Colorado Business Litigation Lawyer Blog

With the exception of the Mercedes-Benz S550, the Nissan Titan, and the Smart Fortwo, American companies made all the vehicles on the Forbes "Worst-Made Cars On The Road" list. The only bright note is that no Ford vehicles made their way onto the list.

Forbes' list starts with the lowest-rated vehicles in at least three of Consumer Reports' 2011 reliability, safety and performance studies. These are based on Consumer Reports' overall scores for 2011 vehicles, and reports such as: The Most Reliable Cars; Best and Worst Values; Highest Cost of Ownership; Best and Worst Safety Performance Survey; and Best and Worst Fuel-Economy.

The worst-rated vehicles are: Cadillac Escalade (base model), Chevrolet Tahoe Hybrid, Dodge Nitro SLT, Dodge Dakota, Jeep Wrangler Unlimited, Mercedes-Benz S550, Chrysler Town & Country, Chevrolet Colorado, Chevrolet Aveo/Aveo5, Jeep Liberty/Jeep Liberty Sport, Nissan Titan, and Smart ForTwo.

Forbes notes that the Mercedes S550 only made the list because of its high cost of ownership, low fuel efficiency, and a low rating for overall value (as opposed to problems with reliability, safety or performance, which affected the other vehicles on the list). Forbes also points out that nearly every car or truck made today is safer, more efficient, and more reliable than anything on the road that was manufactured as recently as 15 years ago.

Bloomberg.com reports that a former officer and general counsel for GlaxoSmithKline (GSK), a London-based drug manufacturer, was indicted on November 8, 2010, for making false statements to the FDA and with obstructing an FDA investigation.

In 2002-2003, the FDA was investigating the promotion of Wellbutrin SR, an antidepressant drug, for possible uses not approved by the FDA. The attorney, Lauren Stevens, now residing in North Carolina, is charged with making false statements in a series of correspondence with the FDA and with withholding documents that could have proved that Wellbutrin SR was being promoted for uses such as weight loss, which had not been approved by the FDA.

Among other things, Stevens had sent letters to various doctors and had learned about the improper and illegal promotion of the drug. GSK had paid at least two doctors to give about 1,000 promotional talks to other doctors promoting the off-label (non-approved) use of the drugs. The indictment alleges that Stevens knew about the off-label promotions but concealed such materials from the FDA and made false statements concerning her knowledge of the off-label promotion activity.

If convicted on each of the six counts of the indictment, Stevens could be sentenced to a total jail term of up to sixty years. Stevens’ attorneys say that she is innocent of all charges and that she relied on the advice of a nationally prominent law firm that had expertise in working with the FDA.

We wait with bated breath to see whether or not any other officers of GSK will be charged or indicted. And of course, under our law, Stevens is presumed to be innocent of all charges.

Continue reading "GlaxoSmithKline in Spotlight Again" »

In announcing a voluntary recall by Abbott of certain Similac® brand powder infant formulas, the FDA says that the formulas “did not meet (Abbott’s) quality standards.”

The September 22 FDA press release says that although ingesting the beetle-and larvae-contaminated formula does not pose an immediate health risk, it may cause “gastrointestinal discomfort” and a refusal to eat. See a doctor if these symptoms persist for more than a few days.

Concerned parents and caregivers should visit www.similac.com/recall to find out what specific products are included in the recall.

Have any of you ever had the experience of caring for an infant with gastrointestinal discomfort? And just how do beetles find their way into infant formula?

Type II diabetics are now being told that the drug Actos, manufactured by Takeda Pharmaceutical Co., may be linked to a higher risk of bladder cancer. The information comes from preliminary results of a 10-year study sponsored by Takeda following over 193,000 Actos users.

This unsettling news comes on the heels of study results by the manufacturer of Avandia, an Actos competitor, that there may be a connection between Avandia and an increased risk of heart attacks and strokes.

The Actos study appears to show that the bladder cancer risk is higher among those who have used Actos for more than two years.

The FDA has both drugs under study. It is unknown when a decision will be made. In the meantime, those who use either drug have been advised to follow the advice of their physicians.

And whose advice should the physicians follow?

More Avandia postings:

"An Introduction to Business Ethics," Colorado Business Litigation Lawyer Blog, posted 08/18/10

"Update on the Avandia/Actos Saga," Colorado Business Litigation Lawyer Blog, posted 09/02/10

"Avandia Health Concerns Crosses the Pond," Colorado Business Litigation Lawyer Blog, posted 09/08/10

We previously wrote here and here concerning increased heart attack and heart failure risks to those taking the prescription drug Avandia (Rosiglitazone). The drug, manufactured by GlaxoSmithKline (GSK), is prescribed to Type II (non-insulin dependent) diabetics. The FDA has taken under advisement the issue of whether or not to increase warnings and precautions of taking the drug or to completely remove the drug from the U.S. market.

A September 5, 2010 article by BBC Panorama disclosed that the drug was recommended for withdrawal in the UK two months ago by an expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s equivalent of the FDA. In July, clinicians at the Commission on Human Medicines (CHM), the MHRA’s advisory body, recommended unanimously that Avandia be withdrawn from the UK. This recommendation was not made public. MHRA has sent letters to healthcare officials, suggesting they should “consider alternative treatments where appropriate.”

Avandia has been prescribed to tens of thousand of patients in the UK over the last ten years, earning GSK billions of pounds. The European Medicines Agency, in a Europe- wide review of Avandia, will announce later this month whether or restrict Avandia’s prescription or to withdraw it completely. Meanwhile, GSK said its research proved the drug was “safe and effective when it is prescribed appropriately,” and that “patient safety is our first priority.”

Actos, a competitor drug to Avandia, is being widely prescribed in the U.S., although some studies claim to show that Actos is no more safe for Type II diabetics than Avandia.

The drug choice facing prescribing physicians and patients at this time is a difficult one and appears to be little more than a roll of the dice.

When this blog was first started, it was clearly understood that the subject was to be about legal issues of general interest. After all, why have a website promoting a Colorado-based law firm if the purpose is to entertain with tales of whimsy?

This law firm, which primarily represents victims of defective and unreasonably dangerous consumer products pretty much all over the U.S., depends mostly on word of mouth referrals from hopefully satisfied clients and their families and friends, and referrals from other lawyers. We don’t advertise in brochures, newspapers or magazines, or on radio, television and the like, or on billboards or buses or bus stop benches. Still, we don’t criticize lawyers who do.

But isn’t advertising on the web the same as any other form of self promotion? Not exactly. It seems to us to be just a little less irritating. And it’s a whole lot cheaper. But more importantly, it cuts out the middleman. Why should a person who is looking for a competent and experienced lawyer on a matter of importance have to rely on content that may be filtered through an advertising agency? We should be able to tell prospective clients about our experience, what our practice emphasizes, and what our track record is. We expect you to ask us questions and to ask around about us. We believe our national reputation will withstand your scrutiny.

That being said, stay tuned. Every so often, we’ll continue to inform about legal issues of interest to many of you. When we stray from that objective, we hope we can still say something interesting, or at least entertaining.

After all, don’t most of us already have enough serious matters to think about?

Continue reading "What is the Purpose of This Blog?" »

A Colorado Business Litigation Lawyer Blog posted August 18, 2010 (click here for entry) reported on the SmithKline study that clearly showed that Avandia (a diabetes drug) had a significantly higher heart attack and death risk than its competitor drug Actos.

Along comes a new study funded by WellPoint, Inc. that claims to show that the increased risk of heart problems linked to either drug is exactly the same at 4%. This latest study reported on subjects whose age averaged 54 years, while the earlier study’s subjects averaged 74.4 years young (a politically correct word). Some scientific observers commented that the age difference may have skewed the WellPoint results, since younger persons would likely be in better overall health than older persons.

One diabetes researcher from Australia suggested that it appears that both drugs may be risky, since the 4% heart attack and death increase is “pretty high” given the short study periods.

The FDA is expected to make a decision on whether Avandia should be taken off the market or perhaps change its warnings to reflect the risks involved. It is unclear (a word used by journalists when they don’t have the answer) when the decision will be made. Given the fact that our government sometimes (almost always) moves at less than a snail’s pace, and given the fact of the new, conflicting study results, we should not hold our collective breath.

While we wait, let’s think about the dilemma our prescribing doctors have until the FDA acts.

Here’s an article I wrote back in July. Before a decision was made whether or not to post it, the FDA advisory panel (a group of scientists) recommended by a split vote that Avandia be left on the market, pending a decision by the head of the FDA, which should be forthcoming. When her decision is made, I will write a follow-up.

How often have we read or watched media stories about greedy trial lawyers filing spurious class action lawsuits against big tobacco and other giants of American industry? And don’t we sometimes enjoy it immensely when we hear that some jury somewhere stiffed the dying-of-cancer plaintiff with a verdict in favor of the huge corporate defendant? After all, the person harmed should have known better than to have been suckered by the massive advertising campaign touting the safety of a deadly product.

Just when people felt they had reached a comfortable level of complacency on this issue, along comes SmithKline Beechman. Documents recently obtained by the New York Times allegedly show that SmithKline (now known as GlaxoSmithKline) actively hid from regulators and the public the fact that Avandia, a SmithKline diabetes drug known as rosiglitazone, was riskier to the heart than Actos, a competing drug manufactured by Takeda.

In 1999, SmithKline completed a secret study comparing the heart risk of the two drugs. The results clearly showed that Avandia was not safer and in fact may actually cause heart attacks. Researchers began discovering Avandia’s risk in 2007. Shortly thereafter, SmithKline admitted that it had known of the heart attack risk at least since 2005.

Instead of reporting their findings to drug regulators as they should have done, SmithKline apparently suppressed the results for eleven years. A recently-discovered 2001 email discloses that a SmithKline executive wrote that the study “was done for the U.S. business, way under the radar. Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.” A GSK spokesperson recently said the study’s results were not disclosed because they “did not contribute any significant new information.”

Do you get the picture now?

Lead lawyers in the class actions filed against Toyota in Colorado and across the country are adding claims that the vehicle manufacturer is guilty of racketeering under the Racketeer Influenced and Corrupt Organization Act (RICO).

Plaintiffs in the initial class actions claim that the resale value of their Toyotas has decreased because of problems of unintended acceleration that prompted the recall of millions of Toyota vehicles. If successful, this theory of damages could cost Toyota as much as $2 billion.

The lawsuits allege that Toyota knew of the unintended acceleration problems-- possibly as far back as 2002-- but Toyota nevertheless continued to advertise its vehicles as safe and reliable and concealed the problems from the public. If the RICO claims are proved, damages could approach $10 billion.

Support for the RICO claims is allegedly based upon Toyota documents and the congressional testimony of Toyota officials. Toyota has declined to comment on the litigation to date.

Continue reading "Toyota Guilty of Racketeering?" »