Please ensure Javascript is enabled for purposes of website accessibility

09-1273 Astra USA, Inc., v. Santa Clara County

By: WISCONSIN LAW JOURNAL STAFF//March 29, 2011//

09-1273 Astra USA, Inc., v. Santa Clara County

By: WISCONSIN LAW JOURNAL STAFF//March 29, 2011//

Listen to this article

United States Supreme Court

Public Health

Drug price ceilings

Suits by health care facilities to enforce ceiling-price contracts running between drug manufacturers and the Secretary of Health and Human Services are barred.

As the County has conceded, covered entities have no right of action under §340B itself. Congress vested authority to oversee compliance with the 340B Program in HHS and assigned no auxiliary enforcement role to covered entities. Nonetheless, the County maintains that the PPAs are contracts enforceable by covered entities as third-party beneficiaries. This argument overlooks that the PPAs simply incorporate statutory obligations and record the manufacturers’ agreement to abide by them. The agreements have no negotiable terms. Like the Medicaid Rebate Program agreements, the PPAs provide the means by which drug manufacturers opt into the statutory scheme. A third-party suit to enforce an HHS-drug manufacturer agreement, therefore, is in essence a suit to enforce the statute itself. Telling in this regard, the County based its suit on allegations that the manufacturers charged more than the §340B ceiling price, not that they violated an independent substantive obligation arising from the PPAs.

588 F. 3d 1237, reversed.

09-1273 Astra USA, Inc., v. Santa Clara County

Ginsburg, J.

Polls

Should Steven Avery be granted a new evidentiary hearing?

View Results

Loading ... Loading ...

Legal News

See All Legal News

WLJ People

Sea all WLJ People

Opinion Digests