Drug Recall Lawyer Blog

Here are this week’s stories:

• Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
• Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
• PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
• AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
• Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
• Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
• More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Good morning! Here are the week’s top stories:

• Topamax: Johnson & Johnson is going to pay over $81 million (articles here and here in criminal and civil fines for illegally promoting Topamax. That’s a mere 0.070% of 2009’s $1.15 billion in sales, and 0.039% of 2008’s 2.7 billion in sales (quite the deterrent, eh?). Nevertheless, this compounds J&J’s woes in light of the current Tylenol recall.
• Topamax Whistleblowers: Here’s an article about the courageous Michigan whistleblowers who made it all happen.
• Vaccines & Autism: Dr. Andrew Wakefield, the British physician who wrote the initial Lancet article linking autism to vaccines, has been disbarred from the practice of medicine. He did not offer evidence on his behalf, and he has about a month to appeal.
• BPA—now in cans?: USA Today and Dr. Gupta report on the presence of BPA in cans, and discuss whether pregnant women in particular should be concerned. For more on BPA, see our prior blog posts.
• St. Jude Medical: The FDA recently issued a warning letter to St. Jude Medical about overpromotion of its Epicor Ablation System, used to treat atrial fibrillation. See the Forbes article and the FDA’s warning letter.
• Las Vegas Hepatitis Punitives: See one reactionist and alarmist article, “Health Cost Hikes May Follow $500M Jury Award in Hepatitis C Case.”
• Neurontin: Last week, Pfizer settled a Neurontin wrongful death case for a confidential amount.

Have a great week!

Here are this week’s stories:

• Dietary Supplements: The FDA Law Blog comments about the FDA’s compliance program for dietary supplements.
• Vaccine-Autism Litigation: Drug and Device Law Blog thinks the most recent Federal Circuit decision basically seals the coffin in this litigation.
• Maryland Whistleblower Protection: Pat Malone writes about a Maryland appellate case approving protection of a nurse’s job when reporting dangerous hospital practices. This could have reverberations for other whistleblower cases, including products cases. See this website for more information on the False Claims Act. And, see this website for more about the whistleblower mindset blowing-the-whistle-on-drugmakers-misdeed-takes-guts-stamina.
• Fosamax: most of the belleweather cases will be tried this summer and fall (HT: Shearlings Got Ploughed).
• CT Radiation: great audio article by NPR.
• Big Brother: Pharmalot reports that GlaxoSmithKline doesn’t like its employees visiting CafePharma, a drug blog devoted to employee criticisms of the pharmaceutical and medical device industry.

Happy Monday!

A really nice Bloomberg article on whistleblowers "hit the stands" today. The authors, David Voreacos and Margaret Cronin Fisk did an excellent job of tracing the payouts and controversy surrounding corporate employees of drug companies who alert the DOJ to bad pharmaceutical practices. Essentially, the act of telling the DOJ gives the federal government the ability to recoup millions of dollars, a portion of which is given to the whistleblowers as an incentive payment. Without that payment, few whistleblowers would risk their jobs and peer ostracization to bring these bad practices to light. Some think the payments to whistleblowers are too high. I don't have any problem with it--it may encourage others to report bad practices (and remember--not all whistleblowing cases are accepted, or result in multi-million dollar settlements).

See our prior Seroquel/Whistleblowing blog post.