The U.S. Supreme Court today issued an 8-0 opinion in Williamson v. Mazda, one the major cases dealing with federal preemption before the court this session.

The opinion written by Justice Breyer holds that a federal regulation that gave automakers a choice between installing a lap-belt only or a lap-belt and shoulder harness system for rear-seat passengers did not create federal preemption, and thus people hurt in accidents can sue manufacturers in state courts. As Justice Breyer wrote:

The question presented here is whether this federal regulation pre-empts a state tort suit that, if successful,would deny manufacturers a choice of belts for rear inner seats by imposing tort liability upon those who choose to install a simple lap belt. We conclude that providing manufacturers with this seatbelt choice is not a significant objective of the federal regulation. Consequently, the regulation does not pre-empt the state tort suit.

The National Association of Manufacturers had joined other business groups in an amicus brief on behalf of Mazda. The brief argued that traditional preemption analysis is a settled and vital component of our nationwide system of health, safety and economic regulation, rooted in the Constitution’s structure and the understanding of the Founders.

Congress should speak explicitly to endorse preemption when it means to. However, as the brief argued, it’s not always practical for Congress to legislate distinctly and in adequate detail as to when federal law should and should not displace state law, and it is therefore necessary for the courts to interpret conflict preemption expansively.

That argument did not win the day today.

• ABA Journal, “Tort Suits Citing Car Lap Belts Not Pre-empted by Federal Regs, Supreme Court …“
• Bloomberg, ” US Supreme Court Opens Automakers to Seatbelt Lawsuits“
• Reuters, “US top court allows lawsuits over seat belts“
• Courthouse News Service, “Family’s Suit Over Unsafe Seat Belts Gets New Wind“

The Supreme Court this morning decided an important case dealing with federal preemption, issuing a 6-2 opinion in Bruesewitz v. Wyeth that reaffirms Congress’ intent to protect vaccine manufacturers from speculative lawsuits in state courts.

Congress passed the National Childhood Vaccine Injury Act in 1986 that explicitly preempted all design-defect claims made under state product liability laws. At the same time, the law also created a no-fault compensation program — the National Vaccine Injury Compensation Program — that allowed those parties injured by unavoidable vaccine side effects to either apply to the fund for compensation or reject such compensation and sue for damages in court.

The Court’s ruling means that the suits cannot claim defective design of the vaccine but must entail defective manufacture or warnings. Written by Justice Scalia, the opinion reaffirmed the explicit intent of Congress to rely on federal preemption to establish the most effective and fair system to address injuries from vaccines.

Trial lawyers are constantly trying to undermine the preemption principle in federal legislation and regulation in an attempt to multiply their opportunities for lawsuits against manufacturers. Today’s opinion rebuffs their efforts.

For more background, see the Scotusblog entry on the case, Bruesewitz v. Wyeth.  Also, news coverage …

• Courthouse News Service, “Wyeth Not Liable to Child for Vaccine Side Effects”
• Los Angeles Times, “Supreme Court shields vaccine makers from lawsuits“
• ABA Journal, “Vaccine Design Defect Claims in State Courts Are Pre-Empted by Federal Law…“

UPDATE (2:30 p.m.): From a news release from Pfizer, which acquired Wyeth, “U.S. Supreme Court Decision In Bruesewitz V. Wyeth A Win For Public Health“:

“Vaccines are one of modern medicine’s greatest success stories,” said Pfizer Executive Vice President and General Counsel Amy Schulman. “Their nearly universal administration to children is responsible for the elimination of polio and smallpox in the United States, and the near-elimination and containment of other childhood diseases. The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems. We are pleased that the U.S. Supreme Court affirmed the ruling of the Third Circuit.”

The opinion of the Court, written by Justice Antonin Scalia, stated that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”

The October term of the U.S. Supreme Court  opens today, and Marcia Coyle of the National Law Journal previews the session, “On the High Court’s Fall Docket, Few Blockbusters — but Plenty to Watch.” Among the issues of importance in business cases is federal preemption, that is, whether federal regulation of items in interstate commerce supersedes state regulation and litigation in state courts.

Four pre-emption challenges, including: two involving torts, Williamson v. Mazda Motor (auto safety standards) and Bruesewitz v. Wyeth (National Childhood Vaccine Injury Act); one restricting employers hiring undocumented aliens (Chamber of Commerce v. Whiting), and one challenging class action arbitration waivers (AT&T Mobility v. Concepcion).

The National Association of Manufacturers last week joined other business groups in filing an amicus brief in Williamson v. Mazda Motors. As our Manufacturing Law Center entry summarizes, preemption analysis is a settled and vital component of our nationwide system of health, safety and economic regulation:

This case involves whether an automobile manufacturer may be sued in state court for installing lap-only seatbelts in certain rear seating positions when the National Highway Traffic Safety Administration (NHTSA) specifically rejected such a requirement and gave manufacturers the freedom to choose either a lap-only or a lap/shoulder seatbelt configuration. The agency was delegated the authority to establish a coordinated national safety program, by issuing standards that take into account safety as well as the availability of technology and economic costs. It chose to offer manufacturers two design options, but this lawsuit would require a jury to re-examine the same safety, technological feasibility and cost-effectiveness issues that NHTSA balances under its rulemaking authority.

A copy of the amicus brief is available here. Joining the NAM in the brief are the Grocery Manufacturers Association, Lawyers for Civil Justice, and the American Tort Reform Association.

Coyle previously addressed the preemption issue in the article, “Big names, high stakes in quartet of pre-emption cases,” noting that new Justice Kagan will recuse herself because she argued three of the four cases as solicitor general for the Obama Administration. The Washington Post highlights the Kagan recusals in its court story today.

The trial lawyers’ trade association, the American Association for Justice, has lobbied extensively against federal preemption in Congress and Executive Branch agencies. The AAJ is pleased with its successes in expanding the venues for its product liability lawsuits.

The resignation of the White House’s green jobs adviser, Van Jones, for his radicalism and outrageous statements has been accompanied by a serious outbreak of anti-czardom, i.e., criticism of the Obama Administration for creating “czars” with great authority but no accountability. The fervor is most fearsome among the blogospheric right, and Glenn Beck on Fox has been impassioned on the topic.

It’s a good, legitimate issue, but too much of the criticism about czars has been indiscriminate and wrong. As Jonah Goldberg writes at National Review Online’s The Corner:

Politico has a report up that conservatives, flush with victory over Van Jones, are going to go after other czars. One problem, the three people it lists as next on the conservative list aren’t actually czars.

Cass Sunstein, President Obama’s nominee to head the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget, is a prime example of this misrepresentation.  Nominee. He was nominated. He has to be confirmed by the U.S. Senate.

People who protest czars say the White House creates these ad hoc positions to evade the confirmation process. (Van Jones, for example.) But that doesn’t apply in the case of Sunstein, who underwent a confirmation hearing before the Senate Homeland Security and Government Affairs Committee on May 12 and was reported out on May 20. (Committee news release.) Cloture has been filed and we can expect a Senate floor vote this week.

And the head of OIRA is anything but an ad hoc position. The office is a statutory one within the Office of Management and Budget, created by Congress in the 1980 Paperwork Reduction Act to bring additional accountability to the writing of Executive Branch regulations. Here’s the language — it’s Chapter 35, paragraph 3503. OIRA serves important oversight and coordination duties as Congress specified in law.

So, the czarist critique of Sunstein is just wrong. One can certainly oppose his confirmation on the merits, but the efforts to paint him as a far-out animal rights, anti-gun or organ-harvesting extremist are only tangentially related to reality.  Sunstein’s prepared statement and testimony at his confirmation hearing addressed the first two issues persuasively, and this post today by Glenn Reynolds points out how Sunstein’s positions have been misrepresented on organ donation.

Sunstein was a respected law professor at the University of Chicago for many years before going to Harvard. (White House bio.) In his numerous books and writings, he has written some provocative things, but nothing beyond the pale (or remotely as offensive as Jones’ statements). There should be room for thinkers in government.

On the matter of regulation, he’s top-notch. In his book, “Laws of Fear: Beyond the Precautionary Principle,” Sunstein against against the incoherence of the precautionary principle, which holds that products or practices must be proved safe before they can be allowed into the marketplace. This Boston Globe column by Sunstein, “Throwing precaution to the wind,” summarizes his arguments well. Note:

The simplest problem with the precautionary principle is that regulation might well deprive society of significant benefits, and even produce a large number of deaths that would otherwise not occur. In some cases, government regulation eliminates the “opportunity benefits” of a process or activity, and thus threatens to cause preventable deaths.

Indeed, Sunstein’s appreciation for cost-benefit analysis has brought him of criticism from “consumer activists” who would love to overregulate economic activity into paralysis. The trial-lawyer backed groups are suspicious of him on the issue of federal preemption. Those are signs of his merit in our book.

So Cass Sunstein will not be a White House czar, he’s gone through a thorough confirmation hearing and approval by the Senate Homeland Security and Government Affairs Committee, and his writings show him to be a supporter of regulatory reason and the benefits of the free market.

Those attributes make him a poor target for the political attacks du jour. But they would make him a good head of the Office of Information and Regulatory Affairs.

UPDATE (7:38 p.m.): Welcome Instapundit readers, and thanks, Glenn. (And don’t miss his earlier post on the Sunstein nomination.)

In today’s Washinton Post, prominent liberal columnist Michael Kinsely makes a pointed critique of the Supreme Court’s decision in Wyeth v. Levine and upbraids Congress for its flawed handling of federal drug regulation. From “Drug Regulators in the Jury Box“:

The flaws of litigation as a method of making important government decisions are well rehearsed. It is ungodly expensive: The lawyers typically cost more than even the most worthy plaintiff ever gets. It is arbitrary: The same issues get litigated again and again, usually with a different result each time. Most people who suffer never sue and get nothing. While the FDA has scientists, the courts have jurors, for whom ignorance of the subject at hand is not merely the norm but a virtual requirement. And because trials occur only when a risk has gone wrong, they inevitably overemphasize the risk and undervalue the benefit. Why did Levine return to the hospital for a second time the same day? After long spasms of retching and vomiting, she was desperate for a treatment like Phenergan.

And…
What happened to Diana Levine is a tragedy and a scandal. But what did Wyeth do wrong? Is there any way the company could have stayed out of trouble? It’s unlikely. Phenergan has been legal for half a century. (If you Google the word “Phenergan,” the results include pages containing an ad for Phenergan online.) So if you can’t get them for the product itself, you nail them for a “failure to warn.” The basic fiction at the heart of the whole system of regulation by lawsuits is that people read and act on warning labels. But the FDA approved Wyeth’s original warning label and every change since. “Not good enough,” said a Vermont jury, and, incredibly, a majority of the Supreme Court agreed.

To fill in the one gap in Kinsley’s analysis, it’s worth noting that the medical clinic that improperly administered the anti-nausea drug reached a settlement with Ms. Levine. But it wasn’t enough for her and her lawyers, who turned a clear malpractice case into a multi-million-dollar lawsuit against the manufacturer of a very useful and proven drug.