The extensive direct-to-consumer advertising for Vioxx will not undercut Merck's ability to assert a "learned intermediary" defense against personal injury claims, the company told analysts Dec. 14.

One issue "in the learned intermediary defense is that I think that a lot of commentators are asking the question if patients are making decisions to seek their physicians on the basis of DTC ads, does that in some way undermine the defense that's called the learned intermediary defense?" Merck Senior VP & General Counsel Kenneth Frazier said at the company's annual business review in Whitehouse Station, N.J.

Frazier was responding to a question about how erosion of the learned intermediary doctrine in pharmaceutical product liability cases could impact Vioxx litigation.

"We still believe the way our DTC ads are set up that what we ask patients to do is to go consult their doctor. We think our DTC ads actually are wholly consistent with the philosophy underlying the learned intermediary rule, i.e. that the patient ought to talk to their doctor, that the doctor ought to make an appropriate individualized judgment on behalf of the patient."

Merck heavily promoted Vioxx (rofecoxib) with DTC ads during the 64 months the product was on the market (¹ Also see "Vioxx Withdrawal Fuels Criticism Of DTC; Liability Exposure May Be Test" - Pink Sheet, 11 October, 2004., p. 4).

Vioxx was voluntarily withdrawn Sept. 30 after long-term data from a colon polyp study showed an increased risk of myocardial infarction and stroke after 18 months of use (² Also see "Merck After Vioxx: No Merger, But No Big Near-Term Launches" - Pink Sheet, 4 October, 2004., p. 3).

The learned intermediary defense can shelter pharmaceutical companies from liability because patients must obtain a prescription for a drug from a physician.

The doctrine generally relieves manufacturers from a duty to warn consumers about risks as long as physicians receive adequate safety information.

However, the N.J. Supreme Court ruled in an August 1999 case stemming from Wyeth's Norplant that the learned intermediary doctrine does not apply to the direct marketing of drugs to consumers.

The court said patients deprived of "reliable medical information" as a result of DTC ads could establish that the misinformation was a substantial factor contributing to their use of the product (³ Also see "DTC Ads Fall Outside "Learned Intermediary" Protections, N.J. Court Rules" - Pink Sheet, 16 August, 1999., p. 15).

Frazier asserted that Merck's DTC ads "actually provide a benefit to patients."

"From a legal perspective, we are scrupulous about making sure that our DTC ads meet the legal requirements," he said. "At no point has FDA or anyone taken issue with the DTC ads involved with Vioxx."

Vioxx promotional materials have been the subject of objections by FDA's ad review division.

Merck received an ad division letter in 1999 objecting to a Vioxx reminder print ad less than two months after the drug was approved; the challenged ad ran only in Puerto Rico, Merck said (⁴ Also see "Merck Fosamax Reminder Ads Should Be Withdrawn - FDA Ad Division" - Pink Sheet, 23 August, 1999., p. 23).

In a September 2001 warning letter, FDA said that Vioxx promotional materials minimized the COX-2's cardiovascular safety profile. The letter focused on company-sponsored promotional audio conferences, sales reps' statements at professional meetings and a company press release (⁵ Also see "Merck Vioxx Warning Letter Could Be Incentive For Large Cardio Safety Study" - Pink Sheet, 1 October, 2001., p. 22).

Merck officials provided an update on the Vioxx personal injury litigation during the business review.

To date, 475 cases have been filed. Forty percent of the cases are in federal court, with the remainder in state courts. The company will seek to move all the state-based proceedings to federal court.

Merck expects the first Vioxx trial to commence in the first half of 2005 in either Texas or Alabama.

The company said it will oppose plaintiffs' efforts to certify cases as class actions.

Merck also said it has no interest in a global settlement; rather, each case should be considered on its own, Merck said.

Vioxx DTC Ads Consistent With “Learned Intermediary” Defense, Merck Says

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