Key point!

Amendment 7 - US Constitution

In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law.

Amendment 14 - US Constitution

All persons born or naturalized in the United States, and subject to the jursidiction thereof, are citizens of the United States and of the State wherein they reside. No State shall make or enforce any law which shall abridge the privileges or immunities of citizens of the United States; nor shall any State deprive any person of life, liberty, or property, without due process of law; nor deny to any person within its jurisdaiction the equal protection of the laws.

Taking away the rights of Americans to sue in tort is unconstitutional, un-American and a breach of natural justice of the very worst kind. The FDA pre-emption is something you would expect to see in totalitarian states, not the United States.

For the vast majority of Americans, state courts are what matter, for of the approximately 10 million case tried in the United States every year the federal courts account for fewer than 2 per cent. State municipal and local courts have jursidiction overstate law*.

Tort law is a matter for the state courts not for federal government. The right to have your day in court is a natural right not a political plaything. No one needs to fear litigation if they are in the right. FDA pre-emption protects the guilty and can add nothing to the rule of law or democracy .

In all societies the courts play some political role. In liberal democracies where the independence of the judiciary is regarded as essential to prevent the exersise of irresponsible executive (and sometimes legislative) power the political role of the courts as interpreters of law and as defenders of individual freedoms is well established*.

The FDA is NOT the gold standard in federal regulation. The FDA has signally failed the American people time and time again in its negligent oversight of the pharmaceutical industry. Even worse the FDA has taken the side of the drug companies in tort suits with its amicus briefs. A really independant regulatory authority with the remit to protect American lives would never do that. It is the state tort laws that have been the only real bulwark of protection of Americans. It is through tort litigation that the American people have been alerted to the most dangerous drugs on the market. It is the fear of tort litigation that prevents even more dangerous drugs from being sold to Americans.

FDA pre-emption violates Amendment 7 and Amendment 14 of the Constitution and is an assault on citizens rights and freedoms. FDA pre-emption is a licence to cheat the citizen and to place them in danger and can do no good in a society based on individual rights.

* American Politics and Society, David McKay

If the company is right it has nothing to fear under the law.
No one case should be the end all for everyone because these cases are not all the same.

A big pharmaceutical company changes a branded drug for a condition that requires precise blood serum levels to be maintained. They know the dangers yet offer their consumers no advance warning that they might be placed in a deadly situation.
Doctors no longer know what they are prescribing because the drug company changed a med but not it’s name.
Pharmacists are surprised that the decades old drug they ordered is not what they’re finding in the bottles on their shelves, there is a new version.
Would those things warrant placing blame if the consumers were harmed? Doesn’t that scare you at all? I want my doctors and pharmacists to know exactly what they are giving to me.

Monitoring AEs is only as useful as pharma being willing to do anything but make excuses and deny the problem.

Re: Levine, I wish I had again the post in which we talked about why certain cases end up before the Court. The short version, though, is that the SC’s decision can be impacted in a variety of ways. Putting the Levine case forward was certainly motivated by knowledge that it would not be a good one for those who oppose preemption (and hides many of the real issues at stake). But I think the Justices are pretty smart about this, and, from what I’ve seen so far, if they read these briefs a _wide_ preemption decision in Levine would be about as clear policy-making from the bench as we’ve seen.

Will surprise no one that I strongly agree with JAT on this point: “I cannot see how preemption is going to be good for pharma. Maybe initially and for a very short time…”

Indeed, a genuinely fear it will be very bad, and lead to a cave-in of the public trust that’s left. Given the ways preemption can be modulated (see law prof’s brief) - limiting or ending punitive, limiting any preemption to issues FDA can show it has adequately examing, sustaining judicial review (which includes discovery as indicated) could lead to a fair and rational policy that protects the rights and claims of pts (all of us), industry, and FDA.

I don’t see insurance companies/PBMs paying physician or pharmacist med mal insurance premiums even though in some cases, these entities are entitled to therapeutically substitute prescription drugs and devices that are on their drug/device formularies in the place of what the physician writes for the pharmacist to dispense.

I DO already see a fear of prescribing, and I hear a lot more about med mal insurance agents dictating to physicians practices about what ‘type’ of patients physicians should see, what ‘type’ of patients the pharmacist should walk, what kind of meds the physician’s office should prescribe, and how (not) to write medical consultation appt notes and other medical notes.

We spend so much on healthcare in this country, maybe it is because there are so many unlicensed and unqualified hands in the cookie jar who get paid to practice medicine without a license.

My point to Daenea was that just because a drug is older doesn’t make it safer. There are many older drugs that that are far more dangerous than their more modern counterparts; however, since they are generic, there’s no large pharma to monitor AEs.

To the doctor who fears liability–no one is forcing him to prescribe the newer medications.

As for placing blame–who says there has to be blame? There are very often substantial warnings on drugs; when one of the known AEs occurs, who is to blame?

Atlex

Another key point.

Take Haldol for instance, a very old drug that used to be administered to a huge number of seniors in nursing homes as a chemical restraint. I don’t know if it is illegal to do this now, but if not, it is certainly frowned on. It’s a horribly dangerous drug. The state departments of family health and Senior Services are up to speed on it now. Not a bad thing in my opinion. Some may not care if those old folks lose whatever of their senses they have left. If they don’t care there should be another look at the death with dignity act (which shortens the life span of the industries consumers).

Imagine the distraught parents of all of these kids on antipsychotic drugs and ritilin if something goes awry under preemption. Teachers would be in danger of suggesting a child should be tested for ADHD and similar conditions. Who should be held responsible? The drug companies surely don’t mind that the teachers are taking a first step. Are they going to start protecting those teachers and school districts?
It’s like JC MD said ^above^ about fearing prescribing anything new. Is pharma going to pay his liability insurance? Even if they did, who’s going to save his reputation if he becomes known as the guy that killed or damaged his patients? Preemption does place the blame on everyone but the drug companies.
Imagine what will happen to the FDA- I’m not particularly fond of them right now, but conducted as it should be, it could serve a very valuable purpose. You can bet that they will be forced to be tougher on approvals when they have to take the heat.

I really do try to put the shoe on both feet in my annoying habit of over-thinking everything. I cannot see how preemption is going to be good for pharma. Maybe initially and for a very short time, but in the long run people have to shy away from drugs that they cannot investigate fully, which are the ones that have the public reporting their reactions to. Who else can we trust?

I do appreciate you playing devil’s advocate, Atlex, as it appears you are the only one willing.

The drug in this case is a very old drug, from the 50s or 60s, and its been used heavily. As JiM and I agreed earlier, this is a far from perfect case to test preemption. A stronger case would give the anti-preemption side a better chance at victory. Given the leanings of the court, I’d be surprised of they found in favor of Levine.

Atlex