Hazardous Products / Product Liability


Asbestos Claims

For more than 100 years, asbestos has been used in building products, shipyards, and factories. It has been an airborne presence affecting millions of workers. Even those who do not work in an area where asbestos fibers are found can be affected by fibers brought home on clothing by other family members. With a latency period of 20 to 50 years, asbestos is the cause of diseases such as mesothelioma, asbestosis, and lung cancer many years after the initial exposure. It is estimated that as many as 21 million workers have been exposed to asbestos in the workplace in the last 50 years and nearly 3,000 new cases of disease attributable to asbestos exposure are diagnosed each year.

Claims of damage related to asbestos exposure were filed as early as 1929, when the dangers of such exposure were first noted. Since then, hundreds of suits have been filed against the manufacturers of asbestos products, charging negligence, design defect, and failure to warn, and millions of dollars have been awarded in damages.

Dangers Of Tobacco Use

It is now generally accepted that tobacco-smoking is directly responsible for more than 80% of lung cancer cases, as well as being a major contributor to emphysema, chronic bronchitis, coronary heart disease and stroke, as well as respiratory tract infections in children exposed to second-hand smoke. Mothers who smoke have a higher incidence of poor birth outcomes, including low birth weight babies. Second-hand smoke is also known to contribute to respiratory illnesses and even lung cancer in those who never used tobacco.

With all these facts, it is hard to understand why anyone would continue to use tobacco. The answer is nicotine. Nicotine has been proven to be addictive in human and animal studies. A person who uses tobacco can become addicted very rapidly and find it extremely difficult to quit. Nicotine, upon entering the bloodstream, will affect brain activity, muscle relaxation, and cardiovascular and hormonal responses. While it is not the direct cause of illness, it is the “Hook” which keeps the user exposed to tobacco.

Tobacco smoke harms everyone exposed, whether smoker or second-hand victim. The effects of smoking are massive, killing more people each year than fires, murders, suicides, AIDS, alcohol and drugs combined.

For many years, cigarette companies denied that smoking was a health hazard or addictive. The product was aggressively marketed, especially to young people, and the under 18 age group is still one of the largest user groups. Information which has been produced in the last few years shows that the companies did know that nicotine was addictive and some companies even added extra levels of nicotine artificially to their product.

Litigation with cigarette companies was unsuccessful until 1996, when several states filed suit against a company which agreed to a settlement. More litigation has since taken place with some success and even more is expected.

Guidant Defibrillator

Guidant defibrillators are used as a method of treatment for Ventricular Tachycardia (VT) and Ventricular fibrillation (VF), two heart conditions involving the rhythm of the heart (arrhythmia). Both conditions have the potential to be fatal. Using medicines and surgery, Tachyarrhythmias can sometimes be treated without the use of an implant. The purpose of non-implant methods of treatment is to eliminate the heart tissue causing the arrhythmia. When this method of treatment fails, an implanted electronic device such as a Guidant defibrillator may be used to treat the condition. An implant device delivers electrical current to the heart in order to slow it to a more normal rhythm. In the event of an emergency, an arrhythmia can be treated by on-site medical personnel using a traditional external defibrillator. However, the long-term treatment of a patient suffering from one of these two types of arrhythmias requires a special solution, such as a Guidant defibrillator.

On June 17, 2005, Guidant Corporation recalled nearly 50,000 of its Guidant defibrillators already implanted in patients worldwide due to malfunctions with the device, many of which could lead to serious injury or death. The Guidant defibrillator recall includes several Guidant defibrillator models. According to Guidant, the recalled Guidant defibrillators have reportedly failed at least 45 times and have caused at least two deaths as of May 30, 2005.

On May 23, 2005, Guidant issued a safety advisory concerning its Guidant defibrillators to physicians, reportedly after the company learned the New York Times was preparing an article. The Times later reported Guidant had delayed telling doctors or patients that the Guidant defibrillators contain a flaw for three years. The flaw has caused a small number of Guidant defibrillators to short-circuit and stop working.

Guidant advised physicians to halt use of five models of Guidant defibrillators. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter Guidant defibrillators, or ICDs. The Renewal 3 and 4 AVT models were also included in the Guidant defibrillator recall. Guidant said in a statement: “As a precautionary measure, physicians should discontinue implants of these devices pending further notice.”

On July 1, 2005 the FDA urged users of Guidant defibrillators to consult with their doctors. On January 21, 2006, additional models were placed on the list of Guidant defibrillator models placed under the Guidant defibrillator recall.

Your physician may recommend a Guidant defibrillator-type device for one or more of the following reasons:

  • You have experienced at least one episode of VT or VF.
  • You have passed out due to an irregular heartbeat.
  • You have noticed an especially fast, reoccurring heartbeat.
  • Medicinal or surgery-based treatments for your heart condition in the past have failed to yield acceptable results.
  • You have incurred serious side effects from drug therapies.
  • You have suffered a heart attack and your ejection fraction is relatively low.

A Guidant defibrillator can use multiple types of energy to restart a failing heart, including:

  • Defibrillation – For highly irregular, very fast heart rhythms, the Guidant defibrillators can deliver a high energy shock to restore the heart to a normal rhythm.
  • Cardioversion – If the arrhythmia is especially fast, the Guidant defibrillator can deliver a one-time, low energy shock to align the heart to a normal rhythm.
  • Anti-tachycardia pacing (ATP) – For fast rhythms within a semi-normal range, the Guidant defibrillator sends a series of rapid, small pacing pulses to interrupt the arrhythmia.

Pesticides Overview

A pesticide is an agent used to repel any microorganism, plant, insect, or animal that is harmful in some way to humans. These chemical combinations are not only common in environmental applications, such as to control weeds and destructive insects in our yards and crop fields, but are also widely used in households. Some examples of everyday pesticide products would be mosquito repellant, cockroach and ant sprays/traps, kitchen and bathroom disinfectants, rat poison, flea and tick collars and powders for pets, mold and mildew cleaners, and some swimming pool treatments.


Because these substances are in effect poisonous to living organisms, some pesticides have been shown to have dangerous and long-lasting consequences for people who come into contact with them. Pesticides, including fungicides and herbicides, are widely used in agriculture and lawn care, in our homes and schools, and on the job.


ProteGen Vaginal Sling

The ProteGen sling is a synthetic polymer implant introduced in April of 1997 as a treatment for feminine urinary stress incontinence. Urologists implanted the sling underneath the bladder to provide support and reduce stress that can cause incontinence. Instead of providing relief, the device often caused numerous complications including erosion of the vaginal wall, dehiscence (splitting of the tissue), infection, vaginal discharge, vaginal bleeding, foul odor, and other problems. In January of 1999, Boston Scientific Corporation, the manufacturer of the ProteGen, recalled the product due to the unusually high number of complications.

In the December 1999 edition of The Journal of Urology, a group of respected urologists from across the United States reported a high rate of complications such as tissue erosion and urethral erosion in patients who had the ProteGen sling placed.

Many women implanted with the ProteGen sling are not aware of the potential complications because Boston Scientific only recalled unused slings. Women who have been implanted with a synthetic sling should visit their urologist to identify the type of sling used and discuss potential complications.

Silicosis

Silicosis is a respiratory disease of the lungs that develops directly out of prolonged and extensive exposure to airborne crystalline silica. This work-related disease can be disabling and, in certain cases, even fatal. Victims of silicosis typically work in jobs with high levels of silica-exposure, such as construction, sand blasting, and mining. Lungs will react to the silica by developing scarring around the silica which leads to difficulty breathing. The most common form of silicosis might not be detected for ten to 35 years after a worker's initial exposure. Some telltale signs of silica exposure are shortness of breath, fatigue, chest pain, severe cough, and flu-like symptoms.

St. Jude Heart Valve

People implanted with St. Jude mechanical heart valves with Silzone coated sewing cuffs ("silzone valves") may be at higher risk for paravalvular leak. For this reason, on January 21, 2000, St. Jude Medical Inc. instituted a recall of all silzone valves that had not yet been implanted into patients.

There is also a concern that persons implanted with silzone valves face higher risks of thrombus formation, thrombosis and stroke. A thrombus is a blood clot that can form upon the valve, affecting its operation or even rendering it inoperable. Thrombosis is a condition in which blood clots form and then move through the blood stream. These clots can ultimately cause a transient ischemic attack (TIA) or a stroke due to thromboembolism.

In November of 1999, The Medical Device Agency in London issued an Advice entitled "Thromboembolic Complications involving Silzoneļæ½ Mechanical Heart Valves." This bulletin reported a study in the United Kingdom of 51 patients implanted with silzone valves. Seven of these patients suffered a stroke. Upon reviewing the data, the Society of Cardiothoracic Surgeons of Great Britain and Ireland confirmed that there is a greater thromboembolic event rate associated with silzone valves compared to standard St. Jude mechanical heart valves. This data was presented at a recent meeting of the American Heart Association in Atlanta.

That data compared two groups of patients, 118 persons implanted with standard St. Jude valves and 75 patients implanted with silzone valves. The data showed that persons implanted with the silzone valves had much higher incidences of stroke and major embolism. The increase in incidence was greatest among patients implanted with either a mitral silzone valve or both a mitral and aortic silzone valve.

Sulzer Hip Implants

On 12/8/00, Sulzer Orthopaedics announced a recall of certain manufacturing lots of its inter-op hip shells. According to Sulzer, roughly 17,500 hip shells from the recalled lots have been implanted in patients. An acetabular shell is a hip implant part implanted into the upper part of the hip called the acetabulum. Usually, the bone would form an integrated bond with the shell. However, the recalled shells may have a trace of lubricant residue on the surface that was not completely removed when they were manufactured. The presence of this lubricant may prevent the bone from bonding with the shell, causing the shell to loosen, resulting in painful, physical symptoms.

Some of the symptoms include severe groin pain and inability to bear weight on the affected leg. Other symptoms may include severe pain in the inner thigh, pain in the buttocks, pain when rising from a seated position, and pain when standing and walking.

Patients who are experiencing any of these symptoms are encouraged to contact their physician. In order to determine if you have received a recalled hip shell, your surgeon can recover the specific lot number used in your hip replacement surgery from your medical records.

Thimerosal / Mercury Poisoning

Thimerosal is the most common preservative that is used in vaccines and biologics that are marketed in the United States. Thimerosal is used to help prevent a vaccine from spoiling, for inactivating bacteria used to formulate several vaccines, and in preventing bacterial contamination of the final product. Several of the vaccines recommended routinely for children in the United States contain thimerosal. However, reports have surfaced linking thimerosal to mercury poisoning in infants often causing autism.

On July 7, 1999, the American Academy of Pediatrics (AAP) issued with the US Public Health Service (USPHS) a joint statement alerting clinicians and the public of concern about thimerosal, a mercury-containing preservative used in some vaccines. The reason for the warning is that thimerosal contains a related mercury compound called ethyl mercury. Mercury is a toxic metal that can cause immune, sensory, neurological, motor, and behavioral dysfunctions.

The Food and Drug Administration suggested that some infants, depending on which vaccines they receive and the timing of those vaccines, may be exposed to levels of ethyl mercury that could build up to exceed one of the federal guidelines established for the intake of methyl mercury. Symptoms of mercury toxicity in young children are extremely similar to those of autism.

This can explain the recent increase in the numbers of children diagnosed with autism since the early 1990's. The numerous amount of children diagnosed with autism seems to directly correlate with the recommendation of both the hepatitis B and HIB vaccine to infants in the early 1990s. Autism is a neurological disorder that is characterized by impairments in language, cognitive and social development.

Autism symptoms are usually encountered in the first two years of life. In the past, autism was considered a rare disorder with an incidence of occurrence of approximately 1-3 per 10,000 births. More recently however, autism is being diagnosed much more frequently with an incidence of occurrence of 20-40 per 10,000 births and reports of 1 per 150 births have been reported in several states including New Jersey and California.

Welding Rod

A recent study from scientists at the Washington University School of Medicine in St. Louis, Missouri, has discovered data that relates Parkinson's disease to exposure to fumes from welding rods. Scientific studies have related Parkinson's disease to welding in the past through exposure to manganese in the welding rods and materials have sometimes referred to this welders' illness as manganese poisoning or manganism. The Washington University study states that the conditions experienced by welders are not two different illnesses, but are in fact both Parkinson's disease.

Both scientists and manufacturers of welding rods have known that there was a higher incidence of Parkinson's disease and asthma among welders and other individuals exposed to manganese and other dangerous elements contained in welding rods. The manufacturers, however, failed to adequately warn of these ill effects, and for years, have failed to instruct employers of welders on how they can keep their workers safe. It is likely that the average welder never knew the danger that lingered even after the job was done.


More Information

Asbestos
Thimerosal In Vaccines
Pesticide Information Profiles
Hip Replacement Patients May Face More Surgery
Silzone Coating Recall