Approximately half of all American women over the age of 50 and 25 percent of all men in that same age group suffer serious bone loss leading to weakness and breaks. When these bones break, elderly people face a longer recovery time than younger patients simply because the rebuilding process slows as we age. A class of bone loss drugs containing zoledronic acid including Reclast and Zomera claim to stop bone loss. However, new research indicates that these drugs actually keep new bone from rebuilding and reforming at all.
]]> Preventing bone loss is a critical goal for many patients. But preventing bone loss can be deeply dangerous if the drugs used to prevent loss actually prevent bone formation as well. The human body constantly regenerates old, defective and otherwise damaged cells. When these medications prevent new bone from forming, they completely undermine the goal of increasing bone mass in patients suffering from bone loss.This new research suggests that combining these medications with others may help certain patients. However, patients being prescribed these drugs alone may be suffering more damage from these medications than benefits. When this occurs, it is critical that patients speak both to a physician and an attorney about their medical and legal options for remedy and redress.
Source: Medical Daily, "Uh-Oh, Osteoporosis Drug Actually Blocks Bone Growth," Jonathan Weiss, Apr. 18, 2013
]]>Certainly, our justice system maintains that both individuals and businesses are to be considered innocent of wrongdoing until proven guilty. However, overwhelming evidence suggests that Yaz and Yasmin's potential to inspire both deep vein thrombosis and blood clots generally are substantially higher than that of other oral birth control medications. Bayer's failure to admit this risk factor is almost certainly deeply frustrating for those thousands of plaintiffs who may have suffered as a result of these very conditions.
]]> And yet, it is the bravery and tenacity of those who come forward to challenge the vocal assumptions of drug manufacturers that ultimately inspire changes to the market. Had victims of Diethylstilbestrol (DES) or Avandia never attempted to stand up for their rights as patients and consumers, others would have undoubtedly been harmed by these drugs. Hopefully, the perseverance of nearly 10,000 plaintiffs waiting for justice in suits against Bayer will similarly help spare other similarly situated patients from harm.Class action drug lawsuits can take time and they can be frustrating to navigate. But many of these battles are critical to ensuring the safety of patients moving forward and to helping victims receive proper compensation and closure. The pending Yaz and Yasmin suits almost certainly fall within these categories.
Source: Lawyers and Settlements, "9,566 Reasons Not to Believe Yasmin Birth Control Is Safe," Gordon Gibb, Apr. 15, 2013
]]>The first Fosamax trial concluded last month in New Jersey. The jury serving on this particular federal case found in favor of Fosamax manufacturer Merck. This one setback does not mean that other Fosamax victims will not be given their say or awarded just compensation. But it does mean that the truth about this dangerous drug may not be fully understood and vindicated until a later date.
]]> The jury in this first trial determined that the victim's bone fractures were not caused by Fosamax use. Rather, the jury placed blame for the fractures beyond Merck's liability. However, an additional 3,000 Fosamax lawsuits related to femur fractures and jawbone death remain pending against Merck.Merck may not be held accountable for this first plaintiff's injuries, but evidence strongly suggests that it will be held accountable for others. This first trial exposed Merck's alleged knowledge of the drug's dangers and explored the company's failure to alert regulators and patients to these risks for years on end. If these allegations are indeed true, they will hopefully set victims as free as lawsuits can. This release just has not happened quite yet.
Source: FiercePharma, "Merck wins bellwether Fosamax femur-fracture trial," Tracy Staton, Apr. 30, 2013
]]>Patients allege that mesh manufacturers knew of the dangers that the product poses and failed to properly warn them. Manufacturers and even some physicians are blaming inadequate and inexperienced care on the part of surgeons. Others have even pointed fingers at the Food and Drug Administration (FDA) itself for failing to catch the mesh's complications during the approval process.
]]> Meanwhile, over 6,000 lawsuits filed in federal court are pending. Patients who have experienced severe pain and various medical complications remain without compensation for that pain, their related medical bills and other damages that they are almost certainly entitled to. As the number of lawsuits filed continues to multiply, it is time to stop finger pointing generally and attempt to resolve this issue for the benefit of those affected.Innovation is a must in the field of patient care. When transvaginal mesh was introduced into the marketplace, it was welcomed as a less invasive alternative to traditional stitching methods for various pelvic conditions including prolapse.
However, with innovation comes risk. And this product was introduced before that risk had been properly assessed. As a result, it is necessary that those responsible be held accountable for their negligence and patients granted the compensation to which they are due. The longer that this issue goes unresolved, the more harm is being done to those affected. It is time that that harm is properly addressed.
Source: Associated Press, "Thousands of Women Sue Over Surgical Mesh," Kate Brumback, Feb. 8, 2013
]]>The FDA has attempted to bridge this gap before, by allowing certain drugs access to an expedited approval process if they meet certain criteria and may potentially help critically ill or injured patients. The FDA is now considering a new approval process that would further benefit these populations. Specifically, the agency is asking for input on the possibility of allowing for expedited approval of drugs aimed at unmet patient needs that have been studied in well-defined patient subpopulations suffering from serious manifestations of a targeted condition.
]]> This approval process may lead to potentially dangerous or defective drugs in the marketplace before they have been adequately studied. However, the FDA is attempting to address the needs of critical subpopulations through making needed drugs available earlier. Thus, the tension of drug safety versus drug availability for critically ill patients rages on.This approval process may prove to be lifesaving for countless individuals. However, if it is instituted, this process makes it all the more vital that physicians only prescribe drugs for approved uses in approved populations. While critical drugs may need to become available for certain populations, this does not mean that inadequately tested drugs should be prescribed for other vulnerable patients.
Source: The Pharma Letter, "US FDA considering alternative drug approval pathway," Jan. 17, 2013
]]>BOSTON (AP) - Eli Lilly and Co. has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country.
]]> A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the second day of testimony.
DES, or diethylstilbestrol, was prescribed to millions of pregnant women over three decades to prevent miscarriages, premature births and other problems. It was taken off the market in the early 1970s after it was linked to a rare vaginal cancer in women whose mothers used it. Studies later showed the drug didn't prevent miscarriages.
Attorney Aaron Levine, representing the Melnick sisters, told the jury during opening statements that Eli Lilly failed to test the drug's effect on fetuses before promoting it as a way to prevent miscarriages.
Lawyer James Dillon, for Indianapolis-based Eli Lilly, told the jury that there was no evidence the drug causes breast cancer in the daughters of women who took it.
Dillon also said that no medical records show that the mother of the Melnick sisters took DES or that, if she did take it, it was made by Eli Lilly. Leading researchers at the time recommended that DES be used for pregnant women who had consecutive miscarriages, he said.
DES was not patented and was made by many companies.
Boston attorney Andrew Meyer, who's handled numerous medical malpractice cases, said the settlement in this case could signal settlements in other cases.
"When one settles a case, they recognize they can lose it," he said. "The reason they can lose it is because there's enough evidence for the plaintiffs to be able to win it. So it's not just optics, it isn't."
Columbus, Ohio, resident Irene Sawyer also is suing Eli Lilly, alleging that her prenatal exposure to DES caused her breast cancer. She called the settlement "a huge victory" for DES daughters.
"The bottom line is that this company put out a drug without testing, without knowing the consequences of this drug," she said.
It's wonderful, she said, that drug companies "are starting to realize this is not right, that there are consequences."
The Melnick sisters, who grew up in Tresckow, Pa., said they all developed breast cancer in their 40s.
Levine told the jury that their mother did not take DES while pregnant with a fifth sister and that sister has not developed breast cancer.
The four Melnick sisters also had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Thousands of lawsuits have been filed alleging links between DES and vaginal cancer, cervical cancer and fertility problems. Many of those cases were settled.
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Associated Press writer Jay Lindsay contributed to this report.
]]>Defendant Eli Lilly manufactured DES between the late 1940s to early 1970s. DES was prescribed to 3 million pregnant women. Not only was DES a carcinogen and teratogen, but it also had no effect in preventing miscarriages. DES manufacturers like Eli Lilly never conducted controlled testing or warned of the dangers of the drug and its known carcinogenic effects. The FDA banned the use of DES in pregnancy in 1971.
DES daughter Jackie White, of Centerburg, Ohio, was diagnosed in 2010 with stage 3 breast cancer, with 20 tumors in one breast and two pre-cancerous lumps in the other. The cancer had also spread to her lymph nodes, all at the age 47. Ms. White is one of over 100 DES daughter clients of Aaron Levine & Associates looking to hold multiple pharmaceuticals liable for their breast cancer injuries caused by prenatal DES exposure. When asked why she is involved in this litigation, Ms. White stated she "joined the lawsuit because drug companies need to be held accountable for the harm they caused. Research shows-and I firmly believe-the DES prescribed to my mother caused my breast cancer." Ms. White is currently in remission, following double breast mastectomies, chemotherapy, and radiation treatments. She is encouraging all DES daughters to not only become aware of the link between prenatal DES exposure and breast cancer, but to also diligently maintain breast cancer screenings.
DES daughters, such as the Fecho sisters and Ms. White, 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 Fecho v. Eli Lilly trial is open to the public. All interested parties and media are welcomed to attend the trial at the John Joseph Moakley United States District Courthouse in Boston, Courtroom 8 on the third floor on Monday, January 7, 2013 at 9:00 a.m. For more information, please visit www.aaronlevinelaw.com.
]]>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 Defendant in this case, the pharmaceutical company Eli Lilly, manufactured DES between the late 1940's to early 1970's. DES was touted as a miscarriage-prevention drug. However, it was proven to be a carcinogen and teratogen to the fetus. DES also had no effect in preventing miscarriages. DES manufacturers like Eli Lilly never tested or warned of the dangers of the drug and its known carcinogenic effects. The FDA banned the use of DES in pregnancy in 1971.The Defendants attempted to block the Plaintiffs from their day in court and claimed that they are unable to prove that DES would not have been prescribed if Eli Lilly had adequately warned of the dangerous effects of DES to unborn children. Additionally, Defendant Eli Lilly, the largest DES maker in the country for two decades, argued that the Plaintiffs cannot prove which brand of DES the Plaintiffs were exposed to despite testimony from eye-witnesses to the contrary. Judge Bowler found that the Plaintiffs' case presents genuine disputed issues of material facts, which warrants a jury trial to determine the liability of Eli Lilly. Plaintiffs will present evidence at trial that Eli Lilly made the DES that the Plaintiffs' mother ingested, and that had Eli Lilly provided an adequate warning, the Fecho sisters would not have been exposed in utero to DES, which led to the development of their breast cancer.
DES daughters, such as the Fecho sisters, 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.
]]>Specifically, the study discovered that patients taking two different TZDs - one of which was the diabetes drug Actos - for more than five years have a two-to-three-fold increase in their chances of acquiring bladder cancer when measured against those taking sulfonylureas.
Unfortunately, TZDs are quite common as they account for almost 20 percent of all drugs prescribed to treat diabetes in the United States. Actos alone is prescribed roughly 15 million times each year, making it the ninth most common drug prescribed in the United States.
]]> Tragically, this is not the first study to link Actos use with an increased chance of developing bladder cancer. There have been several studies discovering this link, with the most recent being a Canadian study concluding just months ago that Actos users have a 22 percent increased chance of developing bladder cancer.Hopefully with further research and action, treatments may be established for those who develop cancer after taking Actos. Until then, it is important for patients prescribed Actos to discuss all of the risks associated with Actos use with their doctors.
Source: Penn Medicine, "Diabetes Drugs Prescribed to More than 15 Million Americans Raises Risk of Bladder Cancer, Penn Medicine Study Shows," News Release, August 13, 2012
Our firm often handles situations in which patients develop bladder cancer after taking Actos long-term. If you would like to learn more about our defective drugs practice, please feel free to visit our Actos Bladder Cancer page.
]]>Like many cancers, colon cancer is treatable when caught early enough. Unfortunately, sometimes doctors make mistakes in professional judgment. They may not diagnose the symptoms of colon cancer correctly, miss a malignancy, or fail to carefully examine the tell-tale symptoms early enough in the disease's development.
Diagnosed early enough, surgery, radiation, chemotherapy and other drug treatments may be available. If colon cancer is misdiagnosed or not caught early enough, it may be too late for proper recovery or any recovery at all.
Historically considered a disease mostly occurring in elderly populations, colon cancer is getting more and more common in people younger than 50. Because this trend is newer, medical professionals may be less likely to aggressively screen for the disease in younger persons.
]]> According to The Baltimore Sun, overall colon cancer rates have declined since the 1980s, but increasing in those under 50 - especially for people in their 40s. Professionals do not yet understand why this trend is happening, but sedentary lifestyle, poor diet and obesity are probable culprits.Genetics can also play a role, and patients with family histories of cancer, especially of the colon, should be carefully screened at any age when symptoms appear. African-American males in particular are experiencing higher rates of colon cancer.
While younger patients may be able to better withstand aggressive treatments, one particular concern can be their effects on reproductive health and the ability to have children.
Ultimately though, it is important that doctors screen for colon cancer in younger patients - after all, a late diagnosis or misdiagnosis can have deadly consequences.
Source: The Baltimore Sun, "More younger people getting colorectal cancer," Andrea K. Walker, July 29, 2012
]]>Bayer, the manufacturer of Yaz, is more than happy to highlight the benefits of the drug; however, Bayer may not be so keen on discussing the drug's downside or the many lawsuits it faces.
In a newsletter to stockholders, Bayer recently stated that it faces over 12,000 lawsuits for injuries caused by Yaz and other oral contraceptives containing the synthetic hormone drospirenone. To date, Bayer has paid out over $405.5 million to settle nearly 1,900 claims that Yaz and Yasmin (another contraceptive manufactured by Bayer) cause blood clots.
Yaz, along with other contraceptives, has been linked to blood clots that lead to heart attacks and strokes. According to the United States Food and Drug Administration, between 2004 and 2008 at least 50 women were killed after taking the contraceptive pills.
]]> Blood clots are not the only injuries alleged to be caused by Yaz and other Bayer contraceptives. According to other lawsuits filed against the drug manufacturer, women are also claiming that taking Yaz led to gallbladder damage. Other serious side effects allegedly caused by Yaz include:If taking Yaz or another drospirenone-containing drug, such as Yasmin has led to blood clots or other medical issues, an experienced attorney may be able to get you compensation for your injuries, including monies for medical bills, lost wages, and pain and suffering.
Source: Business Week, "Bayer's Yasmin Lawsuit Settlements Rise to $402.6 Million," Jef Feeley, July 31, 2012
]]>In 2005, Johnson & Johnson brought the vaginal mesh product to market without first filing a new application with the Food and Drug Administration. At the time, Johnson & Johnson believed the product was substantially similar to another product already approved for use by the FDA.
In 2007, the FDA ordered Johnson & Johnson to halt the sales of Prolift until questions about the product's safety could be answered and a determination about its similarity to the approved mesh product could be assessed. In 2008, the FDA cleared Prolift and allowed to Johnson & Johnson to resume its sales of the product.
However, Bloomberg News reports that court records show that Johnson & Johnson continued to sell Prolift during the nine-month period the FDA had ordered it not to.
]]> Transvaginal MeshTransvaginal mesh - also called surgical mesh - products like Prolift are used to repair weak or damaged tissues. Commonly, transvaginal mesh is used to treat pelvic organ prolapsed (POP) and stress urinary incontinence (SUI).
Despite transvaginal mesh's popularity to help women with POP and SUI - the FDA estimates 300,000 mesh products were used in 2010 - severe complications and side effects often develop after its use, hence the FDA's hesitancy to allow the continued sale of Prolift without further information.
Common injuries caused by transvaginal mesh include:
If you have experienced complications, side effects or injuries from transvaginal mesh, an experienced personal injury attorney can provide helpful guidance and advice.
Source: Bloomberg News, "J&J Sold Vaginal Mesh Implant After Sales Halt Ordered," David Voreacos, June 26, 2012
]]>In the Swiss study - which was published in the Archives of Internal Medicine - researchers observed various patients aged 50 and above who had been treated for femoral fractures. Four-hundred-seventy-seven patients were tracked in total. Of those 477 patients, 438 had common classical fractures and 39 had atypical fractures. Atypical fractures are fractures that occur spontaneously without any significant leg injury. These unusual breaks can even occur while the victim is involved in low-impact activities, such as walking.
The researchers discovered that of those patients who were being treated with bisphosphonates, 6 percent suffered classic femur breaks. In contrast, a whopping 82 percent of those patients suffering atypical femur fractures were being treated with bisphosphonates such as Fosamax and Actonel.
]]> In addition, researchers assigned odds ratios for atypical breaks versus classic fractures based upon how long the patient had been taking bisphosphonates. They found:In a journal news release, researcher Dr. Raphael Meier, in conjunction with his colleagues from University Hospitals of Geneva and Faculty of Medicine in Geneva, concluded, "[W]e have demonstrated that the association between bisphosphonate treatment and the occurrence of atypical fractures of the femur is highly likely and that the duration of such treatment significantly correlates with augmented risk."
Source: US News, "More Research Points to Long-Term Ills With Bond Drugs," May 21, 2012
]]>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
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