Posts Tagged ‘ DePuy ’

Should the FDA Share Some of the Blame on DePuy?

December 14th, 2010. By Hunter West

Earlier this month it was announced that all pretrial proceedings for lawsuits centered on the recalled DePuy hip replacement system, will be heard before a single judge in Toledo.

While there are about 150 lawsuits so far, those in the know expect that number to grow to well beyond 1,000. More than 30,000 patients in the US received the complete DePuy hip replacement system that is seen to be failing in a large number of cases, since it was approved by the US Food and Drug Administration (FDA) in 2005.

Surely Billy Joel expects his hip replacements to last more than 5 years…

I’ll get back to the FDA in a moment. But imagine, if you will, the frustration borne by hip replacement patients realizing that medical products designed to last 20 years, are failing after only a few.

Let’s remember that individuals who are getting hips now, are by and large more active than our fathers and grandfathers at a similar age. We’re not ready for the nursing homes at 50, or 60 or even 70. There are people who are running, skiing, even competing in various sports well into their 80s.

For the remainder of us not inclined toward athletic pursuits, we remain by and large much more active than our forefathers.

Look at Billy Joel. He is still a relatively young man at 61, is he not? In the last two weeks he received a double hip replacement. We fully expect to see him dancing up there on the stage in no time, and I’m sure he expects to have that capacity for the next 20 years if he so chooses.

That’s the point—the expectation. Twenty years is the expectation.

Not five.

So pity the patient, in his 50s who receives a hip and rather than the promised 20-year lifespan, is met instead with pain and suffering, together with a second surgery just a few years on.

Little wonder the expectation is for so many lawsuits over the recalled DePuy system.

That said, I hope the FDA gets some of the blame…

Here’s why.

Our country’s great overseer of all things drug and medicinal employs this little-known rule Read the rest of this entry »

Tags: DePuy, DePuy ASR Hip, DePuy Orthopaedics Metal Hip Replacement
Posted in Emerging Issues | 5 Comments »

Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure… 

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events. 

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.  

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product. 

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI
Posted in DePuy ASR Hip Recall, Drugs/Medical | No Comments »