DePuy Hip Recall: Attorneys Licensed in IA, MA, MN and RI
Our attorneys have filed DePuy hip recall lawsuits against Johnson & Johnson and DePuy Orthopaedics. Attorney David Szerlag, lead attorney for our DePuy cases, is licensed in Massachusetts, Minnesota and Rhode Island. David recently won over $20 million for clients injured by another medical product.
Attorney Elliot Olsen is licensed to practice law in Minnesota and Iowa. He is on the DePuy litigation team and focuses on product liability and medical malpractice issues.
DePuy Hip Recall Investigation
Attorney David Szerlag and his team are investigating the facts surrounding the DePuy recall for our clients. One of the issues is the timing of the recall, which came months after reports of early failure of the DePuy ASR™ XL Acetabular System and cases of chromium and cobalt poisoning. The recall involved sending information to surgeons telling them not to implant DePuy ASR hip replacements and to return any unused implants to the manufacturer.
Our DePuy hip recall investigation is uncovering evidence to prove that DePuy’s ASR XL Acetabular Hip System, a device used in hip replacement surgery, was defectively designed and/or manufactured, and that DePuy failed to provide adequate warnings concerning the device, which DePuy recalled in August 2010.
Attorney David Szerlag and his team are available for a free consultation to DePuy hip patients in Iowa, Massachusetts, Minnesota and Rhode Island. All patients, even those with no current pain or other symptoms of device failure, should contact our lawyers now.
Metal-on-Metal Hip Replacements Subject of FDA Expert Advisory Panel Meeting
The U.S. Food and Drug Administration (FDA) is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems for an expert advisory panel meeting scheduled for June 27-28, 2012. The issue is whether to make MoM hip systems subject to more rigorous testing and premarket review requirements.
There are two categories of MoM hip systems:
- Metal-on-metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component).
- Metal-on-metal hip resurfacing systems consisting of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component).
The reason for the increased concern regarding metal-on-metal hip systems is that some studies have found that these MoM hip systems may be subject to early failure and, related to this, that they may cause dangerous levels of metal ion concentrations in the bloodstream (chromium and cobalt poisoning). In May 2011, the agency issued an order for manufacturers of MoM hip systems to conduct post-market surveillance studies to collect more safety data on these devices, including data related to metal ion concentrations in the bloodstream.
Experts on the FDA’s expert advisory panel will discuss:
- Failure rates and modes of failure, including whether larger metal heads put patients at greater risk;
- Chromium and cobalt ion testing;
- Imaging methods;
- Local and systemic complications, including organ failure and tissue death;
- Patient risk factors;and
- Considerations for follow-up after surgery.
Attorney David Szerlag is lead attorney for our metal-on-metal hip replacement lawsuits. He and his litigation team are representing several people who had DePuy ASR™ XL Acetabular System hip replacements implanted in their bodies, which then failed, causing severe pain, chromium and cobalt poisoning, tissue necrosis (tissue death), and other serious medical complications. To contact David, call 888-377-8900 or submit our free consultation form.
Pradaxa: Recall Not Issued
There does not need to be a recall of Pradaxa for you to file a lawsuit. Call 612-338-0202 for a free consultation.
People are suffering irreversible bleeding leading to serious injury and death after taking Pradaxa, a blood thinner used to reduce the risk of stroke and blood clots in people with atrial fibrillation. The manufacturer, Boehringer Ingelheim,1has not issued a recall of this product.
Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in October 2010 for stroke prevention in patients with atrial fibrillation. By December, FDA had received reports of severe, irreversible bleeding after using Pradaxa that could lead to serious injury or death. On December 7, 2011, the FDA issued a safety communication regarding Pradaxa, in which it stated it was investigating “post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate).”2
In January of 2012, Boehringer Ingleheim announced safety label changes that had been approved by the FDA3, including the following:
5 WARNING AND PRECAUTIONS
5.1 Risk of Bleeding
- Pradaxa’s anticoagulant activity and half-life are increased in patients with renal impairment.
- Lack of a specific reversal agent; futility of using vitamin K to affect anticoagulant effect
Brendan Flaherty is lead attorney for our Pradaxa lawsuits. Contact Attorney Brendan Flaherty for a free consultation. Our law firm represents clients in personal injury and wrongful death lawsuits throughout the United States.
1. Pradaxa was and is manufactured, marketed, distributed and sold by Boehringer Ingleheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma Gmb H & Co. KG and Boehringer Ingelheim International Gmb H (collectively referred to as Boehringer Ingelheim).
2. December 7, 2011 FDA Safety Communication regarding Pradaxa: http://www.fda.gov/Drugs/DrugSafety/ucm282724.htm
3. FDA announcement regarding Pradaxa label changes: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm250657.htm
Pradaxa Lawsuit
Call 888-377-8900 for a free consultation regarding a Pradaxa lawsuit.
Attorney Brendan Flaherty is lead attorney for our Pradaxa lawsuit cases. An investigation of Pradaxa (dabigatran etexilate) has found that this medication can cause irreversible bleeding. In some cases, people who took Pradaxa for a brief period of time were at increased risk for life-threatening bleeding.
Are you someone who suffered from severe bleeding after taking Pradaxa? If so, Brendan Flaherty and his team of attorneys can help you win your case. Contact Brendan for a free consultation regarding your legal rights.
Pradaxa Lawsuit Investigation
Your lawsuit will allege that the Pradaxa you ingested was defective, that the product label and associated documents did not adequately warn you or your doctor of the risk of irreversible bleeding, and that you should be fully compensated you for your injuries. If you are a family member of someone who died from severe bleeding after taking Pradaxa, your lawsuit will allege that it was a wrongful death.
Your Pradaxa lawsuit investigation will require legal procedures to obtain documents from the manufacturer of Pradaxa and related companies: Boehringer Ingleheim Pharmaceuticals, Inc. and Boehringer Ingelheim Pharma Gmb H & Co. KG, Boehringer Ingelheim International Gmb H, and Bidachem Sp. A. (collectively referred to hereafter as Boehringer Ingelheim). In addition, executives of these companies and others will need to be interviewed in the presence of a court reporter. These interviews are called depositions. A list of written questions is also sent to each company. These written questions are called interrogatories.
Some of the questions that need to be answered include the following:
- When did the company know of specific cases of injury and death associated with Pradaxa use?
- Why didn’t the company pull the product off of the market when they knew of the high risk of injury and death?
- Did the company provide the FDA with all relevant results from all clinical trials before the FDA approved the drug for sale in the United States?
- How did the company promote the product and did they fully explain, or explain at all, the risk of irreversible bleeding to doctors?
Attorney Brendan Flaherty and his team can help you get the answers you want and the money you deserve. Contact Brendan for a free Pradaxa case review.
Our attorneys work with local counsel throughout the Unites States to represent clients in product liability injury and death lawsuits. States in which one or more of our attorneys are licensed to practice include: Iowa, Massachusetts, Minnesota, Rhode Island.
Metal-on-Metal Hip Pain Leads to Revision Surgery and Legal Action
Contact our attorneys for a free review of your metal-on-metal hip case.
Terri Wagner-Morley told the Star-Tribune that the new hip she had implanted to ease her chronic arthritis pain in 2008 started to cause her pain in 2009 and was later surgically removed, a procedure called revision surgery. He artificial hip was a DePuy metal-on-metal ASR hip, which was recalled in 2010.
Ms. Wagner-Morley is not alone. Her case is just one of thousands involving a metal-on-metal hip implant that failed years before it was supposed to. DePuy Orthopaedics, Inc. recalled its ASR™ XL Acetabular System, and we expect that other manufacturers of metal-on-metal hip replacement systems will follow.
Problems with the metal-on-metal hip implants reported to the Food and Drug Administration (FDA) include the following:
- loosening of the hip
- inflammation in the tissues around the hip
- dislocation
- cobalt and chromium ions in the bloodstream, resulting in cobalt and chromium poisoning.
Metal-on-Metal Hip Replacement Lawsuit: Attorneys Call on FDA to Update Warning
When the Food and Drug Administration (FDA) fails to protect patients from defective products, lawsuits against manufacturers become even more important.
Yesterday, the Medicines and Healthcare products Regulatory Agency (MHRA), the UK equivalent of the FDA, issued updated advice to surgeons that patients with certain metal-on-metal hip replacements (those with 36 millimetres heads or larger) should be monitored annually for the life of the hip replacement. This updates previous advice from April 2010 that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation.
The FDA has lagged behind the MHRA in warning surgeons about metal-on-metal hip replacements. As of today, FDA has not followed MHRA’s lead and recommended annual monitoring for life.
Attorneys Fred Pritzker and David Szerlag are calling on the FDA to recommend annual monitoring for life for patients in the United States who have metal-on-metal hip replacements, including the DePuy ASR hip replacement system. They are also calling on DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, to pay for this care.
To hold the companies accountable, attorneys Fred Pritzker and David Szerlag have filed several lawsuits against DePuy and Johnson & Johnson. They are available for a free consultation regarding your metal-on-metal hip replacement. You should call them at 1-888-377-8900 (toll free) or submit our free consultation form.
In the video above, Dr. David Langton of Newcastle University discusses the problems with ASR total hip replacement and other large metal-on-metal hip replacements. The video is from ww.bmj.com.
