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MORE THAN A HILL OF BEANS

If you have a civil case against a drug company for compensation for personal injuries that you claim were caused by its drug, the fact that that same drug company was fined millions or even billions of dollars does not mean that your case will settle for that much money, that it will settle sooner, or that it will settle at all.

The fact is that from 1991 through 2012 total nearly $20 Billion in fines were levied by the US Department of Justice against the giant drug companies. However, these Justice Department fines do not in and of themselves effect the settlement of civil tort lawsuits. It just doesn t mean a hill of beans to these giants. The practices of illegal promotion and failure to disclose safety data that got them into trouble with the Justice Department is just part of the blockbuster, billion dollar profit game for these companies, and to them, these fines are merely the price of doing business. So, too, are the settlements they pay in civil tot lawsuit settlements. Bad corporate citizens break state and federal, civil and criminal laws. They do it knowingly. They know they will get caught. They voluntarily pay these huge fines and settlements.

If it sounds cold and cavalier, it is. Giant drug companies do put profits over people. However, as to your civil tort lawsuit, as bad as it may all sound, none of it is likely to be heard by a jury. The reason is two fold: This information is not relevant or probative.

That it is not relevant means that these bad acts of illegal, off-label promotion are not directly related to the tort laws used in the individual personal injury cases. The most frequent offense of off-label promotion is the marketing of drugs to physicians for uses not approved by the FDA. It is, for sure, a common practice. The drug companies call it positioning the drug for uses in addition to those approved by the FDA to physicians who can legally prescribe drugs for non-FDA approved uses. That’s right, the drug company cannot tell the doctors about the non-FDA approved uses of their drugs but the doctors can legally prescribe them for non-FDA approved uses. While drug giants deny, justify and explain away this practice, the Justice Department sees it as illegal and imposes fines that the drug giants call the cost of doing business. The bottom line is that the practices and fines have nothing to do with the allegations and injuries in the civil tort lawsuits.

Also called mass tort litigation, civil tort lawsuits use state tort laws to impose civil penalties or fines through obtaining civil judgments and settlements. This civil arm of enforcement focuses on the drug companies failure to fairly and complete disclose all of the know risks of their drugs. The question in civil tort cases is what did the drug company know about the serious risks, when did they know it, and did they fully and accurately disclose all of those serious risks. More frequently than not, these three questions answers reveal that the serious risks were not fully and accurately disclosed. The defense of these cases focuses on the legal issues of general causation (Can this drug cause the injury(ies) in question?) and specific causation (Did this drug cause a specific person’s injury(ies)?) and ultimately, settlements are reached.

So fines levied against the drug giants for conduct not related to the civil personal injury case will never be heard in the trial of your case because they are not relevant to your case and will not be available to show what a bad corporate citizen the manufacture of the drug that hurt you is.

That it is not probative means that the court might determine that the value of the information of a fine for prior conduct to prove a tendency toward committing the offenses at issue in the civil case may be outweighed by its potential prejudicial effect.

In conclusion, do not get excited if you see headlines that a corporate citizen that you have a civil suit against has paid a Justice Department fine. The two are not related and payment of a fine doesn’t make a hill of beans to these giants.

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Company – Settlement – Violation(s) – Year – Product(s) – Laws allegedly violated (if applicable)

GlaxoSmithKline – $3 billion – Off-label promotion/failure to disclose safety data – 2012 Avandia/Wellbutrin/Paxil – False Claims Act/FDCA

Pfizer – $2.3 billion – Off-label promotion/kickbacks – 2009 – Bextra/Geodon/Zyvox/Lyrica – False Claims Act/FDCA

Abbott Laboratories – $1.5 billion – Off-label promotion – 2012 – Depakote – False Claims Act/FDCA

Eli Lilly – $1.4 billion – Off-label promotion – 2009 – Zyprexa – False Claims Act/FDCA

TAP Pharmaceutical Products – $875 million – Medicare fraud/kickbacks – 2001 – Lupron – False Claims Act/Prescription Drug Marketing Act

Amgen – $762 million – Off-label promotion/kickbacks – 2012 – Aranesp – False Claims Act/FDCA

GlaxoSmithKline – $750 million – Poor manufacturing practices – 2010 – Kytril/Bactroban/Paxil CR/Avandamet – False Claims Act/FDCA

Serono – $704 million – Off-label promotion/kickbacks/monopoly practices – 2005 – Serostim – False Claims Act

Merck – $650 million – Medicare fraud/kickbacks – 2008 – Zocor/Vioxx/Pepsid – False Claims Act/Medicaid Rebate Statute

Purdue Pharma – $601 million – Off-label promotion – 2007 – Oxycontin – False Claims Act

Allergan – $600 million – Off-label promotion – 2010 – Botox – False Claims Act/FDCA

AstraZeneca – $520 million – Off-label promotion/kickbacks – 2010 – Seroquel – False Claims Act

Bristol-Myers Squibb – $515 million – Off-label promotion/kickbacks/Medicare fraud – 2007 – Abilify/Serzone – False Claims Act/FDCA

Schering-Plough – $500 million – Poor manufacturing practices – 2002 – Claritin – FDA Current Good Manufacturing Practices

Schering-Plough – $435 million – Off-label promotion/kickbacks/Medicare fraud – 2006 – Temodar/Intron A/K-Dur/Claritin RediTabs – False Claims Act/FDCA

Pfizer – $430 million – Off-label promotion – 2004 – Neurontin False Claims Act/FDCA

Cephalon – $425 million – Off-label promotion – 2008 – Actiq/Gabitril/Provigil – False Claims Act/FDCA

Novartis – $423 million Off-label promotion/kickbacks – 2010 – Trileptal – False Claims Act/FDCA

AstraZeneca – $355 million – Medicare fraud – 2003 – Zoladex – Prescription Drug Marketing Act

Schering-Plough – $345 million – Medicare fraud/kickbacks – 2004 – Claritin – False Claims Act/Anti-Kickback Statute

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IS FASTER BETTER AT THE FDA?


The FDA has proudly patted itself on the back, again. It announced that its 36-point Plan of Action to streamline and speed up the pre-market approval process for medical devices is a success! How do you streamline and speed up the pre-market approval process for medical devices, at what risk to the consumer, and why would any consumer want to increase any potential risk that this might cause? Well, the consumers did not ask for it, the medical device manufacturers did, and consumers were not asked if they wanted a streamlined process or what that streamlined that process would look like.

The FDA tells us now that streamlined process is a 2 year initiative that was created to deal with complaints by the device manufacturers about the amount of time it was taking the FDA to approve their medical devices so it could start making money from their sales. The manufactures complained about the lengthy application approval review process and resulting backlog of medical device applications. So the FDA sought to and has reduced the average time it takes to clear an application, reduced the backlog of applications and reduced the amount of time it takes to reach a decision on the applications. To the FDA, it was not a matter of making the process more efficient. The FDA shortened the approval process itself. Here is the result:
The percentage of submitted applications that are approved have increased 10% from its low in 2010 when this initiative was begun, a rate that had been declining since 2004. The percentage of filed pre market approval applications that are approved has risen 20% from its 2010 low, which rate had been declining since 2005.

One more very interesting and telling fact: The percentage of applications in which the FDA requested additional information from the manufacturer during the 1st review cycle under this initiative has begun to decrease, following a steady rise from 2002 through 2010.

So, with the device manufacturers’ help the FDA figured out that what was bogging down their approval process was the FDA’s diligence in making sure the medical devices seeking approval were safe. To successfully speed up the approval process, the FDA requested less information from the manufacturers regarding the devices safety.

If you ever doubted that the medical device manufacturers lobby the FDA, or the extent to which it lobbies the FDA, doubt no more. The device manufacturers lobby efforts have emasculated the rigid approval process that while it slowed the process down – protected consumers from unreasonable dangerous medical devices. This increased risk is compounded by the U.S. Supreme Court’s check of state tort law protections that provided recourse to hold a medical device manufacturer responsible for serious injuries or death caused by and unsafe products.

Faster is not better in an application review system’s checks and balances designed to protect innocent consumers. Fast track medical device approvals from the FDA’s asking less questions of the manufacturers about the safety of their products is not good public policy and does not protect consumers. Just as fast dogs that chase cars are sure to get hit, medical devices that race through an abbreviated approval process sure to seriously injury and kill innocent consumers.

Faster is not better. Questions regarding safety have to be asked and answered until the FDA is confident that the medical device is safe, even if it slows the approval process. The FDA is charged with the responsibility of policing the drug and medical device companies and protecting the public health. It has to assure the safety, effectiveness, and security of medical devices.

It cannot put innocent consumers at risk of serious injury or death to appease the device manufacturers and their lobby. The process of taking the time needed to ask important questions and get answers about the risks of medical devices cannot be shortened at the innocent consumer’s expense. Had the FDA asked consumers about the short cuts that were taken that could put them at risk for serious injuries and death, they surely would have told them they did not want the FDA to lower the bar for a medical device to be approved.

Again, the FDA claims it has not lower the bar for a medical device to be approved. It only sped up the approval process by requesting less information from the manufacturers regarding the medical devices safety.