FDA Must Classify Mercury Fillings

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----- Forwarded Message ----From: "humanadjuvantdisease@..." humanadjuvantdisease@...We Win -- FDA Must Classify Mercury Fillings We have won our ten-year battle to get the Food and Drug Administration to comply with the law and set a date to classify mercury amalgam. On Monday, we settled our lawsuit, Moms Against Mercury et al. v. Von Eschenbach, Commissioner, et al. FDA will finish classifying within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009. There’s more good news. During a several hour negotiation session, FDA agreed to change its website on amalgam --dramatically. Gone, gone, gone are

all of FDA’s claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 Scientific Panel vote affirmed amalgam’s safety. Instead -- see http://www.fda.gov/cdrh/consumer/amalgams.html -- FDA has moved to a neutral course, while recognizing the serious health concerns posed by amalgam in particular for children and unborn children, for pregnant women, for those with mercury immuno-sensitivity or high mercury body burdens. FDA now states, for example: “Dental amalgams contain mercury, which may have neurotoxic effects On the nervous systems of developing children and fetus.â€ï¿½ “Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their

health practitioner.�†Perfect? No. A 180-degree reversal from FDA’s 30-year policy of protecting mercury fillings? Absolutely. To change FDA policy, we tried petitions, Congressional hearings, state fact sheet laws, Scientific Advisory Committee hearings, and letters galore -- to no avail. So in the great American tradition, we sued. The case came to a head this spring. On April 22, working with Johann Wehrle and Gwen , I filed a motion for an injunction before Judge Ellen Huvelle. Three sets of briefs later, the government and I presented our oral arguments on May 16. In a crucial ruling, Judge Huvelle ruled that our 11 plaintiffs -- the diverse group listed below -- have standing. She said FDA should classify, and invited the two sides to mediate. On May 30, before Magistrate Judge Facciola, Bob Reeves (who flew in from Lexington KY) and I hammered out an agreement with FDA officials and lawyers. The

impact of the re-writing of its position on amalgam can hardly be understated. FDA’s website will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam’s risk to children, young women, and the immuno-sensitive persons in its website, I find it inconceivable that FDA will not in some way protect them in its upcoming rule. Charlie Brown 3 June 2008 PS 1: Our talented (and pro bono publico) legal team includes Consumers for Dental Choice president Sandy Duffy, Bob Reeves, Johann Wehrle, Keech, Mike McClory, and Gwen ; Larry Pilot served as legal advisor on the FDCA. PS 2: Great appreciation to our gutsy plaintiffs, a team of four nonprofit groups, two public officials, three dental

professionals, and two consumer victims: Moms Against Mercury (Amy Carson and Medlin), Connecticut Coalition for Environmental Justice (Dr. Mark ), Oregonians for Life ( Starrett), mercury expert Bender (in his capacity as Commissioner of a Vermont advisory board on mercury), Arizona Senator , Dr. Andy Landerman, Dr. Corrie Crowe, dental assistant Palmer, consumer advocates Brocato and Anita Vazquez Tibau, and (of course) Consumers for Dental Choice. G. Brown, National Counsel Consumers for Dental Choice 316 F St., N.E., Suite 210, Washington, DC 20002 Ph. 202.544-6333; fax 202.544-6331 charlie@..., www.toxicteeth.org

More Dental Amalgam News: Send your comments to the FDA about the hazards associated with dental amalgams. The deadline is July 28, 2008. Communication may be sent via the following methods of transmission: 1. Fax (301) 827 6870 2. Electronically http://www.regulations.gov. In the search box enter: FDA-2008-N-0163 3. Mail Division of Dockets Management (HFA-305) FDA 5630 Fishers Lane, Room 1061 Rockville, MD 20852

Medical Device News

Dems Readying Liability Legislation Wed. Jun 4, 2008 Democrats rankled by a recent Supreme Court decision shielding medical device companies from state liability lawsuits plan to unveil legislation to reverse the ruling, the first of many expected efforts to chop away at federal rules that restrict consumers' ability to sue. House Energy and Commerce Health Subcommittee Chairman Pallone, D-N.J., and House Oversight and Government Reform Chairman Henry Waxman will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients' ability to seek damages under state law, a Pallone spokesman said. The two were spurred to act after the Supreme Court ruled in February that patients injured by defective medical devices

cannot sue for damages in state courts if the FDA approved the marketing of the product. The justices found that the 1976 Medical Device Amendments pre-empted the right of injured patients to sue for damages in state courts against the most complicated or high-risk devices that undergo FDA's strictest approval process. Justices are in various stages of weighing pharmaceutical preemption cases. Moreover, the issue has revved up the long-standing rivalry between trial lawyers and big-business lobbying groups, this time over the issue of how far can federal regulatory agencies go in preempting states on all sorts of consumer and product liability laws. With Democrats in control of Congress, the trial bar senses an opportunity to play offense after having to fend off attacks during 12 years of Republican control. Trial lawyers have started to target issues on a case-by-case basis where they sense that preemption has run amok

to the detriment of consumers who are unable to seek redress in the courts. They contend that pre-emption does not allow corporations to be held fully accountable for faulty products in the same way that the threat of a massive lawsuit does. Their first legislative bid will be on the recent Supreme Court ruling in favor of Medtronic Inc., which produced a heart catheter at the center of the case. The device burst during a 1996 angioplasty. "It basically threw out all the medical device cases in the country based on the wrong supposition that compliance with the device act constituted preemption of state tort law remedies," said Lipsen, senior vice president for public affairs for the American Association for Justice, the primary lobbying group for trial lawyers. Democrats came down on the side of the trial lawyers and immediately blasted the Supreme Court's decision. Senate Health, Education, Labor and Pensions Chairman

Kennedy, Pallone and Waxman all said Congress never intended when it passed the 1976 medical device law to give medical device manufacturers blanket immunity. Democrats attempted last summer to preserve patients' right to sue despite FDA regulation in legislation that would have given the agency additional drug and device oversight authority. Republicans quickly squashed the effort after billing it as a gift for trial lawyers. Given the dwindling legislative calendar this year, particularly with the November elections looming, any measure introduced will have to fight for time on the floor. It is likely to frame the debate for the 111th Congress, particularly if Democrats add to their legislative majorities in the House and Senate and especially if a Democrat wins the White House. "Patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries. This doctrine is

known as preemption," Waxman said during a hearing last month on issue. "The result is that one of the most powerful incentives for safety -- the threat of liability -- would vanish." The U.S. Chamber of Commerce's Institute for Legal Reform is fighting efforts to deny preemption, noting that federal law should trump state statutes when there are inconsistencies between the two. It further argues that preemption allows companies that conduct business in different states one set of rules for compliance, instead of a hodgepodge of laws that stifle growth. "I think they have articulated for a long time the weakening preemption at the federal level," said Rickard, president of the institute. "They have highlighted this in their magazines and their conferences," she said, referring to the American Association for Justice. Opponents rely on an old standby: bashing the trial bar. At the urging of business leaders, Republicans

targeted trial lawyers when they were in control, passing legislation that limited class-action suits and restricted bankruptcy filings. They argue that preemption is narrowly tailored in response to high court damages that threaten to wreak havoc on the medical and pharmaceutical fields as well as other sectors. "Current preemption policy is nothing novel or radical, but a dynamic response to an increasingly litigious environment that undermines the effectiveness of the long-established FDA regulatory system," said House Oversight and Government Reform ranking member Tom . The trial bar argues that the Bush administration has instituted the preemption strategy to an unprecedented degree, noting that since 2005 federal agencies have issued 51 different rules that have preempted state law. The FDA and the National Highway Traffic Safety Administration issued most of the rules, but they also came from smaller agencies such as

the Federal Railroad Administration. For example, NHTSA is in the process of finalizing a rule before the end of the month that would institute new requirements for car roofs in an attempt to reduce injuries and death from rollover crashes, where 10,000 people die annually and another 24,000 are seriously injured. A preliminary rule would allow preemption of state law on product liability suits if carmakers met the NHTSA standard. One critic, Vladeck, a town University law professor, said that he is concerned with NHTSA's position given that the federal statue it operates under contains a "savings clause" that says compliance with the agency's standard does not exempt a business from liability on the state level. The Senate Commerce Consumer Affairs Subcommittee will hold a hearing on the proposal today. "If they don't succeed in the legislature, they will go to the regulatory process," Lipsen said of the

business lobbyists. "They are asking these regulatory agencies when they address rules on safety that if you are injured by one of these products, your case is pre-empted. ... It's really a whack-a-mole process." by Bill Swindell and Edney

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