there were a number of court decisions before riegel -- before riegel the device manufacturer did not know if they going to win or lose. let me just say for the record that the last year before the riegel decision, the last year before the top 25 medical device companies had a net profit of $173 billion net profit, they were doing quite well. they were coming up with new devices all the time even though they didn't know if they would be subject to a tort claim or not. it doesn't seem innovation was stifled. i must also say, regardless of the difference between drugs and devices, new drugs on the market all the time, they are not preempted from tort claims. mr. maisel, is it not true that after medtronic started receiving reports, you state it was within months of initial market release, they did not recall until three years later, fda inspection report cited them for objectionable conditions, failing to implement appropriate directed and preventive action procedures related to the company's investigation of the product anomaly. dr. maisel, do you believe the fda approval process is so

we are here because last year in the supreme court case riegel v. medtronic, the court held on that the statute's purpose was to provide the safety and effectiveness of medical devices. the court said that this law pre-empts state court claims when a medical device does harm. this means complete immunity from lawsuits from corporations that in danger consumers with unsafe devices. and negligent corporation cannot be held accountable and victims could not receive fair compensation, and thus consumers are at risk. this had catastrophic consequences for ordinary americans. take the example a man from illinois who was born with a hereditary heart defect when she was only 2 years old the doctor implanted pacemaker in her chest. at age 3 the defibrillator shuttered nine times. avery's parents had the defibrillator replace but medtronic told them that they would not cover the cost. avery's parents are still struggling to pay off the medical bills. is every here today? good to see you. i like that daisy you have in your hair. or consider jed. he sustained a

. >> i would agree with that right now, but under riegel, if they can say we will never have to give those documents up, it would be a rare instance for the fda ever to take us to court to sue, and mr. mulvihill can't sue us and his lawyers can't get discovered to get those documents. >> their lawyers are going to tell them of we don't produce these documents, we can go to jail. the ceo can go to jail. that is to the fda brings criminal prosecution against, not some low-level people. there were two supreme court decisions, one in 1944 and one in 1975, to bring criminal prosecution against the highest corporate officials, because they are ultimately responsible for the actions of the company. >> mr. mcgarity, i want to -- >> a couple points, that might happen but it doesn't. you don't see that many criminal prosecutions hopefully because it doesn't happen that often but the fact of the matter is the underlying fact of the matter is when we get this information about what was going on in the drug company files and device manufacturer files, it is not because fda inspectors got it, it w

if a device manufacturer knows now under riegel that they are not subject to tort lawsuits, therefore they're not subject to discovery that would go on in a lawsuit, and if fda doesn't have subpoena power, and let's say that, you know, yeah, i was thinking about this because there's a case here. warner-lambert kent, which you probably know about. manufacturers who commit fraud on the fda are not immune from lawsuits. well, okay. let's say that a device manufacturer doesn't submit all the information to the fda. the fda does not have subpoena power. therefore, they approve it. it goes on the market. people are injured. there's a recall. but because they cannot sue, you cannot get discovery to find out whether or not they ever even committed fraud on the fda. so i hope i made myself clear. if a device manufacturer commits fraud on the fda, puts the device out there but@@@@@ @ @ @ and regarded by fda as the most serious violation if a company that fails to submit all the relevant safety and effectiveness information as part of their pma. and i can assure you when i was chief counsel, the