Celebrex among its patients. Cigna Health Care regarded Vioxx as a "non-preferred medication" for its policy holders.
Aetna, Inc., the third largest health insurer in the United States, announced that Vioxx was the subject of an ongoing study and recommended "alternative drugs" be prescribed in its place.
October 5, 2002:
A study done at Vanderbilt University, and published in The Lancet, noted that patients taking 50mg. of VIOXX for more than 5 days demonstrated a 70% greater likelihood of developing coronary heart disease (CHD).
Despite requests from the American Heart Association, the National Stroke Association, and the Arthritis Foundation that Merck conduct additional safety studies, Merck claimed that Vioxx was safe and that it did not plan to conduct any such study.
Early 2004:
A study, which was funded by Merck, disclosed that Vioxx posed a risk of heart attack and stroke which was three times greater than that of other COX-2 pain relievers. Shockingly, when this finding was made, Merck had the name of its scientist removed from the list of authors on the study.
April 2004: A study published in the journal, Circulation, observed an elevated risk of hospitalization for acute myocardial infarction (AMI) among elderly Medicare enrollees treated with rofecoxib. This risk was higher in persons taking >25 mg of rofecoxib than in patients taking the most common dosages used of 25 mg. The risk was elevated during the first 90 days of exposure but not thereafter.
August 2004:
At the annual meeting of The International Society for Pharmacoepidemiology, in Bordeaux, France, new data from a trial sponsored by the FDA indicated that patients taking 25 mg or more of Vioxx per day had a risk of experiencing AMI or sudden cardiac death more than three times greater than patients taking non-selective NSAIDs.
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About the author: Jerrold S. Parker Esq. limits his practice to cases regarding drug and medical device liability. He has most recently appointed to the Plaintiff's Steering Committee in the Zyprexa Products Liability Litigation (MDL # 1596). He makes frequent appearances on television shows such as Court TV and Good Day New York.
See Also: YourLawyer.com; extensive database of data and case-law regarding drug liability actions .
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