Actos and an Increased Risk for Bladder Cancer

Posted on September 29, 2011 by glmain

Freehold, New Jersey Actos Injury Attorneys

In June of 2011, the Food and Drug Administration (FDA) issued a warning regarding an increased risk for bladder cancer associated with the use of the diabetes drug Actos (pioglitazone). The FDA’s warning was issued after reviewing five year’s worth of data collected during a study conducted by Actos’ manufacturer, Takeda Pharmaceuticals. According to the data collected, patients who used Actos the longest or were among those exposed to the highest cumulative amount of Actos, demonstrated an increased risk for developing bladder cancer. While the study did not demonstrate an overall increased risk for developing bladder cancer among those who used Actos, those that used it the longest or in the highest cumulative dose did.

Actos Receives a Black Box Warning Label

As a result of the study conducted by Takeda Pharmaceuticals, the FDA indicated a black box warning label will be added to Actos. What is a black box warning label? A black box warning label is the strongest warning a drug can receive without being recalled by the FDA. It indicates medical studies have demonstrated an increased risk for serious side-effects and life-threatening conditions associated with the use of the drug.

The fact that Actos has now received a black box warning label from the FDA indicates it has received the highest warning label a drug can receive without being recalled. Due to other studies, some countries (France and Germany) have actually suspended the use of Actos.

Warning Signs and Symptoms associated with Bladder Cancer

If you’ve been prescribed Actos or have taken it in the past, it’s important to consult your doctor immediately if you experience any of the following kinds of symptoms:

  • Pain during urination
  • Blood in urine
  • Inability to urinate even through you feel like you need to
  • An noticeable increase in the need to urinate

While any number of conditions can cause these symptoms, they’re also consistent with bladder cancer. As such, if you’re currently using Actos or have used it in the past, contact your doctor should you experience any of these symptoms.

Freehold Dangerous Drug Attorneys – Tomes & Hanratty

At Tomes & Hanratty, our personal injury attorneys have years of experience in taking on pharmaceutical manufacturers who market dangerous drugs that injure and kill patients. If you’ve suffered serious health complications due to the use of Actos, contact Freehold, New Jersey dangerous drug attorneys at Tomes & Hanratty today. We can review the specifics of your case and discuss the legal options available to you.

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Artelon CMC Spacer Implant Problems

Posted on August 19, 2011 by glmain

Freehold, NJ Defective Medical Device Attorneys

The Artelon CMC Spacer is a biocompatible t-shaped implant used to treat people suffering from arthritis of the hand. Typically, it is implanted in the carpometacarpal joint at the base of the thumb during outpatient surgery. The Artelon implant acts as an interpositional spacer between the trapezium bone and the first metacarpal bone, increasing joint function while preserving surrounding tissue and bone. Made out of plastic gauze and manufactured by Artimplant AB, the Artelon CMC Spacer is distributed by Small Bone Innovations, Inc. throughout the United States.

Problems with the Artelon CMC Spacer

The Artelon implant is supposed to relieve pain and loss of mobility associated with certain kinds of arthritis. Although supposedly biocompatible and degradable, a number of patients have reported negative side effects and reactions to the implant.

Problems include the following:

  • Swelling
  • Loss of movement of the thumb
  • Inflammatory synovitis
  • Bone loss

Additionally, there have been cases where the Artelon CMC Spacer has broken after being implanted. In some cases, fragments have broken off from the implant, causing serious complications. As a result, additional surgery is needed to remove the implant and any fragments that may have broken off. Depending on the complications involved, it may be necessary to remove tendons in the arm in order to fully repair the thumb joint affected.

Liability and the Artelon CMC Spacer Implant

To date, neither Artimplant AB nor Small Bone Innovations, Inc., have warned patients regarding potential problems and side effects associated with the Artelon CMC Spacer implant. Since its approval for the US market in 2007, the Food and Drug Administration (FDA) has received a number of complaints regarding serious side effects and health complications associated with the Artelon CMC Spacer. And, in April of 2011, a Pennsylvania Court of Common Pleas approved class action lawsuit status for those seeking damages in cases involving injuries attributable to the Artelon CMC Spacer implant.

Contact Freehold, New Jersey Defective Medical Device Attorneys

If you’ve suffered medical complications or a severe reaction due to an Artelon CMC Spacer implant, contact Freehold defective medical device attorneys at Tomes & Hanratty today. As with any personal injury case, you have a limited amount of time within which to act to recover compensation for your losses. For more information regarding problems with the Artelon CMC Spacer and the legal options available to you, call our office today.

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Zimmer Knee Replacement Lawsuits

Posted on July 27, 2011 by glmain

East Brunswick Defective Medical Device Attorneys

Increasingly, patients and doctors are reporting problems associated with the Zimmer NexGen CR-Flex femoral implant, used in over 1.45 million knee replacement surgeries since 1994. Problems reported concern the failure rate of the NexGen CR-Flex replacement. A number of orthopedic surgeons have indicated the onset of problems just two years after surgery prompting a call for investigation from Iowa Republican Senator Charles Grassley. Additionally, as reported by the New York Times, part of the problem concerns alleged kickbacks between Zimmer and certain doctors for promoting their products.

The Problem with Zimmer’s NexGen CR-Flex Implant

Zimmer’s NexGen implant is associated with a high rate of failure due to their coming loose and causing pain. The Zimmer NexGen implant attaches to the thighbone without using a bonding agent, like cement, to keep it firmly in place. It attaches to the femur where it connects to the tibia of the knee. Made out of a porous metal and a cobalt-chromium-molybdenum alloy, it is supposed to stay in place once attached to the femur. However, as several orthopedic surgeons have observed, over time the implant loosens to the point of detaching itself completely. As a result, the implant patient experiences pain and erosion of the bone.

Symptoms of a Loose Zimmer NexGen Implant

While each person is different, the following are associated with a loosening or problem with a NexGen knee replacement implant:

  • Stiffness in the knee affected
  • Pain in the knee
  • Difficultly walking, limping,
  • A diminished capacity for movement in the knee joint
  • Pain or difficulty when putting weight on the knee

Chicago Doctors Call for a Recall of the Zimmer NexGen Implant

Doctors Richard Berger and Craig Della Valle from the Rush University Medical Center have asked that a recall be issued in regard to the Zimmer NexGen implant. Based on information collected, Doctor Berger and Della Valle report a failure rate of 36% after two years for the Zimmer NexGen implant. To date, Zimmer has refused requests for a voluntary recall, claiming the failure rate noted by Dr. Berger and Dr. Della Valle are most likely due to both doctors implanting the devices incorrectly. While the Zimmer implant is supposed to last up to 15 years, more and more patients are stepping forward to report problems far earlier than the time-frame claimed by Zimmer.

Problems with a Zimmer Knee Implant? Contact Tomes & Hanratty

If you’re suffering from symptoms associated with a loosening of the Zimmer NexGen knee implant consult your doctor. If the implant has come loose, contact East Brunswick defective medical device attorneys at Tomes & Hanratty today. We can discuss the legal options available to you and begin the process of preparing your case.

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Hip-Replacement Product Recalls

Posted on May 23, 2011 by glmain

East Brunswick Hip Replacement Product Recall Attorney

As early as 2008, the Food and Drug Administration (FDA) received 300 complaints regarding DePuy Johnson and Johnson hip replacement implants. If this isn’t bad enough, the Australian National Joint Replacement Registry issued a report indicating DePuy hip replacement implants typically failed within five years in 12 to 13 percent of hip replacements. As more and more evidence began to accumulate indicating a serious problem with DePuy hip replacements, DePuy delayed a recall as long as possible. How did this happen?

DePuy Hip Replacement Recalls

As more information comes to light, it appears DePuy exploited an approval process loophole that allowed it to avoid important clinical testing of its products. While this may have saved DePuy money, it has cost a number of hip replacement surgery patients a great deal in pain and suffering. Utilizing a metal-on-metal design, the DePuy implant seems to promise excellent results in increased mobility and durability.

However, use of the DePuy implant has resulted in an increase in osteolysis, a destruction of the bone surrounding the implant. In fact, DePuy has its own internal information indicating higher than normal failure rates for the ASR XL Acetabular System and the ASR Hip Resurfacing System.

The DePuy Hip Replacement Implants Involved in the Recall

To date, there are two implants involved in the DePuy recall: the ASR XL Acetabular System and the ASR Hip Resurfacing System. Both hip replacement systems are prone to the release of chromium particles and cobalt ions due to friction arising from working metal components in each implant. Referred to as “edge-loading,” these chromium particles and cobalt ions affect surrounding tissue, enter the bloodstream, and cause metallosis, an inflammatory reaction that can harm a patient’s heart and cause neurological damage.

Contact East Brunswick Hip Replacement Recall Attorneys at Tomes Law

If you or a family member have experienced medical complications and other problems due to a DePuy hip replacement implant, contact East Brunswick, New Jersey defective medical devices attorneys at Tomes & Hanratty, P.C. today. There are several legal issues that must be taken into consideration. Our personal injury attorneys can evaluate your case and discuss the legal options available to you.

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The Dangers of Heparin – Do I have a Cause for Action?

Posted on April 10, 2011 by glmain

East Brunswick Heparin HIT Amputation Attorneys

According to a special report published by GlaxoSmithKline, heparin-induced thrombocytopenia (HIT) affects 3% of patients exposed to heparin. Given the large number of patients that receive heparin either in conjunction with surgery or for other medical conditions that call for the use of an anticoagulant, roughly 350,000 people are likely to develop HIT a year. People who suffer from HIT are at increased risk for amputations, while the mortality rate for those that develop HIT is between 17% and 30%. Although heparin is used to treat or prevent thrombosis, thrombocytopenia occurs when there are too few blood platelets in the blood after heparin is given to a patient. Unfortunately, diagnosing HIT isn’t always associated with symptoms and reactions that are immediately and easily identifiable.

Type 1 and Type 2 Heparin-Induced Thrombocytopenia

There are two kinds of HIT: Type 1 and Type 2 HIT. Type 1 HIT does not cause symptoms and is not related to problems associated with the immune system. While it typically presents within 2 days after receiving heparin, the patient’s thrombocyte count usually normalizes with continued use of heparin.

In the case of Type 2 HIT, blood clots usually form in blood vessels due to an immune system problem. As a result, these clots can cause serious, catastrophic problems for the heart, brain, lungs, or extremities. The onset of Type 2 HIT usually occurs within 4 to 10 days although with delayed-onset HIT it may take up to 100 days for a decrease in a patient’s platelet count to manifest itself.

The Cost of HIT – Why It’s important to Talk to a HIT Attorney

The cost of HIT in cases involving cardiac surgery alone is estimated at between $100 million and $300 million a year (GlaxoSmithKline report). Since thromboembolic events occur in 60% of patients with HIT, this means additional health care costs related to amputations, heart attacks, and pulmonary embolism in HIT cases associated with cardiac surgery alone.

In the case of amputations, HIT-related injuries translate into lost wages, costs related to physical therapy, medical equipment, and short- and long-term disability.

Contact East Brunswick Heparin HIT Attorneys at Tomes & Hanratty, PC

If you or a family member has suffered an amputation or other medical complication due to the onset of HIT, contact East Brunswick, New Jersey heparin attorneys at Tomes & Hanratty, PC. Our personal injury lawyers understand the medical issues involved and what must be done in dealing with heparin manufacturers. We understand how to file heparin cases, what experts to consult, and how to prepare heparin-induced thrombocytopenia cases. Call today to learn how we can help you receive the compensation you deserve.

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