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Tuesday, September 19, 2006

Judge OKs Owens bankruptcy exit plan: "Judge OKs Owens bankruptcy exit plan

By MICHAEL COWDEN Associated Press Writer
� 2006 The Associated Press
PITTSBURGH � A federal bankruptcy judge indicated Monday she approved of Owens Corning's plan for emerging from bankruptcy, more than five years after the building materials maker sought protection from creditors over health claims related to its asbestos products"

Body parts mystery remains for Masterpiece Theatre host: "Body parts mystery remains for Masterpiece Theatre host

Associated Press
NEW YORK -- After Masterpiece Theatre host Alistair Cooke died, errors in the medical records accompanying his body fell through the cracks, one by one.
His name was misspelled. His birthdate was off by 10 years. His Social Security number wasn't even close. The name of his doctor, contact information for a relative, the time and cause of his death: all wrong.
None of that prevented the removal and sale of the 95-year-old's arms and legs. The fate of his pelvis and other tissue remains a mystery.
The medical records, obtained by The Associated Press, provide the most in-depth look so far into the case of the famed TV personality, and raise more questions about the safety of the cadaver tissue industry: Why didn't the tissue processor that acquired Cooke's body parts catch any of the bogus entries?
For Susan Cooke Kittredge, the celebrity's daughter, the deception destroyed her trust.
'It's deeply disturbing,' she said. 'It throws out any kind of faith I had in the system. It's so broken. It's horrible to me that this wasn't caught.'
Where Kittredge's name might have appeared on the records, there is instead a bogus name and phone number for a family member who supposedly agreed to donate her father's body parts for tissue transplants.
Donated cadaver tissue is used in more than a million procedures a year in the United States to repair bad backs, fix ailing knees and replace heart valves. Most of these operations are safe and do tremendous good, but tissue that has not been treated properly or is taken from unscreened donors can infect a patient with hepatitis, HIV and other potentially deadly infections.
Tissue processor "

Drivers say Halliburton ignored dangers in Iraq: "Sept. 18, 2006, 11:35PM
Halliburton ignored dangers, drivers say

Copyright 2006 Houston Chronicle Washington Bureau
WASHINGTON - Halliburton Co. officials knew a highway intersection near Iraq's Abu Ghraib prison was fraught with danger hours before the deadly ambush of a truck convoy known as the Good Friday Massacre, former company truck drivers told Democratic senators Monday.
And the Houston-based contracting giant may have tried to shield itself from lawsuits by including a clause in an application for a Defense of Freedom Medal, in which survivors would sign away their rights to sue, according to a document unveiled by the panel Monday.
'That is almost an unbelievable piece of paper,' said Sen. Byron Dorgan, D-S.D., chairman of the Senate Democratic Policy Committee.
Asked about the clause, Halliburton spokeswoman Cathy Mann said: 'It was never KBR's intention to utilize any such release to preclude claims by current or former employees against the company. And we have no intention of doing so in the future.'
Appearing before Dorgan's panel of Democrats, former workers accused Halliburton subsidiary KBR of sending unarmed civilians into an area they had been warned was the site of attacks by insurgents.
'One question haunts me: Why would KBR/Halliburton knowingly send unarmed noncombatant civilians in military tankers down a closed road where there was an ongoing battle?' said Ed Sanchez of Silver City, N.M., who survived the Good Friday Massacre.
Six KBR truck drivers and two soldiers were killed in that ambush. Another driver and one soldier are still listed as missing.
The leader of the convoy, Tommy Hamill, was kidnapped. He later escaped.
Mann said Halliburton's 'priority has always been the sa"

Next Vioxx trial set to get under way - Yahoo! News: "NEW ORLEANS - The next federal Vioxx trial, which opens in federal court here on Monday, focuses on a man who began taking the painkiller after its label said that it could increase the risk of heart attacks.

But Robert Garry Smith, 56, said he didn't realize the drug, once a blockbuster for Merck & Co., might have brought on his February 2003 heart attack until he saw a lawyer's television advertisement in 2005.
'I was a perfectly healthy man until I took Vioxx and I had a heart attack,' Smith, a maintenance supervisor at a chemical plant in the Cincinnati suburb of Covington, Ky., said in a pretrial deposition.
The other nine plaintiffs whose cases have been heard so far in state and federal courts all began taking Vioxx before April 2002, when Merck added information in the label's 'precautions' section to say that using the drug could increase the risk of heart attacks.
The questions of whether that information should have been in the stronger 'warnings' section, and whether Merck should have added it two years earlier, have played major parts in those trials.
About 16,000 Vioxx lawsuits have been filed in state and federal courts, and Merck has said it wants each case heard on its own. However, U.S. District Judge Eldon Fallon has said he wants to work out a global settlement for the 5,700 federal Vioxx cases on his docket after hearing just five of them.
After the first verdict came in, Fallon had lawyers for the plaintiffs and for Merck each choose two other cases for early trial in his court. Smith's case is the second of this group of four, and the first that was chosen by Merck.
Seven other cases have been heard in state courts in Texas, New Jersey and California. Merck has won five cases and "

Monday, September 18, 2006

Two Vioxx Cases Combined for One Trial - Los Angeles Times: "Two Vioxx Cases Combined for One Trial
From Bloomberg News
September 14, 2006

Merck & Co. will face two plaintiffs at its second California trial over the painkiller Vioxx.

Los Angeles County Superior Court Judge Victoria Chaney on Tuesday overruled Merck's objections to trying the two cases simultaneously. Rudolph Arrigale, 77, and Lawrence Appell, 57, claim that Vioxx caused their heart attacks. Merck could have faced as many as four plaintiffs at next month's trial.

'We believe that each case is unique and that each plaintiff represents a different medical history,' Merck lawyer Thomas Yoo said Wednesday. 'Combining these cases invites jury confusion.'

Vioxx users or their family members have filed about 16,000 product liability suits against Merck. The Whitehouse Station, N.J.-based company pulled Vioxx from the market almost two years ago, when a study showed a higher risk of heart attack and strokes after 18 months of use. Last month, Merck won the first Vioxx trial in California.

The Journal of the American Medical Assn. on Tuesday published reviews of 137 studies that concluded Vioxx raised heart and kidney risks in some cases within a month of starting treatment, earlier than Merck has claimed.

Shares of Merck fell $1.06 to $41.09 on Wednesday. "

Court Approves Congoleum Settlement: Financial News - Yahoo! Finance: "Court Approves Congoleum Settlement
Wednesday September 13, 5:52 pm ET
By Marie Beaudette, Dow Jones Newswires
Court Approves Congoleum $16.95M Insurance Settlement for Asbestos Fund
WASHINGTON (AP) -- A federal court approved a settlement that will add $16.95 million to Congoleum Corp.'s trust to pay victims who were exposed to the company's asbestos-containing products.
The U.S. Bankruptcy Court in Trenton, N.J., signed off on the flooring manufacturer's settlement with insurer Century Indemnity on Monday, according to a note on the court's docket.

Congoleum said the Century deal brings total insurance settlements in the case to about $207 million. The company will use the settlement money to fund a trust to repay asbestos victims.
The Mercerville, N.J.-based flooring company is facing thousands of asbestos-related personal injury claims.
The company recently announced it has reached a tentative deal with bondholders and asbestos claimants' representatives on the terms of its Chapter 11 reorganization plan.
Congoleum said its bondholders have agreed to withdraw a reorganization plan they filed and support Congoleum's own turnaround plan. The official committee of bondholders had previously supported the Chapter 11 plan it proposed along with insurers Continental Casualty Co. and Continental Insurance Co.
Congoleum said it will file a new reorganization plan with the court by Friday and expects to seek approval of the plan's disclosure statement at an Oct. 19 hearing in the U.S. Bankruptcy Court in Trenton, N.J.
Congoleum, a subsidiary of American Biltrite Inc., filed for bankruptcy protection on Dec. 31, 2003.
Shares of Congoleum rose 1 cent to close at $2.22 Wednesday on the Am" Search: "Merck didn't reveal Vioxx risks, professor says
Man's suit blames drug for heart attack
Wednesday, September 13, 2006
By Susan Finch
A Harvard Medical School professor who studies prescription drugs told a federal court jury in New Orleans on Tuesday that Merck & Co. didn't level with doctors about the risks and benefits of Vioxx, a painkiller approved for sale in 1999 but pulled off the market in the fall of 2004 after studies linked its use to heart attacks.
Testifying via videotaped deposition in the lawsuit of a Kentucky man who blames Vioxx for his 2003 heart attack, Dr. Jerry Avorn said a Merck-financed study that compared the effects of Vioxx and Naproxen, an older drug of the same type, in 8,000 arthritis patients turned up an unexpected finding: Patients on Vioxx had five times more heart attacks as those on Naproxen.
But in a published article about the study, which also showed the two drugs performed about equally as painkillers, Merck said only that patients who took Naproxen had a decreased rate of heart attacks, Avorn said."

Merck tells workers not to discuss Vioxx in voicemails - MarketWatch: "Merck tells workers not to discuss Vioxx in voicemails

PrintE-mailDisable live quotesRSSDigg itDel.icio.usBy Peter Loftus
Last Update: 11:27 PM ET Sep 11, 2006

PHILADELPHIA (MarketWatch) -- Merck & Co. (MRK) agreed to tell its U.S. employees to immediately stop leaving messages about the painkiller Vioxx on the drug company's telephone voicemail system, according to an order from a New Jersey judge.
In an order signed Friday, New Jersey Superior Court Judge Carol Higbee in Atlantic City also said Merck and its employees must securely preserve existing Vioxx-related voicemail messages. She said the order doesn't apply to messages to and from Merck legal employees directly related to the massive Vioxx litigation, in which thousands of people have claimed the drug caused heart attacks and other health problems.
Higbee's order stemmed from a request by plaintiffs' attorneys for a court order requiring the company to preserve voicemails regarding Vioxx for potential use as evidence in litigation. Merck responded that doing so would be 'unduly burdensome,' Merck's outside attorney, Ted Mayer, said in a written statement Monday.
'Until the court has an opportunity to rule on this issue, we have instructed employees not to leave any Vioxx-related voicemails going forward and agreed to preserve whatever existing voice mails employees may have,' Mayer said.
Plaintiff attorneys with knowledge of the issue couldn't immediately be reached Monday.
Merck had about 31,900 employees in the U.S., including Puerto Rico, as of Dec. 31, the last period for which the company reported a head count. "

Smokers Seek Class-Action Suit Status

Sept. 12, 2006, 4:28PMSmokers Seek Class-Action Suit Status
By TOM HAYS Associated Press Writer © 2006 The Associated Press

NEW YORK — Lawyers for smokers of light cigarettes have asked a federal judge to grant class-action status to a lawsuit against major tobacco companies, allowing tens of millions of people nationwide to seek as much as $200 billion in damages.
In the lawsuit, filed in 2004, the smokers accused Altria Group Inc.'s Philip Morris USA Inc., R.J. Reynolds Tobacco Co., which is now part of Reynolds American Inc., and other defendants of deceiving them for more than 30 years by claiming low-tar cigarettes were less harmful than regular cigarettes. The manufacturers, they allege, knew the health risks were about the same.

U.S. District Judge Jack Weinstein is scheduled to hear arguments on Wednesday in Brooklyn.
As a class, light cigarette smokers would be entitled to between $120 billion and $200 billion in refunds for a deceptive product, plaintiff attorney Michael D. Hausfeld said Tuesday.

"Asbestos claimants predicted to OK exit plan


With bondholders, shareholders, and other creditors largely voting for Owens Corning's plan to exit bankruptcy, the Toledo firm sailed by another landmark this week in its six-year-old Chapter 11 case.
One other big creditor group, the asbestos-injury claimants, is expected to give its nod to OC's reorganization plan Friday.
That should clear the way for a court hearing Monday in Pittsburgh after which a judge could give the building products maker approval to emerge from bankruptcy. The city's third largest corporation filed for Chapter 11 protection on Oct. 5, 2000, because of mounting asbestos-liability claims.
'We remain on track to emerge from Chapter 11 before the end of October this year,' Jason Saragian, an OC spokesman, told The Blade yesterday.
OC's reorganization plan in U.S. Bankruptcy Court in Wilmington, Del., calls for paying asbestos victims $5.2 billion and banks and some other creditors $2.5 billion.
More than 131 million new shares of company stock valued at an estimated $3.9 billion would be issued under the plan, most of which would go to bondholders. Existing stock would be canceled.
In voting on this latest version of the exit plan - earlier plans had too much opposition - 94 percent of the bondholders approved it. The action was key, because some bondholders had been among the critics of previous bankruptcy-exit plans."

Tuesday, September 12, 2006

Studies Provide New Evidence on Risks Associated with Cox-2 Inhibitors and Non-Steroidal Anti-Inflammatory Drugs

CHICAGO - Two new review studies evaluating the safety of the pain-relieving medications selective cyclooxygenase 2 (COX-2) inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) find increased cardiovascular and kidney risks. The studies and an accompanying editorial were posted online today by JAMA because of the public health implications of the findings. The articles will appear in the October 4 print issue of JAMA.

"It is estimated that more than 30 million people worldwide take nonsteroidal anti-inflammatory drugs (NSAIDs) daily for treatment of pain and inflammation," according to background information provided in one of the articles. Adverse effects of some conventional NSAIDs include toxic gastrointestinal (GI) effects, as well as adverse renal (kidney) effects. "Overall, an estimated 2.5 million individuals in the United States annually experience adverse renal effects caused by use of NSAIDs," the authors write. "With decreased risk of adverse GI effects, a class of drugs that selectively inhibits COX-2 enzyme was introduced for analgesia (pain relief) and the treatment of arthritis." According to the authors, the adverse renal effects of selective COX-2 inhibition are unclear. Evidence is accumulating on the potential class effect of COX-2 inhibitors on cardiovascular risk. Two COX-2 inhibitors have already been withdrawn from the market: rofecoxib (marketed as Vioxx) and valdecoxib (marketed as Bextra).

Jingjing Zhang, M.D., Ph.D., from Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues evaluated the adverse risks of renal events and arrhythmia (disturbance of the normal heart rhythm) events in patients prescribed COX-2 inhibitors from a systematic review of the medical literature to determine if these negative side-effects involve every drug in this class.

"In this comprehensive meta-analysis of 114 randomized trials of COX-2 inhibitors comprised of 116,094 participants, rofecoxib uniquely increased risks of renal events (peripheral edema, renal dysfunction, hypertension) and arrhythmia events, with apparent adverse effects by the end of year 2000 and 2004, respectively," the researchers write. "However, the results did not show adverse effects of other COX-2 inhibitors on renal events and arrhythmia, indicating no overall evidence for a COX-2 inhibitor class effect."

In conclusion, the authors write: "Notably for policy and clinical decision making, our results also suggest that a time-cumulative meta-analytic approach for examining available trial safety data would have helped clarify apparently adverse effects several years earlier than the current report. The knowledge of all potential adverse effects is important and indeed time-sensitive, for physicians and patients both need complete information about risks and benefits to properly use COX-2 inhibitors and other clinical treatments." They continue, "future drug safety monitoring of emerging clinical treatments may benefit from continuous cumulative meta-analytic aggregation of safety data for all drug-approval applications and experimental agents."
(JAMA. 2006; 296:doi:10.1001/jama.296.13.jrv60015. Available pre-embargo to the media at

Editor's Note: Corresponding author Mr. Ding was supported by a grant from the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) and by an institutional training grant from the National Cancer Institute, National Institutes of Health. Dr. Song was supported by grants from the NIDDK, National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

In a related study, Patricia McGettigan, M.B.B.S., B.Pharm., F.R.A.C.P., Ph.D., and David Henry, M.B., Ch.B., F.R.C.P., from The University of Newcastle, New South Wales, Australia, conducted a meta-analysis of the observational studies in the medical literature to compare the risks of serious cardiovascular events (predominantly, myocardial infarction [heart attack]) with individual NSAIDs and cyclooxygenase 2 inhibitors (COX-2).

In background information, the authors write that interest in the cardiovascular effects of the relatively selective inhibitors of COX-2 has been intense. Although rofecoxib was withdrawn from world markets, celecoxib (marketed as Celebrex) "continues to be widely used, despite meta-analyses of randomized controlled trials showing an increased risk of myocardial infarction." The authors add, "attention has turned to the cardiovascular safety of the older non-selective non-steroidal anti-inflammatory drugs (NSAIDs). These agents are used extensively and some are available in many countries without prescription."

The authors based their analysis on 17 case-control analyses that included 86,193 cases with cardiovascular events and over 500,000 controls, and six cohort analyses that included 75,520 users of selective COX-2 inhibitors, 375,619 users of nonselective NSAIDs, and nearly 600,000 unexposed participants.

"A dose-related risk was evident with rofecoxib (relative risk 1.33 with 25 milligrams or less per day and 2.19 with more than 25 mg/day)," the authors report. "The risk was elevated during the first month of treatment. Celecoxib was not associated with an elevated risk of vascular occlusion. Among older non-selective drugs, diclofenac had the highest risk with a summary relative risk of 1.40. The other drugs had summary relative risks close to one: naproxen, 0.97; piroxicam, 1.06; and ibuprofen 1.07." The authors state that this review "contradicts claims of a 'protective' effect of naproxen and raises serious questions about the safety of diclofenac… "

"In conclusion, controlled data from observational and randomized studies confirm a dose-related risk of cardiovascular events with selective COX-2 inhibitors. The observational data indicate that the risk increases early in treatment. An older NSAID, diclofenac, seems to share this risk and, unlike celecoxib, it appears to be harmful at commonly used doses. We believe there are grounds for reviewing its regulatory status."
(JAMA. 2006; 296: doi:10.1001/JAMA.296.13.jrv60011. Available pre-embargo to the media at

Editor's Note: Funding for this review was provided through project grants from the National Health and Medical Research Council of Australia and the National Heart Foundation Australia. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: The Seduction of Common Sense
In an accompanying editorial, David J. Graham, M.D., M.P.H., from Silver Spring, MD writes, "in this issue of JAMA, two systematic reviews [by Zhang et al and by McGettigan and Henry] provide clarity on a topic that has been dominated more by disinformation than reason." He also discusses the findings of these two new studies and places them in context of other reports on risks associated with COX-2 inhibitors and other NSAIDS.

Dr. Graham writes, "What does this all mean? First, rofecoxib increases the risk of acute MI at low and high doses. … There is no initial 18-month period of immunity from risk. Celecoxib also increases risk at doses higher than 200 mg/d; at lower doses, the potential risk is less clear. Several other NSAIDs increase risk, including the COX-2 selective NSAIDs diclofenac and meloxicam, and the non-selective NSAID indomethacin and probably ibuprofen. Meta-analyses of randomized clinical trials and observational studies agree that naproxen is neutral for MI risk."

Dr. Graham also mentions that another COX-2 inhibitor NSAID, etoricoxib (which is not approved for use in the United States), recently was reported to have a risk of thrombotic cardiovascular events similar to diclofenac, with the implication that etoricoxib is safe from a cardiovascular perspective. However, he points out that "etoricoxib was compared with diclofenac, a drug shown to substantially increase the risk of acute MI" in another previous study and in the meta-analysis by McGettigan and Henry.

Dr. Graham concludes, "if the lessons of recent history have been learned, the FDA's concerns will now be squarely focused on patient safety rather than corporate profitability, and, ultimately, common sense will prevail."
(JAMA. 2006; 296:doi.10.1001/JAMA.296.13.jed60058). Available to the media pre-embargo at

Editor's Note: Dr. Graham reported no financial conflicts of interest, but reported that he was subpoenaed as a federal government expert by plaintiffs, for the purpose of providing testimony (in May 2006) that may be used in a number of Vioxx-related lawsuits, and reported that he received no compensation for this activity, other than his federal salary.

Dr. Graham is an employee of the U.S. Food and Drug Administration. This editorial was written by Dr. Graham as an officially approved outside activity in his private capacity and not as a Food and Drug Administration employee. The views expressed in this Editorial are the author's own, and do not reflect the official policy or position of the Food and Drug Administration.


For More Information: Contact the JAMA/Archives Media Relations Department at 312-464-JAMA or e-mail

Nail Polish Makers Yield on Disputed Chemical - New York Times: "Nail Polish Makers Yield on Disputed Chemical
Tony Cenicola/The New York Times
CHANGING FORMULA OPI Products has reformulated its nail polish to exclude dibutyl phthalate; Sally Hansen will make the change in 2007.
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Published: September 7, 2006
BOWING to pressure from environmental groups and European lawmakers, several cosmetics makers are removing a chemical from nail polish that is suspected of interfering with the endocrine system.
Orly International and OPI Products have already started selling reformulated nail polishes without the chemical, dibutyl phthalate. Sally Hansen plans to start selling similarly reformulated products in 2007.
Some studies have linked exposure to dibutyl phthalate � a plasticizing ingredient that has been used to increase flexibility in nail polishes as well as medical equipment � with testicular problems in rats and humans. The chemical is banned from use in cosmetics in Europe and is considered a reproductive toxin by California.
A study that examined nail polishes and perfumes, published in 2004 in The Journal of Toxicology and Environmental Health, concluded that the amount of exposure to dibutyl phthalate from these cosmetics is relatively small. The study cautioned, however, that total exposure to the chemical from multiple sources may be greater and requires further investigation.
Companies are adjusting formulas even though beauty executives said the ingredient is safe in the concentrations in which it is used in cosmetics.
�We are reacting here to changing consumer trends and a changing regulatory environment,� said Bruce MacKay, the vice president for scientific affairs/R&D of Del Laboratories, the maker of Sally Hansen. "

Merck Inquiry Backs Conduct Over Vioxx - New York Times: "Merck Inquiry Backs Conduct Over Vioxx
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Published: September 7, 2006
After 20 months and $21 million, the investigator that Merck�s board hired to examine the company�s conduct regarding Vioxx has rendered his verdict: The company behaved more or less perfectly.
So said a former federal judge, John S. Martin Jr., after an inquiry into whether the senior management at Merck hid the risks of Vioxx, its former best-selling pain drug.
�The report is essentially a very positive report, because that�s the conclusion I reached,� Mr. Martin said at a news conference yesterday to discuss his findings. The investigation by his law firm, Debevoise & Plimpton, was entirely independent, Mr. Martin said.
Mark Lanier, a lawyer for plaintiffs, said the report was a whitewash that contained no new information about Merck�s actions and had been prepared primarily to bolster the company�s defense in the civil suits.
In the report�s main body, there appear to be no company documents, e-mail messages or other evidence that has not already been publicly disclosed in the two years since Merck stopped selling Vioxx.
Nor did investigators involved in preparing the report interview Dr. Steven E. Nissen, Dr. Eric J. Topol or other prominent scientists who have criticized Merck, Mr. Martin said.
Merck stopped selling Vioxx in September 2004 after a clinical trial showed the drug could cause heart attacks and strokes. More than 30,000 people have sued the company, contending that Vioxx caused heart problems.
In four of the eight suits to reach a verdict, jurors have found the company liable, and in each of those cas"

Monday, September 11, 2006

Jury Finds for Widow in Body Armor Lawsuit - Los Angeles Times: "Jury Finds for Widow in Body Armor Lawsuit
Her husband, an Oceanside police officer, died after a bullet pierced his vest. Manufacturers are held partially responsible.
By Tony Perry, Times Staff Writer
September 8, 2006

SAN DIEGO � A jury awarded the widow of a slain police officer $3.6 million Thursday because his protective vest failed to stop a bullet fired by an ex-convict during a traffic stop.

After five days of deliberation, the San Diego County Superior Court jury found that the vest makers failed to warn Oceanside Police Officer Anthony Zeppetella that the vest could fail because its synthetic fibers would degrade over time.

Zeppetella, 27, was shot June 13, 2003, after stopping Adrian Camacho, a drug addict and ex-convict.

Camacho has been convicted and sentenced to death.

The jury couldn't reach a verdict on whether the vest was defective. But jurors rejected the manufacturers' argument that the bullet pierced the vest because of the angle at which it was fired.

The angle that the defense attorneys insisted the bullet had traveled was different from the angle determined by detectives in Camacho's trial.

'That was something we went over a lot,' said juror Camille Stern.

Juror Nancy Avila said she hopes the verdict sends a message. 'We have to do better to keep our officers and military safe,' she said. 'Personally, I wanted to give her more.'

Zeppetella was survived by his wife, Jamie, and a son, now 4. Second Chance Armor Inc., based in Michigan, and Japanese fiber-maker Toyobo Co. are liable for about $2.5 million of the $3.6 millio"

Tuesday, September 05, 2006

FDA Forms Task Force on Human Tissue Safety

The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety. The FDA Human Tissue Task Force (HTTF), which will be led by senior FDA officials from within the Center for Biologics Evaluation and Research
(CBER) and the Office of Regulatory Affairs (ORA), was established as part of the agency's efforts to strengthen its comprehensive, risk-based system for regulating human cells and tissue.
The main priority of HTTF will be to assess the effectiveness of the implementation of the new tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery.
"The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products," said Jesse Goodman, MD, MPH, director of CBER. "The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible."
While the agency believes most firms involved in tissue manufacturing comply with the new regulations, FDA wants to explore where additional steps could help strengthen its approach to making sure firms follow required practices to prevent the transmission of communicable diseases.
The agency continues to work diligently to identify and, where appropriate, take action against establishments and individuals that violate the rules. These actions may include both administrative and criminal proceedings.
"FDA is committed to rapidly identifying and stopping those establishments and individuals that risk endangering the public health by not complying with the regulations," said Margaret O'K Glavin, Associate Commissioner of the Office of Regulatory Affairs. "We also will continue to work with professional and trade associations to support their ongoing efforts to assure quality oversight of manufacturing operations and product safety."
"The creation of this task force underscores FDA's recognition that compliance with the rules in place to ensure recipient safety is our highest priority," Dr. Goodman said.
Within the next three months, the task force will develop an action plan, and where necessary, propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement its action plan.

Edward Jones Settles Class Actions: Financial News - Yahoo! Finance: "Edward Jones Settles Class Action Suits Over Mutual-Fund Sales for $127M
ST. LOUIS (AP) -- Edward D. Jones & Co. has signed a tentative $127 million settlement in nine class action lawsuits for questionable revenue-sharing and sales practices from 2004, the brokerage firm announced Thursday.

The St. Louis-based company is still awaiting a U.S. District Court judge's approval on the settlement. It would return $55 million in cash to customers and cover legal fees. It would also provide $72.5 million in non-cash vouchers to current clients over three years.
In December 2004, the Securities and Exchange Commission finished its investigation of the brokerage firm and found that the company created a conflict of interest by failing to disclose to its customers a revenue-sharing deal with mutual-fund companies."

Plaintiff Loaned Money to Vioxx Juror: "Plaintiff Loaned Money to Vioxx Juror

By LYNN BREZOSKY Associated Press Writer
� 2006 The Associated Press
HARLINGEN, Texas � Attorneys for Merck & Co. attorneys want to see bank and cell phone records that could show the extent of a juror's financial relationship with a plaintiff who won a $32 million verdict against the drug company in the death of a 71-year-old man who took Vioxx.
Jose Manuel Rios, a $22,000-a-year school janitor who served on the panel that found Merck liable for Leonel Garza's fatal heart attack after taking the painkiller Vioxx, testified in a post-trial deposition to borrowing up to $10,000 interest free from Garza's widow, Felicia, the plaintiff in the lawsuit against Merck. He said the loans included $2,500 that was paid off just weeks before he was selected as a juror in the case."