Dramatic Disorder in the Courts

Editorial
New York Daily News
November 7, 2005

Last week, Merck slipped the noose in a trial that hung on whether the executives in charge of protecting the drug company's customers messed around for so long that people had heart troubles because of the foot-dragging that preceded Vioxx's removal from the market.

After the victory in a case brought by a man who had taken Vioxx and suffered a heart attack, the company's stock went up. Now, it seems Merck might duck $50 million in liabilities in the thousands of suits filed against it.

According to the lawyer representing the plaintiff, the company's legal team won not with science, but with the good old mud-slinging tactic of attacking his client. Here is where the legal system always seems porous: If the attorneys on either side have enough skill at drama, victory is theirs.

This means that our legal system can hinge on a good performance at key moments of decision. It also means that juries can be considered more audiences than citizens given to fair judgment, which trashes everything the law should be about.

At the same time, we should know that once litigations become successful, the monkey-see-monkey-do response sets in and our courts get filled with as many frivolous suits as important ones. Since there is no liability for wasting the time of the state and the money of the defendant, these cases continue to pile up.

What to do? We are in quite a pickle because there is no reason people should assume goodwill on the part of executives who are too often concerned more with profit than quality, or danger to the public. This has, of course, changed a good deal in the automobile industry because, after years of playing from the bottom of the deck and wearing down plaintiffs, blood was drawn and the game changed. Now, entire lines of vehicles are recalled if a dangerous flaw is discovered because the industry knows the average jury might feel it should avenge the most recent victims and make up for all those who were not rewarded in the past.

But this new victory by a drug company that might itself face many court dates because of irresponsible executives brings us to a particular place. Since Americans have only so much patience with tragedy and tend to swallow whole almost all conspiracy theories, we are always eager to blame someone for whatever went wrong. If the defendant is not guilty, the plaintiff must be, and if neither one of them can be left holding the bag, we blame it on the system, hold our noses and walk away shaking our heads.

So what are we to do when faced with circumstances such as the ones in the Merck case? We should try and stick to the facts and draw all conclusions from them. The less willingness to be swayed by drama, the better.
 

Merck Wins Big in Vioxx Trial

By Lisa Brennan
New York Lawyer
New Jersey Law Journal
November 4, 2005

The nation's second trial over health effects of the drug Vioxx got swamped in New Jersey on Thursday, as a jury categorically rejected claims that failure to warn about the painkiller's risks caused a user's heart attack.

The jury found, 8-1, that Merck & Co. properly alerted prescribing physicians to a link between Vioxx and an increased risk of cardiovascular events, and found unanimously that there were no consumer fraud violations in the way Merck marketed Vioxx to physicians.

As a result, the jury never reached the question of proximate causation of postal worker Frederick "Mike" Humeston's heart attack.

The verdict, rendered after eight hours of deliberation, is a victory on several fronts for the Whitehouse Station, N.J., drugmaker and its lawyers. It likely will deter suits by plaintiffs like Humeston, who have short-term exposure to Vioxx and who are still alive.

The verdict also resonated on Wall Street, where Merck shares rose 6 percent after the verdict, a welcome comeback after the stock plummeted in the wake of a $253 million verdict in the first Vioxx trial in Angleton, Texas, in August.

The verdict enables Merck to overcome the risk of collateral estoppel on the failure-to-warn issue. Had the jury found in the plaintiff's favor on that count, the drugmaker could have been precluded from retrying the issue of adequacy of its warnings. About half of the nation's 6,400 Vioxx cases are venued in New Jersey.

"Collateral estoppel as a risk is completely off the table," says John Brenner of Newark's McCarter & English, who is not involved in Vioxx cases but defends pharmaceutical companies. "This victory is very significant to Merck."

Moreover, the verdict showed Merck's prowess in winning litigation on the ground. The company overcame a series of negative rulings by and friction with Atlantic County Superior Court Judge Carol Higbee throughout the eight-week trial, especially over the admissibility of certain scientific studies.

The trial, and even the pretrial conferences, had been marked by skirmishes between Higbee and Merck lawyer Diane Sullivan, of Dechert in Philadelphia. The judge delivered a major blow when she struck the testimony of Merck's lead witness, finding he had "materially changed" what he had been expected to say based upon his deposition.

At the center of the defense strategy was a memo by two Food and Drug Administration officials, concluding that short-term Vioxx use poses no greater risk of heart attack than similar pain relievers. Higbee first found the memo scientifically flawed, then allowed part of it in.

During the trial, some observing plaintiffs lawyers said that Humeston's lead attorney, Christopher Seeger, erred in putting emphasis on the complicated scientific issues, rather than on marketing practices. They also criticized the decision not to call David Egilman, a Brown University epidemiologist who had been expected to testify that scientific studies showed risks from short-term Vioxx use.

Seeger, of Seeger Weiss in Newark, told reporters he was devastated by the verdict and sad for his clients, Humeston and his wife, Mary. Seeger has several hundred other Vioxx cases and he pledged to keep fighting.

Other plaintiffs lawyers who have banded to litigate future Vioxx cases in state courts said Thursday that the defense verdict would not have negative implications for their strategy.

"Everyone knew from the beginning that this was a difficult medical case and that Merck would present a vigorous and well-orchestrated defense focusing on the plaintiff," said spokesman Christopher Placitella of Cohen, Placitella & Roth in Red Bank. "There will be wins and losses during the course of this litigation for both sides, depending upon the facts as presented in individual cases."

Placitella noted that the first six asbestos cases were lost before asbestos companies' conduct was fully explained. "That is not the case here. One jury has already found the drugmaker's conduct so reprehensible that they awarded $250 million," he said. "The liability evidence introduced was compelling."

Vioxx is the brand name for a painkiller Merck introduced in 1999. It is in a class of drugs known as Cox-2 inhibitors. More than 20 million Americans took the drug, making it one of Merck's biggest sellers, grossing $2.5 billion annually. In September 2004, Merck withdrew Vioxx from the market based on studies that showed it caused heart attacks and strokes after prolonged usage -- 18 months or more.

The recall triggered an avalanche of litigation against the drugmaker. The next Vioxx case is scheduled to go to trial on Nov. 21 before a federal judge in the Eastern District of Louisiana, who has been temporarily relocated to Houston.

Pfizer Mounts Grueling Beauty Contest

By Eriq Gardner
Corporate Counsel
New York Lawyer
November 3, 2005

It was a cold day for a beauty contest. On a blustery morning last December, a small army of product liability lawyers tried not to slip on the ice as they made their way to the Plaza Hotel in New York. The largest pharmaceutical corporation in the world, Pfizer Inc, had rented a ballroom in the grand old hotel and summoned them.

Allen Waxman, Pfizer's litigation chief, told the hundreds of lawyers that the company was beginning an intense nine-month competition among its product liability outside counsel. Pfizer wanted the 103 firms in attendance which included many that had worked with Pfizer before and some that had not  to compete against each other for some 20 coveted spots as preferred providers. As he spoke, Mr. Waxman brandished a 50-page Request For Information form and outlined the elaborate vetting process.

A midwinter beauty pageant does not sound like such a great idea. But for Pfizer's legal department, the timing could not have been better. Company lawyers were staggering under the heavy litigation burden that Pfizer assumed from acquiring other pharmaceutical businesses. At the same time, Merck & Co., Inc.'s recall of Vioxx last year had Big Pharma's adversaries personal injury lawyers, securities class action attorneys, state attorneys general, and others dragging drug corporations into court to answer for the ways their products are developed and marketed. Pfizer alone has faced more than 10,000 lawsuits in the past few years over its drugs and their alleged side effects. Mr. Waxman said the hundreds of firms representing Pfizer on product liability work were a nightmare to manage. The legal department thought that it would benefit, both operationally and financially, from working more closely with a smaller group of firms, though lawyers there refuse to put a dollar amount on any potential savings.

How would Pfizer pick its preferred providers? As part of "P3," Pfizer-speak for Pfizer Partnering Program, the company demanded to know each firm's history of handling product litigation, its minority hiring statistics, and whether it had ever represented a generic drugmaker, as well as details of any alternative fee arrangements it had with other clients. On paper with documentation.

That was the easy part. After sending in their replies, finalists traveled to Pfizer's New York headquarters, where small panels composed of company lawyers and outside consultants grilled them on their answers. Then came a fee review from a Pfizer procurement executive known for wrangling discounts on copy paper and paper clips. One law firm partner, echoing the sentiments of others, would later call the selection experience "the most painful ever."

Finally, in late September, the drug company announced its choices. Prominent national product litigation players made the cut, including Dechert; Kaye Scholer; Skadden, Arps, Slate, Meagher & Flom; and Reed Smith. That is not surprising. But Pfizer made some other notable choices. Smaller litigation boutiques like New Orleans-based Irwin Fritchie Urquhart & Moore and Los Angeles-based O'Donnell Shaeffer Mortimer were in. And the company rejected well-known heavyweights, even though some had played historically large roles in Pfizer litigation.

The delisted firms include Alston & Bird; Arnold & Porter; Gibson, Dunn & Crutcher; Jones Day; and Mayer, Brown, Rowe & Maw. Frederick Paulmann IV, a Pfizer senior corporate counsel who oversaw the P3 competition, said Pfizer's lawyers looked for geographical diversity, but each firm is not assigned to a specific region. The drug company also insists that its firms are on equal footing with one another; even some of the smaller firms may be asked to play a role in national cases.

'Eliminate Subjectivity'

Mr. Paulmann added that P3's goal was to "totally eliminate subjectivity" from the process. "We can't effectively put four catchers on the field at one time, even if each is an All-Star," he said. And the way to cut three of them? Make them show off and "measure the quality of the individual players . . . by a reasoned assessment of objective markers."

Pfizer is not the first company to initiate an elaborate "partnering" process for its outside counsel. Most notably, E.I. du Pont de Nemours and Company; Motorola, Inc.; and Sears, Roebuck and Co. all have instituted some form of "convergence" working closely with a relatively small, select group of firms and, in return, getting a break on their fees. Two years ago, Shell Oil Company created a stir by inviting dozens of law firms to its Houston headquarters for a beauty contest, and requiring them to answer detailed questions about their (lack of) minority hiring. Last year Tyco International Ltd. rattled the legal community by becoming one of the first large companies to outsource all its product liability work via an RFP and a "reverse auction" (firms bid for the work; the lowest bidder typically wins). Shook, Hardy won by bidding a low 18-month fixed fee for Tyco's entire product liability portfolio.

In all, according to Peter Zeughauser, a legal consultant at Newport Beach, Calif.-based Zeughauser Group, more than 200 companies have attempted to run "partnership" competitions of some kind. Most, he said, conduct them with the idea of realizing savings in legal costs, and "in the better competitions, the number of competing firms is relatively small, usually between four and eight firms."

Commenting on Pfizer's beauty pageant, he said: "Two consultants, nine months, and a 50-page RFI? . . . It sounds to me like it was overlawyered."

Mounting Litigation

If that is true, blame Mr. Waxman, 43, who walked into Pfizer's legal department in January 2003 from Washington, D.C.-based Williams & Connolly. There, he had defended some of America's largest pharmaceutical companies, including Wyeth, Warner-Lambert Company, and Bayer Corporation, in litigation over products like Norplant, Rezulin, and Baycol, respectively.

The Harvard Law School-educated lawyer, with his trial fame and outsider's perspective, did not exactly fit in with his new colleagues at Pfizer. But that did not matter to general counsel Jeffrey Kindler, who believed that only an outsider could get on top of the company's mounting litigation problem. "There was no doubt that he was the guy to make some moves that needed to be made here," said Mr. Kindler, who was also a partner at Williams & Connolly before going in-house.

Mr. Kindler has his own reasons for wanting to make a splash. In February he was promoted to vice-

chairman of Pfizer, and joined two other senior executives on a newly formed Pfizer executive committee. Company watchers say that Mr. Kindler and his fellow vice-chairmen, Karen Katen and David Shedlarz, are in a runoff to succeed outgoing CEO Henry McKinnell, Jr. Trimming legal costs significantly can only help burnish Mr. Kindler's star. A Pfizer spokesperson denied that the P3 process is a vehicle to advance Mr. Kindler's CEO chances, saying, "It's just so not so." She added that Pfizer is trying to cut $4 billion in costs, and that the legal department is doing its part.

Mr. Waxman began to reorganize the department shortly after he took over. Two management consulting firms, Chicago-based Huron Consulting Group and Boston-based Axia Consulting, recommended untangling the responsibilities of the department's lawyers. Now the in-house litigation team has separate groups that specialize in managing commercial litigation and defending government claims. The consultants also urged Pfizer to draft more rigorous litigation budgets early in the case process.

In late 2003 Mr. Waxman began formal discussions with his litigation group about what they wanted from their outside product liability counsel. Over the next several months the lawyers decided to winnow their product liability defense counsel down to about 20 firms.

An Intensive Review

The RFI was the first stage. It ran to 50 pages, divided into 12 sections. The first part asked for a list of all prior litigation handled, familiarity using various case assessment techniques, prior use of alternative fee structures, and a detailed list of attorney training. Pfizer wanted references from other clients, too.

The middle section demanded more creative thinking. Pfizer asked for the firm's thoughts on the pharmaceutical business, and how the firm demonstrated the company's core values. A sample question: "It is often said that the industry is not doing a good job of representing itself in the public domain. Do you agree? If so, what do you think the industry and Pfizer should be doing differently?"

The last section focused on money. Here, Pfizer pushed the envelope of what clients ask of service providers. Pfizer wanted law firms to include monthly budget forecasts for representing Pfizer, annual revenue breakdowns for the firm, and the percentage of revenue derived from a firm's top client. Pfizer also asked for what it calls "most favored nations" status, meaning it wanted rates no higher than those charged to a firm's largest and most influential non-pro bono client. And Pfizer asked the firms whether they would be willing to freeze their rates from the inception of a matter until its conclusion.

Providing those answers was not easy. Some firms brought in outside consultants and accountants. Steven Glickstein, a partner at New York-based Kaye Scholer, said his firm had 25 partners devoting "hundreds of manhours" to the project. (Kaye Scholer made the final list.)

Some firms went beyond the normal marketing department drafting. Hunton & Williams, which Pfizer said did "not have a great deal of pharmaceutical experience," hired a jury consultant to conduct a focus group on how jurors view pharmaceutical issues. There were testaments, too. DLA Piper Rudnick Gray Cary's response included a 1997 letter from New York state judge W. Denis Donovan to the firm complimenting one of its product liability attorneys as "undoubtedly the finest, most proficient, best prepared, and most gentlemanly trial lawyer, I, in my 27 years as a judge and justice, ever witnessed." (The extra efforts paid off. Both firms were chosen.)

New York Interviews

The first cut came in March. From the original 103 firms, Pfizer pared the list to 43. Then, through May and July, lawyers from those firms traveled to New York for a cross-examination by a phalanx of Pfizer lawyers and its consultants. The sessions caused more than a little internal friction. For instance, Pfizer suggested that firms bring six or fewer lawyers to the table, including one person whom the firm considered a rising superstar. Lawyers at one giant firm argued over whom to take. "You can't imagine the amount of politicking this raised," said an insider there who requested anonymity.

The sessions got pretty lively. Many of the slick PowerPoint presentations were ignored as Pfizer's inquisitors pressed lawyers on their RFI responses. Chuck Socha, a partner at Denver's Socha, Perczak, Setter & Anderson, said his questioners wanted to know how his small firm, which had never handled Pfizer business before, could possibly handle litigation from Utah all the way up to Washington State. "They said, 'You have a 14-member team. What makes you think you're capable of running the region?' "We have skins on the wall," Mr. Socha said he responded, pointing to its vigorous defenses in asbestos and silica litigation. (Socha, Perczak made the final list.)

'A Lot Expected'

This fall Pfizer contacted the 24 firms that made the final list. Later this year lawyers from the winning firms will travel to Pfizer's research & development labs in Groton, Conn., to take a tour of the labs and meet with its litigation team, including Mr. Waxman, Mr. Paulmann, and Sandra Phillips, a Pfizer assistant general counsel and section chief for product litigation. "I want these folks to see the lifeblood of this company and to understand in a much more intimate fashion  what's going on here, what's driving us, what are we doing as a company," said Mr. Waxman.

But the winning firms cannot rest easy. "The feedback I've gotten from the firms was 'This was painful. This was long. It was arduous,'" Mr. Waxman said. But he stressed the outcome: "Better relationships, better value there's a lot expected at this point."

 Eriq Gardner is a writer for Corporate Counsel magazine, an affiliate of the New York Law Journal. A version of this article will appear in the December issue of the magazine.

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