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With the score 1-1 in the high-stakes game of Vioxx pharmaceutical litigation, the tiebreaking trial begins on Tuesday in federal court in Houston. The results of the trial in Evelyn Irvin Plunkett, et al. v. Merck & Co. Inc. may give a better idea of the long-term viability of Vioxx litigation, and the value of the personal-injury suits filed by people who allege Vioxx harmed them or led to a relative’s death. In August, a state court jury in Angleton, Texas, located 30 miles south of Houston, returned a $253.5 million verdict for the plaintiffs in the nation’s first Vioxx trial. In November, a state court jury in New Jersey, where Merck is headquartered, returned a defense verdict in Humeston v. Merck & Co. for the pharmaceutical company. Now, in the third trial, it’s up to a federal court jury from the Southern District of Texas to decide if Vioxx caused the death of a 53-year-old Florida man, Richard Irvin Jr., who took the pain-killer for a few weeks in 2001 and died of a heart attack. The trial will take place at the Bob Casey U.S. Courthouse in Houston because U.S. District Judge Eldon Fallon of New Orleans, the federal multidistrict litigation judge for Vioxx litigation, was temporarily working out of Houston due to Hurricane Katrina. Fallon is back in New Orleans — and in fact held a pretrial conference in Plunkett v. Merck in the Big Easy on Nov. 21 — but he will try the suit in Houston, where it is expected to last at least two weeks. The MDL is known as In Re: Vioxx Products Liability Litigation. In Plunkett, Irvin’s widow sued Merck on behalf of Irvin’s two minor children and his estate. She alleges Vioxx is a defective product, Merck knew it was defective and the company failed to adequately warn Irvin of Vioxx’s defective nature. But because Irvin, who suffered from severe back and hip pain, took Vioxx for only a short period of time, the trial may help test Merck’s defense contention that the drug does not result in heart problems in people who took it for fewer than 18 months. Merck pulled the drug from the market in September 2004 after a study indicated the drug could double the risk of heart attack or stroke if taken for 18 months or longer. But lawyers for Plunkett say short-term use of Vioxx can still be dangerous, and the trial will help put the “18-month myth” to rest. “Merck’s position is that Vioxx cannot cause heart attacks within 30 days, like Dickie Irvin took here. They [Merck] made a big deal out of this. That’s a theory that is just absolutely nothing more than a myth,” plaintiffs’ lawyer Andrew Birchfield said during a press conference on Nov. 16. “What happened to Dickie Irvin here is exactly what the Merck scientists said would happen … you are going to get blood clots. You are going to get ruptures and what’s going to happen is the blood flow slows down, your heart just starts beating like a bag of worms and you die,” said Birchfield, a shareholder in Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Ala. Birchfield will try the suit along with partner Jere Beasley. Defense lawyers cannot respond to the allegations from the plaintiffs lawyers due to a pretrial request from Fallon that they refrain from making comment until after a jury verdict. “The judge has requested that we not comment on the substance of the trial,” says Kent Jarrell, a spokesman for the defense trial team. Philip Beck, a partner in Bartlit Beck Herman Palenchar & Scott in Chicago, is lead defense counsel for Merck. The team also includes Beck’s partner Tarek Ismail. Brian Levitt, a spokesman for the plaintiffs’ legal team, says the plaintiffs lawyers will not make additional comments about the trial until after the verdict. FOR THE JURY The battle over short-term use and long-term use of Vioxx is “extraordinarily important” for the litigation, says Rand Nolen, a Houston plaintiffs lawyer who is not involved in Vioxx litigation. “Merck wants to maintain, in every case, that the person needs to take Vioxx for 18 months or longer in order to have an increased risk of injury due to the drug. There were tens of thousands of plaintiffs who had events that were reasonably attributable to Vioxx that didn’t take the drug for 18 months,” Nolen, an associate with Fleming & Associates, says. “It’s Merck’s defense that you have to take the Vioxx for 18 months, and if you didn’t, we can’t be liable.” Nolen says, based on Fallon’s ruling on Daubert motions and Daubert-like motions, the judge will let the plaintiffs put on their case on the short-term use issue. In an order on Nov. 18, Fallon denied most of the motions from both sides seeking to disqualify some experts from testifying during trial. Fallon, meanwhile, denied a motion from Plunkett to prevent testimony from Merck experts that a study indicates that “adverse thrombotic cardiac events” only occur if Vioxx is ingested for 18 months or longer. In his order, Fallon wrote that because experts from both sides are relying on the same study, but interpreting it differently, it should be up to the jury to decide which conclusion is correct. “The proper forum for challenging conclusions is at cross-examination, not in a Daubert Motion,” Fallon wrote in the order. Rulings like that in the Daubert order are a “good sign” for the plaintiffs in Plunkett, and in the MDL in general, because it indicates Fallon will let both sides present their cases on scientific evidence, says Tommy Fibich, a Houston lawyer who heads the plaintiffs steering committee in the Texas Vioxx MDL. The Texas MDL, In Re: Texas State Vioxx Litigation, was formed for pretrial matters for Texas state court Vioxx suits. W. Mark Lanier, the Houston plaintiffs lawyer who won the $253.5 million verdict in Angleton, believes Merck’s strategy in Plunkett will be “attack the plaintiff, the medicine and the lawyers.” “It is what Merck has done in each trial so far,” Lanier, of the Lanier Law Firm, says about the trial. Lanier was on vacation in England last week, but responded to e-mail questions on Nov. 23. Lanier says the plaintiffs’ team will emphasize the Merck documents that show Merck was “more concerned with its sales and profits than communicating the truth about Vioxx’s dangers.” CAUSATION QUESTION In her complaint, Plunkett brings negligence, strict liability defective design, strict liability failure to warn, breach of express warranty, breach of implied warranty, fraudulent misrepresentation and fraudulent concealment causes of action against Merck. She seeks unspecified actual and punitive damages. In an answer filed in October, Merck denies the allegations. The company also alleges various defenses, including allegations Plunkett failed to state a claim upon which relief can be granted, the plaintiffs and Irvin were “careless and negligent” and caused and contributed to any alleged injuries, and they failed to exercise reasonable care to mitigate their alleged damages. Merck alleges any injuries to the plaintiffs or Irvin were caused by pre-existing and/or unrelated medical, genetic or environmental conditions. Merck also alleges that any injuries or losses were caused by “misuse” or “abuse” of Vioxx by the plaintiffs and/or Irvin. Merck also alleges in its answer that any award of punitive damages is barred because Florida Statute 768.73(2)(a) provides that punitive damages cannot be awarded if there has been a previous award for the “same act or single course of conduct.” Merck points out that the $229 million in punitive damages awarded by the Angleton jury in Carol A. Ernst v. Merck & Co. Inc. would bar an additional punitive damage award. Merck alleges in the answer that even though it will appeal Ernst, and a punitive damage award would be reduced to $1.65 million under Texas law, that doesn’t matter. “Neither of these facts is relevant to application of Florida’s statutory punitive damage limitations, which plainly bar punitive damages where — as here — there has been an award of punitive damages to punish the same allegedly wrongful conduct,” Merck alleges in its answer. At the Nov. 16 press conference, Birchfield said Florida law provides for some exceptions to caps on punitive damages. Lanier says he hasn’t yet asked the judge in Ernst, the Angleton suit, to enter a judgment. Beasley, Birchfield’s partner, says that while lawyers will watch the Plunkett trial that kicks off with voir dire on Tuesday, he isn’t feeling particular pressure to win big — beyond his responsibility to his clients. “Merck says they will try them all anyway, so I don’t know if it makes a difference to them,” Beasley says. Jarrell, the spokesman for the Merck trial team, confirms that Merck has not moved off its stance that it will try each and every Vioxx suit. Merck reports that as of Sept. 30, it has been named as a defendant in about 6,400 Vioxx suits. About 2,750 suits are pending before New Jersey Judge Carol E. Higbee, and about 2,900 suits are in the federal MDL, according to information from Merck. Lanier, the lawyer who won the first Vioxx verdict, says the Plunkett trial isn’t more important than others based on the fact it’s the first federal trial or because it’s an opportunity for one side of the bar to get an edge up on the other. “In mass torts, it’s like batting in baseball. The plaintiffs are great if they bat .333 (win 1 of 3),” Lanier says. Because Irvin took Vioxx for such a short period of time — he filled his prescription on April 22, 2001, and died of a heart attack on May 15, 2001 — it wouldn’t be too surprising if Merck wins the trial, Lanier says. But, he adds, “If Merck loses this, it is in deep trouble.” Lanier is one of a group of plaintiffs lawyers nationwide with Vioxx suits who want to try their suits in state court, and not within the federal MDL. Because of that, in October, Lanier resigned from a state liaison committee in the MDL, a group created to help coordinate efforts in the MDL. Fibich, another Houston plaintiffs lawyer with Vioxx suits, says the verdict in Plunkett won’t have a defining effect on Vioxx trials. “We are going to have to have several cases, I’d say five to eight, to see any kind of a trend. The plaintiffs are going to win their share and it’s going to be big when the jury goes with them,” says Fibich, a partner in Fibich, Hampton & Leebron. But he suggests the verdict could be significant on the question of short-term use. “The company takes a position that short-term use does not cause cardiovascular events that the plaintiffs are complaining of. To the extent that the jury finds there is causation, I think that is really significant for the plaintiffs,” he says. “On the other hand, if Merck wins, lawyers are not going to stop trying these short-term use cases.”

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