Supreme Court strikes down state drug data-mining law (Reuters)

WASHINGTON (Reuters) – The Supreme Court struck down a law that prohibits the use of prescription drug records for marketing, ruling for free-speech rights over a state government's medical privacy concerns.

The high court handed a victory to data-mining companies IMS Health, Verispan and Source Healthcare Analytics, a unit of Dutch publisher Wolters Kluwer, which had challenged the law. The companies collect and sell such information.

By a 6-3 vote, the justices on Thursday upheld a ruling by a U.S. appeals court that Vermont's law infringed on commercial free-speech rights in violation of the First Amendment of the U.S. Constitution.

The law, adopted in 2007, prohibited the sale, transmission or use of prescriber-identifiable information for marketing a prescription drug unless the prescribing doctor had consented.

Vermont, Maine and New Hampshire are the only states to have adopted such laws, although similar measures have been proposed in about 25 states in the last three years.

Pharmaceutical manufacturers use data about a doctor's prescribing habits to better inform their drug salespeople when they visit physician offices to market certain products.

According to evidence presented in the case, pharmaceutical manufacturers spend nearly $8 billion annually on marketing efforts directed at doctors.

"Speech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment," Justice Anthony Kennedy wrote in the court's majority opinion.

PRIVACY OF DOCTORS AT ISSUE

The case did not involve the privacy rights of patients, as that already is protected under federal law. But Vermont said its law was aimed at protecting the privacy of doctors.

Companies that collect the data have said the information about doctors' prescribing patterns can be used to help monitor safety issues of new medications, to reduce costs, and for research purposes like studying treatment outcomes.

The law's supporters, including the Obama administration, said it helped protect medical privacy and control escalating healthcare costs by promoting cheaper generic drugs over more expensive brand-name drugs.

Vermont pharmacies must collect prescription drug information. The law bars pharmacies from disclosing the data and gives prescribing doctors the right to consent before any information is sold or used in marketing.

Attorneys for the drug companies said the law discriminated against the companies, making it harder for them to get their message to doctors. They argued the law unfairly favored views espoused by the state and insurance companies that favor generic drugs.

Kennedy agreed and said the law imposed content-based and speaker-based burdens on protected free-speech expression.

While Vermont's goals of lowering the costs of medical services and promoting public health may be proper, the state does not achieve those goals in a permissible way, he said.

"The state may not burden the speech of others in order to tilt public debate in a preferred direction," Kennedy concluded in the 25-page opinion.

"We're extremely pleased with the outcome," said Thomas Goldstein, an attorney who represented the data companies.

"It validates what the companies have been saying about the implications of information for healthcare," Goldstein told reporters in a press briefing. "The court agrees with us that the use of information here like in other contexts is a public good and that it will help healthcare."

"The court says here that information is extremely valuable for good decision-making in our society and that's true in medicine as well," Goldstein said. "And that if doctors want to hear from detailers, they need to be able to hear from them without the government getting in the way."

Justices Stephen Breyer, Ruth Bader Ginsburg and Elena Kagan dissented. Breyer called it a lawful governmental effort to regulate a commercial enterprise.

Vermont Attorney General Bill Sorrell expressed disappointment with the ruling. "We knew going in that this Supreme Court has frequently sided with large corporations," he said. He called the decision "a step back, but not the end of the story."

Senator Patrick Leahy, a Vermont Democrat who chairs the judiciary committee, denounced the ruling. "This decision is another example of this court using the First Amendment as a tool to bolster the rights of big business at the expense of individual Americans," he said.

The Supreme Court case is Sorrell v. IMS Health, No. 10-779.

(additional reporting by Lewis Krauskopf in New York; editing by Gerald E. McCormick, Maureen Bavdek, John Wallace and Gunna Dickson)

Supreme Court rejects generic drug labeling suits (Reuters)

WASHINGTON (Reuters) – The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.

By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.

The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.

Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.

The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.

But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.

The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.

Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.

COURT 'HIT NAIL ON THE HEAD'

Attorney Jay Lefkowitz, who represented Teva, said, "The Supreme Court hit the nail on the head today by making clear that federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use."

Actavis CEO Doug Boothe called the ruling "an important and necessary step by the Supreme Court to clarify the proper interpretation of regulations governing pharmaceutical labeling."

Bob Billings, the trade group's executive director, said assessing liability would have placed "the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but prevented by law from changing."

One case involved Julie Demahy, who sued Actavis and said it should have warned her of the risks of developing a neurological movement disorder from metoclopramide, a generic drug for heartburn, nausea and vomiting.

The drug's brand name equivalent is Reglan.

In another case, Gladys Mensing sued the three generic drug makers in federal court in Minnesota after allegedly developing the same disorder after taking generic versions of Reglan.

When the women first took the drug, the approved labeling said that "therapy longer than 12 weeks has not been evaluated and cannot be recommended."

That warning was changed in 2004 to say simply that therapy should not exceed 12 weeks and in 2009 the FDA ordered that specific warnings about the movement disorder be added to Reglan and metoclopramide.

The Obama administration supported the two women. It said the companies could have sought changes to the drug's label.

Generic drugs account for more than 70 percent of all prescriptions filled in the United States.

Liberal Justices Sonia Sotomayor, Ruth Bader Ginsburg, Stephen Breyer and Elena Kagan dissented.

The Supreme Court cases are Pliva v. Mensing, No. 09-993, Actavis v. Mensing, No. 09-1039 and Actavis v. Demahy, No. 09-1501.

(Reporting by James Vicini, Editing by Gerald E. McCormick, Dave Zimmerman and Matthew Lewis)

No state lawsuits on generic drugs: US Supreme Court (AFP)

WASHINGTON (AFP) – The US Supreme Court narrowly ruled on Thursday that people may not sue generic drug makers under state laws if they believe a generic drug label failed to adequately warn of side effects.

The 5-4 ruling handed a victory to drug makers Teva Pharmaceutical Industries Ltd of Israel, the US company Mylan Inc and Actavis Inc of Iceland by blocking three consolidated lawsuits against them.

Plaintiffs had argued that they suffered a neurological disorder called tardive dyskinesia after taking the generic anti-heartburn drug metoclopramide (Reglan, Metozolv), which they said did not contain adequate warning labels.

The plaintiffs were prescribed the generic drug for Reglan in 2001 and 2002.

As early as 1985, evidence began to surface that long-term use of the drug could have serious side effects, but strong warnings were not added to the brand name drug labels by federal regulators until 2004 and 2009.

In 2009, the Food and Drug Administration ordered its strongest black box label warning that "metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible... treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases."

Even though the plaintiffs were prescribed the generic drugs before the stronger labels were federally ordered, they argued that the state should have done more to protect them by changing the generic drug labels because there was evidence to suggest long-term use could be harmful.

They sued the generic manufacturers under state tort laws that said the companies should have taken steps to protect consumers.

However the US high court said that federal laws require generic drugs to have the same labels as the brand names they copy, so courts could not demand they meet a different state standard at the same time.

"State tort law places a duty directly on all drug manufacturers to adequately and safely label their products," said the decision read by Justice Clarence Thomas.

"If the manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law.

"Thus, it was impossible for the manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same."

The four liberal justices -- Sonia Sotomayor, Ruth Bader Ginsburg, Elena Kagan and Stephen Breyer -- dissented.

"As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug," said Sotomayor.

The decision affects 75 percent of all prescription drugs dispensed in the United States, the court said. When a generic is available to substitute for a brand name drug, the generic version is given out 90 percent of the time.