Alberta Chiropractor Settles Vertebral Subluxation Claim

Alberta Chiropractor Settles Vertebral Subluxation Claim

 

Sandra Gay Nette, who was injured by her chiropractor,  Gregory John Stiles, recently settled her claim. [The amount of the settlement is covered by confidentiality provisions.] The couple attempted a class-action lawsuit against Stiles, but was denied certification over their inability to act as representative plaintiffs due to their catastrophic injuries.

The couple claimed that sessions involving vertebral subluxation treatment to the cervical vertebrae disrupted blood flow to her brain, causing stroke and neurological damage rendering her a tetraplegic. Court documents also demonstrated that Stiles forged Sandra Nette’s signature on an informed consent form provided to the Canadian Chiropractic Protective Association (CCPA).

The claim questions the scientific basis of the subluxation treatments and claims they are dangerous. It cites other cases such as the 1998 death of Laurie Mathiason following neck manipulations, and the subsequent coroner’s inquest that concluded the cause of death was due to stroke from trauma to the left vertebral artery. The claim also cites a 1981 article in Malpractice Alert, which states:

Evidence has now accumulated to the point that the chiropractic profession can no longer ignore the increasing incidents of strokes occurring concomitant with cervical manipulation. The reports of chiropractors, the statements of patients, and the results of medical examinations and autopsies cumulatively compel serious consideration of the problem. Possible injury to the patient overshadows the cost element and demands that we take immediate and decisive action to curtail the number and severity of these incidents.
Almost all techniques in the atlas-axis region have been the subject of stroke complaints. A few cases have been reported involving the HIO technique and one case, the mild Grostic technique. Far more often, however, accusing fmgers have been pointed to the cervical break and rotary maneuvers, done by other practitioners as well as D.C.s

The claim names the Alberta College and Association of Chiropractors as defendants who should have known of the risk of the treatment.

The impact on the plaintiff as a result of this treatmeent was described in the claim as follows:

Sandra has Locked-In syndrome. She is cognitively not impaired and she is aware that other than very limited function in her right ann, she cannot move or communicate due to complete paralysis of nearly all voluntary muscles in her body. It is a condition that has been described as “the closest thing to being buried alive”. There is no treatment nor is there a cure. She has retained sensation throughout her body by which she perceives pain. She cannot swallow, speak or breathe without regular mechanical ventilations and suctioning of her secretions. She cannot attend to her own personal care. She has survived a number of emergency crises in her condition solely as a result of the expert, dedicated 2417 efforts of the finest medical, nursing and technical hospital personnel available who have treated her since Stiles’ procedure at Life Stiles.
[emphasis added]

After the claim was not certified as a class action, the couple proceeded against Stiles independently, resulting in the current settlement.

The Statement of Claim in Nette v. Stiles follows, as well as the certification judgement.

Omar Ha-Redeye is the Principal of Fleet Street Law, a full-service law chambers in Toronto.

Nette v. Stiles Statement of Claim

Nette v. Stiles Certification Judgment[This post has been edited to redact the settlement amount, which is covered by confidentiality agreements]

 

Merck to Settle Canadian Class Action over Vioxx

Merck & Co. has agreed to settle a Canadian class action on the order of $37 million over its blockbuster drug, Vioxx. Vioxx was pulled from the market in September 2004 over concerns that it increased the risk of cardiac complications.

Source: CTV News

Neurontin® (Gabapentin) Certification Disseminated

The London, Ontario law firm, Siskinds LLP, disseminated the Notice of Certification in Goodridge et al. v. Pfizer Canada Inc. et al. today for the class action over Neurontin® (Gabapentin), the  GABA analogue used for epilepsy and neuropathic pain.  The claim alleges that the use of Neurontin increases the risk of suicidal behaviour.

The Plaintiffs were successful in having the action certified on February 18, 2010.  On certification, the Defendants were succesful in part in striking portions of the statement of claim, with leave granted to amend.   The basis of the claim was described by Justice Perell,

[5]               There are five aspects to the claims being brought against the two Pfizer companies.

First, the Plaintiffs allege that the Defendants were negligent and caused harm to Neurontin consumers by falsely and wrongfully promoting Neurontin for “off-label” uses, which is to say for uses for which the drug has not received Canadian regulatory approval.

Second, it is alleged that the Defendants were negligent and caused harm to Neurontin consumers by designing and distributing a drug that was useless for its off-label uses.

Third, it is alleged that the Defendants were negligent and caused harm to Neurontin consumers by designing and distributing a drug that had a harmful side effect; namely, propensity for suicidal behaviour.

Fourth, it is alleged that the Defendants are liable not only for the harm caused to consumers of Neurontin but they are also liable for the harm caused to consumers of generic gabapentin that was manufactured and distributed by the Defendants’ competitors.

Five, it is alleged that the family members of the Neurontin consumers and the generic gabapentin consumers have derivative claims under the Family Law Act or similar provincial statutory provisions.

Justice Perell held that the certification would not include claims about wrongfully and falsely promoting Neurontin for off-label purposes.  Although he agreed that it was reasonably foreseeable that harm would be caused by competitors manufacturing the drug, he did not find a duty of care due to lack of proximity and policy reasons under the Anns/Cooper test,

[98]           Would it be fair to make the Defendants, as innovators, liable simply for releasing an idea that is copied? I think not, because once again this would be to impose strict liability and because the harm in releasing the idea is caused by releasing the idea without appropriate warnings about how the associated product may be used, but the innovator is not in a position to give any warnings about the uses being made by consumers of a copied version of the innovator’s product. A drug innovator cannot issue warnings about the hazards of a drug manufactured and sold by another pharmaceutical company, particularly when the hazards may be associated with off-label uses. Although the drug innovator can control the manufacture of its own product, monitor for adverse reactions to its product and give warnings about its own product, the innovator is not in a position to stop the generic manufacturer from releasing the generic drug or to stop physicians from prescribing the generic drug for off label uses. This conduct is not the innovator’s conduct, and, in my opinion, it would be unfair to impose a duty of care on the innovator for another’s conduct when the innovator cannot control, qualify, or stop that conduct. In my opinion, it would not be fair or just to make the innovator liable for failing to do something that should and can only be done by others.

[99]           Put differently, normally, an innovator of a prescription drug may discharge its duty of care by giving a warning about the risks associated with its own drug, but imposing a duty of care on the innovator for simply releasing the idea of the drug into the stream of commerce is to impose strict liability on the innovator and also to deny the innovator the defence of having given an adequate warning to a learned intermediary. In my opinion, such an imposition of liability would be unfair. 

[102]      In my opinion, in the case at bar about the duty of care between a drug innovator and the consumer of a drug manufactured by another pharmaceutical company, there are two public policy factors that ought to negative the scope of any duty of care and the class of persons to whom the duty is owed by the innovator of a drug. First, the imposition of a duty of care on the innovator to the competitor’s consumer would be to impose strict liability for defective products and to make an innovator an insurer against all harm from its innovation, which would be a radical change in Canadian law and one for the legislature and not the courts to make. Second, the imposition of liability on the innovator would discourage medical advances and innovative technologies that could be beneficial to society.

The class was certified subject to a number of changes, including a removal of the generic  gabapentin and a narrowing of the scope.  A copy of the Amended Statement of Claim is available here, and Notice of Certification follows.

Neurontin – Notice of Certification

Omar Ha-Redeye is the Principal of Fleet Street Law, a full-service law chambers in Toronto.

Class Action Launched Over Actos Drug

Toronto class action firm, Rochon Genova, filed a claim earlier today over a diabetes drug.

Actos (pioglitazone) is manufactured by Takeda Pharmaceutical Company, the largest pharmaceutical company in Japan and one of the top 20 pharmaceutical companies in the world.

The lead plaintiff was prescribed Actos for diabetes in 2002, before contracting bladder cancer in 2009 and passing away in April of this year.  A U.S. Food and Drug Administration (FDA) safety alert from August 4, 2011 indicates,

The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

Omar Ha-Redeye is the Principal of Fleet Street Law, a full-service law chambers in Toronto.