Tag: Wyeth

Supreme Court Ruling a Victory for Kids’ Health, Accountability

Hans von Spakovsky at the Heritage Foundation explains why the Supreme Court’s 6-2 opinion released Tuesday in Bruesewitz v. Wyeth is so important to children’s health. From “Supreme Court Ruling On Vaccines Keeps Kids Safe“:

I don’t usually feel a personal connection to a Supreme Court decision, but as the parent of three children, I was elated (and relieved) to see the Court come to the right conclusion today in Bruesewitz v. Wyeth. The Court’s holding that state tort suits against vaccine manufacturers are preempted by federal law is absolutely crucial to maintaining the continued availability of the many vaccines that protect the lives and health of tens of millions of Americans, particular school-age children like mine.

Hans notes the collapse of the “vaccines-cause autism” claims, which were even mocked recently in Doonesbury.

Pfizer, which now owns Wyeth, issued a news release on the ruling Tuesday, “U.S. Supreme Court Decision In Bruesewitz V. Wyeth A Win For Public Health.”

For extensive commentary on the ruling and federal preemption, including the relevance to manufacturers, see Jim Beck’s discussion at the Drug and Device Law Blog, “Notes on Bruesewitz.” Beck is really good.

1) Express preemption has more friends on the Court than implied preemption.
(2) The great DTP versus DPT controversy has been definitively settled in favor of DTP. As we recall from doing vaccine cases pre-Act, that’s a defense win.
(3) Vaccines have successfully staked a claim to the ultimate public good in our sandbox, and the Supreme Court knows it.
(4) Vaccine manufacturers were “immunized” from warning claims before (assuming compliance) and with design claims now barred, the only thing really left for a non-listed-injury vaccine plaintiff is a defective manufacture/violation claim. This result could create pressure to list more injuries as within the program.

Beck makes 22 points in all.

UPDATE Wall Street Journal editorializes, concluding: “The trial bar has preyed on parents, especially those of autistic children, by telling them someone is to blame for their child’s diagnosis. Study after scientific study has debunked these claims, and the Supreme Court’s decision will at least prevent the lawyers from cashing in by exploiting heartache.”

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Wyeth v. Levine, the Consequences for Innovation

The Wall Street Journal comments on “drug labeling by jury verdict” in an editorial, “Pre-empting Drug Innovation“:

Juries are presented with tragic plaintiffs who were injured, not the unknown patients who are helped, by a product. Hence, they tend to focus on risks more than overall benefits. By contrast, federal regulators are tasked to take the long view and factor in the interests of all potential users of a drug. Just as importantly, “the FDA conveys its warning with one voice,” writes Justice Alito, “rather than whipsawing the medical community with 50 (or more) potentially conflicting ones.”

A consequence of this ruling is an almost-certain spike in product-liability suits aimed at drug companies. Merck’s Vioxx litigation has already cost the company $4 billion, and Eli Lilly has paid out more than $1 billion to settle suits related to the antipsychotic drug Zyprexa. A legal standard that said the FDA, not a state tort jury, is responsible for regulating warning labels would have given both drug companies a stronger position in these lawsuits.

Yesterday’s ruling will expose drug companies to a kind of double innovation jeopardy. They typically spend $1 billion on research and development to bring a drug to market, with an 11% success rate on average. But they endure that burden on the understanding that FDA approval will give them a period to sell that drug with patent protection and that FDA approval provides some protection from lawsuits. Now they will have to contemplate paying up front — and paying later, even if the tragic mistake in applying the drug is someone else’s. Wyeth is a dream come true for the plaintiffs bar.

Ten years from now, when somebody dies because no drug was available to treat his illness, well, who will know? But that’s a result that can be anticipated thanks to a legal system that punishes innovation.

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Bad News on Jobs, Manufacturing Front

From the Washington Post, “Major U.S. Companies to Slash 45,000 Jobs“:

American companies announced job cuts totaling 45,000 this morning, as the global downturn slammed the profits of exporters like Caterpillar and a domestic recession hit hard at retailer Home Depot.

As companies begin announcing their financial results for the end of 2008, they are also moving fast to cut costs in response to poor results and a diminished outlook for the coming year.

The job cuts announced so far today include 20,000 at heavy equipment maker Caterpillar, 8,000 at the Sprint Nextel telecommunications company, 7,000 at Home Depot, and 8,000 anticipated from the pending merger of the Pfizer and Wyeth pharmaceutical companies.

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Wyeth v. Levine, Preemption and Federal Standards

On Monday morning, the U.S. Supreme Court hears oral arguments in Wyeth v. Levine, a major case dealing with pre-emption, that is, whether federal rules governing such products as medical devices or prescription drugs take precedent over state regulation. Generally speaking, businesses support the principle of pre-emption because a national regulatory regime — one that includes a single safety standard — provides for consistent legal treatment and predictability in costs.

Trial lawyers and self-proclaimed consumer activists dislike pre-emption because, they contend, state enforcement can encourage safer products and injured parties should not lose access to the state courts. Preemption also limits the number of venues where the trial lawyers can cash in on outrageous jury verdicts, it reduces the opportunity to play “Jackpot Justice.”

(The Wyeth case actually deals with drug labeling. The NAM’s Legal Beagle summary of the case is here; and earlier Shopfloor.org posts here.)

Anyway, a review of the news coverage previewing Monday’s oral arguments. Now, we haven’t read the articles yet in order to test a thesis: Just in time for Tuesday’s election, the articles will feature references to a “pro-business Supreme Court,” framed in the context of court appointments by the next President. So here goes…

Nope! (He said, cheerfully acknowledging error.) The stories all play the issue straight, not trying to fit the issue into a predetermined line about Obama v. McCain’s court appointments needed to fix the one-sided, anti-consumer Supreme Court.

Included in several is a very silly comment from a Fordham law professor , Ben Zipursky, commenting on the effect of a ruling in of Wyeth: “That effectively would cut off virtually all pharmaceutical liability for prescription drugs.”

The coverage does acknowledge a legitimate political angle, though, that is, Congressional Democrats have supported legislation to allow state lawsuits. Rep. Henry Waxman’s House Oversight Committee last week released a “report” on FDA career staffers objecting to the agency’s support for pre-emption. Because apparently some people believe mid-level agency staffers should have determine regulatory policy, no matter the results of an election.

Walter Olson has a post at Point of Law on pre-emption, with many links, including to several examining the Waxman document.

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