Internet Pharmacies and Shipper Liability

INTERNET DRUG SALES AND SHIPPER LIABILITY

United Parcel Service “NonProsecution Agreement”

Does a shipper such as FedX or United Parcel Service, INC. (UPS) have a legal duty to refuse to ship drug products to United States customers who obtain controlled substances and prescription drugs without a prescription from “Internet Pharmacies”? UPS agreed in 2013 to a “Nonprosecution Agreement” with the United States Department of Justice in which the company agreed to forfeit $40 million in payments it received from illicit online pharmacies. UPS agreed to institute a compliance program to assure that illegal online pharmacies will not be able to use UPS for shipment. For example, an online pharmacy compliance officer position is responsible to implement, monitor and provide regular reports to UPS’s chief executive officer. According to FDA and the Department of Justice, UPS was on notice since 2004 that Internet pharmacies were illegally shipping prescription through common carriers such as UPS. Yet, despite a compliance program instituted in 2004, it was deemed ineffective. See: UPS Agrees To Forfeit $40 Million In Payments From Illicit Online Pharmacies For Shipping Service

FedEx Corporation Indictment

More recently, FedEx Corporation was charged See: United States v. FedEx Corp., N.D. Cal., No. 14-cr-00380, indictment 7/17/14) /See: FDA FedEx Indictment. The grand jury issued a 15 count indictment . If there is a conviction FedEx  could face fines, penalties, forfeiture. Most likely, there would be mandatory compliance parameters as well. See also: FDA News Release.

 

 

 

Wheaton College v. Burwell —A Follow-up to Hobby Lobby

WHEATON COLLEGE V. BURWELL

The United States Supreme Court issued an Order on July 3, 2014 shortly after the Hobby Lobby decision concerning the pending case of Wheaton College v. Burwell.

The Order in part provides:  “If the applicant informs the Secretary of Health and Human Services in writing that it is a non- profit organization that holds itself out as religious and has religious objections to providing coverage for contraceptive services, the respondents are enjoined from enforcing against the applicant the challenged provisions of the Patient Protection and Affordable Care Act and related regulations pending final disposition of appellate review. To meet the condition for injunction pending appeal, the applicant need not use the form prescribed by the Government, EBSA Form 700, and need not send copies to health insurance issuers or third-party administrators.

The Circuit Courts have divided on whether to enjoin the requirement that religious nonprofit organizations use EBSA Form 700. Such division is a traditional ground for certiorari. See S. Ct. Rule 10(a).

Nothing in this interim order affects the ability of the applicant’s employees and students to obtain, without cost, the full range of FDA approved contraceptives. The Gov- ernment contends that the applicant’s health insurance issuer and third-party administrator are required by federal law to provide full contraceptive coverage regard- less whether the applicant completes EBSA Form 700.

The applicant contends, by contrast, that the obligations of its health insurance issuer and third-party administrator are dependent on their receipt of notice that the applicant objects to the contraceptive coverage requirement. But the applicant has already notified the Government— without using EBSA Form 700—that it meets the re- quirements for exemption from the contraceptive coverage requirement on religious grounds. Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provi- sion of full contraceptive coverage under the Act.In light of the foregoing, this order should not be con strued as an expression of the Court’s views on the merits.

The full Order including the dissent by Justice Sotomajor joined by Justices Kagan and Ginsburg is directly linked here: Wheaton College v. Burwell.