Question:

At the bottom of the second page of Lance v. Wyeth, the court referred to its previous decision rejecting the application of design defect liability to pharmaceutical manufacturers. The court based this ruling on comment k to Section 402A of the Restatement of Torts (Second), which is quoted on the following page of the opinion. In 1997, the American Law Instituted published a new Restatement of Torts (Third), which states the following:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Although this provision does not absolutely preclude design defect liability for pharmaceutical manufacturers, it sets a very high standard that most plaintiffs will be unable to meet.

Do you think this standard is appropriate?

Consider the following alternative standard (which is not the law anywhere, but has been made up for purposes of this question):

A prescription drug or medical device is not reasonably safe due to defective design if the overall foreseeable risks of harm posed by the drug or medical device outweigh its overall foreseeable therapeutic benefits.

How would this standard differ from the standard in the Restatement of Torts (Third)? In your opinion, should the law be changed to reflect the alternative standard? Why or why not?