Drug and Medical Device Manufacturers: "It is someone else's fault"
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A responsible FDA has brought a drug manufacturer to justice. The FDA has settled with Pfizer over its off label and deceptive marketing of the drug Bextra; $2.3 billion in fines and penalties. Sounds like a lot of money until you consider that in 2004 alone, Pfizer sold over $1.4 billion in Bextra. Sadly, this chapter is simply the tip of an ever increasing iceberg.
Assistant Attorney General Tony West had this to say about the settlement:
"Illegal Conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers and costs the government billions of dollars. This civil settlement and plea agreement by Pfizer represent (sic) yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”
Mr. West is correct as long as there is an FDA willing to hold manufacturers to compliance with the law and judges who see corporate obfuscation when it is in front of them. When drug and medical device manufacturers encourage off label, unapproved uses it should be with a foundation of study and evaluation for the safety of the recommended use.
Manufacturers of pain pumps, for example, encouraged an off label, unapproved use of their devices causing severe and crippling injuries in young adults with their whole lives in front of them. Although pain pump manufacturers did no research or evaluation of the safety of their off label use recommendations, they did go to considerable expense to produce manuals and DVD’s to teach doctors how to code billing to maximize profit if the physicians used the pain pumps in the ways recommended by the manufacturer. Breg, Stryker, IFlow and other manufacturers told physicians to use pain pumps in a way that they knew had not been approved by the FDA, in fact in ways that at least some of the manufacturers knew has been absolutely forbidden by the FDA without specific testing and research.
Did the pain pump manufacturers do the testing or research that the FDA had set forth was necessary? Did these manufacturers avoid intensive marketing to physicians for use of the pain pumps in a way not approved by the FDA? The answer is a resounding, no!
But, wait, it gets better. Through their lawyers, the pain pump industry appears to have devised a scheme to create a defense to their conduct by not complying with the FDA. They apparently understood that if they neglected to conduct the appropriate, required scientific studies, no one else would either. If no one conducted any meaningful scientific studies, then pain pump manufacturers would be able to pull the devices once they started hurting people and then argue to judges that all the victims’ lawsuits should be dismissed because no reliable scientific evidence exists to substantiate the injured victims’ claims.
So, manufacturers violated the law by not conducting safety research on their devices.
Devices start causing crippling injuries after being on the market long enough for manufacturers to amass huge profits.
Injured victims sue manufacturers.
Pain pump companies pull their devices before anyone does any meaningful testing (the same testing the FDA told the manufacturers to do before putting pain pumps on the market).
Do pain pump manufacturers defend the lawsuits by arguing that their devices were safe and here is the evidence of the testing they did to ensure the safety of the public? No.
Pain pump manufacturers actually argue that it was the doctors’ fault for using the pain pumps and they (the physicians) should have known better. In the alternative, pain pump manufacturers tell scientifically unsophisticated judges that lawsuits should be dismissed because no reliable evidence exists to prove their pain pumps are defective. Injured victims ask the manufacturers for their studies and pain pump makers respond by boldly stating they did none.
Experts for injured victims testify that the violation of the law by not conducting analysis, which the FDA specifically requires, is negligence. Orthopedic surgeons testify that the patient’s injuries were caused by the improper use of the medical devices. Pain pump manufacturers respond by arguing this testimony is purely opinion and irrelevant because the absence of scientific studies means the injured victims can not prove their cases.
Some judges listen to the medical device manufacturers’ arguments that the lack of scientific study, largely caused by their failure to follow the law, should give them a free ride away from injured victims’ claims.
In the Pfizer case, whistle blower John Kopchinski revealed: “In the Army, I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that." Apparently there are plenty of drug and medical device employees who can make money on the backs of injured people.
So, do not blindly allow physicians to use medical devices and drugs to treat you. Ask questions. Make inquiries. Do research. Require complete answers. The physicians may possibly be as much in the dark as the patient in some cases.