Friday, October 01, 2004

Merck recalls VIOXX on Sept. 30, 2004

Linda A. Johnson of AP reported that Merck pulled VIOXX from the market on September 30, 2004 after a study found it doubled the risk of heart attacks and strokes. "News of the drug's dangers came from a three-year study aimed at showing that Vioxx could prevent the recurrence of polyps..." (for example, Trenton Times, A1 (Oct. 1, 2004))

Endnote 9 of an article in the June 2000 issue of Intellectual Property Today (Increasingly Aggressive Efforts at Patent Enforcement, available LEXIS) had stated:

(...)According to a report from the group of Dr. Ganet A. FitzGerald in the Proceedings of the National Academy of Science, 1999, 96:272-277, the drug may increase the risk of heart attack, stroke and blood clotting disorders. Many older people who may want to take COX-2 inhibitors for conditions like arthritis could be at risk for developing heart and blood vessel problems from the drug. Dr. Saul Bloomfield said that taking COX-2 inhibitors might be a matter of exchanging a gastrointestinal risk from one painkiller to a cardiovascular risk for another. See also Wall St. Jour., April 20, 1999. On April 27, 2000, there was a Reuters release "Merck's Vioxx seen facing FDA scrutiny on heart attacks." [Vioxx (rofecoxib) is a different COX-2 inhibitor.] On April 28, 2000, PR Newswire reported results of a study in which Pharmacia found even at very high doses, Celebrex showed no increases in stroke or heart attack with or without aspirin. [See Hoover's Online]


One day after Merck & Co. announced the recall of its anti-inflammatory drug Vioxx, a prominent Long Island plaintiffs lawyer filed two product liability lawsuits against the drug company in the Nassau County Supreme Court.

Robert G. Sullivan, senior partner in the Mineola, N.Y., office of Sullivan Papain Block McGrath & Cannavo, said the suits are the first in New York to his knowledge.

More suits are already in the works, he said. By late last week, Sullivan's firm had already signed up more than 200 Vioxx clients, he said.

Six Sullivan Papain attorneys have been assigned to handle case intake, five in the firm's Long Island office, the sixth in Manhattan. The firm has a third office in Hackensack, N.J. They are "receiving calls all day long," he added.

Helped, at least in part, by a full page ad in the Oct. 6 edition of New York Newsday, Sullivan said, his firm is getting 50 to 60 new cases daily.

Sullivan predicts that given the number of people taking the drug, within the next four years national Vioxx litigation could come to dwarf every other product liability mass tort except for asbestos and tobacco. Sullivan is intent on having his firm lead the way.

Merck & Co. spokespeople declined to talk about how the company will handle the rising tide of litigation. Theodore V.H. Mayer of Hughes Hubbard & Reed, one of the pharmaceutical company's outside counsel, said that Merck's lawyers are reliant upon the defenses of full disclosure and lack of causation.

Veteran products liability defense attorney William M. Savino, who is not connected with the case or either side, cautioned, "It's one thing to try your case on the six o'clock news. It's another thing to put your proofs to the jury." Savino is managing partner at Rivkin Radler.


Approved by the federal Food and Drug Administration in 1999, and brought to the market that year, Vioxx was one of a class of non-steroidal anti-inflammatory drugs called "Cox-2 inhibitors," named after the enzyme they block. Other name-brand drugs in the same class are Celebrex and Bextra, both made by Pfizer.

All three became popular as arthritis pain relievers. It is that popularity that Sullivan is banking on. "There were 80 million people on this drug," he said.

That figure is contested by Merck. Spokesman Antonius Plohoros said that while 100 million prescriptions have been written for the drug, it had only 20 million users in the United States.

Merck announced its voluntary recall of the drug on Sept. 21, four days after receiving a warning letter from the FDA. That letter chastised the company for engaging in a promotional campaign for Vioxx "that minimizes the potentially serious cardiovascular findings" revealed during the company's study of the drug's gastrointestinal effects.

Sullivan asserted that a Vioxx user was 50 percent more likely to suffer a heart attack than users of the other Cox-2 drugs.

According to the pleadings, each of the plaintiffs in the suits filed by Sullivan suffered heart attacks. Echoing the FDA letter, each of those filed complaints accuses the company of minimizing the risk of cardiovascular injury. Both allege a breach of duty to disclose that risk; that the pills weren't safe for their intended use; and that the company's advertising was misleading.

In accordance with New York State law, neither complaint makes an express demand for a particular sum of money. Both, however, request a sum "in excess of the jurisdictional limits" of the court.

The results of the gastrointestinal study were reported to the FDA and published in the New England Journal of Medicine. The information available from placebo-controlled clinical trials at the time supported the cardiovascular safety of the drug and the doctors made the ultimate decision to prescribe the medication based upon available clinical trials and their knowledge of their own patients, Mayer said.

"The primary decision-maker is the physician," he said. "The physician makes the determination" as to which anti-inflammatory drug to prescribe, Mayer said.

From that perspective, said Mayer, it is likely that a component of Merck's defense would be the learned intermediary doctrine. It holds that a physician's having adequate notice of a drug's harmful side effects who nevertheless prescribes that drug to the detriment of his patient may vitiate a drug manufacturer's liability for side effect-related injuries.

In cases filed thus far, however, the physicians have not been named as defendants.

Sullivan said they may well be in the future, particularly cardiologists who arguably should have read published reports and those who failed to tell their patients that Celebrex might have been a safer alternative.

Sullivan's firm was one of three appointed by Attorney General Eliot Spitzer to represent the state in the mass tobacco lawsuit aimed at recouping the public money spent treating smoking-related illnesses.

New York State is receiving $25 billion from the national settlement of those claims. The three New York law firms, which included Schneider Kleinick Weitz & Damashek and Albany's Thuillez Ford Gold & Johnson, reaped $281 million in attorney fees.

Sullivan's firm is receiving $98.4 million of that. Part of that money is being paid to departed name partner Pamela Liapakis, but the lion's share is helping to fuel the Vioxx lawsuits, he said.

"Cash flow hasn't been a problem," he said. "Tobacco funds it."

The tobacco money will now be used to advance filing fees and the costs of discovery items such as deposition transcripts and expert witnesses.

At least preliminarily, Sullivan puts great stock and faith in the attorneys he has doing his intake screening: "You have to have a toxic tort department to do this, and we do."

Sullivan Papain's Vioxx project is led by partners Frank V. Floriani and Andrew J. Carboy. Attorneys do the case intake and paralegals obtain the plaintiffs' medical histories and retrieve the medical records.

Once screened and accepted, cases are then graded according to their severity. At one end of the scale are the fatalities -- Sullivan said that his firm already has five of them. Below the fatalities are the serious heart attack and disability patients.

Sullivan said that he expects none of the cases to go to trial. "They'll all settle," he predicted. "The liability is too strong." He said the only purpose in going to trial would be to establish damages.

Mayer, however, said, "An important component of the defense in these cases is disclosure of the results of clinical trials. Individual causation in these cases will be a high hurdle for plaintiffs."

Speaking as an observer, Savino said, "Pharmaceuticals that are alleged to have caused bodily injuries are among the most challenging [cases] to win," he said. "They are very very difficult to prove, because you have to prove causation."

By causation, Savino said he meant isolating the deleterious effect of one drug from any other possible causes of an ill plaintiff's condition.

For more than 20 years, Savino's firm has represented Dow Chemical in its defense of what he called "the grandfather of mass torts litigation, Agent Orange." His Uniondale-based firm, Long Island's largest, has also defended asbestos, ephedra and lead paint cases.

As for Sullivan, on Friday he was already on to the next thing, filing his first case against Pfizer over its Cox-2 drug Celebrex.


UPDATE. from NJ Law Journal (Tim O'Brien, October 19, 2004):

-->One key to Merck's defense would seem to be its position on a key study begun in 1999 that compared Vioxx with a generic painkiller called naproxen to determine the effects on colon polyps. In March 2000, the results of that study showed that patients with polyps who took Vioxx over a long term had four times the risk of heart attack as naproxen users.

Merck, which gave the results to the Food and Drug Administration, argues that the result was due in large measure to naproxen's heart-protecting ingredients. The most recent study showed Vioxx was putting patients at risk for heart attacks or strokes, say Merck scientists. "Any claim that Merck didn't react responsibly is in direct conflict with the facts," said Merck Research Laboratories president Dr. Peter Kim at last Wednesday's press conference.

But the complaints filed thus far say the makers of naproxen never marketed the drug for cardiac problems, and they and other critics maintain that Merck never did a big clinical trial to specifically prove that Vioxx was safe for the heart.

Plaintiffs will rely heavily on an August 2001 paper, published in the Journal of the American Medical Association, by two Cleveland Clinic cardiologists who called for such a study.

Also not helping Merck is a pair of warnings by the FDA to the company to change its labeling and promotion of the drug. A 2002 letter chastised the company for putting out a "false and misleading" press release, saying its claims that Vioxx has a "favorable cardiovascular safety profile" is "simply incomprehensible" given the heart problems found in the comparison study with naproxen.

Gregory Nespole, a lawyer in the Arnoff v. Merck & Co. class action filed in New Jersey on behalf of shareholders disagrees, saying, "I believe the litigation belongs in New Jersey. The company is there. The acts were committed there. The science was there, their labs, their management and their clinicians. And the press releases and correspondence back and forth to the FDA were all in New Jersey."

The ERISA cases have been assigned to District Judge Mary Cooper, while the shareholders' action has been assigned to District Judge Stanley Chesler, who has handled class actions against Merck in the recent past. Both sit in Trenton. <--

UPDATE. from the Wall Street Journal on October 20:

"Merck is the ghost of Pfizer's future. . .Investors are slowly realizing that pharmaceutical companies should stay as small as they can, avoid distracting megamergers, invest large amounts in R&D, partner aggressively across the biotech spectrum and strive for novel, breakthrough medicines that add value."

UPDATE. from cover story of Fortune on November 1:

The event precipitating the crisis, of course, was Merck's announcement on Sept. 30 that it was recalling Vioxx, its $2.5-billion-a-year arthritis medicine, because the drug has been shown to double the risk of heart attacks and strokes in long-term users. On the day of the announcement, Merck suffered its own heart attack as investors fled the stock, and $27 billion in market cap—27% of the total—evaporated. (The company has subsequently lost an additional $6 billion in market cap.) Merck has taken a devastating public relations hit too; the recall has raised serious ethical questions about whether Merck inappropriately downplayed Vioxx safety issues over the past several years. And then there's the litigation problem: Although the company won't disclose how many lawsuits have been filed so far, roughly 20 million Americans had taken Vioxx by the time of the recall. According to an estimate in the Oct. 21 issue of the New England Journal of Medicine, tens of thousands of them may have had "major adverse events" attributable to the drug. Tort lawyers around the country have already set up toll-free numbers to solicit potential clients among Vioxx patients. The cost of settling the lawsuits will almost surely be in the billions of dollars, quite possibly in the tens of billions (see How Bad Will the Lawsuits Get?).


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