Drug Recall Lawyer Blog

Yesterday 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.

The last four days of Mr. Bennett’s life cost his insurance company $43,711. My mom, a respiratory therapist in Colorado, says that extraordinary measures and costs in the last days of life are the norm. My review of medical records and bills in my own clients' catastrophic cases confirms it.

The story also brings this to mind: though the focus of this blog is on defective drugs and medical devices, it goes without saying that drug companies and medical device manufacturers do great things. They develop products that frequently do help people to live better (if not longer), lives. Of course, our focus is on the negative 5-10% of their behavior and products (I’m just making numbers up, here. You get the idea). The majority of the time, the products are good, and the decisions are responsible. Genetech Inc. and Bayer AG paid for experimental medications for Mr. Bennett. That’s a responsible and noteworthy thing to do.

Clearly, as Dr. Ross notes in his editorial from yesterday’s post, there is a cost-benefit analysis to bringing new drugs to market and approving them. Everyone agrees to that. And, when we decide where the line is that allows some drugs and excludes others, someone is going to be unhappy. But the line has to be drawn somewhere, and we need to do it with the best information possible.

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).

Judge Martinotti has been busy at work, and has already filed a twelve-page initial case management order. Interestingly, in the order’s preamble he cites the Manual for Complex Litigation, which is commonly used for MDL proceedings, but has wide use for even state-run mass litigation. Here are the order’s highlights:

• Initial conference set for April 26, 2010 at 10:00 a.m.
• Counsel are required to confer regarding the judge’s proposed agenda
• Counsel are required to submit brief statements regarding the status of the cases
• All motions are stayed
• Discovery may proceed, and automatic discovery of certain matters is required to begin immediately
• Parties are encouraged to agree on electronic discovery protocols, document depositories and protective orders
• Parties are limited to three pro hac vice attorneys, except for good cause

As with all consolidated mass torts, this will go a long way toward streamlining the process, preventing duplicative discovery and inconsistent rulings. Everyone wins.

One 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 "YAZ in Canada" »

A 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:

1. It ignores the evidence that YAZ and Yasmin are more dangerous than other comparable birth control pills. That is, a woman’s risks of encountering “side effects” (read: blood clots, deep vein thrombosis, stroke, gallbladder disease/removal, pulmonary embolism, pancreatitis and heart attack). So, it is irrelevant that the risks were warned about—the point is that YAZ and Yasmin have a much higher rate of risks.
2. Overlooking the fact that Bayer knows women often control their own prescriptions (or else, why would they spend so much money on Direct-to-Consumer (DTC) Advertising) it presumes that health-care providers, when writing prescriptions for YAZ and Yasmin, knew that Bayer’s products were more dangerous, but prescribed them anyway for other reasons. The problem is, Bayer wasn’t warning doctors about the relative risks (YAZ and Yasmin versus other comparable products).

Bayer is trying to steer the conversation to one they can control and win. No one disputes that all birth control pills carry risks. It’s just that women taking YAZ and Yasmin have an increased chance of risk exposure.

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 "Bayer Wants Private Information About YAZ Users" »

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 "What Does A New Report Say About YAZ?" »

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 "On Multivitamins and Medical Benefits " »