Articles Posted in Bayer

Published on:

Here are the stories we’re following this week.

  • Marketing: Bayer Schering Pharma is set to double its Indian sales team, and triple its workforce in Vietnam in anticipation of a larger market share in the region (Wall Street Journal).
  • Plavix: Black-box warning mandated by FDA: it may be less effective for patients who cannot metabolize it (FDA News Release; see safety announcement).
Posted in:
Published on:
Updated:
Published on:

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com.

Published on:

Copy%20of%20Avandia%20Much%20Ado%20about%20nothing%20Sequel-03-05-10%29.JPGYesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.

This story, the story of Amanda Bennett, Terrence Bennett and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises a number of issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:

Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.

Published on:

Yaz-new%20jersey%29%2802-26-10%29.JPG
On November 10, 2009 we wrote that New Jersey state court Assignment Judge Donald Volkert, Jr. formally requested consolidation of the YAZ, Yasmin and Ocella birth control lawsuits in New Jersey state courts. In an order dated February 9, 2010 (and posted to the New Jersey website on February 18, 2010) , Chief Justice Stuart Rabner ordered that all pending and future state court actions regarding the birth control pills would be designated as a mass tort and assigned to Bergen County Judge Brian R. Martinotti. Furthermore, Judge Martinotti will oversee those cases and may return them to their original counties as he sees fit (presumably for individual trials after common work is completed).

More New Jersey YAZ Lawsuit Information

Published on:

Canada%20Yaz-02-12-10%29.JPGOne thing product liability lawyers look at when litigation medical device and pharmaceutical cases is the experiences of foreign countries with the product at issue. I ran across a story about YAZ in Canada that reminds us of the importance of investigating what goes on outside of our borders (hat tip: Girard Gibbs LLP & The Danko Law Firm)
Starting last year, Bayer was promoting YAZ in Canada through a young television actress, Lauren “Lo” Bosworth. MTV’s announcement is woefully inadequate. Granted, it is not marketing directly from YAZ manufacturer Bayer, but it seems that the actress is doing an end-run around the FDA’s restrictions by talking about the benefits of YAZ with regard to regular PMS symptoms. The article states:

Last week [actually, in 2009], the young actress spent a day in Toronto and then Vancouver doing media interviews, where she focused on the fact that Yaz can lead to fewer symptoms like headaches and cramps during that time of the month.

Continue Reading

Published on:

Yaz-logo-02-09-10.jpgA new article on YAZ and Yasmin lawsuits in the IndyStar sheds a little light on manufacturer Bayer’s defense to the cases:

“But the complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” according to a statement from company spokeswoman Rose Talarie. “Bayer’s oral contraceptives are safe and effective when used according to product labeling. Health-care professionals prescribe oral contraceptives following a comprehensive evaluation of the risks and benefits for the individual woman.”

Bayer’s statement ignores two things:

Published on:

The Yasmin and YAZ litigation continues to heat up in the Pennsylvania market, with over 160 cases filed. On Friday, the parties argued to Judge Sandra Mazer Moss about the full scope of questionnaires (often called “Plaintiff Fact Sheets”) that individual plaintiffs would be required to answer. Bayer is clearly overreaching, here.
Bayer wants to know the sum total of each plaintiff’s contraceptive history, even extending beyond hormonal birth control methods. This is coming from a company that spends untold millions advertising its product directly to consumers in an effort to get them to go on their brand of “the Pill.” They cannot, however, give a good reason for needing to know whether an individual plaintiff used condoms or the rhythm method when she was 25. Furthermore, that request for information, much like the number of sexual partners, is so private and so beyond the scope of this litigation, that the very request for it is offensive. Many young women, for example, may be dissuaded from this litigation if doing so will mean that others, including their parents, might find out too many details about their sexual history (remember—YAZ was marketed to women for the prevention of acne, sexual activity notwithstanding). Even Judge Moss recognized that Bayer was likely asking for more than they were entitled to, when she sarcastically commented that plaintiffs could tell Bayer about the number of sexual partners they had, “then we could put out a brochure and everyone will know.”

Continue Reading

Published on:

Tough to say. It’s in German. And, my German skills were at their highest back in high school. During my trip to Munich for the holidays last year, I was able to competently read road signs and to order a cheeseburger from the local McDonalds. That’s about the extent of my current abilities.
But, Bayer is singing the praises of the new report, claiming that it shows YAZ is as harmless as any other birth control pill, particularly with regard to deep venous thrombosis. The report was written by officials at Swissmedica (the FDA’s Switzerland counterpart). Swissmedica experts reviewed existing studies. Bayer’s website cites the Swissmedica press release that “contraceptives containing the active substance drospirenone have a comparable safety profile to that of other preparations available on the market.” Then, Bayer goes on to state that they’ve examined post-marketing studies on more than 42 million women years of drospirenone use, basically implying that the pill is fine.
But, what does the press release really say?

Continue Reading

Published on:

Bayer-Multivitamin-10-07-09.jpg
Bayer, the manufacturer of other terrific products (YAZ and Yasmin birth control pills: improperly advertised, cause blood clots, and can necessitate gallbladder removal, among other things; gadolinium-based contrast agents: turn skin orange and hard, make movement difficult, and can harden organs; and Trasylol: blood-clotting drug that causes clots, heart attacks, amputations, and kidney failure), also makes multi-vitamins. Today we’ll talk about the selenium-containing Men’s One A Day (MOAD) multivitamin.

Continue Reading