Common painkillers such as ibuprofen are at the centre of a major health alert today.

The drugs are under investigation by European regulators after being linked with an increased risk of heart attacks and stroke.

Millions of people regularly take such drugs, technically known as non-selective nonsteroidal anti-inflammatories and including ibuprofen, commonly marketed as Nurofen.

Experts say only those who are prescribed high doses for conditions such as arthritis are at risk.

A recent version of the drug, Vioxx, was taken off the market in 2004 after it was linked with hundreds of US heart attacks.

New research suggesting there could be a similar risk in older versions has prompted the review of the whole class of drugs.

The European Medicines Agency will decide next month whether doctors need new guidance over long-term use of the drugs.

Meanwhile it recommends patients use the smallest dose as briefly as possible.

The new data, culled from 140,000 patients, suggested some of the drugs doubled heart attack risk.

Questions were also raised over the safety of taking high doses of ibuprofen for long periods.

It was suggested that for every 1,000 people taking the drugs, three people a year would suffer a related heart attack.

Patients who are already taking aspirin to prevent heart attacks and stroke are being told not to take non-steroidal anti-inflammatory drugs as well unless absolutely necessary.

An Arthritis Research Campaign spokeswoman said: "What we need to know is whether the benefit of these drugs outweigh the risks."

Under investigation are diclofenac, etodolac, ibuprofen, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen, nimesulide and piroxicam.

Two years after the painkiller Vioxx was withdrawn from the market, the lawsuits still make front-page news.

Trial lawyers drool over huge damages awarded to heart-attack victims or their families. Merck & Co. Inc. crows whenever a jury decides that its drug didn't hurt anyone. And investors hang on every verdict as they try to gauge how much money the more than 15,000 personal-injury lawsuits will cost the drug maker.

Lurking behind the headlines is a different type of lawsuit that has potentially huge ramifications for the company. The outcome may be worth billions of dollars, but because the details turn on the dry facts of health insurance, the lawsuit has taken a back seat to the sensational stories about ruined lives.

"The case may not appear as sexy as the personal-injury cases," said Howard Erichson, a Seton Hall University Law School professor who specializes in complex litigation. "But there is a lot at stake."

Among insiders, the lawsuit has a simple nickname: "the engineers' case." That's because it was filed by the International Union of Operating Engineers Local 68, which represents about 6,000 building engineers, boiler operators, maintenance mechanics, plumbers, electricians and carpenters throughout New Jersey.

Like other unions, Local 68 runs a health care plan for its members and for several years paid for Vioxx prescriptions worth millions of dollars annually. A precise figure was not available, but the union wants its money back. A trial is scheduled for early next year. In response to an appeal from Merck, the New Jersey Supreme Court has agreed to review the case.

The union's argument in many ways resembles the accusations in lawsuits filed by heart-attack victims: that Merck concealed serious side-effect issues from regulators and the public and improperly marketed the medicine. Unlike with the personal-injury lawsuits, the union does not have to prove that Vioxx caused a heart attack. The lawsuit claims that Merck violated New Jersey's Consumer Fraud Act.

Local 68 simply maintains that it would not have paid for Vioxx if the heart problems were properly investigated and disclosed.

"We generally had thousands of Vioxx prescriptions each month," said Dennis Giblin, Local 68's president. "And they cost us a lot."

Local 68 isn't the only organization that shelled out $3 for each pill. Various health insurers and other third-party payers also say they paid a lot for a harmful drug. So last year, Superior Court Judge Carol Higbee, who oversees thousands of personal-injury cases in state court, certified the case as a nationwide class-action suit.

Her decision meant private insurers from across the country could join Local 68's lawsuit and seek reimbursement from Merck. Overall, health plans paid a few billion dollars for Vioxx, said David Buchanan, one of the union's attorneys. And under New Jersey law, Merck may have to pay triple the damages awarded at trial.

Some Wall Street analysts estimate that Merck's total Vioxx liability could reach as much as $50 billion. Vioxx litigation also includes a shareholder lawsuit filed in federal court in Trenton, N.J.

Merck reiterates the defense used in the personal-injury cases: that Vioxx was developed and tested properly, that nothing about heart problems was hidden from the Food and Drug Administration and that the medicine was properly promoted. Merck also says Higbee was incorrect to grant class-action status to the engineers' case.

"There were some fundamental flaws in the order," said Ted Mayer, an attorney who represents Merck. "What you're really talking about is a group of HMOs and insurers, all of which purchased Vioxx under different circumstances and used different decision-making processes to evaluate the medicine. And they're governed by different state laws."

Mayer is referring to clinical studies reviewed by health-plan committees, which attempt to balance a drug's safety and effectiveness against its cost. Those evaluations, which can differ among health plans, are used to determine whether coverage will be provided and, if so, how much reimbursement to offer.

Merck also objects to the notion that health plans based in other states should press their case using New Jersey law instead of filing individual actions in their home states. From Merck's point of view, doing so could mitigate the financial impact of the engineers' case and reduce its exposure in what currently amounts to an all-or-nothing lawsuit.

The state Supreme Court has not scheduled hearings, although lawyers for both sides have been filing motions since the court agreed two months ago to review the case.

For now, Merck continues to face a trial in Higbee's Atlantic City courtroom in March.

Key Vioxx events:

-May 1999: Food and Drug Administration approves Merck & Co.'s Vioxx, a Cox-2 inhibitor, for treatment of arthritis and acute pain in adults.

-June 2000: Merck gives FDA results of a study known as VIGOR, in which patients taking Vioxx had five times the rate of heart attacks than those taking an older pain reliever, naproxen. Merck contended naproxen had cardioprotective effects that prevented users from suffering heart problems.

-September 2001: FDA sends Merck a warning letter saying a promotional campaign "minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."

-April 2002: FDA changes Vioxx package insert to reflect VIGOR heart attack findings.

-Sept. 30, 2004: Merck voluntarily withdraws Vioxx from the market after halting a long-term study that it said showed Vioxx could double risk of heart attack or stroke if taken for at least 18 months. The study, called APPROVe, had focused on whether Vioxx could prevent reoccurrence of colon polyps.

-February 2005: FDA panel concludes Vioxx and other similar drugs all pose heart risks, but should be available to consumers.

-Aug. 19, 2005: Texas jury awards $253.4 million to the widow of Robert Ernst, who died in May 2001. Texas punitive damage caps will cut that to about $26 million.

-Nov. 3, 2005: A jury in Atlantic City, N.J., clears Merck in September 2001 heart attack of Boise, Idaho, postal worker Federick "Mike" Humeston, who had taken Vioxx for about two months.

-Feb. 17, 2006: Federal jurors in New Orleans clear Merck in the May 2001 death of Richard "Dicky" Irvin, who took Vioxx for about a month. This was a retrial; a December trial ended with a hung jury.

-April 11, 2006: A split verdict in Atlantic City, N.J. A state jury awards $13.9 million to 77-year-old John McDarby, who had a heart attack in April 2004, after four years on Vioxx. But it absolves Merck in the case of 60-year-old Thomas Cona, stricken June 9, 2003, after almost two years on the drug.

-April 21, 2006: A jury in Rio Grande City, Texas, awards $32 million to the family of Leonel Garza, 71, who had heart disease for 23 years and died in 2001 after less than a month on Vioxx.

-June 26, 2006: The prestigious New England Journal of Medicine publishes a correction to APPROVe: the risk of heart problems rose soon after people began taking the drug, not only after 18 months of use as Merck still contends.

-July 13, 2006: A jury in Atlantic City, N.J., rules Merck was not responsible for a heart attack suffered by Elaine Doherty, a 68-year-old diabetic homemaker. She had a heart attack in January 2004, after 2 1/2 years on the drug.

-Aug. 8, 2006: A jury in Los Angeles clears Merck in the 2001 heart attack suffered by Stewart Grossberg, 71.

-Aug. 17, 2006: A state judge in New Jersey overturns Merck's victory in the Humeston case, saying evidence uncovered since the November verdict warranted a new trial. She found of particular note the revelation that Merck left some heart attack data out of its VIGOR report.

-Aug. 17, 2006: A federal jury in New Orleans orders Merck to pay $51 million to Gerald Barnett, who began taking Vioxx in 2000, had a heart attack Sept. 6, 2002, and continued taking Vioxx until the week before it was withdrawn from the market.

-Aug. 30, 2006: Federal judge orders a new trial on Barnett's damages, saying $50 million compensatory is "grossly excessive."

WASHINGTON –(USDOJ) An American-based ship operator, Pacific-Gulf Marine, Inc. (PGM), has agreed to plead guilty to criminal charges that it engaged in deliberate acts of pollution involving a fleet of four ships in violation of the Act to Prevent Pollution from Ships, the Justice Department announced today. As part of the plea agreement, PGM will pay a $1 million criminal fine and $500,000 for community service, if approved by the court. In a related case, a federal grand jury returned an indictment late yesterday, charging two former Chief Engineers of the M/V Tanabata (one of the ships in the fleet), with various environmental crimes.

According to documents filed in court, including a Joint Factual Statement signed by the company’s Chief Executive Officer, PGM has admitted that ship records misrepresented that hundreds of thousands of gallons of oil-contaminated bilge waste were properly discharged overboard through required pollution prevention equipment, when in reality the ships used bypass equipment, sometimes referred to as a magical pipe, to circumvent the device, known as an Oily Water Separator.

In agreeing to plead guilty, PGM admitted that its shore-side management “failed to provide sufficient management resources and support to the ships, and also failed to exercise sufficient supervision and management controls to prevent or detect criminal violations by its employees.” The motive for the criminal conduct was to save money, according to papers filed in court.

After learning of the federal investigation, PGM voluntarily disclosed to the United States the results of an internal investigation comprised of approximately 50 reports of interviews with various current and former employees who had worked aboard the from the four giant “Car Carrier” vessels used to transport vehicles. “The government was previously unaware of PGM’s internal investigation and did not request or require the disclosure,” according to papers filed in court. “Many of the interviews contained confessions, admissions or otherwise revealed incriminating information and evidence of illegal conduct relating to environmental violations,” according to documents filed in court.

“Companies that voluntarily assist in federal criminal investigations and accept responsibility for their own crimes will receive credit,” said U.S. Attorney Rod J. Rosenstein for the District of Maryland. “By waiving privilege claims and disclosing the results of its own internal investigation, PGM helped to ensure that others also will be held accountable. Just as we give consideration to individual criminals who tell us what they know about crimes by other people, so too we reward corporations that voluntarily disclose the results of their internal investigations.”

Both the Department of Justice and the EPA have voluntary disclosure programs under which a company can seek non-prosecution if it discovers violations and reports them in a timely manner prior to a government investigation.

“The defendants in this case have openly admitted to committing serious criminal acts over a prolonged period of time, including intentionally bypassing pollution controls to make illegal oil discharges from multiple ships,” said Sue Ellen Wooldridge, Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division. “We remain committed to working with the Coast Guard and the EPA to prosecute cases of deliberate pollution and to deter others from engaging in similar acts.”

The criminal investigation began on September 2, 2003, after U.S. Coast Guard inspections of the M/V Tellus and M/V Tanabata in Baltimore, MD. However, like an earlier inspection on March 29, 2003, in which a bypass pipe laden with oil was found hidden under the engine room floor of the M/V Fidelio, another ship managed by PGM, engineers denied any illegal conduct. On the M/V Tanabata, the pipe used to bypass the Oily Water Separator was referred to on board as “the Magical Pipe,” and it was allegedly thrown overboard by the ship’s Chief Engineer after the Coast Guard inspected the vessel in Baltimore.

“The Coast Guard is particularly concerned that those responsible for operation of U.S.-flagged vessel would engage in such systematic and egregious conduct. We are fully committed to fulfilling our mission as a steward of our oceans and will continue to seek punishment for both corporations and individuals that knowingly pollute the marine environment regardless of their nationality,” said Rear Admiral Craig E. Bone, U.S. Coast Guard Assistant Commandant for Prevention.

“The laws are to prevent our oceans and waterways from being used as dumping grounds for hazardous materials and waste,” said Granta Y. Nakayama, EPA's Assistant Administrator for the Office of Enforcement and Compliance Assurance. “Those who violate these laws for the sake of illegal profits will be prosecuted.”

Engine room operations on board large ocean going vessels generate large amounts of waste oil and oil-contaminated bilge waste. International and U.S. law prohibit the discharge of waste containing more than 15 parts per million oil and without treatment by an Oil Water Separator and oil sensing equipment—a required pollution prevention device. The regime, established by the MARPOL Convention (Annex I), a treaty signed by more than 135 countries representing approximately 97.5 % of the world’s commercial tonnage and implemented into U.S. law by the Act to Prevent Pollution from Ships, also requires that overboard discharges be recorded in an Oil Record Book.

Under the terms of the proposed plea agreement, which must be approved by the court, $1 million will be paid as a criminal fine and $500,000 will be devoted to community service. The community service projects, to be administered by the National Fish & Wildlife Foundation, include funding of environmental projects in Chesapeake Bay and to provide environmental training to those enrolled in U.S. maritime academies. PGM must also remain on probation for three years under the terms of a government required environmental compliance plan that includes an outside independent auditor and a court appointed monitor paid for by the defendant.

Stephen Karas and Mark Humphries, former Chief Engineers of the M/V Tanabata, were charged with conspiracy, violation of the Act to Prevent Pollution from Ships for failing to maintain an Oil Record Book, and false statements. Karas was also charged with a count of obstruction of justice for alleged witness tampering while Humphries has been charged with a count of obstruction for the alleged destruction of evidence — allegedly throwing the bypass pipe overboard after the Coast Guard inspection in Baltimore. The investigation is continuing. An indictment represents allegations brought by a grand jury. Defendants are presumed innocent until proven guilty.

This investigation was conducted by the Chesapeake Regional Office of the Coast Guard Investigative Service and the EPA Criminal Investigation Division. Additional assistance was provided by U.S. Coast Guard Sector Baltimore, U.S. Coast Guard Activities Europe, U.S. Coast Guard Fifth District Legal Office, Coast Guard Office of International and Maritime Law, and Coast Guard Headquarters Office of Investigations and Analysis. The case is being prosecuted by the U.S. Department of Justice Environmental Crimes Section and the U.S. Attorney’s Office for the District of Maryland.

Breaking Legal News.Com
Sheryl M. Jones
Staf Writer

WASHINGTON, D.C. (USDOJ) —The first members of pre-release music piracy groups from Operation FastLink were sentenced today, Assistant Attorney General Alice S. Fisher of the Justice Department’s Criminal Division and U.S. Attorney Chuck Rosenberg of the Eastern District of Virginia announced. Derek A. Borchardt, age 22, of Charlotte, NC, Aaron O. Jones, age 30, of Hillsboro, Ore., and George S. Hayes, age 31, of Danville, Va. were sentenced for their involvement with Internet music piracy groups.

Borchardt and Jones each pleaded guilty to a single felony count of conspiracy to commit copyright infringement for their involvement in the pre-release music group “Apocalypse Crew” or “APC.” Jones was sentenced to six months in prison/six months home confinement and Borchardt was sentenced to six months home confinement by United States District Court Judge Claude M. Hilton. Matthew B. Howard, age 24, of Longmont, Colo., another member of the APC conspiracy, will be sentenced by Judge Hilton on May 26, 2006.

Hayes who previously pleaded guilty to one count of criminal copyright infringement related to his involvement in another pre-release music group called “Chromance” or “CHR” was sentenced to 15 months in prison by United States District Court Judge Leonie M. Brinkema.

These are the first federal criminal sentences for members of pre-release music groups from Operation FastLink, an ongoing federal crackdown against the organized piracy groups responsible for most of the initial illegal distribution of copyrighted movies, software, games and music on the Internet. Operation FastLink has resulted, to date, more than 120 search warrants executed in 12 countries; the confiscation of hundreds of computers and illegal online distribution hubs; and the removal of more than $50 million worth of illegally-copied copyrighted software, games, movies and music from illicit distribution channels. As of today, Operation FastLink has yielded felony convictions for 30 individuals.

“Federal law enforcement is dedicated to prosecuting online piracy in all forms,” said U.S. Attorney Rosenberg. “These sentences are part of a concerted federal effort to ensure that pirates cannot hide behind the perceived anonymity of the Internet.”

The defendants sentenced today were leading members of pre-release music groups. As detailed in the statements of facts filed with the three plea agreements, these individuals were active members of pre-release groups; that is, groups that acted as "first-providers" of copyrighted works to the Internet – the so-called "release" groups that are the original sources for a majority of the pirated works distributed and downloaded via the Internet.

As leading members of the pre-release music groups Apocalypse Crew and Chromance, these defendants sought to acquire digital copies of songs and albums before their commercial release in the United States. Once a group prepared a stolen work for distribution, the material was distributed in minutes to secure computer servers throughout the world. From there, within a matter of hours, the pirated works are distributed globally, filtering down to peer-to-peer and other public file sharing networks accessible to anyone with Internet access.

Operation FastLink is the culmination of multiple FBI undercover investigations. The Recording Industry Association of America (RIAA) and several of its member companies provided substantial assistance to the FBI in its investigation of the pre-release music scene. RIAA members create, manufacture and/or distribute approximately 90 percent of all legitimate sound recordings produced and sold in the United States.

This case was prosecuted by Jay V. Prabhu, trial attorney for the Justice Department’s Computer Crime and Intellectual Property Section and a Special Assistant U.S. Attorney in the Eastern District of Virginia.