Pharmaceutical Litigation Update

01/19/06

Bextra Michigan Complaint 4.12.05
Bextra New York Complaint 4.13.05
Celebrex Michigan Complaint 4.21
Ditropan Fargo Complaint 11.14.05
Ditropan SMW Complaint 11.17.05
Lovenox California Complaint 7.27
Neurontin Michigan Complaint 11.1.04
Nexium Delaware Complaint 4.05.04
Tricor Delaware Complaint 7.21.05
Vioxx Michigan Complaint 4.21.05

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10/25/05

Lovenox Stip and Order No 1

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06/24/05

OXYCONTIN PATENT INVALID

Yesterday a federal court of appeals agreed that Purdue Pharma had acted wrongful in obtaining patents for its blockbuster drug Oxycontin. The patents are unenforceable, which allows claims that Generics should have been in the market.

The ruling last year, by Judge Sidney H. Stein of United States District Court in Manhattan, found that Purdue Pharma had intentionally deceived patent officials to secure OxyContin's patent by implying that the company had clinical evidence to show that OxyContin was easier for doctors to use to control pain, when in fact such data did not exist. That finding of "inequitable conduct" invalidated Purdue's patent.

The three-judge appeals panel also found, in reviewing the facts of the case, that Purdue had "failed to disclose material information that was inconsistent with its arguments for patentability." The ruling was unanimous. Purdue has requested a full 12-member panel review the decision.

All this means that healthplans have been overcharged. Oxycontin sales have averaged $1.5 billion annually over the last five years.

We will be monitoring the progress of the Oxycontin litigation and keep you advised.

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05/26/05

CQ HEALTHBEAT NEWS
May 2, 2005 – 6:16 p.m.
Tauzin: Drug Industry Must Discipline Itself Or Congress Will
By Mary Agnes Carey, CQ HealthBeat Associate Editor

In Billy Tauzin’s mind, there’s only one way to stop a bad news story from getting published: “Stop doing bad things.”

The new head of the much-maligned pharmaceutical industry said Monday he is redefining drugmakers by focusing on what the industry has done right rather than the missteps that have resulted in headlines about unsafe drugs recalled once they were approved for consumer use.

‘It’s not about PR. It’s about doing the right thing,” Tauzin told reporters in one of the first interviews he has conducted since joining the Pharmaceutical Research and Manufacturers of America (PhRMA) four months ago. “It’s not about buying respect. It’s about earning it.”

Some have suggested that Tauzin’s credibility has suffered as well since the longtime lawmaker took the helm of PhRMA. As the chairman of the House Energy and Commerce Committee, the former lawmaker (1979-2004) was one of the congressional negotiators who wrote the Medicare drug law (PL 108-173). Among its provisions, it prohibits the secretary of Health and Human Services (HHS) from negotiating prescription drug prices on behalf of Medicare’s more than 40 million beneficiaries.

PhRMA and many Republicans opposed the provision, saying it is tantamount to price controls. But Democrats and consumer groups said allowing the HHS secretary to negotiate drug prices for Medicare beneficiaries could save taxpayers billions and possibly lower drug prices for all Americans.

“I welcome that scrutiny and any scrutiny they want to give me,” said Tauzin, 61, adding that his own struggle with cancer —he is now in remission — has emboldened him to tell the success stories of the industry and help it broaden efforts to make pharmaceuticals available to patients who cannot afford them.

For starters, Tauzin said, the drug industry must be more open with the press. “It’s about never saying ‘no comment’ to you,” Tauzin said at a luncheon briefing, adding that when mistakes are made, pharmaceutical makers must be open about that and take corrective action.

The industry must also take a more active role in addressing the issues that have brought it unwanted public and congressional attention, such as the monitoring of drugs once they have been approved for consumer use.

Drug manufacturers and the Food and Drug Administration (FDA) have faced increasing congressional scrutiny after a series of highly publicized findings about the adverse effects of some FDA-approved drugs, including heightened suicide risks in children who use antidepressants and heart risks associated with the painkillers Vioxx, Celebrex and Bextra — drugs in a class called Cox-2 inhibitors.

Last month, Pfizer, the manufacturer of Bextra, pulled the drug off the market at the FDA’s request. Merck pulled its painkiller Vioxx from shelves last year after a higher risk of heart ailments was found in users of the drug. Consumer advocates and some lawmakers have charged the companies involved with intentionally withholding data that made it clear the drugs posed an increased risk, accusations the manufacturers say are untrue.

The Vioxx debacle has shown the drug industry that its system of monitoring drugs once they hit the market “has to be improved,” Tauzin said, with any data shared showing adverse outcomes being made public as soon as it is known. “If there are suspicions about it we ought to know about it and communicate about it earlier,” he said.

Although some lawmakers have proposed legislation to create a new office within FDA to monitor drug safety, such steps are not needed, Tauzin said. The Bush’s administration’s proposal to create a drug safety board within FDA will suffice.

“What we don’t think you need to do is reinvent the wheel when it comes to all these other activities,” Tauzin said, referring to additional powers that would be given in some legislative proposals, such as the ability to demand changes to direct-to-consumer advertising and recommend that a drug be removed from the market if it is deemed unsafe.

But he also cautioned that consumers must realize there are risks with every drug they take. Sometimes, he said, potential risks aren’t know until the drugs are marketed to the broad population.

The industry must also do a better job of promoting the many drugs it has developed that have saved lives —including Tauzin’s —and continue to promote programs such as Partnership for Prescription Assistance, which helps provide drugs to people who cannot pay for them and also helps find other assistance at the state and federal level.

“We have only one enemy and it is disease,” Tauzin said. “We make a product that is vital to people’s lives.”

Source: CQ HealthBeat News
Same-day coverage of the people and events shaping health care policy from Washington.
© 2005 Congressional Quarterly Inc. All Rights Reserved

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02/11/05

Charfoos & Christensen has protected American families from pharmaceutical industry abuses since the 1970’s. For decades, brand name prescription drug makers have consistently been among the most profitable industries in America. In 1998, pharmaceutical companies ranked first among all industries in rates of return on equity, assets, and revenues, according to a report by Public Citizen. However, their huge profits are often generated by illegal price inflation strategies that cost Americans billions in fraudulent charges.

As part of its mission to make healthcare affordable for all Americans, Charfoos & Christensen has recently started a Healthcare Litigation practice group. Our attorneys use their expertise in class action litigation to fight illegal pharmaceutical price inflation. We have pursued several pharmaceutical companies for illegal price scams arising out of fraud, patent abuses, anti-trust violations, and other laws. The results have been tremendous.

Attorney Jason J. Thompson leads the firm’s Healthcare Litigation group. Mr. Thompson has represented individual consumers and several health care plans in litigation against some of the largest pharmaceutical companies in the world, including Pfizer, GlaxoSmithKlien, Bayer, TAP Pharmaceutical Product and AstraZeneca. In January 2005, he was selected to work on the Neurontin Marketing and Sales Practice Litigation, MDL No. 1629 pending in the Federal District Court of Massachusetts.

Recently, Mr. Thompson has joined other plaintiff lawyers in litigation against AstraZeneca for its unlawful scheme to switch consumers from Prilosec to Nexium. According to AstraZeneca’s 2003 Annual Report, Nexium’s share of the U.S. proton pump inhibitor market is 25.3%, and sales exceeded $2.4 billion. Currently, Prilosec is sold over the counter and costs about one-eighth the price of Nexium. We are currently working on cases involving, Neurontin, Paxil, Remeron, Lupron, Relafen and Wholesale Drug Pricing (WDP)..

If you are aware of drug pricing abuses, contact Jason J. Thompson to discuss your case.