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Category : FDA Recall
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.
Fosamax, the subject of an ongoing Seeger Weiss investigation, is one of the four brands of bisphosphonates discussed in two advisory panels to the FDA on September 9. Bisphosphonates, drugs prescribed to women at risk of osteoporosis, have in recent years been demonstrated to cause fractures to the femur. Examining the mounting evidence, including the testimony of 18 victims who suffered atypical femoral fractures after taking the medication, the panels voted to recommend more specific instructions for how long Fosamax and other bisphosphonates should be used.
Blood clots are a well-known risk of taking birth control pills. Now the FDA is investigating oral contraceptives that contain drospirenone, such as Yaz and Yasmin, after new research suggests that these pills increase the risk of blood clots above that of other oral contraceptives.
Most birth control pills combine estrogen with another female sex hormone, progestin. In two studies published in the British Medical Journal in April, pills containing drospirenone, a type of progestin, were found to carry a two- to three-fold higher risk of venous thromboembolism, or a blood clot in a deep vein, than pills containing a different progestin, levonorgestrel.
The FDA said it was “aware of two newly published studies” that found what appeared to be an increased risk for venous thromboembolism (VTE)—blood clots— in women taking birth control pills containing the synthetic version of the hormone progestin called drospirenone. Older birth control pills tend to contain a version of progestin called levonorgestrel.
“This risk is reported to be up to two to three times greater than the risk of VTE associated with using levonorgestrel-containing pills,” the FDA said.
Among the pills containing drospirenone are Yaz, which is sold generically as Gianvi and Loryna; Yasmin, which is sold generically as Ocella, Syeda and Zarah; and Beyaz and Safyral.
Any U.S. citizen can file a petition with the FDA to ban a drug or medical device for safety issues. Most petitions are rejected, though Public Citizen has a rare track record of successful drug withdrawals. Last year, both the diet pill Meridia and painkiller Darvon were both withdrawn from the U.S. market, years after Public Citizen filed petitions against them.
In a telephone interview, Dr. Nissen said that he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some have died because of failed medical devices that were cleared for sale with little testing.
“This is an area where the F.D.A. has failed the public,” Dr. Nissen said.