Drug Recall Lawyer Blog

Here are some links to what’s going on the world of drug and device recalls, and pharmaceutical litigation:

• Numerous blog posts featuring inside information on Vytorin and Zetia research studies, including the Arbiter 6 study that we recently posted on (courtesy Schearlings-Got-Plowed).
  
• Twitter hashtag of information on the FDA’s Social Media Meeting (courtesy @skypen).
• FDA celebrates International Internet Week of Action by sending 22 warning letters to operators of websites for illegally selling unapproved or misbranded drugs to U.S. customers.
• Procter & Gamble recalls three lots of Vicks Sinex Nasal Spray, because of bacterial contamination.
• Google Scholar now available to perform legal research—free opinions from U.S. federal and state district, appellate and supreme court opinions.
• Visit the Drug Industry Document Archive (DIDA) for over 1500 drug company documents, many only revealed after litigation. Included are some Wyeth ghostwriting documents (courtesy Tom Lamb).
• Fun new blog on Evidence in Medicine.

It seems that everyone but Merck is satisfied with the results of the Arbiter 6-Halts study (copy in the New England Journal of Medicine). Allen Taylor of the Medstar Research Institute states that “The results are very clear, Niacin was superior.” John Kastelein of the University of Amsterdam said “I fully support” the study’s findings.

Continue reading "More on the Recent Zetia and Vytorin Study" »

Just to clarify, the study itself is not bad; rather, the results are bad for Merck & Co., which already has two studies on Vytorin and Zetia that leave negative conclusions for the drugs. These cholesterol drugs are the subject of a $41.5 million Zetia/Vytorin settlement. Sales of the drugs have sunk down about 14% since January, 2009.

Continue reading "Another Bad Zetia and Vytorin Study" »

Busy week ahead—lawsuits to file, meetings to attend, articles to write and continuing legal education seminars to plan. So, we’ll keep this short:

• More on Aranesp, the anemia drug by Amgen: It is associated with increased risk of stroke in patients with diabetes and chronic kidney disease (courtesy @TomLamb and www.drug-injury.com).
• The FDA will discuss Merck’s cholesterol drugs Vytorin and Zetia as they relate to pediatric-focused safety reviews on November 18 in Maryland. See our prior blog post on the dangers of Vytorin and Zetia).
• A quick criminal history of Pfizer (courtesy @PharmaGossip). Are they more focused on saving lives than making money?
• A little on the merger between Merck and Schering-Plough and their new web issues (courtesy www.shearlingsplowed.blogspot.com).
• More on Accutane, which has been recalled in light of links to inflammatory bowel disease
• New Jersey considers giving mass tort status to the YAZ, Yasmin and Ocella birth control injury litigation

Happy Monday!

Merck & Co. and Schering-Plough have agreed to settle class action lawsuits over their joint cholesterol drugs, Vytorin and Zetia, in the amount of $41.5 million. The settlements are with consumers as well as health plans that purchased the drugs.

The class action lawsuits were not for personal injury damages, but rather for economic damages. The lawsuits alleged that, contrary to manufacturer marketing, the drugs provided no medical benefit over cheaper and generic competitors. The lawsuits came on the heels of a January 14, 2008 study (the Enhance Trial) which revealed that Vytorin was not more effective at reducing carotid artery plaque. In fact, the study was hotly investigated by lawmakers—it seems the drug companies concluded the study in April, 2006, but continued to market their products inappropriately well after the data became available. Why let a little thing like drug effectiveness get in the way of sales?

The plaintiffs in those cases sought to recover reimbursement for the cost of the prescriptions, or the difference between these drugs and the generic alternatives. Of course, compare the settlement to the annual sales of Vytorin since it was first marketed in 2004, which reached $5 billion per year. Granted, that is not all profit, and perhaps there was no bad behavior until January 2008, but it looks like the drug makers win again. It would be refreshing to see them divest all profits from the drug from the time they had data showing that it was basically useless.

Not going to happen.