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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 œpositioning 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