Lawsuits, autism and the Supreme Court

[Guest guest]

Wall Street Journal A Real Vaccine Scare

Lawsuits, autism and the Supreme Court.

The Supreme Court waded into one of the great scare campaigns of the past decade

this week, considering whether drug manufacturers may be sued for injuries

allegedly caused by vaccines. The case will determine whether hundreds of

lawsuits blaming vaccines for a child's autism may descend on state courts.

In Bruesewitz v. Wyeth, the case was brought by the parents of Hannah

Bruesewitz, who say her inoculation to prevent diphtheria, pertussis and tetanus

in 1992 created seizures that left her disabled. The vaccine in question was

discontinued and replaced in 1998, and the Bruesewitzs argue that Wyeth and the

FDA were too slow to make the switch.

At the center of the debate is the National Childhood Vaccine Injury Act, which

Congress passed in 1986 to prevent vaccine manufacturers from being driven out

of business by tort claims. Under that law, vaccine manufacturers could not be

held liable for tort claims if the injury in question was " unavoidable, even

though the vaccine was properly prepared and accompanied by proper directions

and warnings. " Congress also created a Vaccine Court within the Court of Federal

Claims to manage injury allegations. It is operated as a no-fault system, and

those who believe they were injured may receive compensation from a

government-managed kitty funded by a tax on vaccine manufacturers.

The Vaccine Court ruled that Hannah Bruesewitz's injuries had not been

adequately shown to be caused by the vaccine, leading the family to file suit in

Pennsylvania. The case was moved to federal district court, which ruled that the

family's claim was pre-empted by federal law. The Third Circuit Court of Appeals

agreed.

While the Bruesewitz's vaccine claim is not autism related, its outcome will

have legal implications for the efforts to link vaccinations to autism. Attempts

to seek compensation for the diagnosis have persisted despite overwhelming

scientific evidence that has found no connection. In February, the British

medical journal The Lancet retracted a study that linked the

measles-mumps-rubella vaccine to autism and contributed to a rash of parents

fleeing the inoculation. In March, special masters in the Vaccine Court likewise

ruled against parents claiming the vaccine was responsible for their children's

autism.

While the 1986 Vaccine Injury Act bars state tort lawsuits alleging defective

design, two other kinds of lawsuits go forward all the time in pharmaceutical

industry product liability cases. In the first version, plaintiffs may allege

that the manufacturer failed to give adequate warnings about the dangers of the

product. In the second, plaintiffs may claim that the vaccine itself was not

manufactured properly.

The Bruesewitz case is of particular interest because it falls into the bucket

of so-called express pre-emption cases, in which a law explicitly bars state

tort claims. In 2008's Riegel v. Medtronic, the Supreme Court ruled that federal

law explicitly pre-empted state product liability for medical device claims.

There, as here, the alternative remedy was favored by a horde of trial lawyers

hoping for a new state tort jackpot.

At oral argument on Tuesday, the Justices seemed to be dubious of plaintiff

claims that the 1986 vaccine law left room for debate. Responding to the

suggestion that Congress's intent was not to pre-empt all suits, Chief Justice

responded that " I would have thought the argument would go the

other way: That because they set up a compensation scheme, that was a good sign

that they didn't want to allow state law claims. " Kennedy, often a swing

vote, was skeptical that manufacturers could survive the assault from new tort

claims.

Vaccinating children against the many diseases that used to afflict them has

been one of the most successful public health improvements in modern times. The

Obama Administration, which filed an amicus brief in support of Wyeth in the

case, has said it is appropriate to recognize pre-emption in cases where the

statute makes the pre-emption explicit. That's a shot of good sense.