Drug War

Drug War

Merckis Vioxx center of legal wrangling.

By Staff and Bloomberg News

U.S. Senate investigators probing Merck & Co.is recall of its Vioxx painkiller interviewed an Alabama attorney whose firm has filed 58 lawsuits on behalf of people claiming injuries.

Attorney Andrew Birchfield met for 3 1/2 hours in Washington with staff on the Senate Finance Committee, chaired by Sen. Charles Grassley, an Iowa Republican. Birchfield said he handed over company documents and statements of Merck executives and scientists taken during the litigation.

Grassley has been probing whether the U.S. Food and Drug Administration was too slow in responding to safety concerns about Vioxx. Merck, the No. 2 U.S. drugmaker, withdrew the product from the market Sept. 30 after a study showed patients who took it 18 months or more had twice the risk of heart attacks or strokes.

iMy take is that the committee is trying to answer how the company kept Vioxx on the market that long and where was the FDA,i Birchfield said.

Merck shares fell Nov. 1 after the Wall Street Journal printed documents showing that the company tried for years to stop safety concerns from hurting sales.

Company spokesman Tony Plohoros declined to comment.

Birchfield said the committee asked him Oct. 29 for documents after assuring Merck that material gained through the pre-trial gathering of evidence would remain confidential. His firm, Beasley, Allen, Crow, Methvin, Portis & Miles PC in Montgomery, Ala., has taken sworn statements from more than 30 company scientists and executives.

iThe more we learned, the more concerned we became,i he said.

The e-mails are ias damaging as anything you can imagine as far as content and intent,i said another firm partner, Jere Beasley. iIt really incriminates Merck to the highest degree. This company knew exactly what they were dealing with. They knew that people would run the risk of strokes and heart attacks and did not reveal that risk.i

Profit over safety

iThey put profits over the safety of their customers, pure and simple,i he said. iIt was total irresponsibility.i

In a statement e-mailed from the committee, Grassley said the documents brought to the committee by Birchfield include idisturbing marketing materials and internal e-mails.i

The Senate panel, which also has asked Merck to supply documents, met with the company last week, the senator said.

iI intend to obtain answers and context from Merck on Vioxx,i Grassley said. iMillions of Americans deserve an explanation from Merck and the FDA about why this dangerous drug was on the market for so long, apparently without adequate warnings.i

Merck, based in Whitehouse Station, N.J., pulled the $2.5 billion drug voluntarily from the market in the biggest prescription drug recall in history. Vioxx accounted for 11% of Merckis sales.

Hundreds of suits

The company faces several hundred lawsuits so far over Vioxx in state and federal courts in California, Texas, Florida, New Jersey, Alabama, Mississippi, Georgia, and Arkansas, court docket records show.

Birchfield and other customer attorneys said they believed that Merck has not settled or gone to trial on any of the lawsuits. Birchfieldis firm has a case approaching trial in federal court in Birmingham, Ala., involving William Cook, 50, a retired coal miner.

Cook claims he suffered a heart attack after taking Vioxx for a year, according to Birchfield. The trial may be put off if Merck succeeds in an effort to consolidate all federal cases before a single judge.

In Florida, like elsewhere, personal injury lawyers are advertising their services in hopes of attracting clients damaged by Vioxx.

Throughout the Tampa Bay area, firms have placed ads, including Clark Charlton & Martino PA, Tampa; Beltz & Ruth PA, St. Petersburg; Florin Roebig PA, Palm Harbor; and Saunders & Walker PA, Pinellas Park.

Some firms o including heavy hitters such as James Hoyer Newcomer & Smiljanich PA and Wilkes & McHugh PA o have revised their Web sites to promote their availability to those who took Vioxx.

It looks like Vioxx is about to become the latest moneymaker for product liability litigators o plaintiff and defense o in the vein of Fen-Phen, the diet drug that to-date has cost Wyeth, another large New Jersey-based pharmaceutical maker, almost $17 billion in claims.

Alley & Ingram partner Brenda Fulmer partnered with Brichfieldis firm, Beasley, Allen, Crow, Methvin, Portis & Miles PC, to file a Vioxx lawsuit about a year ago in Tampa.

Hesitant to talk publicly about the litigation, Fulmer, a Stetson college of law graduate, has experience with Wyeth over Fen-Phen and Bayer AG over Baycol, a cholesterol reduction drug.

Fulmer says the recall of Vioxx o a non-steroidal anti-inflammatory generically known as rofecoxib o made her job a lot easier.

iBasically, with the recall of the drug, we do not have the same legal hurdles that we faced before,i she says. iThere now are certain legal presumptions about the safety of the drug. The (federal) Food and Drug Administration no longer believes the drug is safe or effective.i

Marshalling resources

Fulmer represents Refic Kozic who alleges the heart attack he suffered in April 2001 was caused by Vioxx. Fulmer alleges Merck & Co. knew of the defects as it executed a mass media advertising campaign that touted the drug as an arthritic pain reliever.

During the first seven months of this year, Merck & Co. spent about $49.3 million on Vioxx direct-to-consumer advertising, according to research published in Advertising Age, the advertising industryis trade journal. Magazine research also shows the pharmaceutical company spent about $100 million a year since it rolled out Vioxx in mid-1999.

Fulmer says itis a tough battle for litigators.

For one, the company has deep pockets. It reported net income of $6.83 billion, or $3.03 a diluted share, on total sales of $22.49 billion for the year ended Dec. 31.

Then thereis Merckis defense counsel.

Merck & Co. has a 25-year client relationship with one the nationis top law firms: New York-based Hughes Hubbard & Reed LLP. American Lawyer magazine recently ranked Hughes Hubbard on its annual A-List, a list of the top 20 U.S. law firms.

But the Alabama firm, Beasley Allen Crow Methvin Portis & Miles, has won verdicts or settlements totaling almost $15 billion in 25 years.

In February, Hughes Hubbard asked the U.S. District Court, Tampa, to take jurisdiction in the Kozic lawsuit. Fulmer argued against change of venue. U.S. District Judge James D. Whittemore agreed with Fulmer.

Meanwhile, Hughes Hubbard answered Kozicis allegations of strict liability, negligence, negligent misrepresentation and fraud. On Merck & Co.is behalf, the firm denied each allegation. Then it cited 30 affirmative defenses.

iTo the extent that plaintiff asserts claims based upon an alleged failure by Merck to warn plaintiff directly of alleged dangers associated with the use of Vioxx, such claims are barred because Merck has discharged (its) duty to warn in (its) warnings to the prescribing physicians,i the company claims as its sixth defense.

In its seventh defense, Merck & Co. put the burden on Kozic.

iIf plaintiff had sustained injuries or losses as alleged in the complaint, such injuries or losses were only so sustained after plaintiff knowingly, voluntarily and willfully assumed the risk of any injury as a result of the consumption of, administration of or exposure to any drug or pharmaceutical preparation manufactured or distributed by Merck or other manufacturer,i according to court records.

Prior to the recall, the company classified as frivolous all Vioxx product liability claims.

Instead of attacking the merit of the litigation, the company disclosed it has product liability insurance for Vioxx claims up to $630 million.

That insurance would apply to all claims against Merck & Co., including a class-action shareholder lawsuit in Louisiana federal courts. It alleges the company issued false and misleading statements about Vioxx.

Tough job

Pinellas Park attorney Joseph Saunders has litigated several hundred claims against Wyeth over Fen-Phen. Unlike Fen-Phen, however, Saunders expects a tougher job this time around.

iItis a little more difficult to screen the cases because Vioxx has been shown to trigger heart attacks and strokes,i he says. iBut the population of people (mostly elderly patients) taking Vioxx generally have a high number of risk factors for those conditions.

iSomebody who has chronic arthritis is the same type of patient to have pre-existing coronary artery disease,i he adds. iSo when they have a heart attack or stroke, itis takes a bit of medical detective work to determine what caused it or to what degree Vioxx contributed.i

Tim Anderson, a Prudential Equity Group analyst said in a recently published stock report that of about 84 million Vioxx users, only about 5.5 million used the drug for 18 months or more. Anderson estimates about 83,160 patients may have legitimate claims.

Claims predicted

Anderson expects about 20% of those 83,160 patients to file a lawsuit, he says. That would be about 16,632 potential Vioxx claims.

Prior to the recall, Merck touted the drug to doctors and patients.

iVioxx remains the countryis fastest growing prescription medicine,i the company claimed in its 1999 annual report. The companyis anti-inflammatory sales totaled $2.68 billion last year, up from $2.59 billion the year before. Vioxx accounted for at least 95% of the companyis anti-inflammatory sales last year.

Given FDA approval in 1999, the company did not submit its Vioxx test data for peer review and national publication until about a year later. Later that year, the New England Journal of Medicine published concerns about the use of Vioxx and myocardial infarctions o heart attacks.

In light of the early scientific concerns, a newly published medical journal report criticizes the company and the FDA over their handling of Vioxx.

iThe company sponsored countless continuing medical eeducationi symposiums at national meetings in an effort to debunk the concern about adverse cardiovascular effects,i Eric J. Topol, MD, wrote in the journalis Oct. 21 issue.

iOver the course of the five-and-half-year saga, many epidemiologic studies confirmed and amplified the concern about the risk of myocardial infarction and serious cardiovascular events associated with rofecoxib,i Topol writes.

Yet Merck & Co. continued to invest almost $100 million a year in direct-to-consumer Vioxx advertising.

iConsidering the tens of millions of patients who were taking rofecoxib, we are dealing with an enormous health issue,i Topol writes. iEven a fraction of a percent excess in the rate of serious cardiovascular events would translate into thousands of affected people.