In Bed with Pfizer

By Kelly Steele of Portland, Oregon. Kelly is the communications director for the Democratic Party of Oregon.

Kevin Mannix & Linda FloresJust four days after the latest FDA-approved multi-million dollar blockbuster drug Bextra was pulled from the market, the Republican leadership allowed a hearing on a bill that would eliminate the rights of Oregonians to hold pharmaceutical companies accountable when their drugs cause harm to Oregon consumers. HB 2743, heard this morning in the House Judiciary Subcommittee on Civil Law, would protect big drug companies from being held accountable in Oregon’s courts, as long as the drugs were approved by the FDA. HB 2743 details here (pdf)

Rewind to last year’s Republican National Convention. Linda Flores, chief sponsor of the bill, on being repeatedly wooed by big pharmaceutical companies with presentations made over expensive meals:

”Republican delegate and state Representative Linda Flores said Pfizer's sponsorship of the meals would not affect her views on prescription drug policy.” (AP, 9/1/04)

Flores, Mannix, Big Campaign Money
HB 2743 is sponsored by Linda Flores, who said the special treatment she received from big drug companies wouldn’t influence her policies when dealing with the pharmaceutical industry as a Representative in Salem. Yet now she is sponsoring legislation that exists almost exclusively to protect those same big pharmaceutical companies. Perhaps it wasn’t only the expensive meals at the RNC. Perhaps the thousands of dollars they’ve donated to her campaigns made a difference as well.

Even more interesting, Flores sponsored HB 2743 on behalf of the Oregon Litigation Fairness Project.

The lobbyist for the Oregon Litigation Fairness Project (lobbyist disclosure, pdf) is none other than Kevin L. Mannix, current Oregon GOP Chair (and Chair while Flores was GOP Vice-Chair) and current candidate for governor.

In 2002, Kevin Mannix accepted $626,000 from the Pharmaceutical & Health Products industry in his 2002 campaign for governor.

Bad Legislation, Wrong Priorities
HB 2743 does nothing to help the 780,000 Oregonians without prescription drug coverage. The only thing it helps is the pharmaceutical companies, who can no longer be held accountable if their products cause harm to Oregonians. Perhaps that is why PhRMA and GlaxoSmithKline showed up this morning to testify in favor of HB 2743.

Marybeth Healey, executive director of Oregonians for Health Security, testified against the bill this morning. HB 2743 “removes accountability and gives companies that sell products that harm Oregonians a free ride,” Healey stated. “It’s a sweeping bill that does nothing to lower health care costs, and only helps the pharmaceutical companies.”

Healey also noted that many of the recently-pulled multi-million dollar drugs, such as Vioxx and Bextra, were initially approved by the FDA. “Patients who have taken these medications as prescribed are now having adverse effects, and this legislation would ask them to pay an even higher price: no recourse,” Healey testified.

“Once again, Republicans are standing with big pharmaceutical companies against the interest of Oregonians,” said Kelly Steele, communications director for the Democratic Party of Oregon. “Democrats in Salem have advanced an agenda that holds big drug companies accountable and lowers prescription drug costs for all Oregonians. This legislation, in conjunction with the campaign contributions to its Republican backers, highlights a stark contrast for Oregonians concerned about holding big drug companies accountable.”

[Editor's note: The above photo illustration was created by BlueOregon, not the Democratic Party of Oregon.]

Comments

  • David Wright (unverified)
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    I'm curious, do Oregonians have the right to sue the FDA when they approve a drug that is later found to be harmful?

    Seems to me that in such a case, the FDA is the primary culprit for failing in its role as a watchdog.

    It also seems to me that in an environment that is subject to federal regulation, a federal rather than state court would be the appropriate venue to pursue any sort of liability action.

    Not to dispute the link between pharmaceutical companies and the Republican party, I'm just curious about the relative merits of the bill on its own regardless of who sponsors it.

  • afs (unverified)
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    David Wright hits another GOP talking point. What a big surprise. Moving lawsuits out of state courts to Federal courts is a HUGE goal of the GOP.

  • portland_stories (unverified)
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    Well said!

    These companies (PHRMA) and the legislators that cave into them need to be reckoned with. I was glad to see this piece posted today.

    Another FYI for any who care and more especially any who live in Salem. There will be a public hearing at the Capitol this Friday morning regarding pharmaceutical companies and gift disclosure.

    Date: Friday-April 15 Time: 9:00 A.M. Room: HR D

    HB 2817 - Requires pharmaceutical manufacturing companies to disclose certain economic benefits provided in conjunction with marketing of prescription drugs.

    Hope to see you there. Perhaps we'll all get a free pen and lunch if we attend?

  • David Wright (unverified)
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    Yes, AFS, as it happens the GOP generally would like to see many types of liability lawsuits moved to federal courts. In many cases, there's little if any rational basis for such a change of venue short of benefit to the companies involved.

    That doesn't address my specific question here, though, where there is an entirely rational basis for moving these particular types of lawsuits to a federal court independent of any benefits gained with such a move by the company.

    A federal agency is responsible for approval of the drug. Thus it seems to me that any liability involved, either by the agency or the drug company, would be most appropriately handled at the federal level.

    Here's a curveball for ya, though, AFS. I don't happen to think that gun manufacturer liability or tobacco company liability should be moved to federal courts. Oops... sorry there AFS, guess I misread my "GOP Talking Points".... no, no on second thought, it turns out that I'm actually using my BRAIN for something and considering individual issues on their own merits.

    Something you might give a shot some time... <nobr>;-)</nobr>

    Hey, since we're talking about pharmaceutical companies... how about national legislation to restrict direct-to-consumer marketing of prescription drugs? What the hell are the drug companies doing, telling us to tell our doctor what they should prescribe? Wasn't there a reason our docs went to med school for all those years, other than to listen to the masses clamoring for drugs that half the time we aren't even told what they cure? I'm generally no fan of market controls, but if ever there was a good case to be made for ad restrictions, I think this is it.

    Just a thought...

  • nader (unverified)
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    David Wright: Do you have any education in the law, or are you just guessing?

    You think that because a Federal Agency is responsible for approving a drug that is sufficient to grant Federal Jurisdiction? The FDA is not a party to the lawsuit my friend, so that alone is not going to grant you federal jurisdiction.

    States have the power to ensure the safety of their own citizens; one way of ensuring the safety is through the availability of tort civil actions. Each state has a particular and unique public safety interest - namely the protection of it's own citizens. The fact that an Oregonian has been harmed in Oregon, by a product marketed and sold in Oregon, gives general jurisdiction over the civil action.

    Automobiles sold in the US must be approved by the Dept. of Transportation. Are you arguing that if, say Audi, advertised and sold a car here which had a dangerous defect that caused unintended accelleration resulting in horrible accidents, that Audi would have immunity because the DOT had not uncovered the problem?

    Your argument seems to suggest that the Feds might as well nationalize any industry it intends to regulate.

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    David write: how about national legislation to restrict direct-to-consumer marketing of prescription drugs?

    Excellent point. After ad restrictions were lifted in 1996, prices really went through the roof. The standard pharma line: "we need all money for R&D" really doesn't hold water when you look at their budgets. And of all major drug companies, Pfizer has the highest advertising to R&D spending.

    Nice handle, Nader. How's that Bush environmental policy working out for ya?

  • David Wright (unverified)
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    Nader, I have neither an education in the law, nor am I "just guessing". I'm expressing an opinion about how I think the system should work, not explaining how it does work today.

    I think the FDA should be a party to the lawsuit. If they are charged with determining that a given drug is safe, and that drug turns out not to be safe, and the person bringing suit can prove that the FDA was negligent in approving the drug, why not?

    If the DOT is charged with ensuring that a vehicle is safe for consumers (is that their regulatory function?) and a defect was missed during the regulatory approval process (which presumably would take years, as the drug approval process takes, hence my question about the equivalent roles of FDA and DOT), then I'd say the DOT should also be a party to any resultant liability lawsuit.

    Liability is about failing in some responsibility, correct? So these agencies either have responsibilities or they do not. If they do, then why wouldn't they be liable? If they do not have any such responsibility, then why do the agencies exist at all?

    Just curious...

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    David makes good and logical points addressing the topic at hand, but we'd be pretty naive to look at this thing in a vacuum.

    One of the stated goals of the new and improved Republican Party is to starve out potential revenue sources for Democrats. Any time they can limit awards to plaintiffs and their attorneys and limit liablility to their own donors in Big Pharma, they are on target, if purposely off message regarding their total commitment to caring and sharing in the Barney Way.........

    This is part and parcel of the national effort to get ALL lobbying money flowing to Republicans. On K street in DC you will be punished if you so much as hire a Demcratic lobbyist. This is just more trickle down hamstringing at the state level.

  • auggie (unverified)
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    David: You maybe writing about how you think the system should work, but just to clarify how things do work …

    Governmental Immunity: You can’t sue the federal government, in this case the FDA, unless the government gives you permission and it hasn’t.

    First Amendment/Commercial Speech: Drug companies ads are protected by the 1st Amendment, can’t change that without a change in the Constitution or a change in the interpretation of the Constitution.

    Okay, so now we have those pesky legal issues out of the way, I have a question for you. Why in the heck should our Oregon legislature pass a bill that protects the drug companies at the expense of Oregonians?

    Also, for a little background on the problems with the FDA, check out this article by the ultra-leftist magazine Forbes Five Ways to Fix the FDA

  • David Wright (unverified)
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    Auggie, advertising is I believe regulated to some extent in the US already without requiring any constitutional changes. From what I've read, there's a fine line, but the courts have upheld certain restrictions on commercial speech as being constitutional. There are several bans or restrictions on TV advertising, including a ban on cigarette advertising on TV since 1971. There are restrictions on advertising related to children's television. Clearly, commerical speech does not enjoy quite the same First Amendment protections that private political speech does, correct?

    So, I don't think it's unreasonable or necessarily unconstitutional to look for a way to place some restrictions on TV advertising, at least, of prescription drugs.

    Anyhow, back to the issue of actual liability for drug companies...

    This bill establishes one primary liability limitation for drug companies. And that is, if the harm caused to a person was due to a risk or side effect of the drug which was fully disclosed to the FDA during the approval process, and the drug was approved anyway, then the drug company is not liable.

    It doesn't appear to be strictly speaking true that a drug approved by the FDA is automatically cleared of all liability claims against the manufacturer.

    If the drug company produces a bad drug and hides the risks or side effects during approval, you can still sue the drug company, as far as I can tell. Please correct me if I'm wrong. (The text of the bill is available here, the original link did not work.)

    If the drug company explained the risks to the FDA, and the drug was subsequently approved for use anyhow, then why on Earth should the drug company be held liable when those acknowledged risks manifest themselves?

    I get back to my wish that the FDA could be held accountable in such a situation (good article on the problems with the FDA, by the way). But failing that, if the drug company disclosed these risks or side effects before approval, the drug company has done its part, hasn't it? It's the FDA that has failed in its responsibility.

    I dunno, this just seems like a reasonable measure to me. Drug companies that hide bad side effects or risks can still be held liable for harm caused by those risks. Drug companies that disclose bad side effects or risks ahead of time, can not. What's wrong with that?

    This bill also repeals ORS 30.927, which already seems to deal with limitations on punitive damages for drug companies specifically, under essentially the same circumstances as laid out in this bill and with the same exceptions. In other words, this bill seems to place the general drug liability standard in line with the existing standard for punitive damages, hence 30.927 becomes redundant and may be repealed. If my interpretation of this is wrong, somebody please correct me.

  • Edward (unverified)
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    Just one more quick legal point (for anyone who cares).

    The issue of using a government law or regulation in a civil suit happens all the time and is pretty well accepted.

    One of the big legal issues to prove in a negligence suit has to do with the standard of care. You can well imagine in the absence of any kind of law or regulation that the two sides will argue about whether the alleged bad act was reasonable or not.

    If there is a law or regulation on the books that is designed to protect the general welfare and safety of the anticipated class, then you as a plaintiff can use that law as your standard. For example, in a suit about a traffic accident where the defendant ran a red light or crossed the double yellow line, both of those acts are clearly violations of laws designed to protect the safety of other users of the roadway. Such violations could be used to earn a presumption of negligence (and of course, the case isn't over right there -- the parties still have to argue about causation and damages). Using those types of rules in such situations is pretty well accepted.

    To keep the car analogy going, could a defendant use compliance with the law to earn a presumption of not being negligent? Maybe, depending on the facts. The guy who stops at a red light has a pretty good case that he wasn't negligent (for what? I don't know. Maybe a skateboarder ran into him). But if a little old lady had collapsed in the middle of the intersection and was lying on the ground, could a person who drives through a green light and ran over the little old lady argue that they weren't negligent because the light was green? The green light rule pretty quickly becomes beside the point.

    You can pretty well imagine, the more complex the facts of the case and the more complex the laws and regulations covering the alleged act, the more complex the argument about using those rules as a presumption of negligence gets.

    And the question about drugs is really in a sub-set of negligence law so big as to constitute its own genre: product liability. To get back to the car analogy, it would be like a plaintiff who got injured in a bad accident in which the air bag failed to deploy. Should such a plaintiff be able to bring a suit against the car manufacturer even though the manufacturer abided by the government regulation requiring new cars be equipped with airbags? I think such a plaintiff should be able to bring that kind of suit. Of course, the defendant will argue that the plaintiff continued to drive the car even though the airbag light was on, etc. And just bringing the suit doesn't mean the plaintiff automatically wins. It just means s/he gets a chance.

    Products liability is pretty much just like negligence except that you get to sue anybody in the supply chain. If a consumer product is defective and you get injured using it for its intended and reasonably foreseeable use, you get to sue not only the manufacturer -- but also the store that sold it to you. This gets pretty tricky pretty fast when you start talking about drugs. I mean, we're talking about products that are accompanied by warnings like: "some users may experience discomfort accompanied by discharge." If you happen to be one of those users, do you get to sue your pharmacist and the drug company? Sure you can. But you'll probably lose because you knowingly accepted the risk because the pharmacist and the drug company told you about the possible side effect.

  • Sarah Wetherson (unverified)
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    Um, I think it's important to point out that more than two-thirds ($415,000) of the $626,000 figure comes from Loren Parks, who manufactures some kind of mysterious medical device. The bulk of the remainder ($200,000) comes from Joan Austin, an ADEC executive. ADEC manufactures dental equipment. While these folks may (or may not) share goals with Pfizer and other drug companies, they do not, in fact, manufacture drugs. Those companies contributed about $11,000 to Mannix's 2002 campaign.

    I'm just sayin'.

  • nader (unverified)
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    I find the notion that the Federal government could have assumed full liability for all damages caused by the conduct of a regulated entity completely absurd.

    Beyond auggie's very helpful primer on Governmental Immunity, common sense should tell you that regulation of an industry or activity doesn't immunize the parties involved.

    States have the power to regulate the operation of automobiles. If you have a driver's license the State has tested you for your knowledge of highway safety and the rules of the road. But if you go out and get in a car wreck, you better believe that you are liable, despite the license to operate given by the state.

    Pfizer essentially has a license to sell certain drugs. To get that license they must pass certain tests and regulatory hurdles. But once the drugs are on the market, Pfizer still has liability independent of the FDA regulation.

  • David Wright (unverified)
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    Nader, I take your point, but I don't think it is relevant to my arguments (at least in terms of philosophy rather than legality). Your automobile analogy illustrates nothing to do with what I said.

    To use your DMV analogy, if a blind person goes to get a drivers license, and the state agency (knowing the applicant is blind) grants the license anyway, couldn't a strong case be made that the DMV has failed and bears some responsibility when the blind driver causes an accident?

    But of course, if an applicant had passed all tests, demonstrated clear vision, etc., and was licensed on that basis, then subsequently went blind and caused an accident while driving, of course the DMV has NOT failed in that case.

    We're not talking about a company being licensed by the FDA and thus being forever excused from liability for any actions whatsoever. We're talking about a specific drug being licensed for sale, where the potential effects in question were known before the drug was approved. In that case, the drug's manufacturer is cleared of liability for harm done by those known effects.

    I for one never advocated the federal regulatory agency taking full liability for all actions of the regulated parties. And this bill doesn't do that.

    I'm saying that as a point of philosophy, where a government agency has some responsibility, and fails in that responsibility, the agency should be held accountable. Period. Nothing more. Legally it appears they can't, which is too bad. I'd like to see that changed. But that legal reality doesn't place any greater moral or ethical responsibility on drug manufacturers.

    If Pfizer gets a drug approved by the FDA when the FDA knows that it causes heart attacks in say 1% of the population, and either patients take the drug knowing the 1% risk or the FDA does not mandate disclosure of the 1% risk, why should Pfizer be liabile when 1% of the patients have heart attacks?

    Now, on the other hand, if Pfizer reports a 1% risk to the FDA, and it turns out there's a 20% risk, then clearly that would fall outside the scope of the exemption and the company should be liable. Or if, after licensing, a manufacturing defect for example caused different side effects or risks than when the drug was approved, that would also fall outside the scope of the exemption.

    I'm sorry, I just don't see what the big deal is. Legitimate wrongdoing on the part of the company can still be addressed under this bill, unless there are some super-secret code words contained in the language that I don't understand.

    Beyond that, perhaps it's simply a disagreement over what constitutes "responsibility"?

  • Edward (unverified)
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    What's the problem?

    One of the biggest problems is that the FDA's regulatory system has some major flaws. I'm already pretty dubious about the FDA's ability to objectively weigh evidence and allow drugs to market. I don't even want to seriously think about allowing the FDA to give a "freedom from liability pass" to drug companies.

    From what I understand, drug companies can studies that are turning up evidence about their drugs that will look bad to the people at the FDA. Because the studies are never completed, we never find out what they would have found out about the drugs.

    The other bad thing about the FDA approval system is that once approved for market for a specific use, the drug can then be used for ANY use, whether or not there are any studies on its efficacy and the possible side effects.

    Now, is this really a system that's sooo great and reliable we want to use it as a freedom from all liability for drug companies? And let's not kid ourselves. That's what we're really talking about (i.e., making a plaintiff prove their damage fell beyond the scope of what was submitted to the FDA, yet that the drug company also knew about it).

    I mean, you can say that the company would still be held liable in those instances, but that starts to get pretty close to gross negligence. That standard is so high that it is almost impossible to prove unless you have a company insider who can get you the documents to help prove the fraud.

    What you're really talking about is giving the drug companies the freedom to market products that they know will hurt people without running the risk of having to pay the people that they know their drugs will hurt.

  • David Wright (unverified)
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    Edward, you make excellent points.

    I consider what you've written and think we need to fix the FDA (check out the article that auggie linked to for more on this). I don't consider what you've written and think we need to hold drug companies accountable for the failures of government oversight.

    Guess it's just a different way of looking at the world...

  • nader (unverified)
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    David wrote, "I for one never advocated the federal regulatory agency taking full liability for all actions of the regulated parties. And this bill doesn't do that."

    I'd like to call your attention to HB 2743, Section 1, subsection (1) which reads: "...a civil action may not be brought against any person by reason of the sale or prescription of a drug or medical device described in subsection (4) of this section."

    Scrolling on down...subsection (4)includes any medical device or prescription, "(a) Manufactured and labeled in compliance with the terms of an approval or license issued by the federal Food and Drug Administration..."

    The text seems clear on its face: Oregonians would be barred from brining any civil action in State court against the manufacturer of any medication that had received FDA approval.

    This is such a bad idea, it defies all logic.

    Now I accept you at your word, that you do not want to grant pharmaceutical companies full immunity, but with the exception of cases of fraud and misrepresentation, isn't that what this bill does?

    Additionally, it shifts the liability a little lower on the public health food chain, now instead of suing the manufacturers of dangerous drugs, you can sue the doctors - subsection (2) of the bill authorizes civil suits against health care practitioners who prescribe the very same FDA approved meds that the manufacturers would no longer be liable for.

    Granted, the standard for liability under this section is nigh on impossible to meet - the plaintiff would have to prove that "no reasonble health practitioner would sell the drug or medical device...to any class of patients."

    So, I'm sorry David but I still maintain that this bill effectively immunizes drug manufacturers from liability.

    Now, as to your argument in favor of holding regulatory bodies liable for harm caused by the regulated parties, I guess there is a principled way to adopt your philosophy.

    But understand that your theory could mean the end of all government regulation as we know it. We allow government regulation in some of the most hazardous and dangerous industries. What you are proposing is that businesses which engage in highly dangerous activities, should not be liable for the damages they cause, so long as they comply with the minimal safety procedures required by the FDA.

    If you think that the costs of litigation to the drug companies, for damages caused by their drugs, is high, imagine how much higher it would be if their liability was shifted to the government? The government, which reaped no financial benefit from the drug on the market, has no incentive to put dangerous drugs out on the market, and does not have control over all of the drug companies R&D documents.

    The drug companies are making huge profits from their products, and it seems a little silly to try and find some way to remove their liability when one of their products causes harm.

    You argue that the agency has some responsibility, and thus should be held liable if a product manufactured by a company that agency regulates causes harm. But precisely what is the agency's responsibility? To make safe drugs?

    If you think the FDA's job is to make safe drugs, then you are asking for "big government" in the worst way - not even card-carrying Socialists don't even dare dream that big!

    The agency's responsibility lies in making sure that procedural steps are taken to ensure the drug is safe before letting it out onto the market.

    Now, for the sake of argument, I'll grant you that if the FDA regulations say that a drug must pass tests A, B, and C before release to the public, and the FDA jumps the gun and approves it after passing only test A and B, then perhaps the FDA itself should incur liability.

    But if the drug passes all the tests, the the FDA has done it's job. Imposing liability on the agency when the drug eventually turns out to cause damages allows the manufacturer to escape liability for its own conduct.

    And, as a final point to this rather long post - the fact that there may still be a remedy in federal court, does nothing to diminish the fact that the State of Oregon has an obligation to its own citizens to provide a forum for adjudicating the grievances and civil claims of those citizens.

  • auggie (unverified)
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    David: So if we agree the FDA is broken and does not live up to its responsibility to protect consumers (primarily due to a lack of funding from the federal government & almost of 1/4 of its funding coming from the drug companies), why then should we in Oregon pass a bill that would limit the protections available to Oregonians based on an inadequate government agency? Sure, we should be working to fix the FDA, but fat chance of that happening anytime soon.

    P.S. Who do you think lobbies against giving the FDA adequate independent funds so that they could adequately investigate drugs? The same folks we are behind this bill, the drug companies.

  • auggie (unverified)
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    last sentence should read - "who are behind this bill"

  • nader (unverified)
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    David said, I don't consider what you've written and think we need to hold drug companies accountable for the failures of government oversight.

    Again, I guess I've got you pegged wrong, 'cuz you're sounding more and more like a Socialist the more you write.

    Failures of government oversight?!?! How about individual responsiblity? Is it really your position that the government should regulate industries to such a degree that if any harm results, it is now the government's fault, and not they party that caused the injury? That sounds awfully paternalistic to me.

  • nader (unverified)
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    Yikes - sorry about that broken html tag, I guest the "preview" button is there for a reason! The post should have read like this:

    David said, I don't consider what you've written and think we need to hold drug companies accountable for the failures of government oversight.

    Again, I guess I've got you pegged wrong, 'cuz you're sounding more and more like a Socialist the more you write.

    Failures of government oversight?!?! How about individual responsiblity? Is it really your position that the government should regulate industries to such a degree that if any harm results, it is now the government's fault, and not they party that caused the injury? That sounds awfully paternalistic to me.

  • (Show?)

    Pat Ryan wrote: One of the stated goals of the new and improved Republican Party is to starve out potential revenue sources for Democrats. Any time they can limit awards to plaintiffs and their attorneys and limit liablility to their own donors in Big Pharma, they are on target..

    In last year's effort by insurance and drug companies to limit Oregonian's jury rights, Pfizer contributed a whopping $180,000. And under-reported it by $30,000. Intentionally.

    The only reason our campaign caught it was their C&Es didn't match their own website thanking their good "friends at Pfizer."

  • David Wright (unverified)
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    Nader, you've given me a lot to work on! <nobr>;-)</nobr>

    Let me reiterate, I am not a lawyer. I am simply applying a "common sense" reading of the language of the bill in question. If a legal expert can explain how the "legal" reading of the language would differ, by all means please do so for the benefit of all, thanks!

    OK, first off, Section 1 sub 1, as I read it, essentially gives a free pass to doctors who prescribe the drugs and pharmacists who fill those prescriptions and sell the drugs (also Section 2 explicitly grants immunity to pharmacists). Granted, the term "sale of" could certainly be broad enough to encompass the drug company itself, however if so then I don't think that Section 1 sub 3 makes any sense:

    "A civil action may not be brought against any person by reason of the use of a drug or medical device described in subsection (4) of this section if harm claimed by reason of the use of the drug or medical device was a risk or side effect of using the drug or medical device, and the risk or side effect was fully disclosed by the manufacturer of the drug or medical device to the federal Food and Drug Administration in seeking approval or license for the drug or medical device from the federal Food and Drug Administration."

    So if you couldn't sue a drug company anyhow due to subsection 1, why would you need to explicitly make it clear that you can't sue for harm caused by known risks or side effects? I dunno, maybe it wouldn't be the first time the law contained redundant clauses. <nobr>  :-D  </nobr> But basically I read subsection 1 as covering docs and pharmacists, subsection 3 covering the companies themselves as long as they disclosed those risks.

    I could certainly be wrong about that interpretation.

    And I'm not sure that docs and pharmacists should automatically get a free pass, although there may be other laws on the books that already require them to fully disclose any known risks or side effects to patients before prescribing or filling prescriptions for drugs (in which case, that would make sense to me).

    And, per the above, I don't think that subsection 2 automatically shifts the blame to the docs -- only if it can be shown that no reasonable health care providers would have prescribed the drugs for any class of patients. (This connection between subsections 1 and 2, by the way, strengthens my interpretation of subsection 1 as applying to the docs/pharms and not the drug companies, I think.) So the docs get a free pass on this unless they do something bizarre that no other doc would do (as you pointed out).

    Your other remarks about "what ifs" regarding government agency oversight generally imagine situations that I am not suggesting should arise. I'm not saying that just because a government agency regulates an industry, that the industry gets a free pass on everything it does.

    But I am suggesting that it is the agency's responsibility to set standards and to hold companies (products) to those standards. It is the company's responsibility to demonstrate, truthfully, that their products meet those standards. If and only if that takes place, then when a product causes harm there are basically only two possible reasons for this:

    1. The agency's standards were not strict enough or were not enforced properly (liability on the agency)
    2. The company failed to truthfully comply with the established standards (liability on the company)

    Now, under my interpretation of this bill, condition #2 is covered. If the company did not disclose the risks to the FDA, then the company is clearly liable for any harm resulting from those undisclosed risks. Can we at least agree that, whether or not that's what the bill actually does, that concept is fair and workable?

    If so, then the remaining question is, what happens under condition #1? The earlier complaints were that condition #1 happens with some regularity, so that seems to be the real point of contention.

    And I stick by my assertion that, properly, when condition #1 occurs the agency itself should be held liable. If for whatever reason there are legal barriers to holding the agency liable, that does not then devolve that liability onto the manufacturer, or the doctor, or the pharmacist. That should instead provide impetus to improve the ability of the agency itself so that it can prevent condition #1 from happening in the first place.

    I am not advocating for any sort of "Big Brother" approach to government regulation. I am saying, though, that if you're going to have an FDA in the first place (for example) it had better have some legitimate purpose to exist. The FDA does not make safe drugs, it's supposed to (as far as I know) certify that the drugs others have made are safe. Or is there some other reason we have an FDA? Now if that is in fact the purpose of the FDA, we need to give it the tools to do that job. And we need to hold it accountable (if not legally then administratively, legislatively, whatever) for doing that job.

    If the "minimal standards" imposed by any agency on businesses engaged in dangerous practices are not sufficient to provide a reasonable level of safety (100% safety is an unreasonable expectation, BTW) then those standards need to be changed and enforced. But if the minimal standards are sufficient to provide a reasonable level of safety, then yes the agency has done its job, and the companies have done their jobs if they comply with those standards.

    Finally, I'm glad that you brought up the issue of individual responsibility. Because that's what a great deal of product liability cases come down to. Life, after all, is a risky affair. We all make choices to try to manage our risks, but we can never completely avoid them.

    So if an individual is given accurate and complete information about the risks they might take and they choose to take that risk anyway, they have implicitly accepted responsibility for the outcome of that action.

    On the other hand, if an individual has information withheld, so that it would be impossible for that individual to accurately assess the risks associated with his decisions, then that individual truly can't be held responsible for the outcome of that action.

    How does this apply to drug company liability? If the drug company discloses all known risks associated with a product, and that information goes down the line ultimately to the consumer, it's the responsibility of the individual consumer to weigh those risks before using the product. If the information is withheld, we need to ask where along the line it was withheld. The drug company is the first step in the chain, and if the information passes beyond that step, then whoever else might be responsible it's not the drug company.

    But if the drug company does not disclose the risk (including, by the way, the drug company not knowing themselves of the risk and thus not disclosing it in advance), then the information never makes it anywhere farther down the chain, and the drug company is responsible.

    Does all of that really still sound Socialist or paternalistic to you? <nobr>;-)</nobr>

    ANYHOW... as to the fundamental question raised by several people of why we should be codifying these restrictions/requirements for drug liability cases in Oregon... I guess my ultimate answer is, because it's the right thing to do based on what I've said here. I don't think this bill gives a free pass to drug companies. I think this bill establishes appropriate situations when a drug company can really be considered culpable, and when it can not. It may grant overly generous liability exemptions to doctors and pharmacists, so that should be considered carefully.

    Of course this is all based on my interpretation of what the bill actually means, so let me just say that if the bill does not actually mean what I think it means, then it should be modified to do so.

    And, as a completely separate issue, we clearly need to bolster the FDA. But that is a federal and not a state matter.

    Interesting and thought-provoking discussion...

  • LT (unverified)
    (Show?)

    On Tuesday, I sent an email to Rep. Flores, in part based on what I read here.

    Today I got a response. Below is what she wrote to me, followed by part of what I wrote to her.

    From Rep. Flores:

    Thank you very much for taking time to write to me. I appreciate your interest in the process of setting government policy. Regarding the bill to which you refer: I will be considering your comments as well as the comments of others in the review process. I will copy your response and add it to my bill file, which I will use when the bill is heard. Thank you again for your input.

    Warm Regards,

    Representative Linda Flores

    I had done a web search before writing the email, and this is part of my email, incl. the URL about a business magazine article on how to fix the FDA:

    Forbes.com has an article on how to fix the FDA. http://www.forbes.com/healthcare/2005/01/12/cx_mh_0112fdaintro.html

    Nowhere does it say to make the drug industry happy by limiting lawsuits.

    But this is part of the article:

    Since then, the FDA has become synonymous with drug safety. In a sense, "FDA approved" is the brand that the entire $216 billion U.S. drug market is founded upon. Dilute the confidence of the public in the agency, and many billions of dollars in current and potential sales vanish overnight.

  • Don Erickson (unverified)
    (Show?)
    <h2>Since a corporation is considered to be an individual under the law then as an individual shouldn't they also accept the same level of responsibility for their actions as is expect of a human individual? Why is it then that corporations seem to always work to get "do over" privledges for when they get caught doing something wrong?</h2>
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