Drug Recall Lawyer Blog

Several FDA groups met on December 8 to review warnings on Bayer’s five drospirenone-containing birth control pills. This meeting is the product of several months of mounting evidence that these birth control pills are unreasonably dangerous, particularly in light of safer alternatives.

First a review: Bayer (through Berlex, a company later enveloped by Bayer) developed and released Yasmin in May 2001. Ocella, manufactured by Barr Laboratories, is the generic of Yasmin. These drugs contain an active progestin ingredient to help prevent ovulation. Many other birth control pills contain the progestin levonorgestrel, but Yasmin and Ocella use the newer (and less tested) “fourth-generation” progestin known as drospirenone.

Yaz was approved by the FDA in 2006, and that’s when the heavy marketing (and sales) really took off. Bayer wasn’t actually printing money, and they didn’t have a printing press in their basement, but this was the closest thing to it. Yaz marketing was calculatingly directed at women’s sense of individuality and freedom. Nefariously, it was also directed to uses not approved by the FDA, including PMS, bloating, muscle fatigue and aches. Because of the excellent marketing campaign, Yaz and Yasmin profits were $998 million in 2008.
Predictably, the problems then started surfacing: venous thromboembolism (blood clots) and pulmonary embolism, all leading to strokes and heart attacks. There is also a significant number of studies and anecdotal evidence suggesting a link between drospirenone and gallbladder injuries. Many young and healthy women with no other risk factors are having their gallbladders surgically removed. The only commonality is that they all use a member of the Yaz-family of birth control pills.

After the FDA slapped Bayer with an order requiring $20 million in corrective advertising to undo all of the damage they had done, Bayer needed something to help its new image problem. The answer? A Hollywood-style reboot of the formerly famous pills: Safyral (Yasmin with vitamin B) and Beyaz (also with vitamin B). These are lackluster attempts to regain market share.
A few days ago the FDA had a meeting. The Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee met and took a vote. 21 out of 26 members concluded that the risk profile of these drugs was not adequately reflected in package warnings. They noted, however, that benefits of the drugs may outweigh the risks. In this case, though, it seems it might be a good idea to warn about those risks and let patients and their doctors decide. This was an advisory committee meeting, and the FDA will now have the chance to follow its recommendations and require a new warning (the likely result), or opt to leave the situation alone.

For more information about Yaz, Yasmin and Ocella, see our main webpage.

In the Yaz lawsuits pending around the country, plaintiffs' lawyers argue that blood clots are unacceptable risk of Bayer's decision to add drospirenone to birth control pills. It is not just plaintiffs' attorneys beating that drum. Numerous studies have been published in recent years which showed an increase in risk of blot clot formation in birth control users, and showed decrease in risk with decreases in estrogen dose. But does Yaz/Yasmin cause particular risks?

Earlier this week the British Medical Journal (BMJ) published a study on Danish women, aged 15-49 during 1995-2009, focusing on results after the release of oral contraceptives containing drospirenone. Information was compiled for more than 1.7 million women. Stating the obvious, this is a huge study group. The study was designed so that any confounding factors such as body mass index, smoking, surgery, and social class were addressed, to ensure a robust analysis of the data. As a result, a total of 1.3 million women were included in the analysis. Women were categorized based on birth control pill use, type, dose, and length of use.
A total of 4,307 cases of venous thrombosis (blood clot in the vein) were identified, though not all occurred in women using combined contraceptives. Of these cases, 26% resulted in pulmonary embolism (blood clot travelling to the lung), 63.6% were deep venous thrombosis, and 6.6% were unspecified. The remaining were among cerebral venous thrombosis (blood clot in the veins of the brain), vena cava thrombosis, and kidney venous thrombosis. Approximately 2% suffered a stroke.

Continue reading "Yaz Lawsuits: Another Weapon for Plaintiffs' Lawyers" »

Bayer is facing over 6,000 lawsuits involving Yaz/Yasmin. Yaz sales are plummeting. Bayer is in trouble. Lawsuits are all that matter to these drug companies and it's time to stop pretending otherwise.

Oh wait. Not at all. The German pharmaceuticals giant shrugs off these minor nuisances. Sales rose 5.4 percent in the second quarter. Profits keep flowing.

Lawsuits seem like the whole universe to product liability lawyers and to the in-house lawyers. But they are really a just a drop in the bucket to big drug companies.

Like every plaintiff''s lawyer and their mother, we have been trying to attract potential Yaz lawsuit clients. I think the Yaz cases are going to be good and I think when all is said and done, Yaz/Yasmin is going to come off the market and Bayer is going to reach a global settlement in these cases.

The FDA may indirectly push that ball along. The FDA now says it will take another look at the risks that accompany Yaz/Yasmin. The big risk that Yaz lawsuits allege that are going to make up most of the larger Yaz settlements should these cases resolve are the deep vein thrombosis (DVT)/ pulmonary embolism (PE).

Continue reading "Yaz Lawsuits: FDA Will Look More Closely" »

The U.S. subsidiary of Bayer AG, Bayer HealthCare Pharmaceuticals is facing a "$100 million" class action lawsuit from six class representative plaintiffs alleging illegal gender discrimination.

This lawsuit against Bayer claims that Bayer discriminates in pay, promotions, and the treatment of pregnant women. Bayer allegedly - and I find this hard to believe - published and distributed articles hinting that men are better suited to be managers than women.

Plaintiffs' lawyer said:

Bayer engages in systemic discrimination against its female employees - particularly those with family responsibilities - by paying them less than their counterparts, denying them promotions into better and higher paying positions, limiting their employment opportunities to lower and less desirable job classifications, and exposing them to different treatment and a hostile work environment. To make matters worse, Bayer is often blatant about its disregard for its female employees.

I have no idea if there is any merit to this and I doubt anyone outside of the Bayer circle really knows.

Bayer was also bizarrely in the news earlier this month when a plaintiffs' lawyer in the Yaz/Yasmin lawsuits started beating up a Bayer corporate witness over Bayer's role in the Holocaust, starting the deposition by talking about the Holocaust. Why the Holocaust is relevant to the Yaz lawsuits is beyond me. Personally, I think attacking Bayer about the Holocaust deflects historical blame from the real bad guys: the people who participated in the atrocities.

The Yaz/Yasmin MDL lawsuit picture became a little bit clearer as the MDL judge
set forth a plan for the bellwether trials. The first trial will be a pulmonary embolism
case on September 12, 2011. Over plaintiffs' lawyers' objections, the second trial
will be a gallbladder case on January 9, 2012. The third bellwether trial will be a
thromboembolic (VTE) case on April 2, 2012. The court also lays out the scheduling
order in these cases.

The purpose of these bellwether trials is to begin to get an assessment of what the values of these three types of Yaz/Yasmin cases will be in hopes of bringing about a global Yaz/Yasmin settlement. How much is a Yaz/Yasmin case worth? Anyone who thinks they know for sure is kidding themselves. But you can be pretty confident Bayer is going to continue to dig in until either verdicts start coming back against them or Yaz/Yasmin's market share continues to plummet; because it is hard for any drug company to lay off the gas defending lawsuits where the drug remains profitable and on the market. Bayer has set aside almost $70 million to pay for "anticipated defense costs" to defend the Yaz and Yasmin lawsuits which means, at least in the short term, Bayer is hunkering down for a fight.

The court's order setting forth the MDL trial schedule contains some interesting analysis on the MDL judge's thinking on what cases should be included in the bellwether trials.

Okay, it's a bad play on words.

Bayer (you know them b/c they also make Gadolinium, the subject of other lawsuits) has just lost the fifth straight trial over long-grain rice crops. The Washington Post detailed the overwhelmingly successful efforts of farmers to prove to juries that Bayer's genetically engineered seeds were contaminated, causing U.S. crop exports to plunge, and hurting the business of domestic farmers. There are 500 more cases, and Bayer has already lost $52 million.

Reviewing the YAZ website (“know the enemy”), it seems that Bayer is still contending that YAZ and Yasmin are no riskier than other drugs—that is, the drugs have “comparable” risks to other birth control pills on the market. Here’s the “News You Need To Know” (according to Bayer):

Do YAZ or Yasmin carry any greater risk for blood clots (VTE), than other birth control pills? According to the product information, the scientific data indicates that the risk of developing blood clots while taking YAZ and Yasmin is comparable to other birth control pills.

I’m not sure why this is according to the product information and not according to the scientific data directly, but it isn’t entirely truthful. Even in Bayer’s best case scenario, the scientific data is mixed on the issue. Some data supports their risk assessment, and some data challenges it. However, Bayer is claiming that the two studies contrary to their position (one by Lidegaard, the other by Van Hylckama) are unreliable.

We’re still waiting for the new product labels, both here in the States and in Europe. It will be interesting to see the differences between the two.

Here are this week’s stories:

• Shoulder Pain Pump MDL Denied: The Judicial Panel on Multidistrict Litigation denied the plaintiffs’ request for consolidation in an Order. I disagree with the rationale).
• Hospira: Drug-maker Hospira received two FDA warning letters about manufacturing problems.
• Bayer Price-fixing: The Mississippi Supreme Court has overturned a trial court’s dismissal of a case alleging that Bayer inflated drug prices and “drove up the state’s Medicaid spending.” The attorney arguing the case told the Court that Mississippi lost over $1 billion because of Bayer’s fraud.
• YAZ: The LA Times has an article about the YAZ litigation and injuries. The picture’s caption says that “Studies have not found an increased risk with these pills”; though further in the article it acknowledges that “Research on the issue is divided . . . . some studies show a sixfold greater risk.”
• Kugel Mesh: Ron Miller reviews the recent trial.
• Epilepsy & Depression Drugs Linked to Suicide: A new study gives patients reason to talk to their doctors, especially about off-label uses of these drugs (HT: Drug Injury Lawyer Blog).

Have a great week!

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).
• DuPuy Hip Replacement Lawsuits: Johnson & Johnson is ending sale (though, not recalling) its DuPuy ASR metal-on-metal hip replacement system due to a high failure rate. (HT: Maryland Injury Lawyer Blog).
• Vaccines and Autism: The link between autism and vaccines become more and more attenuated in light of three rulings last week (The New York Times).
• Nerd link of the week: Click here.

Happy Monday!

We've updated our YAZ lawsuit webpage (which includes claims against Yasmin and the generic birth control pill Ocella). Check it out here.

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. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

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 " »