Drug Products Liability
Each year hundreds of new drugs enter the $60 billion per year prescription-drug industry promising to improve our lives. But every year, 200,000 Americans die and numerous more are injured as a result of false and misleading claims by pharmaceutical companies. Despite the series of clinical trials and tests conducted on prescription drugs to protect the public, many drugs are causing serious injuries. According to the General Accounting Office, 51 percent of FDA-approved drugs have major adverse effects that aren't detected until after the general public uses them.
Prescription drugs are regulated and approved by the Food and Drug Administration (FDA). Under current FDA regulations, new drugs are approved in half the time they were 15 years ago. This is because under the Food, Drug, and Cosmetic Act, the FDA can approve new drugs for marketing without long-term testing if it will benefit the public interest. 21 C.F.R. 310.303 (1997). Unfortunately, the current incidents of prescription drug injuries suggest that the public's best interests are not being served. In the last 4 years, the following widely used drugs are among those that have been recalled and banned by the FDA. In many instances, these drugs were recalled within a year due to deaths or serious adverse effects by users
Perscription Drug Reason for Recall / Ban Redux Withdrawn in 1997 for adverse side effects associated with producing heart and lung abnormalities including heart valve damage and primary pulmonary hypertension (high blood pressure). Redux was on the market for approximately 16 months and primarily used for weight loss control. Click here for more on Redux. Rezulin Withdrawn in 2000 for adverse effects associated with liver failure and deaths. The drug was on the market for 3 years, generating $1.8 billion dollars in revenue. Rezulin was primarily used as a diabetic drug to treat Type 2 diabetics. Click here for more on Rezulin. Duract Withdrawn in 1998 for harmful side effects related to liver failure. The drug was on the market for 12 months. Click here for more on Duract. Posicor Withdrawn in 1998 for harmful reactions with other drugs. The drug was on the market for 12 months. Posicor was used for treating hypertension. Click here for more on Posicor. Raxar Withdrawn in 1999 for adverse effects and deaths from heart related ailments. The drug was on the market for 24 months. Raxar was used as an antibiotic. Click here for more on Raxar. Fen-Phen Withdrawn in 1997 after the Mayo Clinic reported that 24 patients developed heart valve disease. In one reported study of five Fen-Phen users who underwent valve replacement surgery, the diseased valves were found to have distinctive features similar to those seen in carcinoid syndrome. Soon after, the New England Journal of Medicine article linked Fen-Phen usage to valve disease. Click here for more on Fen-Phen. Propulsid Withdrawn in 2000 for adverse effects associated with producing heart rhythm abnormalities. Propulsid was used for the treatment of severe heartburn and severe gastrointestinal reflux disease. Reflux diease is an abnormal concentration of stomach acid near the chest. Since 1993 Propulsid had been linked to 111 deaths and 270 instances of irregular heartbeat. The drug was on the market for 7 years. Click here for more on Propulsid. PPA PPA was found in dozens of over-the-counter remedies used to relieve nasal congestion and to treat symptoms of allergy and colds. It is also a common ingredient in weight loss products such as Acutrin and Dexatrim. In 2000 the FDA suggested that PPA poses a significant risk by increasing the odds of suffering hemorrhagic strokes (i.e. bleeding of the brain) by about 50 percent. This risk was even higher among young women and people using a PPA product for the first time. The study also indicated that the ingredient might cause strokes in people under 50 and could cause as many as 500 strokes per year. PPA is no longer sold without a prescription. Click here for more on PPA. Baycol Withdrawn in 2001 for adverse affects from patients who developed rhabdomyolysis. Baycol was used in the treatment of high cholesterol. The drug was on the market for four years. To date the FDA has received 31 reported deaths from Baycol users. Click here for more on Baycol. Pondimin Withdrawn in 1997 for adverse side effects associated with producing heart and lung abnormalities including heart valve and primary pulmonary hypertension. This drug was on the market for approximately 24 years. Pondimin was used as a weight control treatment. Click here for more on Pondimin.
A number of the drugs listed above were aggressively marketed by pharmaceutical companies, even when they knew their drugs could result in serious side effects or deaths. Because side effects for all medications are seriously underreported -- some experts estimate that at best one in 10 are actually reported to the FDA -- the real danger and number of injuries related to prescription drugs may be significantly higher.
Fortunately, the law provides you with rights. Under 402A of the Restatement (Second) of Torts, prescription drug manufacturers can be held strictly liable for selling products in a defective and unreasonably dangerous condition, even though they may have exercised the utmost care in the preparation and sale of their product. A product may be defective or unreasonably dangerous in several ways. One way is if the manufacturer failed to warn consumers of potential injury risks associated with the product. A product might also be defective or unreasonably dangerous if it was improperly designed (i.e. inappropriate chemical composition or dosage). Lastly, the product may also be defective if an error occurred during the manufacturing process. A prescription drug contains a manufacturing defect when it departs from its intended design even though it was carefully prepared and marketed. Manufacturer liability may also extend to what your physician tells you about the prescription drug.
In recent years, the billion dollar dietary supplement industry has fallen under increasing attack. The FDA regulates dietary supplements under a different set of regulations than prescription drugs. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), a dietary supplement manufacturer is responsible for making sure a dietary supplement is safe before it is marketed. Generally, manufacturers do not have to register or get approval from the FDA before producing or selling dietary supplements. All manufacturers have to do is to make sure that product label information is truthful and not misleading.
Although recent government regulations of dietary supplements have created some safeguards, that does not prevent dangerous supplements from entering the market. Dietary supplement manufacturers have already found themselves at the center of lawsuits. One of the first dietary supplements to cause a litigation stir was L-Tryptophan, a sleep and depression aid. After users of L-Tryptophan began reporting serious side-effects, media reports linked the drug to 37 deaths and between 1,500 and 10,000 illnesses from 1989 to 1990. Other herbal supplements and remedies have also fallen under fire as well.
- Germanium has been reported to cause fatal liver damage;
- Comfrey when used internally, may cause liver damage;
- Jin ba huan provoked life-threatening reactions in children;
- Kampuchea mushroom tea has killed at least one person who suffered from severe acidosis;
- Royal jelly has caused fatal asthma attacks in sensitive individuals
- Diet teas containing stimulants and laxatives have caused severe dehydration and death.
One of the more recent dietary supplements under increase scrutiny is ephedra. Cases of death and illness attributed to ephedra are on the rise. Some claim ephedra can cause conditions ranging from hypertension, palpitations, neuropathy and myopathy to psychosis, stroke, seizures and death. Currently, there are 13 pending lawsuits involving ephedra, including two that are seeking certification as class actions.
The growing popularity of dietary supplements in the United States will inevitably lead to increased litigation, especially in the wake of intense media coverage of cases alleging adverse effects and deaths. For more information on this topic click on Dietary Supplements .
Below is an additional list of common drugs and supplements that may have serious side-effects on users:
If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.