Trial Attorney Blog

Many of us who have handled serious personal injury cases, including those involving brain injury have seen MRI’s performed using various contrast agents for years. One of those agents does not appear to be as safe as once thought. Gadolinium, or gadodiamide, is a contrast agent which allows an MRI to define normal tissue from abnormal tissue in the brain and body. The FDA declared Gadolinium safe for use in contrast MRI’s in 1988.

In June 2006, the FDA first notified health care professionals and the general public about the risks of a potentially fatal disease known as nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium. Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

More recently, on May 23, 2007, the U.S. Food and Drug Administration (FDA) asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).

Avandia was approved by the FDA in May 1999 for use in improving control of blood sugar levels in Type 2 diabetics. Since its approval, Avandia, which is manufactured by GlaxoSmithKline, has been used by more than seven million people worldwide and is, today, being used by over one million Americans.

According to a study on Avandia conducted by the Cleveland Clinic which was published on May 21, 2007, by the New England Journal of Medicine, the popular drug is linked to a greater risk of heart attack and, in some cases, death. The study, which compiled data from 42 studies involving 15,560 patients who took the drug and 12,283 patients given other medications or a placebo, showed a 43 percent higher risk of heart attack and other heart-related adverse events while taking Avandia.

The FDA is continuing to analyze the data and to investigate the increased risk of heart attack linked to Avandia. Although the FDA has not reached any conclusions and its analysis of the drug is ongoing, on May 21, 2007, the FDA advised patients using Avandia, especially those who have underlying heart disease or who are at high risk of heart attack, to consult with their physicians about this new information.

The Composix® Kugel Mesh Patch is used to repair inguinal, ventral and laparoscopic hernias. The purpose of the patch is to keep the intestines in the abdominal cavity. The patch is typically placed behind the hernia defect by means of an incision. The patch is then held open by a memory recoil ring.

The Composix® Kugel Mesh Patch was recently recalled by its manufacturer, Davol, Inc., a subsidiary of C.R. Bard, Inc., after it was discovered that the memory recoil ring can break under stress and perforate internal organs. Patients who have had a hernia repair using the patch have been urged by the FDA to contact their hernia surgeons to determine if the recalled Composix® Kugel Mesh Patch was used in their hernia repair.

The defect involving the Composix® Kugel Mesh Patch can lead to serious, life threatening injuries including, bowel perforation, bowel obstruction, chronic intestinal fistulae, serious infection, or death.

Many people we have represented in serious personal injury cases whether they workplace accidents, trucking accidents, automobile accidents or dangerous products have asked whether settlement proceeds or payments made to an injured party as aresult of a jury verdict are taxable. The general rule is that those payments are not taxable.

The Internal Revenue Code provides, “Except as otherwise provided”, gross income for the purpose of calculating Federal income tax includes “all income from whatever source derived”. Sec. 61(a). This definition is sweeping in scope, and exclusions from income are to be narrowly construed. However, Section 104 provides for an exclusion from gross income for certain payments received as compensation for injuries or sickness. Specifically, section 104(a)2 provides in part:

SEC. 104. COMPENSATION FOR INJURIES OR SICKNESS.

In Georgia, the driver of a vehicle involved in an accident resulting in injury to or death of any person or property damage to an apparent extent of $500.00 or more shall immediately, by the quickest means of communication, give notice of such accident to the local police department if such accident occurs within a municipality. If such accident occurs outside a municipality, such notice shall be given to the office of the county sheriff or to the nearest office of the state patrol.
In addition to what the law requires, you should ask people around the accident site if they observed the accident and if you can, get their name and telephone number, so they could be a witness for you if you should need a witness later on. Get as many witnesses as possible, because a person may move or change phone numbers or may not want to be a witness for you later on. If you or anyone that was in the car with you has been injured you should get medical treatment right away.
If you have been injured, do not discuss your injury or the way it happened with any insurance company adjuster, investigator or representative until you have consulted a lawyer. These statements might be incomplete or taken out of context and be harmful to your claim at a later date. Do not sign any papers or agree to any settlement, as this may affect your right to pursue your claim. Always seek competent legal advice first! The sooner your attorney gets involved the better he or she is able to protect your rights. If you have any visible injuries take photographs of your injuries as soon as possible, as well as photographs of the damage to your car. Another important reason to involve a competent lawyer as soon as possible is so that the lawyer can do whatever additional investigation is necessary to protect you.

A recent study reported in the Archives of Internal Medicine has concluded that reports to the Food and Drug Administration of dangerous side effects and deaths from widely used medicines almost tripled between 1998 and 2005. The number of deaths and serious injuries from prescription and over-the-counter drugs climbed from 34,966 to 89,842 during the time period.

Powerful narcotic painkillers such as Oxycontin, were among 15 drugs most often linked with deaths in the study. Other drugs such as insulin, the arthritis drugs Vioxx and Remicade, and the antidepressant Paxil were frequently linked to serious nonfatal complications.

The report adds to recent criticism of FDA oversight on drug safety, including its handling of serious problems connected with Vioxx, which was removed from the market in 2004. “This growing toll of serious injury shows that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes,” the authors said.

Any trial lawyer who has ever handled a closed head injury case knows that brain damage can occur even if there is no direct blow to the head. Quite literally, the brain is like a bowl of Jell-O. If the head is shaken, the brain moves within the skull and due to acceleration and rotational forces, not necessarily direct blows, the brain can be damaged. Nor does an injury have to be severe to cause lasting brain injury. In short, a closed head injury without any skull fracture can result in more serious injuries than can an injury where a skull fracture has occurred.

Almost 20 years ago at the University of Virginia Medical Center in Charlottesville, a study of 424 people who had been hospitalized for 2 days or less revealed that after discharge, 79% complained of headaches, 59% of memory problems and 34% had not yet returned to their jobs 3 months later. Seventy-seven head injury patients who had been hospitalized for less than 24 hours and discharged with “normal” findings showed that a third later had difficulties with memory, attention span and concentration. In short, the data has been publicly available for years demonstrating that a closed head injury can cause serious long term complications for those unfortunate enough to have such an injury. Indeed, recovery from a brain injury, however minor it may seem, can last for years earmarked by periodic improvements over time.

In our practice, we have seen numerous symptoms of subtle brain damage. These often include a person who loses interest in their family or hobbies, people that have short attention spans or are unable to do their job, difficulty with relationships, trouble learning new things, sexual problems, etc. Many times, there is a lack of self-confidence and a lack of drive. In short, the brain is a very complicated organ, of course, and while the medical profession is still dealing with its attempts to understand closed head injuries, the fact remains that people who experience head injuries often times are not properly diagnosed initially and many times suffer from the side effects of such injuries for years.

According to an article that appeared in the U. S. News and World Report on September 10, 2007, the number of serious “adverse” drug events more than doubled between 1998 and 2005 in the United States as did a number of related deaths. Adverse event reports are filed when a doctor or hospital realizes that a patient has suffered a serious drug event that has resulted in death, hospitalization and/or other life threatening complications which requires medical intervention to prevent harm. Between 1998 and 2005, the number of reported serious adverse drug events increased from 34,966 in 1998 to 89,842 in 2005. During the same period, the number of deaths related to drug usage increased threefold from 5,519 in 1998 to 15,107 in 2005.
Critics of the federal government contend that the U. S. Food and Drug Administration have relaxed regulations to the point that many drugs are being approved which have not yet been proven to be either efficacious or safe for the public’s use. The statistics seem to bear out this criticism. Because of increased bio-technology and the pressure of the market to introduce drugs prior to comprehensive clinical trials, the reported data seems to indicate that we need a more aggressive government “watchdog” agency than we currently have in the FDA.
Hopefully, these statistics will motivate the government to do a better a job in protecting the public from unsafe drugs. At present, many drugs are causing serious damage to the consuming public. Unfortunately, “the cure is often worse than the cold” when it comes to drugs prematurely rushed to market. These statistics clearly demonstrate that the profit motivated rush to market should be suspended while more emphasis is placed upon safety considerations for the public.

Our lawyers frequently review cases in which cars sustain side impacts which result in serious injury and death. Beginning in the 2013 model-year all new passenger vehicles will be required to provide head protection for side crashes. New regulations, announced by the National Highway Traffic Safety Administration, are designed to reduce deaths and injuries of motorists who are struck by another car or truck along the vehicle’s side

The safety upgrades, which have been under review since 2004, could save more than 300 lives and prevent more than 400 serious injuries annually through the installation of side air bags that protect the torso and side curtain air bags that guard the head. Side-impact crashes killed 9,200 people in 2005, the most recent figures available, or about 29 percent of motorists killed in passenger vehicle crashes. A study reported last year by the Insurance Institute for Highway Safety found that driver deaths were reduced by 52 percent in sport utility vehicles equipped with head-protecting side air bags, while the same air bags reduced driver deaths by 37 percent in passenger cars.

The auto industry has voluntarily agreed to install side air bags in all new passenger vehicles by September 2009 and the safety equipment, including air bags that provide more protection in rollover accidents, is becoming more widely available. Under the government’s plan, automakers will be required to phase-in the head protection in 20 percent of passenger vehicles in the 2010 model year, 50 percent by the 2011 model year, 75 percent in 2012 vehicles and in all passenger vehicles for 2013 models. All new passenger vehicles will need to comply by September 2012.

The US Food and Drug Administration (FDA) adverse event and reporting program has issued a warning that medications containing codeine given to breast-feeding mothers who rapidly metabolize codeine into morphine may cause adverse effects in their infants.

Codeine is generally considered safe for use in nursing mothers; however, last year, a healthy 13-day- old breast-fed infant died from very high levels of morphine received through breast milk. The mother was taking codeine at a dose lower than that usually prescribed for post delivery pain. However, testing revealed that the mother was an ultrarapid metabolizer of codeine.

According to the FDA, depending on ethnicity, approximately anywhere from 1 to 28 per 100 individuals rapidly metabolize codeine. Unfortunately, genetic testing is the only way to determine whether someone is a rapid metabolizer.