Tennessee Law Blog

Ortho Evra contraceptive patch users should be aware of injuries caused by the transdermal (skin) birth control patch. FDA investigations have revealed Ortha Evra contraceptive users have a significantly higher risk of developing serious blood clots (aka “venous thromboembolism” or VTE) than women taking oral contraceptives. Ortha Evra patch-caused VTE can lead to serious injury or sudden death from pulmonary embolism.
FDA has modified the prescription information for Ortho Evra after the release of the independent study of women ages 15-44. This drug safety study confirmed earlier safety studies showing the VTE dangerous side effect of Ortho Evra contraceptive patches.
Ortho Evra contraceptive patches have been under safety investigation for VTE and other side effects since the patch’s approval in 2001. Previous studies have shown women taking the contraceptive patch have twice the risk of developing VTE than women using birth control pills. This dangerous side effect appears to be caused by the patch’s birth control hormones which expose patch users to about 60 percent more estrogen than those who take oral birth control pills.
FDA officials have taken no other action than this label change announcing the results of this study.
If you or a loved one has suffered an Ortho Evra side effect injury, contact Nashville’s esteemed drug injury attorney Jim Higgins for a free consultation. Call toll free 1.800.705.2121 or fill out HHP's contraceptive patch injury form.

Children’s OTC cold medication was the subject of the FDA’s public warning issued yesterday, a subject that has been awaiting strong censure for many years. The FDA report states

“Over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use.”

That serious side effects can occur from nonprescription medications given to young children has been known for years. Unfortunately, the FDA has been dragging its feet, despite reported toddler and infant deaths from drug medications readily available over-the-counter.

FDA officials are remain undecided on an issue that first gained momentum last year when it announced it would review the drug safety (whether dangerous drug side effects outweighed drug efficacy) data for children ages 2-11.

October 2006, many children’s OTC drug companies quit selling their medicines marketing specifically to infants after FDA reports showed that the drugs are ineffectivein children under age 6 and are unnecessarily dangerous.

Yesterday’s advisory is the first time the U.S. government has released a direct statement on the drug dangers posed to children with a strong recommendation that parents not give children under 2 these drugs.

If your child or loved one has suffered a dangerous drug injury, contact HHP today for a free consultation with me or another Tennessee drug injury attorney.

Benzene lawsuits have been big news lately in Texas, Tennessee, and Florida--some good news and some bad news. Good news is these benzene lawsuits are having their day in court; bad news is these benzene lawsuits are occurring because government oversight of its citizens’ safety is lax--forcing personal injury lawyers to step in and clean up the carcinogens through lawsuits after the cancer has been caused, soil contaminated, damage done.

Benzene is an industrial chemical used in the production of a number of products, including refineries, tire manufacturing, and microchip production. It is a known carcinogen, responsible for most cases of workplace-caused acute myelogenous leukemia (AML). Atmospheric and workplace exposure to this leukemia-causing chemical is supposed to be regulated by EPA, OSHA, and other regulatory agencies. Unfortunately, as recent news events show, federal and state government officials' hands are tied by loose laws regulating benzene or for punishing those who do not take appropriate benzene safeguards to prevent potential cancer from benzene exposure.

Concerned Houston-area citizens and Texas environmental watchdogs filed a Clear Air lawsuit last week to protect themselves from benzene and other carcinogenic and dangerous emissions from a Deer Park (southeast Houston) Shell Oil refinery. This is the first time benzene lawyers and private citizens have used a provision of the Clean Air Act that allows individuals to sue for violations when government enforcement fails.

The aim of this lawsuit is to prevent further “upset events,” that is, when safety procedures or equipment fails and releases air pollutants from refineries. According to attorneys filing the lawsuit, benzene and other dangerous chemicals are frequently released from this oil refinery but can be prevented with simple investments in equipment. Instead, millions of pounds of toxic substances (including carbon monoxide, benzene, sulfur dioxide, and nitrous oxide) have been released into the air, according to the lawsuit. While the Shell refinery has paid slap-on-the-wrist fines (ultimately amounting to what one attorney calls a “pay to pollute” policy), this new lawsuit will fine the refinery up to $32,500 per day for violations dating back to 2002.

Meanwhile, benzene lawsuits in New York charge an IBM computer plant with cancers caused by over 70 years of toxic dumping in Endicott, birthplace of IBM. Over 90 present and former residents are part of the lawsuit originally filed over four years ago who have come down with a variety of health conditions, including birth defects and cancer.

Finally, closer to home, Publix, as subject of a benzene in soda lawsuit, will change the formula of and put expiration dates on their cans of diet lemon lime. Publix was one of many producers of citrus sodas found to contain benzene levels higher than EPA safety regulations for drinking water. Unfortunately, neither the EPA nor the FDA have set standards for benzene in soft drinks and could only issue warnings to the public and producers. Carcinogenic benzene molecules were released from chemical reactions in certain carbonated citrus drinks. This change occurred as part of a undisclosed settlement from a benzene lawsuit.

Like asbestos in the 70s, it’s taking benzene personal injury lawsuits to clean up industry's act and to make our citizens’ home safer and reduce risks involved from workplace exposure to this leukemia-causing industrial solvent.

If you or a loved one has been diagnosed with acute myelogenous leukemia (AML) and you believe this cancer is a result of long-term benzene exposure, contact our HHP personal injury lawyers for a free consultation on what legal action you can take in Tennessee for benzene-caused cancer.

News 4 in Nashville ran a story that Wackenhut has billed the government for security services that were not provided. If this is true they have billed us as tax payers for nothing. I think we would all agree that billing someone for work you do not perform is nothing more than stealing.

The state and federal government has now given us a powerful tool to punish companies that defraud the government. It is commonly known as the false claims act. The false claims act allows people, whether affiliated with the government or not, to file actions against federal and state contractors claiming fraud against the government. The act of filing such actions is informally called "whistle blowing". Persons filing under the Act stand to receive a portion of any recovered damages. More importantly it deters any company from cheating us all.

If you have a potential whistle blower claim, feel free to contact our office.

The Duragesic pain patch and other, generic pain patches similar to Duragesic have received a second safety warning from FDA regulators.

FDA officials have issued this second warning to doctors and patients using the Duragesic pain patch due to many injuries and deaths reportedly caused by the drug fentanyl. This most recent warning about dangerous effects of Duragestic pain patches comes after the patch was put on high alert in July 2005 when 120 patients who had used the pain patch had died.

Fentanyl is a narcotic most often used to assuage patients suffering from terminal forms of cancer. In Duragestic pain patches, this painkiller (opoid) is administered through the skin (transdermal delivery).

When this pain drug is incorrectly prescribed by medical professionals, deaths can result. Almost all deaths related to Duragestic pain patches are preventable, according to FDA officials.

Duragestic and other fentanyl pain patches required a second warning, according to FDA officials, because they have been inappropriately prescribed for surgery pain and head aches. These are not the intended and FDA approved uses for the Duragestic pain patch. Additionally, this dangerous drug medication can be abused by patients who may develop an addition to the drug or may incorrectly administer the patch; fentatnyl, estimated to be 80 times more potent than morphine, is highly addictive. Fentanyl patches should only be used and prescribed for constant, severe pain in patients.

Duragestics deaths can result from any number of dangerous side effects but most commonly occur because fentanyl in even moderate doses can cause difficulty breathing.

The Duragesic pain patch is marketed by Johnson & Johnson and is considered a Class II substance.

Since June 2005, survivors of relatives who have died from fentanyl overdose caused by Duragesic pain patches have been awarded compensation.

If you or a Tennessee loved one has suffered serious side effects of a Duragesic pain patch, you may be eligible to file a Tennessee Duragesic lawsuit. I and the other qualified, personal injury attorney at HHP offer free case evaluations in dangerous and recalled drug medication matters.

Call us at (615) 353-0930 or fill out our dangerous medication and recalls attorney contact form.

A few weeks ago I reported on a dangerous medical device FDA recall involving infusion pumps. In that Tennessee Law Blog, I wanted to include more information on FDA recalls but didn’t have the luxury of space or time. As a Nashville plaintiff’s attorney, I feel it is my place to make the public aware of FDA recalls and other dangerous products so that I might offer my services to the injured, just as I do whenever a Tennessee client suffers physical damage from a workplace injury or defective products or financially from workplace discrimination or denied social security. And I want to start this new year off right.

Fortunately, the FDA (despite rushing too many dangerous drugs like Vioxx and Ketek to market) also wants to start 2008 by raising public awareness about the recall process. They've published a downloadable document that has saved me the explanation. They’ve even included illustrations (well, clip art) in a handy PDF you can access by clicking FDA 101: Product Recalls (products include dangerous drugs, medical devices, food, cosmetics, and a number of other dangerous products for which HHP attorneys help injured clients win compensation).

The two-page document details the processes of FDA recall, reasons why drug medications or other products might be recalled by the FDA, and the three (3) levels of hazard associated with FDA recall.

It is important to realize that publicized FDA recalls such as tainted foods (remember the tainted spinach scares and peanut butter salmonella?) are only a small portion of FDA recall actions against pharmaceutical, medical device, and food and cosmetic companies. Most FDA interventions and warnings go unreported except for minor mention on the FDA website or press releases hosted by the producers of the dangerous, recalled product.

Don’t assume your dangerous product injuries are insignificant or not worth pursuing. Most recalls are voluntary and come only after the company has evaluated the costs of leaving dangerous products on the market versus paying settlement costs for the injuries the cause and lives they negatively affect. Working with an attorney can help make sure that you are compensated for your or a loved one’s injuries and that companies producing dangerous or harmful products take responsibility for their products. It's one of the checks our free market system has and serves to protect Tennesseans.

From all of us at HHP, we wish you, our Tennessee Law Blog readers, a happy and safe 2008.