With the rising costs of health care, and the growing demographics of baby boomers, health administrators are always looking for savings. A new and provocative study out of the Indiana University suggests that computer modelling can choose better and less-expensive treatments than the physicians alone, resulting in a 50% reduction in costs and 40% increase in patient outcomes.
By using a new framework that employs sequential decision-making, the previous single-decision research can be expanded into models that simulate numerous alternative treatment paths out into the future; maintain beliefs about patient health status over time even when measurements are unavailable or uncertain; and continually plan/re-plan as new information becomes available. In other words, it can “think like a doctor.”
Although Derrick Harris at Digacom states that nobody is suggesting we replace physicians with computers, he does point out other advances in this area:
IBM has been banging this drum loudly, most recently with two new commercial versions of its Watson system — one of which is designed to determine the best-possible course of treatment for lung cancer patient by analyzing their situations against a library of millions of pages of clinical evidence and medical research.
In July, I highlighted 10 ways that health care providers and startups are using big data to improve effectiveness and decrease treatment costs.
More recently, I explained how access to more — and better — data is critical to everything from rating doctors to, possibly, curing cancer.
Sandra Gay Nette, who was injured by her chiropractor, Gregory John Stiles, recently settled her claim. She received $3.9 million, and her husband, David Nette, received $1.17 million. 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.
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.
1. Clements v. Clements (2012) SCC 32 (CanLII)
Clements is the current authority on causation in Canadian personal injury cases. It indicates that the “but for” test is the appropriate test to determine causation. Clement’s effectively limits the use of “material contribution” test to cases with multiple negligent tortfeasors where the “but for” test is insufficient to determine which tortfeasor caused the damages.
Clements is a case involving a motorcycle accident whereby the defendant’s motorcycle crashed, seriously injuring his plaintiff passenger. A number of factors contributed to the accident. Most of the factors stemmed from the defendants negligence. Namely, the defendant was driving a motorcycle in wet weather and approximately 20km/h over the speed limit. The motorcycle was overloaded by approximately 100lbs. One factor was not related to the defendant’s negligence; a nail punctured rear tire of motorcycle. When the defendant accelerated the nail fell out, the rear tired deflated and the defendant lost control of the motorcycle.
The defendant’s negligence in speeding and in operating an overloaded motorcycle was not in dispute. The defendants took the position that it was the nail and not the other factors which caused the accident.
ii. Trial level – (2009) BCSC 112 (CanLII).
At the trial level the judge found that the plaintiff “through no fault of her own is unable to prove that ‘but for’ the defendant’s breaches, she would not have been injured”. The trial judge found that the plaintiff’s inability to prove causation using the “but for” test was to the limitations of the scientific reconstruction evidence.
The trial judge found that since it was impossible to determine the amount each factor contributed to the injury, the but for test should be replaced with the “material contribution” test. The defendant was found liable on the basis of the “material contribution” test. The defendant appealed.
- iii. Court of Appeal – (2010) BCCA 581, 12 B.C.L.R. (5th) 310.
On appeal the court set aside the judgment. The court found that the “but for” test was the appropriate test and set aside the judgment. The plaintiff appealed the decision to the Supreme Court.
- iv. Supreme Court (2012) SCC 32 (CanLII)
The Supreme Court clarified that the “material contribution” test will only apply in cases of multiple defendants where the plaintiff has proven that “but for” the negligence of one or more of said defendants, the damages would not have occurred.
- a. The current test for causation
McLachlin J. speaking for the majority, described the “but for” test as the ordinarily test for establishing causation. The Chief Justice reiterated that the plaintiff must show on a balance of probabilities that “but for” the defendant’s negligent act, the injury would not have occurred.
The “but for” test must be applied in a robust common sense fashion with no need for scientific evidence of the precise contribution of the defendant’s negligence to the injury. At paragraph 15, McLachlin recapped the law of causation as follows:
the basic rule of recovery for negligence is that the plaintiff must establish on a balance of probabilities that the defendant caused the plaintiff’s injury on the “but for” test. This is a factual determination. Exceptionally, however, courts have accepted that a plaintiff may be able to recovery on the basis of “material contribution to risk of injury”, without showing factual “but for” causation.
- b. The Material Contribution test
Justice McLachlin held that the correct application of the material contribution test requires the plaintiff to show that the defendant’s conduct materially contributed to the plaintiff’s risk of injury. In other words, it is not the injury itself that requires examination but the circumstances surrounding the increase in risk of injury.
- c. Review of the Canadian jurisprudence
In determining whether the material contribution test was appropriate in Clements, McLachlin J. reviewed the Supreme Court jurisdiction on the issue of material contribution. Of relevance is McLachlin J’s interpretation of Athey v. Leonati (1996) 3 S.C.R. 458 [Athey]. At paragraph 22 MacLachlin J. described Athey as follows:
The plaintiff who suffered from pre-existing back problems, suffered a herniated disc after two motor vehicle accidents. He sued the drivers of the motor vehicles in negligence for his injury. The trial judge held that although the accidents were “not the sole cause” of the disc herniation, they played “some causative role” (para. 8). She accordingly found the defendants liable for 25 percent of the plaintiff’s loss. In the Court of Appeal, the plaintiff sought to uphold the result on the basis of material contribution, but that court declined to consider the issue as it had not been raised at trial.
[The Supreme Court], per Major J., discussed the limitations of the “but for” test and the propriety of exceptionally using a material contribution test. Major J. emphasized that a robust common sense approach to the “but for” test permits an inference of “but for” causation from evidence that the defendant’s conduct was a significant factor in the injury, and concluded that “[t]he plaintiff must prove causation by meeting the ‘but for’ or material contribution test” (para. 41). Major J. concluded that the 25 percent contribution found by the trial judge was a “material contribution” sufficient to meet the “but for” test. The term “material contribution”, read in context, does not detract from the fact that the Court in the end applied a robust, common sense application of the “but for” test, in accordance with Snell.
At paragraph 28, McLachlin J. summarized the Canadian Supreme Court jurisprudence on material contribution as follows:
First, while accepting that it might be appropriate in “special circumstances”, the Court has never in fact applied a material contribution to risk test. Cook was analyzed on a reverse onus basis. Snell, Athey, Walker Estate and Resurfice were all resolved on a robust and common sense application of the “but for” test of causation. Nevertheless, the Court has acknowledged the difficulties of proof that multi-tortefeasor cases may pose – difficulties which in some cases may justify relaxing the requirement of “but for” causation and finding liability on a material contribution to risk approach.
- d. Review of the United Kingdom Jurisprudence
At paragraphs 30-32, the court reviewed the leading UK jurisdiction on causation and the material contribution test. McLachlin J. paid considerable consideration to the 2012 United Kingdom High Court decisions of Fairchild v. Glenhaven Funeral Services Ltd., (2002) UKHL 22 [Fairhcild], Baker v. Corus UK Ltd., (2006) UKHL 20 [Baker] and Sienkiewicz v. Greif (UK) Ltd., (2011) UKSC 10 [Sienkiewicz].
In Fairchild and Baker, the plaintiffs developed disease related to toxic workforce agents with multiple negligent tortfeasors exposing the plaintiff’s to asbestos. To determine causation, the courts applied the material contribution test as it was impossible to determine which of the defendants’ negligence exposed the plaintiff’s to the risks. In that situation, fairness and policy supported a relaxation of the “but for” test.
The Sienkiewicz decision is similar to Fairchild and Baker in that multiple sources of toxic agents which contributed to the plaintiff’s damages. However, Sienkiewicz pertained to the negligence of a single tortfeasor. The court in Sienkiewicz relied on the Fairchild and Baker precedents to apply the material contribution test. At paragraph 42 McLachlin J. differentiated the Sienkiewicz decision from Clements finding as follows:
The United Kingdom Supreme Court took the view that it was bound by precedent to apply a material contribution to risk approach in all mesothelioma cases. Several members of the court in Sienkiewicz noted the difficulty with such a result. Lady Hale observed (at para. 167) that she found it hard to believe that a defendant .whose wrongful exposure might or might not have led to the disease would be liable in full for the consequences even if it was more likely than not that some other cause was to blame (let alone that it was not more likely than not that he was to blame).. In my view, nothing compels a similar result in Canada, and thus far, although Sopinka J.’s remarks in Snell (quoted above at para. 20) do not preclude it, courts in Canada have not applied a material contribution to risk test in a case with a single tortfeasor.
GlaxoSmithKline LLC (GSK) was fined $3 billion today after pleading guilty to off-label marketing the drugs Paxil and Wellbutrin, and will be monitored for 5 years to ensure compliance.
This is the largest fine that a drug company has ever paid in the U.S., but will have to be approved by a federal court in Massachusetts.
Acting Assistant Attorney General Stuart F. Deler told the media,
For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business. That is why this administration is committed to using every available tool to defeat health care fraud.
Today’s resolution seeks not only to punish wrongdoing and recover taxpayer dollars, but to ensure GSK’s future compliance with the law.
Off-label marketing refers to when a pharmaceutical company promotes a drug for uses that haven’t been approved by the FDA.
According to prosecutors, GSK illegally promoted the use of Paxil for treating childhood depression, despite the FDA approval only for those over 18. Wellbutrin was only approved to treat major depressive disorder, but was promoted for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder. GSK also failed to include post-marketing studies for Avandia about increased risk of congestive heart failure and heart attack which should have been included in safety data.
GSK CEO Sir Andrew Witty stated,
Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.
We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.
In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management.
We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.
On February 23, 2012, Toronto Police arrested 37 individuals in connection with an insurance scam. The operation, called Project Whiplash, targeted a group that allegedly staged 77 motor vehicle collisions.
This week the ringleader of the operation, Uthayakanthan Thirunavukkarasu, was sent to prison for 3.5 years and was ordered to pay restitution of $375,000. An estimated $1.2 million flowed through his account for the scam.
At least one of the staged crashes in May 2007 resulted in a brain injury.
Josh Tapper and Wendy Gillis of the Toronto Star explained how the scam worked:
A recruiter might scope possible participants inside a public space, like a coffee shop, insisting the plan is foolproof, an easy way to earn money. From there, the recruiter acts as coach. He tells people where the accident will occur, where inside the vehicle they should sit and what to tell authorities following the crash…
While police say that numerous collisions allegedly submitted for insurance claims did not actually occur, those that did were also planned carefully. In one collision racket, a scheming driver might stop in front of a laneway and motion an oncoming vehicle to enter traffic; his partner, driving in the opposite lane, then “accidentally” collides with the car… emergency personnel are sometimes called to make the scene more realistic.
With a police investigation underway, the scammers would allegedly forge medical documents claiming injury, often signing on behalf of doctors who never actually assessed the patients. Some of the accused are identified as paralegals, who allegedly filed the insurance claims seeking financial recovery for vehicle damage, physiotherapy, chiropractic work and lost wages.
Insurance companies have decried the practice of staged collisions as one of the reasons for higher premium rates.
In Nayar, the court followed the precedent established in Guiliani v. Saville to find that a plaintiff who put his hands on the hood of the defendant’s vehicle was not contributory negligent when the defendant accelerated and hit the plaintiff.
The facts as accepted by the court were as follows. The plaintiff was a gas station attendant who followed the defendant as she was slowly driving away without paying for gas. The plaintiff was under the impression that the defendant simply forgot to pay. The plaintiff put himself in front of the defendant’s vehicle with his palms out. The defendant began revving the engine of her vehicle and inching it towards the plaintiff. The plaintiff then proceeded to place his hands on the hood of the defendant’s vehicle. The defendant accelerated, hitting the plaintiff in knee.
The court acknowledged that the plaintiff was reckless in placing himself in front of the defendant’s vehicle and putting his hands on the hood. However, the court found that the defendant was entirely to blame for the incident
At paragraph 33 the court found that:
[The defendant] was there to be seen, as was the plaintiff. It was not reasonably foreseeable that [the defendant] would drive into [the plaintiff].
It follows that the plaintiff may not be found contributory negligent applies even if the plaintiff puts his hands on the defendant’s vehicle and even if the defendant acts in a matter that indicates that she will accelerate.
In Guiliani the British Columbia Court of Appeal found that the plaintiff standing in the middle of the road, in the path of the defendant’s approaching vehicle was not contributory negligent when the defendant’s vehicle collided with the plaintiff.
The plaintiff Guiliani and his friends were driving past the defendant when the defendant “gave them the finger”. An invitation to fight ensued and the defendant escaped by getting into his vehicle and speeding off. The plaintiff proceeded to stand in the roadway waiting for the defendant to return. The court accepted that the plaintiff was standing in the roadway in order to identify the defendant when he returns and to take down the defendant’s license plate number.
When the defendant finally returned, he was approaching the plaintiff at an accelerated speed. The plaintiff continued to stand in the roadway despite having ample opportunity to get out of the way of the defendant’s vehicle. The trial judge accepted the evidence that the plaintiff did not move until the car was virtually upon him and it was too late to get out of the way.
The trial judge found that the plaintiff was 30% responsible for his injuries. The court of appeal reversed the finding of contributory negligence. At paragraph 10, it held that the trial judge reached her conclusion:
“without regard for the flagrant and almost unforeseeable conduct of the defendants and without regard for the fact that the defendant had ample room to steer clear of the plaintiff.”
The court rejected the submission that having regard to the previous altercation between the parties the plaintiff should have known that standing in the path of the defendant’s vehicle was particularly dangerous.
At paragraph 11, the court stated that:
the plaintiff could see the defendant coming but it was not reasonably foreseeable that the defendant, who could see him equally well, would continue to drive towards him at an accelerated speed.