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Embracing risk factors in pharmaceutical litigation: plaintiff lawyers tend to be reluctant to take on a drug injury case unless the client has few or no risk factors for the injury alleged. But attorneys who take the road less traveled may discover it's the quickest path to success.

Article Excerpt
I never realized that there was a similarity between being a successful professional golfer and being a successful trial lawyer until I heard former professional golfer David Feherty say these words: "Successful people want to place themselves in a spot where they are uncomfortable." It is easy for either professional to become complacent and seek to operate solely within a "comfort zone." The young golfer to whom Feherty was referring had never won a golf tournament before, and judging by the way his knees quivered as he stood over a short putt to win the tournament, he was definitely in an uncomfortable place.

Lawyers representing plaintiffs in pharmaceutical products cases could take a lesson from that young golfer. The strategy among attorneys representing individuals injured by unreasonably dangerous drugs has typically been to seek out and litigate only the "clean cases"--those in which the injured person has few or no underlying risk factors such as diabetes, hypertension, hypercholesterolemia, and a history of smoking.

To be truly successful in the representation of our clients, we must embrace these seemingly uncomfortable cases and handle them professionally and competently. Not doing this constitutes a tragic disservice to the multitude of individuals who have been seriously wronged.

Many of the trials involving Cox-2 inhibitors that resulted in successful plaintiff verdicts have strategically incorporated the injured party's known risk factors into the case presentation. (1) The tactics used in these cases may be useful in other pharmaceutical cases.

Relative risk

General causation tends to be the linchpin of a pharmaceutical company's defense of a claim alleging that a drug was defective or unreasonably dangerous. In the Cox-2 litigation, however, a plethora of clinical, epidemiological, and animal studies have helped shift the focus in individual cases to specific causation.

Jurors in these cases have a conceptual causation hurdle to overcome because no specific "signature injury" is associated with Cox-2 inhibitor use. A plaintiff attorney must convince jurors that even in the absence of a signature injury, the drug was the cause of, or at least a substantial contributing factor to, the plaintiff's injury.

This may seem onerous considering that Cox-2 inhibitors have typically been prescribed for the treatment of osteoarthritis and rheumatoid arthritis and are mainly used by the elderly, a population exhibiting risk factors for injuries attributed to Cox-2 inhibitor use: heart attacks and strokes. These cardiovascular problems--often a result of atherosclerosis--are among the most common injuries and causes of death within the elderly population in this country. (2)

The pharmaceutical companies' primary defense in this litigation has been that, since 300,000 to 400,000 people die of heart attacks each year in the United States alone, no one can prove that a Cox-2 inhibitor caused or contributed to any one person's heart attack or stroke. (3)

Not surprisingly, the cases have been a prime breeding ground for Daubert motions. (4) The key to slaying the Daubert beast and proving specific causation lies within the field of epidemiology and the Cox-2 inhibitor clinical trials conducted by...