August 2010

Some types of medical products have to go through a special FDA approval process before they can be sold.  The manufacturers of those products are immune from suit due to a questionable Supreme Court decision.  Thankfully, the DePuy hip replacement components are not covered by that Supreme Court decision and individuals injured by those components can find a lawyer to help them:

DePuy Orthopaedics Inc., Warsaw, U.S.A., has voluntarily recalled two of its ASR hip replacement components — the ASR XL Acetabular System and the ASR Hip Resurfacing System — due to the rates of revision surgery with them.

New, unpublished data from the National Joint Registry of England and Wales (NJR) show a 5-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System. Those revision rates included all ranges of component sizes, but the revision risk was highest with ASR head sizes less than 50 mm in diameter and among women, according to an August 26 press release from DePuy Orthopaedics.

Source: DePuy recalls ASR Hip System due to revision rates

I haven’t done much investigation into the DePuy hip replacement recall, but if you think you have one, contact me and I’ll see what I can find out for you.

A little skepticism is a healthy thing:

Many patients taking prescription drugs believe that pharmaceutical companies have too much influence over their physicians’ prescribing practices, according to a new survey.

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About half of the medication users believed that their doctors were too eager to write a prescription when other non-pharmacological options are available.

Source: Consumer Reports Survey: Patients Think Doctors Too Cozy With Pharma – ABC News

Some people don’t understand why pharmaceutical companies shouldn’t be allowed to engage in off-label marketing.  Here’s one reason:

Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the Food and Drug Administration had not approved it for that use.

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Peetz took Rituxan for two years before developing a near-fatal viral infection that left him "a ventilator-dependent flaccid quadriplegic," the lawsuit said. Peetz’ court filing said the drug puts all users at risk, not just those taking it for off-label conditions

Source: Omaha man sues makers of drug Rituxan – San Jose Mercury News

I haven’t had a chance to take a look at the label for Rituxan, so I can’t comment on whether I think there’s a valid failure-to-warn claim there or not.

Did you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document.  Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power. 

Citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation’s drug supply.

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Bennet’s proposal would update FDA data systems to track all global manufacturers feeding America’s drug supply; force companies to document each contributor to their products; grant FDA subpoena authority when conducting investigations; and empower FDA officials to recall drugs when safety issues arise — a power the agency currently has over medical device makers, but not the pharmaceutical industry.

Supporters of the proposal are armed with a slew of statistics backing their case. Last year, for instance, the country saw a record 1,742 drug recalls, they note — a 400 percent jump over 2008. More than 100 Americans, they add, died in 2007 and 2008 from the Chinese-made blood thinner heparin. 

Source: Senate bill would bolster drug safety requirements – The Hill’s Healthwatch

I hope that this bill gets passed so the FDA has the tools it needs to do its job.