The Right To Sue: A Case Against Preemption
34 CommentsBy Ed Silverman // August 15th, 2008 // 8:54 am
This is a new twist on summer reading. Now that the key parties have filed their briefs with the US Supreme Court, which will review a case involving Wyeth on November 3, a host of interested parties - including 47 state attorneys general, former FDA commissioners, members of Congress, constitutional experts and editors of The New England Journal of Medicine - have just filed their own briefs arguing against preemption. What is all the fuss about?
The background: During an emergency room hospital visit, Diana Levine was given a Wyeth nausea med called Phenergan, which was administered improperly and caused the Vermont musician to lose her right arm below the elbow. She successfully argued that, even though labeling complied with FDA requirements, the adequacy of the warning still wasn’t established for a particular method of administering the drug.
And she contended Wyeth wasn’t prevented from adding or strengthening the warning on the label, even though the FDA rejected a proposed change. Levine was awarded more than $6 million and, despite appeals, the Vermont Supreme Court sided with her. But Wyeth has appealed again and now the US Supreme Court will review the case.
Wyeth’s defense hinges on preemption - the legal notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, is being closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
There are numerous arguments being made against preemption in the amici curiae, or friend of the court briefs. The attorneys general, for instance, maintain states are “responsible for the enforcement of laws that safeguard public health, safety, and welfare. We therefore have a fundamental interest in preserving the appropriate balance of authority between the states and the federal government…
“…In our view, courts should only rarely infer that Congress, although silent on the issue, nonetheless intended to displace state law where it is possible to comply with both state and federal law…This particular case is of crucial importance because the position espoused by (Wyeth) and the United States would represent an unprecedented elimination of remedies available to consumers injured by drugs.”
Here are the briefs filed by the 47 state attorneys general; the former FDA commissioners; constitutional scholars; Senior Citizens League; National Conference of State Legislatures; New England Journal of Medicine editors; the California Medical Association; AARP; consumer activists; trial lawyers’ association; members of Congress; various unions; various economists and various tort law professors.
And if this isn’t enough, you can sift through Levine’s brief, an interview with Levine, the Wyeth brief and the brief filed by the US Solicitor General. And if you look here, you can read friend-of-the-court briefs filed earlier by PhRMA, BIO, the Generic Pharmaceutical Association, the US Chamber of Commerce, the American Enterprise Institute and the Washington Legal Foundation in support of preemption.
Vacations are good for reading, yes?
Justice in Michigan
Well, Ed quietly came in from the warm and added to this post - in an amazing way! We now have links to all the amici briefs in Levine. Thank you, Ed! Maybe if I assign these to a class, I will have time to read them too! (Also noticed that Michigan’s attorney general is one of the three who did not sign on; not a surprise.)
Some of you may also have seen the article (by Alicia Mundy) and editorial in the Wall Street Journal during the week. Both were “provocative” - I will leave it at that.
In any event, it does not now look like the preemption issue - which we have revisited many times here - will stay in the wider public closet. The public debate I’ve been hoping for appears to be in the offing.
I do, indeed, hope that preemption is “all the rage.” Interpret that as you wish!
Justice in Michigan
Besides Michigan, the other missing AGs are the one from Texas (which has the second most prohibitive drug shield law in the country) and, of course, Vermont itself - since the petition is supporting the Vermont Supreme Court.
laurie
This is VERY encouraging! Nice to see NJ on the list.
Justice in Michigan
Ed notes: “Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness.”
They do, indeed. People opposed to preemption do _not_ challenge the notion that “the agency’s actions are the final word on safety and effectiveness.”
Rather, they argue that when serious questions come up, FDA must do more than simply assert its authority. It must show, through its own records, that it did, in fact, adequately review the issue in question. And, as follows from that, it must be demonstrated by judicial review (generally in a discovery process) that the manufacturer provided FDA the information required to make that review.
To paraphrase Catherine Sharkey, if FDA wants such authority it must also take on the responsibilities that would rationally justify that.
In the great majority of instances, FDA’s initial determinations will be confirmed. In a few - which are the ones we’re concerned about - they may not be.
Either way, their authority is not challenged. It just does not exist in a vaccuum, which is true of most institutions in democratic nations.
Just A Thought
Justice says:
People opposed to preemption do _not_ challenge the notion that “the agency’s actions are the final word on safety and effectiveness.”
I challenge it, actually, but not without reason.
What I don’t get is why the FDA wants the weight of the consequences of preemption?
As for the pharmaceutical companies- protection from a bunch of people who are likely sick or mourning? Some who are maybe not well enough to make a stand, yet do? I guess that’s one way to play it. My guess is that people are going to shy away from new drugs. My doc can be a guinea pig if he chooses. I’ll be sticking with long tested drugs from here on, long off patent, cheap drugs. Ones that I can be fairly certain won’t damage me. If he won’t prescribe those I’ll find a new doctor. Because really, why would anyone buy into a post-marketing study under preemption? It’s bad business and not as if the courts don’t give pharma equal time and consideration under the existing system.
In the end it is the consumer that decides what (s)he is willing to swallow.
Maybe I’ll buy some shares in an aspirin company or write a book on poultices.
:-P
Jaynesday
from JAT -”What I don’t get is why the FDA wants the weight of the consequences of preemption?”
Good question! The only thing I can think of is that the FDA’s coziness with pharma is more important to them than the safety of the nation’s drug/devise products.
Justice in Michigan
Re: FDA’s motives, this is what happens when a regulatory agency gets taken over by the industries it regulates. I’m not talking about “ooziness” here. I’m talking about the direct appointment in key positions of the same people who fought the agency when its regulations were not in their clients’ interests. No need to list the relevant folks.
So it is really not “the FDA” that wants preemption, but its current leadership and those lifers in senior management who thrive mostly by bending over when requested. By the time disaster strikes, as it will, the political folks will be long gone - as they mostly already are. And there will be no shortage of ways to try to make others responsible for the “mess” (to put it most politely).
Re; my point about FDA having ‘final word,’ it is a purely institutional point. The preemptors whole argument is based on equating state civil libility with a competing regulatory scheme. As though juries could revise labels, send warning letters, etc.. In fact, 90% of civil cases come to whether a company appropriately _met_ FDA requirements, as well as other basic expectations of non-ngegligence - what did they know, when did they know it, what did they do.
So the alleged conflict between tort law and FDA is part of preemption’s big lie.
Justice in Michigan
“ooziness” should have been “coziness” in the above, but I must say I kinda like “ooziness”…..
laurie
” In fact, 90% of civil cases come to whether a company appropriately _met_ FDA requirements, as well as other basic expectations of non-ngegligence - what did they know, when did they know it, what did they do. ”
This is the key point, in my opinion. A drug can be FDA approved based on their “best knowledge at the time of approval”, but that, as proven in recent cases, isn’t reality.
Information comes out all the time about suppressed data that the FDA didn’t know about, or at least didn’t admit to knowing about. So why should the public be denied due process in a situation like this?
As I’ve said over and over again..if the FDA was a true regulatory agency there would be no data that they didn’t get for consideration in drug approval. But the system isn’t set up that way currently. The FDA gets what the manufacturer “chooses” to send them.Cherry picked clinical trials do NOT meet anyones standard of complete disclosure. Until that situation is remedied ,giving the FDA complete authority over legal action is a HUGE public disservice.
Justice in Michigan
Laurie - I obviously appreciate what you say. And, as we’ve discussed here, there are also things that can happen that are entirely _outside_ FDA’s purview but potentially relevant in civil liability.
These include the ways journals can be used (FDA has no control over JAMA or NEJM’s editorial policies, let alone the ‘lesser’ journals); bribing or intimidating researchers (also outside FDA purview); and “passive-aggressive” compliance - “dragging out” various obligations just to the point of avoiding penalty.
Thus, even if we had a utopian FDA - wistful thought - it would not cover the range of actions that can become relevant in civil trials.
This is an important point since so often the preemptors’ argue some version of “lawsuits won’t fix the FDA” = as though a “fixed FDA” would resolve all the issues.
So, in my view, even _if_ “that situation was remedied,” we would still need both systems.
jooe
from JAT -”What I don’t get is why the FDA wants the weight of the consequences of preemption?”
Can you imagine if the FAA took over preemption of all the airlines? Yes, the FAA is in charge of inspecting all of the airplanes and issuing safety standards, making sure the pilots have a specific amount of training and rest time after a full day, overseeing the air trafic controllers and suppose to be securing our safety. But if the pilot shows up drunk, if the plane crashes wether it’s for safety, weather or terrorist activity..I’m sure the airlines would like it if they had preemption. Why should there be preemtpion when it comes to pharmaceuticals when we know those same companies have killed more people than any war or terrorist activity. If airline “A” was flying yearly flights and killing 30,000 people a year, don’t you think the airline would be shut down by the FAA?
JC MD
If the prescribing physicians also became liable for the unintended consequences of these drugs, then they would think twice about handing out every new drug on the block. Disclaimer, I am a physician.
Anne PME
I am not a lawyer, so maybe I am missing something because when look at all of the resources that are being expended on this, it just seems like such a waste. I thought that the goal was for FDA, states and pharma to work together to protect American citizens’ health and safety. Seems like everyone has the potential to win when resources are spent on working with each other instead of against each other. No matter who ultimately ‘wins’ the preemption battle, I can’t help but think that in a very fundamental way, we’ve all lost the war.
atlex
Jooe,
Your FAA analogy just doesn’t hold up. A drunken pilot IS a violation of FAA regulations. That would be analogous to a pharma company violating FDA regulations by having a poisonous contaminant enter during the manufacturing process causing harm to a user. Preemption, from the pharma industry perspective provides protection when the pharma company follows FDA regulations and approvals, but unexpected and unforeseen harm still comes to a user. Of course, as JiM and I have discussed, a broad interpretation could expand those protections to include cases where critical information was hidden from the FDA.
Atlex
Chris
Anne PME -
Pharmaceutical firms have a strong financial incentive to minimize potential risks of drugs, which can on occasion trump any concerns for protecting patient safety. To the extent clearly communicating the risks of a drug dampen the demand, the pharma companies do not win. Thus, the need for corporate accountability (ie. no preemption).
Jaynesday
Alex, maybe what Jooe was saying was what if other industries start using the same preemption idea for protection. For example - what if the auto industry started to claim preemption from product liability for rollover accidents? They too are regulated by the government. (By the way they are attempting to go that direction now, I’m sure they are watching the pharma cases closely).
What if the railroad industry started to claim that rail accidents were preempted because of the government’s regulation of rail road safety? (There is a case pending now that is claiming such)
So where does it end? I suppose it ends with every industry that has a government safety overseer (National Highway Safety, National Railroad Safety, etc) becoming free from product liability. And those that don’t have a governmental regulating organization will certainly petition to have one created for them.
In essence manufacturers would push to be regulated by the government so that they can get away with selling *less* safe products.
“Make that whiny customer go away Uncle Sam, I can’t make enough money to put gas in my helicopter.”
Anne PME
Chris-
Thanks for the post. I agree with you about corporate accountability, but would like to point out that everyone needs to be accountable.
Justice in Michigan
Anne writes: “I thought that the goal was for FDA, states and pharma to work together to protect American citizens’ health and safety.”
That is surely the ideal goal, and - overall - it has worked well in most instances over the last 100 years. Of course, each institution also has other interests (maximizing profit, etc.) which may or may not always be in synch with maximizing health and safety).
FDA preemption would take away one of the pieces, leaving only FDA and pharma. That (said too simply) is why many think it’s a bad idea, and we really _will_ lose more with that result than otherwise.
Re: Atlex’s point, the law profs’ amicus includes some interesting commentary on degrees of preemption - from full and broad to more narrow. Since these discussions often lead people to try to find a third way, this brief may be of particular interest.
atlex
Jaynesday,
The issue isn’t whether an industry is regulated or not. It is whether the specific possible tort is regulated and in what way. The government sets minimum safety requirements for cars, but it doesn’t mandate a very specific solution. In the case of drugs, though, essentially a manufacturer can be told what warnings to put in its label by the FDA. That does make a big difference. If preemption is endorsed by the courts, it should not be assumed that attempts by other industries would have the same results.
Atlex
Justice in Michigan
I don’t know much (anything?) about regulation in other industries, but - if you read DDL - there is no question that the FDA preemption argument and preemption by other regulatory agencies are fully intertwined in terms of where corp. lawyers seek relevant precedents.
Likewise, it is clear that those who favor FDA preemption also generally favor preemption in those other areas - from the Chamber of Commerce perspective, it’s all about defeating Greedy Trial Lawywer, Inc. wherever.
And, indeed, the decisions of the current Supreme Court have tended to favor preemption in these other arenas, despite differences in particulars.
atlex
JiM,
Isn’t the term “greedy trial lawyer” redundant? I guess trial lawyers are like members of congress. The approval rating of Congress is very low; but, my approval rating of my congressman is very high.
Atlex
Daenea
I totally agree with “Just a thought”. I think more and more people are becoming wiser about taking only the older safer drugs. You couldn’t pay me to take a new drug, or even some of the drugs that just came off patent. I believe the less drugs we all take, the better off we all are.
Pharma is only concerned about ROI. I’ve been educating myself over the last five years about pharma and their legal drug pushing. I’m spreading the word to everyone I know. I want my friends and family to stay out of harm’s way.
Jaynesday
Alex
Your point – “The issue isn’t whether an industry is regulated or not. It is whether the specific possible tort is regulated and in what way.”
My point is that it appears that other regulated industries are using their status as federally regulated to eliminate state torte challenges altogether.
Your point – “If preemption is endorsed by the courts, it should not be assumed that attempts by other industries would have the same results.”
They certainly are trying - see:
Railroad Industry -
California Court of Appeals Holds That Federal Railroad Safety Act Preempts State Law Negligence Claims Against Push-Pull Commuter Rail Operator http://www.klgates.com/newsstand/Detail.aspx?publication=4630
Automotive Industry
http://www.consumeraffairs.com/news04/2008/06/nhtsa_roof.html
Comments from this article are very much like what we see in the case of Pharma.
Sen. Mark Pryor (D-Ark.), chair of the subcommittee, warned Ports that NHTSA is “overstepping (its) bounds.”
“If you pursue this preemption language, I think you’ll get bipartisan opposition to it,” Pryor said.
“There’s preemption language popping up everywhere like Spring flowers,” McCaskill said.
Justice in Michigan
Agree with Jaynesday, as above.
Re: lawyers, I think “greedy trial lawyer” has the same usefulness as “big bad pharma” in discussion of these issues. Or, as I’ve said, The Constant Gardner versus the King of Torts.
But both kinds of cross-the-board demonizing are emotionally and politically compelling, and there are always enough kernels of truth to keep them going, however _not_ useful in other ways.
I admit temptation, and so I have started to mimic DDL and refer to the “preemption lobby” (as they refer to the “plantiffs’ lobby”) to cover everyone with whom I may disagree.
It could be worse - I’ve also imagined “Corp. Lawyers, Inc.” or even “Corpse Lawyers, Inc.”
But I’m too nice a guy.
atlex
Daenea,
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
Just A Thought
You may be right, Atlex. Except it’s far easier to get news about these things than it was in the 50s or 60s and people no longer have blind faith after case after case of misrepresentations and dangerous reactions(not the public’s fault, btw).
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.
laurie
“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.”
Another key point.
atlex
JaT,
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
Anne PME
Laurie:
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.
Justice in Michigan
All - I hope clear that I was being sarcastic in last post, and mimicking a style of “debate” which I think always gets in the way. (Although it does “really troops” briefly).
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.
Just A Thought
Atlex,
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.
Barry Turner
The United States of America was founded on the principles of individual rights under the law. The democratic institutions of the United States have been and still are the example to the world and the United States has historically been the champion of individual rights since its foundation in the last quarter of the eighteenth century. I can think of nothing more un-American than the government of the United States of America wishing to strip away the rights under the law of American citizens. The FDA pre-emption is exactly that, a fundamental denial of a constitutional right that goes back the founding of the nation.
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
Jaynesday
Well stated Mr. Turner!
laurie
” 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.”
Key point!