Ortho Evra, Preemption, And The New York Times: Another Drug Company Response Letter

And, We Learn About More Of Merck's Vioxx Shenanigans -- Another Benefit Of Pharmaceutical Product Liability Litigation

(Posted by Tom Lamb at DrugInjuryWatch.com)

For the second time in as many weeks, it was the Johnson & Johnson (J&J) company blog that tipped us off that Ortho-McNeil is responding to an item from The New York Times by posting a letter on the Ortho Evra web site.

To start, on April 14, 2008 the Times ran an editorial, "The Dangers in Pre-emption", which begins:

The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices....

Next, here's the same-day post on the J&J blog, titled "ORTHO EVRA and Preemption — Revisited":

Today, The New York Times editorial page commented on the concept of preemption, basing much of their position on an April 6 New York Times article on the same subject and once again featuring ORTHO EVRA®, the birth control patch marketed in the U.S. by our Ortho-McNeil unit. Today, Ortho-McNeil published a letter from David Norton, the Company Group Chairman, Worldwide Commercial and Operations, who is responsible for the Ortho-McNeil business that provides more context from our perspective for those who are interested.

If you prefer, go directly to this "April 13, 2008 Employee Follow-up Communication", written by Ortho-McNeil's David Y. Norton.

Meanwhile, in a convenient coincidence, in the past couple of days there has been a tremendous amount of media coverage given to the discovery that Merck used "ghostwriters" for Vioxx articles and failed to disclose to the FDA an internal analysis which found Alzheimer's patients who were taking Vioxx in a clinical study sponsored by Merck had a three times greater risk of death than patients taking a placebo.

As summarized by Peggy Peck for MedPage Today in an April 15, 2008 online article, "Rofecoxib (Vioxx) Studies on Mortality Were Controlled by Drug Company":

Ongoing litigation about rofecoxib (Vioxx) has provided confirmation that Merck employees or hired ghostwriters were the true authors of manuscripts about the drug published as the work of academic researchers.

That finding was published in the April 16 issue of the Journal of the American Medical Association along with a second study -- also mined from a paper flood uncovered by lawyers -- that suggests Merck manipulated data to hide an increased mortality risk with rofecoxib.

Bruce M. Psaty, M.D., Ph.D., and Richard A. Kronmal, Ph.D., of the University of Washington in Seattle, said Merck told the FDA that an intention-to-treat analysis of data from three trials designed to assess the effects of rofecoxib on the occurrence or progression of Alzheimer's disease revealed an increased mortality risk with the drug....

The underlying study is "Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From Rofecoxib Litigation (JAMA. 2008;299(15):1813-1817).

For additional detail, we turn to "Merck May Have Misrepresented Vioxx Risks", by Anna Sophia McKenney, and posted April 16, 2008 at Medical News Today: 

The risk-benefit profile of rofecoxib (marketed under the names Vioxx, Ceoxx and Ceeoxx) may be have been misrepresented by the study sponsor, Merck, in clinical trials with patients with cognitive impairment. This was the result of a comparison of internal company documents, data submitted by the company to the Food and Drug Administration (FDA,) and published clinical trial results, according to an article in the April 16 issues of JAMA....

... These documents were made available during litigation related to rofecoxib and Merck, including internal company analyses and information provided by the sponsor to the Food and Drug Administration....

It seems to me that this conduct by Ortho-McNeil and Merck demonstrates that federal preemption is a concept which does not fit the reality of how drug companies "interact" with FDA officials as regards the safety of their products.  Likewise, what we have learned about Ortho Evra and Vioxx as the result of pharmceutical product liability litigation shows why preemption is a bad idea.