Generic drug makers not liable for warnings

By Jesse J. Holland

Associated Press

WASHINGTON (AP) -- The Supreme Court on Thursday ruled that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines.

The majority opinion acknowledged that the decision dealt an "unfortunate hand" that "makes little sense" to those who were harmed by generic drugs and are unable to sue the drug makers.

A sharply divided court decided in a 5-4 judgment that the federal law requiring generics to have the same warnings as their brand-name equivalents trumps state laws that allow people to sue drug companies that fail to present proper warnings for their products.

This decision could affect millions of Americans, given that generics make up 75 percent of the prescription drugs dispensed in the United States, justices said.

"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," Justice Sonia Sotomayor said in a strongly worded dissent. "The court gets one thing right: This outcome makes little sense."

Fordham Law School professor Benjamin Zipursky called the case especially striking, considering a "6-3 majority decided only two years ago in Wyeth v. Levine that non-generic manufacturers should not be shielded from failure-to-warn claims."

Gladys Mensing and Julie Demahy had sued PLIVA Inc. and other generic drug manufacturers in state courts in Minnesota and Louisiana over the labels for metoclopramide, the generic version of Reglan. The two women alleged that metoclopramide gave them a severe neurological movement disorder called tardive dyskinesia, but none of the generic drug's manufacturers and distributors made any effort to include warnings on the label.

PLIVA Inc. and other generic drug manufacturers argue that it's not their legal responsibility to request label changes, and that lawsuits filed in state courts over the content of labels improperly infringe on the Food and Drug Administration's enforcement area.

Reglan did not have a warning about tardive dyskinesia when Mensing and Demahy were taking it. The FDA ordered warnings about tardive dyskinesia to be added to Reglan and metoclopramide in February 2009.

Justice Clarence Thomas, who wrote the majority opinion, said it was impossible for generic drug manufacturers to comply both with federal laws requiring them to have the same label as the brand-name drugs and state laws that require them to add additional warnings. So the federal law prevails.

Thomas acknowledged the "unfortunate hand" dealt to people who are harmed by inadequate labels on generic drugs. They would be able to sue the companies who make brand name drugs for the same offense but are barred from suing the generic manufacturers.

For those people, the pre-emption of federal law over state laws makes little sense, Thomas said. "Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors ... their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy and others similarly situated."

He was joined in his judgment by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy and Samuel Alito.

Lawyer Jay Lefkowitz, who represented Teva Pharmaceuticals in this case, said the Supreme Court "hit the nail on the head today."

"Federal law does not permit states to hold generic drug manufacturers liable for using the very warnings federal law required them to use," he said.

Sotomayor, who wrote the dissent, said PLIVA and the other generic manufacturers didn't even try to get the Food and Drug Administration to change the labels of Reglan. If they had, the FDA might have forced Reglan to change its label, she said.

"Once that occurs, a generic manufacturer is in full compliance with both federal law and a state-law duty to warn," she said.

Louis Bograd, lawyer for Gladys Mensing and Julie Demahy, said they all were "dismayed and disappointed" and the court's decision leaves generic drug makers "absolutely no incentive whatsoever to police themselves and the products that they sell."

They plan to go to Congress and the FDA in hopes that the law can be changed, but "any change will come too late for Gladys Mensing and Julie Demahy," he said.

The high court's decision overturns the ruling by the 8th U.S. Circuit Court of Appeals in St. Louis, which agreed with Sotomayor that more should have been done to warn consumers about possible risks.

The cases are PLIVA Inc. v Mensing, 09-993, Actavis Elizabeth LLC v. Mensing, 09-1039 and Actavis, Inc., v. Demahy, 09-1501.

Lab analyst must

testify to own work

By Mark Sherman

Associated Press

WASHINGTON (AP) -- The Supreme Court on Thursday said the lab analyst who testifies at a criminal trial must be the one who performed or witnessed the lab tests in question, the latest decision bolstering the constitutional requirement that defendants be able to confront witnesses against them.

In a 5-4 decision, the court ruled in favor of a New Mexico man convicted of drunken driving who objected when the lab analyst who testified about lab tests had no role in performing them.

The ruling reversed a New Mexico Supreme Court decision in the state's favor.

When Donald Bullcoming's case went to trial on charges he was driving while intoxicated, the main evidence against him was a lab report showing his blood-alcohol level was well above the legal limit for driving.

But instead of calling as a witness the analyst who performed the lab test, the state chose someone else. Prosecutors said the analyst who did the test had been placed on unpaid leave, but did not say why.

Bullcoming objected to the testimony, but the judge allowed it and a jury convicted Bullcoming. The New Mexico high court said the substitute analyst's testimony satisfied the Constitution's cross-examination right.

But, writing for the U.S. Supreme Court, Justice Ruth Bader Ginsburg said the surrogate testimony could not convey what the original analyst knew about the tests he performed.

"The Sixth Amendment does not tolerate dispensing with confrontation simply because a court believes that questioning one witness about another's testimonial statements provides a fair enough opportunity for cross-examination," Ginsburg said.

Justice Anthony Kennedy said in a dissenting opinion that the court was distorting the meaning of the word "witness" because the tests are entirely machine-run and often, as in this case, can be performed after everyone has left for the day.

"In these circumstances, requiring the state to call the technician who filled out a form and recorded the results of a test is a hollow formality," Kennedy said, in an opinion that was joined by Chief Justice John Roberts and Justices Samuel Alito and Stephen Breyer.

Bullcoming's case was important because it might have signaled the court's retreat from a 2004 decision that significantly strengthened the right to cross-examine witnesses. Justice Sonia Sotomayor wrote the decision in February ruling against a defendant in a murder trial who said he had been unfairly denied the chance to cross-examine the victim. Justice Elena Kagan, who did not take part in that case, had no track record on the topic before Thursday.

But they signed onto almost all of Ginsburg's opinion Thursday, a development that Stanford law professor Jeffrey Fisher, Bullcoming's lawyer, called "very reassuring."

As for Bullcoming himself, state courts will now have to determine whether the conviction can stand.

The case is Bullcoming v. New Mexico, 09-10876.

Prescription drug data mining law struck down

By Mark Sherman

Associated Press

WASHINGTON (AP) -- States cannot stop drug manufacturers and data-mining companies from using information about the prescription drugs individual doctors like to prescribe, the Supreme Court ruled Thursday.

The court voted 6-3 to strike down a Vermont data-mining law aimed at controlling health care costs by boosting the use of generic drugs. The ruling imperils similar laws in Maine and New Hampshire that seek to control the flow of information about brand-name medications.

The information is extremely valuable to brand-name drug makers, which spend a reported $8 billion a year marketing their products to doctors. Among those efforts is the practice of detailing, in which sales representatives tailor their pitch to individual doctors based on the doctors' own prescribing habits.

Backers of the laws generally believe that drug prices are too high and that one reason is the money drug makers spend to market and advertise their products. The laws' supporters say that by preventing the sale of the information, they help protect medical privacy, control health care costs by promoting generic drugs and improve public health.

But Justice Anthony Kennedy, writing for the court, said the Vermont law violates the speech rights of the data-mining and pharmaceutical companies. Kennedy said that "the state cannot engage in content-based discrimination to advance its own side of a debate."

Kennedy said that the free flow of commercial speech "has great relevance in the fields of medicine and public health where information can save lives."

The Vermont law prevents the sale of information about individual doctors' prescribing records without the doctors' permission.

Pharmacies are required by state and federal law to get that information when they fill prescriptions. They sell the information, without patient names, to data mining companies that, in turn, provide drug makers with a detailed look at what drugs doctors choose for their patients.

Three companies that sell the information they gather -- IMS Health, SDI and Source Healthcare Analytics -- challenged the Vermont law.

The drug industry's trade group, the Pharmaceutical Research and Manufacturers of America, also joined the lawsuit because the Vermont law also prohibits drug companies from using the information for sales and marketing purposes.

The lawsuit says the information about doctors' prescribing patterns is important in helping spot trends, keeping tabs on the safety of new medications and studying treatment outcomes. The data-mining companies make the information available to researchers and the government, at little or no cost.

Randy Frankel, an IMS vice president, praised Thursday's decision "as a great benefit in terms of improving patient care."

Frankel said the data is used in many areas of health care beyond pharmaceutical company marketing.

In dissent, Justice Stephen Breyer said the law should have been upheld as a constitutional regulation of business activity. Justices Ruth Bader Ginsburg and Elena Kagan also signed on to Breyer's dissent.

Breyer said that the court's ruling was broad enough to threaten significant "judicial interference with widely accepted regulatory activity."

He suggested that the drug makers could use the ruling to challenge Food and Drug Administration limits on the "off-label" marketing of prescription drugs. Under existing regulations, companies may not tell doctors that a drug can be put to a use other than the one approved by the FDA.

Sen. Patrick Leady, D-Vermont, criticized the decision as "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."

The Associated Press joined other media companies and press freedom groups in urging the court to strike down the Vermont law.

The case is Sorrell v. IMS Health, 10-779.

Crack convict can

seek shorter term

WASHINGTON (AP) -- The Supreme Court says a defendant who pleaded guilty to crack cocaine possession and a specific prison term can seek a shorter sentence following a change in the federal sentencing guidelines for his crime.

The court ruled 5-4 Thursday that William Freeman can ask a federal judge to cut his sentence by nine months, to eight years. The U.S. Sentencing Commission recently moved to shrink the disparity that imposes far harsher penalties for crack crimes than those involving powder cocaine.

The issue for the court was whether the normal rule allowing a sentence reduction applied to a person whose guilty plea included a specific prison term or sentencing range.

Man can collect

damages from railroad

WASHINGTON (AP) -- The Supreme Court says a man can use a federal law to collect damages against a railroad.

The high court on Thursday ruled in a 5-4 decision that CSX Transportation, Inc. should compensate Robert McBride for an accident under the Federal Employees Liability Act.

McBride sued CSX after being hurt while working on a train between Evansville, Ind., and Nashville, Tenn. A judge told the jury that CSX "caused or contributed" to the accident if their negligence in any way caused the accident. CSX says that was the wrong instruction under the FELA, saying McBride had to prove the injury happened "in whole or in part" from their negligence.

Lower courts agreed with McBride and the high court confirmed their ruling.

The case is CSX Transportation Inc. v. McBride, 10-235.

High Court rules against Anna Nicole Smith's estate

By Jesse J. Holland

Associated Press

WASHINGTON (AP) -- The Supreme Court on Thursday ruled against the estate of Anna Nicole Smith in the latest chapter of the long-running saga over whether a Texas billionaire's alleged promise to give millions from his $1.6 billion estate to his young Playmate wife trumped a will that left his fortune to his son.

The high court ruled that a bankruptcy judge's decision giving millions to Smith from the estate of oil tycoon J. Howard Marshall was decided incorrectly because those judges do not have the constitutional right to reach outside of bankruptcy cases into a probate case.

Chief Justice John Roberts said in a 5-4 decision that the Constitution gives lifetime tenure to federal judges during good behavior and without diminution of salary.

Bankruptcy judges "enjoy neither tenure during good behavior nor salary protection," Roberts said. "We conclude that, although the bankruptcy court had the statutory authority to enter judgment on Vickie's counterclaim, it lacked the constitutional authority to do so." Smith's real name was Vickie Lynn Marshall.

Federal bankruptcy judges are appointed and can be removed by judges on the U.S. Appeals Court and their salaries are linked to that of federal judges. Bankruptcy judges serve 14-year terms.

The family of E. Pierce Marshall, son of J. Howard Marshall, cheered the decision.

"J. Howard's wishes were always perfectly clear: He gave Anna Nicole Smith approximately $8 million in gifts during his lifetime, and those gifts were all that he intended to give her," said Eric Brunstad, the Marshalls' lawyer.

The convoluted dispute over the elder Marshall's money has its roots in a Houston strip club where he met Smith. The two were wed in 1994 when he was 89 and she 26. Marshall died the next year and his will left his estate to his son and nothing to Smith.

Smith challenged the will, claiming that her husband promised to leave her more than $300 million above the cash and gifts showered on her during their 14-month marriage. A Houston jury said Marshall was mentally fit and under no undue pressure when he wrote a will leaving nearly all of his $1.6 billion estate to his son and nothing to Smith, a decision that has been upheld by the federal appeals court.

Smith moved to California after Marshall's death and then filed bankruptcy in Los Angeles, alleging in federal court filings that her husband promised her a large share of the estate. A bankruptcy judge awarded her $475 million from Marshall's estate, with a federal judge reducing that amount to $89 million in 2002.

Smith had wanted the courts to accept that ruling. But the 9th U.S. Circuit Court of Appeals in in San Francisco appeals court threw the bankruptcy court ruling out, saying a bankruptcy judge could not rule on the probate case.

Roberts agreed with that decision, and was joined in his judgment by Justices Antonin Scalia, Anthony Kennedy, Clarence Thomas and Samuel Alito.

Justice Stephen Breyer wrote the dissent for himself and Justices Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan.

A federal bankruptcy court "plays a critical role in Congress' constitutionally based effort to create an efficient, effective federal bankruptcy system," Breyer said. "At the least, that is what Congress concluded. We owe deference to that determination, which shows the absence of any legislative or executive motive, intent, purpose or desire to encroach upon areas that Article III reserves to judges."

This decision could throw a large number of cases being handled by bankruptcy courts into the federal courts, Breyer said, noting that there were almost 1.6 million filings in bankruptcy court compared to a federal district court docket of around 280,000 civil cases and 78,000 criminal cases.

"Under these circumstances, a constitutionally required game of jurisdictional ping-pong between courts would lead to inefficiency, increased cost, delay and needless additional suffering among those faced with bankruptcy," Breyer said.

Roberts acknowledged the long-running nature of the case, quoting from Charles Dickens' novel "Bleak House" in the opinion: This "suit has, in course of time, become so complicated, that ... no two ... lawyers can talk about it for five minutes, without coming to a total disagreement as to all the premises. Innumerable children have been born into the cause; innumerable young people have married into it;" and sadly, the original parties "have died out of it."

The younger Marshall died in 2006 and Smith died of a drug overdose in 2007. Smith's daughter, Dannielynn Birkhead, was named Smith's heir in 2008. The girl's father, Larry Birkhead, and attorney Howard K. Stern are in charge of the estate.

The case number is Stern v. Marshall, 10-179.

Published: Mon, Jun 27, 2011