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Category : FDA
Last week, Japan-based Takeda Pharmaceutical Co Ltd, makers of the drug Actos, announced that the FDA will extend its review of the company’s drug alogliptin. Alogliptin, a diabetes medication, was expected to be the successor to Takeda’s top-selling drug Actos. Before Takeda lost its patent protection on Actos, the type-2 diabetes treatment had been linked to an increased risk of bladder cancer in studies. In response, the FDA issued a warning to doctors who prescribed Actos to patients.
Seeger Weiss LLP, a national plaintiffs’ law firm, has been actively investigating the link between Actos and bladder cancer. If you believe you or someone you know developed bladder cancer as a result of taking Actos, the firm’s drug injury practice will review your case for free. Contact them here.
Earlier this week, The New York Times uncovered a 2009 email authored by an executive at DePuy Orthopaedics, a Johnson & Johnson subsidiary, that seems to refute the company’s later claims that it believed its artificial surface replacement (ASR) hip replacement to be safe. The message was sent in August 2009, just days after the Food and Drug Administration confidentially informed DePuy that it would not approve the ASR device. In the email, vice-president Pamela Plouhar explains the reasons for the FDA’s decision to three other top executives, including then president, David Floyd. The New York Times writes that Ms. Plouhar, “reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in ‘significant’ numbers, requiring repeat surgeries for patients.”
Although the ASR implant was denied approval by the FDA, it was sold overseas and was placed in 30,000 patients in the United States before it was officially recalled in 2010. While DePuy’s apparent lack of transparency does not alone constitute a violation of the law, the 2009 email certainly contradicts statements from Johnson & Johnson prior to the recall. After the metal-on-metal hip implants were indeed found to be defective in a number of cases in 2010, the company maintained that its internal studies had demonstrated the safety of the device, and shifted blame onto the doctors and surgeons who were responsible for the implant procedures. The 2009 email, however, proves that DePuy knew the ASR hip implant was unsafe, even when applied by doctors the company hand-picked itself. As The New York Times notes, “DePuy’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it…”
If you are the victim of a defective ASR hip implant, contact Seeger Weiss LLP today. Our experienced defective products attorneys will make sure your case receives the attention and retribution you deserve.
For information on the current 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.
In a warning letter published last week, the Food and Drug Administration announced that fourteen types of devices sold by DePuy Orthopaedics Inc. lacked necessary approval. The letter, sent by Steven D. Silverman, director of the office of compliance, was the result of a near month-long inspection of the Warsaw, Indiana-based company. The inspection also found that DePuy’s quality system did not comply with FDA requirements.
DePuy Orthopaedics Inc., a subsidiary of Johnson & Johnson, has been the subject of significant FDA attention in the past. In 2010, the FDA released another warning letter regarding the manufacturer’s defective hip replacements, the ASR Hip Resurfacing System and the ASR XL Acetabular Cups System. These “metal on metal” hip replacements released dangerous metal shavings in patients, often leading to debilitating pain and other health complications. DePuy recalled the hip implants in 2010, and since then, Seeger Weiss LLP has been working with victims to restore their health and recover compensation for their suffering. If you have been affected by the DePuy ASR hip replacement recall, contact Seeger Weiss today. One of our experienced attorneys will review your case for free.
For information on the 2012 Stryker hip implant recall, visit http://www.seegerweiss.com/stryker-hip-recall.
Last week, the Washington Post reported the story of a Washington state couple suing Tylenol manufacturers, Johnson & Johnson. According to the Post, Daniel and Katy Moore claim that their 2-year-old son River Moore died as a result of consuming a Children’s Tylenol product. The specific package in question had been recalled due to high levels of the active ingredient acetaminophen. Shortly after taking the over-the-counter medication for a slight fever, the young boy died of liver failure, a known effect of an acetaminophen overdose. “The lawsuit, filed…in Philadelphia’s Court of Common Pleas, accuses Johnson & Johnson of recklessness, negligence, breach of warranty, infliction of emotional distress, conspiracy and other offenses,” the story explains.
The article also notes that Johnson & Johnson’s 2009 recall of the product at the center of this lawsuit is “part of the company’s continuing string of recalls of drugs and medical devices.” In fact, the drug injury practice of Seeger Weiss LLP is currently investigating complaints of liver damage at the hands of Tylenol. If you or someone you know has suffered liver damage as a result of taking Tylenol, let Seeger Weiss help you seek justice. Our experienced drug injury attorneys have won billions of dollars for our clients and will review your Tylenol liver damage case for free.
A recent health report from CBS Philadelphia investigates DePuy Orthopaedics’ defective hip replacements, and asks, “Why were so many people being injured by implants that are FDA approved?” The hip implants, which due to their design have been shown to lead to blood poisoning, were recalled in August 2010. Before they were however, they caused many of the patients who received them life-threatening conditions, toxic injuries and debilitating pain. Visit CBS Philadelphia to watch a video featuring two of these stories and read the entire report.
Seeger Weiss LLP is currently investigating the claims of those harmed by the DePuy ASR Hip Implant. If you or someone you know has suffered complications from the DePuy ASR Hip Implant, contact Seeger Weiss LLP today. An attorney with our award-winning drug injury class action practice will assist you in evaluating your claim. Attorney consultations incur no obligation on your part and all initial consultations are free of charge. Seeger Weiss LLP has office locations in New York, New Jersey, Pennsylvania and California.
Reports surfaced early today that profits for Japan-based Takeda Pharmaceutical Co. have substantially declined. One factor that several news sources, including Bloomberg Businessweek, have attributed to the company’s losses is the controversy surrounding its top-selling drug, Actos. Calls for the FDA to release cautionary warnings for the diabetes medication began to emerge after it was linked to an increased risk of bladder cancer. Takeda projects that its net income will plunge by over 30 percent over the course of the next four months.
Following negative media attention and a swarm of recent pharmaceutical drug litigation involving the medication, the European Commission has requested that the European Medicines Agency (EMA) clarify its position on the use of Actos. Both France and Germany prohibited the diabetes drug after reports indicated that it increased patients’ risk of heart attack and bladder cancer. Although the FDA did not officially ban Actos in the U.S., it added warnings to its label. Now, the EMA has asserted that while the drug can be a “valid treatment” for type 2 diabetes, it should only be prescribed when other medications have failed. Furthermore, the agency urges doctors who prescribe Actos to closely monitor their patients. Read the full story.
The experienced pharmaceutical injury attorneys in Seeger Weiss’ drug injury practice are closely following developments about reported Actos side effects. To learn more, visit our Actos Investigation Page.
In a Los Angeles Times article from the beginning of this summer, writer Chris Woolston reports a recent FDA announcement to include new labels on Zocor that will warn doctors against prescribing his doses of the medication. As Woolston notes, the FDA’s decision came after the drug, which is prescribed for lowering cholestorol, was shown to cause injuries to muscles that can potentially be fatal. Seeger Weiss is currently investigating claims of patients who have been harmed by Zocor.