As jurors in the third Vioxx trial resume deliberating today in Houston, Merck & Co.’s legal strategy for future trials has a new challenge: One of its critical witnesses may have become a liability.
As a defense witness, Alise Reicin, a top Merck scientist, has been poised, authoritative and firm about her conviction that the drug maker acted appropriately and fully disclosed all its information about Vioxx, the painkiller Merck pulled from the market last year after it proved to increase risks for heart attacks.
But last week, editors of the New England Journal of Medicine raised questions about the scientific integrity of a Vioxx article that Dr. Reicin co-wrote. The disclosure puts a harsh spotlight on Dr. Reicin, who colleagues have called a “tenacious defender” of Vioxx, and is likely to make her job as a key witness for the defense tougher. Plaintiffs attorneys say they now consider her one of their best weapons as they face off against Merck in more than 6,500 Vioxx lawsuits.
Jim Fitzpatrick, an attorney with Hughes Hubbard & Reed LLP, Merck’s lead outside law firm, defended Dr. Reicin. “She’s always done an excellent job explaining” Merck’s efforts in disclosing all the information it had. “I expect that she’ll continue to do that.” A spokesman for Merck lawyers said that because Dr. Reicin is a witness in the ongoing trial, she will respect the judge’s request not to speak about the case.
New England Journal of Medicine editors said last week that a Merck-funded study, written by a group of authors with financial ties to Merck, including Dr. Reicin and two other employees of the company, was submitted with critical data missing. Information about three heart attacks suffered by patients taking Vioxx in a clinical trial wasn’t sent to the journal’s editors before the article was published in November of 2000. Merck has acknowledged the three heart attacks in discussions about the study in recent years. Last week’s revelations raise the question of when Merck learned of the three incidents, and why it didn’t update the study before publication.
The medical-journal developments came as jurors in Houston began deliberations. Evelyn Irvin Plunkett alleges that Vioxx caused the 2001 fatal heart attack of her husband, Richard Irvin who took the drug for less than a month to treat back pain. This is the third of what could be many suits against Merck to come to trial. The company lost the first case in a Texas state court, and won the second in a New Jersey state court last month.
Plaintiffs attorneys are now focusing on Dr. Reicin’s role as an author of the November 2000 article, which stated that in a study of Vioxx versus naproxen, an older, generic painkiller, 0.4% of Vioxx users had heart attacks compared with 0.1% of naproxen users. The studies aggregate numbers, which weren’t in the article, showed that 17 out of about 4,000 Vioxx users had heart attacks versus four of 4,000 naproxen users. Merck explained the difference by concluding that naproxen helps prevent heart attacks, though no clinical trials have shown that to be the case.
The article didn’t mention an additional three heart attacks among Vioxx users, which raised the total heart attacks to 20 of 4,000 patients, or 0.5%. That seemingly small increase had potentially big implications when multiplied times the estimated 20 million people who took Vioxx.
Merck said last week that it excluded the three heart attacks because they took place after the cut-off date the scientists had set for measuring benefits or risks. And Mr. Fitzpatrick, the attorney for Merck, said that the additional heart attacks wouldn’t have changed the conclusions of the journal article.
There is debate in the scientific community about when and whether events that fall outside the official time period for a clinical trial should be included in the study from the data. New England Journal of Medicine executive editor Gregory Curfman said he believed that the data should have been included, because the added risk would have been important for the publication’s readers—mostly doctors who prescribe medicines—to know. Other experts have concurred. Dr. Curfman learned that the additional heart attacks were known to Merck before publication when he was shown an internal Merck memo during a deposition last month.
Dr. Reicin’s dozens of hours of depositions and court testimony are also getting scrutinized for any inconsistencies with the latest disclosures. One incident that raises questions: Dr. Reicin testified in the New Jersey case that when the article was submitted to the New England Journal, the company didn’t yet have the data about the three heart attacks that produced the 0.5% risk level. “We did not have that data when we submitted this manuscript,” she testified on the stand in Atlantic City in early October.
Merck says her statement is accurate because the manuscript was initially submitted in May of 2000 and the new heart-attack data only became available in July, though editing of the article continued up until publication. “Dr. Reicin’s testimony is completely accurate and we continue to think that she has been a very important witness in explaining to the jury that with all the data, Merck always made the appropriate disclosures,” said Mr. Fitzpatrick.
Plaintiffs attorneys say they are eager to ask Dr. Reicin in future trials why the company didn’t include even a sentence in the article that noted there had been an additional three heart attacks.
Attorneys for Ms. Irvin Plunkett, who has since remarried, called on Friday for a mistrial based on the New England Journal disclosures. U.S. District Court Judge Eldon Fallon said he would take the motion under advisement, but appears to be waiting to see the jury’s verdict first.
In an unusual Saturday session called by the judge to speed up the proceedings, jurors said they had deadlocked but then continued to deliberate under instructions from Judge Fallon. Early afternoon on Saturday, they said were making progress, and will return this morning to continue.
Regardless of this case’s outcome, Merck faces a long road of litigation. A key factor in how it fares will be whether the company can preserve Dr. Reicin’s credibility. On the stand in recent Vioxx trials, Dr. Reicin delivered her arguments with conviction, rarely ceding a point to plaintiffs attorneys. She refused to be boxed into corners, frequently saying she “wouldn’t characterize” a given situation the same way they had. She often leaned forward in the witness box, appearing rapt and attentive to the lawyers and jurors. Following Merck’s victory in Atlantic City, jurors said they liked her and thought she was smart and convincing.
A biochemist with degrees from Barnard College and Harvard University, Dr. Reicin first worked at Columbia Presbyterian Hospital in New York. “She’s a wonderful scientist and did some terrific work on HIV in my lab,” said Stephen Goff, a Columbia biochemistry professor.
But Dr. Reicin, now 45 years old, says she soon began to question her ability to make a difference for patients. “What I realized was even if I found something phenomenal in the lab, it would probably take a pharmaceutical company to actually translate that into something that could help patient care,” she testified in the New Jersey trial.
In 1996 she joined Merck and worked on Singulair, Merck’s successful asthma and allergy medication. The following year, she began working on a compound that would come to be called Vioxx, which was approved by the Food and Drug Administration in May 1999. Even after she joined Merck, she testified, Dr. Reicin continued to volunteer at Columbia for six or seven years.
Merck will lose a valuable witness if it decides Dr. Reicin has become a liability. “There’s a reason Merck called her in all three trials,” said Mark Lanier, who won
the first case against Merck in August and will try another Vioxx case in New Jersey in February.