Pity Mr. Michael J. Reinhart. He enlisted in 1962 and separated in 1964. He got the HCV diagnosis in February 2002, began the bug juice November 2002 and started to notice some odd effects he hadn’t been counseled on. The VA gave Mr. Reinhart a brief one-two on the side-effects and ordered up the program literature/video. They waited until January 2003 to discuss “side-effect” management in detail, gave him the pep talk and told him, well, they told him a lot of things. One thing they failed to go into in detail was the possibility of going blind.
On May 13th, 2003 he discovered he had blurred vision. VA told him to discontinue the juice. If I read this right, he’d been on the program about 26 weeks. The side effects of the chemical misadventure were papilledema http://en.wikipedia.org/wiki/Papilledema and disk hemorrhages with binasal visual field effect (inferior) http://en.wikipedia.org/wiki/Binasal_hemianopsia . A month later he was DXed with optic neuropathy due to IFN toxicity.
http://en.wikipedia.org/wiki/Optic_neuropathy#Ischemic_optic_neuropathy
September began but there was going to be no dove hunting for Mr. Reinhart. He was having chronic vision issues that failed to resolve as the VA doctor had hoped for. He thus filed in September 2003 for severe damage to his eyes from the rat poison in a 38 USC § 1151 venue. His February 2004 C&P revealed the right eye was worse than the left and the VA examiner concluded that the IFN was the culprit. He noted that the vision issues did not precede the treatment. Good to go, right?
Not so fast, Michael. VA denied in March 2004 and said the evidence failed to show “fault” on VA’s part. I would have loved to have been a fly on the wall in that office to hear them sound it out with phonics. Mr. Reinhart promptly filed his appeal to get the ball rolling. VA opted for another Dog and Pony show in September 2007-four years later- on the off chance they had missed something. The examiner came to the exact same conclusion, but this time he was instructed to rephrase the rationale. He did so by saying the vision abnormality was simply a side effect that was rare but not unheard of. Therefore Mr. Reinhart shouldn’t have been surprised to wake up blind one day in May. Since they had gone over this and he’d signed off on it, he couldn’t return and claim an injury. In essence, he went into this with eyes wide open (pun intended).
During his DRO hearing (where he was denied again), he mentioned that he wasn’t told anything about going blind.
During a November 2007 hearing, the appellant testified that when he began interferon treatment in January 2003, a list of 10 to 15 side effects was included in the information package that
he received but ocular damage was not mentioned as a possible result of treatment. Reinhart v. Shinseki 2011
He got his Board hearing in February of 2009-five years and three months after filing.
At a subsequent Board hearing in February 2009, the appellant testified that side effects were discussed with him prior to beginning the hepatitis C treatment and that he received literature from the VA about the side effects. R. at 53-54. He testified that ocular damage was not mentioned as a potential side effect. Reinhart supra
So we have testimony on two different occasions on this subject and VA still has not associated the “informational packet” with the file folder. Seems suspicious. And where is the signed authorization giving them permission to blind this Vet?
As usual, the VA trotted out their patsy to “opine” and give a reasoned explanation to the VLJ and the Vet as to why this was almost a given…
In October 2009, an independent medical expert opined that while the appellant’s ocular disability was generally uncommon, occurring in less than 10 in 100,000 patients, Pegasys/Ribavirin treatment has a known adverse reaction of optic neuritis, retinal thrombosis and hemorrhages, and papilledema. R. at 41. He further explained that although adverse reactions such as those experienced by the appellant were quite rare, they were known to occur. Id. Reihart supra
At this point I have to wonder what the “expert’s” field of expertise was. I’m willing to bet it changes regularly from one discipline to another as needed. At any rate, the writing was on the wall and the fix was in. No money for Michael.
On March 5, 2010, the Board issued the decision here on appeal. R. at 16-25. In that decision, the Board found that “[b]ilateral optic atrophy and arteriolar attenuation were not caused or aggravated as the result of carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault by VA in furnishing medical care, nor were they caused or aggravated as a result of an event not reasonably foreseeable.” R. at 17. The Board also found that the appellant provided informed consent prior to beginning the Pegasys/Ribavirin treatment regimen. Reinhart supra
I guess we could say that a win for this man was “not reasonably foreseeable” either. Michael promptly filed his NOA and headed to Indiana Ave. NW. Notice, though, the innocent little phrase at the end of the above record. The VLJ had gone on record as saying he had signed the informed consent prior to beginning this. Were that the case, it would be embedded in his VISTA records. All four of mine are. They don’t get lost. They’re done electronically so as to become a permanent part of the record in case of a situation, well, like this one.
The Court looked at the BVA record and decided to include it. Remember how I have discussed the habit of moving evidence around on the table and getting some in the wrong order? The BVA has done just this highlighted by red type.
In discussing the informed consent process in this case, the Board stated the following: The Board notes the testimony of the Veteran during his November 2007 RO hearing and February 2009 Board hearing indicating that, prior to giving informed consent for his Peginterferon/ribavirin treatment, the Veteran was informed of potential side effects such as nausea and depression but none involving his eyes or vision. The Board also notes that the details of the information regarding the potential side effects of Peginterferon/ribavirin treatment provided to the Veteran prior to his giving informed consent for treatment are not of record.
However, the record reflects that VA providers discussed the risks of Peginterferon/ribavirin several times with the Veteran prior to the beginning of such treatment, and that the Veteran was provided written and video information regarding the risks of such treatment. Furthermore, the October 2009 IME explained that, although adverse reactions such as optic neuritis, retinal thrombosis and hemorrhages were rare, they were known to occur secondary to Peginterferon/ribavirin treatment.
The examiner also stated that, although he could not find the details of the information, there was documentation of discussions of side effects of treatment and literature being given to the Veteran several times prior to treatment. Reinhart supra
Let’s summarize. VA gave him the briefing. They forgot to have him sign something giving the informed consent. They had to order in the video on the risks. They then semantically “create” the consent because they had to have it to start treatment. The 2009 IME’s conclusions are now incorporated into a “side-effects” discussion six years prior. Huh? All the King’s men and all the King’s horses are not going to manufacture that informed consent because it doesn’t exist or they lost it. I suspect the former.
I will conclude with this morsel from Judge Ivers:
The parties are correct that the Board’s discussion of the informed consent process is inadequate. See Appellant’s Br. at 10-12; Secretary’s Br. at 7-9. The Board completely failed to explain how the informed consent requirements espoused in 38 C.F.R. § 17.32 (c) were met in this case and failed to point to or discuss any specific evidence documenting consent. In fact, the Board even appears to recognize the lack of such documentary evidence, stating that “the details of the information regarding the potential side effects” are not of record. Reinhart supra.
http://www.law.cornell.edu/cfr/text/38/17/32 (38 CFR §17.32)
VA has strung this poor boy out so long that the publications they were handing out in 2003 are out of print and no longer “operable”. I’m sure the new ones include the vision warning.
In conclusion, the VASEC has arrived without his evidence. Worse, he has implied he had it, it was reviewed and the evidence did not support Mike, yet he cannot produce it. VA does this all the time and gets away with it until someone points out the emperor is running around naked. Strangely, they are willing to remand about the time the judge points this out. This will give them needed time to search the floor of the shredder room and try to piece the informed consent document back together. Always read those decisions, Vets. VA examiners are good, but they always try to cheat or bluster their way through these things instead of just telling the truth. If the informed consent document was absent, they should have manned up and said “Okay. We screwed up. Mike wins, but we did tell him what was coming”. End of battle. VA just can’t turn and walk away, though. Remember Tin Cup with Kevin Costner? Recall how he lost the tournament because he just kept hitting balls to get over the water hazard? The parallel to VA’s intransigence is remarkable. They screwed up, but are fatally resigned to continuing Mike’s denial even though the cause was lost years ago.
Meet Mr. Reinhart who now has eight years and two months invested in this:
http://search.uscourts.cavc.gov/isysquery/5ccd79a7-ce5c-46fe-8b53-3cf275f359d9/64/doc/
P.s. Notice the ankle holster on the left ankle? Don’t leave home without it. It was an FN .25 cal. “Baby” model.
WOW!! “informed consent document”? What the ****? I started 6 month, 3 times a week, alphainterferon 2b injection in 1995. I don’t recall signing anything to the effect of what I just read. I got talked into the ribivirin-interferon when available in late 90’s. I don’t recall signing anything then as well. Isn’t signing away your rights via (sculpatory clause?) illegal in CA? PLEASE LET ME KNOW HOW TO FIND THIS DOCUMENT ASAP.
Anybody here who can help Robert? My computer skills can hide under a walnut shell (along with my brains).
The document exists electronically in the VA VISTA computer. Prior to the institution of it, there would be an archived paper file on microfiche. Go to a VAMC and ask for a complete record of your medical files. If it occurred in a civilian setting, you may not be so lucky. Remember, Interferon was really toxic back in the 90s and far more potent. Malpractice lawsuits did not become the norm until later. The use of release forms started in the late 90s (I think). As for IFX treatment, I am not up on that. Bing? Google it? Ask other Vets on the site under the comment heading. We have many who are whizz kids at this computer stuff. I’m not one.
Therein lies the problem, Loyal. Define “substantially unjustified” with VAspeak. It simply doesn’t translate into DickandJanespeak. Witness what they “interpret” and “construe” regularly. Alien abduction seems more probable than some of their suppositions. As for the “Independent Medical Experts”? I see no qualifiers after their names and in some cases nothing more than “an expert was consulted.” If you submit a nexus from a doctor, I guarantee he had better sign it and discuss his bona fides for it to be taken seriously.
My VAMC is trying to get me to take the poison without even being screened by a hepatologist. My primary care doctor knows nothing about the Tx for HCV. I am directed to a “counselor” who isn’t even a RN. No films, or informational packets. In fact I wasn’t given much information at all about the disease in general. I came to this site in a panic years ago, not knowing and in fear. I will not sign any release forms given the danger of the drug. The VA speak is that the interferon is good enough. I just don’t want to give them any ammo that I refused treatment just to get a higher rating for HCV. Given the situation of my claim though that is a possible reason for denial coming down the road that I think I should prepare for.
The Chief Justice of the Supreme Court, Roberts, said it this way:
ROBERTS: So whenever it really makes a difference, 70 percent of the time the government’s position (against the Veteran) is substantially unjustified?
He was quoted here:
http://www.veteranstoday.com/2010/02/25/chief-justice-startled-by-gov-errors-in-veterans-cases/
In other words, more than 50% of the time, the VA takes a position AGAINST THE VETERAN, that is “substantially unjustified”.
One would wonder WHY a “benevolent VA” with a “non adversarial benefit system” would expend its resources to take a “substantially unjustified” position against a Veteran?