Court hears amputee's case on limits of drug suits

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Posted on 3rd November 2008 by Gordon Johnson in Uncategorized

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Date: 11/3/2008

By MARK SHERMAN
Associated Press Writer

WASHINGTON (AP) — The Bush administration and a drug maker urged the Supreme Court on Monday to throw out a multimillion dollar verdict to a Vermont musician who lost her arm because of a botched injection to relieve nausea.

The case is being watched closely by the pharmaceutical industry and consumer groups because of its potential for broad limits on lawsuits by people, such as Diana Levine, who were harmed by prescription drugs.

But the justices seemed more likely on Monday to be headed toward a narrow ruling that might be confined to the facts of Levine’s case.

A Vermont jury awarded Levine $6.7 million after the improper injection of Phenergan, an anti-nausea drug made by Wyeth Pharmaceuticals, caused gangrene that led to the amputation of her right arm.

The jury agreed with Levine that Wyeth should have included a stronger warning about the risks of a method of intravenous injection known as IV push.

But lawyers for Wyeth and the government said Levine’s case should have been thrown out of court because Phenergan has been approved by the federal Food and Drug Administration and its label adequately warned about its risks. FDA approval serves as a shield against liability lawsuits under state law in such cases, they said.

“The labeling plainly comprehended and warned about the specific risks of IV administration,” Seth Waxman, representing Wyeth, told the justices.

In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

But Justice Samuel Alito, among others, had a more basic question for Waxman.

“How could the FDA have concluded that IV push was safe and effective,” Alito asked, given that Phenergan is not a lifesaving drug and gangrene can result from improper administration?

Justice Ruth Bader Ginsburg chimed in, “How could the benefit outweigh the substantial risk?”

Waxman responded that testimony in this case was clear that there are circumstances in which IV push is “medically warranted.”

David Frederick, representing Levine, argued that Wyeth never made clear to the FDA how dangerous IV push could be. He noted that Pfizer, Inc., stopped making IV push an acceptable method of injecting its anti-nausea drug after two amputations were reported.

A ruling probably will not come before early next year.

Copyright 2008 The Associated Press.

Pfizer completes part of painkiller settlement

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Posted on 23rd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/22/2008

NEW YORK (AP) _ Pfizer Inc. said Wednesday it finalized part of a larger, $894 million deal to settle lawsuits over its promotion of the painkillers Celebrex and discontinued Bextra.

The company made official a deal that would pay $60 million to settle investigations by 33 states and Washington, D.C., over Bextra, while also agreeing to adopt compliance measures. Various states alleged Pfizer promoted the painkiller for “off-label” uses, or uses it was not approved for. While a physician is allowed to prescribe drugs for off-label uses, a company cannot market them for unapproved uses.

States also alleged the company misrepresented the safety of the drug.

As part of the settlement, Pfizer denied that its promotional practices violated any laws.

Among other strictures, the settlement requires Pfizer to submit all consumer television advertisements to the FDA for approval, the New Jersey attorney general’s office said. Pfizer said such practice was already company policy.

Last week, the company said it would pay $745 million to settle personal injury cases, $60 million to cover settlements with attorneys general in the 33 states and Washington, D.C., and $89 million to cover consumer fraud class action cases over reimbursement for money spent on the two drugs.

In all, the company said the settlements would cover more than 90 percent of the pending legal actions.

“As we announced last week, these settlements avoid the disruption and expense of litigation and put these matters behind us,” Amy W. Schulman, senior vice president and general counsel of Pfizer, said in a statement.

Celebrex and Bextra came under scrutiny following lawsuits over a similar drug made by Merck & Co., called Vioxx. Merck has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming the drug caused heart attacks, ischemic strokes or death.

Bextra, like Vioxx, was a Cox-2 inhibitor.

“This medicine (Bextra) was rigorously studied and tested by the company and independent medical experts, and information about its benefits and risks was fully disclosed to the FDA,” Schulman said.

Celebrex is currently the only Cox-2 inhibitor on the market.

Pfizer has also agreed to other compliance measures regarding its promotional programs. The New Jersey Attorney General’s office, in a statement, said the settlement places strictures on such practices as companies “ghost writing” drug-related articles and studies, deceptively using scientific data when marketing to doctors, and awarding incentives to sales staff to increase off-label prescribing by doctors.

“This case should send a strong message to the industry at large that New Jersey does not tolerate deception and misleading claims in the promotion of prescription drugs,” Attorney General Anne Milgram said in a statement.

Copyright 2008 The Associated Press.

Study: Vioxx risk lingered after use of painkiller

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Posted on 13th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/13/2008 8:04 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ A doubled risk of heart attack, stroke and death persisted at least a year after people stopped taking withdrawn painkiller Vioxx, according to an analysis of long-term data from the study that led drugmaker Merck & Co. to stop selling the drug.

The analysis, published online Tuesday by the British medical journal The Lancet, also appears to show the higher risk started soon after patients began taking Vioxx, though the study notes a small sample size precludes a definitive finding on this issue.

Doctors critical of Merck and its reporting of Vioxx studies have long argued increased cardiovascular risks from the former blockbuster arthritis drug started after just a few months’ use and persisted after use ended.

Merck continues to insist cardiac risks didn’t increase until people took Vioxx for about 18 months — a cornerstone of its strategy to fight tens of thousands of lawsuits by people claiming harm from Vioxx.

The new findings should be interpreted cautiously because of the small number of patients who suffered heart attacks, strokes and related problems after participating in the three-year study, said Doug Watson, a cardiovascular epidemiologist and senior director at Merck Research Labs.

He said the study had some other limitations and noted the authors stated that “small numbers prohibit detailed conclusions about when the increased risk begins and ends.”

“But our data are compatible with an early increase in risk that seems to persist for about 1 year after 3 years of treatment,” the authors added.

Known by the acronym APPROVe, the study was intended to prove that Vioxx, heavily promoted as relieving pain with lower gastrointestinal risks than older anti-inflammatory drugs, could prevent recurrence of colon cancer. Merck stopped the study two months early and pulled the drug from the market on Sept. 30, 2004, when data showed roughly double the risk of cardiovascular complications and death in the group getting Vioxx, over those getting placebo.

Merck funded the new analysis, provided the data and commented on an early draft of the report but said it had no other involvement. The analysis was conducted by six scientists who worked on APPROVe, plus two statistics experts at the University of Wisconsin who were not involved then, the company said.

The eight researchers reported in The Lancet that in the year after the 2,587-patient study was halted, 34 people who had taken Vioxx and 18 who had taken placebo suffered a heart attack, for a 94 percent higher risk with Vioxx; strokes occurred in 19 Vioxx users and nine people on placebo, for a risk slightly more than double. Altogether, 76 Vioxx users and 46 placebo takers had a heart attack, stroke, blood clot or died during that follow-up year.

The increase in those complications was roughly the same as what was found during the three-year trial and the first two weeks after the study ended — the period included when Merck first reported results of APPROVe in the New England Journal of Medicine in February 2005.

Merck critics have said it was inappropriate to end patient follow-up 14 days after the study.

“This study is raising an important red flag about that” cutoff, showing the risk persisted for at least a year, although too few patients were followed longer than that to see if the risk subsided, said Dr. Harlan Krumholz, a Yale University cardiologist who has assisted Vioxx plaintiffs suing Merck.

“It adds another important chapter to the Vioxx story, but also is an important warning to us about how we assess the safety of medication” long-term, including after use stops, Krumholz said.

After Merck published its first analysis of APPROVe, numerous experts criticized it. Editors of the New England Journal in 2006 published a correction stating the risk of heart problems was elevated throughout the time people took Vioxx.

Merck posted all the data from APPROVe — the data used in the new study — on its Web site that same month.

In an editorial, doctors from the University of Oxford in England and Catholic University of Rome wrote that differences in the approach of the new analysis make it clear there’s no “latent period” before Vioxx increases heart risks, and shows the danger appears to have been worse in people who already had risk factors — something they said is shown in a combined analysis of six studies of Celebrex.

Made by Pfizer Inc., Celebrex is the only drug from the same class as Vioxx still on the market in the United States.

The editorial writers also note that older nonsteroidal anti-inflammatory drugs — such as naproxen and ibuprofen — also can bring cardiovascular risk, plus risks of stomach bleeding and other complications.

Copyright 2008 The Associated Press.

Eli Lilly settles Zyprexa inquiries in 32 states

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Posted on 7th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/7/2008 2:25 PM

By TOM MURPHY and MARLEY SEAMAN
AP Business Writers

INDIANAPOLIS (AP) _ Drugmaker Eli Lilly & Co. cleared another legal cloud hanging over its top-selling drug Zyprexa when it announced a $62 million settlement Tuesday, but several other storms are still brewing for the antipsychotic medication.

Lilly agreed to pay 32 states and Washington, D.C., to resolve an investigation into the company’s marketing practices.

Attorneys general from several states had accused Lilly of marketing Zyprexa for off-label uses and inadequately disclosing the drug’s side effects to health care providers, the same claims made in reams of other litigation against the drugmaker.

Lilly was accused of marketing the drug for pediatric care, for use at a high dose and for the treatment of dementia, according to a statement from the Indiana attorney general’s office. Doctors are free to prescribe drugs for uses not approved by the FDA, but drug companies cannot market them for those situations.

The company did not admit wrongdoing in the settlement.

Tuesday’s settlement will be divided among the states and the district based on population, said Greg Zoeller, Indiana’s chief deputy attorney general. Indiana, for instance, will receive $1.6 million.

Lilly also agreed to several mandates that will last until 2014, well beyond Zyprexa’s patent expiration in 2011. The company agreed to avoid making false, misleading or deceptive claims about the drug and not to promote it outside FDA-approved uses.

The drugmaker also agreed to give its medical staff, not the marketing staff, ultimate responsibility for approving the content in “all medical letters and medical references regarding Zyprexa,” according to the Indiana attorney general’s statement.

“The one thing that’s really key here is they’ve agreed to have a much more transparent system,” Zoeller said.

However, Lilly spokesman Phil Belt said many of the items his company agreed to were things it either already did or was in the process of doing.

“There’s no admission of wrongdoing, there’s no dramatic changes in the way we’re doing business,” he said.

He said Lilly agreed to the settlement to avoid being wrapped up in litigation and other things it deems counterproductive to drug development.

“We think its better for Lilly, better for patients, better for prescribers to have this kind of activity behind us,” he said.

Lilly said it will take a related charge of 4 cents per share in the third quarter for the settlement.

The states involved in Tuesday’s settlement are Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin, as well as the District of Columbia.

Zyprexa rang up $4.8 billion in sales last year. But Lilly also has settled more than 31,000 product liability claims against the drug since 2005, shelling out more than $1.1 billion in the process.

Last year, Lilly paid $15 million to settle a lawsuit with the state of Alaska in March. The drugmaker still faces litigation with 11 states, generally involving consumer protection issues or Medicaid reimbursement. These cases are separate from the settlement announced Tuesday.

Those states include Arkansas, Connecticut, Idaho, Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah and West Virginia.

The U.S. Attorney’s office for the Eastern District of Pennsylvania also is investigating Zyprexa marketing.

A group of insurance companies, unions and others are suing Lilly for billions of dollars, saying the drugmaker charged too much for Zyprexa and marketed the drug for off-label uses. A federal judge has recommended that Lilly settle that case and last month granted the plaintiffs class-action status.

All told, Lilly still faces about 185 product liability lawsuits involving 1,185 plaintiffs, according to its latest quarterly statement.

Lilly shares rose more than 3 percent to $39.73 in trading Tuesday.

Copyright 2008 The Associated Press.
Summary

Cephalon to pay $425M for improper drug marketing

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Posted on 30th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/29/2008 6:28 PM

By MARYCLAIRE DALE
Associated Press Writer

PHILADELPHIA (AP) _ Drug maker Cephalon Inc., completing a previously announced settlement, will pay $425 million for illegally marketing a highly addictive lollipop painkiller and two other drugs for non-approved uses.

Federal prosecutors also announced Monday that Cephalon, as planned, will plead to a criminal misdemeanor for its off-label marketing.

“This company … put patients at risk for nothing more than the bottom line,” Acting U.S. Attorney Laurie Magid said at a news conference.

Doctors can prescribe drugs for uses other than what has been approved by the U.S. Food and Drug Administration, but pharmaceutical companies cannot promote such “off-label” use in their marketing.

One of Cephalon’s drugs, Actiq, was marketed to doctors for maladies including migraines and injuries when the fentanyl lollipop is a highly addictive narcotic approved only for cancer patients with severe pain, authorities said.

Cephalon encouraged off-label marketing at lavish physician-education conferences and through its compensation and bonus structure, authorities said. The company also had its sales force call on doctors who would not normally prescribe the three drugs, they said.

The off-label use proved harmful and even fatal at times, Magid said. However, the settlement does not encompass any individual cases.

Cephalon disclosed the tentative settlement last November. The Frazer-based company has signed an agreement to plead guilty to one misdemeanor count of distribution of misbranded drugs.

Cephalon also marketed Gabitril, an anti-epilepsy drug, for anxiety, insomnia and pain, authorities said. Provigil, which is approved for narcolepsy, was marketed for fatigue, among other things, they said.

The $425 million settlement includes a $375 million civil settlement, a $40 million criminal fine and $10 million in criminal forfeiture, prosecutors said.

Whistleblowers — former Cephalon sales representatives disturbed by the company’s practices — will share $46.5 million from the settlement.

Much of the money recovered will be shared by state and federal Medicaid programs that paid the tab for many of the prescriptions. Sales of Actiq soared from $50 million to $500 million from 2001 to 2006, authorities said.

Prosecutors considered charging the company with a felony, but agreed to a misdemeanor in part to preserve the company’s ability to sell the drugs to patients who need them, Magid said.

“We are pleased to have these long-standing matters behind us, while preserving our ability to participate in all federal and state health care programs, thereby maintaining the access of patients in those programs to our medications,” Jerry Pappert, Cephalon’s executive vice president and general counsel, said in a statement Monday.

Cephalon will also pay an estimated $12 million in interest.

Copyright 2008 The Associated Press.