Justices rule for drugmakers in 2 high-profile cases

Physicians' prescribing data can continue to be sold for marketing purposes, the Supreme Court rules. Manufacturers of generic drugs are not responsible for brand-name labeling errors.

By Alicia Gallegos — Posted July 4, 2011

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Brand-name and generic drug manufacturers have prevailed in two U.S. Supreme Court cases that could have wide-reaching effects on physicians who prescribe drugs and the patients who take them.

In William Sorrell v. IMS Health Inc., the Supreme Court ruled June 23 that data firms can sell information on a physician's prescribing history, and drug companies can use the information without a doctor's consent unless he or she explicitly opts out of the process. The transmission of the information is protected by free speech laws, the court said.

In Pliva Inc. v. Mensing, the high court ruled the same day that generic drugmakers are not liable for labeling errors made by brand-name companies that manufactured the original version of the medications. Federal law requires that generic labels match only those of brand-name labels and need not include additional warnings or updates, according to the decision.

Data ban violates free speech

In the first case, IMS Health, a consulting firm that provides market research to the drug and health care industries, challenged a data ban approved by the Vermont Legislature in 2007. The state law said companies couldn't sell prescribing information for marketing purposes, and drug companies couldn't use the data unless prescribing doctors consented.

IMS Health argued that the law hindered its First Amendment rights under the U.S. Constitution. The firm, joined by the Pharmaceutical Research and Manufacturers of America and others, sued Vermont Attorney General William Sorrell over the law's enforcement.

A district court sided with the state, but the 2nd U.S. Circuit Court of Appeals overturned the decision on constitutional grounds. The appellate ruling conflicted with rulings in Maine and New Hampshire that upheld similar laws.

In its opinion, the high court questioned the intent of Vermont's data ban law, concluding that it only discriminated against one type of class.

"Under Vermont's law, pharmacies may share prescriber-identifying information with anyone for any reason, save one: They must not allow the information to be used for marketing. ... Given the information's widespread availability ... the state's asserted interest in physician confidentiality does not justify the burden that [the law] places on protected expression," the majority said in a 6-3 ruling.

The decision is not only a victory for free speech, but also a triumph for future research by biopharmaceutical companies, said Josephine Martin, a PhRMA executive vice president. "The use of prescriber data, with all patient identification removed, helps companies properly inform doctors about prescription medicines and their characteristics -- including new indications, proper dosage forms and potential side effects -- in a targeted and expedited manner," she said in a statement.

But the ruling violates physicians' privacy and exposes patients to higher drug costs, said Paul Harrington, executive vice president of the Vermont Medical Society. The society pushed for the state data ban to keep drugmakers from using personal data to tailor their marketing messages and influence doctors' prescribing choices. These efforts are frequently directed toward increasing sales of costlier brand-name drugs, he said.

The American Medical Association called the Supreme Court decision "important" and said every physician ultimately has the right to decide whether his or her prescribing data should be shielded from pharmaceutical detailers. The AMA encourages physicians to participate in its Physician Data Restriction Program, which enables physicians to opt out of such disclosures, while still allowing their data to be available for academic and government research, the Association said in a statement. The PDRP started in 2006, and its enrollment has grown to nearly 28,000 doctors. The program is open to both AMA and non-AMA members.

"We believe the PDRP balances individual physician concerns regarding prescription data with First Amendment freedoms and the fundamental public interest in robust medical research," the Association said.

The AMA licenses Physician Masterfile information such as names and specialties on about 1 million doctors to firms such as IMS Health. These companies also purchase prescribing information from pharmacies, then link prescribers to drug orders and resell the data to drugmakers and others for marketing and research purposes.

A liability shield for generics

In the Mensing case, the Supreme Court ruling leaves patients with no legal recourse if harmed by generic drugs, and it makes prescribing decisions more difficult for doctors, said Louis Bograd, an attorney for the Center for Constitutional Litigation, which represented the plaintiff.

"To do their jobs adequately, doctors need to have accurate information about prescriptions," he said. "Under this decision, it is less likely they will have accurate information about those drugs. There is [also] a greater risk patients will look to their doctor for recoveries when they're injured by a drug."

The case stems from a 2005 lawsuit filed by Gladys Mensing against generic drug company Pliva, claiming that Mensing developed tardive dyskinesia after using the drug metoproclamide. Mensing also sued drug companies Schwarz Pharma and Wyeth, which made the drug's brand-name equivalent, Reglan. Research showed that extended use of metoproclamide could result in tardive dyskinesia, but that warning was missing from both the brand-name and generic drug labels, the suit said.

Pliva argued that because Reglan labeling did not include the warning on tardive dyskinesia, the generic firm could not be blamed for injuries associated with metoproclamide.

A lower court ruled in favor of Pliva, but the 8th U.S. Circuit Court of Appeals partially reversed that decision. The appellate court dismissed the brand-name firms from the suit but said the generic drugmaker could have proposed a label change to the Food and Drug Administration to correct the oversight.

In a 5-4 opinion, the Supreme Court acknowledged that state laws require drugs to be labeled with the latest safety warnings, but the court said federal label "sameness" statute preempted those rules. Under the sameness requirement, generic labeling must be identical to the brand-name language because the original labeling is the basis for the generic's approval by the FDA.

In a statement, the Generic Pharmaceutical Assn. said it was pleased with the court's decision.

"As the Supreme Court recognized in this decision, assessing liability based on label content that is beyond the control of the generic manufacturer places the generic manufacturer in the impossible position of defending the content of a label that they are required by law to use but are prevented by law from changing," said GPhA Executive Director Bob Billings.

However, American Assn. for Justice President Gibson Vance argued that the ruling holds brand-name and generic drug companies to varying standards and sends patients the message that brand-name drugs are safer than generics. His organization represents trial lawyers.

"Patients will now be taking generic drugs at their own risk," he said. "It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers -- not generics -- can be held accountable for their drugs' dangerous side effects."

The AMA had filed an amicus brief in support of the plaintiff.

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How to opt out

Physicians who want to enroll in the AMA's Prescribing Data Restriction Program should visit the Prescribing Data Information Center's website (link). For assistance with the opt-out process, interested physicians should contact the center at 800-621-8335.

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External links

Pliva Inc., et al v. Mensing, U.S. Supreme Court, June 23 (link)

Sorrell, attorney general of Vermont, et al v. IMS Health Inc., U.S. Supreme Court, June 23 (link)

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