Posts
This case has been billed as the biggest case of fraud against medicare and medicaid and primarily involves the now discontinued Bextra as well as Zyvox, Geodon and Lyrica.
Interestingly the article states:"Marketing fraud cases against pharmaceutical companies have become almost routine, with almost every major drug maker having been accused of giving kickbacks to doctors or shortchanging the Medicaid program on prices. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would soon start charging doctors individually as well."
I hope they put the billion dollars in fines received back into the health care plans.....
Wednesday, September 2, 2009
Subscribe to:
Post Comments (Atom)
Yes, this makes official what we learned in January when the settlement was reported by Pfizer itself. They chose to "release" it the day they also announced the merger with Wyeth. Funny how things work.
ReplyDeleteThis penalty meant that the prior record-holder, Lilly for Zyprexa, only held the record for a few weeks. Poor Lilly. Prior to that, you have to go back a few years to the Neurontin bust--Warner-Lambert/Pfizer.
Good news! The only thing better would be jail time for the criminals involved.
ReplyDeleteBelieve it or not, even _this_ kind of criminal and civil conviction of a company for fraud would not break their immunity from accountability in Michigan.
ReplyDeleteWe are learning more particulars about Pfizer's off-label scam. See this from the Philadelphia Inquirer:
ReplyDeletehttp://www.philly.com/inquirer/breaking/business_breaking/20090902_FDA__Pfizer_ignored_warnings__gets_record_fine.html
As with the Neurontin and Zyprexa sagas, it is not simply that off-label uses were heavily promoted, with physician kick-backs, etc. Uses were promoted with _known_ risks and which the FDA had specifically rejected because of safety concerns.
If that isn't homicide, what is?
The fines could very well mean nothing if they or their distributors are allowed to increase the cost of any of their drugs.
ReplyDeleteAlong with the fines there should be stipulation that Pfizer or anyone caught in these types of schemes, along with their distributors, cannot increase the prices of any of their drugs for at least one year or two, and then only if it is absolutely justified.
There is no point in levying these fines only to have them turn around and devise a scheme to have the patients/consumers pick up the tab.
Indeed. 2B comes down to three weeks of Pfizer sales.
ReplyDeleteUnder Michigan law, drug companies whose drugs are FDA approved enjoy total immunity from product liability. What are the responsibilities of the FDA after a drug’s approval? Who is responsible when an approved FDA drug, used in an off-label manner, causes harm or death? In Michigan, is the drug company, doctors and reps involved all off the hook? Who pays for the lost wages, health cost, every day living expenses, funeral, mortgage, etc, etc. etc? When in the hell is someone going to help the people of Michigan? When is Michigan’s story going to be told? When are the pols who support this travesty going to be investigated?
ReplyDeleteThis fine will not stop the marketing of off-label. It's too lucrative.
ReplyDeletehttp://www.thelouroe.com/2009/09/pfizers-23b-settlement-wont-stop-off.html
Dianne--Yes, even though Pfizer pled guilty to felony fraud, this will mean nothing in term's of Michigan's shield law.
ReplyDeleteIt is not because of post-approval. As the law is written, a company that concealed data from FDA such that the drug would not have been approved, or would be withdrawn, might still lose immunity (although not as interpreted by higher courts).
But none of the conditions are fulfilled in this case. Most of the drugs involved were not withdrawn. Bextra was, but not because of felony fraud against the FDA (which is what it takes).
Citizens in other states have and will bring personal liability suits against Pfizer, and they will use some of the info unearthed by the DOJ.
But citizens in Michigan will remain entirely wihout recourse.
no way that can't be possible that's terrible
ReplyDeleteAlbruno--It is possible and it is actual. Michigan citizens remain entirely without recourse, and the latest negligent homicide by Pfizer changes nothing.
ReplyDeleteBelow an op ed I sent to the Detroit Free Press that explains why:
DESPITE PFIZER’S FELONY FRAUD, MICHIGAN CITIZENS REMAIN WITHOUT RECOURSE
This week we learned that the Department of Justice will fine Pfizer $2.3 billion in civil and criminal penalties for their illegal marketing of the drugs Bextra, Zyvox, Geodon, and Lyrica. This is not only the largest penalty ever levied against a drug company. It is the largest penalty the federal government has ever levied against any entity whatsoever, throughout American history.
That is saying something.
Pfizer and its subsidiary entities—the former Upjohn and Pharmacia—did not only aggressively market these drugs for uses that were not approved by the FDA. They promoted the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer’s off-label marketing scheme amounts to a form of assault, even homicide.
It would be assuring if there were a different interpretation. Tragically, there is not.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In virtually every prior case, plea-bargaining resulted in admission of misdemeanor infractions, fines were levied, and that was the end of it. Because of the seriousness of these cases, and Pfizer’s recurrent infractions, the Department of Justice did not settle for the usual misdemeanor pleas.
Pfizer’s malfeasance, therefore, was as egregious as it gets. Nevertheless, Michigan’s fourteen-year-old drug industry immunity law will remain in place. While citizens in other states have and will continue to bring suit over deaths or injuries alleged to be caused by the Pfizer drugs in question—and they will draw on the material uncovered by the Department of Justice to make their case—Michigan citizens will be entirely without recourse.
Even in the context of felony fraud. Even in the context of de facto homicide.
The reason is simple. Our statute contains two conditions for exception to Michigan’s shield law. First, there must be felony fraud against the FDA. In the Pfizer case, fraud was perpetrated, not against the FDA, but against Medicare, Medicaid, and the armed forces. Second, the exceptions to immunity written into the Michigan law assert that a drug must be withdrawn, or would not have been approved, had the fraud not occurred. This condition does not apply to any of the drugs in question. Bextra was withdrawn, but not because of an allegation of fraud. The other three drugs remain on the market.
So we are left with this conclusion:
By its own admission, Pfizer committed felony fraud and was punished on a scale unparalleled in American history. By implication, that fraud may have resulted in death and injury to a large number of people. But, in Michigan, it remains impossible for any of those people, or their survivors, to hold Pfizer accountable.
The politicians who defend Michigan’s drug industry immunity law—and that includes almost all Republicans in state government including those likely to run for Governor—will have to explain their position to Michigan voters.
Meanwhile, if Pfizer is not held accountable in Michigan, the public officials who have supported drug industry immunity must be. Election day is a year from November.
It would be great if our sick law became an issue and politicians were made to defend their positions. How wonderful it would be if investigative reporters really delved into the matter. It would be another Watergate, I’m sure. Sadly, however, the media barely mentions the law. Most people still don’t know they lost their right to sue a drug company. It has been the law for 14 years and I should have accepted it by now. It’s just that it is still hard to believe that our rights were taken away in the middle of the night, and no one did anything about it.
ReplyDeleteLike cancer, it’s the silent killer of democracy.