## Facts

- Kathy D. Tobin, a Kentucky resident, received ritodrine hydrochloride (a beta-agonist tocolytic) during a twin pregnancy to treat preterm labor.
- Tobin had a preexisting heart condition described as mitral valve prolapse/heart murmur but was otherwise healthy before the drug therapy.
- During ritodrine treatment, Tobin developed serious cardiopulmonary symptoms, including rapid breathing, shortness of breath, and an abnormal heart rhythm.
- After delivery, Tobin developed congestive heart failure and ultimately required a heart transplant.
- Tobin sued the U.S. distributor (Astra Pharmaceutical Products, Inc.) and the foreign manufacturer (Duphar B.V.) under Kentucky products-liability law, alleging:
  - a risk-utility design defect (the drug’s risks outweighed any demonstrated neonatal benefit), and
  - failure to warn prescribing physicians about serious cardiac risks, particularly for patients with cardiac conditions.
- The federal district court dismissed Duphar for lack of personal jurisdiction, tried the case against Astra, and a jury returned a verdict for Tobin on both theories for nearly $4.5 million; the court denied Astra’s post-trial motions.

## Issues

1. Whether the evidence, including plaintiff’s expert causation testimony, was sufficient to support the verdict and withstand judgment as a matter of law.
2. Whether Kentucky law permits design-defect (risk-utility) and failure-to-warn liability for an FDA-approved prescription drug.
3. Whether the district court abused its discretion by denying a new trial based on alleged expert-disclosure problems and asserted weight-of-the-evidence concerns.
4. Whether Kentucky could exercise personal jurisdiction over a foreign manufacturer that used a national distributor to sell the product throughout the United States.

## Decision

- The court affirmed the denial of judgment as a matter of law and the denial of a new trial for Astra.
- The court held that plaintiff’s expert evidence on causation was admissible and provided a sufficient basis for the jury’s finding that ritodrine caused or contributed to Tobin’s heart failure.
- The court held that Kentucky law allowed both a risk-utility design-defect theory and a failure-to-warn theory for a prescription drug; FDA approval was relevant but not dispositive.
- The court found no abuse of discretion in the trial court’s handling of alleged expert-disclosure issues and concluded the verdict was supported by substantial evidence.
- On Tobin’s cross-appeal, the court reversed the dismissal of Duphar and held Kentucky could exercise personal jurisdiction because Duphar purposefully availed itself of the U.S. and Kentucky markets through nationwide distribution.

## Legal Principles

- Expert medical causation testimony may support a verdict if grounded in recognized scientific and medical knowledge and tied to the patient’s clinical course; unanimity in the scientific community is not required.
- Under Kentucky products-liability law, a prescription drug may be found defectively designed under a risk-utility approach if a reasonable manufacturer, fully aware of the risks, would not have marketed the product.
- FDA approval does not preclude state-law design-defect or failure-to-warn liability; it is evidence for the jury to weigh, not a complete defense.
- A prescription-drug manufacturer or distributor must provide adequate warnings to prescribing physicians about clinically significant risks; inadequate warnings may support liability if they were a substantial factor in causing injury.
- A trial court has broad discretion in managing discovery disputes and deciding whether asserted disclosure shortcomings justify a new trial.
- A foreign manufacturer that uses a national distributor to place products into the U.S. market can be subject to specific jurisdiction in a state where injury occurs when its conduct shows purposeful availment and the forum consequences are foreseeable.

## Conclusion

The Sixth Circuit sustained a jury verdict holding a prescription-drug distributor liable for design defect and failure to warn, rejecting arguments that FDA approval or asserted limits on expert causation evidence barred recovery, and it revived claims against the foreign manufacturer by finding purposeful availment through nationwide distribution sufficient for Kentucky jurisdiction.


Tobin v. Astra Pharm. Prods., Inc., 993 F.2d 528 (6th Cir. 1993)