The FDA issued a warning today today  that consumers should not take the diet supplement Hydroxycut due to its potential to cause liver damage. Here is a link to the FDA notice.

I’ve been down this road before in the ephedra litigation. One of the things that would shock most consumers is that many over-the-counter diet supplements aren’t tested before release to the public.  The synthetic ephedra products caused a trail of carnage to consumers. Looks like we may be in for another round.

David Sugerman

This one sent a bit of a chill down my spine, as I have a number of friends, clients, and acquaintances who are insulin-dependent diabetics. Apparently, a labelling error by Covidien, Ltd. has led to a recall of over 400,000 disposable syringes. The error reportedly could result in insulin doses more than double the intended level. Affected products were apparently sold at Sam’s and Wal-Mart.

I don’t like to play fear-monger, but it seems like this is enough of a danger to insulin-dependent diabetics that getting the word out is a good thing.

David Sugerman

I grew up on Mad magazine, and one of my favorite features was “What they say…What they really mean.” And I’m reminded of that feature with this L.A. Times report on the Food and Drug Administration staff’s opposition to preemption.

Digression, first off, to credit reader JW on the pithy term “Kleptocracy” to describe the current regime’s fondness for allowing all its friends to gather at the trough. JDub says that he got it from wiki. Even so, his reverb is worthy of thanks and recognition.

And then some legal geek background on preemption. It’s a federal legal doctrine–based in the U.S. Constitution’s supremacy clause–that allows federal law to preempt or displace or block all state laws in a particular field. “State laws” is read broadly to include even a claim that might be based on state law. What it means for purposes of the kleptocracy is that a corporate wrongdoer who injures a citizen need not answer in court if the claim is preempted by federal law.

So one more little piece of foundation for this forehead smacker. Next week, the U.S. Supreme Court hears argument in the case of Wyeth v. Levine, Case No. 06-1249. In that case, the Bush Administration and FDA counsel are arguing that federal Food and Drug Act should preempt state law claims.  That’s to say, if you’re injured by a dangerous drug regulated by the FDA, our kleptocrats believe that you shouldn’t be able to sue.

The LA Times article demonstrates the inane basis of the argument. FDA staff knows full well that the agency does not and cannot protect consumers from drug company mistakes and misconduct. So it’s folly to assert that preemption should limit these claims. Back to Mad. They say: “Preemption is the best way to protect consumers because the FDA rigorously monitors drug safety.” What they really mean: “These consumer lawsuits from unsafe products are eating at our profits. We don’t like them.”

David Sugerman

The recent FDA announcement of the tomato salmonella outbreak leads me to wonder about how we got here. Announcements like this give the media great material to play with the fear process. I call it the “don’t eat that,” or scare-of-the-moment journalism. The danger is real, of course, as salmonella can pose a serious health hazard for children, elderly, and people with compromised immune systems.

The real problem is a lax food safety system. This is not something that’s simply limited to tomatoes.  The reality is that deregulation–the heralded salvation and light of the American economy–has a very nasty underside.

Food safety is one of those classic government functions. If we want a safe food system, we have to pay for it and know that sometimes regulations are a pain in the neck. Oh, and it costs money, as in higher taxes.  Of course, that pain in the neck is part of how we protect our toddlers and aging parents who can be felled by a manufacturer’s failure to maintain food safety standards.

The alternatives give us two things. One is this scare-of-the-moment journalism. Annoying. But here’s the bigger one. The other consequence of deregulation is that people like me–trial lawyers–have more and more work.  My job starts when injured people call about calamities that have befallen them.  I am like “All the Kings’ horses and all the Kings men” as I go about trying to re-assemble lives and families broken by unsafe practices.

Our food supply system needs to be regulated properly, and we need to dedicate the resources to it so that regular inspections and enforcement processes prevent these outbreaks.

David Sugerman

For consumers who have taken Vytorin, here’s a good summary of the problem from the New York Times: http://www.nytimes.com/2008/01/15/business/15drug.html

Interestingly, the companies have apparently known since April 2006 that their higher-priced drugs were not more effective than generics. But they sat on that information until Congress pressured them to release their study this month. In the meantime, the manufacturers continued to sell the higher-priced less effective drugs.

I don’t routinely pay close attention to such things, but I have to wonder whether the companies ran some of those glossy TV ads for Vytorin. Sure would be interesting to see what they said. I suppose that will be part of the discussion as the various consumer class actions move forward.

One other thing. A google search also turned up a fairly hostile editorial in Wall Street Journal. According to the writer, these cases are inappropriate because no one has been injured. I guess the Journal is bound to side with its friends on Wall Street and not consumers. But you would think that even the Journal’s editorial writers could appreciate the obvious point.

Taking money from consumers by way of deceptive trade practices IS an injury. Sure, it’s not a big deal to the well-heeled at the Journal. But of course, if we’re talking about $30 per month per person, and you’re selling this thing everyday to consumers across the nation, that’s a lot of money. Maybe it looks too much like business as usual to the Journal?

David F. Sugerman

Coming on the revelations that Vytorin is no more effective than generics, the FDA announced that it would investigate the drug and its manufacturers,Merck & Co Inc. and and Schering-Plough Corp.

Here is the url for more information on FDA action: http://www.msnbc.msn.com/id/22847409/

The press accounts don’t specify the scope of the investigation, but based upon an earlier study released this month, it appears that the companies knew that Vytorin was no more effective than generic drugs in treating cholesterol issues.

Consumer laws, like Oregon’s Unlawful Trade Practices Act give consumers a way to obtain refunds when a drug manufacturer falsely represents that its new drug is more effective than a less expensive generic. While there is certainly more to this story, it looks as if consumers are filing class actions in multiple states.

David F. Sugerman

New studies released earlier this month raise troubling questions about the effectiveness of two prescript medications used to control cholesterol. The generic products Ezetimibe–marketed under the registered trademark Zetia–and Ezetimibe/Simvastatin–marketed under the registered trademark Vytorin–apparently aren’t effective, as represented by their manufacturers.

Disclosure: the author of this blog routinely handles consumer class actions and may become involved in this litigation in the future.

Consumers are lining up in various states to pursue claims for reimbursements and refunds for money spent on these drugs. According to a complaint filed in U.S. District Court of Kansas, the drugs are alleged to increase the formation of fatty plaques, which raises the risk of heart attack.

It’s going to be interesting to see how this plays out.

David F. Sugerman