The use of transvaginal surgical mesh is predicted to go up even though a safety notification from the Food and Drug Administration has raised concerns about the mesh. These results come from a recent survey of physicians in the United States, and are surprising considering decreased confidence in these products. Besides the doubts among doctors, patient concerns are high due to a greater reported number of adverse events associated with the products.
The survey shows that procedure volume remained stagnant in 2011 because of the lack of confidence from both doctors and patients. In 2012, however, the number of transvaginal pelvic floor repair procedures using a synthetic mesh or biological graft is expected to increase by two percent.
]]> Problems with Transvaginal MeshTransvaginal surgical mesh devices are used to repair pelvic organ prolapse and stress urinary incontinence. Common injuries and symptoms associated with transvaginal mesh products are infection, pain, bleeding and urinary problems. Serious complications include vaginal scarring or shrinkage. Neuro-muscular and emotional problems are also reported. Sometimes the complications require numerous painful surgeries to repair.
Some companies and mesh brands develop physician loyalty despite the negative occurrences and potential regulatory changes. Given the expected rise in use of transvaginal surgical mesh products in the coming year, complications and injuries could also be on the rise.
Source: Millennium Research Group, "Physician Confidence In Urogynecologic Surgical Mesh Shaken In Wake Of Adverse Events And Increased Regulatory Oversight"
]]>Health Canada believes the link to bladder cancer is genuine, based on data obtained halfway into a 10-year study being conducted by the drug manufacturer, Takeda Canada Inc.
According to Takeda drug trials, 10 out of 10,000 Actos users developed bladder cancer, whereas only seven out of 10,000 non-Actos users had the same diagnosis. For fear of this negative side effect, Canadian doctors are now not able to prescribe Actos without prior special permission.
]]> Red Flags for Bladder CancerCurrent and former users of Actos should be aware of the potential side effects of the medication and pay particular attention to the potential warning signs of bladder cancer. Common warning signs of bladder cancer include urgency or a worsening of urgency to urinate and blood in the urine without pain.
Actos users who appear to be at the greatest risk for bladder cancer are patients who received the medication at higher dosages or took it for prolonged periods. Those who took or are taking Actos and have cancer risk factors, like a family history of bladder cancer or smoking, also have a heightened risk.
Doctors need to reassess carefully whether using this medication is in the best interest of patients. Anyone who is prescribed Actos needs to be fully informed about its risks.
Source: Winnipeg Free Press, "Health Canada warns diabetes drug Actos may pose bladder cancer risk," Helen Branswell, April 19, 2012
]]>The Fecho sisters, a family of four DES daughters from Pennsylvania, will be the first DES breast cancer case to be tried in court. The four Fecho sisters were all exposed to DES in utero and all suffered infertility as well as a myriad of signature DES reproductive tract abnormalities. All four sisters contracted breast cancer on or before the age of 50. The eldest, fifth Fecho sister, who is not a party to the lawsuit, was not exposed to DES. She was able to have a child, and remains cancer-free.
The Plaintiffs expect to present the scientific evidence from the National Cancer Institute, New England Journal of Medicine, and experts from Harvard and other prominent institutions from around the world to establish that prenatal DES exposure substantially increase the risk of breast cancer.
DES was touted as a miscarriage-prevention drug that was popular between the 1950's to early 1970's; it was proven to be a carcinogen and teratogen to the fetus. DES also had no effect in preventing miscarriages. Drug companies like Eli Lilly and Bristol Myer-Squibb never tested or warned of the dangers of the drug and its known carcinogenic effects. DES daughters exposed in utero are at an elevated risk for clear-cell adenocarcinoma of the vagina and cervix, infertility, subfertility, and breast cancer. DES daughters should be vigilant about breast cancer screening and check with their doctors regarding the avoidance of female hormone therapies to reduce cancer risk.
The attorneys at Aaron M. Levine & Associates are at the frontlines of the DES breast cancer fight against Big Pharma. Please contact us if you have questions about DES lawsuits.
]]>Since 2006, pharmaceutical giant, Pfizer, has marketed the drug Chantix to adults 18 and older who are trying to kick the smoking habit. So far, more than 2,400 lawsuits have been filed throughout the nation alleging various claims against Pfizer regarding Chantix. These cases have now all be consolidated in Alabama.
The Alabama federal judge assigned the consolidated docket has selected two cases - one originating from Minnesota and the other from Oregon - as the first to be heard. In both cases, the victims committed suicide while using Chantix. The plaintiffs in the cases hope to prove that there is a link between Chantix use and suicide attempts.
Unfortunately, an increased likelihood of attempting suicide is not the only side effect alleged by Chantix users, or as in the case of the first two trials, alleged by the families and estates of the Chantix users.
]]> Studies Show Chantix Users May Experience Heart ProblemsParticularly troubling is Chantix's link to cardiovascular problems. An FDA 12-week clinical trial found, for example, that while the drug was effective as an anti-smoking aid, Chantix users were twice as likely to require coronary revascularization as patients who were treated with a placebo. In recent years, the FDA has been proactive in listing the dangers associated with the use of the drug Chantix.
If you or a loved one has suffered these serious side effects or injury due to the use of Chantix, an experienced personal injury attorney can help you determine your best course of action.
Source: Associated Press, "Ala. judge sets trial dates for suits over Chantix," March 26, 2012
]]>Specifically, the order issued by Judge Doherty last month said a status conference for the consolidated action will be held on March 22.
The lawsuits allege that studies have discovered an increased risk of bladder cancer for those who take Actos for more than a year. Furthermore, the suits claim Takeda had reason to know of these risks, concealed the information and failed to warn those taking the drug or health care providers.
Actos was approved by the U.S. Food and Drug Administration (FDA) in 1999, but in 2010, the FDA issued a warning about the potential bladder cancer risks associated with the drug. And even though the sale of Actos continues in the U.S., Takeda stopped selling Actos in France and Germany last year.
]]> Even with these perceived bladder cancer risks, Actos remains the best-selling Type 2 diabetes drug on the market, according to IMS Health. The same source states that in 2011, Actos accounted for around 84 percent of all sales of drugs in the same class, or $3.4 billion - although their sales did fall about 3 percent in the U.S. last year.Bladder cancer can have a devastating impact on a victim's life, but unfortunately the dozens of Actos lawsuits before Judge Doherty may just be the beginning - it has been estimated that there may be as many as 10,000 Actos lawsuits before all is said and done.
Source: CBS News, "Judge sets 1st hearing for diabetes drug lawsuits,"
]]>Judge Bowler has set the first mediation to proceed on April 3 - 5, 2012 before the Court. This first mediation will include the two bellwether cases involving five DES daughter plaintiffs. The outcome of this mediation is expected to set a benchmark for the resolution of other DES breast cancer cases.
Judge Bowler has further required the attendance of each individual plaintiff during their own mediation in Boston, the timing of which will be announced after the initial mediation in April. The order in which each individual plaintiff's case will be mediated depends upon the health of the plaintiff, the order in which she joined the litigation, and the readiness of the individual case.
Please check back for further update. If you have questions about joining the DES breast cancer litigation, please contact us for an evaluation of your potential claims.
]]>Today, Judge Bowler denied the Defendants' Motion for Reconsideration from the bench sua sponte, which means without prompting from the Plaintiffs. Judge Bowler has further scheduled to oversee mediation planning and organization between the parties on February 29, 2012.
If you are a DES daughter who contracted breast cancer, please contact our DES attorneys. We will help you evaluate whether you have an actionable case against DES drug manufacturers. Meanwhile, DES daughters should be diligent about routine breast exam screening and the avoidance of HRTs.
]]>From the cereal aisle in a store to the cold medicine or pain medication, choices abound. And while not much of a problem for cold cereal, it can become a very big problem for prescription drugs.
A study reported in the Archives of Internal Medicine, entitled "Less Is More--Communicating Uncertainties About Prescription Drugs to the Public," highlights the issue.
The study measured the U.S. public's understanding of Food and Drug Administration (FDA drug approval process and tested how different brief explanations of the drugs uncertainties affected what drugs were chosen by consumers.
It found 'Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25 percent mistakenly believed that the FDA approves only drugs without serious side effects.' Thus, the report concluded that much of the public believes wrongly that the FDA approves only extremely effective drugs and drugs lacking serious side effects.
]]> Beta TestingThe FDA has a very broad mandate. It is charged with protecting the public health by working to maintain the safety of food and drugs. While food is to be safe, wholesome, sanitary and properly labeled, drugs and medical devices are to be safe and effective.
Safe and effective does not mean it is the best drug for a given purpose or that is it "very effective." If you read the long disclosure documents the FDA requires all prescription drugs to carry, you may notice with some that their effectiveness may only be marginally better than a placebo (i.e. nothing).
As the study comments, "approval does not mean that the FDA believes benefits are large (or important) or that all serious side effects are known."
In fact, it may only be a few years after a drug is approved that we find out the full extent of the "side effects." Everyone who uses a new drug is in essence a beta tester.
Because of the duration of some drug trials and the limited number of people tested, many drug's real effects become apparent only after large numbers of people begin using them for a period of time - such as the case of DES (diethylstilbestrol), which effects are being encountered decades later.
The study suggests that the FDA's message should be clearer - instructing people to choose a drug that has had human trials, as opposed to surrogate outcomes. The FDA needs clarify its role (what does approval mean) and combat the presumption that what is new is always better that what is old, especially when both the notion of tried and true and newness are no guarantee of a drug's safety, like Fosamax.
]]>Suffering a miscarriage can be a traumatic and life-changing event. When millions of women attempted to avoid this heartbreaking occurrence by ingesting diethylstilbestrol (DES), they unwittingly exposed their unborn daughters to catastrophic medical consequences. These affected women are often referred to as "DES Daughters."
The dangerous drug DES was prescribed to pregnant women from 1947-1971. The drug was taken off the market when it was discovered that the daughters of women who took DES during their pregnancy had a high risk of a rare, reproductive tract cancer as a result of in-utero exposure.
The attorneys of Aaron Levine & Associates represent 53 DES Daughters with breast cancer in the federal court case Fecho v. Eli Lilly. This lawsuit seeks just compensation for the breast cancer injuries suffered by DES daughters around the country. Currently, our attorneys are representing other DES daughters and filing new DES breast cancer lawsuits nationwide.
According to the New England Journal of Medicine, prenatal DES exposure is causally associated with breast cancer in DES Daughters over 40 years of age. A recent report from the Institute of Medicine of the National Academy of Sciences equated the breast cancer risk conferred by prenatal DES exposure to ionizing radiation and stated: "One of the best known examples in humans of an in utero exposure altering risk for cancer later in life is that of DES,...including an elevated risk of breast cancer."
A National Cancer Institute study has determined that DES daughters over the age of 40 are more than twice as likely to develop breast cancer as women who were not exposed to the drug in utero. The escalating DES breast cancer risk triples at the age of 50.
DES drug manufacturers failed to test or warn of the dangers of the drug and withheld vital information during its approval for pregnancy use from the FDA.
Women who believe they may have been exposed to DES in utero must be vigilant about regular breast cancer screenings and the avoidance of female hormone therapies. These regular examinations are imperative. Early breast cancer detection can save the lives of DES daughters.
If you are a DES daughter over 40 and you have developed breast cancer, please contact our office. Our attorneys have been diligently advocating for DES Daughters for over 30 years and you may be eligible to join this case for free.
]]>In a precedent-setting decision this afternoon at the United State District Court of Massachusetts in Boston, Judge Marianne Bowler denied a motion filed by 14 drug companies seeking to block the plaintiffs, 53 women with breast cancer, from proceeding with their case seeking compensation from the makers of diethylstilbestrol (DES). The plaintiffs, known as DES daughters, were exposed to DES in utero more than 40 years ago when their mothers took the drug purported to prevent miscarriages. (For a copy of the original order, click here DES Order.pdf)
Attorneys Aaron Levine and Julie Oliver-Zhang, representing the plaintiff DES daughters, presented final argument opposing the motion followed by responses from drugmakers Eli Lilly and Bristol-Myers Squibb. One hour after the final arguments, Judge Bowler denied the Defendants' motion and ordered immediate mediation for compensation to the plaintiffs.
Calling upon a team of expert witnesses including the Chair of the Harvard's Department of Epidemiology and other scientists from academic institutions such as Georgetown University and University of Paris, the plaintiffs presented sufficient facts to support the relevance and reliability of their experts and their opinions that prenatal DES exposure substantially increased the risk of breastcancer in women over the age of 40.
This decision emphasizes the critical need for annual mammography, heightened surveillance for breast cancer, and avoidance of female hormone replacement therapy for the 2-3 million DES daughters across the country.
For further information about eligibility to joining the lawsuit, please contact Aaron Levine & Associates at 202-833-8040 or visit our website at www.aaronlevinelaw.com.
]]>Judge Marianne B. Bowler will hear final oral arguments in the diethylstilbestrol breast cancer case, Fecho v. Eli Lilly, et al, on Thursday January 19, 2012. After the final oral arguments, the Court may further instruct the parties on whether she believes that the Plaintiffs' experts are qualified to reliably testify before a jury on the causal association between prenatal DES exposure and the substantial increase of the risk of breast cancer in women over the age of forty.
Last week, national news agencies such as the Associated Press, ABC News, and USA Today covered this DES breast cancer case being held in Boston, Massachusetts. Two DES Daughters, Arline MacCormack and Jackie White, discussed their prenatal DES exposure and their struggle with breast cancer. They are only two of the fifty-three DES Daughters represented by the lawyers of Aaron Levine & Associates in this DES Breast Cancer case.
Closing arguments will be held tomorrow, Janurary 19th, in the John Joseph Moakley United States Courthouse in Boston at 10am, in Court Room 25, 7th Floor. All clients and interested parties are welcome to attend.
Please contact us if you have any questions about the ongoing DES breast cancer litigation or if you are interesting in joining for free.
]]>Various past studies have concluded there is an increased risk of cardiovascular disease while taking Yaz, including one study conducted by the FDA. However, another recent study carried out in Denmark, and published in the British Medical Journal, has also determined that birth control pills such as Yaz have a higher risk of causing blood clots.
The study - which observed 1.3 million Danish women over nine years - found that women who took newer contraceptives containing a synthetic hormone called drospirenone, such as Yaz, had a six-fold increased risk of venous thromboembolism - which is when blood clots form in the lower extremities, break up, and travel to the lungs. However, women who took older contraceptives containing a different synthetic hormone, levonorgestrel, only had a three-fold increased risk for the same type of blood clots.
]]> Ultimately, the study concluded that women taking birth control containing drospirenone - which includes Yaz - had double the risk of venous thromboembolism when compared to other birth control pills. This conclusion mirrors the preliminary findings by the FDA which indicated a 1.5-fold increase in blood clot risk for drospirenone users.Even with these continuing health concerns, Yaz continues to be marketed at full-throttle. Last year, in was projected that Yaz and its sister drug Yasmin had worldwide sales of $1.42 billion - and $1.5 billion the year before that. Blood clots caused by these drugs can lead to severe injuries, or even death. Women who take these forms of birth control need to be aware of the risks and hold those drug-makers responsible if they suffer blood clots.
]]>U.S. District Court Judge Cynthia Rufe recently appointed a mediator to facilitate settlement negotiations for an unspecified number of Avandia cases. According to court filings, at the time of the decision Judge Rufe set a time limit of 75 days to settle 85 percent of Avandia cases - with a pledge to have 100 of the oldest cases ready for trial in 60 days if they fail to reach that threshold.
London-based Glaxo has had legal issues related to Avandia going back more than a decade - they recently agreed to pay $3 billion to settle claims that they illegally marketed Avandia and other medications.
After studies emerged linking Avandia to increased risks of heart attacks, regulators withdrew Avandia in Europe and the FDA limited prescriptions in the U.S. - leading to a 43 percent drop in sales. It has been estimated that Glaxo faces about 20,000 lawsuits related to Avandia use.
]]> According to a Federal District Court order, some of the injuries alleged by patients who took Avandia include, but are not limited to:As referenced above, this list is by no means exclusive as patients have experienced numerous other life-altering injuries. If you believe you have been injured as a result of taking Avandia, it is important to take action immediately in order hold accountable those parties responsible.
]]>Judge Bowler also denied the Defendants' request for further post-hearing briefing. Both sides have already submitted extensive Daubert briefing and the discovery has been voluminous in this case. In addition, Judge Bowler has devoted over two weeks of the Court's time to hearing each of the twelve experts on both sides. The Court granted final oral arguments of one hour for each side in January of 2012. After the final oral arguments, the Court may further instruct the parties on whether she believes that the Plaintiffs' experts are qualified to reliably testify before a jury on the causal association between prenatal DES exposure and the substantial increase of the risk of breast cancer in women over the age of forty.
Our fight against the DES drug makers in court has been fierce since September; this development is both exciting and encouraging. We will keep you posted on the latest. Please contact us if you have questions about the ongoing DES breast cancer litigation and your eligibility to join for free.
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