Report: FDA officials opposed drug suit policy

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Posted on 30th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/29/2008

By KEVIN FREKING
Associated Press Writer

WASHINGTON (AP) _ Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers’ ability to sue drug makers, congressional investigators said Wednesday.

At issue is language in a drug-labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.

Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.

“Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real time basis,” the report quoted Dr. John Jenkins, who oversees FDA’s new drug reviews, as saying. “We know that such an assumption is false.”

Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.

In a case to be argued before the Supreme Court on Monday, a Vermont woman sued Wyeth after she lost her right arm below the elbow following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, prompting gangrene to set in. Levine argued that the company had a duty to warn consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million.

Wyeth appealed, saying it was protected from such suits. It argued a state court cannot overrule the FDA’s judgment on label warnings.

FDA scientists had weighed the risks and benefits of Phenergan, used to treat nausea and allergies, when it approved the prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.

The FDA said in its 2006 rule and in a 2008 rule that state suits could encourage drug makers to propose unnecessary labeling. Such labeling could result in scientifically unsubstantiated warnings and less use of beneficial treatments.

Waxman’s staff obtained documents rejecting that warning. Jane Axelrad, an associate director for policy at the agency, wrote: “We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary,” she said. “To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.”

FDA officials said the agency encourages robust debate on public policy, so some dissension can be expected.

“As in any organization, there is rarely unanimity of opinion,” said spokeswoman Rita Chappelle.

In the end, the agency determined that finalizing the rules were the appropriate action.

“It was appropriate because FDA is the public health agency charged by Congress with the responsibility to ensure that drugs and certain medical devices are safe and effective and that the labeling adequately informs users of the risks and benefits of the product,” Chappelle said. “In addition, the agency is uniquely qualified to make such important and complex judgments.”

Public Citizen, the consumer advocacy group, said the Bush administration had pushed pre-emption clauses in a wide array of regulations.

“This effort to prevent injured citizens from using the courts and holding negligent companies’ accountable must be stopped,” said Brian Wolfman, director of Public Citizen’s litigation group.

The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included.

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On the Net:

House Oversight and Government Reform Committee: http://oversight.house.gov


Copyright 2008 The Associated Press.

Florida sues Merck to recover money spent on Vioxx

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/1/2008 4:46 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Florida has joined eight other states in suing drugmaker Merck & Co. over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.

In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.

Florida’s Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.

The lawsuit alleges that “Merck’s costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment,” according to a statement from the attorney general.

The suit also seeks civil penalties of up to $10,000 for each time that Merck’s advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.

“The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx,” the statement adds.

Merck spokesman Ron Rogers said Tuesday that Merck acted responsibly.

The Whitehouse Station, N.J.-based company said in a statement that Vioxx was an effective pain reliever and that the company carefully studied the drug and consistently made results of its studies available to U.S. regulators and the medical community.

“We intend to defend ourselves against the complaint,” Rogers said.

Alaska, Louisiana, Michigan, Mississippi, Montana, New York, Texas and Utah have previously brought similar suits, as has New York City.

Except for the Texas case, all those suits currently are pending in New Orleans under U.S. District Judge Eldon Fallon, who is overseeing the bulk of the massive Vioxx litigation, according to Rogers.

The litigation includes a $4.85 billion settlement that will end about 50,000 lawsuits by people alleging Vioxx caused heart attacks or strokes. Several thousand other lawsuits filed by people claiming other types of injuries from Vioxx also are pending, and Merck faces two personal injury class-action suits in Canada and a class action suit by shareholders seeking to recover losses on Merck stock.

Merck has already paid out $58 million under a settlement reached in May to end allegations its ads for Vioxx deceptively downplayed health risks. That settlement ended investigations by 29 states and the District of Columbia and also required Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review.

Merck shares rose 53 cents, or 1.7 percent, at $32.09.

Copyright 2008 The Associated Press.

China milk scandal claims victim outside mainland

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Posted on 22nd September 2008 by Gordon Johnson in Uncategorized

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Date: 9/21/2008 11:37 AM

By SCOTT McDONALD
Associated Press Writer

BEIJING (AP) — A Hong Kong toddler has developed a kidney stone after drinking Chinese milk — the first reported victim outside the mainland affected by a widening scandal over a toxic chemical found in baby formula and other Chinese dairy products.

More than 6,200 infants have become sick and four babies have died in China after being fed baby formula laced with melamine, a banned industrial chemical.

No illnesses had been reported elsewhere until the Hong Kong government said late Saturday that a 3-year-old girl was diagnosed with a kidney stone after drinking milk produced by the Chinese dairy Yili that contained melamine.

The Hong Kong government also announced Sunday that tests found melamine in Chinese-made Nestle milk. The Dairy Farm milk was made by Nestle’s division in the Chinese coastal city Qingdao, it said.

The Swiss food and drinks giant issued a statement Sunday saying that none of its China-made dairy products contained melamine.

“Nestle once again expresses confidence that none of its products in China is made from milk adulterated with melamine,” the statement said. It did not specifically respond to the Hong Kong report of tainted Dairy Farm milk.

Nestle offices in Hong Kong and Geneva did not immediately respond to a message seeking comment. Calls after work hours to its Beijing office and Beijing hot line went unanswered.

Meanwhile, Singapore said Sunday melamine was detected in samples of White Rabbit-brand Creamy Candy. The popular Chinese milk candy was pulled from shelves in the Philippines last year after health officials there claimed it was tainted with formaldehyde.

Chinese candy maker Guan Sheng Yuan Co. denied the Philippine allegations, saying the candy tested was likely a counterfeit version and subsequent tests showed samples of the candy were formaldehyde-free.

Already on Friday, Singapore suspended the sale and import of all Chinese milk and dairy products including milk, ice-cream, yogurt, chocolate, biscuits and candy, as well as any other products containing milk from China as an ingredient.

Japan, Malaysia and Brunei have also recalled or banned Chinese-made dairy products.

Since the problem of tainted milk products became public knowledge less than two weeks ago, the crisis has spread to include almost all of China’s biggest dairy companies.

A top official with the World Health Organization said Sunday that delays in releasing critical information about contaminated Chinese milk had hampered Beijing’s ability to rapidly deal with the problem and warn consumers.

Shigeru Omi, the WHO’s head of Western Pacific operations, told reporters at a press conference in Manila that “some people withheld the information for some time,” but he did not give specifics.

The scandal began with complaints over milk powder by Sanlu Group Co. — one of China’s best-known and most respected brands. But it quickly became a much larger crisis as government tests found that one-fifth of the companies producing baby milk powder had melamine in their products.

A New Zealand stakeholder in Sanlu has said it was told before the start of the Beijing Olympics on Aug. 8 that there was a problem. The dairy farmers’ group Fonterra, which owns 43 percent of Sanlu Group, told the New Zealand government, which informed Chinese officials.

The public was not told until Sept. 11 that the powder, used in baby formula and other products, was laced with melamine.

Melamine is used in making plastics and is high in nitrogen, which registers as protein in tests of milk. Though health experts believe ingesting minute amounts poses no danger, melamine can cause kidney stones, which can lead to kidney failure. Infants are particularly vulnerable.

Some of the farmers who sell milk to Chinese food companies are thought to have used melamine to disguise watered-down milk and fatten profit margins hurt by rising costs for feed, fuel and labor.

The parents of the Hong Kong girl diagnosed with a kidney stone took her for a precautionary checkup because she had been drinking Yili milk daily for the past 15 months. Yili Industrial Group Co. is one of 22 companies whose milk and dairy products were recalled after batches of their products were found to contain melamine.

The toddler was in good condition after receiving medical treatment and had been discharged from the hospital, the government said.

China’s communist leadership has launched high-profile efforts to show it is on top of the crisis, with Premier Wen Jiabao appearing on state-run television Sunday to say dairy companies had to show more “social responsibility.”

Wen was shown visiting a Beijing hospital where children were having health checks. He also stopped at a supermarket to look at dairy products.

“What we need to do now is to ensure that nothing like this happens in the future, not only in dairy products but in all food,” Wen said.

Food and product safety scandals have been a feature of Chinese life. Only last year, the government promised to overhaul inspection procedures after exports of medicines, toys, pet food ingredients and other products killed and sickened people and pets in North and South America.

The chemical in the dangerous pet food was the same as in the milk scandal — melamine.

Many of the largest companies whose products have been recalled, such as Yili Industrial Group Co. and Mengniu Dairy Group Co., did not have government inspections before the problem became public. The government scrapped that exemption this past week.

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Associated Press reporter Min Lee in Hong Kong contributed to this report.

Copyright 2008 The Associated Press.

Merck to start Vioxx settlement payouts in August

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Posted on 17th July 2008 by Gordon Johnson in Uncategorized

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Date: 07/17/2008 02:46 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Merck & Co. will start cutting checks for former users of its withdrawn painkiller Vioxx next month after announcing Thursday that it will fund a $4.85 billion settlement expected to resolve roughly 50,000 lawsuits.

The decision marks the beginning of the end of the four-year legal saga, which began when cardiovascular side effects forced Merck to pull Vioxx off the market in 2004, triggering tens of thousands of lawsuits, sullying its once-spotless reputation and forcing out its then-chief executive.

The Vioxx case has cost Merck at least $6.38 billion, including more than $1.53 billion through March 31 on legal costs for defense research and individual trials, most of which it has won.

Vioxx, which was launched in 1999, brought Merck revenue of $2.5 billion at its peak in 2003and $1.3 billion in 2004. Merck has not been disclosing revenue from prior years.

On Thursday, Whitehouse Station, N.J.-based Merck said more than 97 percent of eligible claimants — 48,550 out of 49,960 — have enrolled in the settlement program, surpassing threshold levels the company required for the deal to proceed. Therefore, Merck said that on Aug. 4 it will waive its right to walk away from the deal reached with plaintiffs’ attorneys last fall.

“I’m just glad that it’s almost over,” said Evelyn Irvin Plunkett of Palm Coast, Fla., who sued Merck in 2003 over the May 2001 heart attack death of her first husband, Richard “Dickie” Irvin. “It’s just been a long, hard fight.”

Plunkett’s family had gone through a mistrial, then lost to Merck at a retrial and won the right to a third trial before being allowed to join in the settlement. She does not know how much she will receive.

Settlement amounts can run from the minimum of $5,000 up to a few million dollars. Payments will be decided by a complicated formula that factors in how serious a claimant’s injury was, how much Vioxx was taken and how many other risk factors the person had.

“Long-term users of Vioxx who had a very severe injury will be well compensated,” said lawyer Andy Birchfield, who served on the plaintiffs’ steering and negotiating committees.

He said the number of plaintiffs participating shows the settlement is a good one.

“This is a great day for the plaintiffs injured by Vioxx who will within weeks begin to receive compensation for their injuries,” said lawyer Chris Seeger, a member of the plaintiffs steering committee coordinating the massive litigation. “I couldn’t be happier for my clients.”

“We’re very pleased to be reaching this milestone because we feel it confirms the program is a good one and a fair one,” said Ted Mayer, Merck’s chief Vioxx lawyer.

Roughly 700 more plaintiffs are considering participating, so Merck has extended the deadline for them to enroll until Oct. 30, he said. About 700 more have not been located by their attorneys.

Former Vioxx users, or their survivors, are eligible for part of the settlement if the patient suffered a heart attack, stroke or death. They must have had pending lawsuits or tolling agreements, which suspend the statute of limitations, as of Nov. 9, 2007, the date the settlement was reached.

To ensure that the settlement ended the bulk of the lawsuits, the company had required participation from at least 85 percent of eligible claimants in four groups: those who had used Vioxx for more than 12 months, had a heart attack, had an ischemic stroke or died.

Merck will put $4.85 billion into the settlement fund over time, with the first $500 million payment scheduled for Aug. 6. The company took a charge for the full $4.85 billion last year.

Eligible claimants who enrolled by March 31 and allege a heart attack or sudden cardiac death could then receive an interim payment, expected to be made by the end of August.

Interim payments to people alleging Vioxx caused an ischemic stroke are to begin in or after February 2009.

Mayer said several thousand additional claimants don’t have injuries eligible for the settlement and have been ordered by judges to produce expert reports supporting their claims.

“We expect to be making motions to dismiss a large number of those claims during the coming weeks and months,” he said.

Merck also faces about 260 potential class-action suits, alleging either harm or financial losses related to Vioxx, that still must be resolved.

Merck withdrew Vioxx from the market on Sept. 30, 2004, after its own research showed the once-blockbuster arthritis pill doubled the risk of heart attack and stroke.

U.S. District Judge Eldon E. Fallon in New Orleans, who has been coordinating much of the litigation, said it’s one of the country’s biggest multidistrict litigation cases — those assigned to one federal judge for pretrial purposes and possible settlement.

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Associated Press writer Janet McConnaughey in New Orleans contributed to this report.

On the Web: http://officialvioxxsettlement.com

Copyright 2008 The Associated Press.