Frequently Asked Questions About Product liability Regarding Lotronex
US, Canada and Puerto Rico
What is product liability?
What is Lotronex?
What is IBS?
When and Why was Lotronex withdrawn from the market?
What are some of the early signs of the adverse effects associated with the use of Lotronex?
What are some of the other side effects associated with Lotronex?
Do Lotronex users have a right to be compensated for any health problems caused by Lotronex?
What should I do if I am currently taking Lotronex?
Will Lotronex be recalled from the pharmacy?
What is a “failure to warn” claim?
What kind of claims can be brought for product liability?
What is strict liability?
What is negligence?
What is breach of warranty?
What damages does the law allow in product liability cases?
What are economic damages?
What are noneconomic damages?
What are punitive damages, and may they be recovered in product liability cases?
If I bring my case to you, what will you do?
How do I know that you will do a good job on my case?
What are your fees?
Q. What is product liability?
A. Product liability is the body of law that provides for compensation for physical injuries resulting from defective and unreasonably dangerous products and from the failure of a manufacturer or seller to warn the consumer of product dangers.
Q. What is Lotronex?
A. Lotronex is a prescription medicine used to treat women with irritable bowel syndrome (IBS) who have diarrhea as their main symptom (diarrhea-predominant IBS). Lotronex has not been shown to help men with IBS.
Q. What is IBS?
A. IBS is also called irritable colon and spastic colon. IBS causes lower abdominal pain and discomfort, urgency (a sudden need to have a bowel movement), and irregular bowel habits, such as diarrhea or constipation. In some people IBS causes mostly constipation; in others mostly diarrhea; some people have alternating periods of diarrhea and constipation. Lotronex was approved only for women with diarrhea-predominant IBS. Lotronex should not have been used by women who have constipation as their main IBS symptom. IBS is a symptomatic disease that can cause significant discomfort but which does not result in complications that need bowel surgery (an operation).
Q. When and Why was Lotronex withdrawn from the market?
A. On November 28, 2000, Glaxo Welcome, the manufacturer of Lotronex (alosetron) tablets-a drug used to treat irritable bowel syndrome in women-withdrew Lotronex from the market. This action was taken because the drug had been associated with reports of serious side effects such as intestinal damage as a result of reduced blood flow to the intestine (ischemic colitis), severely obstructed or ruptured bowels (complications of severe constipation), and death. As of November 10, 2000, the FDA had reviewed a total of 70 cases of serious adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of these 70 cases, 34 resulted in hospitalizations without surgery, 10 resulted in surgical procedures (some of which involved the removal of parts of patients' intestines), and three resulted in death.
Q. What are some of the early signs of the adverse effects associated with the use of Lotronex?
A. One of the possible serious side effects of Lotronex is severe constipation, which may be serious enough to completely block movement of stools through the intestines. Another is development of ischemic colitis, a serious condition caused by reduced blood flow to the intestines. Early signs of this condition include new or worsening abdominal (lower stomach area) pain, bloody diarrhea or blood in your bowel movements. Either of these side effects could lead to hospitalization and possibly surgery.
Q. What are some of the other side effects associated with Lotronex?
A. Some of the other reported side effects include: hypertension, gastrointestinal or abdominal discomfort and pain, gastrointestinal gaseous symptoms, viral gastrointestinal infections, heartburn, nausea and vomiting, abdominal distension (bloating) and hemorrhoids.
Q. Do Lotronex users have a right to be compensated for any health problems caused by Lotronex?
A. If Lotronex has caused you or a loved one significant physical damage, you may be entitled to a large compensatory award. You must protect those legal rights before they lapse by passage of time and are barred by various states' statutes of limitations. You should contact us to evaluate your rights. Many valuable legal rights are lost everyday because of peoples' failure to take legal precautions. Call us now at 1-800-DRUG LINE to protect your rights. Or E-Mail us for more information.
Q. What should I do if I am currently taking Lotronex?
A. We encourage those people who have taken Lotronex to contact their doctor and discuss the appropriate follow-up, and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your doctor based on an assessment of your specific treatment needs, specific risk profile, and other factors. We are not health care professionals and cannot comment on, or recommend a course of treatment for any individual.
Q. Will Lotronex be recalled from the pharmacy?
A. The FDA has not yet recalled Lotronex. However, the company has indicated that they are planning to recall the product from pharmacies.
Q. What is a “failure to warn” claim?
A. Failure to warn is the claim that a manufacturer failed to provide directions for the safe use of a product.
Q. What kind of claims can be brought for product liability?
A. The alternative theories of liability in a product liability case are (1) strict liability; (2) negligence and (3) breach of warranty. Sometimes all three theories are pursued in one case.
Q. What is strict liability?
A. Strict liability is the legal principle that a person or company which sells a product in a “defective condition” that is unreasonably dangerous to the ordinary user may be liable for any physical injuries. The defect may be in the product’s design or manufacturing, in the product’s container or packaging, or in the instructions or warning necessary for the product’s safe use. In a strict liability case, the injured person is not required to prove the manufacturer or seller was negligent.
Q. What is negligence?
A. Negligence is a breach of a duty owed by the manufacturer to the user in light of the reasonably anticipated harm arising from all reasonably foreseeable uses of the product. The duty includes design, manufacturing, instructing and warning. In a negligence case the injured party must prove a violation of a standard of reasonable care by the manufacturer in the manufacture of the product.
Q. What is breach of warranty?
A. A warranty is an expressed or implied representation about the product to the consumer. Common warranties are that the product is fit for the ordinary purpose for which it is used or that the product is fit for a particular specific purpose. Breach of warranty generally means that the product did not perform as represented or expected.
Q. What damages does the law allow in product liability cases?
A. Generally, the plaintiff is to be reasonably compensated for all injuries and losses resulting from the occurrence in question. Damages are split into two general categories: economic (past and future), and noneconomic (past and future).
Q. What are economic damages?
A. Economic damages include almost everything that can be replaced with a checkbook. This category of damages is very broad and will vary from case to case. Economic damages can include the reasonable expenses of necessary medical care; hospitalization and treatment; loss of income or earning capacity; the reasonable value of services provided by family members for free; the cost of hiring others to perform normal household duties; and the loss of the injured person's services to his or her spouse. These losses are projected into the future based, among other factors, on medical testimony regarding continuing disability and future needs.
Q. What are noneconomic damages?
A. Noneconomic damages are those losses which cannot be quantified in a dollar amount. The most prominent examples are pain and suffering, mental anguish, inconvenience, physical impairment or disability, disfigurement, and loss of enjoyment of life. The importance of categorizing damages as economic or noneconomic lies in the fact that noneconomic damages are sometimes limited under some state laws. We often see cases where people's lives are devastated by catastrophic injuries, but if they are children or elderly, economic losses are limited and the capped amount of noneconomic damages is unfairly inadequate.
Q. What are punitive damages, and may they be recovered in product liability cases?
A. Punitive damages are not based upon the severity of the injury to the plaintiff, but rather upon the need to punish the defendant and deter others from engaging in like conduct. Before punitive damages may be awarded, the plaintiff must prove that the defendant acted in a “wanton or intentional” way, which includes the “reckless disregard” of a known danger to the plaintiff’s health and safety. This must be proven by clear and convincing evidence. Punitive damages are extremely rare, but available in appropriate circumstances.
Q. If I bring my case to you, what will you do and how much will it cost?
A. First of all, we will not charge you for any of the time we spend visiting with you or for the cost of investigating your case. We start with an interview to determine the facts as you know them, and make a judgment about whether the case is one which falls within our expertise and interests. The ensuing investigation begins with the collection of all pertinent records, including accident reports, product literature, company brochures, and medical records. We ask you to sign releases authorizing us to obtain these records. We then review and analyze the records. If we believe there is a strong possibility that a product was defective, we will submit it to the appropriate experts for review, asking them for their opinions on the issues of the defective nature of the product, damages and causation. If, after consultation with experts, we believe that we can satisfy our burden of proof, we recommend that the case be filed.
Q. How do I know that you will do a good job on my case?
A. We believe that our experience and results in product liability cases count. We have a commitment to getting an excellent result in every case we decide to pursue, and our track record and credibility are extremely important to us. Please keep in mind, however, that every case is different and no result is guaranteed. All we can promise is our best effort on each and every case.
Q. What are your fees?
A. Balkin & Eisbrouch handle all cases on what is called a contingency fee. This means that no fees or costs are charged unless we collect money damages for you. We advance all costs for investigators, court reporters, expert witness testimony, accident reconstructionists, filing fees and any other expenses related to your case. All of the consultations with our office are absolutely free. When you receive compensation, meaning we have successfully concluded your case, either by settlement or litigation, our fees are a percentage of the gross settlement. This percentage is agreed upon before we begin work on your case and is generally between 20% and 40%. The percentage depends on the complexity and type of case.
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