Frequently Asked Questions About Product Liability Regarding Phenylpropanolamine
US, Canada and Puerto Rico
What is product liability?
What is Phenylpropanolamine (PPA)?
Why is Phenylpropanolamine unsafe when this product has been in use for many years?
Are there any population groups at higher risk when using products containing phenylpropanolamine?
What types of products contain phenylpropanolamine?
How will I know if my OTC products contain phenylpropanolamine?
How will I know if my prescription nasal decongestant or cough/cold products contains phenylpropanolamine?
What should I do if I am currently taking a product that contains PPA?
How do I recognize a stroke when it occurs?
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 Phenylpropanolamine?
A. Phenylpropanolamine (PPA) is an ingredient used in prescription and over-the-counter (OTC) drug products as a nasal decongestant to relieve stuffy nose or sinus congestion and in OTC weight control drug products to control appetite.
Q. Why is Phenylpropanolamine unsafe when this product has bee in use for many years?
A. On May 11, 2000, FDA received results of a study conducted by scientists at Yale University School of Medicine that showed an increased risk of hemorrhagic stroke (bleeding of the brain) in people who were taking phenylpropanolamine. PPA has been used for many years and some people taking the drug have had strokes. The Yale study helped show that the number of people having strokes when taking PPA was greater than the number of people having strokes who were not taking PPA. The FDA has significant concerns because of the seriousness of a stroke and the inability to predict who is at risk. Because of continued reports to the FDA of hemorrhagic stroke associated with PPA and the results of the Yale study, they now feel that the risks of using PPA outweigh the benefits and recommend that consumers no longer use products containing PPA.
Q. Are there any population groups at higher risk when using products containing phenylpropanolamine?
A. The Yale University study showed that the risk of hemorrhagic stroke was found mostly in women; however, men may also be at risk.
Q. What types of products contain phenylpropanolamine?
A. Phenylpropanolamine is found in some prescription and OTC nasal decongestants and cough/cold products and OTC products for weight control.
Q. How will I know if my OTC products contain phenylpropanolamine?
A. OTC drug products containing this ingredient may be identified by looking for "phenylpropanolamine" in the list of active ingredients on the label. If you are still unsure, check with your pharmacist to help you determine if a product contains phenylpropanolamine.
Click here for a complete list of products: prescription and OTC..
Q. How will I know if my prescription nasal decongestant or cough/cold products contains phenylpropanolamine?
A. If you are using a prescription nasal decongestant or cough/cold product you should talk to your pharmacist or health care provider to determine if phenylpropanolamine is present.
Q. What should I do if I am currently taking a product that contains PPA?
A. We encourage those people currently taking a product containing PPA to contact their doctor or pharmacist and discuss alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your doctor or pharmacist. We are not health care professionals and cannot comment on, or recommend a course of treatment for any individual.
Q. How do I recognize a stroke when it occurs?
A. Symptoms of stroke include:
- Weakness or inability to move a body part
- Numbness or loss of sensation
- Tingling or other abnormal sensations
- Decreased or lost vision (possibly partial or temporary)
- Different sized pupils
- Drooping eyelid
- Language difficulties (slurred speech)
- Inability to recognize or identify sensory stimuli
- Loss of memory
- Vertigo
- Dizziness
- Loss of Coordination
- Swallowing difficulties
- Personality changes
- Mood/emotion changes
- Lack of control over bladder/bowels
- Consciousness changes
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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