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Defective Products and Product Liability Information
Serious Risk and Ongoing Exposure
Workplace exposure to asbestos remains a serious occupational health problem in the United States, with both vast numbers of workers at risk due to past occupational exposures and many other workers experiencing ongoing occupational exposures.
Deaths associated with asbestosis increased from fewer than 100 annually in 1968 to more than 1200 per year in 1998.
asbestosis a disease characterized by scarring of the alveolar regions of the lungs
lung cancer for which asbestos is one of the leading causes among nonsmokers, and which occurs at dramatically high rates among asbestos-exposed smokers
malignant mesothelioma a cancer of the tissue lining the chest or abdomen for which asbestos and similar fibers are the only known cause
nonmalignant pleural disease which can appear as a painful accumulation of bloody fluid surrounding the lungs, but which more commonly is seen as thick and sometimes constricting scarring of the tissue surrounding the lungs.
In addition, asbestos exposure is associated with excess mortality due to cancer of the larynx and cancer of the gastrointestinal tract. The malignant diseases the cancers including mesothelioma are often fatal within a year or a few years of initial diagnosis. In contrast, asbestosis deaths typically occur only after many years of suffering from impaired breathing.
Symptoms: Asbestosis (chronic exposure): dyspnea (breathing difficulty), interstitial fibrosis, restricted pulmonary function, finger clubbing; irritation eyes; [potential occupational carcinogen]
Baxter voluntarily recalled their dialyzers (Baxter recall notice) in mid-October after reports of deaths associated with its product in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the U.S. The U.S. deaths occurred at dialysis facilities in Austin, Tex., and Kearney, Neb. Most of the dialysis patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed.
Baycol (cerivastatin) Bayer Pharmaceutical Division (website)
Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund. Baycol, which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream.
Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.
Celebrex (website) and other NSAID medicines can cause stomach ulcers that bleed. The chance of this serious problem increases the longer you take Celebrex and with higher doses of Celebrex. Stomach bleeding can also happen suddenly while you take Celebrex. Stop taking Celebrex and call your healthcare provider right away if you get:
* a burning stomach pain
* black bowel movements that look like tar
* vomit that looks like blood or coffee grounds
The main ingredient of most herbal fen-phen products is ephedra, commonly known as Ma Huang. Ephedra is an amphetamine -like compound with potentially powerful stimulant effects on the nervous system and heart. FDA has received and investigated more than 800 reports of adverse events associated with the use of ephedrine alkaloid-containing products since 1994. These events ranged from episodes of high blood pressure, heart rate irregularities, insomnia, nervousness, tremors and headaches to seizures, heart attacks, strokes and death.
The Food and Drug Administration (website) is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as "ecstacy," because these products pose significant health risks to consumers. These products contain botanical, or so-called "natural," sources of ephedrine. Ephedrine is an amphetamine-like stimulant that can have potentially dangerous effects on the nervous system and heart.
Consumers who have been injured or suffered an adverse effect after taking a dietary supplement or any product containing an ephedrine alkaloid should call 1-800-FDA-4010. Health professionals who have treated patients suffering from an adverse event to these products are urged to report the event to the FDA's MedWatch adverse event and product problem hot line at 1-800-MEDWATCH.
On September 15, at the request of the Food and Drug Administration, Wyeth-Ayerst Laboratories and Interneuron Pharmaceuticals, which manufactured and marketed fenfluramine under the brand name Pondimin and dexfenfluramine under the brand name Redux, voluntarily withdrew these products from the market. The withdrawal was based on initial echocardiographic findings in five surveys indicating that approximately 30 percent of patients in these surveys who took these drugs had valvular abnormalities, even though most had no symptoms.
Anyone who has taken fenfluramine or dexfenfluramine for any period of time, either alone or with another drug or drugs, should see their doctor for a medical history and physical
examination to determine whether there are signs or symptoms of heart or lung disease.
Anyone who has taken these drugs for any period of time, either alone or with another drug or drugs, who has signs or symptoms of heart or lung disease, such as a new heart murmur or shortness of breath, should have an echocardiogram performed.
An echocardiogram should be strongly considered for any patient who has taken these drugs, either alone or with another drug or drugs -- regardless of whether they have signs and symptoms of the heart or lung diseases -- BEFORE having any invasive procedure for which the American Heart Association recommends antibiotic prophylactic treatment to prevent the development of bacterial endocarditis. This will provide an accurate determination of whether or not the person needs the antibiotic treatment.
Kava (Piper methysticum) is a plant indigenous to the islands in the South Pacific where it is commonly used to prepare a traditional beverage. Supplements containing the herbal ingredient kava are promoted for relaxation (e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal symptoms and other uses. FDA has not made a determination about the ability of kava dietary supplements to provide such benefits.
Liver-related risks associated with the use of kava have prompted regulatory agencies in other countries, including those in Germany, Switzerland, France, Canada, and the United Kingdom, to take action ranging from warning consumers about the potential risks of kava use to removing kava-containing products from the marketplace. Although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk.
FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury.
Meridia (sibutramine hydrochloride monohydrate) Abbott Laboratories (website)
Although Meridia has been implicated in the deaths of 29 users in 3 years from apparent cardiac complications, Abbott Laboratories has not voluntarily withdrawn Meridia from the market. Abbott Labs refutes these death claims.
The Food and Drug Administration (FDA) is taking steps to remove phenylpropanolamine (PPA) from all drug products and has requested that all drug companies discontinue marketing products containing PPA. In addition, FDA has issued a public health advisory concerning phenylpropanolamine. This drug is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products.
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) Wyeth (website)
Prempro is a medicine that contains two kinds of hormones: estrogens and a progestin. Adding progestin reduces the risk of endometrial cancer in a woman with a uterus. Because Premphase contains the same combination of hormones as Prempro, this document will only refer to Prempro.
Long-term risks of Prempro in postmenopausal women include increased risks of breast cancer and thromboembolic disease associated with estrogen and combination estrogen/progestin therapy, as well as increased risk of cardiovascular disease, including myocardial infarction and stroke, in healthy women. (more)
Propulsid (cisapride) Janssen Pharmaceutica (website)
FDA, May-June 2000:
The manufacturer of the prescription drug Propulsid (cisapride), Janssen Pharmaceutica Inc., Titusville, N.J., announced in March that it was voluntarily withdrawing the drug from the U.S. market. Propulsid is a prescription drug treatment for severe nighttime heartburn experienced by patients with gastroesophageal reflux disease (GERD) that does not adequately respond to other therapies.
Propulsid has been associated with a significant number of reports of heart rhythm abnormalities and several deaths. Most adverse events have occurred while patients were taking other medications or suffering from underlying conditions known to increase risk.
Patients currently taking Propulsid are urged to promptly contact their health care providers to discuss alternative treatments. Physicians who are treating patients with severely debilitating conditions are encouraged to contact Janssen at 1-800-JANSSEN.
Rezulin (troglitazone) Pfizer (Website)
The FDA asked the manufacturer of Rezulin (troglitazone), a drug used to treat type 2 diabetes mellitus, to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.
FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.
Serzone (nefazodone hydrochloride) (website) Bristol-Myers Squibb Company (website)
Cases of life-threatening hepatic failure have been reported in patients treated with Serzone.
The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 300,000 patient-years of SERZONE treatment. This represents a rate of about 3-4 times the estimated background rate of liver failure. This rate is an underestimate because of under reporting, and the true risk could be considerably greater than this.
If you get any of the following symptoms while taking Serzone, call your doctor right away because you may be developing a liver problem:
*Yellowing of the skin or whites of eyes (jaundice)
*Unusually dark urine
*Loss of appetite that lasts several days or longer
*Abdominal (lower stomach) pain
Sulzer Hip and Knee Products
Switzerland based Sulzer Medica (website) and Austin, TX based Sulzer Orthopedics (website), are now known as Centerpulse and Centerpulse Orthopedics, respectively.
CLEVELAND, OHIO.-- December 19, 2002 -- James J. McMonagle, Claims Administrator to the Sulzer Settlement Trust, announced today that the Trust is issuing payments totaling over $285,000,000 to approximately 5,500 claimants who have filed Claims arising from the implantation of certain hip and knee replacement joints manufactured by United States subsidiaries of Swiss medical device manufacturer, Sulzer (now Centerpulse).
Vioxx (rofecoxib) Merck & Co., Inc. (website)
Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away
Check with your health care provider. Vioxx may not be right for you,. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.
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