The Supreme Court on Friday agreed to clarify the legal duty of makers of generic medicines to change their labels to warn consumers of a new threat of harmful side effects, and to decide whether state court lawsuits may be filed for failure to do so.  The issue is parallel to one the Court decided in March 2009 against manufacturers of brand-name drugs.  This was one of three new cases accepted for decision in the current Term.  The others involve the duties of local telephone companies toward new competitors, and an issue of federal sentencing law related to a case it has already heard.

The new cases involving medicine labels are a followup to the Court’s ruling last year in Wyeth v. Levine (06-1249), allowing state court lawsuits raising failure-to-warn claims against manufacturers of brand-name drugs.  That ruling did not address its impact on generic drug makers, and that is the issue the Justices have now taken on. The Court consolidated three separate cases on the issue, to be heard in one hour of oral argument: PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  The cases involved two women who developed tardive dyskinesia, a serious condition affecting neurological movement, after taking a generic version of the brand-name drug Reglan.  (Reglan was manufactured by Wyeth; the 2009 Wyeth case involved another of its brand-name medicines, Phenergan, which was prescribed for nausea.)

About 70 percent of all drug prescriptions are now filled with generic drugs, so the impact of the new case could be widespread.

The generic manufacturers involved in the new cases argued in their appeals that Congress did not intend for state court lawsuits to impede the marketing of generic drugs, as cheaper versions of brand-name drugs, and that should make a difference from the situation with a brand-name manufacturer like Wyeth.  The Court granted review of the issue over the advice of the Justice Department, which suggested a denial of the Mensing cases after the Court had asked for its views on those two cases.

The local telephone company cases the Court will hear are Talk America v. Michigan Bell (10-313) and Isiogu v. Michigan Bell (10-329).  The cases will be heard together for one hour; Justice Elena Kagan will not take part; she was recused from the order granting review. At issue is whether federal law requires local telephone companies, already established, to allow new competitors in their markets to link to the existing networks through connecting wires at low, government-regulated rates, or whether they may charge higher market rates.  Both sides in the cases urged the Supreme Court to grant review. (Michigan Bell is also known as AT&T Michigan.)

When the cases were unfolding at the Sixth Circuit, the Federal Communications Commission took part and advanced the same position that those pursuing the new appeals had taken.  It did not take part in the Supreme Court, but perhaps will file its own views as the briefing continues.

The new criminal sentencing case the Court agreed to review is Tapia v. U.S. (10-5400), testing whether a federal judge may give a convicted individual a longer prison sentence to promote rehabilitation. That issue has divided the federal Circuit Courts, the petition argued.  The Court already is reviewing an aspect of the rehabilitation question in federal sentencing — in the case of Pepper v. U.S. (09-6822).  The Justices, in fact, heard the Pepper case just last Monday.

The question before the Court in Pepper is whether a convicted individual who makes considerable strides in rehabilitating himself after his initial sentencing should have a chance to have a reduction in the sentence under the federal advisory Sentencing Guidelines, if the first sentence was overturned.  That is different from the situation with Alejandra Tapia in the newly granted case.  The issue there is, when the judge has decided that prison time is an appropriate sentence, whether the term can be lengthened to improve the individual’s chances of rehabilitation.  The petition argued that the Eighth and Ninth Circuits allow the use of that factor, in conflict with the Second, Third, Eleventh and D.C. Circuits, which do not.

The Justice Department, which supports Jason Pepper in the case already under review, told the Court that it agreed with Tapia’s view of what federal law allows, but nevertheless urged the Court not to hear the Tapia petition.   Acting Solicitor General Neal K. Katyal said that the Justice Department had sometimes supported the view that rehabilitation needs could be a factor in giving a longer sentence, but it no longer will take that position.  The Court, Katyal said, should allow the Circuit Courts to weigh the Department’s new views.

The Court, however, went ahead and agreed to hear the Tapia case this Term.  The woman in the case was convicted of bringing illegal aliens into the U.S. and of jumping bail after being charged with immigration crimes.  The judge said one factor in giving her a longer sentence was to make sure she remained confined long enough to take part in a drug rehab program.

The newly granted cases are expected to be heard in March or April.  The Court apparently had no need to expedite these cases in order to allow a full briefing schedule.  There was no explanation why it decided to announce its grants on Friday, rather than waiting until new orders are issued next Monday morning, although the slightly earlier grant may make it possible to schedule them for argument in March rather than April.

Posted in Actavis Elizabeth, L.L.C. v. Mensing, Actavis v. Demahy, PLIVA v. Mensing, Talk America v. MI Bell Tel., Isiogu v. Michigan Bell Telephone Co., Tapia v. U.S., Featured, Merits Cases

Recommended Citation: Lyle Denniston, Court grants 3 new cases, SCOTUSblog (Dec. 10, 2010, 5:23 PM), http://www.scotusblog.com/2010/12/court-grants-3-cases/