Chicago Injury Law Blog

A recent ruling by Texas state court Judge Randy Wilson may be the end of nearly 1000 Texas Vioxx cases. The ruling was based on a recent FDA Administrative Rule which effectively preempts all state law failure to warn claims.

Read more at WSJ.com.

"The high-profile trial over Vioxx late last month in Madison County was just an early skirmish in what could be years of litigation here and elsewhere over Merck & Co.'s once highly touted painkiller.

The jury, after a month-long trial, rejected pleas to slap Merck with tens of millions of dollars in damages for the 2003 death of a Granite City woman who spent 20 months on Vioxx.

Though the drugmaker's lawyers celebrated their win in a county with a reputation for being unfriendly to corporate defendants, they'll be back soon for the next Vioxx trial in Madison County, scheduled for September.

Two Vioxx trials are also set for December in the county, according to Merck's trial calendar, but those would probably be pushed off. A fourth was slated to face a jury in October but was transferred to Chicago."

Read the full article in the St. Louis Dispatch.

Merck pulled off another victory in federal court recently, with the New Orleans jury finding that Vioxx did not cause a 64 year-old's heart attack after taking VIoxx for ten months. The case took a bad turn for the plaintiff when he testified that he had stopped taking Vioxx about four days before his heart attack.  He had maintained that he was on Vioxx continuously for 10 months before the event up until his testimony. A handful of trials in federal and New Jersey state court are slated for the new year.

Judge Eldon Fallon threw out the jury's $50 million dollar compensatory verdict in the recent federal Vioxx case.  Finding that no reasonable jury, absent passion or prejudice, could find $50 million in compensatories for the plaintiff.  Compensatory damages include items such as past and future medical bills, past and future lost wages, loss of normal life, loss of society. Considering only compensatories, the $50 million seems excessive.
However, this is a clear indication that the jury found Merck's conduct so reprehensible that they awarded an amount in excess of the plaintiff's actual damages. Judge Fallon refused to overturn the jury's finding that Merck negligently failed to adequately warn of Vioxx's risks and knowingly withheld information regarding the drugs risks from the FDA and consumers.  
Consistent with federal law, Judge Fallon threw out the punitive verdict of $1 million along with the compensatory award. As the damages portion of the case is retried, I would forcast that the compensatory amount will be considerably less, and the punitive award to be considerably more.

Read more here.

On the same day a jury in federal court awarded Vioxx plaintiff $51 million, New Jersey state court Judge Carol Higbee  threw out the verdict for Merck from the November of last year. Citing new evidence, including the fact that Merck withheld crucial data from the VIGOR study and new deposition evidence, Judge Higbee awarded the plaintiff's request for a new trial. This second victory for those injured by Vioxx brings the win-loss tally to 4 and 4.

In a monumental victory for those injured by Vioxx across the country, a jury awarded Mr. Gerald Barnett $50 million in compensatory damages, and an additional $1 million in punitives damages. Mr. Barnett, a retired FBI agent, suffered a heart attack after 31 months of Vioxx use.
The award is especially significant because of the defense attorney that the plaintiff was up against. Phil Beck, out of Chicago, is considered to be the best in these types of cases. He was an integral figure in the Baycol litigation years ago, saving manufacturer Bayer billions in liability.
However, even the mighty Phil Beck could not overcome the weight of evidence against Merck. The jury found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to Gerald Barnett's doctors. In awarding punitive damages, the jury found that Merck "acted in wanton, malicious, willful or reckless disregard for the plaintiff's rights."

"Stewart Grossberg soldiers into a Los Angeles courthouse this week as the latest combatant in a drug litigation war that's made the pharmaceutical industry the nation's No. 1 target of product liability lawsuits.

Grossberg, a retired Northridge construction manager, blames Merck & Co.'s pain reliever Vioxx for a heart attack he suffered in 2001. He is the first California plaintiff among more than 23,500 nationwide to have his suit against Merck go to trial."

Read the full article in the LA Times here.

A recent report on National Public Radio uncovered another disturbing fact in the Vioxx saga. As we know, Merck halted a study in 2004, and withdrew the drug from the market, after researchers discovered an increase in heart attack deaths. However, the cardiovascular risk showed up as early as 1999 in a study that Merck researches decided to continue. Started before the 2001 VIGOR study, results from the earlier study indicated a two fold risk of heart attack.
Not only did Merck continue the study, but they made a concerted effort to downplay the results.

See the NPR transcript here.

A second look at the APPROVe study, which indicated an increased risk of heart attacks and strokes after 18 months of Vioxx use, shows an actual risk increase after only 4 months of use. Researchers reviewing the APPROVe data show an increase in the amount of reported heart attacks after only 4 months of Vioxx use.
Of course this strikes at the very core of Merck's key defense: that the increased risk of cardiovascular events only arises after 18 months of Vioxx use.
The papers lead author, Dr. Bresalier, stood by the articles main results, but said that researchers did not find the 18-month threshold critical. Only Merck thought this to be especially significant. "Of course they (Merck) want to minimize their liability," was Dr. Bresalier comment in reponse to Merck's playing up the 18-month data.

"Painkillers called COX-2 inhibitors may increase the risk of heart attacks by raising blood pressure and making the blood more likely to clot, researchers said on Thursday.

They do so by the same mechanisms that they use to reduce pain and inflammation, said University of Pennsylvania School of Medicine researcher Dr. Garret FitzGerald, who led the study.

But the finding shows that a new generation of anti-inflammatory drugs could avoid the problem, FitzGerald reported in the Journal of Clinical Investigation."

Read the full article from Reuter's here.

A Texas state jury awarded $7 million in compensatory damages and an additional $25 million in punitive damages to the family of a 71 year old man who died of a heart attack after one month of Vioxx use. The jury found that Vioxx caused the man's heart attack, and that Merck willfully withheld important information regarding the drug's cardiovascular risks from the FDA, doctors, and the American public.
This brings the scorecard to 3 wins and 3 losses for Merck, with many more trials to come.
The important thing to note is that with all plaintiffs' victories, the jury awarded punitive damages against Merck.

Read more here.

The same jury that found Merck failed to properly warn and committed consumer fraud in two Vioxx cases last week, awarded $9 million in punitive damages as punishment for Merck's malfeasance.

In the 'two trials in one' last week, the jury held Merck accountable for failing to timely warn of Vioxx's cardiovascular risks, finding that Vioxx was a substantial cause in one plaintiff's heart attack and awarding him $4.5 million in compensatory damages. The jury did not find that Vioxx caused the second plaintiff's heart attack, and awarded him only $45 for the cost of Vioxx prescriptions.

Under new tort reform laws in New Jersey, punitives are decided during a separate trial. Punitives may be awarded only if the jury finds that Merck intentionally withheld information from the FDA. No drug company has ever had punitives awarded against them since the new tort reform law was enacted.

As the jury found, even under the most stringent standard for proving punitives, Merck willfully withheld crucial information from the FDA, doctors and consumers that may have prevented tens of thousands of heart attacks.

The verdict forms are reprinted below:

Question: Has the plaintiff proved by clear and convincing evidence that Merck knowingly withheld or misrepresented information required to be submitted to the FDA under the FDA regulations which information was material and relevant to the harm in question?

Answer: Yes.

Question: Has the plaintiff proven by clear and convincing evidence that Merck's actions show a wanton and willful disregard of another's rights so as to justify an award of punitive damages?

Answer: Yes.

Question: What amount, if any, of punitive damages should be awarded?

Answer: $9 million.

Read more here.

The second New Jersey state trial, involving two plaintiff's cases in the same trial, ended yesterday with the jury finding that Merck failed to properly warn of Vioxx's risks of heart attack and stroke. The jury awarded the 77 year old plaintiff $4.5 million in compensatory damages, finding that Vioxx substantially caused his heart attack. The jury only awarded the 60 year old plaintiff in the trial $45, compensating him for money spent on Vioxx prescriptions. The nominal amount was awarded as the jury found that Vioxx was not the cause of the 60 year old's heart attack.

This is a big victory for those injured by Vioxx across the country. Not only did the jury find that Merck failed to properly warn of the cardiovascular risks of Vioxx, but they found the drug to be a substantial cause of a 77 year old's heart attack; a man who suffered from diabetes and had many other complicating risk factors in his medical history. This finding could not have been more correct. People with risk factors for heart attack and stroke are exactly the group that should not have been on Vioxx, and if Merck would have acted responsibly and timely warned people of the dangers, many lives would have been saved.

Under New Jersey law, a separate trial immediately begins to determine if Merck's actions should be punished, and if so, the amount of punitive damages to award.

The fourth Vioxx trial began today in a Starr County Texas state court. The case involves the late Loenel Garza, a 71 year old man who died of a massive heart attack in 2001. Mr. Garza took samples of Vioxx for about a month before the heart attack, and was told after a stress test shortly before his death that he had a 2% chance of dying from a heart attack.
To further bolster the plaintiff's case, emails where recently released by the editor for the New England Journal of Medicine regarding Merck's failure to report 3 heart attacks to the VIGOR study in 2001. Merck blamed the 4-5 fold increase in heart attacks on the prophylactic effect of naproxen, a comparative drug used in the study. An excerpt from one of the emails reads "[y]our explanation lacked scientific objectivity, the relative risks [of Vioxx and heart attacks] were presented so as to favor naproxen and discount the possibilty that [Vioxx] might be harmful."

The Texas trial is expected to last into March.

Judge Eldon Fallon, the presiding judge in the federal Vioxx litigation, set the Vioxx retrial for February 6 in New Orleans. The last trial, held in Houston, ended in mistrial after the jury could not come to an unanimous verdict after 18 hours of deliberation.
Plaintiffs in the February trial will be able to present evidence of the recent New England Journal of Medicine report that Merck withheld reporting 3 heart attacks from the VIGOR study back in 2001.

A recent study study performed by a Danish University supports the link between Cox-2 inhibitors and heart attacks. Taking Cox-2's and high doses of NSAID's after suffering a heart attack raised the risk of death as much as 5 times.
The study was presented at the annual meeting of the American Heart Association. The study showed people taking 25mg of Vioxx had a 5.03 ties greater risk of dying. Celebrex users of 200mg or more a day had a 4.24 times greater risk.
The study may be found here.

The first federal Vioxx lawsuit ended today in a mistrial. U.S. District Court Judge Eldon Fallon declared a mistrial after the jury could not reach a required unanimous verdict after 18 hours of deliberations. The nine person jury recessed on Saturday with five votes for the Plaintiff and four for Merck. Judge Fallon that the jury deliberated for a reasonable amount of time and entered the mistrial. The parties meet next week to determine the next trial date.
Although not a victory for the Plaintiff, it is clearly a blow to Merck's momentum after their victory in New Jersey. The plaintiff in this case used Vioxx intermittently for only 28 days before the heart attack, and is considered a weak case for the Plaintiff. Considering the recent news of even more Merck malfeasance, the added evidence could tip the scales in favor of the Plaintiff.

Judge Higbee set a Jan. 30 trial date for the next New Jersey lawsuit against Merck & Co. over its once-popular painkiller Vioxx. After a daylong closed-door hearing with lawyers, Superior Court Judge Carol Higbee narrowed the list of potential cases to go to trial on that date to seven. In each, the plaintiffs are New Jersey residents who suffered heart attacks after taking the drug for 18 months or longer. One of the heart attacks was fatal. More than 3,400 cases blaming Merck for Vioxx-related injuries have been filed in New Jersey and all are consolidated under Higbee.
The first federal trial began in early November in Houston. That trial should finish before the new year.

It is no wonder that Plaintiff Mike Humeston lost in his trial against Merck on Friday. Recent comments by the jurors in the trial indicate that corporate deception is not only common place, but accepted as part of business. The following is an except from the Wall Street Journal:

Juror Marie Kerr, a 51-year-old administrative assistant, said she and other jurors read through the emails while deliberating and felt many of the inflammatory lines were taken out of context.

"We read the emails completely, and not just the part that said 'bastards,' " she said. Ms. Kerr also said she wasn't moved by a Merck document titled "Dodgeball" that Mr. Seeger portrayed as a way to teach sales representatives how to avoid questions about heart attacks. "We've all seen games like dodgeball at our work," she said.

Overall, Merck succeeded in persuading jurors that concerns voiced by Dr. Scolnick and other executives were a normal part of the scientific process of discovery and of safety investigations. Vickie Heintz, a 40-year-old juror, said she felt Mr. Seeger "cherry picked" a few select emails and tried to impugn the company with them.

Ms. Heintz said she wasn't bothered by Merck's aggressive marketing of Vioxx or documents that showed the company calculating the loss in profits if the warning label was changed to reflect increased risk of heart attack. "Medicine is business," she said. "If I had a business I would calculate what the loss of one of my big products would mean...This is about making money. Merck doesn't do this because they are flower people."

Another juror, Patricia Harley, 44, said: "If someone peeked through all my emails, forget about it."

I do not question the result the jury found in this case. However I must comment that their statements afterwards are a terrifying wake up call to all Americans of the moral decline in our country. That a company's malfeasance is quickly justified by comments like "Merck doesn't do this because they are flower people" and "[w]e've all seen games like Dodgeball at our work" is scary to say the least.

In a stunning defeat for those all those injured by Vioxx across the country, a jury in New Jersey state court found against plaintiff Mike Humeston in the second Vioxx trial in the country. The jury voted 8-1 that Merck did not fail to warn of the known cardiovascular risks of Vioxx. The jury voted unanimously that Merck did not commit consumer fraud, and neither concealed nor misrepresentated the known dangers associated with Vioxx.
The verdict is a surprise considering the FDA did everything short of telling Merck that they failed to warn of the cardiovascular risks associated with Vioxx.
After following the trial for most of the last seven weeks, it is safe to say that Merck successfully employed a strategy of attacking the plaintiff's character versus explaining the science. You might remember the last trial that Merck lost. Many people opposing the verdict cited the juries inabililty to understand the science behind the drug. Conservative groups rallied to the tune of discarding the trail-by-jury system for civil trial, stating that juries are incapable of understanding complicated cases and properly dispensing justice. No doubt these same people will be touting the recent verdict as a triumph of the jury system.
Regardless of the result, our Seventh Amendment right to trial-by-jury should be exahlted.

Last month, Merck attorney stated that they would consider settling some Vioxx cases. Falling short of a global settlement, Merck will look at cases where plaintiffs took Vioxx for long periods of time (i.e., 18 months or longer) and indicated little risk for heart disease. To date, no settlements have occurred. However, considering the fact that potentially 100,000 Americans suffered heart attacks as a result of Vioxx, the settlements are inevitable.

Read the full article here.

The recent punitive damage award in the Vioxx case was $252 million. This amount will be reduced by Texas law to about $1.6 million. Punitive awards are in place as a punishment and deterrant. When federal and state legislation fails, civil trials hit companies for their malfeasance where they really feel it; their pocket books.
So what does $1.6 million mean to Merck? Very little. An excellent breakdown of Merck profits over the years can be found here.

A Texas jury of twelve men and women recently awarded $253 million to the widow of a man whose death was contributed to by Vioxx. The verdict is a victory for all consumers put at risk by drugs that are improperly tested, marketed and absent warnings. However, proponents of tort reform use the verdict as an example of “jackpot justice.” This is the idea that huge awards are handed out to unworthy plaintiffs. The truth is verdicts like these are almost always reduced, sometimes to the extent that it is questionable whether justice is served at all.
Consider closely the Vioxx verdict. The jury awarded $450,000 in economic damages for the deceased lost pay. $24 million for mental anguish and loss of companionship awarded to the widow for the loss of her husband. Finally, $229 awarded in punitive damages, designed to punish Merck for acting irresponsibly in testing and promoting Vioxx. It is important to note that the punitive award is the exact amount that Merck saved in delaying updating Vioxx’s warning label of cardiovascular risks. Merck contested the FDA’s request to update the Vioxx label, delaying the update for seven months in 2002 by inundating the FDA with irrelevant studies and paperwork. The estimated amount that Merck saved by this delay is the exact amount of the punitive award.
Due to tort reform laws in Texas, this punitive award will by reduced to $1.6 million. Considering Merck’s revenue is in the billions of dollars, the $1.6 million is the monetary equivalent of a $30 parking ticket.

The jury is selected and opening statements have begun in the second Vioxx trial. The trial is in New Jersey state court, the first of nearly 2,500 cases pending there.
The Plaintiff is Frederick "Mike" Humeston who suffered a heart attack after taking Vioxx for pain stemming from a Vietnam War wound.
Just like the case in Texas, there are some difficulties with the case. Mr. Humeston suffered his heart attack after taking the drug for two months. The largest studies involving Vioxx and cardiovascular risks show an increased risk of heart attack after being on the drug for 18 months.
This trial will be unique in that camaras and audio equipment will be allowed in the courtroom.

In spite of the recent victory for Vioxx plaintiffs in Texas, Merck continues to flirt with the idea of returning Vioxx to the market. The FDA will only allow this if the drug's use is limited and heavy warnings are added to its label.
The problem is the real reason Merck may return the drug to the market is so that plaintiff's attorney may not use the withdrawal of the drug from the market as ammunition for their courtroom arguments. In reality, the overall effect of plaintiff's arguments would be effected little. However, the risk the drug may pose to citizens if it is returned to the marketplace is significant.

Read the full article here.

Justice was served in Texas today. The jury in the first Vioxx case to go to trial awarded $253 million to the wife of the deceased marathon runner, Robert Ernst. This award included $229 million in "exemplary" or punitive damages, sending a clear message to Merck that the public will not stand for the harm caused to potentially tens of thousands of Americans. The $229 million awarded in punitives is the exact amount Merck saved by delaying the warning label update for nearly seven months after the FDA's request. Unfortunately, this punitive award will be reduced under Texas law to twice the amount of economic damages awarded plus $750,000 or about $1.65 million.
Mr. Ernst died of an arrythmia that the jury found was caused by a heart attack. He was in excellent health, and was only married to his wife for four years before his death.
This verdict is excellent news for all Vioxx plaintiffs across the country. It is the first step in forcing Merck to account for the damage caused by their defective drug and deceptive marketing practices.
Merck of course continues to run from responsibility, and vows to appeal the decision.
A clear breakdown of the verdict can be found here.

In 2001 Merck had a dilemma on its hands. A study indicated Vioxx's three-to-five fold increase in the risk of heart attack and other serious cardiovascular events. Doctors were asking questions. Why should they prescribe this drug if there are so many risks associated with the drug? Merck responded by arming their sales force with a pamphlet called "Dodge Ball". The pamphlet included information on how to respond to these doctors' questions while avoiding Vioxx's real risks.

Today there is no way for Merck to dodge the thousands of people that Vioxx has harmed.

A copy of the pamphlet is found here. Be prepared to be infuriated.

A Texas state court of appeals ruled in favor of the plaintiffs last week in the first Vioxx trial in the nation. The interlocutory appeal (an appeal taken before the end of a trial) was filed last week in an attempt to prevent testimony from going to the jury from the coroner who performed the autopsy. The Coroner, Dr. Araneta, did not mention any blood clots in the autopsy report or death certificate. However, she testified on behalf of the plaintiffs that a clot more likely than not caused the arrythmia that ultimately killed the plaintiff.
Merck attorneys appealed the decision to the Texas Supreme Court on Friday.

Read the full article here.

The jury selection process, called voir dire, began today in the first Vioxx trial. The Texas state trial should last weeks. The fate of many Vioxx cases will be determined by this first case, but there will be many trials to follow over the next year.

Read related article here.

The first crack at Merck goes to attorney Mark Lanier of Houston, Texas, in the first of many Vioxx trials. Lanier represents Carol Ernst, whose husband died of an arrhythmia at the age of 59 after taking Vioxx for about 6 months. A personal trainer and marathon runner, Mr. Ernst clocked 62 miles per hour on his bicycle just eight days before dying of heart failure in his bed.
This is the bellwether case for the some 3,500 Vioxx cases filed against Merck. A victory for Mr. Ernst is a victory for plaintiffs across the country, as Merck will consider settleing other cases if defeated in the Ernst case.
Read full article here.

Documents recently surfaced in the media that indicate Merck took great efforts to silence those scientist who spoke of the cardiovascular risk of Vioxx. An excerpt of a Merck intercompany email indicates that pressures were put on scientists who were critical of Vioxx. The November 7, 2000, email from Merck's medical director goes as follows:

Tell [Dr. Gurkirpal] Singh that we've told his boss about his Merck-bashing... should it continue further actions will be necessary (don't define it).

Dr. Singh is a doctor from Stanford who initially performed as a spokesperson for Vioxx until the VIGOR study in 2000 indicated a serious cardiovascular risk. Dr. Singh changed his opinion of the drug in light of the study, and made it a point to warn of the cardiovascular risks. This prompted Merck's threats to censure Dr. Singh.

Hear the full report on NPR.

The Vioxx litigation turned up another damning document against Merck. The documents from 2000 indicate that Merck scientists were formulating another version of Vioxx that did not have cardiovascular risks. Remember that this is the same time the Merck and its 3000 salespeople were aggresively denying any such risk. It begs the question: if there was not a risk, why were they trying to make it safer?

See full article here.

An article in the Philadelphia Inquirer reported today that a Harvard Professor lecturing in 2000 on the potential dangers of Vioxx received a call from Merck telling him to stop.
Professor Lee Simon got a call from Louis M. Sherwood, at the time a senior vice president with Merck & Co., regarding the Professor's belief that Vioxx caused more strokes than rival drugs. The article explains

To cultivate experts for their products, drug companies often donate to medical schools, finance research, and sponsor conferences, in addition to paying for clinical trials. Each institution has its own guidelines on whether to accept such financial support.
Companies dangle or withdraw the money at any time, but using it expressly to influence a researcher's opinion is considered by academicians a violation of open scientific debate.
In this environment, Merck and G.D. Searle & Co. - later acquired by Pfizer Inc. - went to battle in 1999 over the multibillion-dollar market in pain relievers called Cox-2 inhibitors. Corporate money quickly tinged the scientific debate by casting researchers as protagonists for one product or another.

See full article here.

The federal judge overseeing the consolidated federal court Vioxx cases in New Orleans told plaintiff and defense attorneys that there may be over 100,000 Vioxx lawsuits filed. Judge Eldon Fallon, an experienced mass tort litigation judge, presided over the status hearing where attorneys argued over scheduling and discovery matters. The first Vioxx trials are scheduled to be held in state court. A July trial is set in Texas, followed by an August trial in New Jersey.

Read the full article here.

It is true that statistics can be used to reach almost any desired effect depending on the context of their use. Conceding this fact, the following numbers taken from a brief article in the April, 2005, edition of Popular Science is numbing:

100 Percent increase in risk of heart attack and stroke found in a 2004 Merck-sponsored study of 2,586 patients taking the painkiller Vioxx (MD Anderson Cancer Center)

88,000 Estimated cases of serious coronary heart disease in the
140,000 U.S. caused by Vioxx since its launch in 1999, according to an FDA study

The more lawsuits that are filed on behalf of those injured by Bextra and Celebrex, the more consolidation seems appropriate. A handful of attorneys in Louisiana are asking the JPML to place Bextra and Celebrex cases in with the Vioxx MDL. Learn about MDL's here. This makes sense considering that the drugs work the same way on the body, cause the same types of cardiovascular events, and present similar questions of fact. The unknown is how this will effect the MDL as a whole. Most likely, the benefits of consolidating these cases will be tempered, if not nulled, by the drag of additional cases in an already large MDL. (See Related Article, Nationwide Bextra and Celebrex Lawsuits Requested to be Consolidated and Transferred to Louisiana Federal Court)

Check out this article on Vioxx and an attempted settlement:

Vioxx Settlement Negotiations Fail in an Alabama Case