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Tuesday, August 27, 2013

Supreme Court Rules Drug Companies Exempt From Lawsuits

Been watching the headlines lately. It's what a Policy Geek does. The last few days we found people enraged over mostly silly stuff.

(Fic, ComicBookMovie.com)
For instance, Warner Brothers announced that Ben Affleck is gonna be Batman over the course of a few films. The twitterverse went insane. We didn't see that coming. After all, Batman has no real powers, just a utility belt and a mission. And a bat plane, bat boat, bat car, bat flying wings, and the bat signal. But still, no super powers.

Of course there were more important waves of social muttering crashing against our shores. This week is already interesting. Not trying to leave anyone out, we have:

  • Syria absolutely used chemical weapons,
  • "Impeach Obama" said The Frog/French Canadian Ted Cruz who thinks he should be President,
  • Former Secretary of State Colin Powell stating (twice) that SCOTUS got the Voting Rights Act decision dead wrong,
  • Voting rights being limited in Texas and North Carolina at an accelerated rate,
  • Donald Trump blaming everyone but himself for starting a fake university,
  • San Diego Mayor stepping down under multiple accusations of sexual harassment, and
  • Tens of thousands of people are marching in Washington for basically the same things they marched for back in 1963.

It's enough to make a normal person want to punch a teddy bear. A couple of headlines got swallowed up, too. So, in case you missed them:

  • Dr. Sanjay Gupta came out as a weed fan.
  • Governor Chris Christie vetoed a couple of his own bills on gun control,
  • Republican Shennaman vowed to right the wrongs done by gutting the Voting Rights Act, and
  • Supreme Court Rules Drug Companies Exempt From Lawsuits.

The headlines really have been piling up. Oh yeah, like the one for this article. Similar to Batman, a Policy Geek really has no super powers. Just the desire to pay attention, and a mission to push back on misinformation. An educated voter is a better voter, and it follows, an educated web surfer makes a better 'sharer'.

Back to the headline. The reason you clicked in the first place. Google was taken over in July by that banner: Supreme Court Rules Drug Companies Exempt From Lawsuits. Now it's spreading on social sites. You can find very similar articles reprinted on these sites, complete with scary photos and outrage:
This is What Obamacare Looks Like
(whiteoutpress.com)

Prepared Society

Antioligarch

Hubberts-Arms.org

Organic Consumers.org

White Out Press.com

consciouslifenews.com

'Unknown' yet posted as evidence by
(ISideWith.com)
Thom Hartmann.com World Truth.tv

Political Blind Spot.com

Above Top Secret.com

I Side With.com

InfoWars.Com

Signs Of The Times.com

Oped News.com

Occupy Corporatism.com

Even some on the Right got on the bandwagon at Tea Partyorg. After all, this would be Obamacare's fault. Every single article with the same headline, all suggesting that perhaps you missed this important decision news last month, most referencing whiteoutpress.com.

If you follow The Policy Geek, you know that we have pointed out some less than reliable places to collect news and information. You might want to add those mentioned above to your watch list, or at least take their published blogs and articles with more than a grain of salt.

Justice Breyer: Courts shouldn't usurp regulators.
Image via Frobes
Did anyone bother to vet this? Doesn't seem like 'yes' is the answer.

Here's some reality. It's 2009. Companies that manufacture generic and less expensive versions of pharmaceuticals, something we should all be for, had to abide by some rules regarding labeling. So 4 years ago, in Wyeth v. Levine, the Supreme Court found drug manufacturers, esp. generic manufacturers,"liable for any deficiency on their labeling". To repeat, the high court found the drug companies "responsible regardless of what the Food and Drug Administration may or may not have previously approved.

Federal law requires generic drugs to match their brand-name warning label counterparts word for word. So when a generic company makes a cheaper version of an approved drug, as of now, their hands are tied in terms of changing the product. The problem with this argument, is that if a generic company were to notice more damaging responses to the drug, the process to change the drug or change the labeling is not designed for ease, and allows Big Pharma to just point at the FDA and shrug when a drug is dangerous.

In 2011, the Supreme Court decided to hear Pliva v. Mensing. This is the real case and decision the left conspiracy fun factor spin zone is going nuts over. In fact, the decision in this case is what gave rise to our lovely dramatic and hyperbolic title. Supreme Court Rules Drug Companies Exempt From Lawsuits. Boo!!

In Pliva v. Mensing (2011), they found that Minnesota and Louisiana tort law require a drug manufacturer that is or should be aware of its product’s danger to label that product in a way that renders it reasonably safe. Under Minnesota law, which applies to Mensing’s lawsuit, “where the manufacturer of a product has actual or constructive knowledge of danger to users, the manufacturer has a duty to give warning of such dangers.” By regulation, the FDA has interpreted that “labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” This 2011 landmark case found that pharmaceutical companies that make branded drugs are liable for inadequacies in safety warnings of a medicine's label, but not the makers of cheaper copies of those medicines.

This is a definite conundrum. Generic manufacturers can not make changes to their labeling, or warn pharmacies of any dangers in writing, until the FDA finds sufficient cause to warn of dangers, and subsequently orders a change in the brand name label. When a lawsuit is brought on the state level, whether against a brand name or a generic, and the lawsuit goes after packaging or labeling, Big Pharma repeats they are at the mercy of the FDA. They have the money and the time to take it to take the case all the way to the SCOTUS. Even when states claim the packaging should have been changed, SCOTUS upholds the FDA's authority. This is a state vs federal problem that needs to be dealt with, for sure.

June 2013, the high court decided to narrow its earlier decision that was indeed decided in favor of the plaintiff, Wyeth. The ruling is somewhat strange given the sweeping nature of Wyeth. Right? The drug companies are responsible. So what was this new narrowing all about? In Pliva, a 5:4 majority led by Justice Clarence Thomas held that generics don’t need to comply with the same duties under STATE tort law because FEDERAL law (previously referred to) requires them to match the brand-name warning labels word for word. If the FDA doesn't find enough evidence to warrant a warning on the label, no warning is necessary on the brand name, therefore no warning is necessary on the generic version. The FDA may be slow, bureaucratic, and perhaps even understaffed, but they're all we have.

Michael Carome, director of Public Citizen's Health Research Group, pointed out that, in many cases, the potentially dangerous side effects of medicines have not come to light until decades after they were approved and often after there was no longer a branded version on the market.

'Facism' bloggers are yelling, The headline is no longer news, it's being used to make all government bad, and it's as much bait and switch as The Donald's teacher-keeps-you-after-school money making fantasy classroom. The fear mongering headline is just to sell papers. And here we are using it in the same way. Let's see if we can turn this into a productive use of your time.

Each of these mimeographed articles refer to 'Bartlett', a case brought before the SCOTUS, saying the sky was falling, and the court stepped on the health rights of every American. We agree. If that were true, it would be pretty awful. But barring it's appearance on The Onion, this information should not have been re-posted as gospel. The decision that was made in Mutual Pharmaceutical vs Bartlett found that State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. That's all.

For the sake of clarity, federal law currently addresses the absolute responsibility of drug companies to label correctly, and the generic drugs have to do whatever the brand names do. In the case of Bartlett, possible side effects, including this flesh eating outcome, were listed on and in inserts for both versions of the drug, warning that the drug could cause “severe skin reactions” and “fatalities.” Stevens-Johnson Syndrome and toxic epidermal necrolysis were listed as potential adverse reactions on the drug’s package insert. When a case hinges on labeling or packaging, and only if a case hinges on labeling design or packaging, generics can only do what brand names do, and brand name drugs can only mark a label with what the FDA tells them they can say. When a product is "properly labeled", what else are we asking SCOTUS to do? Is the FDA immune to lawsuits? Well, yes.

You might be thinking to yourself, "An FDA employee did something wrong by approving pelvic mesh or Pradaxa or another defective drug, so I should be allowed to sue the agency under the Federal Torts Claims Act." However, there are a number of exceptions written into the Act, and one of them bars lawsuits against the FDA in conjunction with its responsibilities for licensing and approving drugs and vaccines. As a result, you cannot sue the FDA for approving a defective drug.

A look at the big picture might show that the "we fear and hate government" types are crying wolf. Strategists suggest that the white paper type phrasing and repetitious style indicate the invisible, yet well manicured hands, of Karl Rove and Heritage's Jim DeMint.

We prefer to think a correction just needs to be made. Like in the old days, when papers would post retractments when they got things wrong. Perhaps Justice Kennedy put the situation in the best light in his written opinion. Per Forbes:
"In the final paragraphs of the opinion (Bartlett) Justice Anthony Kennedy muses upon the importance of settling disputes such as the merits of generic versus brand-name drugs through “free and uninhibited speech.” He acknowledges how technology has made it possible for information to spread more widely, a right too essential to freedom to allow its manipulation.”
Translation: let the mini tsunami of nothingness just ease back out to sea. There will be real things to fight against. There will be bat signals to answer.

We will have to use whatever powers we have to turn the tide in 2014. A Democratic President may be able to replace another Supreme Court Justice. A Democratic Congress could pass some meaningful legislation in the last two years of this Presidency, including making federal law mesh with states' product laws of liability.

So figure out now what items you'll need hanging off your utility belt. Who is running in your area? Who are you going to back? What will the talking points be during the election, and what's the actual reality. Most importantly, who can you tell, and how can you spread the word when you hear something that is damaging, but may not be accurate?

Well, you can check here, we'll always tell it like it is. Or you can do your own research. But when you see a headline that takes over google is the same word for word, site after site, blog after blog, and isn't picked up by anyone you respect, maybe take a second before you hit that share button.

The Policy Geek

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