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Archives : 2010 : November

Controversial painkiller Darvon pulled at FDA’s request

November 22nd, 2010

From the Washington Post:

About 120 million prescriptions have been filled for the drug in the United States since Britain removed the drug, said Sidney Wolfe of Public Citizen’s Health Research Group, which has long called for the drug’s removal.

“Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the UK ban was announced,” Wolfe said in a statement. He called the FDA’s failure to act more quickly a “serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.”

Darvon Pulled From Market by F.D.A.

November 19th, 2010

From the NYT:

The pain-killing drugs Darvon, Darvocet and their generic ingredient propoxyphene are being removed from the market because of serious heart risks, the Food and Drug Administration announced on Friday.

The agency recommended that doctors and pharmacists immediately stop prescribing the drug and contact patients to advise them to throw it away and switch to another pain-killer.

Fosamax Suits Raise Questions for Doctors, and Juries

November 18th, 2010

From the New York Times:

The lawsuit is one of a handful of bellwether cases against Merck representing litigation involving about 1,400 people across the country who say they developed jawbone ailments after taking Fosamax, Mr. O’Brien said.

In Mrs. Graves’s case, the trial is providing a palpable backdrop for a broadening debate among many doctors and researchers who are rethinking Fosamax and similar bone medications known as oral bisphosphonates, particularly as a treatment for women who have not yet developed osteoporosis.

Efficiency in Vioxx litigation unprecedented

November 16th, 2010

From the American Lawyer:

[Fallon] heaped praise on the plaintiffs lawyers who led the Vioxx litigation, noting that in 31 months the parties were able to reach a global settlement and provide benefits to 32,886 claimants, out of a pool of 49,893 eligible and enrolled claimants. “[That] efficiency is unprecedented in mass tort settlements of this size,” Fallon wrote. “Counsel met and exceeded this court’s desire for expedited resolution of this matter.”

The judge enumerated accomplishments of the lead plaintiffs lawyers: “Following the formal appointment of the PLC and the [Plaintiffs’ Steering Committee], the attorneys committed to intensive discovery and pretrial efforts. The PSC operated on many fronts, preparing pleadings and master class action complaints, taking over 2,000 depositions, reviewing and compiling over 50,000,000 documents, briefing and arguing over 1,000 discovery motions, assembling a trial package, conducting bellwether trials, negotiating the global settlement agreement, and implementing the payout under the agreement. The time and labor expended in this effort is impressive.”

BP pays $518 million for oil-spill cleanup

November 15th, 2010

From the Washington Post’s Federal Eye:

BP has reimbursed the federal government $518 million for clean-up costs for the April oil spill in the Gulf of Mexico, a sum that has hit $581 million and keeps growing, congressional auditors said.

Auditors said there was about $1.6 billion in the fund as of the end of September. But to limit the government’s exposure, the law caps at $1 billion what agencies can draw from it for cleanup costs — even if the oil company responsible for a spill pledges to reimburse the government for all costs. The fund is at risk in the near future of reaching the limit of what the government can spend, the GAO said.

‘Jawbone Death’ and the Law: The Latest Fosamax Trial Rolls On

November 12th, 2010

From the Wall Street Journal Law Blog:

The condition, a debilitating jaw deterioration, has taken center stage in a trial in Manhattan over Merck’s drug Fosamax, which thousands have alleged causes the condition. Fosamax is most typically prescribed to older women with thinning bones.

The case is pitting Judith Graves, a 67-year-old retired investigator for the United States Army, against Merck. According to the NYT, her lawyer, Timothy O’Brien recently told the jury that Graves’s jaw deterioration, allegedly caused by Fosamax, had required five surgeries, including one to replace part of her jaw with a bone from her left arm.

FDA refuses to approve another diet drug

November 11th, 2010

From the Washington Post blog, The Checkup:

The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug’s approval. The letter does not bode well for the drug winning approval.

The move was expected, given that an FDA advisory panel had voted against the drug’s approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.

But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.

Spill Panel’s Chief Counsel: Media Misinterpreted Remarks

November 8th, 2010

From the Wall Street Journal:

A federal investigator said Monday that reporters misinterpreted his findings about whether the pressure to cut costs contributed to the Gulf of Mexico oil spill.

“We didn’t see a situation where there was a man or two men or three men and they said we can do it this way and it will be more expensive, or we can do it this way and it will be safer,” Fred Bartlit, the chief counsel for the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling, told reporters.

“I said that at least six times and I’m disappointed that you don’t seem to get it,” he said.

“Reporters always make these overarching conclusions,” he said. “Any time you’re talking about $1.5 million a day, money enters in.”

William Reilly, a co-chair of the panel, defended Bartlit. “What I heard him say was that he didn’t see any evidence of that,” Reilly said. “He didn’t see any evidence the other way either.”

Bob Graham, the other co-chair of the panel, said that the issue of whether a culture of cost-cutting undermined safety would be a topic for another day.

Dead Coral Found Near Site of Oil Spill

November 8th, 2010

From the New York Times:

A survey of the seafloor near BP’s blown-out well in the Gulf of Mexico has turned up dead and dying coral reefs that were probably damaged by the oil spill, scientists said Friday.

The large areas of darkened coral and other damaged marine organisms were almost certainly dying from exposure to toxic substances, scientists said.

Did Lowe’s Sell Chinese Drywall?

November 5th, 2010

From the Charlotte Observer:

Despite Lowe’s assurances that it sold only American drywall, the proposed settlement in that case has touched a nerve with attorneys in the multi-district litigation in New Orleans federal court, which is focused strictly on Chinese drywall. The case involves thousands of homeowners, builders and suppliers.

Plaintiffs’ attorneys involved in the federal case asked U.S. District Judge Eldon Fallon to block the original Lowe’s settlement, arguing that it “interferes with and erodes” the federal litigation and Fallon’s authority to deal with the wide scope of the drywall problem. Fallon has scheduled a hearing on the matter for next week.

Russ Herman, lead counsel for the plaintiffs in the federal case, told ProPublica and the Herald-Tribune his clients will oppose the Lowe’s agreement as long as it appears to include Chinese drywall.

“There’s one way to cure this situation: Just take the word ‘Chinese’ drywall out of that settlement,” Herman said. “If Lowe’s is going to contend under oath that they sold no Chinese drywall, then there’s no reason they should be forcing Chinese drywall homeowners to release their claims against the company.”

Herman said his clients aren’t convinced that Lowe’s didn’t sell Chinese drywall. He said his team of attorneys is investigating whether Lowe’s bought drywall from Interior-Exterior Building Supply, one of the Louisiana-based suppliers at the center of the Chinese drywall case.

“As far as I’m concerned, either they (Lowe’s) are telling the truth or they’re not. If they’re telling the truth, then eliminate Chinese drywall from your settlement,” Herman said.