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Germany Archives - Carey Danis & Lowe

Second Actos Bladder Cancer Lawsuit Goes to Trial in Baltimore

By | Actos, Pharmaceutical litigation, Uncategorized

actos_bladder_cancer_lawsuits_settlements_diabetes_litigation_fda_warningThe second Actos bladder cancer lawsuit is currently on trial in the Circuirt Court for the City of Baltimore.

The plaintiffs in the case, the family of Diep An, a former Actos user who died from bladder cancer in January 2012, filed their Actos lawsuit contending that the diabetes drug was the cause of Diep An’s bladder cancer and death.

In opening arguments delivered in early September, the plaintiffs’ legal counsel argued that Takeda Pharmaceuticals, the Japanese company responsible for the development and marketing of Actos, did not make patients aware about the risks involved with using Actos, specifically about the bladder cancer risk. According to the plaintiffs’ lawyer, Takeda Pharmaceuticals instead focused on Actos sales.

As detailed in a Bloomberg report, the Diep An Actos bladder cancer lawsuit is the second case in over 3,000 to go to trial. Of the 3,000 Actos lawsuits in the U.S., approximately 1,200 have been consolidated into a federal court in Louisiana, with the  first case set to go to trial in January 2014. Carey Danis & Lowe Actos lawyers are interested to see, come January, how the federal trial affects lawsuits across the nation.

Still on the market in the United States, but banned in both France and Germany following a French epidemiological study, Actos is a drug used to treat diabetes. Due to increased reports of patients developing bladder cancer while using Actos, the U.S. Food and Drug Administration (FDA), reviewed a ten year Actos study, whose results are due out next year.

In its review of the partial data from the collaborative study conducted by Takeda Pharmaceuticals and Kaiser Permanente Northern California, the FDA found that in patients taking high dosages of Actos for longer durations, there exists a higher risk of developing bladder cancer.

Plaintiffs have filed Actos bladder cancer lawsuits alleging that Takeda Pharmaceuticals knew about the bladder cancer risk, yet made the decision to dismiss it as the drug was released onto the market.

If you or someone you love has been harmed by Actos, the experienced lawyers and medical experts at Carey Danis & Lowe are here to help. Receive a free legal consultation about your Actos case, and get medical advice from one of our nurses.

Contact Carey Danis & Lowe today by calling 800.721.2519, or by submitting a personal injury claim form.

European Medicines Agency’s Takes a Stand on Actos

By | Actos, Pharmaceutical litigation, Uncategorized

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European Medicines Agency's Takes a Stand on ActosThe European Medicines Agency made an effort to provide more detail on its conclusion regarding the safety of drugs containing pioglitazone, including the diabetes drug Actos. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded in July 2011 that in patients taking medicines containing pioglitazone, such as Actos, their researchers observed an increased risk in the development of bladder cancer.

Though the European Medicines Agency recognizes the risk for patients to develop bladder cancer, they are still recommending that doctors prescribe drugs such as Actos, and other pioglitazone medications, for the treatment of type 2 diabetes.

Their recommendation does place some patients at an increased risk of developing bladder cancer, and in recognizing the threat of cancer development, the European Medicines Agency has added to their stance on pioglitazone medications that doctors prescribing such drugs must closely monitor their patients for any signs of bladder cancer.

Furthermore, the European Medicines Agency recommended that doctors should use careful discretion in determining when to prescribe drugs such as Actos.

In recognizing the link between Actos and increased risk of bladder cancer, France and Germany have made efforts to halt sales of Actos and other pioglitazone medications.

In the United States, the U.S. Food & Drug Administration is currently analyzing data being collected in a 10 year study conducted by Kaiser Permanente Northern California and Takeda Pharmaceuticals Inc., the manufacturer of Actos. After its review of data from the Kaiser Permanente and Takeda study, the FDA will make a conclusion regarding the safety of Actos and other pioglitazone medications.

Currently, the FDA recommends that Actos not be prescribed to patients who are currently suffering from bladder cancer. Signs of bladder cancer include hematuria, or blood present in urine, painful urination, back and pelvic pain, and a frequent need to urinate. If you are taking Actos and are experiencing any of these bladder cancer symptoms, contact your healthcare provider as soon as possible.

In light of the dangers associated with Actos and other pioglitazone medications, lawyers at Carey Danis & Lowe are currently accepting Actos claims.

If you or someone you love has developed bladder cancer as a result of taking Actos or pioglitazone, understand that you do not have to suffer alone. Our experienced pharmaceutical litigation lawyers work closely with clients to win them much deserved justice and compensation.

Receive a free legal consultation about an Actos lawsuit today by calling a lawyer at Carey Danis & Lowe at 800.721.2519.

Carey Danis & Lowe Lawyers Examine the Link Between Actos and Bladder Cancer

By | Actos, Pharmaceutical litigation, Uncategorized

Published November 29, 2012 by PR Web

Carey Danis & Lowe Lawyers Examine the Link Between Actos and Bladder CancerSt. Louis, Missouri (PRWEB) November 29, 2012

November is American Diabetes Month and the pharmaceutical product liability lawyers at Carey Danis & Lowe are examining the relationship of Actos and bladder cancer. In recent months, the European Medicines Agency and the U.S Food and Drug Administration (FDA) have reviewed the safety of the drug and its potential to cause bladder cancer.

Based on these studies, Carey Danis & Lowe provides consultation to those who may have been harmed by Actos and may be entitled to compensation.

According to the European Medicines Agency, last fall the French Medicines Agency made the decision to discontinue prescribing medicines in France containing pioglitazone, such as Actos. The French Medicines Agency came to this resolution based off of a French epidemiological study.

This French study was undertaken by Caisse National d’Assurance Maladie, a French health insurance organization. The French epidemiological study was conducted during 2006 – 2009. From the data compiled during the French study, it became clear that there is a significant link between the use of Actos and the development of bladder cancer.

Following suit, health officials in Germany have advised German health care providers to stop writing prescriptions for Actos, specifically for new diabetes patients.

Like the European Medicines Agency, the U.S. Food and Drug Administration (FDA) is currently reviewing the safety of Actos in regards to the development of bladder cancer in patients prescribed with the diabetes drug. In this review process, the FDA is actively watching a study being conducted by Takeda Pharmaceuticals involving over 100,000 diabetes patients.

The manufacturer of Actos, Takeda Pharmaceuticals, is leading a 10-year cohort study involving patients in the Kaiser Permanente Northern California health plan. In the Takeda Pharmaceuticals and Kaiser Permanente Northern California study, a 5-year interim analysis of data was undergone, which revealed that, in patients who had taken Actos for more than one year, the researchers saw a 40% increased risk of the development of bladder cancer.

Patients who used Actos and developed bladder cancer may be entitled to compensation. Carey Danis & Lowe provides consultation to those patients who may have been harmed by Actos. Please contact our pharmaceutical lawyers to learn more and file a case.

References:

[European Medicines Agency: Update on ongoing European review of pioglitazone–containing medicines.
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure. FDA Web site. Accessed November 14, 2012.

Diabetes Drug Actos Connected to Bladder Cancer

By | Actos, Pharmaceutical litigation, Uncategorized

Diabetes Drug Actos Connected to Bladder CancerResearch demonstrates a strong connection between the development of bladder cancer and the use of Actos, a drug prescribed to patients with diabetes. Actos is known generically as pioglitazone, and is categorized within the drug class thiazolidinedione (TZD). Actos is manufactured by Takeda Pharmaceuticals.

The U.S. Food and Drug Administration (FDA) made a decision in June 2011 to deliver a warning about the link between Actos and and increased risk of developing bladder cancer. The FDA released this warning based on information gathered from an examination of Takeda’s own ongoing study of Actos.

As a result of the FDA warning, the Actos packaging has been updated with a warning about the increased risk of bladder cancer. Furthermore, the Actos patient medication guide was also updated in a similar manner with information regarding the risks of bladder cancer.

After reviewing data collected from a French study of the drug Actos, two European countries have since banned Actos. France no longer prescribes the diabetes medicine as a result of the findings from the French  epidemiological study. The diabetes drug Actos is also banned in Germany.

The French study was conducted by the French Medicines Agency from 2006 – 2009. The Actos research study looked at the health of 1.5 million patients. During the study, the French scientists discovered a strong link between the use of Actos and the development of bladder cancer.

Another Actos study which saw data linking Actos to bladder cancer is a 10 year study of the drug undertaken by Kaiser Permanente Northern California. Starting in 2002, The Kaiser Permanente data demonstrates an 40% increased risk of developing bladder cancer from the use of Actos for more than 1 year.

Takeda Pharmaceuticals developed Actos for the purpose of intensifying the body’s ability to use insulin in order to regulate blood sugar levels in patients with diabetes. Those patients more at risk of developing bladder cancer are individuals who have been using Actos for the longest duration, and those who are prescribed high doses of the drug.

Signs of bladder cancer include the following:

  • Blood in urine
  • Red-colored uring
  • Frequent urination
  • Pain while urinating

Patients already suffering from bladder cancer, or other bladder health issues, should not take the drug Actos. Also, patients currently taking Actos should discuss stopping the use of the drug with their doctors.

If you or someone you love has suffered from bladder cancer due to use of the diabetes drug, Actos, you may be eligible to receive compensation for your suffering and losses. For more information about filing an Actos lawsuit, contact Carey Danis & Lowe. Our pharmaceutical product liability lawyers work hard to win our clients the justice they deserve.

Boehringer Ingelheim Pharmaceuticals, Inc. Under Fire for Manufacture and Distribution of Pradaxa

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa

The blood thinner medication known as Pradaxa is currently under scrutiny, as the drug has been known to cause severe bleeding, sometimes resulting in death. Pradaxa is a drug manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., a pharmaceutical company headquartered in Germany.

Originally, Pradaxa was developed in an effort to find a better and safer alternative to the generic blood thinner drug first introduced in the 1950s known as warfarin. The blood thinning drug warfarin, since its introduction, has developed a reputation for being unsafe in the treatment of atrial fibrillation.

Patients are prescribed a blood thinning medication, such as warfarin or Pradaxa, the latter drug having been approved for distribution and patient use in October 2010 by the U.S. Food and Drug Administration (FDA), in order to treat a heart condition known as atrial fibrillation.

Patients with this heart condition demonstrate an irregular heart beat, inhibiting the flow of blood, and essentially causing blood to accumulate in one of the heart’s chambers. The accumulation of blood in a chamber can lead to the formation of blood clots, which can migrate towards the brain, resulting in a stroke.

Pradaxa is a drug that works to thin the blood in order to prevent blood clots, and ultimately, to prevent a stroke in the patient suffering from atrial fibrillation.

Unfortunately, Pradaxa does not work as intended. It has been known to cause excessive bleeding, causing death in quite a large number of cases, especially in patients with severe kidney dysfunction and overall poor kidney health. Some important data points have been released by the nonprofit medical organization known as the Institute for Safe Medication Practices.

In their research on the drug Pradaxa, the Institute for Safe Medication Practices noted that in 2011, 542 patients died from taking Pradaxa compared to 72 patients dying from warfarin use.

As a result of the high number of deaths resulting from Pradaxa use, the pharmaceutical company Boehringer Ingelheim is currently facing over two dozen U.S. Federal lawsuits citing Pradaxa’s excessive bleeding risk and negligence to warn atrial fibrillation patients and doctors about the risks involved in taking the drug.

If you have experienced a severe injustice and undue amount of suffering through the use of Pradaxa yourself or have a loved one who has suffered or died as a result of using Pradaxa, expert Pharmaceutical litigation attorneys at Carey Danis & Lowe can provide you first-rate legal counsel to get you the justice and compensation you deserve.

Pharmaceutical company negligence is not acceptable, and attorneys at Carey Danis & Lowe are incredibly skilled in representing clients in cases filed against some of the largest pharmaceutical corporations in the world.

Bayer Yaz and Yasmin Lawsuit Settlements Climb to $142 Million

By | Pharmaceutical litigation, Uncategorized, Yaz/Yasmin

Published April 26, 2012 by LawsuitInformation.org

Bayer AG (BAYN) said settlements of U.S. lawsuits claiming that its Yasmin line of birth-control pills caused blood clots in women have increased to $142 million.

Bayer, based in Leverkusen, Germany, has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused sometimes- fatal clots that can lead to heart attacks and strokes, the company said today in its Stockholders’ Newsletter for the first quarter. The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

“This company wants to avoid the possibility of a large jury award in these clot cases,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview. “Settlements provide predictability when it comes to the cost of resolving these cases.”

Bayer’s update comes less than two weeks after Richard Vosser, a JPMorgan Chase & Co. analyst, said the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives.

Bloomberg News reported April 13 that Bayer agreed to pay about $110 million to settle the first 500 U.S. suits over Yasmin, according to people familiar with the accords.

The U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.

Triple Risk

Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line, according to the FDA report. Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betaseron, a multiple sclerosis medication.

“Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records,” the company said in the report.

11,900 Suits

Fewer than half of the cases brought over the contraceptives so far include those injuries, Bayer said. As of April 18, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs, the company said.

Bayer’s American depositary receipts, each representing one ordinary share, rose 2.2 percent to $69.78 in over-the counter trading today. Shares in Germany climbed 2.6 percent to 54.44 euros.

Bayer officials said they were “increasingly confident” about the drugmaker’s outlook for the year after reporting sales and profits in the first quarter that beat analysts’ estimates.

Earnings before interest, tax, depreciation, amortization and special items rose 9.4 percent to 2.44 billion euros, the company said in a statement. That beat the average analyst estimate of 2.24 billion euros compiled by Bloomberg.

In the newsletter, Bayer officials said they weren’t admitting wrongdoing in any of the settlements. Bayer’s available insurance for product-liability claims may not be enough to “cover all expenses and potential liability” from the litigation, according to the newsletter.

Gallbladder Cases

Michael Burg, one of the leaders of a group of plaintiffs’ lawyers that is overseeing the progress of Yasmin cases consolidated before a federal judge in Illinois, said Bayer is pressing ahead with settlement talks about clot cases.

The drugmaker is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones, Burg, who is based in Colorado, said in a telephone interview.

“At this point, they’ve said they don’t anticipate settling any of the gallbladder cases,” he said.

Since 2009, the German drugmaker has faced a wave of litigation over the birth-control pills. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Plaintiffs’ lawyers contend in court filings that Bayer officials marketed the contraceptives for unapproved uses and misled women about the drugs’ risks.

Trials on Hold

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.

Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.

At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December order.

The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users. “I don’t anticipate seeing any trials this year,” Burg said today.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).