Litigation Overdose

by Eron Ben-Yehuda
(Los Angeles Daily Journal)

In many ways, Michael Tyus is the worst nightmare for Merck & Co.

The pharmaceutical giant faces hundreds of lawsuits across the country brought on behalf of people who allegedly suffered injury or death by taking the anti-inflammatory drug Vioxx.

In September, Merck initiated the largest withdrawal of a prescription drug in history, citing concern about the results of a new study showing a higher risk of heart attacks and strokes among users.

Tyus, who had taken the drug for three years, had a "minor" heart attack Oct 19, followed by a "massive" one the next day, his attorney Suzelle Smith says.

Until then, Tyus, 46 of Upland, had led an active life.

The Los Angeles Police Department detective had a black belt in karate and had coached his children's soccer teams, Smith of Los Angeles' Howarth & Smith says.

Now, he's "essentially an invalid," she says. Smith expects to file suit against Merck on Tyus' behalf by the end of February.

After Merck yanked its medication, critics leveled the same charges of cardiac dangers against Pfizer Inc. pain reliever Celebrex and related drug Bextra. Both drugs remain on the market although the company pulled their ads pending further study.

After alarm bells also rang out about the risk of Bayer's painkiller Aleve and GlaxoSmithKline's antidepressant Paxil, Fortune magazine summed up the year that was as “Pharma’s Annus Horribilis.”

The right prescription for pharmaceutical's ails may be good lawyering because, among the grim news, Big Pharma did score some notable defense verdicts in 2004. And the tactics used by attorneys who led these companies to victory may offer clues to what could help drug makers succeed in the latest wave of lawsuits.

Allergan Inc. won a trial in a case brought by Hollywood socialite Irena Medavoy, who claimed that the company's wrinkle cure Botox caused her four-month migraine, allover body pain, respiratory problems and fatigue.

Pfizer-owned Warner Lambert defeated a suit brought by three plaintiffs who alleged that the diabetes medication Rezulin caused their liver damage.

And Novartis Consumer Health Inc. beat back a complaint that its cold and allergy medicine containing phenypropanolamine, known as PPA, caused strokes.

Of course, the industry didn't escape last year completely untarnished.

A Texas jury awarded $1 billion, which included $900 million in punitive damages, to the family of a Texas woman who died after taking the Wyeth-made diet drug Pondimin, part of the now-banned weight-loss combination fen-phen.

Probing hard for bias among prospective jurors during voir dire is key, according to Pierce O'Donnell, who successfully defended the Rezulin case.

O'Donnell says he brought up the worst assumptions made against pharmaceutical companies. He asked possible panelists whether they believed that these companies care more about profits than the public's health, for example, by trying to extend their patents while blocking cheaper Canadian imports or generics from competing.

After 2 1/2 hours of questioning, O'Donnell had five of the 30 potential jurors removed for cause because of the prejudice they expressed, he says.

"A sleeper on the jury is devastating to a pharmaceutical company," O'Donnell of Los Angeles' O'Donnell & Schaeffer says.

One juror on the Botox jury nearly cost Allergen its victory.

Medavoy's medical experts blamed Botox at least in part for the woman suffering fibromyalgia, which refers to musculoskeletal pain and fatigue.

One of the jurors had the same illness. During deliberations, the jury asked that he be replaced. Los Angeles Superior Court judge Victor Chavez granted the request without offering an explanation.

According to a press account, one juror said the man removed "didn't even want to consider any of the expert testimony. He said they were all lying."

The jury ended up siding with Allergan md Medavoy's physician, Dr. Arnold Klein, by a vote of 9-3, the minimum required for a victory. If the dismissed juror had stayed, it would have ended as a mistrial.

Allergan co-counsel Ellen L. Darling says the juror revealed his fibromyalgia during jury selection, but she kept him on, anyway.

"Everything he said led us to believe that he would be a fair and impartial juror," Darling of Irvine's Snell & Wilmer says.

Medavoy's trial counsel, Jeffrey S. Benice of Costa Mesa, says, "His dismissal, which we objected to, is going to be an issue on Appeal."

For the Rezulin trial, O'Donnell says he decided not to challenge some jurors who either suffered "freakish" results from drugs or had family members who did.

O'Donnell says he figured that they could better understand an important theme he stressed during trial.

Even drugs that are commonly considered safe, such as aspirin and antibiotics like penicillin, can cause some to have a bad reaction, he says. But O'Donnell argued to the jury that the vast majority of Rezulin takers benefitted from its use.

The jury did find that Rezulin could cause liver disease, but jurors awarded no damages after determining that the plaintiffs' injuries resulted from other factors.

O'Donnell's opposing counsel, Thomas V. Girardi, minimizes the significance of the loss, saying that the plaintiffs had weak claims.

“These cases, quite honestly, didn't mean anything," Girardi of Los Angeles' Girardi & Keese says. "We didn't learn much by it."

He says he represents five plaintiffs who have a better chance of success with their Rezulin cases set for trial in May.

Los Angeles attorney Jan E. Dodd, who successfully defended the PPA case for her client Novartis, echoes the importance of conveying the potential risks of drugs to jurors. Dodd says the first order of business is to explain that "no drug is 100 percent safe, 100 percent of the time for 100 percent of the people."

That argument may work in the Vioxx cases because the drug was so astoundingly popular that even the seemingly large number of suits filed so far, estimated in the hundreds, pale in comparison to its once-widespread consumption.

Twenty million patients in the United States alone took the drug over the five years it was on the market until its withdrawal last year.

But more suits are on the way.

“Each day, we open a new file," Stephen D. Archer of the Los Angeles office of Minneapolis-based Robins, Kaplan, Miller & Ciresi says.

Archer says his firm has taken 50 cases in California alone.

Bruce Fishelman of Santa Monica's Greene, Broillet, Panish & Wheeler says he expects his firm eventually to file hundreds of suits in the Vioxx litigation.

Plaintiffs' lawyers also are gunning for Pfizer because of concerns about the safety of Celebrex.

"It’s clear that we'll be doing some Celebrex [cases]," Fishelman says.

But Celebrex isn't causing as much litigation activity as Vioxx.

Archer says that part of the reason is that allegedly compromising company documents have come to light against Merck, whereas none has surfaced against Pfizer. He says he's also not impressed with the current data on the risk of Celebrex, which so far shows significantly less danger than Vioxx.

The central argument in the Vioxx cases is that Merck was aware of the risks long before the drug was withdrawn but failed to properly warn doctors and consumers while, at the same time, vouching for the drug's safety.

A recently published study sponsored by the U.S. Food and Drug Administration found that as many as 140,000 cases of heart disease in the United States and as many as 56,000 deaths were caused by Vioxx.

"I really think this is a public-health disaster," Archer says.

In November, Vioxx legal conferences held in Pasadena and Las Vegas brought together plaintiffs' attorneys from across the nation to discuss strategies. A website called encourages prospective plaintiffs to receive a free case evaluation.

The site is hosted by the Los Angeles Law Office of Sherman Salkow & Newkirk. Firm Attorney Richard Salkow did not respond to a request for an interview.

Merck reportedly may face as much as $18 billion in liability for Vioxx, according to a Jan. 14 Los Angeles Times article.

Local attorneys representing Merck in the Vioxx litigation, including Michael K. Brown of Los Angeles' Reed Smith and Thomas M. Moore of Los Angeles' Drinker Biddle & Reath, declined to comment.

Ted Mayer of New York's Hughes, Hubbard & Reed, which also is defending Merck, declined to discuss strategies or tactics he plans to use in the Vioxx cases.

In a press release, the company stated, "Merck believes it has strong and meritorious defenses and intends to vigorously defend all of the personal injury cases on an individual basis."

Merck claims that removing the drug wasn't necessary until September, when results of the co-called APPROVe clinical trial showed that, "for the first time, there was an increased risk of confirmed cardiovascular events beginning after 18 months of treatment in patients taking Vioxx compared to those taking placebo," the statement reads.

But plaintiffs' attorneys allege that Merck was aware of the danger at least four years earlier, shortly after receiving FDA approval, but hid the risks while racking up a fortune in sales, $2.5 billion in 2003 alone.

“There were clear alarms, clear warning signs, that should not have been ignored," Fishelman says.

The VIGOR study, released in March 2000, compared Vioxx to naproxen, the generic name for pain reliever Aleve. The use of Vioxx increased fivefold the risk of nonfatal heart attacks, the study showed.

But Merck claims that the VIGOR study was flawed. Because Vioxx was compared to naproxen as opposed to a placebo, it was not clear whether naproxen was providing an added benefit to the heart or Vioxx was having a detrimental effect, the company claims.

"Merck acted responsibly every step of the way, from researching the drug prior to approval, to monitoring the drug while it was on the market, to voluntarily withdrawing the drug when it did,” the press release states. "We based our decisions at each step on the data from well-controlled clinical trials."

Internal company documents may play a large role in the litigation.

In a March 9, 2000, e-mail, Edward Dcolnick, at the time the president of Merck’s research labs, referred to the results of the VIGOR study as a "shame." He also questioned whether the problems with the drug could be "mechanism-based," suggesting that all drugs in the class Vioxx belonged to, known as cox-2 inhibitor anti-inflammatory drugs, might cause heart problems.

Mayer says that e-mail simply reflected Scolnick's first reaction to the results. But when he looked at further scientific data, he eventually came around to believe in Vioxx's safety, Mayer says.

The e-mail doesn't support the contention of plaintiffs' attorneys that Merck knew something was wrong at the time, Mayer says.

The e-mail is evidence that Merck encourages people within the organization to raise concerns, he says.

That's a good approach to take at trial, Dodd of Kaye Scholer says.

In general, she says, "you want open discussions in pharmaceutical companies about the science.

"God forbid, if we discourage that. If there are scientists with differing views, let's hope there's an open forum within the company that allows them to express that."

Fishelman doesn't buy Mayer's explanation for the Scolnick e-mail. But Fishelman says the defense is stuck without a good excuse for continuing to promote the drug for widespread use.

"What can they say?" he says.

The e-mail shows "careful science raised real questions" about Vioxx's safety, Fishelman says.

Potentially the most devastating piece of evidence for Merck is a flash-card game developed in 2001 for the company's sales force called "Dodge Ball Vioxx."

Plaintiffs' attorneys claim the game is evidence that Merck trained its sales representatives to avoid tough questions by physicians about the drug's effects on the heart.

“It will be impossible to put a good spin on that," Archer says.

But Merck attorney Mayer calls the allegation ridiculous. The game was used during breaks from training sessions as a way to reinforce the learning of FDA-approved information on the benefits and safety of Vioxx, he says.

The cards had questions with answers on the back, and if someone drew a card with the word "DODGE!" on it, the person could skip the question, and the next trainee had to answer it, he says.

Dodd, who is not involved in the Vioxx cases, says that internal documents that might seem at "at first blush" to damage the defense aren't necessarily so bad.

"Your job as a defense trial lawyer is to help juries to walk behind the scene, if possible, [to find out] what the real motivations were," she says. "That's tough."

But it can be done.

Bayer won a defense verdict in a Texas suit in 2003 over the alleged dangers of its anti-cholesterol drug Baycol, which was pulled from the market in August 2001.

At trial, the plaintiffs lawyers introduced a slide that was presented to top Bayer executives at a global planning meeting in December 2001 that reportedly said, "DIG; THROW (The Corpse); COVER (With Sand)."

The negative implication is astounding to Dodd, who didn’t work on the case but read about it.

“It just takes your breath away," she says.

According to press accounts, the plaintiff's legal team argued that the slide supports the allegation that Bayer hid the serious risks of Baycol.

Defense attorney Philip S. Beck of Chicago's Bartlit Beck Herman Palenchar & Scott reportedly told the jury that the slide refers to a plan by people at the company who wanted Baycol put back on the market. The author of the slide wanted to drive home the point that doing so would be a lousy idea that should be buried, he said.

Scientific studies and medical experts are expected to take up a large part of Vioxx trials with jurors subjected to testimony about technical jargon such as "cyclooxygenases" and "prothrombin time."

Neither side likely will benefit from a confused jury, according to San Francisco trial consultant Beth Bonora.

“I think it’s wrong to say it necessarily helps one side or the other," Bonora of Bonora D'Andrea says. "When jurors don't understand, that’s when they do unpredictable things."

Maintaining the jury's focus could prove difficult.

Referring to the Botox trial, Darling says, “I’m sure there were times when the jury zoned out."

To help prevent that from happening too often, Darling and her legal team scanned exhibits into a computer, and the images were projected onto a screen so jurors could follow along better than having a witness hold a document and refer to it, she says.

“It kept the jury awake," Darling says.

For the most part.

"In a seven-week trial, somebody is going to fall asleep at some point," she says.

In the PPA case, Dodd used computer animation that demonstrated how strokes occur in the brain. After the presentation, Dodd says she launched into an explanation of how Novartis' drug Tavist-D didn't cause strokes.

What may be the biggest obstacle for plaintiffs to overcome is to prove "specific causation," that Vioxx is the reason their clients suffered heart attacks or strokes.

The problem is those ailments are relatively common and have many risk factors including age, diet, weight and family medical history.

In its statement, Merck described the plaintiffs' challenge to show causation as a "considerable burden."

To win his Trial, O'Donnell argued that the plaintiffs lacked the telltale signs of Rezulin-induced liver damage. They didn't have a spike in a specific liver enzyme or jaundice, each of which he described as a "fingerprint" of the drug.

The plaintiffs in the Rezulin case had preexisting conditions: morbid obesity, heart problems and liver disease.

In Dodd's case, she poked holes in the causation claim by pointing out that, in addition to one Tavist-D pill, the plaintiff had taken six Actifed pills and four aspirin within four hours of her stroke. And she was a heavy smoker.

After hearing that about the plaintiff, “I think the jury looked at her cross-eyed," Dodd says.

Dodd's opposing counsel, Mark P. Robinson Jr., agrees with her.

"[But] it is important to try a case that has some possibility of proving causation, whether it be Vioxx or PPA or anything else," Robinson of Newport Beach's Robinson, Calcagnie & Robinson says. "Unfortunately, the trial we had was a loser on causation. I mean, it just was.

“I think the Vioxx liability facts are much better than the PPA liability facts."

In Smith's view, her client Tyus' case is especially strong.

Tyus had taken the drug, sold for the treatment of acute pain and arthritis, because he hurt his knees and shoulders, Smith says.

He didn't have any of the risk factors or pre-existing conditions that could weaken other claims, she says.

Tyus took the drug for more than 18 months, he is younger than 55, he didn't smoke and he's not seriously overweight, Smith says. Plus, there is no family history of heart attacks, she says.

"It sounds like we got a call by someone who ought to be the poster boy for these cases," Smith says.

Mayer declined to discuss specific cases.

Archer says he isn't taking Vioxx cases on behalf of people who have had prior heart attacks or strokes. But if they have high cholesterol or are smokers, he says he won't necessarily turn them down.

“Those are risk factors, and you deal with them," he says. "Everybody's got a risk factor."

Fishelman agrees.

“To be alive, you have some risk factors," he says.

O'Donnell cautions that high cholesterol and smoking are two of the biggest risk factors for heart attacks.

"I think the defense has something to talk about," he says. “I’d like to have [on the opposing side] a plaintiff with that profile.”

No matter at which courthouse in the state Vioxx suits are filed, they are all coordinated for basic pretrial discovery through Los Angeles Superior Court Judge Peter D. Lichtman.

The recent negative publicity regarding Vioxx and other drugs has taken its toll on the public's perception of pharmaceutical companies, defense attorneys say.

But the public is a huge consumer. Americans spent $200 billion on prescription drugs in 2002, with 3.5 million prescriptions filled in 2003, according to press accounts.

The critical media coverage can be overcome at trial, defense counsel adds.

“The whole purpose of a pharmaceutical company is to help people get well," Dodd says. "Unfortunately, in the media and press, that's not what we're hearing about pharmaceutical companies right now."

In the PPA case, to underscore Novartis' aim to do good, Dodd showed clips of testimony from nine company officials from their videotaped depositions at the end of trial. They all vouched for the drug's safety by stating that either they themselves or their family members had taken the drug.

"I think that has a powerful impact," Dodd says. “In my closing argument, I called it 'the wall of safety.'"

She introduced each clip by mentioning the name and title of the employee.

"It was kind of like calling out the Grammy Award winners," Dodd says. “The courtroom was pretty quiet at that moment and pretty attentive."

O'Donnell reminds jurors that drug makers are "life savers," not “life takers" and that the goal of making better medicine is "to do what God can't do."

Fishelman sees a less holy aspect to Merck's manufacture and marketing of Vioxx.

“The company's profits were being driven by this medication," he says.