7 posts categorized "Regulation"

Oregon works to protect citizens from toxic mold

Admittedly, I had never even heard of synthetic stucco until I read this article: 

The State of Oregon has taken a huge step in preventing toxic mold in new home construction with House Bill 2112-B by banning the use of synthetic stucco. Synthetic stucco has been the subject of a number of investigations including one by NBC Dateline. Homeowners have claimed the product causes water retention within the walls leading to wood rot which in turn leads to mold contamination.

Source: Bay Area Houston: Toxic Mold. When it Happens to You.

The most interesting fact is that the legislation didn't happen until a Senator's granddaughter got ill from mold...

The Pharmaceutical Industry and Tort Reform

It's no secret that the pharmaceutical industry is a big proponent of tort "reform."  That industry is lobbying heavily for laws that will basically eliminate the ability for individuals to sue over defective prescription drugs - like the law we have in Michigan.

Part of their argument for such immunity is the notion that the companies would never knowingly release a defective drug and that pharmaceutical companies are good, ethical companies.

Here is just a sampling of posts regarding fines, convictions, and guilty pleas of pharmaceutical companies and executives.  All of these are pulled from one of my new favorite sites, Pharmalot.  As you'll notice, there are quite a few examples.  And all of them have been reported since May 1st.

Before we pass laws to benefit this industry, why don't we regulate the industry in an effective manner that forces them to comply with the laws they routinely break?  It seems foolish to grant lawbreakers protection from the law.

Continue reading "The Pharmaceutical Industry and Tort Reform" »

Replace "AGs" with "Reformers" and...

The latest propaganda from the ATRA is Agwatch.org, a website dedicated to ensuring state attorneys general aren't able to enforce the law.  I saw this quote and immediately thought of the reform movement.

  “AGs often use isolated instances of misconduct as a lever to discredit – and then to “reform” – perfectly legal, legitimate, and often efficient business practices.”
  - Michael S. Greve, American Enterprise Institute

Source: AGAgendaWatch - What Others Are Saying

Reworded, the sentence is as follows:

"Reformers often use isolated instances of misconduct as a lever to discredit - and then to "reform" - perfectly legal, legitimate, and often efficient court systems."

I note with much humor that they're putting quotes around the word "reform."  I also note with disbelief they imply attorneys general are wrong to try and enforce the law against large industries.

The single most brilliant satire, ever. EVER.

I am humbled.  I have tried to use sarcasm, satire, and parody to explain exactly why tort "reform" is bad for the public and will lead to a lives being traded for money.  I thought I was pretty good at it.  Apparently, I'm an amateur.

My new heroes at The Yes Men impersonated a Dow Chemical VP and gave a fake speech at a banking conference in London.  This excerpt explains why tort "reformers" are so adamant that we must bring "predictability" to the civil justice system.

"You may have heard the joke: How many Americans does it take to screw in a lightbulb? 12: one to climb the ladder and 11 to file the lawsuit. What about Indians? Oh, just one!

This joke could well be about those cases in which regional differences in law, culture, income, and so on produce radically different risk outcomes. I'd like to illustrate this with a hypothetical use of the AR Calculator™.

Suppose Bill wants to set up a factory to produce a new pesticide. He logs on to the AR Calculator™ and plugs in the various chemicals, how much he wants to produce, and so on. The database finds roughly analogous cases, adjusts for geography and changes in law and income, and tells Bill that the risk of setting up in the US might well involve over $2 billion in liability from potential area lawsuits. After comparing that with profit projections, it's very clear that taking this route will make Bill an unhappy camper.

But the database proposes alternatives. The harm risk in India, for example, translates into potential losses of less than $400 million, based on previous liability settlements. Meanwhile, profit margins actually increase thanks to cheaper manufacturing, less draconian inspection requirements, etc. It is clear already that the skeletons here will be golden."

Source: Acceptable Risk

You simply must visit this link, if only to watch the video where the golden skeleton is unveiled, and various bankers pose for pictures with it.

Real Tort Reform in Pennsylvania Introduced

 Hot off the wire, it looks like Senator Greenleaf has introduced a real tort reform bill in Pennsylvania.

PHILADELPHIA, May 8 /PRNewswire-USNewswire/ -- The Pennsylvania Trial Lawyers Association (PaTLA) today welcomed legislation recently introduced in the state legislature: a Senate bill that levels the playing field for victims of bad faith on the part of insurance companies and a House bill designed to help consumers make more informed choices when purchasing automobile insurance.

Senate Bill 745 introduced by Sen. Stewart Greenleaf would allow juries to determine fault and award damages in bad faith insurance cases. Currently in Pennsylvania, only a judge can decide bad faith, while in federal court juries make the decision in such cases. "If a jury is competent enough to decide cases involving negligence or criminal conduct-and it is--we should have confidence in them to make a determination of whether an insurance company was wrong in denying or stonewalling a claim," said Ruben Honik, President of PaTLA. "The founding fathers knew the jury system would work 200 years ago and it works today."

Source: State Trial Lawyers Applaud Bills Protecting Rights of Pennsylvania Consumers - - insurancenewsnet.com

Count on the insurers fighting tooth and nail against being forced to endure a fair trial.  And also count on the "reform" movement claiming this bill is bad public policy and either a handout or a payback to the trial bar.

Cross-posted to TortDeform 

By the numbers defense of OSHA leaves an important number out

 I saw this over at Point of Law:

"Just out in The American: our own Jim Copland pokes some holes in New York Times reporter Stephen Labaton's supposed expose of lax enforcement practices at the Occupational Safety and Health Administration:

...here’s the rub: under Bush’s tenure, American workplaces have actually gotten safer. From 2000 to 2005, workplace fatalities fell from 5,920 to 5,702—a slightly better annual rate of improvement than under Bill Clinton’s tenure. Non-fatal workplace injuries have also fallen from 6.1 to 4.6 cases per 100 workers, a decline of almost 25 percent."

Source: PointofLaw.com | PointOfLaw Forum: OSHA and its critics

From 2000 to 2005, workplace fatalities dropped by 200.  During that same period of time, over 2 million manufacturing jobs were eliminated or shipped overseas.  So we took 2 million workers out of dangerous jobs and saw 200 less fatalities.  Hardly evidence that OSHA under Bush has been as effective or more effective than under Clinton. 

The manufacturing sector accounts for roughly 15 million workers, and accounts for roughly 20% of nonfatal injuries.  One would presume that since manufacturing jobs declined by 15%, that would be a significant reason why nonfatal injuries were down, too.  Again, not compelling evidence that the OSHA's policy of "Trust and don't verify compliance" is making workers safer.

What side will the "reform" advocates take?

"Reform" advocates often claim that trial lawyers and the lawsuits they file prevent many people from getting access to needed medicines.  Supposedly, the threat of product liability lawsuits is so scary that pharmaceuticals aren't releasing perfectly safe drugs.  To hear them tell it, "reformers" are actually consumer advocates, working to ensure more people have access to better medications. 

If increasing access to medications is one of their goals, I would hope that "reform" advocates will work to end the practice of "reverse payments" or "reverse settlements" in the pharmaceutical industry.  Reverse payments allow large pharmaceuticals to pay their competitors not to bring generic drugs to market.  Here are some relevant articles about the practice:

"To qualify for the program [The program that simplifies the approval process for generic drugs. - Justinian], however, the generic lab must show that the original drug's patent is either expired or invalid. When generic labs opting for the latter route -- known as "Paragraph IV certification," after the section of the application attesting to the patent's invalidity -- file their ANDA, they automatically create a patent-infringement cause of action against them by the pioneer drug company. In return for imposing the burden of litigating that patent's validity on a generic manufacturer, the Hatch-Waxman Act rewards it with a 180-day exclusivity period so that it can get a jump on other generic labs if the patent is declared invalid.

If the pioneer company is insecure about the validity of its patent, it may simply choose to reach a "reverse settlement" with the generic entrant -- i.e., it pays the generic manufacturer to drop the case and agree not to bring the generic version to market. An arrangement of this sort between pharmaceutical giant Zeneca and generic manufacturer Barr Laboratories is at the heart of a case up for consideration on Friday by the Court, Joblove v. Barr Labs (No. 06-830). At issue is the patent for tamoxifen, a drug used to treat breast cancer that has become the most widely used cancer drug in the world." (Emphasis in original.)

Source: Philip Brooks' Patent Infringement Updates: Reverse Payments

"AstraZeneca paid Barr $56.9 million to delay its generic version of the breast-cancer drug Tamoxifen, and supplied Barr with Tamoxifen for resale in the US under a royalty arrangement."

Source: Pharmalot: DOJ To FTC: Reverse Payments Are OK

Conveniently, Philip Brooks already emphasized a very important part of his article.  The Hatch-Waxman encourages generic drug manufacturers to bring patent challenges, because if the challenge is successful, the generic manufacturer is rewarded with a six-month period of time in which it will be the only manufacturer allowed to market the generic drug in question.  This is a strong incentive for generic manufacturers to bring patent challenges - which is good for consumers as it leads to cheaper generic drugs.  But it is unquestionably bad for consumers when pharmaceuticals are allowed to bribe generic manufacturers to keep their factories idle.

It will be interesting to see how the Supeme Court resolves the Barr Laboratories case.  Even if the Court continues to allow these bribes, the practice still may be doomed:

"The Senate Judiciary Committee today passed a bill that takes aim at the growing problem of brand-name drug manufacturers using pay-off agreements to delay the public’s access to generic medicines.  The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market." (Emphasis in original.)

Source: Philip Brooks' Patent Infringement Updates: Reverse Payments

Groups like the American Tort Reform Association are generously funded by the drug manufacturers who bribe their competitors.  Will the ATRA bite the hand that feeds it and prove they really are consumer advocates and oppose the loophole?  Or will they show their true color is green and support the "right" of their funders to deny people access to lifesaving medications?  If the latter, I would hope the ATRA will have the integrity not to accuse trial lawyers of denying consumers access to the medications the ATRA's funders are spending millions to keep off the market.

Consumers: 1, Merck: 0 - FDA Panel Rejects Vioxx Successor "Arcoxia"

Remember Vioxx?  The "safe" drug that Merck yanked from the market after a few pesky deaths and heart attacks hurt the shareholders?  Merck apparently is trying to forget it; Merck has been trying to bring  "Arcoxia" to the U.S., a drug so similar to Vioxx that some have dubbed it " The Son of Vioxx."  Thankfully, the FDA panel of experts reviewing the drug have recommended by a landslide 20-1 that the FDA not approve the drug for sale:

From Reuters: "The Food and Drug Administration's panel of outside experts voted 20-1 against recommending clearance for the drug, called Arcoxia.

The agency is not required to follow panel recommendations but usually does. Merck said it expects a final FDA decision on Arcoxia by month's end.

The company had argued Arcoxia was as safe as other pain relievers on the market and would be a valuable alternative for arthritis patients who do not respond well to current options. "

Hmmmm...  Do you think they made that safety argument while Vioxx was still on the market? 

Honestly, I'm surprised that the vote was 20-1, considering three of the FDA panelists have substantial financial ties to Merck.  I wonder if the 1 who did vote for it is one of the three.

Dr. Sidney Wolfe testified before the FDA advisory committee and not only recommended that Arcoxia be banned in the U.S., but that Merck should (voluntarily) withdraw the drug the rest of the world:

From Public Citizen: "It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval...

In addition to strongly urging your committee and the FDA to reject Merck’s effort to approve etoricoxib in the U.S., I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug."

Color me skeptical, but I don't think Merck is going to yank Arcoxia from the rest of the world market.  Unless of course it's not profitable.

No doubt the blogosphere will be aflame with corporate propaganda about how the FDA is keeping "much needed" and "safe" medicines from the market.  You know what I say to that?  If two out of the three doctors that are on Merck's payroll or own Merck's stock say the drug isn't safe... the drug isn't safe.

Corp Reform - Not Tort Reform Resources

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