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The Challenge of Proving Causation in a Dangerous Drug Lawsuit

February 24, 2013

When a plaintiff is trying to prove that a particular drug is to blame for an illness or injury, there are two different things that must be established:

General Causation: The term refers to the fact that the drug in question is actually capable of causing the specific injury or illness.


Specific Causation: This is based on the drug being “what” actually caused the plaintiff's illness.

It is getting increasingly challenging to prove specific causation in defective drug lawsuits because many courts are excluding specific causation opinions as being unreliable. It is no longer safe to assume that if you have proved general causation that you will be able to create a specific causation issue that is going to stand up under scrutiny.

Many expert witnesses may rely on a concept referred to as “attributable risk,” which is the statistical analysis of epidemiological data as a foundation for testimony as to specific causation. The concept of “attributable risk” is based on the idea that if more than half of the specific illnesses or injuries in a population can be attributed to the drug at issue, then it is more likely than not that the drug contributed to the plaintiff's illness or injury. Some courts will accept specific causation that is inferred on this basis while others will not. Some courts reject application of the concept of attributable risk because it does not differentiate between those individuals whose injuries resulted from taking the drug and those whose injuries resulted from other factors.

Plaintiffs can still satisfy their burden of proof by providing experts whose testimony relies on a "differential diagnosis" to reach a conclusion that the defective drug in question caused the patient’s injuries. To arrive at a differential diagnosis, a doctor starts with all of the scientifically plausible causes of the plaintiff's injury. Then out of those causes, he continues to rule out the least remaining plausible cause of injury until he is left with the most plausible cause. The expert then concludes that the specific dangerous drug caused (or did not cause) the plaintiff's injury.

A plaintiff in a pharmaceutical products liability case must establish by admissible evidence that the drug in question more likely than not caused or contributed to his or her injury. Trying to prove that some commonplace injuries or diseases are caused by exposure to a particular dangerous drug is difficult in many cases because a lot of these injuries and illnesses can result from natural causes, such as age, high cholesterol, stress, genetic predisposition, or poor liver function.

The case of Daubert v. Merrell Dow Pharmaceuticals, Inc, in 1993, established the court standard for Federal Rule of Evidence, Rule 702. Under Daubert, Rule 702 provides general standards to assess the reliability and helpfulness of proffered expert testimony and requires the trial court to act as a "gatekeeper" for expert testimony to prevent "junk science from reaching a jury."

As gatekeepers, the court can consider:

  • whether the expert's testimony or theory can be or has been tested
  • whether the technique or theory has been subject to peer review
  • the rate of error involved
  • the existence and maintenance of standards of controls
  • whether or not the theory or technique is accepted within the scientific community

When causation is questionable, Daubert challenges to testimony by medical experts in product liability cases involving defective drugs are common. In 2009, there were many cases where specific causation testimony was excluded in dangerous drug cases under the Daubert standard. In cases involving scientific evidence, such as prescription drug cases, it is imperative that attorneys are familiar with scientific medical evidence, epidemiology and Daubert challenges.

Montlick and Associates understands the challenges and complexities involved in proving causation in dangerous drug cases. Our attorneys work closely with medical experts so that we can develop effective litigation strategies and persuasive scientific evidence that will meet the Daubert standard. If you or your loved one have suffered serious side effects from a dangerous or defective drug, the experienced product liability attorneys at Montlick and Associates will diligently pursue the best possible outcome in your dangerous drug case.

If you or someone you love has suffered serious side effects of pharmaceutical drugs, you should contact the experienced Georgia defective drug attorneys at Montlick and Associates for a free consultation to discuss your rights to compensation. Our attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Dalton, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. Call us today for your free consultation at 1-800-LAW-NEED (1-800-529-6333) or visit us on the web at where you can use our free case evaluation form or 24 Hour Live Online Chat. No matter where you are located we are just a phone call away, and we will even come to you.

Category: Personal Injury

Please Note:
Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.