## Facts

- Rosalyn Retkwa (plaintiff) sued Norman Orentreich, M.D., and Orentreich Medical Group, P.C. (defendants) for medical malpractice and lack of informed consent arising from facial injections of liquid silicone.
- In 1983, defendants injected liquid silicone into Retkwa’s face on three occasions using a “microdroplet” technique as part of cosmetic/dermatologic treatment.
- Defendants obtained nonmedical-grade “base” silicone that was shipped to New York from Dow Chemical in Delaware.
- After receipt in New York, defendants (through their staff) compounded the base silicone into an injectable form used in Retkwa’s treatment.
- In the malpractice proceeding, defendants did not dispute that the compounded microdroplet silicone was a class III “device” without required FDA premarket approval and therefore “adulterated” under the Federal Food, Drug, and Cosmetic Act (FDCA).
- Under New York’s then-applicable medical malpractice panel procedure, a panel unanimously found defendants liable, including on the ground that the silicone injections involved a violation of the FDCA.
- Before trial, defendants moved in Supreme Court, New York County, to vacate the panel’s FDCA-based finding.
- Defendants argued (1) the FDCA’s interstate-commerce element was missing because the base silicone was not adulterated when shipped interstate and only became an adulterated device after in-state compounding, and (2) the FDCA was not meant to interfere with a physician’s medical use of a product, approved or not.

## Issues

1. Whether the FDCA’s interstate-commerce requirement is satisfied when a physician receives base silicone shipped from another state and later compounds it in New York into an adulterated class III device that is then used in treatment.
2. Whether the FDCA’s noninterference with medical practice bars applying the FDCA to a physician who compounds and uses an unapproved, adulterated device.
3. Whether the medical malpractice panel’s reliance on an FDCA violation as part of its liability finding was legally improper such that the finding should be vacated.

## Decision

- The court denied defendants’ motion to vacate the medical malpractice panel’s FDCA-based finding.
- The court held that the interstate-commerce nexus required by the FDCA was met because the base silicone was shipped into New York and the resulting device was held for use in defendants’ practice after that interstate shipment, even if the product became “adulterated” after further processing in New York.
- The court rejected the argument that the FDCA’s respect for medical practice insulated defendants’ conduct, concluding that a physician is not exempt from FDCA limits when the physician effectively compounds/manufactures an unapproved and adulterated device for use on patients.
- Because the FDCA could apply on these facts, the panel was not barred from treating FDCA noncompliance as part of its malpractice determination.

## Legal Principles

- A compounded injectable substance intended to affect the structure or function of the body may qualify as a “device” under the FDCA.
- For FDCA jurisdiction, it can be enough that a component or base material was shipped in interstate commerce and the finished device is held for use or distribution after that shipment; the interstate element is not defeated solely because the adulteration occurs after in-state processing.
- A class III device lacking required FDA premarket approval may be treated as “adulterated” under the FDCA.
- The FDCA’s general nonregulation of clinical judgment does not give physicians a carve-out to compound or use an unapproved, adulterated device outside the statute’s restrictions.
- In a state medical-malpractice proceeding, statutory violations directed at patient safety may be considered as evidence supporting a finding that the physician departed from accepted standards of care.

## Conclusion

Retkwa v. Orentreich upheld a medical malpractice panel’s unanimous liability finding against a physician who compounded nonmedical-grade silicone shipped from out of state into an injectable microdroplet product lacking FDA premarket approval. The court ruled that the FDCA’s interstate-commerce requirement was satisfied despite the in-state compounding step, and that a physician’s status and treatment decisions did not exempt the creation and use of an adulterated, unapproved device from FDCA-based scrutiny in the malpractice panel’s assessment.


Retkwa v. Orentreich, 579 N.Y.S.2d 577 (1991)