LawyersandSettlements.com recently shared its list of the hottest consumer-related pharmaceutical legal news stories during the last year. Of note is that while the top drug-related topic on the legal news website in 2011 had been Tylenol—prompted by concerns over a series of Tylenol recall notices as reported by The New York Times; for 2012, the most sought out pharmaceutical topics have shifted to women’s health.
Third-generation contraceptives such as Yasmin/Yaz, NuvaRing and Mirena top the list this year as numerous birth control lawsuits either settled, or began the process of consolidation into multi-district litigation (MDL).
Reader interest in Yaz/Yasmin rose in response to Yasmin lawsuit settlements that were announced in April (In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois, East St. Louis). Bloomberg reported Bayer AG settled about 500 Yasmin lawsuits over claims of blood clots that had, in some cases, led to stroke or heart attack.
Along with Yaz, readers remained concerned about NuvaRing (etonogestrel/ethinyl estradiol) and blood clot risk even as a new study on non-oral hormonal contraception, published in the British Medical Journal (BMJ 2012;344:e2990), was presented at the annual meeting of the American College of Obstetricians and Gynecologists (May, 2012). The study, aimed at quantifying NuvaRing blood clot risk, indicated no significant difference in risk of venous thromboembolism when compared to oral contraceptives.
Still, NuvaRing lawsuits continue and have been consolidated into a federal MDL court in Missouri (In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri). As of September 5, 2012, according to the U.S. Panel on Multidistrict Litigation, more than 1,000 NuvaRing lawsuits have been filed.
Mirena IUD (levonorgestrel) saw an increase in reader interest after August 2012, as Bayer Healthcare Pharmaceuticals, Inc. submitted an Application for Centralized Management of Certain Cases involving Mirena. As FoxNews reported (11/11/12), the request seeks to create a multi-district litigation (MDL) for 16 pending Mirena lawsuits in NJ that allege Mirena caused uterine perforation, infection and hemorrhaging injuries.
After the top three women’s health-related drugs, Pradaxa (dabigatran), an alternative to warfarin, joined the list this year making the Top 5. In November 2012, the FDA issued a Drug Safety Communication regarding Pradaxa bleeding events which in turn helped drive reader interest.
Thousands of LawyersandSettlements.com monthly readers have followed the latest legal news and information on these topics, many of which have fallen from the radar of traditional media outlets.
“We believe these issues are of great importance to the public, mostly due to the life-changing impact they can have on an individual,” said Stephen King, CEO. “Some of our most interesting stories of the year related to pharmaceuticals. Many of them have pending lawsuits or have had substantial settlements related to their life-altering side effects and it’s important to get this information out to the public. While many pharmaceutical companies continue to earn significant profits, people are suffering. They may think they have no recourse but in many cases they do. By keeping these topics alive, LawyersandSettlements.com is helping people stay up-to-date on these important topics every day.”
The LawyersandSettlements.com Top 10 Pharmaceutical Topics of 2012, along with the potential side effects readers were seeking information on, are:
1. Yasmin/YAZ (gall bladder disease, blood clots, deep vein thrombosis, pulmonary embolism)
2. NuvaRing & Mirena (blood clots, infection, perforation of the uterus)
3. Pradaxa (uncontrollable bleeding, lack of an available antidote)
4. Granuflo (elevated bicarbonate levels, risk for metabolic alkalosis)
5. SSRIs (birth defects including heart defects, spina bifida, cleft palate, club foot, PPHN)
6. Actos (bladder cancer, heart failure, kidney failure, rhabdomyolysis)
7. Diethylstilbestrol/DES (cancer)
8. Crestor / Statins (diabetes, cardiomyopathy, rhabdomyolysis)
9. Fosamax (bone fractures, esophageal cancer)
10. Propecia (sexual dysfunction, erectile dysfunction, sterility, prostate cancer)
LawyersandSettlements.com readers are looking for the latest and most comprehensive legal news available. Those seeking legal help can request assistance by completing a form which is then distributed to attorneys specializing in these cases. Over two and a half million people visit the site yearly, and hundreds of thousands of request forms have been submitted by qualified readers looking for legal guidance.
The journalists at LawyersandSettlements.com conduct hundreds of lawyer interviews each year on the latest legal issues—lawsuits, mass torts, class actions, settlements—that our readers are most interested in. The attorneys our journalists interview provide a birds-eye view into the cases we report on. Here are the top 10 attorney interviews that readers clicked during the first half of this year (in reverse order):
10. Attorney Stacy Hauer, co-lead counsel in the Minnesota State Court American Medical Systems litigation, discusses the transvaginal mesh lawsuits being consolidated into an MDL (multi-district litigation).
9. Attorney Tim McCarthy shares insight on the Starbucks class action lawsuit regarding the company’s switch from Tassimo to Keurig single-serve coffee. The lawsuit alleges consumer fraud.
8. Attorney Dr. Shezad Malik discusses the outcome of the FDA advisory panel meeting held at the end of 2011 regarding the safety and efficacy of oral contraceptives, including drospirenone-based birth control drugs Yasmin and Yaz.
7. Attorney Brenda Fulmer, who specializes in medical device litigation, talks about allegations surrounding CardioGen 82 over-radiation.
6. Attorney Eric B. Brown shares some information on making a Social Security Disability Insurance (SSDI) claim and what needs to be included to prove a 100 percent inability to work.
5. Attorney Shaun Setareh—a California labor law attorney—answers five commonly asked questions on filing a wage and hour lawsuit.
4. Attorney Dr. Shezad Malik, who is both an attorney and a cardiologist, discusses Yasmin and Yaz settlements and how Bayer had indicated it would handle settling Yaz claims.
3. Attorney Barry Kramer informs readers about excessive emergency room charges and how it is typically uninsured patients who are victims of hospital overcharging—and compounding the issue, emergency room costs are increasing.
2. Attorney Dr. Shezad Malik on the Yaz litigation concerning oral contraceptives that contain drospirenone and their alleged side effects which range from gallbladder problems to DVTS to stroke—and even death.
1. Attorney Stacy Hauer discusses the legal claim “loss of consortium” and how it plays into the allegations regarding the transvaginal mesh litigation. She explains that, “The woman and their partners who have been injured have significant loss of intimacy in their relationships due to their injuries.”
LawyersandSettlements.com publishes hundreds of lawyer interviews each year on the latest legal issues—lawsuits, mass torts, class actions, settlements—that our readers are most interested in. The attorneys—and expert witnesses—our journalists’ interviews provide a birds-eye view into the cases we report on.
Here are the top 10 attorney interviews that readers clicked during the month of May, 2012 (in reverse order):
10. Attorney Tim McCarthy, from McCarthy Law Group, on the consumer fraud class action lawsuit over Starbuck’s quitting its Tassimo coffee maker deal with Kraft Foods for one with Keurig.
9. Attorney Barry Kramer, on patients who have either paid, or have been billed, excessive emergency room charges.
8. Attorney Andy Hollis of Hollis, Wright, and Couch, P.C., on the case against ADHD drug Adderall.
7. Attorney Mark Thierman, on filing a class action lawsuit on behalf of Las Vegas limousine drivers against Bell Trans, Nevada’s largest limousine company, alleging failure to pay minimum wage and overtime.
6. Attorney Dr. Shezad Malik, on Bayer being in the process of settling certain Yasmin, Yaz and Ocella blood clot lawsuits.
5. Medical consultant and analyst Lana Keeton, on the dangers of synthetic transvaginal mesh and transvaginal sling for Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI).
4. Attorney Dr. Shezad Malik, on the Yaz and Yasmin bellwether trials. (See more info on bellwether trials)
3. Attorney Leonard Emma of The Law Office of Randall Crane, on California labor—what “independent contractor” means and employee misclassifications.
2. California Labor Attorney Randall Crane answers the question: “Can I be Fired if I’m Disabled?“
1. California Employee Attorney Donna M. Ballman, P.A., on bullying and harassment on the job.
Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.
Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.
What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).
According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”
Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.
That was the draft version.
The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”
Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.
According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”
Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.
The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.
Is a new warning label in the offing? Stay tuned.
If you’ve followed news about Fosamax lately, you’ve probably heard the term “bellwether trial” thrown around. The judge in that case has ordered two more bellwether trials in addition to the five that have either already been decided or will be decided later this year. So…
Basically, a bellwether trial is a trial to indicate future trends in a specific litigation. They are used when a large group of plaintiffs have filed suit based on the same theory or claim and the only feasible way to handle the caseload is through a bellwether trial.
Think of it this way—NASA has flight simulators. Marketing departments have focus groups and in-home trials. Pharmaceutical companies have clinical trials. And your local car dealership hands you the keys for a test drive. Law schools may have mock trials, but the only way to really get a sense of how a major lawsuit is going to play out is the bellwether trial.
In a bellwether trial, a small group of plaintiffs is chosen to represent the group. Those plaintiffs are chosen because their issues are common amongst all the plaintiffs. Most large-scale lawsuits, such as asbestos or Fosamax, will run three to five bellwether trials, although the judge can order more or fewer.
Also, because a major lawsuit can take a long time to wind its way through the legal process, the bellwether trials become a key milestone for both plaintiffs and defendants–and are, therefore, eagerly awaited by all involved. For example, talk of Yaz lawsuits (or Yasmin lawsuits for that matter) has been going on for a while. But the first Yaz bellwether trial is scheduled to take place later this year, on September 12, 2011 for pulmonary embolism side effects; that will be followed by one set for January 9, 2012 and finally a Yaz thromboembolic case on April 2, 2011. Given such a drawn out timeline, it’s no wonder everyone looks to Read the rest of this entry »