Alaska Injury Law Blog

One of the difficulties faced by our clients who have suffered "mild" traumatic brain injury (TBI) is that there has been no objective means of establishing that brain injury exists even though the clinical signs of dysfunction are present. This has often resulted in clients not getting the medical care that would help them with their rehabilitation, or they have suffered the undeserved claims by defense practioners that they were "malingering" or "magnifying" their symptoms.

Two new studies support the early data on the efficacy of a new MRI tool--diffusion tensor imaging--in the diagnosis of traumatic brain injury (TBI). Diffusion tensor imaging allows the care provider to visualize the brain's white matter, which contains the fibers that connect nerve cells. Conventional MRI would commonly not reveal any differences between the patients with mild TBI and controls. DTI, however, is finding objective evidence on imaging that is consistent with a positive finding on neuropsychological testing.

One study at the University of New Mexico has found that diffusion tensor imaging can be used to reliably detect and track brain abnormalites in patients with mild TBI. The study compared patients with known mild TBI and found that conventional MRI did not reveal any differences between those with TBI and control subjects. The diffusion tensor imaging, however, demonstrated white matter abnormalities in the subjects known to have TBI. Thus, the technique was successful in finding objective evidence of injury when conventional MRI failed to do so. Another important finding was that, when the patients found to have such abnormalities were evaluted with diffusion tensor imaging 3-5 months later, a period by which recovery is expected, the diffusion tensor imaging was able to track these white matter changes, as well. The study concluded that diffusion tensor imaging can provide an objective biomarker that can assist in the classification and tracking of mild TBI injuries and their effects.

With this kind of literature developing about the effectiveness of diffusion tensor imaging, we expect this imaging technique to provide patients with better diagnosis and treatment. The reader may also be interested in our previous reports about this literature, here, and here.

Sources:

Mayer, AR et al. “A Prospective Diffusion Tensor Imaging Study in Mild Traumatic Brain Injury.” Neurology, February 23, 2010, Vol. 74, pp. 643-650.

Bigler, ED and Bazarian, JJ. “Diffusion Tensor Imaging: A Biomarker for Mild Traumatic Brain Injury?” Neurology, February 23, 2010, Vol. 74, pp. 626-627.

The Journal of the American College of Cardiology has just published a review of 44 years of research and has concluded that herbal products can contribute to cardiovascular morbidity and mortality. The risks noted include increased bleeding, and reducing or increasing the effect of a patient's cardiovascular medications, Many of the ingredients used (aloe vera, ginkgo biloba, ginseng, and green tea) can interact with a patient's heart medications and lead to serious adverse reactions. For example, some ingredients increase the blood levels of statins, calcium channel antagonists, and several anti-arrhythmic drugs. Another herbal ingredient is known to inhibit platelet aggregation and can lead to increased bleeding risk when the patient is also taking anti-coagulants such as aspirin, Plavix, or Coumadin. Some ingredients (garlic, ginkgo biloba, ginseng, saw palmeto) can have their own cardiovascular effects, and some can induce arrhythmias on their own. The authors, all Mayo Clinic physicians, have called for increased regulation of the products.

Sources:

"Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases," Journal of the American College of Cardiology, 2020; 55:515-525.

Medpage Today, 2/1/10.

Litigation by the Alaska Personal Injury Law Group has been cited in the Journal of Clinical Pharmacology & Therapeutics for its role in aiding the FDA in its decision to finally rule that ephedra products were adulterated under the Federal Food, Drug, and Cosmetic Act. The litigation, Talbert v. E'ola Products, Inc., 3AN-97-4046, was handled by Richard E. Vollertsen and arose out of stroke injuries suffered by a young woman using an ephedra weight loss product that had also been spiked with ephedrine hydrochloride.

Source:

"Clinical Pharmacology and Dietary Supplements: An Evolving Relationship," Clinical Pharmacology & Therapeutics, Vol. 87, No. 2, Feb. 2010.

The USDA has recalled 17,235 pounds of Daniele International salami because it is suspected of being contaminated with salmonella. To date, over 203 individuals have been sickened in 42 states, including one here in Alaska. Costco, a local retailer, is one of the retailers that has sold the company's products.

Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12–72 hours after infection. Infection is usually diagnosed by culture of a stool sample. The illness usually lasts from 4 to 7 days. Although most people recover without treatment, severe infections may occur. Infants, elderly persons, and those with weakened immune systems are more likely than others to develop severe illness. When severe infection occurs, Salmonella may spread from the intestines to the bloodstream and then to other body sites and can cause death unless the person is treated promptly with antibiotics.

Sources:
Feb. 1, 2010, USDA

January 31, 2010, USDA

CDC Investigation of Multistate Outbreak of Salmonella

Researchers from the UK, Sweden and the US have established that using drugs purchased from the internet can kill and cause patients to bypass health systems that could diagnose life-threatening problems. They estimate that 90% of counterfeit drugs are sold via the internet, which has spawned global sales of over $75 billion, sales which have increased 92% in the last 5 years.

The findings are set out in an article in the International Journal of Clinical Practice. The researchers reviewed over 50 studies published since 1995. The data particularly focused on erectile dysfunction medication, and showed the over 44% of these drugs were fake. The consequences were dire for some, including 150 men admitted to hospitals after taking counterfeit tadalafil and herbal preparations that claimed to cure the dysfunction. Seven were comatose and four subsequently died. Two pregnant women died after being given injections of a counterfeit iron preparation for anemia. Fifty-one children died of kidney failure after taking paracetamol syrup contaminated with glycol, an antifreeze used in cars.

We have previously reported on the problem of herbal preparations being spiked with prescription medications here, here, here, here and here.

Source:

Jackson et al. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. International Journal of Clinical Practice, 2010

The public is often clueless about the true malice some corporations demonstrate in their willingness to put people's lives in jeopardy for the sake of profit. The anti-plaintiff rhetoric of recent years has reached a fevered pitch with little understanding that to give into it undermines one's constitutional right to a jury trial and the ability of a single person to use the courts to stop corporate wrongdoing when the government has failed to act. And the news tells us each day how ineffective government can be in this regard--because it is slothful, because it has been bought off with lobbyists, or because it is unwilling to challenge the prevailing political prediliections of the party in power at the moment.

We see corporate deceit in many of the cases we handle, so we get hardened to it. Sometimes we see a story, however, that amazes even us. This is one of them. A St. Petersburg, Florida company, Youth Research, had been hired to perform child safety tests on cigarette lighters. It has now been found to have falsified the tests and to have submitted fraudulent reports to federal regulators. The discovery of the fraud has prompted the Consumer Product Safety Commission to order 12 lighters off the market until they have been retested.

The CPSC implemented lighter safety standards after research showed that children under the age of 5 had inadvertently started 5,900 residential fires resulting in 170 deaths and 1,150 injuries in a two-year period. The standards require that panels of 100 children be given dummy lighters to see if they can activate the lighters. A lighter would pass only if 85% of the children could not activate it. In creating the fraudulent test results, the company altered birth dates and identity records and eliminated data that showed that a child could ignite the lighters.

The woman at the center of the fraud, Karen Forcade, has now pleaded guilty to fraud in federal court.

Sources:

St. Petersburg Times, January 23, 2010.

The Tampa Tribune, January 24, 2010

United States of America v. Karen Forcade, U.S. District Court, Middle District of Florida, Case No. 8:09-CR-544-T-27TBM.

Today's news is that gingko biloba, touted since the 1970's by the diet supplement industry as an herb that would improve memory or forestall cognitive decline in aging or in dementia, has been found to be useless. As routine scientific scrutiny has been applied to the nostrums of the industry in recent years, we see these "ancient healing" claims fall one by one: chondroitin and glucosamine for osteoarthritis, vitamin E and selenium for prostate cancer, or vitamin E and C for prevention of cancer or heart disease. (Indeed, recent studies have shown that the use of vitamin therapies can sometimes increase the risk of disease, as in folic acid increasing the risk for precancerous polyps or higher lung cancer rates for those trusting to beta carotene supplements.) When asked for data in support of their claims of efficacy, the industry simply trots out the claim that the Chinese have used the product for 5,000 years or that sharks never get cancer. By doing so, they seek to avoid the hard work of any scientific endeavor, i.e., proving that their product works.

As for the safety of these products, the industry has repeatedly picked the pockets of consumers with this magical thinking: "it is all-natural, so it has no side-effects but it works better than drugs." Of course, for a compound to work, it must have an effect, which means it is capable of affecting the body and causing side effects. It can't be effective and affect the body positively but never affect the body negatively. If it can affect the body at all, it is capable of having side effects, period. It is as if they were saying, "yes you can have the money and never pay taxes on it." Yet, we know that the IRS always gets its piece. And, herbals and diet supplements will always tax the body--there are always side effects.

We can't blame the industry, because we let them get away with selling billions of dollars of useless or dangerous or tainted products. We let Congress take money from the industry's lobbyists to pass DSHEA and dodge the effective regulation of the marketing and manufacturing of these products. We let the diet supplement industry tell consumers, "Ego exigo, proinde is est bonus,"...."I sell it, therefore it is good." We do not demand that the marketeers prove their case that a product is safe or efficacious, the simple standard the drug and OTC industries must meet.

Today's news comes to us from the Journal of the American Medical Association reporting on a study of over 3,000 people between 72 and 96 who were followed for over 6 years. None had dementia before the study began. Those who took the supplement fared no better than those who took a sugar pill in tests examining memory, language, attention, and other measures of cognitive function.

With annual sales of gingko biloba of over $250 million dollars, the industry could well afford to pay for its own testing for safety and efficacy. But, instead we paid for the testing with public funds. We let that happen, too.

Sources:

Snitz BE, et al "Ginkgo Biloba For Preventing Cognitive Decline In Older Adults" JAMA 2009; 302(24): 2663-70.

Diet Supplement Glucosamine No Better Than Placebo, February 20, 2008

New York Times, Extra Vitamin E: No Benefit, Maybe Harm, March 24, 2009

New York Times, Vitamin Pills: A False Hope?, February 16, 2009

As consumers, we have been repeatedly told that generic drugs are exact copies of their brand-name counterparts. We have been forced by insurers to accept generics over brand-name drugs. This is done by the insurer imposing financial disincentives and refusing to honor our physicians' prescriptions without getting the doctor's office to confirm the prescription. Pharmacies substitute generics for brand-name drugs without asking us first or telling us when they have made the switch. All the while there is an unsettling and nagging question in the back of our brains about whether generics are truly equivalent.

The FDA has taken the position that generics are equivalent, but the public is not informed about the agency's standard of review: a generic is deemed "bioequivalent" if it achieves 80 to 125% of what the brand-name drug provides. This is a huge variance, and one we don't accept in many human endeavors, whether we are talking about a pilot landing a plane or sending in what we owe to the IRS.

Indeed, specialists acknowledge a growing concern that patient experiences on generics are problematic, especially for those patients who have conditions that present significant risk of injury if chronic conditions are not properly treated, as in epilepsy or atrial fibrillation. For example, The American Academy of Neurology has released a position paper on generics, stating that: “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”

If you take medications for a condition that has the risk of significant injury or death if your medications are not effective, you should discuss this concern about generics with your prescribing physician. Become an informed consumer about the generic drug you are being asked to take. And regardless what you are told, pay close attention to your symptoms and changes in your condition after taking generics so that you can determine from your own experience whether a generic drug is right for you.

Sources:
New York Times, Dec. 17, 2009

The People's Pharmacy, Dec. 17, 2009

The United States Court of Appeals for the Eighth Circuit, in Mensing v. Wyeth, Inc., has just ruled that generic drug manufacturers cannot use the doctrine of federal preemption as a shield to avoid liability in claims arising out of the manufacturers' failure to warn consumers about their drugs' dangers.

This decision follows on the heels of the United States Supreme Court's ruling in Wyeth, Inc. v. Levine that the FDA's approval of a drug's label does not provide immunity from suit by federal preemption when name-brand drugs cause injury. The Eighth Circuit's decision in Mensing was the first federal appellate decision since Levine to rule that federal preemption does not immunize generic drug manufacturers from liability.

Please see our earlier discussions about the importance of defeating this preemption doctrine.

3/4/09, 12/15/08, 10/20/08, 9/11/08, 8/15/08, and 7/17/08.

Sources:

Mensing v. Wyeth, Inc., (pdf)

The most recent issue of the New England Journal of Medicine has directly called upon Congress to give the FDA the requisite authority and resources to regulate diet supplements. The article is written by Dr. Pieter Cohen, of Cambridge Hospital, and emphasized some alarming statistics:

•More than half of the adult population, about 114 million people, consume dietary supplements.
•The majority of consumers mistakenly believe that dietary supplements are approved by a government agency –- two-thirds of them thought that the government requires that labels on supplements include warnings about their potential side effects or dangers.
•The great majority of the estimated 50,000 adverse events that occur annually remain unreported to the FDA, even though manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA.
•A recent survey of more than 300 physicians who were residents in internal medicine at fifteen different U.S. training programs showed that one-third of them believed that diet supplements require FDA approval – the majority did not know that adverse events suspected to have been caused by supplements must be reported to the FDA.

The Journal emphasized that a wide range of supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Moreover, dozens of supplements have been found to be intentionally contaminated (“spiked”) with prescription medications, controlled substances, experimental compounds, or drugs already rejected by the FDA for safety concerns. As recently as July 2009, the FDA alerted the public to a list of 75 tainted weight loss products that contained undeclared medications, including the stimulant sibutramine, some at levels three times the maximum recommended daily dose. Others contains rimonabant (linked to suicide) and fenproporex (linked to addiction and suicide). Some weight loss pills, many from Brazil, combine multiple medications in a single formula, substantially increasing the risk of adverse events.

The Journal also explained how unscrupulous manufacturers were attempting to fly below the FDA’s radar by using analogues of pharmaceutical compounds. A recent analysis showed that half of 26 supplements marketed for enhancement of sexual function contained analogues of phosphodiesterase Type 5 inhibitors. Reports from three separate countries establish that the analogue of fenfluramine has been linked to liver damage, including fulminant hepatic failure requiring transplantation.

Most recently, tainted products were found being manufactured by a domestic company, American Cellular Labs, which was manufacturing supplements contaminated with anabolic steroids.

The article closed with the admonition that physicians should maintain a high index of suspicion for supplement-induced adverse effects, even when the component stated on the label are not known to cause the symptoms the patient is suffering. After recognizing that DSHEA presents "serious obstacles to the FDA's ability to detect and eliminate contaminated supplements," it called upon Congress to give the FDA the necessary authority and resources to regulate this industry, the author concluded that, until that regulatory authority was given: “Millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.”

Source:

New England Journal of Medicine, Volume 361:1523-1525 October 15, 2009 Number 16

Neil O'Donnell of the Alaska Personal Injury Law Group has been selected for inclusion in the 2010 edition of The Best Lawyers in America. Mr. O'Donnell was selected for inclusion in Best Lawyers in the area of product liability litigation. Selection to Best Lawyers is based on rigorous peer-review surveys. Mr. O'Donnell has now been listed in Best Lawyers for several years. Mr. O'Donnell practices in the area of product liability and personal injury litigation, business tort litigation, and professional liability litigation.

America's highways are unsafe because trucking companies routinely violate safety standards, keeping unsafe trucks and drivers on the road. These are not minor violations, but include practices like routinely overloading trucks, failing to maintain brakes and tires, using unqualified and untrained drivers, and paying drivers in a way that encourages them to exceed speed limits and driving hour limits. Given the crucial role of brakes, it is hard to comprehend that defective brakes account for more than 50% of all violations!

Those are just some of the conclusions contained in a new report just released by the American Association for Justice. Researches analyzed more than a million lines of data obtained from the Federal Motor Carrier Safety Administration (FMCSA). The full report Warning! Safety Violations Ahead may be read here.

When big heavily loaded trucks hit cars, the cars and their occupants usually lose. That's just the law of physics. So consumers have the right to expect trucking companies to be especially vigilant about equipment maintenance and safety. But many needless injuries and deaths are caused because truckers ignore equipment problems. One egregious example is the truckers who fixed a leak in the air brake line with a toothpick and electrical tape. As any thinking person would expect, the "fix" failed after a short time, causing the needless death of a motorist.

The study found that more than 28,000 trucking companies are operating on U.S. roads with safety violations, representing over 200,000 trucks. Truck crashes caused over 12% of all motor vehicle deaths, even though trucks make up only 4% of all vehicles on the road. And that statistic is not a result of trucks covering more miles, because trucks cause deaths per mile driven that are 56% higher than those caused by all vehicles combined.

Continue reading " New Study Finds Trucking Companies, Unsafe Trucks Causing Injuries and Deaths " »