Legal Claims Involving Accutane Related Birth Defects

In a legal claim against La Roche for side effects associated with Accutane, a plaintiff may have three theories of recovery available: negligence, strict liability in tort, and breach of implied warranty. In a strict liability action, as in a negligence action, the court analyzes the liability of a drug manufacturer in terms of duty ­ whether a duty to warn existed, the nature of that duty, whether the drug maker breached the duty, and whether the drug manufacturer's breach of duty caused the injury.

Regardless of the theory upon which a plaintiff relies, a drug manufacturer's liability for failure to warn of side effects associated with a prescription drug requires the plaintiff to prove: (1) that the drug manufacturer had a duty to warn either the medical profession or, under limited circumstances, the consumer, of side effects; (2) the standard of care the drug manufacturer was required to adhere to in fulfilling its duty to warn; (3) breach of the drug manufacturer's duty to warn by providing an inadequate warning; (4) injury suffered by the plaintiff attributable to the manufacturer's failure to warn; and (5) that the drug manufacturer's failure to warn was the proximate cause of the plaintiff's injury.

To establish that the drug manufacturer had a duty to warn of side effects, the plaintiff must prove that use of the prescription drug created a risk of injury and that the manufacturer had knowledge of the risk. In the case of Accutane, evidence appears to exist that both La Roche and the FDA were aware of the risks associated with the drug. Evidence also appears to exist that La Roche took steps to warn physicians of the dangers associated with La Roche.

Because of La Roche's steps to warn doctors and patients of the potential side effects and the FDA's continued approval of Accutane, a products liability claim may prove unsuccessful. If a jury finds that La Roche's warnings were sufficient, an injured plaintiff may still recover from a doctor or pharmacist who failed to take those warnings into consideration when prescribing and filling a prescription for Accutane. In general, a malpractice claim requires that the defendant-doctor failed to act as a reasonable doctor in that community would act in the same situation. In a case in which a doctor prescribes Accutane to a patient without requiring a pregnancy test or without providing the Pregnancy Prevention Program literature or suggesting contraception counseling, a plaintiff may have a viable claim.

In such a case, a patient whose child suffers birth defects, who suffers a miscarriage or stillbirth, or suffers a developmental disability could collect damages for medical expenses, pain and suffering, loss of wages, and mental anguish. If a child dies as a result of a problem pregnancy because of the negligence of the doctor in prescribing Accutane without the proper warning or precautions, the child's family could also sue for loss of consortium.

Conclusion

If you have taken Accutane and believe its use has resulted in birth defects, miscarriage, stillbirth, or developmental disabilities, contact a qualified attorney in order to ensure that your rights are protected. The law limits the amount of time that you have to file failure to warn and malpractice claims. A qualified attorney can help you to understand your rights and options, and ensure that you have the opportunity to seek compensation for your injuries.