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Judge lets Vioxx lawyers discuss FDA memo.


ATLANTIC CITY Atlantic City, city (1990 pop. 37,986), Atlantic co., SE N.J., an Atlantic resort and convention center; settled c.1790, inc. 1854. Situated on Absecon Island, a barrier island 10 mi (16. , N.J. -- A day after refusing to admit a U.S. Food and Drug Administration memo into evidence, the judge hearing a Vioxx product liability case had a change of heart, telling lawyers for both sides they could discuss its key conclusions but not show it to jurors.

In an unexpected twist, state Superior Court Judge Carol E. Higbee ruled Tuesday that an expert cardiologist testifying for Vioxx maker Merck & Co. could be questioned about the memo. It said other anti-inflammatory drugs Anti-inflammatory drugs
A class of drugs that lower inflammation and that includes NSAIDs and corticosteroids.

Mentioned in: Antirheumatic Drugs
 also carry risk of heart attack, stroke and death.

Merck wants jurors to see the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 memo because it concludes there's no risk to patients with short-term use of Vioxx and other Cox-2 inhibitors Cox-2 Inhibitors Definition

Cox-2 inhibitors are non-steroidal anti-inflammatory drugs (NSAIDs) which selectively inhibit cyclooxygenase-2. The cyclooxygenases are required for the creation of prostaglandins.
, a newer class of anti-inflammatory drugs that are easier on the stomach. That goes to the heart of Merck's defense in the suit brought by Frederick "Mike" Humeston. He blames his 2001 heart attack on Vioxx, which he took for two months.

However, the memo also says Cox-2's are associated with increased risk of cardiovascular events--heart attack, stroke and death. And it recommends a "black box warning"--the most serious possible--on the detailed package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific  of all three Cox-2 drugs: Vioxx, Celebrex and Bextra. Those two elements could bolster Humeston's case.

"There's an upside for both sides," said Humeston attorney David Buchanan David Thomas Hugh Buchanan (born May 6 1986 in Rochdale, England) is a Northern Irish footballer, currently playing for Bury. Statistics
Club Performance
Club Season League FA Cup League Cup Other Total
. "From our perspective, it's that the FDA said Cox-2 inhibitors are associated with an increased risk of cardiovascular events."

Higbee, who had barred the April 6, 2005, memo previously and again Monday, said Tuesday that she stood by her belief the 19-page memo would confuse jurors, but that jurors should hear its conclusions.

Higbee sent to jurors home without them heating any testimony, then met with attorneys in chambers in chambers adj. referring to discussions or hearings held in the judge's office, called his chambers. It is also called "in camera." (See: in camera)  for nearly two hours before announcing the ruling.

Kevin Thornton, an Atlantic City defense attorney monitoring the trial, said Higbee's decision could help Merck because Humeston took Vioxx briefly.

Merck pulled Vioxx off the market in September 2004 after an internal study showed Vioxx doubled risk of heart attacks and strokes after 18 months of use.

Merck would rather have the entire memo shown to jurors, said spokesman Jim Fitzpatrick.

Also Tuesday, Higbee agreed to a request by Merck and Humeston to have all nine of the sitting jurors decide the verdict.

Instead of designating three as alternates and six deliberating, the two sides asked that all nine deliberate at the end of the case. Seven votes will be needed to reach a verdict.

Humeston, 60, a postal worker from Boise, Idaho, took Vioxx for lingering knee pain from a Vietnam war Vietnam War, conflict in Southeast Asia, primarily fought in South Vietnam between government forces aided by the United States and guerrilla forces aided by North Vietnam.  wound. Merck says Humeston's job stress and health risks, not Vioxx, caused his heart attack.
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Title Annotation:Food and Drug Administration
Author:Curran, John
Publication:Los Angeles Business Journal
Geographic Code:1USA
Date:Oct 26, 2005
Words:446
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