Today we hear from a pharmaceutical and medical device lawyer who is working to make vaccines safer. He explains some critical problems with the vaccine court and how his current lawsuit against Merck could have a big impact.
Mark Sadaka is the founder of Sadaka Associates. He is an attorney focused on medical litigation and has handled over 175 vaccination cases since 2005. To inform the public about the risks of vaccine adverse reactions, Mark created the Vaccine Injury Help Center.
The Vaccine Court
He explains the difference between making a personal injury claim and a lawsuit to help us better understand how the vaccine court works.
Mark Sadaka: The vaccine court functions as a claims system where you can go through this process and at the end decide whether or not to accept the outcome or to file a lawsuit. Whereas if you go down to your local court and you got into a car accident, you file your lawsuit, and that’s the end of the story. Unless it gets to the end, you go to jury trial or it settles and that’s that. There’s no other process. So after that’s over, either appeal it or it’s over. Whereas in the vaccine program, you go through the vaccine court and you have the option at the end to actually file a lawsuit against the vaccine manufacturer or the person who administered the vaccine and go on from there.
Compensation Limited to Childhood Vaccines
Only vaccines that are recommended for children are compensated through the program, right?
Mark Sadaka: That’s correct. What you’re asking is kind of a legally complicated subject. Whether you’re an adult or a child, if you receive a vaccine that’s recommended for children–which includes the various tetanus vaccines, the various hepatitis vaccines, the various influenza vaccines, and the various MMR, MMRV, varicella–all those different vaccines that children receive at regular routine visits. If you receive one of those and you’re injured, you have to first go through the vaccine injury compensation program. Now at the end of the program you have a choice. You can either accept the judgment of the court or you can opt out and follow your own lawsuit.
Weakening of the Law
Congress has amended the vaccine law a number of times. The results have made filing a lawsuit against vaccine makers more difficult. In 2011, the Supreme Court made a 6-2 decision in the Bruesewitz v. Wyeth case reaffirming that “vaccines were unavoidably unsafe.” That means vaccine makers cannot be sued for faulty manufacturing.
Mark Sadaka: There was a Supreme Court decision in regard to cases that come out of the vaccine injury compensation program, which says that you are no longer able to sue a vaccine manufacturer for vaccines covered by the program based on a poor design. So a lot of these vaccines are an old design. They could be improved, they can be made safer. But our conservative Supreme Court has made a decision that says, tough nuggies, the vaccine program is set up to provide compensation; therefore, injured citizens, you’re not allowed to sue the vaccine manufacturer based on a faulty design, that they could have designed it safer.
No Incentives to Improve Vaccines
Are there any incentives for vaccine manufactures to make safer vaccines?
Mark Sadaka: Absolutely not. For childhood vaccines, no incentive, zero whatsoever, none for childhood vaccines. That is a major problem. Having done drug litigation for my entire career, pharmaceutical drug litigation and medical device litigation my entire career, I’ve seen so many dark things that these companies do. And they don’t care. Maybe I’m the guy in the corner that screams crazy, it’s the end of the world. But they don’t care until they lose money. And the way that the program is set up now, there is no incentive for them to make improvements. Because you have to remember, a corporation like Merck, like GSK, all these big corporations, Novartis, they’re huge entities, living, breathing entities by themselves.
If you go and ask the CEO of any of these companies and say, hey, do you want to hurt these people? You want to hurt like the average citizen? They’ll say no because they’re human beings. They don’t want to. But the entity itself, the corporation is a living entity that only operates as the people inside it direct it to. — Mark Sadaka
Could you talk about your current litigation case?
Mark Sadaka: I’m co-lead counsel in Zostavax. It’s a vaccine that was given–or it’s kind of off the market now, but it’s still there. It’s given to people ages 50 and over for the prevention of shingles. And what we’ve learned through the process, and our allegations are that the vaccine actually causes shingles and some of the bad consequences of shingles, such as brain injuries and other neurological problems…Because it’s a vaccine that’s only for adults, we’re allowed to sue Merck directly about it. And it’s ongoing. We have our cases selected for trial, and we have a trial date for next year. So that case is moving along quickly and there could be good, good things that come out of this with regard to vaccine design and the development of different vaccines.
The virus that’s contained in Zostavax is the exact same virus that’s given to children in Varivax, which is the chicken pox vaccine. It’s the exact same components. They just add more virus to the adult version. Meanwhile, the virus is the same. So we’re hopeful that the litigation can spur innovation and safer vaccine design when it comes to these live virus vaccines, which can often be very dangerous. — Mark Sadaka
What motivates you to keep doing this?
Mark Sadaka: Helping the children makes it all worthwhile, and helping families. I won the very first case linking Gardasil to death, and that experience was one of the best of my career. I could’ve made more money doing something else, anything. But the personal satisfaction of helping these families have some sort of sense of closure makes it all worth worthwhile. It’s the only reason why I do this.
Press play to listen to Mark Sadaka’s in-depth interview.
- Listen to Part 1 of this series: The National Vaccine Injury Compensation Program — Then and Now
- Listen to Part 2 of this series: Why the Vaccine Court Mostly Compensates Adult Flu Vaccine Injuries Now