The Argument of Preemption In Practice

Wisconsin Court Finds Preemption Argument to be Invalid in Paxil Case

As reported in ExpertClick on August 7 2009 - "A Wisconsin federal judge has denied GlaxoSmithKline's claim of immunity from liability for a Paxil-induced injury case, allowing the plaintiffs product liability case to move forward. "

For months arguments for and against FDA Preemption have been bandied about both here and elsewhere on the internet. Countless hours of sometimes heated discussion have passed as we speculate on preemption’s use and its affect in the real world.

In the attached article we can see the real world attempted application of FDA Preemption in a court of law. Its use as a blunt force instrument to drive plaintiffs out of the court room has failed in this case.

The case is also significant because it involves the Paxil – Suicide allegation. It will be interesting given what we already know about GlaxoSmithKline's management failures with Paxil. The court will now be able to take a deep dive into the situation.

Note that the court held, among other things -

• "Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it 'bears responsibility for the content of its label at all times.”

• "State tort claims are harmonious with Congress' regulatory goals and do not compel application of preemption"
• ". . . the fact that the FDA approved prior Paxil labeling without an enhanced warning does not mean that the agency would oppose a request by GSK to include such a warning"
• "GSK's 'overwarning' argument also assumes that the subject drug label warns of a non-existent risk," however, the Court stated that it "refuse[s] to find that Paxil does not increase suicidality as a matter of law"
• "State law litigation provides an additional oversight on drug labeling and helps flesh out which warnings are 'substantiated' and necessary for the protection of consumers"

GAO Has an Opinion of the FDA - Not Good

Add one more in the long line of respected authorities to raise the flag of danger about the FDA's capability to protect the American public.

The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.

"...these shortcomings in both premarket and postmarket activities raise serious
concerns about FDA's regulation of medical devices."

The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.

Scare Tactics and Presumptions Continue as Congress Debates Medical Device Safety

As time approaches for Congress to protect our civil rights we see another misguided article intended to scare Congressional decision makers into believing that ending the 2 year old policy of FDA Preemption will destroy the inventiveness of the Pharmaceutical industry.
Shame on them for presuming (or at least presenting the position) that our Pharmaceutical Industry is not capable of making both effective and safe products.

Here again is the article in full to be examined for its falsity. Please also note the source -

Patients Call for Continued FDA Preemption Authority

FDA Best Positioned to Review Medical Technology
WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.
"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"
"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."
Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."
The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Patients came to Washington from across the country to explain the importance of medical devices in saving and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:
Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.
The patients emphasized how critical it was for them to have access to devices when they needed them most.
"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."
"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replacement surgery.
"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."
Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.
"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.
"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."
The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.
SOURCE AdvaMed

SOCIOPATHY AND STANDARD OPERATING PROCEDURE IN PHARMA

A Note on Pharmaporn

Every few days, it seems we get a new one-liner from the annals of trial materials. “We may need to seek them out and destroy them where they live,” said a Merck insider about Vioxx critics. “"Thus far, we have buried Trials 15, 31, 56…”, writes John at AstraZeneca. Trial 15, as it turns out, showed the diabetic risks of Seroquel. This is the same study about which we also read company players congratulating each other for their “smoke and mirrors” success in downplaying its significance.

The examples go on. Endlessly. But what I am always left with is the question of what we do with such “material.” All the defense arguments have a degree of truth. It would be a rare company (or individual) who didn’t write a bad-looking email at some point. Materials of this sort sometimes reveal what is a widely shared marketing plan. At other times, they may represent the views of a lone sociopath.

Perhaps the most recurring theme—when the issue of fraud or cover-up is broached in these communications—is that other companies are doing it “so why shouldn’t we.” All of us learned from our mothers about what “just because others are doing it” means. The relevance here is the question of whether these assertions are rationalizations (and, inevitably, self-fulfilling) and/or whether they represent an accurate snapshot of standard industry practice, at least in the marketing-of-blockbusters arena.

Understandably, people from within industry almost never comment on this question. That was true on Pharmalot when there was plenty of opportunity. Again, this makes sense for all the relevant reasons—the great majority of people in a company have no involvement with such goings-on; there is the anticipation of vicious push-back by critics; there is probably also the anticipation of sanctions from within the company if one’s identity is uncovered.

The rest of us are left with the question of what to make of these bits and pieces. Like porn of other kinds, there is undeniably a certain titillation in the face other people’s corruption. Many of us carry an “inner church lady.”

But lives are, indeed, on the line. My guess is that nothing good will happen to change these aspects of industry short of revulsion within companies robust enough to clean up their scuz. Strongly as I oppose preemption, I think that it will take whistleblowers, not private plaintiffs, to do the job. Only insiders can distinguish, and document, what represents the views of lone cowpokes versus the orchestrated strategy of a significant coterie of senior management.

Unfortunately, the latter appears to be the most common.

Medical Device Patient Lobby Day - March 31 2009

Stop Corporate Immunity. Org is the site that is sponsoring the Medical Device Patient Lobby Day.

On March 31st, Medical Device Patients from around the country will travel
to Washington, DC and ask Congress to pass the Medical Device Safety Act.

These organizers have written a letter to Congress in support of HR 1346/S 540, THE MEDICAL DEVICE SAFETY ACT

Now is the time to contact your Senators and Representatives to enlist their support for this measure.

New England Journal of Medicine Urges Congress - Pass Medical Device Safety Act!

In an editorial published on the 18th of March 2009, the New England Journal of Medicine states that FDA Preemption places consumers in harms way. They further request that bills in the House of Representatives and Senate be passed to repeal Preemption.

"We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The article is titled:

The Medical Device Safety Act of 2009

Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.

MICHIGAN PREEMPTION SAVING MILLIONS!!!!

America's Bantustan: Michigan Ready to Fall on Spear to Save Nation

Yesterday, there was a hearing at our state capital concerning Michigan's unique drug industry immunity law. Michigan is alone among the fifty states in having a full preemption law--no exceptions, even if the company commits felony fraud. In the U.S., such fraud is considered the moral equivalent of rape in public polls. In Sweden, it is considered the moral equivalent of murder (not manslaughter). We have had that law since 1996.

Thus, a vote against repeal is a vote favoring no accountability for rape or murder.

At yesterday's hearing, PhRMA put together a series of "talking points" for the state legislators opposed to rescinding our law. (In earlier votes, repeal was supported by most Dems and about one-third of the Republican representatives).

PhRMA's document was interesting. Among the highlights:

"Repealing this FDA lawsuit abuse law would keep millions of patients waiting unncessarily for medicines to save their lives or to improve the quality of their lives."

Most citizens in Michigans had not realized that they were performing combat-level sacrifice in order to save millions of lives. But we are patriotic state. And now that PhRMA has told us how much benefit derives from our legal apartheid, we are ready to do our duty.

Bless us.

Lord save us.

FURTHER THOUGHTS ON WYETH V. LEVINE

Supreme Court Rejects FDA Preemption—Nine to Nothing.

I have now read the complete set of opinions in Wyeth v. Levine. While I cannot claim to have followed every nuance, and I’m sure I’ve missed much, certain conclusions seem warranted.

The most important one is this: None of the opinions, neither the majority finding nor the dissents, support anything remotely like the kind of broad preemption that has been argued in most of the pro-preemption positions—whether in amici, white papers, or in the Bush FDA’s own pronouncements. Indeed, the entire structure that the FDA put together to justify preemption—most specifically, the 2006 preamble and the 2008 CBE redefinitions—are missing from Justice Alito’s dissent (in which he was joined by Chief Justice Roberts and Justice Scalia). In this regard, the dissent is also strikingly unlike a number lower court decisions which did turn on these FDA assertions. Here, what is striking is that nothing turns on them at all. They are windblown leaves; the scattered remnants of a house of cards.

Instead, the dissent is framed quite narrowly. It makes the very specific argument that FDA extensively considered the risks of IV push injection of Phenergan, established considered and appropriate warnings, and that—given those specific facts and their similarity to other precedents (the Geier case is noted most prominently)—preemption should prevail in this instance. Again, this is a far more narrow support of preemption than almost everything that we have heard from preemption’s advocates. And that narrowness is made explicit in Justice Alito’s conclusion, which itself merits close attention:

“To be sure, state tort suits can peacefully coexist with the FDA’s labeling regime, and they have done so for decades. But this case is far from peaceful coexistence.” (26)

The operative language, it seems to me, is “this case.” To those who yearn for the day when FDA approval, in and of itself, inherently preempts failure-to-warn suits, they will find no comfort from Justice Alito. Instead, they will find definitive rebuttal. That, to me, is extraordinary. And it means that the Supreme Court has unanimously rejected FDA preemption in the form in which we have most often heard it articulated.

If the dissent is this narrow on preemption, the majority opinion and concurrences are devastating. Taking a strong federalist view, Justice Thomas asserts that FDA preemption is little less than tyranny. He quotes an 1869 case that “the preservation of the States, and the maintenance of their governments, are as much within the design and care of the Constitution as the preservation of the Union and the maintenance of the National Government.”(3) Later, invoking Justice Story in 1831, he asserts that such “invasions” from the center are “merely acts of usurpation, and will deserve to be treated as such.” (5) Justice Thomas makes no mention of the fact that only Michigan has an FDA preemption law based on precisely the doctrine that he calls "usurpation." And while he does not call on Michigan citizens to dump their tea in the harbor, the text certainly evokes such imagery.

Regarding FDA preemption specifically, Justice Thomas is definitive:

“Initial approval of a label amounts to a finding by the FDA that the label is safe for the purposes of gaining federal approval to market the drug. It does not represent a finding that the drug, as labeled, can never be deemed unsafe by later federal action, or as in this case, the application of state law.” (11)

And further:

“Nothing in the text of the statutory or regulatory scheme necessarily insulates Wyeth from liability under state law simply because the FDA has approved a particular label.” (12)

It is hard to be more clear than that. Or more rejecting of the preemption argument as we have heard it during the past seven years.

Not surprisingly, Justice Thomas also makes no mention of the recent preamble or CBE changes. They are, in his opinion, of no consequence. By contrast, they do appear in the majority opinion—as presumptions entirely without merit and worthy of no deference. Here, there is no reason to go into detail. In a rolling series of arguments and citations, the majority asserts that preemption, as we have heard it asserted in recent years, is little more than an aberration, fully out of touch with the past seventy years of both the FDA’s own understanding of its authority relative to tort law and Congressional intent on the same question. For those of us who agree with that view, the opinion is a treasure trove of relevant citations. But there is no need to reiterate those here.

So I return to my initial conclusion. At core, Wyeth v. Levine was not a 6-3 decision. With regard to the preemption defense as we have most often heard it articulated, it was a 9-0 rejection.

Send in the brooms.

Wary

With the lonely exception of the great state of Michigan, America, for now, has been saved from FDA preemption. However, I find it hard to believe the idea will simply dry up and blow away. Levine won, but the bad guys are still out there, waiting for their chance to pounce.

We need laws that protect citizens from un-American notions like FDA preemption. Michigan’s 1996 Drug Immunity Law--that gave drug makers total immunity from product liability--has been in existence for 14 years. Then governor John Engler asserted the Michigan model was intended to be the law of the land. America missed that bullet, but what about the next time? What loop hole made it possible that an industry had the right to strip citizens of legal redress?

I don’t feel that assured about the future. And, Michigan still has a stinky law.

Please tell us your thoughts. Thanks.

See: ThePopTort: Drug Company Immunity Remains Status Quo in Michigan Unless Legislature Acts

Medical Device Preemption on Stage With Congressional Bill Introduction

As reported by AP today - 
Waxman and Pallone reintroduce their bill to overturn medical device preemption today.

Supporters of preemption claim that without preemption it will -

produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans.

Those against preemption claim that the decision to impliment preemption -

ignored decades of precedent, in which lawsuits brought by patients in state courts helped bolster safety regulation at the federal level.

See the full report by the AP here

PREEMPTION DEFEATED IN LEVINE CASE

Supreme Court Sides With Plaintiff and Vermont, 6-3

The above is a headline I never thought I would be writing, at least not this decade. I have not had time to read beyond the overall summary. But it does appear that every major pro-preemption argument was rejected by the 6-3 majority, including the capacity of Wyeth to have independently warned and the intent of Congress that FDA regulations _not_ preempt state tort law. The opinion below:

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

No doubt, there will be more to say later--just got this ten minutes ago.

Y'ALL COME BACK....

Preemption's March Through Georgia



Viewed from the perspective of Michigan, where we have had a full FDA preemption shield law for fourteen years, it is fascinating to watch the struggle over such a law in Georgia. In some ways, it is like watching an old movie...in slow motion.



Still, 2009 is not the same as 1995. We are living in the post-Vioxx era and with a very different consciousness (post Enron, etc.) about corporate corruption, FDA's inadequacies, and public trust in the industry. Polls show that beginning in 1997, when DTC advertising on television fully blossomed, the public's view of the industry has plummeted. While that has leveled off some in the past couple of years, it is not clear that the overall trend has changed. In the meantime, as all here know, the industry itself is up against much larger challenges re: the pipeline, patent expiration, etc., all in the context of the wider economic collapse.



Below some excerpts from a piece on the efforts in Georgia to pass a full FDA shield law. As of yesterday (Tuesday), the relevant state senate committee already voted against the legislation. It's Chair, however, is one of two supporters. And he invited reintroduction of the bill before the current legislative term runs out.



A link is not available, so a few excerpts instead....Don't miss the reflections of Rep. Seth Harp. And even Medtronic indirectly shows up at the end...




Monday, February 23, 2009

Senators weigh drug-maker bill



By Andy Peters, Staff Reporter

(Zachary D. Porter/Daily Report)


Sen. Seth Harp said the FDA's seal of approval “doesn't work anymore.”
Gov. Sonny Perdue's legislative proposal to grant legal protections to Georgia companies whose products have Food and Drug Administration approval came under heavy fire last week from a Republican lawmaker.

But two attorneys who represent pharmaceutical and medical-device manufacturing companies in products-liability litigation told state senators that Perdue's legislation is needed to preserve the FDA as the arbiter of what products can be sold to the public.

Both exchanges came on Thursday afternoon during a meeting of the Senate Economic Development Committee, which is considering Senate Bill 101. Sponsored by Perdue's legislative floor leaders, the bill would bar suits against Georgia pharmaceutical and medical-device makers that sell FDA-approved products.....

The lawmaker that criticized the proposal sponsored by his fellow Republicans, Sen. B. Seth Harp Jr. of Midland, said that in his previous career as a pharmacist he became aware of a bronchitis drug that caused severe liver problems in some patients. However, the drug, called telithromycin and marketed under the name Ketek, had received FDA approval, Harp said.

“Ketek helped bronchitis, but it tore up your liver,” said Harp, a member of the panel.

A December 2006 FDA report identified cases of acute liver failure in patients who took telithromycin and also identified four deaths among patients who had taken the drug, according to a copy of the report.

“How can we give these companies carte blanche to kill people if their products have FDA approval?” Harp said.
The bill's lead sponsor, Sen. William S. Cowsert, R-Athens, responded that companies that go through “all the hoops required by the FDA” should be immune from being sued.....

In order to qualify for the immunity from litigation, a company must have its U.S. “corporate headquarters, principal place of research and development or manufacturing, or a research and development facility in this state,” according to the terms of the legislation. Or, the company must employ “more than 200 Georgia residents for manufacturing or research and development purposes.”

“That's why this bill is in the economic development committee, we're trying to encourage these companies to come here,” Cowsert said......


Some other opponents of the bill called the committee's attention to a recent amicus brief filed by medical doctors in a drug-safety case pending in the U.S. Supreme Court. In the case, Wyeth v. Levine, a group of eight physicians wrote that “the FDA is in no position to ensure the safety of prescription drugs. Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public.”....


University of Georgia law professor Thomas A. Eaton, who has reviewed the legislation, said that the legislation may violate the commerce clause of the U.S. Constitution.

The bill, he said, is “giving a competitive advantage to companies with a Georgia presence.” He did not speak at the Senate committee meeting.

Ironically, Eaton added, “The only people who will be barred from bringing suits are Georgians. . ... I don't understand why Georgians would seek to put other Georgians at a disadvantage to seek compensation for injuries.”

Another of the bill's supporters, Greenberg Traurig litigation partner Thomas J. Mazziotti, said that the bill would prevent giving too much power to a jury in deciding what drugs are safe.

“I would be concerned that 12 people on a jury, who have deliberated for a couple of hours, would render a verdict for a patient that would be second-guessing the work of engineers and physicians who have spent 1,500 hours reviewing a drug's safety,” said Mazziotti, who said he's represented Medtronic Inc. in medical-device product-liability litigation.......



[plus ca change...Ed.]

Heartache

The results of a 2004-2008 study by Dr. Robert G. Hauser, Minneapolis Heart Institute, and Dr. David L. Hayes of the Mayo Clinic indicate that the failure rate of Medtronic’s Sprint Fidelis lead is, over time, increasing.

The study involved of 3,000 heart defibrillator leads, 848 of which were Medtronic’s Sprint Fidelis. In comparison to the others, the Sprint Fidelis had a significantly higher rate of failure and was less stable. See: Study Suggests Higher Failures for Heart Device - NYTimes.com

Recently, after citing the Riegel v Medtronic Supreme Court decision, a federal judge threw out hundreds of lawsuits regarding Medtronic’s Sprint Fidelis lead. Please read the NYT link and come back and tell us what you think. Should devices with such a poor track record be protected under FDA preemption?

MODEL FOR LIMITED PREEMPTION?

Is the Vaccine Shield a Model for Limited FDA Preemption

The WSJ has an interesting article today about the limits on lawsuits in the arena of certain vaccines. It may require subscription to access, but it can be found here:

http://online.wsj.com/article/SB123535050056344903.html

There are also summaries at various blogs, including Fierce Biotech:

http://www.fiercebiotech.com/story/booming-biz-raises-questions-about-vax-legal-shield/2009-02-23

What is unique about the vaccine law is that the shield is quite limited. If individual plaintiffs are turned down by the "vaccine court," or are otherwise not happy with the verdict, they are still free to file suit privately.

Might this be a model for limited preemption in the wider drug arena? Probably not, in that it would require an enormous "drug court"--or many--to field all the potential claims. Still, according to the article, Henry Waxman has been a key supporter of the current regime re: vaccines and, overall, it seems to have worked reasonably well.

What do you think?

SEAGULL V. MEDTRONIC

Medtronic Sues Aquarium Manufacturer for Faulty Wiring

As most of you Liliputs will know, Medtronic is the company that earned fame--or whatever--for its success in the Riegel case involving device preemption. That case involved a balloon catheter Medtronic manufactures. Meanwhile, Medtronic is dealing with a number of other suits charging faulty wiring in the pacemakers they manufacture. Presumably, in those cases, too, the company is likely to be shielded by FDA preemption.

It is with some irony, therefore, that we learn that Medtronic has filed suit against Petco for manufacting aquaria that themselves have alleged faulty wiring. As reported, the problem is not that the resident fish will die as a result. Indeed, it appears there were no fish in the aquarium at the time. It is rather that alleged faulty wiring caused a fire that, in turn, caused the sprinkler system to go off. A squishy mess ensued (so to speak).

Here is the report:

http://www.twincities.com/ci_11752438?nclick_check=1

As far as we know, aquaria are not pre-approved by FDA and thus do not have to go through the exacting and agonizing process in which FDA provides its optimal scientific weighing and measuring of risks and benefits. Nor do we assume that lay juries are capable of swimming their way into the complexity of aquaria. After all, all liquids have dangers. Particularly, if you are not a fish.

Meanwhile, at the corporate headquaters, we hope that nothing else was short-circuited. Especially integrity.

Past Time to Right a Wrong

Remember Riegel v Medtronic and the Supreme Court decision exonerating Medtronic because their heart catheter was FDA approved? Well, Medtronic is back in the news. It should be apparent to anyone who reads the NYT’s article Lawmakers Seek to Return Right to Sue Device Makers - NYTimes.com, that enough is enough.

Because of the Supreme’s misguided Riegel decision, injured Americans throughout the country have had their cases tossed out of court. Bills have been written to end this insanity, but have not yet passed. Congress needs to pass them, now, before anymore women are burned internally, hearts are shocked or torn apart, and defective implants and treatments go horribly wrong.
Please read the Times piece and come back and tell us your thoughts.

THE MIDNIGHT TRAIN FOR PREEMPTION

Georgia Rejects "Michigan Model" Preemption

According to reports (which will be updated), a key legislative committee in Georgia has voted _not_ to vote a "Michigan model" preemption bill out of committee. This was a stinging rejection both of the Governor, who has been lobbying for the bill, and for many of the same people involved in creating and defending Michigan's 1995 Ground Zero FDA Preemption law. (They have been actively lobbying in Georgia in recent weeks.)

It is reported that an overwhelming bi-partisan majority of the Republican-dominated committee supported the rejection of the bill. And that even hardened "tort reformers" chose not to support a law which they viewed as bad for Georgia, bad for consumers' rights, and ultimately bad for the industry itself.

More info as it arrives.

ANOTHER OFF-LABEL BUST

POff-Label Promotion and "Closet Deregulation"

The NYT reports two guilty pleaas by former Stryker sales reps for off-label promotion.

http://www.nytimes.com/2009/02/20/business/20bone.html?emc=tnt&tntemail1=y

Without getting into the particulars of this case, it does seem that off-label prosecution is coming thick and fast. The record verdicts agaist Lilly/Zyprexa a few weeks ago, the even larger verdict against Pfizer/Bextra (announced on the day of the Wyeth buy), and now this smaller case.

As many of you know, the same folks who fight for FDA preemption are generally also fighting for looser (or non-existent) off-label promotion guidelines. The irony is not subtle. On the one side, we must always defer to FDA's "scientific expertise." Except in those instances when it we opt to ignore it.

This recent case seems especially egregious in that the off-label use was not only unapproved but, allegedly, dangerous in the application for which it was being promoted.

In any event, preemption used to be called "closet tort reform." We can now be clear that it is "closet deregulation" as well -- and neither aspect is in much of a closet.

HERE WE GO AGAIN!

FDA Preemption Ground Zero

Once again, the great State of Michigan will attempt to repeal it's full FDA preemption law which goes back t0 1995. Except for a few flukey instances, no Michigan citizens have been able to file suit against drug companies if their drug has been FDA approved and is in compliance. There are, de facto, no exceptions because of related higher court decisions. That includes a company having committed fraud in the approval or post-approval process.

Two years ago, three bills to repeal our preemption law were passed in the state House by a vote of 70-39, with most but not all Democrats joined by one-third of the Republicans voting against preemption. That parallels state polls, which suggest about 70% of Michiganders are in favor of repealing our preemption law.

The state Senate, which is controlled by a small pro-preemption majority (about 2 votes) killed the bill in committee.

So now we begin again. Below a trio of bills introduced to rescind Michigan's preemption law. A difference between now and 2007 is that many of the pro-preemption Senators will be running for office. You can be certain, whatever the Levine decision, that there will be a great deal of noise coming from the Mitten State on this issue. Keep your ears open.


HB 4316 of 2009 (Lisa Brown) Torts; product liability; limitation on liability for drugs that have been approved by federal food and drug administration; rescind.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4316

HB 4317 of 2009 (Deb Kennedy) Civil procedure; statute of limitations; drug product liability cases previously prohibited because of FDA approval defense; allow to be commenced within 3 years after repeal of the defense. TIE BAR WITH: HB 4316'09Last Action: 2/17/2009 referred to Committee on Judiciary

http://www.legislature.mi.gov/(S(saebng3lgufg24ar3be0wlbt))/mileg.aspx?page=getobject&objectname=2009-HB-4317
HB 4318 of 2009 (Dian Slavens) Consumer protection; unfair trade practices; liability for inaccurate representations concerning risks of certain drugs, medications, and supplements; clarify.Last Action: 2/17/2009 referred to Committee on Judiciary
http://www.legislature.mi.gov/(S(al3eexiy0lqc3uim0jb0pdis))/mileg.aspx?page=getobject&objectname=2009-HB-4318

THE COMPARATIVE EFFICACY HOOPLA

Godzilla versus King Kong: FDA Preemption Meets Comparative Efficacy

Lots of chatter today on the NYT article, linked below, that reports on funds set aside to do comparative efficacy studies in the U.S.. You will note that there is no indication whatsoever about how the resulting information will be used. But we are already hearing dire warnings about the end of the doctor/patient relationship, "rationing" (you're on the iceflow, buddy), and the end of civilization as we know it. Rush hasn't had this intense a day in some time.

http://www.nytimes.com/2009/02/16/health/policy/16health.html?_r=1&emc=tnt&tntemail1=y

Of course, we already have comparative "efficacy": it's called managed care and what your insurance will and will not pay for. It is not based on science. It is based on the lowest bidder and, on occasion, kickbacks. That's how Baycol won the Department of Defense formulary contract, by underbidding the other statins. And that's how we lost a number of good men, and good women.

The real policy questions here are subtle. They will not be solved either by population studies or by disingenuous rants about rationing and socialism. They are issues of policy, ethics, and science. They will require hard thinking, indeed.

In the meantime, it is at least interesting that the same folks who are today hypertensive over the comparative efficacy studies--like Glaxo's leadership--are the first to champion FDA's "expert" and "optimal" weighing of risks and benefits. _Those_ Washington bureaucrats are rightfully uber alles. The ones imagined by the counter comparative efficacy gang are leftist muggers and thieves. (i.e., Canadians). Choose your demons.

Time for everyone to take a deep breath. Medicaid in states like Washington and Oregon did their own comparative efficacy work some years ago. It was not based on cost (despite what its critics say), but on evidence.. That is why a lot fewer people ended up getting Vioxx in those states than in others. And survived.

And, btw, nobody in Idaho or northern California went berserk over this "chaos of conflicting standards."