FDA Archives - LegalNurse.com

25Apr2012

Prescription Painkillers – The Next Wave of Litigation?

Statistically, high-strength painkillers are the most widely prescribed class of drugs in the U.S. This is a class of drugs that, just 15 short years ago, was mostly used for post-operative pain and pain associated with cancer. Today they’re widely used to treat just about every type of pain, with chilling consequences. Patients develop tolerance to the opioids, requiring increasingly higher dosages just to maintain the same level of pain control. Use of painkillers can turn into an addiction, with accompanying symptoms of withdrawal should a patient try and taper off.

18Apr2012

Many Medical Devices Are Tested In the Marketplace – Not the Laboratory

Consumer Reports disclosed in its May 2012 issue that many commonly used medical devices, including artificial hips, defibrillators, lap bands and surgical mesh don’t go through a rigorous testing process before being released for use to the public. Other medical devices may be “grandfathered” into approval based on prior trials conducted on “similar” devices that may or may not be similar. This results not only in recalls, but in countless injured individuals.

27Jan2011

Should the Government Stay Out of Drug Development? Read the Opinions of Nurses and Certified Legal Nurse Consultants

The government recently announced that it would fund a billion-dollar government-run drug development center to help create new drugs. The “National Center for Advancing Translational Sciences” will be tasked with creating new drugs and, according to the Director of the NIH, “any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

13Aug2009

Eyelash or Backlash?

Allergan Medical (remember them? The fun folks who brought us Botox) are at it again. They’ve got a new product on the market called Latisse. Does it help a medical condition? No. Does it create the perception of a medical condition? That depends on your point of view and to me it depends on whether or not you’re a consumer and then, it depends on what you think of the FDA and its “stamp” of approval.

13May2009

Black Box for Botox® – A Warning or Potential Legal Defense?

Last year, Botox, a medication containing Botulinum Toxin A, was routinely injected into over 2.5 million Americans and generated $1.3 billion in sales. All this despite reports that Botox could cause symptoms similar to botulism, loss of bladder control, blurred vision, trouble breathing, swallowing and talking (not because of the size of those lips). Certified Legal Nurse Consultants working for plaintiff and defense firms should be aware that on April 30, 2009, the FDA issued a statement that all botulinum toxin products (including Botox and Botox Cosmetic) carry a black box label warning as well as a risk evaluation and mitigation strategy (REMS).

6Apr2009

FDA Approval Not a Shield from Damages

On March 4th the U.S. Supreme Court decided a case in favor of consumer rights, one that has the potential to reach further than first appearance. In the case of Wyeth v. Levine the Court upheld a $6.7 million dollar verdict in which the jury found that Wyeth’s label had inadequate warnings, thus ruling against the drug manufacturer Wyeth. In doing so, the court allowed state juries to award damages for harm done by unsafe drugs, even in cases where the drugs had been approved by the Food and Drug Administration (FDA).

30Mar2009

Drugstore Cowgirl – Or How I Learned to Hate Darvon and Love Weightlifting

As I’ve grown older I’ve learned to appreciate the difficulty of keeping my body (and mind) in great physical (and mental) shape. I hit the gym three days a week to lift weights with a trainer. On the odd-date days I really stretch myself by doing yoga or speed-walking to the Starbucks a couple of miles from my home. As my age has increased so has my strength and muscle-mass. I only wish I’d been as dedicated when I was in nursing school.

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