Tag: Pfizer

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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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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Reporting of Data, Reporting of News: Pfizer’s View

Worthwhile, if technical, column today in the Wall Street Journal, “Smoking Has Side Effects, Too.” It’s a report  by Dr. Joseph Feczko, Pfizer’s chief medical officer, on how the anti-smoking drug, Chantix, was tested and approved and how the pharmaceutical companies battle misinformation about adverse-event reports and patient safety.

Patients and physicians want breakthrough medicines, and pharmaceutical companies spend years – and billions of dollars – researching and testing such medicines. But this is all becoming increasingly difficult amid the public’s growing confusion about how drug development and safety monitoring actually work. Patients might rush to judgment, making medical decisions without consulting their doctors. We could also wind up with policies that reduce the availability of innovative new medicines in decades to come.

We should keep all that in mind following last month’s release of a collection of adverse-event reports by the Institute for Safe Medication Practices (ISMP), a nonprofit group in Horsham, Pa. The report focused on Chantix, a medicine developed by Pfizer to help people quit smoking. Both the report and the subsequent media coverage of it revealed a lack of understanding about how pharmaceutical companies and regulators monitor drug safety. Missing was important context about the dangers of smoking, and how adverse-event reports are used to improve patient safety.

OK, we’re going to do a little blogging experiment here. Your correspondent completely missed any news about Chantix and what we now assume were news stories about possible harmful side-effects. Here’s the question we aim to test: Have the reports elicited a wave of solicitations from trial lawyers, looking for a reason to sue?

Be right back ….

Well, there’s this from Legalview.com, a web portal sponsored by a group of trial-lawyer firms: “In addition to the extensive mesothelioma information portal, LegalView offers practice areas on other legal issues including Digitek’s digoxin recall, Singulair side effects and the Chantix risks.”

And there’s this news release from a “veteran pharmaceutical litigation attorney” — that’s a euphemism for personal injury lawyer – Kristian Rasmussen of Alabama, “Litigation Predicted in Wake of FAA Ban of Chantix Use by Pilots and Air Traffic Controllers: Smoking Cessation Drug Target of Controversy.” Gin up the controversy. And it looks like Mr. Rasmussen will be giving a talk later this month: “Chantix: Cases, Claims and Liability” Pharmaceutical Litigation Super Conference, June 23-25, 2008 Chicago, IL.”

Here’s another. Just fill out a form to get the lawsuit started. And a YouTube video from a Chantix Lawyer, asking you to call him for a free consultation.

Etc.

It’s a wonder any new drugs ever come on the market.

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