Some over-the-counter (OTC) drugs can kill you. Ephedrine is one of those.  A natural central-nervous-system stimulant that is derived from the Chinese herb ma huang, or ephedra, ephedrine is sold in tablet form and in teas at nutrition and health food stores, convenience stores, gas stations, and rest stops across the United States.
     Ephedrine is variously marketed as a dietary supplement, an appetite suppressant, an herbal stimulant, a muscle builder, and an enhancer of sexual potency. It has been used by truck drivers to stay awake on the road, by high school and college students to lose weight and to keep alert while studying, and by athletes to boost energy and strength.
     The majority of users know little about the drug’s dangers. Consider the following examples from actual cases:
     • A 19-year-old college student begins to take an over-the-counter ephedrine product he bought as a stay-awake aid from the gas station where he works. After taking four caplets over a 24-hour period, he dies while pumping gas. The death, according to the autopsy, was caused by a massive heart attack triggered by ephedrine toxicity.
     • A 17-year-old high school football player suffers a fatal heart attack just before going to sleep one evening. According to the autopsy, the cause was ephedrine toxicity. His use of the produce never exceeded the recommended dosage.
     • A 16-year-old high school student begins using an ephedrine-based product as a diuretic. Shortly after taking the pills, she suffers severe heart palpitations and collapses during a school sporting event. She continues to require treatment for irregular heartbeat years after the incident.
     The Food and Drug Administration (FDA) reports at least 28 deaths in the last six years from ephedrine or ephedrine alkaloids.1   And since 1994, the agency has received and investigated more than 800 reports of adverse events ranging from periods of insomnia, episodes of hypertension, and irregularities in heart rate to seizures, strokes, heart attacks, and even death.2
     Emergency room admissions involving injuries from ephedrine and pseudo-ephedrine—a synthetically manufactured drug identical to ephedrine—have skyrocketed. Admissions for ephedrine abuse went from 57 in 1988 to 900 in 1992, and admissions for pseudo-ephedrine more than quadrupled during that period.3
     As deaths and injuries from ephedrine drugs continue to mount, plaintiff lawyers can expect to see more of these cases. This article provides some background on ephedrine and offers strategies for successfully litigating these cases.

Unregulated Use
     Before its introduction in the United States, ephedrine was used for years in China and Russia as a cough suppressant and an arthritis treatment. The drug was first introduced in its single-component form in the United States during the 1930s as an arthritis treatment.4  It was considered too toxic for clinical use, however, and was not wisely prescribed by physicians.
     In the 1940s, the drug began to be sold in both single-component form and in combination with other drugs for treatment of asthma. As the drug’s use as a bronchodilator increased, serious side effects became apparent. When ephedrine expands the breathing passages, it also constricts the blood vessels by releasing the vasoconstrictor norepinephrine from the sympathetic nerve endings. This vasoconstriction, with corresponding increase in arterial blood pressure, can lead to severe hypertension and heart attack or stroke.
     Because of these side effects, ephedrine has fallen into disfavor with pharmacists and doctors, who no longer sell or recommend it in its single-component form. Unfortunately, it has been enjoying renewed popularity as an easily obtained over-the-counter stimulant, and its sale has risen dramatically in the past 10 years.
     Indeed, domestic suppliers have flooded the market with a variety of products aimed at unsuspecting consumers. As a result of this, the rates of severe injury and death have increased, and so have the numbers of lawsuits and state legislative interventions.
     At least one class action has been certified against the maker and distributor of the herbal ephedrine product Ma Huang, manufactured by Ultimate Nutrition Products and sold by General Nutrition Stores.5   The plaintiffs allege circulatory and cardiovascular injuries resulting from ingestion of the product. The class representative—once an active, healthy police sergeant—allegedly suffered a debilitating stroke at age 29 as a result of using Ma Huang. The parties are awaiting the court’s determination of how notice to the potential class members will be handled.
     As of 1992, at least 14 states had imposed some restrictions on the distribution of ephedrine drugs.6  Unfortunately, they continue to be marketed in most states.
     The 1994 Dietary Supplement Health and Education Act, which amended the federal Food, Drug and Cosmetic Act (FDCA), significantly altered the FDA’s authority with regard to the regulation and labeling of dietary supplements.7
     Unfortunately for consumers, the new act broadly defines the term "dietary supplement" to mean any product intended to supplement the diet that contains one or more dietary ingredients.
     Dietary ingredients, which are defined to include herbs, are not subject to regulation as food additives. Thus, the burden of having a product removed from the market is on the FDA, which must prove the dietary supplement is unsafe before taking action to have it removed.
     This is quite different from the procedures that are employed for new drugs and medical devices, which must be proven safe before marketing. Indeed, a recent newspaper article notes that with the act’s passage, herbal products are essentially unregulated.8

Case Preparation
     In order to handle these cases effectively, it is important to understand how ephedrine works. It stimulates the body’s central nervous system and increases arterial blood pressure by peripheral vasoconstriction and cardiac stimulation, resulting in an increased heart rate and cardiac output.
     Other effects include stimulation of oxygen uptake, thermogenesis (heat or energy production), and relaxation of the bronchial smooth muscle.
     Stimulation of the adrenergic system—the system through which stimulants act on the body—also results in a decline in blood potassium levels, which may trigger cardiac dysrhythmia (abnormal heart rhythm), myocardial ischemia (inadequate circulation of blood and oxygen to the heart), and infarction (heart attack).
     Cardiomyopathy, or heart disease, has been reported with chronic ephedrine use, and it has been implicated in stroke secondary to intracranial and subarachnoid hemorrhage with inflammation of the blood vessels of the brain.
     Complicating the picture is that the drug’s half-life is believed to be anywhere from 6 to 10 hours. Cardiovascular effects of ephedrine are in many ways similar to epinephrine, but they last about 10 times as long.9   With repeated use over the course of a day or several days, the drug can build to toxic levels in the body.
     Even more troublesome is the impact of the long half-life when ephedrine products are combined with other stimulants. Combination with substances such as caffeine in coffee, chocolate, or OTC pain relief drugs such as Excedrin can further amplify the drug’s effects, as can its combination with "hidden" caffeine found in some teas sold in health food stores.
     A toxicologist and pharmacologist can help the attorney and, later, the jury, understand the chemical reactions involved and how they led to toxicity in the client even at what appeared to be a safe dose within recommended parameters.
     In addition to the drug’s toxicology and pharmacology, counsel must also understand the methods by which ephedrine is manufactured, marketed, labeled, and sold. A human factors expert can help explain the complex psychology of consumer marketing and what makes certain advertising deceptive, and a pharmaceutical sales expert can explain industry standards and trends regarding marketing, packaging, and selling of OTC pharmaceuticals.

Legal Theories
     From the start, it is important to identify all potential defendants, including the manufacturer, the wholesale distributor, and the retail seller. Discovery the distributor and retailer is relatively easy if counsel can get the container’s label.
     Alternatively, there may be a store in the vicinity that sells the product. As mentioned earlier, most convenience stores and truck stops sell ephedrine products, as do many companies that advertise in muscle-building and fitness magazines.
     The identify of a distributor or manufacturer not apparent on the label or packaging can be determined through other methods. For example, it is often helpful to talk with other attorneys who have handled similar cases across the country. These attorneys can be located through services such as the ATLA Exchange.
     If the manufacturer or retailer is known, it may be possible to learn the distributor’s identity from these defendants’ attorneys, because it is often in their clients’ best interests to have all parties involved in manufacture and distribution joined in the suit.
     Online research using MEDLINE and MEDLARS and inquiry with the FDA or other appropriate government agencies by way of a Freedom of Information Act request can also provide vital information about these corporate defendants.
     Common claims include strict liability; negligent design, testing or manufacture; breach of express or implied warranty; and misrepresentation for a misbranded or deceptively advertised drug.
     A claim involving heart attack or similar cardiovascular injury could allege negligence in the product’s design because concentrations of more than 20 milligrams per dose have been specifically addressed and deemed dangerous by the FDA.10
     Negligence, failure to warn, breach of warranty, and misrepresentation claims may be based on marketing and distribution practices. Touted as a "safe and natural" energy booster, a stimulant, an appetite suppressant, or a virility enhancer, the product can be challenged as not only failing to live up to these descriptions, but also as creating new and significant health hazards.
     Under case law interpreting the FDCA, a drug is deemed "safe" when its expected therapeutic benefit justifies the risk entailed by its use.11  Thus, the question is whether ephedrine’s significant risks justify its alleged therapeutic benefit.
     Counsel should also consider a failure to warn claim. Manufacturers, distributors, and sellers provide little or no information about the specific risks associated with ephedrine alone or in combination with other stimulants. Failure to warn claims should focus on the dearth of warnings as to any risk whatsoever, let alone specific risks such as heart attack and stroke.
     These claims speak not only to the presence or absence of warnings, but to the quality and substance of the warnings provided. In the face of pending litigation, many manufacturers and distributors have already made labeling changes, such as adding daily dosage limitations and recommending a physician consultation before using the product.
     Often, the names the distributor uses to sell its pills, such as "fast Track", "Fast Break" or "Pep Plus", denote something other than a bronchodilator. When developing a negligence or failure to warn case, counsel should compare the FDA labeling guidelines with the package warnings. Any discrepancy can trigger a claim for mislabeling under the guidelines.12
     State consumer protection statutes should also be reviewed. Frequently, they create an express cause of action by their terms or can be implied to create a private cause of action if the language does not expressly provide one.

Discovery
     Obtaining damaging financial information can be critical to ensuring success at an early stage. This is a billion dollar business, and distributors and retailers typically make the highest profits. Money, which is a prime motivator, fuels deceptive practices in marketing, promotion, and sales.
     In almost all cases, retailers such as convenience stores and truck stops have no understanding of what they are selling. They buy the product from a wholesale distributor for the sole purpose of obtaining a profit from sales to the general public.
     Document requests for state-by-state sales activity and gross profits from the wholesaler or retailer can often precipitate an early settlement if defendants fear that counsel will paint a picture of astronomical profits being made with little proof of product safety.
     In a recent case, the distributor testified to having resold the product to the retailer at a 200 percent markup over the cost of purchase from the manufacturer. This markup was almost pure profit because of the minimal cost of distribution.
     The retailer then made an average of 65 percent profit on its sales. It is believed that a hesitance to expose the tremendous profit margin played a significant role in securing a quick and fair settlement. (A confidentiality agreement precludes revealing case identification information.)
     Many distributors do not keep inventory records. However, sales invoices, which provide the same information, must be kept pursuant to FDA and Drug Enforcement Administration (DEA) regulations.
     In addition to seeking financial information, counsel should ask each distributor and manufacturer whether it has been investigated by the FDA or DEA. Under FDA regulations, manufacturers of OTC pharmaceuticals are required to have their plants inspected by FDA investigators. Documents generated by the local investigator should be obtained promptly. Simply because a plant has been inspected does not mean the manufacturer has acted properly in distributing the product.
     Counsel should send Freedom of Information Act requests to the FDA, DEA, and other government agencies to review their files for investigations conducted against any of the proposed manufacturers or distributors. It is also wise to check state attorneys general’s offices for this information. Transcripts of government hearings on ephedrine sales and from federal regulatory and criminal investigations can yield valuable information.
     Recent FDA hearings and investigation have proved most helpful in uncovering information damaging to ephedrine manufacturers and distributors. For example, an FDA press release outlining the bases for the agency’s proposal to increase restrictions on ephedrine-containing dietary supplements confirms that the agency considers these products associated with "hundreds" of consumer illnesses and injuries.13
     The FDA has proposed prohibiting the marketing of dietary supplements containing 8 milligrams or more of ephedrine per dose. In addition, the agency has recommended labeling that would caution consumers not to ingest more than 24 milligrams per day and has offered specific labeling requirements.14
     Although not determinative of the adequacy of earlier labeling, these findings add credibility to claims that ephedrine has inherent dangers of which consumers were not properly warned.

Defenses
     Causation will be a primary defense. Counsel should try to rule out other possible causes of the illness or injury. It is important to obtain the client’s medical history. If the client had significant health problems—particularly cardiovascular or cerebrovascular problems—counsel should expect a difficult road ahead. In death cases, an autopsy is essential.
     A common tactic of distributors and retailers is to try to shift the blame for warning label deficiencies to the manufacturer. To counter this tactic, counsel should argue that labeling is the distributor’s and retailer’s responsibility as well as the manufacturer’s. Indeed, it is almost always the distributor that names the product.
     The distributors and retailers will probably not have done any marketing analyses or surveys to determine target audiences. In fact, the standard verbiage of wholesale distributors is that they are selling the product for asthma users. Yet, they have no scientific evidence or information to identify the number of asthma sufferers either in their community or in the United States.
     Counsel should point out that the product is not sold at legitimate pharmacies or recognized by pulmonary specialists or internists for the treatment of asthma. Counsel should try to show that the distributors have not consulted with pharmacists, toxicologists, or other medically trainer personnel before recommending use of the product by those suffering from asthma or bronchial defects.
     Other possible defenses in these cases include preemption, lack of proof of purchase or ingestion, and contributory or comparative negligence.
     The recent marketing of ephedrine as a cheap, easily available pick-me-up has led to disastrous results for many. The physiological impact—especially for those who unknowingly use caffeine, nicotine, OTC pain relievers, or any vasoconstricting substance or those who are at risk of catastrophe with sudden elevation of arterial blood pressure or cardiac stimulation—cannot be minimized.
     Because the FDA is underfunded and under pressure not to require prescriptions for nonprescription drugs, plaintiff attorneys are likely to encounter ephedrine cases with increasing frequency. By understanding the way this drug works and what legal theories to pursue, counsel can succeed in these challenging cases.