Colorado Personal Injury Blog

Fire Damage Uncovers Asbestos

Linda Snyder — Wed, 14 May 2008 19:14:19 GMT

State health officials confirmed today, that the early Monday morning fire, which damaged 4 units in the Holly apartments in Boulder, has exposed asbestos in the building materials. Until further testing to check the air quality is completed, the residents who are mostly University of Colorado students will have to wait to retrieve their belongings.

Asbestos is a mineral fiber that has been used commonly in a variety of building construction materials for insulation and as a fire-retardant. EPA and CPSC have banned several asbestos products. Manufacturers have also voluntarily limited uses of asbestos. Today, asbestos is most commonly found in older homes, in pipe and furnace insulation materials, asbestos shingles, millboard, textured paints and other coating materials, and floor tiles.

Elevated concentrations of airborne asbestos can occur after asbestos-containing materials are disturbed by cutting, sanding or other remodeling activities. Improper attempts to remove these materials can release asbestos fibers into the air in homes, increasing asbestos levels and endangering people living in those homes.

Asbestos is impure magnesium silicate minerals in a fibrous form and has been linked to lung cancer and specifically mesothelioma, a rare, deadly cancer that attacks the linings of the lungs, abdomen and heart and is almost exclusively caused by exposure to asbestos.

Due to the long incubation period, symptoms which include shortness of breath, chest pain and severe cough, may not surface for 20 years or more. Thus, mesothelioma is often not diagnosed until the disease has progressed to an advanced state making treatment difficult and the chance of survival compromised.

The fire which is thought to have started in a juniper bush outside the building is under investigation.

Colorado Springs Car Accident Injures Man

Shannon Weidemann — Fri, 09 May 2008 10:29:31 GMT

A 30-year-old man was injured in a car accident in Colorado Springs on Saturday morning. The accident involved only one vehicle. It rolled over many times.

Police say a 1984 Oldsmobile Sedan struck a curb line of Constitution Avenue and Avondale causing the Sedan to rollover several times. The Sedan finally came to rest in the front yard of 4818 Constitution Avenue.

The driver was taken to a local hospital and is listed in critical condition. The police are investigating the accident. They believe alcohol and a high rate of speed were factors in the accident. Toxiocology testing is being performed. No charges have been filed.

The Heparin Debacle Part Four - Baxter International Getting Away with Murder?

Linda Snyder — Wed, 07 May 2008 16:42:12 GMT

Getting away with murder? That's a pretty harsh question to ask when talking about a drug company. But, I question the policy of drug maker, Baxter International to leave a product on the market for as long as possible before issuing a recall. I've heard their arguments, that because the side effects are so rare that more patients are being helped that being harmed. That's an argument that almost makes sense until you talk to the families of the 785 patients that suffered from severe adverse reactions and 81 patients that have died since January 2007.

To help put those numbers in perspective, according to the FDA report, Information on Adverse Reports and Heparin, of those 81 heparin related deaths, 66 deaths occurred between October 2007 and February 2008. In contrast, there were only 3 heparin related deaths for the entire year of 2006.

In October 2007 there were 4 heparin related deaths reported to the FDA. That's more than the entire year of 2006. In November 2007 there were10 heparin related deaths. In December 2007, 13 deaths, that's over 4 times as many deaths as the entire year of 2006. In January 2008, 21 deaths and February 2008 there were 18 heparin related deaths. There were no deaths reported in March 2008.Yet it took the FDA and Baxter over four months to issue a recall. If the recall had been issued in November 2007, 52 deaths might have been prevented.

The FDA does state in its report:

• That the heparin related deaths in the report "concern heparin produced by any manufacturer."

• The fact that someone reports an adverse event does not necessarily mean that a specific drug caused the medical event or death.

      • Reports have to be analyzed to see if there is a plausible causal association between the drug and the medical event.
       •It is often not possible to tell in an individual case if there is a causal relationship between the drug and the medical event or death.
        • Many patients have other serious conditions that could have caused the reported problem.

Is Baxter guilty of murder? According to Wikipedia murder is legally defined as:

.a common law murder is defined as the unlawful killing of a human person with malice aforethought if the defendant acts with any of the following states of mind:

(i) Intent to kill; (ii) Intent to inflict serious bodily harm; (iii) Reckless indifference to an unjustifiably high risk to human life (abandoned and malignant heart); or (iv) Intent to commit a felony (felony-murder doctrine).

Under element (iii) abandoned and malignant heart, the killing must result from defendant's conduct involving a reckless indifference to human life and a conscious disregard of an unreasonable risk of death or serious bodily injury.

Reckless indifference to human life.allowing an additional 52 people die sounds like reckless indifference to me.

Let the FDA Do Its Job? I Don't Think So.

Linda Snyder — Fri, 02 May 2008 13:49:13 GMT

What planet does Diane Bieri live on? It's certainly not on the planet earth that I live on. In her commentary, Opposing view: Let FDA do its job, Ms. Bieri goes on and on about how the outcome of a U.S. Supreme Court case will undermine the FDA and it's the patients who will suffer.

Ms. Bieri claims that we should not "ignore the FDA's scientific expertise," and "we should empower the FDA to accomplish the job Americans expect."

As an "American" here's what I expect from the FDA. I expect the FDA to not allow drug research studies to be ghost written for the doctors by the drug companies. I expect the FDA to inspect foreign drug plants. I expect the FDA to not approve drugs that have known potential adverse side effects without comprehensive warning labels. I expect the FDA to not allow drug makers to dictate when a drug be recalled that has reports adverse effects or deaths. I don't expect to have the FDA run by the drug companies.

Ms. Bieri continues, "Now, lawyers are trying to second-guess FDA's expertise regarding the way to warn about potential drug risks." All I can say to that comment is, thank God for lawyers! Historically the drug companies will not issue a recall or change a warning label until attorneys get involved and file lawsuits on behalf of patients who have suffered from adverse events or have died.

The drug companies are terrified of losing revenue. If, we as patients are more informed about potential adverse effects, we may decide that all of those glorious benefits that we see in the polished television commercials and glossy magazine ads are not worth the risk. A patient who makes an informed decision has the ability to affect the drug companies' bottom line.

In light of the heparin debacle, the ghost written Vioxx studies and the Vytorin and Zetia mess, I find it appalling that anyone thinks the drug companies need less regulation and that the FDA as it exists today is functioning in the best interests of patients.

Oh, wait a second.Diane Bieri is senior vice president and general counsel of PhRMA (the Pharmaceutical Research and Manufacturers of America).

The Heparin Debacle Part Three - The FDA Falls Flat

Linda Snyder — Wed, 30 Apr 2008 06:00:00 GMT

"Protecting and Promoting Your Health." That's the tag line posted on the U.S. Food and Drug Administration web site. Protecting and promoting your health, doesn't seem to have the same meaning to the FDA as it does to the U.S. consumer.

Putting it very simplistically, the FDA is charged with ensuring that the food and drugs we consume are safe before they are made available to the public. Recent news has shown that many of the drugs that the FDA has approved have not only not failed to "protect and promote our health," but in fact have deadly consequences.

Consider these facts:

• FDA approved drugs, Oxycodone, Fentanyl and Clozapine, are on the list of top 10 deadliest drugs and are responsible for over 12,000 deaths from 1998 to 2005.
• The American College of Cardiology has recommended that the popular FDA approved drugs, Vytorin and Zetia should only be used after all other cholesterol lowering drugs fail.
• A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling FDA approved drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

According to a report from the Government Accountability Office, the FDA would need to spend at least an additional $56 million next year in order to fully inspect foreign plants. The FDA would need at least $15 million a year to inspect Chinese drug plants every two years to comply with US standards.

At its present pace, it would take the FDA nearly 27 years to inspect every foreign manufacturer that exports medical devices to the US. It would take 13 years to inspect every foreign drug plant and 1,900 years to inspect every foreign food plant.

Although the Bush administration acknowledges the problem, President Bush's budget does not provide the FDA with the funds to hire additional inspectors. There are proposals in motion to increase the FDA's budget and to shift some of the financial burden onto the domestic and foreign manufacturers to pay fees for inspections.

I don't know about you, but now when I go to my medicine cabinet and take out that bottle of FDA approved prescription medication that I assumed was safe, because the FDA's motto is "Protecting and Promoting Your Health", I get a funny feeling in the pit of my stomach that no medication can fix.

Up Next: The Heparin Debacle Part Four - Is Baxter International Getting Away with Murder?

This post has been removed

Linda Snyder — Mon, 28 Apr 2008 17:06:00 GMT

This post was removed at the request of the contributing author.

The Heparin Debacle Part Two - Chinese Officials Play the Blame Game

Linda Snyder — Fri, 25 Apr 2008 21:17:41 GMT

Chinese officials have finally acknowledged that there is a contaminant in heparin produced in China, but it is not connected to the illnesses. Ning Chen, second secretary at the Chinese Embassy claims, "We don't have a strong evidence to show that is heparin or its contaminant that caused the problem." Mr. Chen asserts that since the adverse reactions and deaths only occurred in the United States, the problems originated here.

According to the director of the FDA's drug center, Janet Woodcock, German officials have found adverse reactions in dialysis patients who took contaminated heparin.

Dr. Woodcock continues, "Heparin should not be contaminated, regardless of whether or not that contamination caused adverse events. We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions."

And we all know, the best defense is a good offsense.Chinese officials are now insisting that the United States' request for American inspections of Chinese company's be a two way street and China be allowed to inspect US facilities.

In light of China's history of exporting toys containing lead, tainted rice, poisonous toothpaste, toxic pet food, tainted fish and now contaminated drugs, you would think China would be bending over backwards to fix this latest debacle. And you would think in light of the FDA's track record lately (Vioxx ghosted studies, Vytorin and Zetia) they would make it a priority to hold China to a minimum safety standard.

So, what does the FDA do? They send Changzhou SPL, the Chinese plant that supplied the contaminated heparin to Baxter International a warning letter. The letter warned that the plant used unclean tanks to make heparin, that it accepted raw materials from an unacceptable vendor and that it had no adequate way to remove impurities. I'm sure that based on that warning letter, Changzhou SPL will never, ever, ever produce a contaminated product ever again.

China also claims that they can/will/have been testing heparin for contaminants. The FDA counterclaims China technology is not sensitive enough to detect the contaminant.

So, the blame game continues.

Up Next: The Heparin Debacle Part Three - The FDA Falls Flat

Sweetened Ginger Recalled for Sulfites

Shannon Weidemann — Wed, 23 Apr 2008 11:53:40 GMT

Jars of sweetened ginger have been recalled due to the presence of undeclared sulfites. The product is distributed by Fine Land Corp. under the Golden Girl brand name. The recalled ginger is sold in a 7 ounce plastic container.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared sulfites in Golden Girl brand "Mut Gung" sweetened ginger which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

The recalled item was distributed to stores across the country. There have been reports of injuries. The company is offering a full refund to consumers that purchased the product. The company is also taking phone calls at 718-714-1850.

The Heparin Debacle Part One

Linda Snyder — Tue, 22 Apr 2008 20:50:42 GMT

Remember what it felt like as a kid when you went into a candy store and you were overwhelmed with how many choices of sweets lay before you? When I read the New York Times article, U.S. Identifies Tainted Heparin in 11 Countries, I felt that same overwhelming indecision, but in a bad way. I was baffled by which angle to take. Do I blog about how the Chinese are trying to pass the buck and blame everyone else for the contaminated Heparin. Do I blog about how the FDA is dismally understaffed to even consider inspecting foreign plants. Do I blog about how huge this Heparin debacle is turning out to be or do I blog about how Baxter International, the manufacturer of Heparin, is more concerned with covering their corporate behinds and is denying that the contaminated drug has caused 81 deaths.

So, I decided to do what any smart kid in a candy store would do.sample a little bit of everything.

In a nutshell, the FDA has found the contaminated drug Heparin, a blood thinner, in 11 countries including, Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. Investigators have also established a definite link between the contaminant and the severe reactions that have caused 81 deaths in the Unites States.

Heparin is made from the mucous membranes of the intestines of pigs and the process of rendering the ingredients takes place in Chinese family workshops which are for the most part, unregulated. The contaminant, oversulfated chondroitin sulfate is a cheaper substitute that was able to slip through the usual testing and was not identified until more sophisticated tests were utilized.

There has been speculation that the concentrated number of deaths in the US may be attributed to the practice of American doctors to use large, quickly infused doses of heparin. Additionally, the FDA may be better than its foreign counterparts at tracking serious side effects.

The FDA had reports as early as 2006 that some lots of heparin contained the cheaper additive, which begs the question.why did Baxter International wait until February 2008 to issue a recall?

Up next: The Heparin Debacle Part Two - Chinese Officials Play the Blame Game

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Linda Snyder — Fri, 18 Apr 2008 09:05:00 GMT

This post was removed at the request of the contributing author.