## Facts

- Robert Rowe lived in Michigan and was prescribed Accutane (isotretinoin) by a Michigan physician in February 1997; the prescription was filled and used in Michigan for about three months.
- After discontinuing the drug, Rowe experienced depression and suicidal thoughts and, in September 1997, crashed a car into a house in an apparent suicide attempt; he later obtained psychiatric treatment in Michigan and Ohio.
- Rowe alleged Accutane caused severe depression and suicidality and that the manufacturers failed to provide adequate warnings, failed to test adequately, and failed to advise the FDA of known psychological risks.
- Hoffman-La Roche, Inc. and Roche Laboratories, Inc. were New Jersey pharmaceutical manufacturers; much of the product’s manufacturing, sales activity, and FDA communications occurred in or emanated from New Jersey.
- In 2001, Rowe filed a product-liability action in New Jersey state court.

## Issues

1. Whether Michigan or New Jersey law governed the adequacy-of-warning issue for a Michigan resident prescribed, dispensed, and injured in Michigan by an FDA-approved drug manufactured by New Jersey companies.
2. If Michigan law applied, whether Michigan’s statute making FDA-approved labeling a conclusive determination of adequacy barred Rowe’s failure-to-warn claims.

## Decision

- The New Jersey Supreme Court reversed the Appellate Division and reinstated summary judgment for defendants.
- The court held Michigan law applied to the failure-to-warn issue.
- Because Michigan treats FDA approval and compliant labeling as conclusively establishing adequacy, Rowe’s suit was barred.

## Legal Principles

- New Jersey applies a governmental-interest/most-significant-relationship approach: courts determine whether a true conflict exists and, if so, apply the law of the state whose policies would be most impaired if its law were not applied.
- A true conflict existed because Michigan treats FDA-approved labeling as conclusively adequate, while New Jersey treats FDA approval as creating only a rebuttable presumption of adequacy.
- A state has a strong interest in defining the scope of remedies available to its residents for injuries occurring within its borders, including legislative limits on products-liability claims involving prescription drugs.
- A forum state’s interests in regulating in-state manufacturers and deterring unsafe conduct may be insufficient to displace another state’s explicit remedial limitations where the plaintiff is a nonresident and the injury occurred in the other state.
- Comity and predictability support applying the injured resident’s home-state liability limits to prevent forum shopping that would circumvent that state’s legislative policy choices.

## Conclusion

The court applied Michigan law to a Michigan plaintiff’s Accutane failure-to-warn claims and held that Michigan’s FDA-compliance statute conclusively established warning adequacy, requiring dismissal of the action despite the defendants’ New Jersey ties.


Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 917 A.2d 767 (N.J. 2007)