Sokolove Success Blog – Our Perspective on Legal News that Matters

It’s supposed to help with your strep throat, but could a widely used antibiotic instead harm your liver?

Health authorities in Canada think so and have raised new concerns about popular antibiotic Avelox and possible increased risks of liver failure. In March, Health Canada (the Canadian equivalent of the US Food and Drug Administration) notified health care professionals and patients of changes to the labeling information for Avelox in Canada.  A safety review by the agency concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure.

Avelox (moxifloxacin) is a prescription drug belonging to a class of antibiotics called fluoroquinolones. According to Bayer, the manufacturer, over 40 million patients worldwide have been treated with Avelox for a broad range of bacterial infections, including respiratory infections.

The Canadian report is not the first sign of trouble for Avelox.  In fact, there have long been concerns about whether fluoroquinolones contribute to tendon injuries, such as those experienced by our Levaquin clients. We have been engaged with these drugs since 2008 when the FDA issued a black box warning for the increased risk of tendinitis and tendon rupture associated with them.  Interestingly, reports of tendon-related issues had been reported for more than a decade, prompting a series of labeling revisions that finally culminated in the black box warning.

The same pattern seems to be emerging with respect to the risk of liver injury and Avelox.  In 2007, Bayer updated the labeling for Avelox in Europe to reflect this risk and sent a “Dear Doctor” letter to European physicians to draw attention to the change in early 2008.  Now Health Canada has stepped in and required the change in Canada.

Yet Avelox labeling remains unchanged in the U.S.  That doesn’t seem to make much sense, and it certainly could open the company up to liability claims should Americans be injured as a result of the product.

We’re continuing to monitor developments with this drug. If you are interested in working with us on cases related to Avelox or other fluoroquinolones, drop me a line.

What if the cost of lowering your cholesterol was excruciating muscle pain, or possibly kidney failure?  Is that a tradeoff you’d be willing to make?

I only ask because some patients are unwittingly making that choice.  The FDA recently issued a warning about the risk of muscle injury for patients who take the highest approved dose of Zocor, a popular cholesterol-lowering medication. Whether you are a gym rat or a couch potato, we’ve all pulled a muscle at some point.  That’s not what we’re talking about here. It’s far worse.

According to the FDA, muscle injury, myopathy, is a known side effect of all statin drugs.  But the warning says patients who are prescribed and use the 80 milligram dose of Zocor run an increased risk of developing muscle injury, including rhabdomyolysis. That’s right: “Rhabdo”.  Remember Baycol? Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and even death.

The risk of rhabdomyolysis is accelerated by potential drug interactions, and there is concern that patients are continuing to be prescribed higher doses of Zocor with other medications that are known to increase the risk despite dose limitations and drug-drug interaction precautions on the drug label. We first began following Zocor in 2008 when the FDA warned of an increased risk of rhabdomyolysis in patients taking this drug concurrently with the heart medication amiodarone.

An estimated 24 million Americans take cholesterol-lowering drugs. And the number is likely to go higher: Last month the FDA approved the preventative use of the cholesterol medication Crestor for millions of people who do not have a cholesterol problem.

We will continue to watch the unfolding announcements about Zocor and other drugs, and will be working with our co-counsel to identify cases where people have been injured.  As always, let me know your thoughts.

The 2nd US Circuit Court of Appeals recently rejected most of New York State’s content-based restrictions on attorney advertising by holding that they violated the right to free speech guaranteed by the First Amendment.

There’s a nice analysis of the court’s ruling here at Law.com (subscription required).

While this ruling only directly affects New York’s legal advertising rules, my hope is that it is a wake-up call to the other states with similar restrictions in place.

In its ruling, the court said a number of the state’s regulations on attorney advertising were unconstitutional including:

•    A ban on the use of nicknames like “heavy hitters”
•    A ban on client testimonials about pending cases
•    A ban on the use of special effects, or the image or likeness of a judge

In throwing out these restrictions, the court held that these ad tactics were not “inherently false, deceptive, or misleading”.  More importantly than the ruling on these specific tactics was that the court held that banning protected commercial free speech because it was potentially misleading was not okay.  The speech had to be actually false or misleading.  This is a huge win for those of us who believe that legal advertising restrictions are anti-consumer, anti-competitive and really about protecting turf and the feelings of those members of the profession who find legal advertising distasteful.

If you look at the specific facts of the case involved in the New York decision, you realize what I mean when I say I think it is about taste and not about protecting the consumer.

One commercial showed a judge in a courtroom, who was there to “make sure [the trial] is fair.” Another used wisps of smoke and blue electrical currents to highlight the firm’s name.  Still another firm dubbed itself “heavy hitters,” and ran ads depicting partners as giants towering over buildings and counseling space aliens.  How are any of these advertising methods misleading?

The bottom line is that the 2nd Circuit essentially said it was permissible for attorneys to use the same advertising techniques, imagery, testimonials, etc. as other industries and professions.

There is at least one piece of the decision that troubles me.  The court found that New York’s 30-day moratorium was constitutional as relates to not only the use of targeted mail to specific victims but also indirect advertising such as TV, radio, newspapers and web sites.  No other state takes this aggressive position - at least they haven’t up until now.  Maybe they will miss this part of the wakeup call I hope they get.