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Unsealed Bayer Documents In Lawsuits Show Yasmin Poses Significant Risk of Deep Vein Thrombosis and Pulmonary Embolism
As we reported in a previous blog, tomorrow the FDA will be considering safety findings on Yasmin and Yaz, but will not be armed with some alarming data Bayer apparently withheld from U.S. regulators.
The former head of the FDA, David Kessler, stated in a document unsealed yesterday by the MDL court in Illinois, that Bayer withheld findings of its own company researchers that demonstrated an increased rate of blood clots in users of its birth control pills. This data, along with other information concerning increased rates compared to other oral contraceptives, was left out of the data Bayer presented to the FDA in 2004. The presentation was a review of Yasmin’s safety.
Because Kessler’s report (along with four other expert opinions) was sealed until yesterday, it was not made available to the FDA in time for tomorrow’s hearing. The deadline for submission, according to Kalyani Bhatt of the FDA’s Division of Advisory Committee and Consultant Management, was November 23. While we at The Levensten Law Firm are disappointed the FDA will not have a chance to review these documents in tomorrow’s hearing, the unsealing of these expert opinions nonetheless help provide more information regarding the knowledge Bayer withheld concerning the safety of Yasmin contraceptives.
Kessler’s report stated that in a draft of an internal report, Bayer employees wrote that Yasmin has a “several fold increase in the reporting rates for DVT (deep venous thrombosis), PE (pulmonary embolism), ATE (arterial thromboembolism) and confirmed VTE (venous thromboembolism)s” compared to three other oral contraceptives.
The report of John Abramson, a Harvard medical school professor, was another of the unsealed documents yesterday. According to the document, Bayer’s Berlex unit paid a well-known gynecologist in LA, Judith Reichman, $450,000.00 to support her book tour. Berlex officials in an email said the money would be compensation for the doctor’s pushing of off-label benefits of Bayer products. Yasmin has only been approved as a contraceptive, but these documents provide further support that Bayer has actively pursued public mentions of possible off-label uses, including paying an author/doctor hundreds of thousands of dollars, to avoid the FDA restrictions on marketing.
Filed under: Yaz Yasmin Ocella Side Effects by levensten
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Transvaginal Mesh and Vaginal Sling Products Pose a Risk of Serious Injury from Life-Threatening Side Effects
For women experiencing Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI), placement of transvaginal surgical mesh was intended to help reinforce the weakened vaginal or urethral walls. Ideally, the permanently implanted surgical mesh would repair POP and/or treat urinary incontinence.
In 2008 the United States Food and Drug Administration (FDA) noticed that the number of ‘adverse events’ reported in the previous 3 years was “over 1,000.” The Adverse Event Reporting System of the FDA is a database for voluntarily (and in the case of a manufacturer receiving an adverse event report, mandatorily) reported information regarding safety concerns and medication errors. In this case, the reports, most specifically, included the erosion of the mesh through the vagina. Reports of pain, infection, bleeding, pain during sexual intercourse, as well as organ perforation and urinary problems, were also among the most frequently reported problems.
Unfortunately, the FDA’s 2011 summer update indicated that such serious complications are “NOT RARE.” Just as troubling, the FDA stated that it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” This is worrisome and even scary for tens of thousands of women who went through the trying ordeal of placement of ‘permanent’ mesh with the thought they would be resolving POP. Study of published scientific literature indicates that the erosion of the mesh through the vagina is the most common mesh-related complication from transvaginal surgical mesh for POP repair. To repair the damages caused by such erosion can take multiple surgeries, with no guarantee of success.
If you have had transvaginal mesh implanted and suffer from any of the symptoms, including but not limited to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse, urinary problems, neuro-muscular problems, pain, infection, bleeding, vaginal scarring/shrinkage, and/or emotional problems, please contact our attorneys at The Levensten Law Firm, P.C. Please call or email to speak with one of our understanding, knowledgeable and caring male or female attorneys for a free case evaluation. Your conversation will be kept confidential, regardless of whether you do choose to pursue your potential case, but we urge you to contact us as soon as possible because any claim you may have is governed by the Statue of Limitations in your state, which sets deadlines for the filing of your lawsuit.
Filed under: Transvaginal Mesh by levensten
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Merck Failed to Adequately Warn That Propecia is Associated With Permanent Impotence, Erectile Dysfunction, Depression, Endocrine Crash and Other Harmful Side Effects
The Levensten Law Firm is currently investigating the filing of Propecia lawsuits against Merck for its failure to adequately warn of Propecia’s harmful side effects. Studies show that Propecia is associated with permanent impotence, erectile dysfunction, depression, endocrine crash and other harmful side effects.
By way of background, Propecia is marketed to treat male-pattern baldness which is caused when dihydrotestosterone (DHT), a hormone related to testosterone, stops hair follicles from producing. DHT causes approximately 50% of males to bald as they age. Propecia is very expensive, and costs close to $2.00 per dose. For Propecia to work, it must be taken daily. Propecia is Merck’s blockbuster cure for baldness. Although most insurance plans don’t pay for Propecia, it generated approximately $447 million for Merck in 2010.
Research available to Merck for many years showed that Propecia causes a statistically significant number of sexual adverse events in men. A 2003 study in the Journal of Urology studied 3,040 men, ages 45 to 78. 15% of the men on finasteride (the generic name for Propecia) suffered new sexual side effects in the first year, compared to only 7% of the study subjects who weren’t on finasteride (Propecia). Hunter Wessells, M.D., chairman of the department of urology at the University of Washington School of medicine, was the lead investigator, and concluded, “there were real, ill effects from the drug… In some men, finasteride (the generic name for Propecia) caused erectile dysfunction; in others it decreased ejaculate volume; in others it reduced libido.”
As the problem in men using Propecia emerged, Merck exacerbated the problem by urging patients to stay on Propecia, stating the side effects lessen over time. The fine print in Merck’s label claimed that the side effects usually stop over time and disappear entirely in men who discontinue the drug. For many unfortunate victims, the Propecia side effects didn’t subside and were permanent. Merck only tells patients to quit taking the drug if there is no improvement, but by that time, it can be too late. Additionally, Merck failed to tell patients in its label that among the patients who dropped out of Dr. Wessells study, only half saw full resolution of their symptoms six (6) months after discontinuing the medication. Half of the patients who dropped out did not get better.
Cases involving men who discontinued Propecia but experienced persistent sexual dysfunction continued to grow at an alarming rate. Researchers at George Washington University and the Greater Baltimore Medical Center proceeded to study a group of victims of post-finasteride syndrome (PFS). A board certified endocrinologist found 71 men who were in good physical, psychological and sexual health before they took finasteride (the generic name for Propecia). It’s reported that after taking the drug, 90% suffered from low sexual desire, erectile dysfunction and decreased arousal – after being free of finasteride for 40 months on average. It was further reported that one man did not improve after being off the drug for 11 years.
To make matters worse, some men who discontinue the drug are experiencing an “endocrine system crash.” This is when the symptoms return more severe than ever, but accompanied by new ones such as hot flashes, extreme fatigue and changes to the structure of the penis and scrotum, which begin to shrink. The libido can vanish completely.
Studies also show that finasteride (the generic name for Propecia) can alter a man’s brain chemicals which play a role in reducing anxiety, enhancing memory, regrowing brain cells and helping people sleep. Two studies have shown that finasteride may cause the onset of depressive symptoms. Last year, researchers in Germany found that the drug inhibits the growth of new neurons in the brains hippocampus.
In 2008, the Swedish regulatory authorities required Merck to change Propecia’s label to include reports of persistent erectile dysfunction after discontinuing the drug. Italy and the UK then required similar label changes as a condition of further marketing the drug in those countries. The FDA required Merck to add adverse event reports to the postmarketing section of Propecia’s label, but Merck knows these changes are not enough to adequately warn of the risk.
The Lawyers at the Levensten Law Firm believe that the risk of permanent sexual dysfunction should appear in a black-box, let alone the warnings or precautions section of the label. Clearly, a physician will conclude that the risk of endocrine crash outweighs the benefit of treating male-pattern baldness. Certainly, no patient would choose hair over impotency. Still, people question why Merck has informed European countries about persistent sexual side effects after discontinuation, but hid it from the United States and Canadian market. We believe that Merck put profits over safety in an attempt to protect its block buster drug.
On April 19, 2011, faced with new research and Propecia class action lawsuits, Merck finally updated the label to include reports of erectile dysfunction that continued after discontinuation of Propecia. Incredibly, Merck continues to deny a causal relationship between Propecia and erectile dysfunction. This is truly a public health crisis in men as Merck cannot reliably estimate how many men are victims of Propecia’s harmful side-effects. The same problems are being found with Proscar, the brand of finasteride prescribed for prostate enlargement.
If you took Propecia and are suffering from sexual dysfunction, including impotence and/or erectile dysfunction, and are seeking legal representation, you may feel free to contact the lawyers at the Levensten Law Firm for a free case evaluation. After a review of your case, we will promptly advise you if the Levensten Law Firm can file a Propecia lawsuit on your behalf. As your claim is governed by a statute of limitations which sets deadlines for the filing of your lawsuit, you should act promptly to protect your rights.
Filed under: Propecia by levensten
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Bayer Attacks Philadelphia County Mass Tort Program Seeking to Scatter Yaz Victims’ Cases Across The Country to Gain Advantage in Yaz Litigation
In an effort to gain an advantage in the Yaz, Yasmin and Ocella personal injury litigation, Bayer launched an assault on the Philadelphia County Mass Tort program and the experienced judges who administer it. Bayer recently filed a King’s Bench petition asking the Pennsylvania Supreme Court to hold that the Philadelphia County Mass Tort program is an inconvenient form for Bayer to defend lawsuits by out-of-state plaintiffs who suffered side effects ranging from Deep Vein Thrombosis, Pulmonary Embolisms, Strokes, Heart Attacks, and Gall Bladder problems while taking Yaz, Yasmin, and Ocella.
Bayer’s lawyers argue that the cases should either be scattered in state courts across the country or consolidated in the Yaz federal Multidistrict Litigation (MDL). Obviously, sending the cases to state courts across the country would be the least efficient way to manage the cases emanating from the public health crisis caused by Yaz, Yasmin and Ocella. Among other problems, it would lead to inconsistent rulings across the country. It would also create overlapping trial schedules which could render it virtually impossible for plaintiffs’ chosen trial counsel and experts to be present when each case is called to trial. Additionally, in the Philadelphia Mass Tort program, which has the benefit of nearly two decades of refining its practices and procedures, cases get to trial much more quickly than they do in MDL’s. This is antithetical to Bayer’s litigation strategy of delaying cases from proceeding to trial—a strategy common to mass tort defendants natiowide. Notably, the Pennsylvania Superior Court denied Bayer’s effort to gain this tactical advantage.
Pennsylvania is the appropriate forum for victims of Yaz, Yasmin and Ocella to file and litigate their lawsuits. Pennsylvania is the United States headquarters for Bayer. The record abounds with facts that support but one conclusion: that the Philadelphia County is the most appropriate state court form for litigation and trial of Yaz, Yasmin, and Ocella personal injury cases. Bayer’s birth control pills were distributed from Pennsylvania, and most of the domestic are located in Pennsylvania or just outside its borders, within 140 miles of the Philadelphia courthouse. Pennsylvania has a compelling interest in encouraging its corporate residents such as Bayer, to market and place safe drugs into the stream of commerce. 60 million pages were produced by Bayer’s counsel in Pittsburgh. Sales force training, market research, marketing, study investigations, monitoring and coordination, medical communications and medical trials” take place in Pennsylvania
Based on our experience litigating forum non conveniens in Philadelphia against Bayer Corporation, and prevailing, the lawyers at the Levensten Law Firm believe that the Pennsylvania Supreme Court will find that Philadelphia County is an appropriate forum for Yaz litigation and trial.
Filed under: Yaz Yasmin Ocella Side Effects by levensten
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An Explanation of How Actos Lawsuits Are Handled In State Courts and Federal Courts
Earlier this year, the public was alerted that the diabetes medication, Actos, causes bladder cancer. It did not take long for the FDA and the public to discover that the manufacturer of Actos tragically failed to adequately warn and properly study the risk of bladder cancer. Takeda, the manufacturer of Actos, deprived physicians of the ability to weigh the benefit of treating a patient with Actos for diabetes, against the risk of developing bladder cancer, which is an insidious disease that is often fatal. Physicians relied on inadequate, misleading information about the drug, and therefore could not make learned decisions when prescribing it.
It is clear that Takeda placed profits over patient safety. Takeda’s negligent failure to adequately warn about the risk of bladder cancer, and reckless disregard for human safety is now the subject of lawsuits filed in state courts and federal courts around the country by patients who suffered bladder cancer while taking Actos. The Levensten Law Firm in Philadelphia, Pennsylvania represents a significant number of these patients, and is dedicating much of firm’s resources and personnel to fighting for Actos victims for years to come.
When a public health crisis like the Actos bladder cancer tragedy occurs, lawsuits are often filed in state and federal courts around the country by the victims. For the first few years, the state cases are typically group in front of one state court judge, and the federal cases in front of one federal court judge. While the cases are grouped together, teams of attorneys for the victims review all of the manufactures studies, internal communications, and communications with the FDA and scientific community, among other documents. It is in these documents, particularly the unpublished studies, inter-company email, and adverse event reports, where we usually learn how dangerous a drug really is. We also learn about how the manufacturers suppress the true information, or fail to pursue the truth, in an effort to build a multi-billion dollar market for blockbuster drugs.
The teams of attorneys for Actos victims also take depositions of the company’s employees to probe further about the manufacturer’s knowledge and its bad acts, and to make a record of the employees’ testimony for trial. Finally, the lawyers for the victims submit expert reports which establish the association between the side effect and the drug, the regulatory failings of the company, the improper, deceptive marketing by the pharmaceutical manufacturer, and other key issues. At the end of the document review, depositions, exchange of expert reports, and expert depositions, the cases are typically set for individual trials if an individual or group settlement is not reached. Scott Levensten of the Levensten Law Firm in Philadelphia, Pennsylvania has participated in the document review, depositions, expert discovery and trial of many high profile pharmaceutical cases over the last fifteen years.
When the federal cases are grouped together, it is called an MDL, which stands for Multidistrict litigation. A group of judges, called the Judicial Panel on Multidistrict Litigation, decides whether the cases should be grouped together after a formal request is made by either the lawyers representing the victims, the lawyers representing the pharmaceutical companies, or both. Pursuant to an order of the United States Judicial Panel on Multidistrict Litigation, a hearing is scheduled on December 1, 2011 at the Tomochichi United States Courthouse, in Savannah Georgia, for consolidation of all federal Actos lawsuits in the United States District Court for Southern District of Illinois, or in the alternative, in the United States District Court for the Central District of California.
We believe that the consolidation of these cases through the multidistrict litigation process will lead to settlements for Actos victims nationwide through the cooperative efforts of battle tested, dedicated plaintiffs lawyers who will be handling these cases. The most important thing however, is that we prevent the manufacturer from causing the litigation to drag on, through multiple delay tactics typically employed by pharmaceutical manufacturer defendants. The sad, shocking fact in many cases like Actos is that the defendants try to delay the resolution of the cases until many of the victims have passed away, in a shameless attempt to devalue the victims’ claim. In short, the pharmaceutical manufacturers often believe that a jury would award less if the victim is deceased at the time of trial. The Levensten Law Firm, along with teams of lawyers around the country, will work hard to thwart these efforts and ensure swift justice and settlements for anyone who suffered bladder cancer while on Actos.
Filed under: Actos and Bladder Cancer by levensten
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