January 5, 2014

Obama fights Generic Drug Exemption for Trial Lawyers

January 5, 2014. This summer, the US Supreme Court ruled that 80% of pharmaceutical drugs are exempt from lawsuits. Since generic drugs are copies of name brands, they can’t be sued for mislabeling, hiding side effects or deaths. Americans were outraged, evidenced by the half-million page views our Whiteout Press article received at the time. Now, President Obama has entered the fight, but not on the side of the American people.

Until two weeks ago, there were only two sides in the debate over generic drug companies’ blanket protection from lawsuits. You were either for the exemption or against it. Those in favor say that the generics are required by law to copy the original name brands exactly and shouldn’t be liable. Those against blanket immunity insist that if any drug company discovers dangers and side effects and keeps them secret, they should be liable.

For a detailed report on the 2013 Supreme Court ruling, read the Whiteout Press article, ‘Supreme Court rules Drug Companies exempt from Lawsuits’.

Democrats and Trial Lawyers

On November 13, 2013, the FDA released new proposed guidelines for generic drugs that would once again make them legally liable for withholding warnings and discoveries from the public, and once again eligible to be sued by millions of potential victims and their attorneys. But as a recent Forbes article suggests, President Obama didn’t advance the change to help victims of pharmaceutical drugs. He did it to pay back the deep-pocketed PAC’s representing the nation’s trial lawyers.

On that date, the FDA released its ‘proposed rule change’ that would put the responsibility for warning patients of side effects and adverse reactions onto the generic drug manufacturers and out of the hands of the FDA. Until now, the courts have consistently ruled that an official FDA decision that there is no danger takes precedent even when incorrect and there are millions of victims. Those injured or killed from prescription drugs without warnings had no legal recourse.

But the new FDA proposal would change that, “The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA’s review of the change.”

Right now, even if a generic drug manufacturer is aware of a dangerous or deadly side effect from its drugs, they’re forbidden from warning patients until the FDA investigates and either approves or denies a request to add a warning to the drug’s label. For all the victims during that years-long process while in the hands of the FDA, they can’t sue anyone. With the new guideline, drug companies would no longer have to wait for the FDA and would be required to add warnings to the drug labels even while the FDA is still researching the proposed change. It would also open the companies back up to lawsuits from patients for not warning them of known risks.

Republicans and Corporations

Taking the opposing view as the White House, Democrats and trial lawyers, Republicans have once again sided with multi-national corporations in their quest to end any and all lawsuits by regular people against the world’s corporations. ‘Tort reform’, ‘frivolous lawsuits’ and ‘ambulance-chasers’ are all terms from the corporate wing of the GOP and have one goal – exempting corporations from lawsuits and the large multi-million-dollar judgments that are often the result.

Illustrating that position, a Forbes report from two weeks ago warns, ‘The new rule will jeopardize the business model that has given the US the world’s most vibrant, and low cost market for generic medicines.’ The account goes on to report, ‘The question has been the subject of intense political lobbying by trial lawyers who argue that generic drug makers shouldn’t be immune to these suits. The trial bar seems to have won the debate.’

Forbes calls these allegedly frivolous lawsuits, ‘the backbone of modern drug torts and a booming legal industry.’ Invoking the vision of ambulance-chasing attorneys, the article explains what it envisions as the typical drug victim lawsuit. ‘Lawyers troll for patients on TV commercials,’ Forbes writes, ‘In 2005 alone, 17,000 lawsuits were filed against the multi-national drug companies. This is more than the litigation filed against the next five most sued industries combined.’

Interesting statistics

What Forbes, the Republicans and Big Pharma aren’t telling you however is that in 2007, the closest year to 2005 we could find, the CDC tells us that 27,000 Americans accidentally died from taking prescription drugs. That number doesn’t even include the ‘intentional’ deaths from overdose. In fact, prescription pain killer overdose deaths alone outnumber overdose deaths from heroin, cocaine, crack, marijuana, LSD, PCP, crystal meth, and all other illegal drugs combined.

The number of people dying from taking prescription drugs has skyrocketed so much over the past ten years that it went from the bottom of the ‘top ten’ list to the number one cause of accidental death in American, passing the decades-long leader ‘auto accidents’. Another interesting statistic is that Americans take 90% of the prescription pain killers consumed by the entire world.

The same CDC report also tells us that the pool of future victims of pharmaceutical drugs is a potential powder keg of coming lawsuits. It says that there are currently as many as 9 million Americans addicted to prescription drugs as a result of a previous injury or illness. Added to that number are 5 million more who are addicted thanks to experimenting without any medical reason.

The website Drug Free World brings us even more startling statistics regarding prescription drug addiction and the drug companies marketing to children. They report that every single day in the United States 2,500 kids aged 12-17 abuse a prescription pain killer for the first time. They also say that in 2006, 2.6 million Americans began abusing prescription drugs. That number of first-time users has grown each subsequent year.

In a survey from 2005, the same year cited in the Forbes report, 4.4 million American teens aged 12-17 admitted to abusing prescription pain killers. 2.3 million more admitted to abusing prescription stimulants, or ‘uppers’. And an additional 2.2 million admitted to abusing prescription depressants, or ‘downers’. The researchers also give us the horrifying statistic that the average age of a first-time prescription drug abuser is now thirteen-and-a-half.

The report from Drug Free World closes with one final, sobering statistic, ‘In 2007, the Drug Enforcement Administration found that abuse of the painkiller Fentanyl killed more than 1,000 people that year in the US. It is thirty to fifty times more powerful than heroin.’

Forbes insists the American people have only two choices, ‘We have to decide if we want generic drugs that are cheap and a business that’s highly competitive. Or we want the industry to subsidize product liability torts.’ The American people might suggest there’s a third option – safe drugs with adequate warnings that aren’t pushed on America’s children by street corner drug dealers whose names all start with the initials ‘Dr.’ And if a drug company is proven to have withheld known dangers and warnings, they should be legally liable. It’s really kind of simple if you ignore the tens of millions of dollars in contributions by pharmaceutical corporations and trial lawyers.

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