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Court denies test drugs to dying patients
Legal Career News |
2007/08/08 14:44
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People who are dying do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court here ruled Tuesday. In an 8-2 decision, the court said federal drug regulators were entrusted by law with deciding when new drugs were safe for wide use.
The families of terminally ill patients, several of whom died after they were denied promising drugs that were still in tests, filed suit. They said that patients who were dying were far more willing to take risks and argued that they should not be forced to wait years for new treatments to win final approval from the Food and Drug Administration.
The judges said the families should take their pleas to Congress, not the courts.
However, the two dissenters said the ruling ignored the Constitution's protection for individuals and their right to life, and instead bowed to "a dangerous brand of paternalism" that put the government's interest first.
Leaders of the Abigail Alliance for Better Access to Developmental Drugs said they would appeal to the Supreme Court. The group was named in honor of Abigail Burroughs, a 21-year-old University of Virginia student who died of cancer in 2001. Her father, Frank, said she was denied the use of two investigational anti-cancer drugs that were recommended by her oncologist. These drugs later received FDA approval.
"We are talking about terminally ill patients and about drugs that were shown to work in earlier trials," said alliance co-founder Steve Walker, a St. Petersburg, Fla., geologist whose wife died of colon cancer.
In 2003, the alliance petitioned the FDA, urging it to change its rules so that drug companies could make available to dying patients "investigational drugs" that had won preliminary approval. There is a "different risk-benefit trade-off facing patients who are terminally ill and have no other treatment options," it said.
The FDA turned away the plea, saying it needed "to maintain a strong clinical trial system" to gather evidence before approving drugs for general use.
With the aid of the Washington Legal Foundation, a conservative nonprofit, the alliance sued the FDA. It said the Constitution should be read to "embrace the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor . . . to seek access to investigational medications that the FDA concedes are safe and promising enough for substantial human testing."
The case touched on issues that had been debated fiercely in medical and legal circles.
Medical experts have long disagreed on whether the FDA moves too slowly or too quickly in approving new drugs. Some doctors have argued that clinical trials should be opened to more patients who might benefit from the new treatments.
And since the Roe vs. Wade ruling in 1973 that set out the right to abortion, many legal scholars have frowned on judges creating "new rights" from vague clauses in the Constitution. The suit over new drugs focused on the 5th Amendment, which says "no person shall be . . . deprived of life, liberty or property, without due process of law."
In 2004, a federal judge rejected the alliance's suit, saying there was "no constitutional right of access to unapproved drugs."
Last year, however, a three-judge panel of the U.S. appeals court sided with the group.
In a 2-1 decision, it said a "terminally ill, mentally competent adult patient" had a right to "potentially lifesaving investigational new drugs" which had been found to be safe for humans.
But before that decision could take effect, the full U.S. Court of Appeals for the District of Columbia voted to rehear the case. And Tuesday, it reversed its panel's ruling.
"We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," said Judge Thomas B. Griffith, a Bush appointee, citing a Supreme Court decision that rejected the notion of a constitutional right to die. Griffith's opinion was joined by conservative and liberal members of the appeals court.
The two dissenters were Judge Judith W. Rogers, a Clinton appointee, and Chief Judge Douglas H. Ginsburg, a Reagan appointee.
"In the end, it is startling," Rogers wrote, that the Constitution has been read to include unnamed "fundamental rights" to marry, to control a child's education, to have sex in private and to have an abortion, "but the right to save one's life is left out."
Julie Zawisza, an FDA spokeswoman, said the agency was pleased with the ruling because it upheld the agency's "role in facilitating appropriate treatment access to investigational therapies while at the same time protecting the public at large by requiring that drugs are proven to be safe and effective before they may be marketed to U.S. consumers."
She also said that "on a limited basis," some patients and their doctors were permitted to obtain new drugs that were in clinical trials. |
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Student pleads not guilty to hazing charge
Lawyer Blog News |
2007/08/08 13:48
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A Rider University student pleaded not guilty on Wednesday to an aggravated hazing charge in connection with the binge drinking death of a freshman earlier this spring. Adriano DiDonato, 22, of Princeton, did not speak during the arraignment at the Mercer County Courthouse as his lawyer Paul Norris entered a not guilty plea on his behalf. A second student, Dominic Olsen, 21, of Kenilworth, who was originally scheduled to be arraigned along with DiDonato had his hearing delayed until next week, said Mercer County Prosecutor spokeswoman Casey DeBlasio.
Speaking after the court hearing, Norris said that his client was devastated by the death of Gary DeVercelly Jr., of Long Beach, Calif.
"This is a tragic event and by no means does Adriano minimize what happened here," Norris said. "He's very sad about what happened, as is the rest of the fraternity."
DeVercelly had a blood-alcohol level of 0.426 percent, or more than five times New Jersey's legal limit for driving, when he was pronounced dead March 30 at a Trenton hospital, authorities said. He died one day after drinking at a party at the Phi Kappa Tau house on the private school's campus in central New Jersey.
The party, according to prosecutors, was a special event in which pledges such as DeVercelly would drink with fraternity members. Some of the pledges drank entire bottles of hard liquor in under an hour, prosecutors have said.
Olsen was the pledge master of the fraternity's spring 2007 pledge class, and DiDonato was the fraternity's residence director and house master.
Two school officials and a third student were also charged in connection with DeVercelly's death: Ada Badgley, 31, the university's director of Greek life; Anthony Campbell, 51, the dean of students; and Michael J. Torney, 21, the fraternity chapter president.
The indictments mark one of the first times that university officials have been criminally charged in a suspected hazing death, according Doug Fierberg, a lawyer retained by DeVercelly's parents, who has represented hazing victims since the mid-1990s.
Torney and Campbell were to be arraigned Thursday, while no date had yet been set for Badgley's court appearance, DeBlasio said.
Jonathan Meer, Rider's vice president of university advancement, said Tuesday that no decision had been made about the employment status of the two school officials.
If convicted, the officials and fraternity members would face a maximum penalty of 18 months in prison and a fine of up to $10,000.
The school dissolved the Phi Kappa Tau chapter last Friday. |
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Cargill Settles Class-Action Suit
Class Action News |
2007/08/08 13:45
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Wichita, Kan.-based Cargill Meat Solutions has settled for $1.1 million a federal class-action lawsuit filed by Pennsylvania-based employees who claimed they weren't compensated for all the hours they worked.
The lawsuit, filed in March 2006 by seven workers at Cargill's meat processing plants in Wyalusing, Pa., and Hazleton, Pa., alleged that, beginning in March 2003, they weren't paid for time spent performing pre- and post-shift duties, including cleaning and sanitizing protective gear.
In August 2006, U.S. District Court Judge William Nealon certified the class-action complaint, joined by 4,100 former and current workers from the Hazleton plant and 2,300 from the Wyalusing facility.
The settlement, reached late last month, will pay those who opt in between $300 and $900, depending on their job and length of service. Their attorneys will receive nearly $330,000.
The judge's approval effectively dismisses the claims, and bars any employee who chooses to receive payment from suing Cargill with the same claims. |
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Conn. Home Invasion Suspects in Court
Lawyer Blog News |
2007/08/08 12:43
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Two suspects in a burglary and arson that left three people dead and rocked a suburban town last month faced a slew of charges Tuesday in a heavily secured courthouse. Family members of the victims - the wife and daughters of a prominent doctor, who survived the attack - filled two rows in the packed courtroom. A man was escorted from the courtroom after he yelled "Killer!" as Joshua Komisarjevsky faced the judge. Otherwise, the brief hearing was quiet. Komisarjevsky, 26, and Steven Hayes, 44, did not enter pleas and spoke only to answer yes or no questions. Department of Corrections special operations team members wearing fatigues and heavy, black vests kept watch on the two. The men have been held on $15 million bond since July 23, when they are accused of taking the family hostage, killing 48-year-old Jennifer Hawke-Petit and her two daughters, Hayley, 17, and Michaela, 11. The state medical examiner said Hawke-Petit, who was taken to a bank and forced to withdraw money during the ordeal, was strangled. The girls died from smoke inhalation after the family's suburban Cheshire home was set ablaze. William Petit Jr. was badly beaten but managed to escape. He did not attend Tuesday's hearing. Jeremiah Donovan, the attorney appointed to represent Komisarjevsky as a special public defender, acknowledged the challenge of working on such a high-profile case. "I myself live with a beloved wife and two lovely daughters, but I'm going to defend Joshua with all the ability and all the vigor that I might have," he said. Komisarjevsky and Hayes, who met in a halfway house and were on parole when the crime occurred, are charged with capital felony, kidnapping, sexual assault, assault, burglary, robbery, arson, larceny and risk of injury to children. Prosecutors have said they will seek the death penalty. |
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Local judge to hear property tax class action suit
Lawyer News |
2007/08/08 11:47
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Hancock County Circuit Court Judge Richard Culver spent two hours this morning in private chambers with attorneys representing the Marion County homeowners who filed a class action lawsuit challenging property assessments and the county assessor's office.
Some of the claims made in the lawsuit were addressed when the Indiana Department of Local Government Finance ordered a reassessment for all real property in the county.
The only remaining questions concern the timing of refunds to taxpayers who paid up before the deadline and who has jurisdiction over the issue.
The hearing was rescheduled for 9 a.m. next Monday and Culver issued a written statement. The court will determine if the remaining issues can be resolved by agreement. |
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W.Va.: Ex-Senator, Husband Plead Guilty
Criminal Law Updates |
2007/08/08 10:51
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| A former West Virginia state senator pleaded guilty Tuesday to federal mail and tax fraud charges. Lisa Smith admitted that she failed to pay the IRS more than $86,000 withheld for taxes from her employees' wages when it was due in 2002. The 43-year-old Putnam County Republican ran two in-home health care companies, Elite Professional Health Associates and Elite Health Care Inc., with her husband. Smith also admitted she mailed a false campaign finance statement to state election officials while running for her Senate seat in 2002. Federal prosecutors allege Smith had given her campaign $15,000 illegally siphoned from her businesses, then concealed it as contributions from various individuals. Smith's husband also pleaded guilty Tuesday. Mark Smith admitted to a tax fraud charge involving $63,000 in withholding taxes due in 2004 from the health care companies. The Smiths had faced a 17-count indictment in the case. The charges also included tax evasion and tax fraud counts against them both, alleging nearly $1 million in unpaid withholding taxes, as well as campaign-related mail fraud counts against the former legislator. Each pleaded guilty as part of separate agreements with prosecutors. Though court officials have yet to calculate the punishment recommended under federal sentencing guidelines, their plea agreements suggest prison terms of up to five years each as well as fines. The couple remains free on bail pending a Nov. 5 sentencing hearing. Lisa Smith had served two terms in the House of Delegates when she challenged and defeated then-Senate Finance Chairman Oshel Craigo, D-Putnam, in a 2002 election upset. She resigned the Senate seat in December 2004, citing an undisclosed illness. The Smiths were indicted in early 2006. The case was delayed after Lisa Smith was found mentally incompetent to stand trial. She received treatment at a Federal Bureau of Prisons facility, and U.S. District Judge Robert C. Chambers declared her competent in late March. Lisa Smith remains in a doctor's care and relies of various medications for her mental health, Chambers was told Tuesday. |
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