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Pharmaceutical Litigation

If an individual suffers ill effects from taking a legal drug, the drug's manufacturer may be held responsible. A defendant in pharmaceutical litigation may not only be held liable for an individual's losses, but an entire class of users-potentially thousands of individuals-may seek and be awarded damages. In addition, punitive damages, which can greatly exceed actual losses, are sometimes awarded in pharmaceutical cases. Accordingly, pharmaceutical litigation defendants must seek the most zealous and competent representation available in order to minimize their exposure and achieve the best possible outcome.

Whare Are Some General Pharmaceutical Cases?

Drugs and medicines are frequently at the center of lawsuits. Manufacturers have a duty to test the drugs and medicines they make before releasing them into the market. The Food and Drug Administration (FDA) has established criteria for the testing of pharmaceutical products before the products are licensed for human use. These criteria are regarded as industry standards, but the fact that a drug was licensed by the FDA is not conclusive on the issue of the manufacturer's liability to an injured plaintiff, should the drug prove otherwise to be defective.

A drug manufacturer has a duty to warn of a drug's side effects when such effects become apparent, but is not expected to warn of unknown dangers. Often the manufacturer discharges this duty to warn by providing the necessary information to the patient's prescribing physician or to the pharmacist. With almost all pharmaceutical products, except for over-the-counter drugs, there is a "learned intermediary" between the drug's manufacturer and the ultimate user. This can be the doctor who prescribes the drug, a nurse who instructs the patient, or the pharmacist who fills the prescription. Often the lines of liability are blurry, and an attorney can help determine who may be at fault for resulting injuries.

The drug manufacturer is considered an expert in its field, and as such it has a continuing duty to keep abreast of knowledge regarding its products and take all reasonable steps to update medical professionals on side effects. There is no duty to warn of possible reactions in unusually susceptible consumers, however, but just because a reaction is rare does not mean the manufacturer has no duty to warn about it or that the persons experiencing the reaction are unusually susceptible.

Some drugs are considered "unavoidably unsafe" products, which means that they cannot be made completely safe no matter how carefully they are manufactured. Such drugs may have potentially harmful side effects, but may be beneficial to the user nonetheless. If these drugs are properly prepared and accompanied by adequate warnings, they usually cannot form the basis of a successful lawsuit.

In some drug-related injury cases, the plaintiff will not be able to identify the precise manufacturer or supplier of the defective product because so much time has elapsed that the evidence is no longer available, such as in cases involving drugs ingested during pregnancy. In those cases, the damages may not become apparent until the later-born children are grown. The burden then shifts to the potential defendants to prove that they could not be responsible or to allocate the damages among a number of potentially liable manufacturers.

Plaintiffs who have claims for damages they suffered as a result of using pharmaceutical products must bring them within the applicable statutes of limitations or their suits will be barred. If their claims are timely and can be proven, however, the plaintiffs will be entitled to monetary damages to compensate them for their losses, and in some cases courts may even award punitive damages to punish a defendant whose conduct was particularly indifferent to the safety of users. On the other hand, defense lawyers can defend manufacturers against unsubstantiated claims and facilitate the quickest possible resolution of the matter.

What is Contraceptive Product Litigation?

Contraceptive products, like any other drug or medical device, can greatly enhance the quality of life, eliminate worry, and help life progress as planned. There can also, however, be risks associated with the use of certain contraceptive products-risks that can result in adverse consequences ranging from annoying to grave, and consequences that often require resolution in the courts.

In 1999, for instance, American Home Product Corporation, manufacturer of the Norplant contraceptive implant, agreed to settle claims brought by women who claimed to have suffered adverse consequences from the use of its product. According to the terms of the settlement, more than $50 million was allocated more than 36,000 women who testified that the contraceptive implant negatively affected their health.

Intrauterine devices have also been the subject of litigation, including class action lawsuits. The Dalkon Shield litigation arose from allegations that the intrauterine contraceptive device, introduced into the U.S. market in 1971 by A.H. Robins Co., caused pelvic inflammatory disease frequently resulting in infertility. More than 3.6 million of these IUDs were sold in the United States before the device was removed from the market in 1974 under government pressure. As a result of the flood of lawsuits against it, A.H. Robins sought bankruptcy protection from litigation in 1985.

Oral contraceptive makers, too, have seen their share of lawsuits. Users have sued pharmaceutical companies, arguing that they were not warned of the potential side effects from taking the pill. Attorneys representing the plaintiffs in these lawsuits have argued that the "third generation" pill caused users to develop blood clots that led to long-term damage to their health, and in about 10 percent of the cases proved fatal. The pharmaceutical companies have rejected suggestions that the third generation pill is slightly riskier than its predecessors.

Commentators have noted that while American women continue to demand new contraceptive options, pharmaceutical companies continue to drop out of contraceptive research and marketing, which prevents women from accessing the most current contraceptive methods available. In 1982, a government report predicted that 10 new contraceptives would soon reach the market. In reality, however, only three new methods were approved by the FDA in the anticipated time period: Norplant, Depo Provera, and the female condom. Critics point to one reason why manufacturers are so afraid to get into the contraceptive market: the fear of litigation.

What is Diet Drug Litigation?

Drug companies have been marketing diet pills in various forms for more than 25 years, and during that time have been bombarded with various diet-drug related lawsuits. In 1992, for instance, pharmaceutical companies marketed two diet pills called Fenfluramine ("Fen") and Phentermine ("Phen"), to be used in combination and therefore dubbed "Fen-Phen." Unfortunately, tens of thousands of Americans claim to have suffered serious injuries from taking these diet drugs and similar products. There is said to be evidence that some of the companies involved in marketing and selling Fen-Phen knew that these drugs were causing serious injuries, and that they deliberately concealed that information from the FDA. Although Fenfluramine and dexfenfluramine were removed from the market in September 1997, some commentators continue to maintain that the drugs did not cause the adverse health consequences for which they have been blamed.

The Fen-Phen combination is not the only diet drug or combination thereof to give rise to litigation. Meridia has also been the subject of recent lawsuits, and over-the-counter diet aids and herbal supplements have come under legal scrutiny after users claimed to have suffered ill consequences.

There have been many individual lawsuits seeking diet drug-related damages, and there have been class action lawsuits as well. Accordingly, the defense of these lawsuits requires experienced counsel with proven track records in products liability law, especially with regard to drugs and pharmaceuticals, and possibly class action litigation. Only with experienced defense counsel can litigation result in the best possible outcome for all concerned.


Pharmaceutical litigation is serious business. When a drug manufacturer becomes the subject of allegations of negligence, strict liability, or failure to warn, the first step should be to seek experienced legal counsel. A seasoned pharmaceutical defense attorney can advise a defendant on whether a claim is valid, discuss available defenses, and provide ardent representation throughout the litigation process in order to minimize damages if the defendant is found liable. Perhaps more importantly, however, a good attorney can work proactively with pharmaceutical companies and advise them on the best course of conduct to avoid litigation in the first place.

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Donald Briggs C. Donald Briggs, III Feb. 7, 1954 - Sept. 7, 2014 Your dedication and hard work continue...