Suits allege Stanford University, physician harmed patients by breaking rules for ethics, safety and medical research in performing CCSVI surgeries outside of a clinical trial
SAN FRANCISCO--(BUSINESS WIRE)-- Today two men announced lawsuit filings (docket #112CV218823) against Dr. Michael Dake and Stanford University (Stanford) for performing experimental surgeries on them for purported CCSVI, a controversial theory hypothetically linked to multiple sclerosis (MS), outside of an approved clinical trial.
Plaintiffs Oliver Zahn and Mark Wittwer allege that Dake abandoned fundamental policies for medical research and patient consent when he conducted experimental surgery to insert arterial stents in their veins, according to their complaints. They also allege that Stanford failed to protect patients by allowing Dake’s unapproved experiments to continue outside of a clinical trial, despite the recognized, life-threatening risks associated with Dake’s procedures and a lack of evidence to support any benefit from the treatment, court documents state. As a result, both men now suffer permanent and life-altering injuries.
“Dake performed invasive and life-threatening surgeries – considered by renowned physicians to be completely experimental – outside of a clinical trial, violating accepted ethical standards for human subject research. In the process, he caused permanent harm to trusting patients. It’s unbelievable that this happened, and under Stanford’s respected banner,” said Cynthia McGuinn of Rouda, Feder, Tietjen & McGuinn, co-counsel for the plaintiffs with the firm of Emison Hullverson LLP.
According to court documents:
Controversial CCSVI theory
Underlying this case is the controversial CCSVI, or chronic cerebro-spinal venous insufficiency, a clinically unproven and hypothetical syndrome theoretically linked to MS. According to the CCSVI theory first proposed in 2007, MS patients may have irregular narrowing of veins in the head and neck. The hypothesis follows that these vein irregularities, or stenoses, do not allow blood to properly drain from the brain, damaging the central nervous system and causing the neurological deficits characterized by MS.
Early proponents of CCSVI began experimenting with angioplasty, or a tiny balloon that is inflated and then removed, to reportedly open veins and improve blood flow in MS patients. Anecdotal outcomes of the procedure have been mixed, and no one has been able to successfully replicate the initial research supporting CCSVI’s existence.
Despite a lack of credible scientific evidence that CCSVI even exists or that treating purported CCSVI offers any benefit, the theoretical condition has spawned significant worldwide interest from MS patients hoping it will yield new solutions for relieving their symptoms.
Numerous experts and organizations, including the National Multiple Sclerosis Society, have urged extreme caution in evaluating the theory of CCSVI and its proposed treatment, calling for randomized clinical trials to test whether CCSVI actually exists, and if so, whether treatment offers benefit.
Dake’s unapproved research
Dake took the opposite approach at Stanford, however, and in 2009 became the first physician in the United States to perform surgical stenting procedures for CCSVI, according to court documents. Dake conducted research outside of a clinical trial by inserting stents in 38 patients without obtaining approval from Stanford’s Internal Review Board – a critical step for any clinician who undertakes experimental research.
By not adhering to a clinical trial, Dake bypassed protocols designed to maintain patient safety and critically evaluate the existence of a proposed disorder and the efficacy of an experimental treatment, according to the complaint.
At the time Dake began his research, there was little, if any, medical evidence to support CCSVI, the court documents show. Compounding the lack of basic clinical evidence, Dake’s approach has drawn criticism for using potentially ineffective and harmful diagnostic and treatment procedures, according to the complaint.
For example, instead of using only angioplasty to open veins, Dake chose to surgically insert arterial stents, or metal or plastic tubes designed for use in arteries but not in veins. Stents remain in the body and are more invasive than angioplasty, and present serious risks such as becoming occluded, slipping and migrating to the heart, fracturing, or penetrating through the vein wall and causing massive bleeding. The blood-thinning medication that patients must take to prevent blood clots and stroke following a stenting procedure also can increase the risk of hemorrhage. One of Dake’s patients died from a brain hemorrhage following the placement of stents for CCSVI.
Finally, on December 5, 2009, after repeated requests from MS and neurology experts at other institutions and also from its own physicians, Stanford publicly announced the suspension of Dake’s CCSVI procedures.
For plaintiffs Zahn and Wittwer, Stanford’s order came too late.
Tragic lapses in patient safety for Zahn and Wittwer
On November 23, 2009, Zahn agreed to allow Dake to perform a diagnostic venogram to identify vein narrowings. Although Zahn has never been diagnosed with MS, he was experiencing some neurological issues at the time and simply wanted to identify any possible causes. Court documents show that Zahn clearly wanted to discuss exploratory findings after the venogram, before proceeding with any form of treatment.
Zahn repeatedly told Dake that he did not want stents. Nonetheless, during the procedure Dake increased the level of Zahn’s sedation until he was essentially unconscious, and then turned the planned 30-minute diagnostic venogram into a five-hour surgery, placing five stents in Zahn’s jugular and azygos veins.
“The evidence we’ve gathered shows that Dr. Dake conducted unproven, high-risk procedures on his patients to address a hypothetical condition that numerous medical experts either questioned or did not believe existed,” said McGuinn. “Dr. Dake did not advise his patients of the fact that CCSVI was only a theory based on an unproven hypothesis or that there were significant and potentially life-threatening risks associated with the procedure he wanted to perform on them. In Mr. Zahn’s case, Dr. Dake implanted five stents into the neck of a man who did not even have multiple sclerosis and who had expressly asked the doctor not to do so.”
Following Dake’s stenting procedure, Zahn was admitted for overnight monitoring after what was supposed to be an outpatient procedure. The following morning, while Zahn remained in the hospital, one of the stents dislodged and traveled directly into the right ventricle of Zahn’s heart. Cardiologists at Stanford had to perform emergency open-heart surgery to save his life, but the damage was done. He continues to experience permanent repercussions from the surgery, and from complications related to the remaining four stents that cannot be removed from his veins without additional harm.
Dake also inserted four stents into Wittwer’s veins in 2009. Wittwer suffers from MS, which has robbed him of the ability to walk and to actively run the aquaculture business he built on the Oregon coast. Believing that CCSVI might represent a “cure” for his disease, Wittwer underwent two separate stenting surgeries. The stents have not improved his symptoms, and one has become completely blocked, or occluded, increasing his long-term health risks. The stents also cause chronic pain, sleeping problems, and lingering fear that others will become blocked or migrate to his heart – potentially fatal complications.
According to the complaint, Dake did not warn plaintiffs Zahn and Wittwer of the serious, life-threatening risks of his experiments. He also failed to tell them that stents are not approved by the Food and Drug Administration (FDA) to treat CCSVI.
“I trusted Dake’s medical opinion – in no small part because of Stanford’s prestigious reputation – and wound up as a guinea pig for his experiments,” Wittwer said. “Every day, I wake up and try to put a smile on my face despite dealing with the giant hurdles of MS. I certainly didn’t need the added pain, health risks and emotional toll of this mistreatment.”
More information about the case is available at www.unauthorized-CCSVI-experiments.com
About Rouda Feder Tietjen & McGuinn
Rouda Feder Tietjen & McGuinn is a San Francisco-based law firm with a national reputation for helping the injured obtain justice. Founded in 1980, the firm focuses on cases involving catastrophic injury, wrongful death, defective product, explosions, fire and electrical injuries, medical negligence and employment-related matters. For more information see: www.rftmlaw.com
About Emison Hullverson LLP
Emison Hullverson LLP represents individuals and their families in serious medical negligence, wrongful death and personal injury cases. More information on the firm and its attorneys may be found at www.emisonhullverson.com
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Source: Firmani + Associates Inc