01/11/2012 - Last month, an FDA advisory committee voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and so the drugs should remain on the market, albeit with added information about the risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies say the risk is evident. However, four of the panel members held ties to Bayer - either as paid consultants or in the form of research funding - but the FDA did not disclose those conflicts. Attorneys for women who are suing Bayer had attempted to publicize the connections last fall, but were prevented from doing so because the information was contained in documents that were deemed to be confidential .<< MORE >>

01/11/2012 - A man who took the male pattern baldness drug Propecia for four years claims it gave him "severe sexual dysfunction and cognitive impairment." Jason McCord sued Merck & Co. in Federal Court. Merck has been sued at least 15 times in the past two years for similar claims, according to the Courthouse News database. McCord says he was 36 when he was prescribed Propecia, in 2006, and he took it for four years. He says the trade-off wasn't worth it.<< MORE >>

01/11/2012 - There's no need to perform a certain genetic test before deciding whether to prescribe the anti-clotting drug clopidogrel (Plavix), according to a new study published in the Journal of the American Medical Association. However, doctors at Scripps Health who have pioneered the use of this test say Plavix testing is indeed helpful in preventing heart attacks and deaths in coronary stent patients, and that the JAMA study is flawed.<< MORE >>

01/09/2012 - On January 3, 2012, the U.S. Food and Drug Administration (FDA) mandated postmarket surveillance studies be performed by manufacturers of urogynecologic surgical mesh devices. The FDA issued 88 postmarket study orders to 33 manufacturers of transvaginal mesh for pelvic organ prolapse (POP) and 11 postmarket study orders to seven manufacturers of mesh mini-slings for stress urinary incontinence (SUI). “These are studies that should have been conducted before the devices were approved by the FDA,” commented attorney Holly Ennis of Ennis & Ennis, P.A.<< MORE >>

01/06/2012 - The FDA has issued a warning, on Jan 5, about post-surgical health risks for women who receive a type of surgical mesh, in relation to pelvic problems. The meshes are produced by many leading medical device manufacturers. The U.S. Food and Drug Administration (FDA) have instructed medical device manufacturers to examine safety complications in relation to a type of surgical mesh which is widely used to repair women's pelvic problems. According to Reuters the FDA received over 1,500 reports of complications related to the use of such meshes between 2008 to 2010, and that the level of complaints has risen throughout 2011. Although surgical meshes have been used for many years for different types of surgery, the application of meshes for pelvic operations is relatively new. << MORE >>

01/06/2012 - The first Yaz pulmonary embolism lawsuit that was scheduled to begin trial January 9, 2012 will not begin as planned. The Honorable David Herndon, who is the presiding judge on many Bayer birth control pill lawsuits, ordered the case to mediation. http://www.ilsd.uscourts.gov/Documents/mdl2100/Order53.pdf. “This is a good sign for both parties to begin the process of a global resolution to the litigation,” commented attorney Holly Ennis of Ennis & Ennis, P.A. Currently there are thousands of lawsuits wherein women allege that Bayer failed to warn of increased risk of blood clots with birth control pills Yaz, Yasmin and Ocella. These lawsuits also allege that Bayer company officials wrongfully touted Yaz to be just a safe as other birth control pills and promoted the drug for uses not approved by the U.S. Food and Drug Administration (FDA). << MORE >>

01/06/2012 - As public pressure mounts over the potential harm caused by transvaginal mesh implants the FDA ordered device makers, including Johnson & Johnson and C.R. Bard , to take another look at complication rates associated with their devices. The watchdog agency asked a total of 33 companies to conduct 3 years of safety and effectiveness trials under growing concerns after deaths and injuries linked to the products spiked in recent years.<< MORE >>

01/04/2012 - On December 28, 2011, the U.S. District Court for the Western District of Louisiana consented to the assignment of all federal Actos cases to Honorable Rebecca F. Doherty. As a result, more than 100 cases will be transferred to the Western District of Louisiana at this time. “I have no doubt this number will increase significantly because consumers are still learning of the link between Actos and bladder cancer,” commented attorney David Ennis of Ennis & Ennis, P.A. << MORE >>

01/04/2012 - A recent study conducted by the National Institute of Neurological Disorders (NINDS) to determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered subcortical strokes was halted after patients on Plavix-aspirin therapy suffered a higher-than-expected number of bleeding events compared to subjects taking aspirin alone. The Plavix-Aspirin arm involved 3,000 patients.<< MORE >>

01/04/2012 - Adult women all over the world are familiar with vaginal mesh implantation for the repair of Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP). Originally, it was considered as the best treatment for these conditions. But recently, vaginal mesh lawsuits have multiplied all over the United States after complaints of deadly complications brought by the implantation of vaginal mesh started to appear and increase at a fast pace.<< MORE >>

01/04/2012 - U.S. regulators ordered Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) to study rates of organ damage, infection and painful sex linked to vaginal mesh implants, reacting to doctors and patients who say the devices have harmed women. The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers yesterday, asking them to collect as much as three years of data on the safety and effectiveness of the implants, the agency’s William Maisel said today in a telephone interview. That followed an FDA report in July that found a fivefold jump in deaths, injuries or malfunctions linked to some of the products.<< MORE >>

01/04/2012 - The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special master is well versed in pharma liability litigation: It's George Washington law professor Stephen Saltzburg, who handled mediation in 26,000 Seroquel lawsuits.<< MORE >>

01/02/2012 - Bayer is facing more than 7000 lawsuits over its popular birth control pills Yaz and Yasmin over serious side effects such as blood clots, deep vein thrombosis (DVT), gallbladder disease, and other cardiovascular complications. Many of the lawsuits allege that Bayer failed to adequately warn about these risks. With so many lawsuits pending with common claims, Judge Herndon will conduct three "test trials" or "bellwether trials" to evaluate how juries are likely to respond to evidence and testimony common to all of the cases. << MORE >>

01/02/2012 - Lawsuits against Takeda Pharmaceutical Co., Asia’s biggest drugmaker, claiming its Actos diabetes drug causes bladder cancer will be consolidated before one judge in federal court in Louisiana, a judicial panel said. The federal Judicial Panel on Multidistrict Litigation sent the lawsuits to the Western District of Louisiana, in Lafayette, to be overseen by U.S. District Judge Rebecca Doherty. Doherty will coordinate pretrial proceedings, including evidence- gathering.<< MORE >>

12/29/2011 - Medical and legal experts estimate that failed metal-on-metal hip implants may cost taxpayers, insurers, employers and others billions of dollars, contributing to the soaring cost of healthcare according to a recent New York Times article. The drastically high rate of all-metal hip implant revisions is now the most widespread medical implant failure in decades. ‘This is not new information to me because for quite some time now, I have received a high volume of complaints from potential clients who are devastated because their metal-on-metal implant only lasted several years when they are supposed to last approximately 15 years,” reports attorney David Ennis of Ennis & Ennis, P.A.<< MORE >>

12/28/2011 - If you have an all-metal hip replacement, you may be among the lucky ones who can walk. Or you may be worse off than you would have been without the allegedly flawed device. One thing’s for sure: Those flaws are going to cost Johnson & Johnson (JNJ) and Zimmer Holdings (ZMH) plenty in legal fees and possible settlement costs. How much? Maybe $5 billion. One thing is for sure: there are people out there suffering tremendously due to the flaws in all-metal hip replacements. As the New York Times reports, the friction of metal parts — the ball and joint — rubbing against each other create splinters that can cause infections and other damage to the people who host these devices.<< MORE >>

12/28/2011 - The most widespread medical implant failure in decades - involving thousands of all-metal artificial hips that need to be replaced prematurely - has entered a new phase, the money one. Medical and legal experts estimate the hip failures could cost taxpayers, insurers, employers and others billions of dollars in coming years, contributing to the soaring cost of health care. The financial fallout is expected to be unusually large and complex because the episode involves a class of products, not a single device or just one company.<< MORE >>

12/28/2011 - A new study suggests that the recent technology for artificial hips and knees did not perform any better than older, less expensive designs. The study, which draws on data from Australia’s orthopedic registry, covered implants introduced from 2003 to 2007 and was published this week. The findings are significant for patients in the United States because many of the new designs, like so-called metal-on-metal hips, are widely used here. Those implants, which have both a ball and cup made of metal, are expected to fail prematurely in tens of thousands of patients rather than lasting 15 years or more as artificial joints are supposed to do.<< MORE >>

12/26/2011 - In further response to the Safety Communication issued by the FDA in July 2011 regarding the use of vaginal mesh, the American College of Obstetricians and Gynecologists (The College) and the American Urogynecologic Society (AUGS) jointly state that the use of vaginal placement of synthetic mesh for the treatment of pelvic organ prolapse (POP) should be reserved for high-risk women for whom the benefits may outweigh the risks. The College and the AUGS also state that there is an urgent need for development of a national registry to track outcomes for all current and future patients who receive vaginal mesh implants. The specific recommendations of The College and AUGS for use of vaginal mesh include the following:<< MORE >>

12/26/2011 - Today's topic is a bit on the "dire" side... Not that I like alarming anyone, but if I come across something that I deem important, I want to share it. So for this post, I would like to discuss Fosamax (aka alendronate) and dentistry, because there is a definitive risk factor involved. To start, let's go over what Fosamax is, and what it's used for. Fosamax is the trade name for Alendronate, which is a drug used to prevent/combat osteoporosis. Osteoporosis is a condition generally associated with age in where your bones become more brittle and more likely to break. Although men can (and do) suffer from it, it's generally associated with post-menopausal women.<< MORE >>

12/22/2011 - Dronedarone is the latest antiarrhythmic drug to be developed for treating atrial fibrillation. In their search for a safe and effective drug for atrial fibrillation, pharmaceutical companies have long imagined their "Holy Grail:" A drug that is as effective as amiodarone, but without its unique toxicity profile. Dronedarone (Multaq) was developed by Sanofi (the makers of amiodarone) specifically in the hopes of creating that holy grail.<< MORE >>

12/22/2011 - A class action has been launched on behalf of people who took the diabetes drug Actos against the manufacturers of the medication. The class action alleges that Takeda Pharmaceutical Company, the manufacturer and distributor of Actos (pioglitazone hydrochloride) and Eli Lilly, who used to sell and distribute the drug, failed to disclose that taking it for longer than one year led to an increased risk of bladder cancer.<< MORE >>

12/21/2011 - Multaq (Dronedarone) reduces the risk of cardiovascular hospitalization in patients with paroxysmal, persistent atrial fibrillation (AF) or atrial flutter (AFL), but it may also cause serious cardiovascular problems, even death, warned the U.S. Food and Drug Administration (FDA). "Healthcare professionals should not prescribe Multaq to patients with Permanent Atrial Fibrillation who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients," the warning said as quoted by media reports Wednesday.<< MORE >>

12/21/2011 - The U.S. Food and Drug Administration (FDA) confirms that the heart drug, Multaq, increases the risk of serious cardiovascular events, including death, stroke and heart failure. “According to the revised label, Multaq doubles the rate of these catastrophic events in patients with permanent atrial fibrillation,” explains David Ennis of Ennis & Ennis, P.A. “Getting the word out quickly can save lives.” In September 2011 the European Medicines Agency, which is the European equivalent of the FDA, recommended restricted use of the anti-arrhythmic medication only to be used on a limited population of patients after all alternative treatment options had been considered. At that time, the FDA was still conducting its own review of the safety of dronedarone, which is the active ingredient in Sanofi’s Multaq heart medication.<< MORE >>

12/20/2011 - Health Canada is alerting Canadians that a class of drugs used for osteoporosis is linked to a slightly higher risk of a rare but serious thigh bone fracture known as an atypical femur fracture. The advice is the result of Health Canada's review of bisphosphonate drugs, which has led to new warnings and precautions for patients and doctors and will lead to new labels for the drugs.<< MORE >>

12/20/2011 - Federal health officials said Monday they have added new safety warnings to the heart rhythm drug Multaq, after a company study by Sanofi linked the tablet to higher rates of heart attack, stroke and death in a subset of patients. The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the Food and Drug Administration.<< MORE >>

12/19/2011 - Popular birth control pills, Yaz and Yasmin, may leave one at a higher risk of clogged veins and arteries. In the US, the FDA has asked for new warning labels, which is something pharma major Bayer has said it will do. Yaz and Yasmin are the part of a new generation of birth control pills that contain the compound drospirenone. The US FDA study found that women who use these are twice as likely to develop blood clots than those on older contraceptives.<< MORE >>

This update is in follow-up to the FDA Drug Safety Communication on July 21, 2011 about Multaq (dronedarone) and increased risk of death and serious cardiovascular events 12/19/2011 - The U.S. Food and Drug Administration (FDA) has completed a safety review of the heart drug Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial (which supported Multaq's approval for treatment of non-permanent AF).1,2 FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug.<< MORE >>

12/15/2011 - Medical implants that have sparked thousands of patient lawsuits, from Johnson & Johnson (JNJ)’s artificial hips to vaginal meshes made by Boston Scientific Corp., would face new tracking requirements under a bill introduced by three U.S. senators. Under the legislation, the Food and Drug Administration could order companies to conduct safety studies of devices even after they’re approved and could grant conditional approvals pending the result of ongoing trials. That would raise the bar for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market.<< MORE >>

12/14/2011 - Sometimes it takes a product recall, such as last month's for more than 6 million contact lenses, to trigger a person's concern for their vision and overall eye health. On Nov. 16, CooperVision expanded a worldwide recall after certain lots of Avaira Sphere contact lenses - totaling 6.6 million - were found to have silicone oil residue on the lenses, according to the U.S. Food and Drug Administration recall notice. An August recall targeted Avaira Toric contacts. According to the recall, the silicone oil residue could cause hazy vision, discomfort, severe eye pain or eye injuries requiring medical treatment. The company recommended that any patient experiencing such symptoms contact their eye doctor and stop wearing the lenses immediately, according to the recall notice.<< MORE >>

12/12/2011 - The newer generation birth control pills, which include Yaz, Yasmin, and Beyaz, may soon be slapped with a new warning label that says the products are more likely to cause blood clots than other forms of oral contraceptives. That’s after an expert panel convened yesterday by the US Food and Drug Administration concluded -- in a 21 to 5 vote -- that the labels currently on these products didn’t adequately reflect the risk of developing blood clots in the legs that could turn life-threatening if they wind up in the lungs. The agency must now decide in the next few months whether to follow the advice of its advisory committee, which it typically does.<< MORE >>

12/12/2011 - One of the most widely used oral contraceptives in the U.S. may be getting a new warning label — a label that would describe the risks of potentially fatal blood clots. Here's what you should know: Is birth control really so dangerous? Blood clots have actually been "a known side effect" of birth control pills ever since these contraceptives "hit the market 50 years ago," says Bloomberg Businessweek. However, a new generation of pills may be raising the risk. According to several recent studies, about 10 in 10,000 women on Yasmin, Yaz, or their generic versions may experience a clot, compared to seven in 10,000 women on older pills. It's still a relatively small risk — but higher than it once was.<< MORE >>

12/07/2011 - U.S. Food and Drug Administration staff reviewed studies comparing an older generation of birth control with newer pills that contain the compound drospirenone, such as Bayer AG's popular Yaz and Yasmin. In a report released on Tuesday, the reviewers said the body of evidence shows conflicting data on a link between pills containing drospirenone and blood clots, but the link could not be ruled out either and that fact may warrant a new label.<< MORE >>

12/07/2011 - A former FDA commissioner accused Bayer of hiding data on the blood clot risks associated with two of its birth control pills, Yasmin and Yaz, and engaging in "extensive" off-label promotion in order to increase sales. The accusations, from David Kessler, MD, were contained in an expert opinion that was unsealed this week by a federal court in Illinois. There are currently multiple lawsuits pending over injuries and deaths related to drospirenone/ethinyl estradiol tablets (Yasmin and Yaz) and generic versions of the pills.<< MORE >>

12/07/2011 - The state FDA has registered a complaint with the Mumbai Police against DePuy, a subsidiary of Johnson & Johnson that manufactured ASR implant, which is used in hip replacement surgery. A year back, DePuy publicly recalled more than 93,000 articular surface replacement joints worldwide. The move came after claims of metal debris from wear on the implant leading to a reaction that destroyed surrounding soft tissue and exposed patients to cobalt and chromium poisoning. In other countries, patients were compensated and re-operated. However, no such steps have been taken in India.<< MORE >>

12/06/2011 - Children exposed to the epilepsy drug valproate have a nearly three times higher risk of having an autism spectrum disorder, new research finds. Researchers in Denmark used national birth data that included nearly 656,000 children born in that country between 1996 and 2006 to 428,000 women. Using a national prescription drug registry, they identified women who had filled a prescription for valproate (Depakote) shortly before pregnancy through the day of the child's birth.<< MORE >>

12/06/2011 - The Food and Drug Administration’s (FDA) primary responsibility is to ensure that all medications it evaluates and approves are safe for public use. The pharmaceutical companies presumably extensively research and test new medications and provide this data to the FDA’s Center for Drug Evaluation Research (CDER). Unfortunately, the CDER conducts no research or testing, rather it simply relies on the data provided to it by the drug company. Ennis & Ennis, P.A. questions this process. << MORE >>

12/06/2011 - A Bayer AG unit withheld from U.S. regulators findings by company researchers of increased reports of blood clots in users of its Yasmin birth-control pills, the former head of the Food and Drug Administration said. David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn't include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin's safety provided to the agency.<< MORE >>

12/05/2011 - Birth control drugs that were heavily promoted as having fewer side effects and the ability to clear up acne and other hormonal bothers are under new scrutiny from safety regulators. Research suggesting that newer birth control formulations are more likely to cause blood clots than older drugs has prompted the Food and Drug Administration to consider new safety measures in meetings later this week. The increased risk is slight but significant because blood clots can cause heart attacks, strokes and blockages in lungs or blood vessels, which can be fatal. << MORE >>

12/05/2011 - The pharma giant Takeda Pharmaceutical is facing tens of thousands of lawsuits in the United States concerning allegations that its Actos diabetes drug can result in bladder cancer. With regulators deciding earlier this year that Actos, which has the chemical name of pioglitazone and is prescribed for adults with type 2 diabetes, could sometimes cause a heightened risk from cancer, judges are now assessing whether the various lawsuits should be consolidated.<< MORE >>

12/01/2011 - Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, may face as many as 10,000 lawsuits in U.S. courts over allegations that its Actos diabetes drug causes bladder cancer, and a group of judges is preparing to decide where they should be consolidated. U.S. regulators found in June that an analysis of a company-sponsored study showed some users of Actos, the world’s best-selling diabetes medication, faced an increased risk of developing the potentially fatal disease. Takeda shares fell 2.2 percent at the 3 p.m. close of trading in Tokyo.<< MORE >>

11/30/2011 - A Connecticut law firm that specializes in suing corporations for alleged securities fraud, consumer and antitrust issues is now suing contact lens maker Cooper Cos. regarding its recalls this year of its Avaira Toric and Avaira Sphere contact lenses. The suit, filed Monday in U.S. District Court for the Northern District of California, alleges that California-based Cooper downplayed the problems it was having with the contact lens lines and thus artificially inflated its stock value, causing investors big losses when those contact lens problems came to light.<< MORE >>

11/29/2011 - The antidepressant medicine Zoloft, which is formulated by Pfizer, has once again been condemned for allegedly causing a harmful side effect that led to an infants death. In October 11, a Missouri couple filed a lawsuit against Pfizer after their child died from alleged Zoloft-attributed birth defect, Tetralogy of Fallot, a couple of years ago. It was an atrial septal heart defect that was allegedly caused by the intake of Zoloft during her pregnancy.<< MORE >>

11/22/2011 - Takeda Pharmaceutical Co is going to have to wait a bit longer to get US approval for its type 2 diabetes therapy alogliptin, and the fixed-dose combination of the drug plus the Japanese drugmaker's Actos. The company says it has received notification from the US Food and Drug Administration that its review of alogliptin, and the combination of the latter and Actos (pioglitazone) will be delayed. A new Prescription Drug User Fee Act action date has been set for April 25, having been originally assigned for January 25.<< MORE >>

11/21/2011 - Units of Bayer AG (BAYN), Germany’s largest drugmaker, may have sought to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks the drug posed, according to company e-mails. Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to company files provided to lawyers for women suing Bayer. U.S. regulators approved Yaz only for the most severe form of PMS. << MORE >>

11/18/2011 - Nearly 5 million more CooperVision contact lenses are being recalled because they may cause blurry vision, eye pain, and injuries requiring medical treatment. CooperVision Inc. says it will expand its recall of Avaira soft contacts to include 4.9 million Sphere lenses, which have already been shipped to customers around the world. The problem appears to be the level of silicone oil left on the lenses during the manufacturing process, according to a company news release.<< MORE >>

11/16/2011 - Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain. CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company's Pleasanton, Calif., office. << MORE >>

11/16/2011 - Last week Chief Judge David R. Herndon denied Plaintiff’s request to use certain “protected” documents from the Yaz litigation to petition the FDA and its advisory committee concerning public health issues associated with drospirenone-containing birth control pills, such as Yaz. Attorney David Ennis of Ennis & Ennis, P.A. commented on the ruling stating, “It’s a shame that certain documents are kept confidential, especially when they may include critical information for the FDA’s determination of the safety of Yaz; however it is understandable that the certain information is protected in order to preserve the discovery process.”<< MORE >>

11/14/2011 - Thomas Spetter Jr. received conflicting messages while being trained as a pharmaceutical sales representative for Abbott Laboratories in the late 1990s, he claims in a court filing. The first message meshed squarely with federal law: Market drugs only for purposes that have been approved by the Food and Drug Administration. Trainees were then taken to a separate room where the door was closed, and an experienced Abbott sales rep said to ignore corporate trainers' directions and instead market Depakote, an epilepsy drug, as a way to treat agitation associated with dementia, a practice that would be illegal, Spetter alleges in a whistle-blower lawsuit filed in 2010.<< MORE >>

11/09/2011 - GlaxoSmithKline which has agreed to pay $3 billion to resolve claims it illegally marketed its Avandia diabetes drug, is facing a judge’s push to resolve most of the remaining patient lawsuits over the medication. U.S. District Judge Cynthia Rufe said yesterday she appointed a mediator to “preside over settlement negotiations” for an unspecified number of Avandia cases consolidated before her in Philadelphia. Rufe set a 75-day deadline to resolve 85 percent of the remaining cases, according to court filings.<< MORE >>