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Docs Support FDA Cough Medicine Warning
Consumer Rights |
2007/08/17 05:20
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Every parent in the country is likely familiar with over-the-counter cold medicines -- and even comfortable reaching for them when their children are ill. But a public health advisory issued by federal health officials Wednesday may change the way many parents view cough and cold preparations intended for their children's relief. The FDA said that children under 2 shouldn't be given these remedies without a doctor's order because of serious adverse effects, including death. Dr. Janet Serwint, associate professor of pediatrics at Johns Hopkins Children's Center in Baltimore, Md., said her past experiences certainly raise a red flag -- especially considering the dosing errors that send many children each year to hospitals for medical treatment. "I've been involved with cases in which the parent and the grandparent both gave the child the preparation without knowing it, and were not worried because it is over-the-counter," she said. "I have been in situations where parents gave more and more doses because they assumed it was safe." The advisory comes two months ahead of a scheduled FDA Nonprescription Drugs Advisory Committee meeting on Oct. 18-19 to discuss the use of the drugs by children -- a meeting spurred by a petition in March by a group of doctors, including Serwint. Concern may well be warranted. In January, a study conducted by the Centers for Disease Control and Prevention (CDC) showed that in 2004 and 2005, more than 1,500 children under the age of 2 had to be taken to an emergency department due to serious health problems after taking these common remedies. Three of these children died. Other reports have suggested that young children up to the age of 6 may be at risk of life-threatening adverse effects from the medications. The findings have prompted some doctors to worry that parents who give these products to their children may be putting them at risk for hallucinations, seizures and potentially fatal heart problems -- all in exchange for little, if any, real benefit. The medicines have since come under harsh scrutiny from at least one professional organization; last year, the American College of Chest Physicians recommended that parents avoid giving cough and cold medicines to their children, particularly younger children. Industry representatives continue to stand by the safety and efficacy of the products, however. In a statement issued Thursday, Linda Suydam, president of the trade association Consumer Healthcare Products Association (CHPA), which represents U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products, defended the remedies. "Millions of Americans safely and effectively use OTC cough and cold medicines every year, both for themselves and for their families," according to the statement. "These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medications families have trusted for decades to help relieve cough and cold symptoms and make their children feel better." But Dr. Joshua Sharfstein, commissioner of the Baltimore City Health Department, called this assertion "completely untrue." "There products have not been evaluated for safety in children," he said. "They kind of snuck in through an evaluatory back door." Cough medicines are one of a number of products whose safety profiles have been tested on adults, but not on children -- a concern reiterated in March by Dr. Charles Ganley, director of the FDA's office of nonprescription drug products. Sharfstein was also part of the group of doctors that petitioned the FDA to review the products on the grounds that they haven't been specifically evaluated for safety and effectiveness in this age group. "What we're asking is for these products to be held to a reasonable standard of safety and efficacy [for children]," he said. "To the extent that there is evidence in kids, the evidence is that they don't work." Pediatricians Urge CautionThe warnings about cough and cold remedies are being echoed by many pediatricians, who note that parents may not be aware of possible adverse effects. "In proper doses it is not dangerous, but some parents don't know what proper doses are," Dr. Lisa Thornton, a pediatrician at Children's Hospital in Chicago told ABC News medical editor Dr. Tim Johnson on ABC News Now's "Healthy Life" program Thursday. Part of the confusion over dosing, she said, has to do with the fact that the amount of the drugs taken by the child should be measured according to the child's weight rather than their age, since children of the same age can vary drastically in terms of weight. However, current dosing recommendations for the product are, in fact, based on a child's age. "What we discuss with parents is that these medicines do have dangerous side effects, even though they are sold over-the-counter," Thornton said. "Pediatricians need to stress to parents that these are medicines that are not without side effects." Alternatives to the Bottle and SpoonThornton noted that there are several drug-free ways to sooth a child's cough. Parents may want to place a vaporizer in the child's room, or have the child take a hot shower, as the steam may soothe their throats and sinuses. Even spending time with a child as they fall asleep can often help relax children when they are uncomfortable. And as for the medicines, it is still unclear whether the Oct. 18-19 meeting will yield new regulations. However, Sharfstein said he is optimistic. "I think it is very encouraging that this is going before an advisory committee," he said. "It's a mechanism for the FDA to really shift tracks on how it's treated these products." |
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Appeals court may let NSA lawsuits proceed
Court Watch |
2007/08/16 09:01
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Three federal appeals court judges hearing challenges Wednesday to the National Security Agency's surveillance programs appeared skeptical of and sometimes hostile to the Bush administration's central argument — that national security concerns require that the lawsuits be dismissed. "Is it the government's position that when our country is engaged in a war that the power of the executive when it comes to wiretapping is unchecked?" Judge Harry Pregerson asked a government lawyer in a tone of incredulity and frustration. Gregory G. Garre, a deputy solicitor general representing the administration, responded that the courts have a role, though a limited one, in assessing the government's assertion of the so-called state secrets privilege, which can require the dismissal of suits that could engender national security. Judges, he said, must give executive branch determinations "utmost deference." "Litigating this action could result in exceptionally grave harm to the national security of the United States," Garre said, referring to the assessment of intelligence officials. The three judges, on the 9th U.S. Circuit Court of Appeals, were hearing arguments in two combined lawsuits challenging the highly classified surveillance programs, which the administration said were essential in combatting international terrorism. The appeals were the first to reach the court after dozens of suits against the government and telecommunications companies over NSA surveillance were consolidated last year before the chief judge of the federal trial court here, Judge Vaughn R. Walker. The appeals concern two related questions that must be answered before the merits of the challenge can be considered: whether the plaintiffs can clearly establish that they have been injured by the programs, giving them standing to sue; and whether the so-called state-secrets privilege requires dismissal of the suits on national security grounds. Though the questions are preliminary, the impact of the appeals court's ruling may be quite broad. Should it rule for the government on either ground, the legality of the NSA programs may never be adjudicated. All three judges — appointed by Democratic presidents — indicated that they were inclined to allow one or both cases to go forward for at least limited additional proceedings before Walker. The two cases deal with different secret programs, but are broadly similar. One, a class action against AT&T, focuses mainly on allegations that the company provided the NSA with its customers' phone and Internet communications for a vast data-mining operation. The lawyers in the AT&T case call that program, which the government has not acknowledged, a "content dragnet." The second case, brought by an Islamic charity and two of its lawyers against the government, concerns a targeted program which the Bush administration calls the Terrorist Surveillance Program. The program, which has since been submitted to a secret court's supervision, bypassed court warrants to monitor international communications involving people in the United States. |
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Class-action lawsuit filed against Radian
Class Action |
2007/08/16 08:04
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A class-action shareholder lawsuit has been filed against Radian Group, the mortgage insurer whose endangered half-billion dollar stake in a subprime mortgage investor has sunk its stock price and put a planned merger with rival MGIC Investment Corp. in doubt. The U.S. District Court suit, filed in Philadelphia by San Francisco-based law firm Lerach Coughlin Stoia Geller Rudman & Robbins, is on behalf of investors who bought securities between Jan. 23 and July 31, the firm said late Wednesday. Among other things, the suit stated, Radian of Philadelphia failed to disclose that its $518 million investment in Credit-Based Asset Servicing and Securitization, known as C-BASS, was materially impaired and quickly declining in value, and that it overstated financial results by failing to write-down that investment in a timely fashion. Radian (NYSE:RDN) has said that the entirety of its investment in C-BASS may be lost. Since Radian issued a statement July 30 about the investment, its stock price has tumbled far below its pre-announcement price of about $40. It was trading down 3 percent Thursday at $16.14. MGIC (NYSE:MTG) of Milwaukee has said it is not obligated to go through with the merger but Radian has disputed that. The stock deal was originally valued at nearly $4.9 billion, but shares of both companies have lost more than half their value since it was announced Feb. 6. The deal called for an exchange of shares with Radian's stock valued at $60.78 per share |
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White House backs banks in Supreme Court case
Breaking Legal News |
2007/08/16 07:55
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The brief by the U.S. solicitor general contradicts a brief filed by the Securities and Exchange Commission, which argued for shareholders' rights to sue those third parties. "Allowing liability for a primary violation under the circumstances presented here would constitute a sweeping expansion of the judicially inferred private right of action" under securities law, wrote Solicitor General Paul Clement.
Such a move could expose customers, vendors and others to "billions of dollars in liability when issuers of securities make misstatements to the market," he wrote. Clement wrote that allowing third parties to be sued would "vastly expand liability in unpredictable ways."
The case, Stoneridge Investment Partners v. Scientific-Atlanta, Inc., has attracted considerable interest from lawmakers and industry associations. On Tuesday, Senate Banking Committee Chairman Christopher Dodd, D-Conn., asked President Bush to back the SEC's position.
Meanwhile, Securities Industry and Financial Markets Association President Marc Lackritz said allowing third parties to be held liable would result in skyrocketing litigation costs for companies.
"Investors already receive substantial protections under the law, and the Securities and Exchange Commission and other securities regulators are already armed with all the necessary regulatory tools to recoup lost money for investors," Lackritz said.
Similarly, the U.S. Chamber of Commerce, a business trade group, had urged the court to reject the expanded liability, known in legal terms as "scheme liability."
"Congress authorized the SEC to enforce securities laws against third parties and disburse funds to harmed investors," said Robin Conrad, executive vice president of the National Chamber Litigation Center.
"The Supreme Court should not upset that legislative decision by allowing class action lawyers to increase litigation risk and further hamper the competitiveness of American markets," Conrad said.
The Supreme Court is scheduled to hear the case in its fall term.
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Ohio Republican leaving the House
Politics |
2007/08/16 07:43
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Eight-term Rep. Deborah Pryce of Ohio will not seek re-election, GOP officials said Wednesday, making her the third prominent House Republican from the Midwest to announce retirement plans in recent days. Pryce, 56, was her party's fourth-ranking leader before the GOP lost control in the 2006 election. She narrowly survived a challenge last fall from Democrat Mary Jo Kilroy. Kilroy, a Franklin County commissioner, is running again in 2008, an election in which Democratic hopes run high because of voter disenchantment with President Bush and the Iraq war. Democrats says they also will compete strongly for the seats being vacated by former Speaker Dennis Hastert and seven-term Rep. Ray LaHood, both of Illinois. Top Republican officials in Ohio and Washington said she plans to step down when her term ends next year. One of the officials said the decision was largely a family matter for Pryce, the single parent of an adopted child. With Pryce's and Hastert's departures, only one of the top four House Republican leaders from the GOP-controlled 109th Congress appears likely to seek election next year: Roy Blunt of Missouri, the GOP whip. Former Majority Leader Tom DeLay, R-Texas, stepped down last year. Even before Pryce's plans became known, Democrats saw her Columbus-based district as among the most competitive held by a Republican. An open seat will be even more difficult for Republicans to defend, but party activists say they will do so, arguing that Democrats already failed once -- in 2006 -- when many factors were in their favor. Doug Thornell, a spokesman for the Democratic Congressional Campaign Committee, said: "Mary Jo Kilroy came within 1,055 votes of winning last cycle, and we expect this race to provide us with a tremendous opportunity to strengthen our majority." |
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Class-action suit filed against Pall
Class Action |
2007/08/16 06:03
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A Manhattan-based law firm has filed a class-action suit against Pall Corp., the manufacturer of high-tech filtration systems, which earlier this month said its financial statements dating to 1999 can no longer be relied upon and will have to be restated. Another law firm, in Hartford, Conn., Wednesday said it is seeking class-action status to file a suit against Pall, based in East Hills, and one of Long Island's largest employers.
The Manhattan law firm Lerach Coughlin Stoia Geller Rudman & Robbins LLP filed the class-action suit late Tuesday in U.S. District Court in Brooklyn, charging Pall and certain of its officers and directors with issuing "materially false and misleading statements that misrepresented and failed to disclose" that the company was overstating its financial results by understating its tax liability.
Pat Iannucci, a Pall spokeswoman, said, "We intend to defend the action vigorously."
The class-action suit noted that Pall reported it could owe more than $130 million in taxes, exclusive of interest or penalties, and that its financial statements for the fiscal years 1999 through 2006 "should no longer be relied upon and that a restatement of some or all of those financial statements will be required."
Pall said after markets closed July 19 that the audit committee of its board of directors had begun an inquiry into possible material understatement of U.S. income tax payments, beginning with the fiscal year ended July 31, 1999.
Investors sent shares of Pall plummeting. The stock fell over 15 percent in unusually high volume, to $41.11. On Aug 2, Pall said that its financial statements for the fiscal years 1999 through 2006 should no longer be relied upon. Additionally, Pall said it could owe up to $130 million in back taxes. Shares fell another 3 percent, or $1.21, to $39.90.
Shares of Pall fell $1.17 yesterday, to close at $35.48. The stock is still up 6 percent this year.
The Hartford-based firm Schatz Nobel Izard P.C. said Wednesday it is seeking class-action status in regard to filing a suit against Pall, but that it has not yet filed any suit against the company.
The law firm said in an announcement that Pall has and certain of its officers and directors have "violated federal securities laws."
Pall manufacturers systems that filter impurities out of everything from beer to blood. It is Long Island's seventh-largest company, in terms of revenues, which last year were $2.2 billion.
The company has about 10,828 employees, including 750 on Long Island.
Pall has sold its headquarters building in East Hills to Lowes, the home improvement retailer. Lowes plans to lease the site back to Pall for two or three years while it seeks approval to build a store there. Pall ultimately plans to consolidate its operations at a smaller facility in Port Washington, which it intends to expand. |
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Brodsky & Smith, LLC Announces Settlement of Class Action
Breaking Legal News |
2007/08/16 05:05
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Brodsky & Smith, LLC announces that a Court has preliminarily approved a class action settlement in TDH Partners v. The Ryland Group, Inc., et. al. involving all persons who purchased or otherwise acquired common stock of the Ryland Group, Inc. (NYSE: RYL) ("RYLAND"), between October 3, 2003 and January 7, 2004, inclusive, ("the Settlement Class"). This case is pending in the United States District Court for the Northern District of Texas. Pursuant to a Court Order, a hearing will be held in this case (the "Action") on December 11, 2007 at 10:00 A.M. before United States District Judge Jane Boyle, at the United States Courthouse, 1100 Commerce Street, Dallas, Texas 75242, to determine: (1) whether the settlement of claims asserted in this Action in return for payment of One Million, Two Hundred Thousand Dollars ($1,200,000.00) in cash plus accrued interest (the "Settlement Fund"), from which all administrative expenses, taxes owed and Court-awarded attorneys' fees and expenses will be paid, should be approved by the Court as fair, reasonable and adequate to the members of the Settlement Class; (2) whether the proposed plan of allocation for the Settlement Fund after payment of all administrative expenses, taxes owed and Court-awarded attorneys' fees and expenses (the "Plan of Allocation") is fair, reasonable and adequate to the members of the Settlement Class; (3) whether and in what amount to approve an incentive award to the Lead Plaintiff and whether to approve the application of the Class' Lead Counsel for an award of attorneys' fees not in excess of 33% and expenses not in excess of $150,000.00 should be approved; and (4) whether the Action should be dismissed with prejudice as set forth in the Settlement Agreement dated as of March 15, 2007 and filed with the Court. Persons who purchased or otherwise acquired the common stock of RYLAND during the period from October 3, 2003 through January 7, 2004, inclusive (the "Settlement Class Period"), may be affected by the settlement of this Action, including the release and extinguishment of claims they may possess relating to the purchase or other acquisition of the common stock of RYLAND during the Settlement Class Period. To share in the distribution of the Settlement Fund, eligible shareholders must establish their rights by mailing a Proof of Claim Form on or before November 15, 2007. Shareholders who desire to be excluded from the Settlement Class must file a request for exclusion by November 15, 2007, in the manner and form explained in the detailed Notice of Pendency and Proposed Settlement of Class Action. All members of the Settlement Class who have not requested exclusion from the Settlement Class will be bound by any judgment entered in the Action. |
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Class action or a representative action is a form of lawsuit in which a large group of people collectively bring a claim to court and/or in which a class of defendants is being sued. This form of collective lawsuit originated in the United States and is still predominantly a U.S. phenomenon, at least the U.S. variant of it. In the United States federal courts, class actions are governed by Federal Rules of Civil Procedure Rule. Since 1938, many states have adopted rules similar to the FRCP. However, some states like California have civil procedure systems which deviate significantly from the federal rules; the California Codes provide for four separate types of class actions. As a result, there are two separate treatises devoted solely to the complex topic of California class actions. Some states, such as Virginia, do not provide for any class actions, while others, such as New York, limit the types of claims that may be brought as class actions. They can construct your law firm a brand new website, lawyer website templates and help you redesign your existing law firm site to secure your place in the internet. |
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