FDA Liability Immunity Ruling

Posted on February 23, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

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The US Supreme Court Rules

[By Staff Reporters]

Did you know that the US Supreme Court just ruled that makers of medical devices – like implantable defibrillators or breast implants – are immune from liability for personal injuries as long as the Food and Drug Administration [FDA] approved the device before it was marketed and it meets the agency’s specifications? 

Background

In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law, but because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards, according to the New York Times.  

The Ruling

The decision does not foreclose lawsuits claiming that a device was made improperly, in violation of Food and Drug Administration [FDA] specifications, while cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them. 

Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced and expensive, while examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees. 

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Assessment

The Bush administration plans to continue its push for pre-emption from personal injury suits in another FDA case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits.

And so, is this ruling a boon for trial lawyers or patients; both or neither?

Conclusion

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The Federal False Claims Act

Posted on February 23, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

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Understanding Qui Tam

[By Dr. Charles F. Fenton III; Esqfenton]  

A civil war era law, titled the False Claims Act (qui tam [in the name of the king]), is increasingly popular with prosecutors who pursue inappropriate billing mishaps by physicians.  

Why the False Claims Act? 

The FCA rose to prominence because in 1990, the healthcare industry accounted for about 10% of all false claims penalties recovered the federal government. By 1998, the healthcare share was almost 40%. Today, it may be even more. 

The “Act”  

The False Claims Act allows a private citizen such as your patient, your employee, or a competing doctor to bring a health care fraud claim against you, on behalf of and in the name of the United States of America. The “relator” who initiates the claim is rewarded by sharing in a percentage of the recovery from the health care provider. 

Essentially, the “Act” allows an informant to receive up to 30% of any judgment recovered against government contractors (Medicare, Medicaid, CHAMPUS, prison systems, American Indian reservations or the VA systems, etc).   

With a low burden of proof, triple damages, and penalties up to $10,000 for each wrongful claims submission, these suits are the enforcement tools of choice for zealous prosecutors pursuing health fraud.   

Assessment  

All that must be proven is that improper claims were submitted with a reckless disregard of the truth. Intentional fraud is irrelevant to these cases, even if submitted by a third party, such as a billing company. 

It is imperative that the attending physicians review all bills before they are submitted to any state of federal agency. The Federal False Claims Act is a federal law that has been on the books since the days of the civil war and which recently has become a tool to battle health care fraud.  

So, what do you think about the Federal FCA?

Conclusion

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