Pennsylvania Injury Lawyer Blog

Once again there’s bad news for people with DePuy hip implants.

According to a recent article, internal email between the FDA and DePuy Orthopaedics, the maker of hip implant knew that the medical device was not going to be approved by the FDA because of the demand for revision surgery caused by early failure problems.

So the hip implant device that was rejected by the FDA was only sold overseas, but its companion version that was recalled around the same time, the ASR Hip Resurfacing System, was implanted in 30,000 patients in the United States and 93,000 worldwide. The DePuy rejected hip device was also a type of resurfacing which is an alternative to standard surgery. The company started selling the implants abroad around 2003 but because resurfacing was a new procedure, the FDA required DePuy to run clinical trials before selling the device in the United States.

In order to win FDA approval for a medical device, the hip implant must show that it’s reasonably safe and effective and at least as effective as, or not inferior to a traditional hip implant.

Continue reading "Hip Implants: Duped by DePuy? " »

In 2010, the DePuy ASR XL Acetabular Hip System was recalled. Yet, in 2012 ASR hip news continues to break and ASR hips continue to be a concern to patients who received these hip replacements prior to the recall. Recently, the New York Times reported that hip replacement failures may cost taxpayers, insurers, and others billions of dollars.

The primary concern about ASR hips, and the reason that new reports of injuries and lawsuits continue to break is that metal on metal hip dislocation can result in serious, potentially fatal, problems. Metal on metal hip dislocation can cause metal to be released into a patient’s bloodstream and may cause the implanted hip to fail.

These problems will not happen for all patients who received DePuy ASR hip replacements. However, they are problems that patients should be aware of and should talk to their doctors about. Doctors can help ensure proper monitoring, which will hopefully lead to early treatment should you need it, and potentially keep you from adding to the bad news associated with ASR hip replacements.

Modern Medicine has come a long way. The Pharmaceutical Industry as we know it began in 1928 when Sir Alexander Fleming discovered Penicillin. The discovery of this antibiotic from the mould, Penicillium notatum, was stated by Time Magazine as the discovery that would change the course of history. This infection-fighting antibiotic inspired other scientists to produce their own synthetic versions of this drug that would go on to treat some of the most common and serious infections and diseases known to mankind.

Since 1994, the Biotechnology Company, LifeCell, has been a pioneer in regenerative medicine. Their success can be attributed to rising sales of their flagship product, AlloDerm.
AlloDerm Regenerative Tissue Matrix, is an Accellular Human Dermis, which is an organic tissue graft produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process. Essentially, the skin, which is derived from cadavers, goes through a process to remove all off the epidermis and dermis skin layers leaving only the collagen and elastin framework of the skin. This process removes that elements of the skin that would ordinarily be rejected by the recipient leaving only what will be accepted by the new body, and ultimately assist in the cellular rebuilding process.

In 1994 AlloDerm was originally developed and used for grafts for burn patients. In the early 2000s it began being marketed for internal procedures. Currently, AlloDerm’s most common uses include hernia repair, abdominal wall reconstruction, and postmasectomy breast reconstruction. AlloDerm is also used by dentists for soft tissue and gum reconstruction.
As stated on LifeCell’s website. AlloDerm has been used successfully in more than one million grafts and implants to date. However, nothing is perfect, and it is impossible to measure success without acknowledging failures.

Continue reading "AlloDerm Explained" »

According to the American Diabetes Association (ADA), in 2007, the most recent year that data is available, a total of 23.6 million people in the United States, including children, have diabetes, which is roughly 7.8 percent of the total population of the country. Diabetes has thus been termed “America's largest healthcare epidemic.”

Diabetes is a metabolic disease in which an individual has high blood sugar. This is because their body doesn’t produce sufficient quantities of insulin, or either because body cells don’t respond to the insulin that is being produced. If left untreated, diabetes can have serious complications, including hypoglycemia, nonketotic hyperosmolar coma, or diabetic ketoacidosis, all of which can result in death. Long-term complications can also arise from diabetes, including retinal damage, chronic renal failure, and various cardiovascular diseases. It is therefore crucial for those affected by diabetes to receive adequate treatment. However, when medications and devices that are given to diabetes patients to help treat their disease are inefficient, serious injury, illness, and even death can result.

In July of 2009, Medtronic, Inc., a medical technology company, announced a voluntary recall via the U.S. Food and Drug Administration (FDA) of certain Quick-set infusion sets used in conjunction with MiniMed Paradigm insulin pumps. An infusion set is a plastic pipe that delivers insulin to a diabetes patient from an insulin pump. Generally, it is replaced every three days.

Affected by the recall are infusion sets with reference numbers of MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with 8. According to Medtronic, an estimated two percent of Quick-set infusion sets in lot 8, roughly 60,000 infusion sets of about the three million infusion sets on the market, may not properly work. The affected infusion sets may prevent insulin pumps from venting air pressure properly, potentially resulting in the insulin pump delivering either too much or too little insulin to diabetes patients, which could lead to serious injuries or even death.

Diabetes patients are advised to stop using Quick-set infusion sets from Lot 8 immediately. No other Medtronic devices or infusion sets were involved in this recall.

If you have been affected by a defective Quick-set infusion set or faulty insulin pump, contact the defective medical device attorneys at Anapol Schwartz to discuss your potential case. Call 866-735-2792 today for a free consultation.