“The ruling could have significant implications beyond drug manufacturing. Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.”
“No Legal Shield in Drug Labeling, Justices Rule”
The New York Times, 3/5/09
“The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.”
“Justices Rule Against Drug Company in Injury Case”
The Washington Post, 3/5/09
"No matter what benefit there was [from the method], how could the benefit outweigh that substantial risk [of gangrene and amputation]?"
Justice Ruth Bader Ginsburg during Wyeth v. Levine oral arguements
"Supreme Court Hears Arguments on Drug Labeling in Case of Woman Who Lost Forearm to Gangrene,"
Fox News, 11/04/08
"Contrary to the view of the White House and the FDA general counsel, the drug regulators said pharmaceutical manufacturers could not be trusted to warn patients of new risks. "Our experience hasn't shown this. Companies rarely press for meaningful risk information or additional warnings," said a memo from Dr. John Jenkins, director of the Office of New Drugs, and Jane Axelrad, associate director for drug policy at the FDA's Center for Drug Evaluation and Research."
"FDA staff, White House disagreed on drug lawsuits, papers show,"
LA Times, 10/30/08
"Even if the court rules narrowly, it could still be a blockbuster,"
-Mark Herrmann, product-liability defense lawyer who represents companies, commenting on the Wyeth v. Levine case which the Supreme Court will hear on Nov. 3rd.
"One-Armed Musician, Wyeth Clash at Top U.S. Court on Drug Suits,"
"The Chamber of Commerce, which has underwritten a multimillion-dollar lobbying campaign supporting pre-emption, has said the outcome of Wyeth v. Levine could affect many questions -- for example, whether states could set their own standards on the environment and vehicles' fuel efficiency."
"In Drug Case, Justices to Weigh Right to Sue,"
"Either way, Congress, not the Supreme Court, seems better suited to decide public policy on patient safety, and it is telling that many members of Congress have joined amici briefs to remind the court that Congress already has decided not to grant preemption to drug manufacturers."
"Editorial: Prescription Drugs, Products Liability, and Preemption of Tort Litigation,"
"The use of rulemaking to protect corporations from product liability was discussed from early in the Bush administration, said former Bush domestic-policy adviser Jay Lefkowitz, who was instrumental in the process."
"Bush Rule Changes Could Block Product-Safety Suits,"
View the Wall Street Journal's video on "Bush Legacy Could Be Found In Tort Reform".
"In the past three years federal agencies, under the direction of Bush administration officials and with the blessing of corporate America, have engaged in a campaign to hand corporations a 'get-out-of jail-free' pass when their products have harmed consumers."
"Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority,"
Huffington Post, 10/15/08
"A spokeswoman for AAJ said the group plans to release a report today or Wednesday that includes examples of how OMB coordinated with agencies on efforts to include pre-emption language in the rulemaking process. The report, assembled through FOIA requests, says the White House's pre-emption language "would effectively block all product liability lawsuits from being adjudicated and would let corporations 'get out of jail free' even when their products seriously injure or even kill Americans."
"Trial Lawyers Blast Pre-Emption Language On Seat Belts,"
Congress Daily, 10/14/08
"The fundamental issue before the court in this case is whether a patient has a right to sue a drug company if something goes wrong."
"CNN American Morning Transcript,"
“In the past, the FDA has said that the label it approves is essentially the minimum warning drug companies must provide, and that they can do more. Since the FDA gets most of its information from the drug companies themselves, it saw lawsuits as an additional check on the pharmaceutical industry. But now, the Bush administration has abandoned that position.”
"Consumer Issues Top Supreme Court's Docket,"
"'Corporate America has discovered that they would much rather be regulated by one government in Washington than by 50 state governments, or by the most aggressive of them,' said Kathleen M. Sullivan, a law professor at Stanford and a Supreme Court advocate."
"Justices Return to Work, With Less Meaty Docket,"
New York Times, 10/5/08
"Prohibiting suits in state court by people injured by prescription drugs is profoundly unfair, particularly when drug-safety tests are considered "proprietary information" owned by drug companies. The larger question is whether the justices will require manufacturers — of all sorts — to stand by their products, or allow them to blame government for their failures."
"(Supreme) Drug Court,"
St. Louis Dispatch, 10/3/08
"Business groups, often supported by the Bush administration, have vigorously pursued pre-emption arguments, hoping to build a barrier against many kinds of injury suits. Plaintiffs’ lawyers oppose broad pre-emption doctrines, saying they short-circuit valid claims arising from terrible injuries."
"Drug Label, Maimed Patient and Crucial Test for Justices,"
New York Times, 09/18/08
"The influence that the pharmaceutical companies, the for-profits, are having on every aspect of medicine ... is so blatant now you'd have to be deaf, blind and dumb not to see it," said Journal of the American Medical Association editor Dr. Catherine DeAngelis, a longtime industry critic."
"Medical schools, journals start to fight drug industry influence,"
USA Today, 09/10/08
“The Bush administration tried a different approach. Bypassing Congress, it had federal agencies reinterpret the laws on the books to conclude that jury verdicts would conflict with federal policy.”
"Drug makers seek shield from lawsuits,"
Los Angeles Times, 09/07/08
"The American Association for Justice, a professional group for attorneys, argues the new rule requires an excessive standard of scientific evidence before companies are required to update their labels. The group's lawyers say the new rule will make it easier for companies to claim they were not obligated to alert consumers."
"Plaintiffs' Lawyers Fight Restrictions On Product-Liability Suits,"
Associated Press, 08/22/08
"The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."
"Lawsuits Help Guarantee Drug Safety, Doctors Say,"
Associated Press, 08/15/08
"Trial lawyers are expected to be heavily outspent. The chamber, which has helped drive the pre-emption and tort-reform campaign, intends to raise $40 million for political candidates this year."
"Plaintiffs' Lawyers Fight Restrictions on Product-Liability Suits,"
Wall Street Jounal, 08/13/08
“The current FDA commissioner, Andrew von Eschenbach, said the agency is independent of industry influence. In an interview, he said he has been moving to get the agency to act faster on information that a drug may have problems. The heparin crisis demonstrated the challenge to the agency from globalized food and drug supplies, which he described as the biggest issue the FDA faces, but he said the agency's resources are limited.”
"Grassley, Dingell Lead Calls For Overhauling FDA,"
The Wall Street Journal, 7/30/08
“Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere."
"Why Doctors Should Worry about Preemption,"
New England Journal of Medicine, 07/3/08
“The court has provided a ‘major endorsement of national uniformity,’ said Robin Conrad, executive vice president of the U.S. Chamber of Commerce's litigation arm.”
"Exxon, Medtronic Win in Business-Friendly Supreme Court Term,"
Bloomberg News, 06/26/08
“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 Davis.”
"Dems Readying Liability Legislation,"
Congress Daily, 6/04/08
"Faced with an unfriendly Congress, the Bush administration has found another, quieter way to make it more difficult for consumers to sue businesses over faulty products. It's rewriting the bureaucratic rulebook."
"Bush administration rules limit lawsuits,"
Associated Press, 05/13/08