AAJ: Generic Drug Immunity Disastrous for Patient Safety
March 28, 2011
Washington, DC—If the U.S. Supreme Court grants the generic drug industry immunity for failing to warn of their drugs’ possible side-effects, patients will face a much greater risk in suffering injuries, according to the American Association for Justice (AAJ) as the Court is set to hear arguments in Pliva v. Mensing on Wednesday. A result in favor of the drug industry could eliminate any incentive for generic manufacturers to ensure their drug is safe and adequately warns consumers of potential dangers.
AAJ: 510(k) Process Cannot Give Complete Immunity to Negligent Device Manufacturers
October 4, 2010
Washington, DC—The Food and Drug Administration (FDA) should strengthen post-approval requirements for 510(k) medical devices and increase scrutiny of complex devices – but not give complete immunity to manufacturers when their products are defective, according to comments submitted today by the American Association for Justice (AAJ).
Device Manufacturer’s Guilty Plea Shows Need for Medical Device Safety Act
April 6, 2010
Washington, DC—Yesterday’s admission by Guidant that the company suppressed critical safety information from the Food and Drug Administration (FDA) regarding two defibrillators shows why Congress must pass the Medical Device Safety Act so patients can hold manufacturers accountable for their defective products.
AAJ: FDA 510(k) Device Approval Process Not Protecting Health and Safety of Patients
March 18, 2010
Washington, DC—The Food and Drug Administration (FDA) should require post-market surveillance of 510(k) medical devices and have the power to repeal clearances if new safety data becomes available, according to comments submitted today by the American Association for Justice (AAJ). The comments are in response to the FDA’s on-going efforts to strengthen the medical device approval process.
Two Years After Riegel, Patients Still Without Legal Recourse
February 18, 2010
Washington, DC—With the two-year anniversary of the Supreme Court’s decision in Riegel v. Medtronic approaching Saturday, thousands of patients still have no legal recourse when they have been injured by faulty medical devices.
Studies Show FDA Lacks Rigorous Scientific Evidence to Approve Cardiovascular Devices
January 4, 2010
Washington, DC— Recently released studies show the Food and Drug Administration (FDA) lacks stringent scientific standards to evaluate cardiovascular devices and underscores the need to pass the Medical Device Safety Act (MDSA), according to the American Association for Justice (AAJ). Currently, device manufacturers have complete immunity from product liability if their devices prove unsafe or defective because of the Supreme Court decision in Riegel v. Medtronic.
Toys to Toxic Waste: New Report Details Corporations that Skirt Responsibility and Shun Consumer Safety to Save Money
October 28, 2009
Washington, DC—As the U.S. Chamber Institute for Legal Reform holds their annual summit – an event dedicated to championing corporate misconduct and evading accountability – a new report released today details true stories of corporations that knew their products were dangerous, yet failed to act and protect consumers.
Senate Hearing Highlights Victim’s Medical Device Nightmare, Asks Congress to Hold Manufacturer Accountable
August 4, 2009
Washington, DC—Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife across the Midwest to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking and thought it was from hitting road debris. He soon realized his heart defibrillator was malfunctioning and sending electrical shocks throughout his body while he was driving on the interstate.
Obama Memo on Complete Immunity Preemption Makes Clear Rule of Law Prevails Over Rule of Politics
May 20, 2009
WASHINGTON, DC—“On behalf of the thousands of people whose cases have been affected by complete immunity preemption, we are heartened by the Presidential Memo released today.
Hearing Highlights Victims' Nightmares with Medical Devices
May 12, 2009
Washington, DC—Two years ago 35-year-old Bridget Robb awoke from a sound sleep by what she describes as the feeling of “cannons repeatedly being shot at her chest at close range,” followed by a strong electrical current racing through her body. The episode was not a dream, but a nightmare because the lead to Bridget’s defibrillator fractured, sending 31 dangerous shocks to her heart and throughout her body.
FDA "Internal Meeting" on Devices Shows Patient Safety at Risk
April 22, 2009
Washington, DC—A report in The New York Times this morning indicating the Food and Drug Administration (FDA) is holding a rare “all-hands meeting” to discuss strategic issues in the medical device division of the agency is a further indication that safety approval of medical devices has been compromised, putting patients’ health and safety at risk according to the American Association for Justice (AAJ).
What Do A Former Major League Umpire, A Kindergartner, and A Former Quality Assurance Tech for the Medical Device Industry Have in Common?
March 30, 2009
Washington, DC—On Tuesday, March 31, 2009, victims harmed by dangerous medical devices and their families will be in Washington, DC, to meet with members of Congress about The Medical Device Safety Act (MDSA), legislation that would restore the right of thousands of Americans who have suffered or even died because of defective medical devices, like heart defibrillators, artificial valves, and prosthetic knees and hips, to seek justice through the civil justice system.
Real Life David v. Goliath: Parents of Injured Five-Year-Old Girl v. Medical Device Manufacturers
March 5, 2009
Washington, DC—Patients, including parents of a five-year-old girl that suffered injuries from a defective medical device, will be able to hold manufacturers accountable in state courts through new legislation introduced today, according to the American Association for Justice.
Statement on Supreme Court Decision in favor of Diana Levine
March 4, 2009
Washington, DC—The U.S. Supreme Court in a 6-3 decision upheld a Vermont jury’s decision that Diana Levine, the plaintiff in the Supreme Court case Wyeth v. Levine could hold the drug manufacturer accountable for the injuries she suffered—which included the loss of her arm—after taking one of Wyeth’s medicines.
AAJ Calls on Congress to Restore Consumer Rights Undone by Midnight Regulations
February 4, 2009
Washington, DC— The Bush administration tried to eliminate consumers' right to civil justice in some last minute regulations, and proposed even broader restrictions to civil justice in proposed regulations, according to the American Association for Justice (AAJ). As pending regulations with anti-consumer language are under review by the Obama administration, AAJ calls on Congress to help restore consumers' access to the courts to hold wrongdoers accountable.
Immediate Stay Memo Helps People Like Kimberly Gueldenzoph
January 21, 2009
Washington, DC – If you tried to guess how Kimberly Gueldenzoph from Lambertville, Michigan, was changed yesterday, it would be doubtful you would guess the immediate stay memorandum issued by President Obama’s Chief of Staff. But that is exactly the reason.
Midnight Regulation Gives Negligent Corporations Immunity from Railroad Accidents
January 13, 2009
Washington, DC—The Federal Railroad Administration (FRA) and the Pipeline and Hazardous Materials Safety Administration’s (PHMSA) last-minute regulation deals a shocking blow to consumers injured by railroads that transport hazardous materials, according to the American Association for Justice (AAJ). The final rule, designed to enhance crashworthiness of rail tank cars for transportation of dangerous materials, includes language that would preempt state tort law claims.
AAJ Sends Obama Team Strategies to Reverse Bush "Complete Immunity" Regulations
January 12, 2009
Washington, DC—– Today the American Association for Justice (AAJ) is asking the Obama administration to reverse Bush-era regulations that have given complete immunity to negligent corporations and “preempted” the right of Americans to hold wrongdoers accountable through the civil justice system.
Midnight Regulation Watch: Bush Administration Gives Gift that Keeps on Giving—Corporate Immunity for Negligence
December 16, 2008
Washington, DC—The American Association for Justice (AAJ) continues to watch for last minute regulations that could weaken consumer safety protections and limit the ability to hold manufacturers responsible for defective and harmful products. Regulations published in the Federal Register this week could have 30 days to take effect before Bush leaves office on January 20, 2009.
AAJ Lauds U.S. Supreme Court’s Decision to Uphold Consumers’ Rights in State Courts
December 15, 2008
Washington, DC—The American Association for Justice (AAJ) today lauded a decision by the U.S. Supreme Court in Altria v. Good to deny immunity for cigarette manufacturers who violate state consumer protection laws with false claims of lowered tar and nicotine.
AAJ Challenges NHTSA's School Bus Safety Rule; Anticipates Long-Delayed Roof Crush Standard Next Week
December 4, 2008
Washington, DC — A final rule put forth by the National Highway Traffic Safety Administration’s (NHTSA) doesn’t go far enough to curb injuries associated with the nearly 2,000 school bus accidents each year, according to the American Association for Justice (AAJ). The association will file a petition for reconsideration with NHTSA tomorrow, challenging the agency’s final rule on school bus safety.
Bush Administration Uses Midnight Regulations to Give Railroads Corporate Immunity Handout
December 1, 2008
Washington, DC— Confirming American Association for Justice’s concern about midnight regulations, the Bush Administration rammed through a final rule that could give railroad corporations complete immunity from lawsuits.
NHTSA Effort to Strengthen Safety of Motorcycle Helmets Spoiled by Preemption Language
December 1, 2008
Washington, DC— In an effort to strengthen the safety of motorcycle helmets, the National Highway Traffic Safety Administration’s (NHTSA) proposed rule on motorcycle helmets still gives corporations a “get out of jail free” pass, according to comments submitted to the agency today by the American Association for Justice (AAJ).
Consumer Justice Groups File Petition Challenging NHTSA's Seating Position Rule;
November 25, 2008
Washington, DC— In the first step towards filing a legal challenge to National Highway Traffic Safety Administration’s (NHTSA) final rule on designated seating positions, the American Association for Justice (AAJ), joined by Consumers for Auto Reliability and Safety, New York State Trial Lawyers Association, Pennsylvania Association for Justice, Washington State Trial Lawyers Association, the Association of Trial Lawyers of America-New Jersey, and Consumer Attorneys of California filed a Petition for Reconsideration with NHTSA on language included in the final rule that would attempt to diminish consumers’ legal right to hold vehicle manufacturers accountable through the civil justice system.
Midnight Regulations Could Be “Nightmare” for Consumers; AAJ Keeping Eye on 21 Regulations that Could Limit Consumers’ Safety
November 20, 2008 Washington, DC—With the deadline approaching for regulations to have 60 days to go into effect before President Bush leaves office, the American Association for Justice (AAJ) will be keeping an eye out for 21 possible regulations that have yet to be finalized that could prove devastating to consumers’ safety and their right to hold corporations accountable for producing dangerous products.
NHTSA’s Proposed Motorcycle Brake System Rule Stops Consumers Legal Right to Justice System
November 17, 2008
Washington, DC—In a rule designed to give consumers an updated standard for motorcycle brakes, the National Highway Traffic Safety Administration (NHTSA) attempts to diminish consumers’ legal right to hold manufacturers accountable through the civil justice system, according to comments filed by the American Association for Justice (AAJ) today
NHTSA Once Again Misses the Mark On Securing Child Passengers
November 12, 2008
Washington, DC—NHTSA’s new proposed rule does nothing to protect children from being injured in car crashes according to the American Association for Justice (AAJ.) AAJ filed comments today advising National Highway Traffic Safety Administration (NHTSA) to remove language stating that its rule could potentially preempt state law.
Federal Agency Gives Free Ride to Negligent Railroad Corporations
November 10, 2008
Washington, DC—In a proposed rule requiring railroads to report more information about train accidents and injuries the agency responsible for promoting safe rail transportation has once again undercut consumer health and safety by granting negligent railroad companies immunity from liability.
AAJ Statement on Wyeth v. Levine Supreme Court Case
November 3, 2008
Washington, DC—The following is a statement from American Association for Justice President Les Weisbrod:
Bush Administration Forced FDA To Make Complete Immunity for Negligent Corporations a Top Priority
October 29, 2008
Washington, DC—The Bush Administration’s efforts to ignore and override the objections of career Food and Drug Administration (FDA) staff to include complete immunity preemption in FDA regulations is further confirmed in a report released today by the U.S. House Committee on Oversight and Government Reform. American Association for Justice (AAJ) released a comprehensive report this month with similar findings, detailing the Bush regulatory strategy called preemption.
AAJ Calls NHTSA's School Bus Rule 'Hypocritical' in Effort to Ensure Passenger Safety
October 16, 2008
Washington, DC—The National Highway Traffic Safety Administration’s (NHTSA) new rule on school bus safety is “hypocritical,” requiring one thing for safety on small school buses, recommending another for large school buses, and then granting blanket immunity from civil justice should any injuries arise, according to the American Association for Justice (AAJ).
FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority
October 15, 2008
Washington, DC—In a stealth effort coordinated at the highest levels of the Bush administration, multiple federal agencies were repeatedly ordered to usurp state law and undermine consumer protections, according to documents obtained through repeated FOIA requests by the American Association for Justice (AAJ). The documents released today detail how helping corporations escape accountability for dangerous products has been the administration’s top priority.
NHTSA’s Seatbelt Rule Straps Consumers’ Legal Rights
October 8, 2008
Washington, DC—In a rule designed to give consumers added seatbelt protection, the National Highway Traffic Safety Administration (NHTSA) today diminished consumers legal right to hold vehicle manufacturers accountable through the civil justice system, according to the American Association for Justice (AAJ). NHTSA’s final rule released today on designated seating positions includes specific language that would preempt state tort law claims related to seatbelt positions.
NHTSA’s Further Delay on Long-Awaited Roof Crush Standard Unacceptable
October 2, 2008
Washington, DC—The nation’s agency dedicated to achieving the highest standards of excellence in motor vehicle and highway safety failed its mission once again by further delaying the final rule on roof crush standards, according to the American Association for Justice (AAJ).
FDA Shields Drug Companies from Responsibility for Harmful Over-the-Counter Drug Ingredients
September 17, 2008 Washington, DC—The Food and Drug Administration (FDA) has gone beyond its statutory authority by including language in a proposed rule on over-the-counter drug ingredients that would give manufacturers complete immunity from lawsuits, according to comments filed today by the American Association for Justice (AAJ).
AAJ: FDA Again Sides with Drug Companies
August 27, 2008
Washington, DC—Drug and device manufacturers will have immunity from lawsuits even if they fail to update warning labels to include dangerous side effects for pregnant and breast-feeding women if a Food and Drug Administration (FDA) proposed rule is made final. The American Association for Justice (AAJ) today submitted comments on the new label requirements.
AAJ on FDA Supplemental Labeling Rule: “Irrational and designed to assist the manufacturers”
August 21, 2008
Washington, DC—AAJ President Les Weisbrod, reacting to the Food and Drug Administration’s (FDA) final rule on supplemental applications for prescription drug and device labels, called the FDA action “irrational and designed to assist the manufacturers.”
Latest Proposal on Railroad Crossings Has Deadly Consequences
August 8, 2008
Washington, DC—The Federal Highway Administration (FHWA) has proposed a dangerous blanket policy to require yield or stop signs at every railroad crossing in America.
Highway Safety Agency “Comes to Its Senses” on Immunity for Manufacturers of Children’s Booster Seats
August 5, 2008
Washington, DC—Families with young children riding in booster seats will be protected by both federal safety regulation as well as state law, according to the National Highway Traffic Safety Administration (NHTSA) in a final rule put out today. The original draft of the NHTSA rule on child booster seats used language to bar families harmed by defective booster seats from bringing suit against the manufacturers.
Medical Device Patients Would Be Protected Under New Safety Legislation
August 1, 2008
Washington, DC—Bridget Robb, who received 31 unnecessary shocks to her heart by a defective Medtronic defibrillator, would have access to justice under legislation introduced in the U.S. Senate today.
NHTSA Ordered to Go Back to the Drawing Board on Roof Crush Rule
July 1, 2008
Washington, DC—Congress ordered the National Highway and Transportation Safety Administration (NHTSA) to go back to the drawing board to improve a weak roof crush standard that endangers rollover accident victims and attempts to give negligent car manufacturers complete immunity.
Preemption Dangers Highlighted by NY Times' "Researchers Fail to Reveal Full Drug Pay"
June 10, 2008
Washington, DC—A June 8 New York Times front-page article reported that world-renowned researchers failed to disclose consulting fees from drug companies, bolstering arguments against preemption of state law and giving corporations total immunity from all lawsuits.
Senators Discourage Preemption in Roof Crush Standards
June 4, 2008
Washington, DC—During a subcommittee hearing today, the National Highway Traffic Safety Administration was blasted for issuing a rule that fails to protect drivers and passengers from being injured in a rollover crash.
Federal Rules Give Railroads Complete Immunity
May 29, 2008
Washington, DC—New rules issued by the Federal Railroad Administration and Pipeline and Hazardous Materials Safety Administration would give negligent corporations complete immunity from lawsuits in railroad injury cases, according to testimony given today before the agencies.
AAJ Statement on President’s Preemption / Climate Change Comments
April 16, 2008
Washington, DC—This afternoon President George W. Bush made the following comments in his address about climate change.
AAJ: FDA Warning to Glaxo Highlights Dangers of Preemption
April 9, 2008
Washington, DC—As reported in today's Wall Street Journal, the Food and Drug Administration (FDA) has issued a serious warning to GlaxoSmithKline after discovering the drugmaker did not inform the agency about clinical trials it was conducting on the diabetes drug Avandia between 2001 and 2007.
AAJ Demands NHTSA Remove Preemption from Roof Crush Rules
March 27, 2008
Washington, DC—American Association for Justice (AAJ) today sent comments to National Highway Traffic Safety Administration (NHTSA) demanding the agency remove the roof crush resistance rule’s preemption language.
AAJ: Latest Medtronic Device Failure Highlights Dangers of Preemption
March 19, 2008
Washington, DC—A new Food and Drug Administration (FDA) public health notification shows a higher death rate after five years among patients treated for abdominal aortic aneurysm with Medtronic Inc.’s Aneu-Rx stent-graft system than among those treated through conventional surgery.
AAJ Urges FDA to put Patient Safety First
March 17, 2008
Washington, DC—The American Association for Justice today sent comments to the Food and Drug Administration (FDA) concerning a proposed rule that would give immunity to drug companies for failing to warn patients of potential drug hazards.
Statement From AAJ CEO Jon Haber on Warner-Lambert v. Kent Decision
March 3, 2008
Washington, DC—Today, the U.S. Supreme Court issued a one-line decision affirming the lower court’s ruling in Warner-Lambert v. Kent. This decision will allow certain Michigan residents to hold drug manufacturers accountable for their negligence. This decision does not apply broadly to all state tort claims.
Statement From AAJ CEO Jon Haber
February 25, 2008
Washington, DC—“Today, the U.S. Supreme Court heard arguments in a case about a unique Michigan law."
Statement From AAJ CEO Jon Haber On Riegel v. Medtronic, Inc. Supreme Court Decision
February 20, 2008
Washington, DC—“Today’s Supreme Court decision in Riegel v. Medtronic limits the rights of people to receive justice through the legal system when they are injured by the negligence or misconduct of others. This decision should be narrowly viewed as applying only to certain medical device cases and should not serve as precedent for cases involving drugs and other consumer products.
Statement From AAJ CEO Jon Haber On Riegel v. Medtronic, Inc. Supreme Court Decision
January 20, 2008
Washington, DC—“Today’s Supreme Court decision in Riegel v. Medtronic limits the rights of people to receive justice through the legal system when they are injured by the negligence or misconduct of others. This decision should be narrowly viewed as applying only to certain medical device cases and should not serve as precedent for cases involving drugs and other consumer products."
AAJ Demands FDA Withdraw Rule Allowing Drug Companies to Claim Immunity for Failing to Warn Patients of Potential Drug Hazards
January 16, 2008
Washington, DC—The American Association for Justice (AAJ) today demanded the Food and Drug Administration (FDA) withdraw a proposed rule that would allow drug companies to claim immunity for failing to warn patients of potential drug hazards.
Administration Assault on Railroad Safety Must End, AAJ Declares
November 5, 2007
Washington, DC — The American Association for Justice (AAJ) today declared that the Bush Administration must end its effort to prohibit railway accident victims from pursuing legal action against railroad companies responsible for their injury or death. The latest proposed federal railroad safety regulations continues an unprecedented assault on state safety standards, directly challenging Congressional intent and jeopardizing public safety and victims’ access to justice.