Colorado Business Litigation Lawyer Blog

In a September 23, 2010 news release, the FDA announced that it will “significantly restrict” the use of the diabetes drug Avandia to Type 2 diabetics who cannot control their diabetes on other medications, and who are unable to take Actos, the only other drug in the thiazolidinedione class. These restrictions are a result of study data that suggests an elevated risk of heart attack and stroke in patients using Avandia, manufactured by GlaxoSmithKline.

Under the restrictions, doctors will be required to certify and document their patients’ eligibility for access to Avandia, and patients who desire to continue to use the drug must acknowledge that they have been informed of and understand the risks.

The FDA is continuing to study the drug and may take additional action as warranted.

More Avandia related postings:

"Between a Rock and a Hard Place," Colorado Business Litigation Lawyer Blog, posted 09/21/10

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

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

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

National Public Radio reports September 27, 2010, that the owner of Segway, a personal transport device, apparently drove one of his products off of a cliff and into a river, causing his death.

Jimi Heselden, the company’s owner, grew up poor in London. He quit school to work in the mines at age 15. He made most of his money after he founded Hesco Bastion, a company that makes concertina barriers that are used to protect military bases and secure areas. The protection devices can withstand a car bomb and are in use all over Iraq and Afghanistan.

Heselden was a philanthropist who gave away 23 million pounds to various charities.

The unique Segway was marketed as a safe and simple form of personal transportation. It is ironic that the very person who owned the company apparently wasn’t using the device as safely as he should have been.

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

“The SEC’s charges are completely unfounded in law and fact and we will vigorously contest them and defend the firm and its reputation,” so said Goldman Sachs & Co. when the SEC filed fraud charges against the investment banking and management firm. Read our original report here.

According to The Washington Post, it now appears that “vigorously contest” means that Goldman will pay $550 million, the largest fine the SEC has ever levied against a financial company.

Goldman was accused of failing to disclose to investors that Paulson & Co., a hedge fund, was advising Goldman to purchase individual mortgage-related securities that Paulson believed would lose value. Paulson would then in effect “bet against” the investments. When the housing market collapsed, Paulson reaped billions of dollars in profits, while Goldman investors, who believed the investments were designed to earn them a profit, lost a reported $1 billion.

The language of the settlement agreement was carefully negotiated so as not to constitute admissions of wrongdoing by Sachs in pending civil suits against the company. Nevertheless, Goldman expressed “regret” that it had included “incomplete information” in its materials marketing the investment to clients.

Don’t you just love our financial industry?

Continue reading "A Belated Follow-up to the Goldman Sachs Debacle" »

As reported in the Denver Post, the Tenth Circuit Court of Appeals in a September 10, 2010 opinion reversed a $926 million award made to an estimated 15,000 owners of property south of the former Rocky Flats nuclear weapons plant, a short distance northwest of Denver.

The award was made in a lawsuit filed in 1990 and tried in a four- month long trial in 2006. The plaintiffs showed that their property had been polluted by plutonium from the weapons plant. The appeals court remanded the case to the U.S. District Court in Colorado because of erroneous jury instructions. In effect, the court held that the plaintiffs were required to prove actual damage to their property caused by the plutonium contamination, rather than merely proving that their property values decreased.

Dow Chemical Co. and the former Rockwell International Corp. successively operated the plant for the Department of Energy from the 1950s until 1989, when the plant was closed for safety and environmental reasons.

The appellate court said, "on remand, Plaintiffs will be tasked with producing additional evidence that could support that a nuclear incident occurred, in the form of 'loss of or damage to property or loss of use of property.' "

This 46-page opinion [click here for link] starkly demonstrates that the strict letter of the law and plain old common sense sometimes do not go hand-in-hand. And we say this with the utmost of respect for the law, the courts and the judges.

Hypothetically, if you are a landowner whose property has been polluted by plutonium and you want to sell the land, would a prospective buyer who is aware of the pollution really care if the property has in fact been damaged, irrespective of the niceties of the law? Who should bear the cost of the diminished value of the property, even if it is caused by the buyer’s honest, yet perhaps speculative fear that the property has been damaged? Why should the innocent landowners have to wait 20 years and another unknown number of years for this litigation to end?

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.