Drug Recall Lawyer Blog

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

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 406 YAZ, Yasmin and Ocella cases filed or transferred to the Southern District of Illinois before Judge David R. Herndon are proceeding apace.

The Judge has been primarily concerned with case management and establishing procedures that will guide the litigation through to completion, including potentially bellwether trials (early trials that can reveal case strengths and weaknesses as viewed by juries, and which often promote settlement). Also on the Judge’s list has been finding a way to deal with several of the foreign entities. In litigation where foreign entities are involved (in this case, the Germany-based Bayer has several corporate offshoots), service is oftentimes required to be done following procedures set in the Hague Convention, which can include translating documents to the foreign language at issue. (Judge Polster dealt with this in the Gadolinium litigation, and decided that after the translation and service of one complaint following Hague guidelines, formal adherence to those rules were no longer necessary). The Docket of the YAZ cases is here—there are 393 filings to date, with most of them being the opening of “member cases.” Member cases are cases received from other federal courts, transferred to the Southern District of Illinois through MDL protocols. You can also see the following documents:

• Minutes of the December 17, 2009 status conference
• Protective Order, as codified in Order 7 by the Court

For more information on the YAZ, Yasmin and Ocella litigation, see prior Drug Recall Lawyer Blog postings, and see our YAZ injury website.

Six more Yasmin and YAZ lawsuits were filed this week against drug manufacturer Bayer in the United States District Court for the Western District Pennsylvania (Pittsburgh Division).

Added to the usual complaints of negligence and strict product liability, the complaints contain allegations of fraud (that Bayer misrepresented product safety, particularly in the media), civil conspiracy and commercial bribery (that Bayer “knowingly and/or intentionally offered, conferred or agreed to confer benefits, gifts, and/or gratuities or conspired to do the same upon physicians, pharmacists and insurance companies for the purpose of enticing these entities to use the drug YASMIN, and to convince their patients and others of the safety and effectiveness of YASMIN”), and punitive damages.

Bayer maintains that the injuries suffered by the plaintiffs are the same injuries that they were warned about on the packaging. Plaintiffs contend, however, that Yasmin and YAZ increase these risks over and above other contraceptive pills. Complaints filed include the following:

In representations to Plaintiff, her healthcare providers, and/or the FDA, Defendants also fraudulently concealed and intentionally omitted the following material information:

1. That YASMIN is not as safe as other available contraceptives;
2. That the risk of adverse events with YASMIN (drospirenone and ethinyl estradiol) was higher than those of other available contraceptives; [and]
3. That the risks of adverse events with YASMIN was not adequately tested and/or known by Defendants.

For more information on Ocella (the generic version), Yasmin and YAZ lawsuits, please visit our YAZ blog posts and our YAZ injury website.

If you or a loved one has suffered because of this drug—heart attack, stroke, gallbladder removal, deep vein thrombosis, pancreatitis or pulmonary embolism, please contact us at 1.800.553.8082, or click here for an internet consultation.

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" »

The U.S. District Court for the Southern District of Illinois, the center of the federal YAZ MDL litigation, has posted to its website the minutes from the initial conference, held on November 19, 2009.

Nothing surprising happened at the hearing—they followed the same path that many initial conferences take, and the following were discussed:

• Document preservation letters (to make sure parties do not destroy documents that may be important in the litigation)
• Plan for discovery (documents requests were expected within about 4 weeks)
• Discussion of joint case management order (to outline the stages in joint discovery and case management)
• Proper defendant identification (this always happens in cases involving lots of corporate defendants and, particularly here, where Bayer has a number of foreign entities that may or may not be related to the YAZ production and marketing here in the U.S.)
• Agreement on Plaintiff and Defendant Fact Sheets (these are tools to unify discovery—every individual plaintiff fills out a fact sheet, typically 50-75 pages, covering their personal and medical histories. Oftentimes, Defendants will also fill out fact sheets relevant to the specific plaintiffs.
• Document production: the parties expect tens of millions of pages of documents to be produced, and may need the assistance of a document depository (oftentimes, these are remote or electronic) to be a center for common discovery.

A lot of work clearly went into preparing for this conference, and the parties have a lot of work ahead to streamline proceedings and discovery. But, compare this to hundreds of individual cases filed all over the country—this is a good way to handle things and conserve judicial resources.

The next conference is set for December 17.

We continue to get calls every day by healthy (and frequently young) women and their families who have suffered because of this drug—heart attack, stroke, gallbladder removal, deep vein thrombosis, pancreatitis and pulmonary embolism. If you or a loved one has questions about the YAZ, Yasmin and Ocella lawsuits, please contact us at 1.800.553.8082, or click here for an internet consultation.

Earlier this week The Washington Times wrote an article about Yaz and Yasmin. Comfortably couched in the middle is this snippet:

“The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all contraceptives, including ours,” Ms. Talarico [of Bayer] said.

The FDA agrees.

“The safety profiles for Yasmin and other combined hormonal contraceptive products containing estrogen . . . are similar,” [FDA] spokeswoman Karen Riley said.

The gist of the article is that young and otherwise healthy woman are suffering blood clots, and suing Bayer because they believe YAZ and Yasmin birth control pills are the cause. It goes through Bayer’s problems, including the FDA-mandated $20 million corrective ad campaign, and the quality control problems besieging Bayer’s manufacturing plant.

Continue reading "YAZ Risks—Greater Than Or Equal To Other Birth Control Pills?" »

Right now, there are three hotbeds of YAZ, Yasmin and Ocella litigation: Illinois, Pennsylvania, and now New Jersey. Here’s the breakdown:

Continue reading "YAZ Litigation Status" »

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’s YAZ woes continue (see prior posts here, and website here) with the advent of lawsuits just filed by pension funds for firefighters and Philadelphia city employees in the U.S. District Court for the Eastern District of Pennsylvania (Philadelphia). The complaints, filed by Philadelphia Firefighters Union Local No. 22 Health and Welfare Fund and the American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund, alleges, like the product liability cases consolidated in an MDL, that Bayer unlawfully promoted the birth control pill and concealed the increased risks of side effects—including blood clots (which cause strokes, heart attacks, pulmonary embolism deep vein thrombosis) and gallbladder disease.

Continue reading "Pension Fund Lawsuits Against Bayer for YAZ" »

The Judicial Panel on MultiDistrict Litigation (JPML) today approved MDL-2100, In Re: Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation. The hearing was just on September 24—a seven day turnaround time and a great victory for Plaintiffs.

The effect of the order is to transfer all YAZ and Yasmin drug defect cases that are now or later filed in federal courts to the United States District Court for the Southern District of Illinois. The judge in charge of coordinated and/or consolidated proceedings there will be Chief Judge David R. Herndon (a Clinton appointee who, while in private practice, primarily represented plaintiffs in FELA railroad cases).

This is a terrific and exciting move for the YAZ and Yasmin litigation. The MDL will enable attorneys to spend more time working on the common discovery in all of their cases, and less time on case management orders and case-specific motions practice. Consolidation will truly promote judicial efficiency, and will probably lead to a better result for all concerned.

For more on the YAZ, Yasmin and Ocella injuries and lawsuits, see other posts of the DrugRecallLawyerBlog, and our Yasmin/Yaz website.

Judge Herndon

Yesterday was the hearing in Richmond, Virgina to determine whether the Yasmin and YAZ drug injury lawsuits will be consolidated into an MDL. Consolidation would be extremely useful for women and their families who have been injured, because there is going to be a large amount of common discovery to be done. An MDL will really facilitate that discovery (and, will preclude the need for lawyers with numerous YAZ cases from going around the country to mundane case management conferences). But, even if the MDL does not happen, these cases can still be pursued. Women with potential YAZ-related injuries should contact attorneys early--many states have draconian rules on the time limit to bring claims.

These decisions sometimes happen quickly, and sometimes not so quickly. We're hoping for a ruling in the next couple of months. When it happens, we'll let you know.

UPDATE: October 1, 2009: The MDL has been approved. Click here for more details.

For more on these claims, visit:

• Our main Yasmin/Yaz information page
• Yasmin/Yaz Lawsuits Blog (describing the other injuries associated with the birth control pills)
  
• Yasmin/Yaz MDL Motion Filed
  
• What is an MDL? -or- Yasmin/Yaz MDL Filed, Take 2

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This post is not meant to be a fake-out—the JPML has a hearing set for tomorrow before it mulls over whether and where to send federal YAZ and Yasmin lawsuits (see our prior post on the MDL). However, Pennsylvania has what some lawyers call a “mini-MDL” program. Now, cases filed in Philadelphia for YAZ and Yasmin will be consolidated in the Philadelphia Court of Common Pleas. The mass tort program will serve the same purposes as an MDL—it will ensure that the YAZ and Yasmin drug cases are all put before one judge who can manage discovery, motions, and generally make things more efficient.

It is not enough that their pills are dangerous—it now turns out that some of them may not even be effective. The FDA inspected Bayer’s Germany plant in March where drospirenone, the fourth-generation progestin, is created for Bayer’s top-selling YAZ and Yasmin birth control pills. Essentially, Bayer had been sampling their product and averaging the results, then delivering the averaged data to the FDA. Instead, Bayer should have been delivering the results of each sample of the product. Averaging increases the likelihood that the samples will pass efficacy muster.

A copy of the FDA’s letter to Bayer may be found on their website.

This video describes the background of Yaz, Yasmin and Ocella, the status of Yaz litigation, and the injuries that can be caused by these birth control pills (including an increased risk of pulmonary embolism, deep vein thrombosis, stoke, heart attack and gallstones). For more information, see our website and prior blog posts of the Drug Recall Lawyer Blog.

Maryland attorney Ron Miller confronts the speculation about whether the lawsuits and medical studies surrounding Yaz, Yasmin and Ocella will lead to a recall. His analysis is spot on. Besides, Bayer will sell as long as there is decent money to be made.

See Yaz/Yasmin Recall? By the Accident and Injury Lawyer Blog.

In addition to the other injuries caused by birth control pills Yasmin, Yaz and Ocella (including pulmonary embolism, deep vein thrombosis, pancreatitis, stroke, and heart attack), Yaz drug injury lawyers are investigating gallbladder problems.

Doctors and the medical literature report a spike in gallbladder disease among otherwise healthy adults (including young adults), and the only connection appears to be that these women are all taking one of these drospirenone-containing birth control medications. Doctors believe that Yaz can increase cholesterol levels in bile while simultaneously decreasing gallbladder movement, leading to gallstones. Many women must have their gallbladder removed (cholecystectomy), and can suffer from impaired digestion, bloating, gas, heartburn, constipation or diarrhea. Of course, many women have abdominal scars from the surgery. Finally, many people who undergo gallbladder removal must radically change their diet.

For more information on Yasmin/Yaz injuries and lawsuits, see other posts of the DrugRecallLawyerBlog, and our Yasmin/Yaz website.

Our lawyers are investigating Yaz gallbladder injuries. If you want to speak with a Yaz lawyer about potential lawsuits involving gallbladder disease (or any other injury from Yaz, Yasmin or Ocella), call 800-553-8082 or click here for a free Yaz lawsuit case evaluation.

• Yaz Lawsuit Overview
• Gallbladder Surgery Risks

A flurry of new medical articles have come out in the past week regarding Yasmin and Yaz. Here are links and some “talking points.”

Vlieg, et al. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, BMJ 2009;339:b2921.

• This Netherlands study found that all oral contraceptives increase the risk for venous thrombosis by about five times (this is not new news). However, it also found that drospirenone-based oral contraceptives had an increased risk of 6.3 times that of non-users.
  
• The study concluded that many women do not use the safest brands of birth control pills.
• The safest option for women (with regard to venous thrombosis) is a birth control pill that contains levonorgestrel, combined with a low dose of estrogen.

Lidegaard, et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009;339:b2890.

• Drosperinone-containing birth control pills are associated with a higher risk of venous thrombosis than contraceptives containing levonorgestrel.

Yasmin and Yaz both contain the progestin drospirenone—the dangerous one cited in the studies. As a reminder, venous thrombosis is a blood clot that forms in the vein. If the clot breaks off, it can be transported through the circulatory system to the heart or lungs (becoming an embolism). These can be fatal if not treated immediately.

Bayer’s comment on the studies: they haven’t seen the data, and can’t comment. If you listen hard, you can almost hear them circling their wagons.

For more on the Yasmin/Yaz saga, visit:

• Our main Yasmin/Yaz information page
• Yasmin/Yaz Lawsuits Blog (describing the other injuries associated with the birth control pills)
  
• Yasmin/Yaz MDL Motion Filed
  
• What is an MDL? -or- Yasmin/Yaz MDL Filed, Take 2

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