Category Archives: Court Assignment

Defeated ex-flying school deputy looks to appeal

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By Rachel Ward

The former deputy commander of Nova Scotia’s cadet gliding school has gone to court – and lost – arguing he was pushed out of a job as part of “three years of procedural wrongdoing.”

Each summer teenagers learn to fly at the school in Debert. Photo: Wikipedia
Each summer teenagers learn to fly at the school in Debert. Photo: Wikipedia

John MacLellan had been working at the Regional Gliding School Atlantic in Debert for 25 years when he got a new, younger boss, Lieutenant Colonel David Lewis. Clashes with Lewis would lead to a court battle that culminated in last month’s court decision.

In January 2010 for the first time in 25 years, MacLellan’s job was posted to competition. Lewis had changed his job’s requirements, adding new technical skills MacLellan had never before needed.

Unable to apply, MacLellan lost his old position, and Captain Curtis Cooper, a man 17 years his junior, was hired. Now unemployed, MacLellan considered leaving the military, but instead enlistede Kevin MacDonald’s legal help.

The two met almost 40 years ago, when MacDonald was hitchhiking to an airshow in Sydney Mines. MacLellan, then an air cadet leader, picked him up, wondering why a teenage kid would be out so early in the morning, alone on the highway.

MacLellan went on to teach at Debert, and in 1985, was hired as deputy commander, directing cadets. Learning to fly, “changes their lives forever,” said MacDonald, a former cadet himself and now a volunteer with the 73-year-old organization. “They come back, biggest smile on their face.”

According to court documents, MacLellan says he was told by his boss that he would always keep that job if he did it acceptably. As the years progressed, that promise held true, and the job contracts got longer – first for three years, then for six. Those short contracts turned into a quarter century.

Then started what the two believe was a “nefarious plot” to get rid of MacLellan. Most recently, they appeared in front of the Supreme Court of Nova Scotia, defending this idea. To support their application, two other former Debert staff members offered to testify about their earlier claims that sparked an internal investigation by the military into the camp’s hiring practices.

“Those are not everyday allegations,” said Ronald Pizzo, a labour lawyer who analysed documents from both court cases.

Labour lawyer Ronald Pizzo. Photo: Submitted
Labour lawyer Ronald Pizzo. Photo: Submitted

The civilian case that ended this July proved difficult, though it took place in court room more familiar to MacDonald, who’s trained in civil – not military – law.

“They didn’t get very far, did they?” said Pizzo.

 Court battles begin

In March 2010 MacDonald, now his lawyer, wrote a letter to region’s commander. As a result, the job change was investigated, according to the civil suit decision, and found MacLellan had not been treated in “a fair and equitable manner.”

MacLellan than accepted an offer of a three-year contract for a more junior position, as the officer in charge of flight safety.

Court documents says tension was building between MacLellan and Lewis over the coming months. On July 24th, 2010, Lewis “verbally assaulted” him in front of junior staff, according to MacLellan’s affidavit. Jason Dawe, then a flight instructor, was in the room.

“I saw the argument,” said Dawe in an interview, “even though I tried to run away from what was happening.”

MacLellan reported the incident, and was later told they would hold mediation. Shortly after, a different story emerged.

Lewis pressed charges, three counts of insubordination, one for each swear word uttered by MacLellan. The court martial would find MacLellan not guilty, with the judge noting that Lewis’s choice of a court martial over mediation was “somewhat unusual, but certainly not abusive.

Chronology
View this partial timeline for a better picture of when events happened:

MacDonald says, according to court documents, he was denied resources normally provided by Defense Counsel Services. Instead, MacDonald volunteered his time to the case.

MacDonald says this has caused stress, as MacLellan still owes money for witnesses’ travel expenses to testify at the court martial and had little to spend on extra research support.

“How can you fight with a hand tied behind your back?”

Other actions by higher-ups raised flags for MacDonald. For example, Captain Darren Garnier, the Chief of Staff for Maritime Forces Atlantic, called MacLellan into his office prior to the court martial. Garnier tried, court documents argue, to persuade MacLellan to pursue a court martial where he would simply plead guilty. MacLellan, instead, wanted to be represented and fight the charges.

“I had the distinct impression then and since that they simply wanted me to admit that I had done something wrong and ‘take my punishment’ – when I had not,” reads MacLellan’s affidavit. Garnier was named as a defendant in a later overturned civil action.

The court martial went back and forth between MacLellan’s side alleging abuse of process, and Lewis’s side rejecting that. The Crown called one witness, Lewis. MacLellan then had to pay to fly in several witnesses, including Dawe, who says he “flew up as cheap as” he could. In the end, the judge, Lieutenant-Colonel M.J. d’Auteuil, found MacLellan not guilty, and acquitted him of all charges.

The judge also found no evidence that Lewis had any “involvement in those proceedings then being the complainant. He was never in a position to influence or to direct people on how to do things.”

Challenge of a mistrial

Had the judge found it to be a mistrial, as MacDonald argued, the Crown could have appealed, and the charges tried again. A mistrial is hard to prove, says Ron Pizzo, a labour lawyer in Halifax.

Even harder was going to court in July, trying to prove the whole thing was a conspiracy – or at least mishandled.

“Any time your job security is put at risk, it feels like a personal attack,” said Pizzo. Perhaps, says Pizzo, more could have been done to smooth the transition originally, and give MacLellan the opportunity to catch up to the new standards.

MacLellan took medical leave due to his mental health, and then retired mid-August, 2011.

MacLellan now lives in a white house in Shubenacadie, East Hants County, a little less than an hour’s drive from the airfield he used to frequent. He turned down an interview through his lawyer.

Lewis could not be reached, nor could his lawyers.

MacDonald says he will appeal the decision.

“That’s not the gliding school. That’s not the military I know.”

Read the Nova Scotia Supreme Court decision:

 

Despite horrific injuries, Levaquin class action suit may be stalled in Nova Scotia

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Statement of Claim (Text)
Johnson & Johnson, the US pharmaceutical giant which manufactures the potent antibiotic Levaquin, has been settling thousands of lawsuits filed against it out of court in the United States.  That is now causing uncertainty about whether a proposed class action suit against Johnson & Johnson and Levaquin (known generically as levofloxacin ) in Nova Scotia will move forward.

Wagner & Co., a class action law firm based in Halifax, has filed a Statement of Claim in the Supreme Court of Nova Scotia on behalf of clients in Atlantic Canada who have suffered possibly compensable injuries after taking Levaquin.  But the firm is also weighing the benefits of proceeding with individual cases only.

A powerful and popular drug

Levaquin was approved by the US Food and Drug Administration (FDA) in 1996 and by Health Canada in 1997.  It was heralded as a wonder drug, an antibiotic that cured infections others couldn’t.

In 2002 and 2007 the FDA insisted that all pharmaceutical companies manufacturing Levaquin place warning labels on the drug to alert doctors to possible tendonitis and tendon rupture, especially in patients over 60 years of age.

By 2008, the FDA warning had been upgraded to a black box warning, the sternest warning from the FDA that a medication can carry and still be sold in the US.

Despite the order,  Johnson & Johnson did not add labels to their product.  Not long after 2008,  lawsuits began to be filed by users of Levaquin in the US, most of whom had suffered tendon rupture.

More than 450 reports of adverse reactions have also been reported in Canada since 2008.

Side Effects

The injuries allegedly suffered as a result of taking Levaquin are clearly horrific.  They include spontaneous tendon ruptures, tendonitis and retinal damage, usually within four to six weeks of taking Levaquin.  Many patients require invasive, possibly life-altering surgery to repair the damage.

Dr.  Judy Mader, a family physician who operates a busy practice from the Professional Building at 5991 Spring Garden Road in Halifax says Levaquin is an “excellent drug”.

Mader was surprised to learn that there was a possible class action lawsuit involving Levaquin and says she has never had a patient complain of side effects, especially  involving tendons.

mages_055A ruptured Achilles tendon/file photo

Where the lawsuits are headed now

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Michael Dull, class action lawyer/ photo: Anne Calder

Michael Dull, a class action lawyer with Wagner & Co, says that lawyers in the US are not allowed to litigate pharmaceutical cases as class action suits.  Instead  they proceed as ”multi-district litigation”.   All cases from one jurisdiction fall under the management of one judge.

The opposing parties then pick two or three of their most hopeful cases from the larger group.  These cases – or “bell weather” cases – are heard in court and at the end of the process both sides should know the strengths and weaknesses of their respective positions, says Dull.

Johnson & Johnson is surprisingly quiet in its financial statements and on its website about lawsuits, including Levaquin.

However, Bloomberg reported recently that “in a filing in federal court, the drug maker said it had agreed to settle, for an undisclosed sum, 845 of the legal actions brought by patients who claimed the drug maker didn’t do enough to warn about the dangers of antibiotic Levaquin, which has been tied to tendon problems. It is in negotiations to settle another 190 of the cases.”

US courts also allow pharmaceutical companies to use the defence that their failure to warn physicians of the possible side effects of taking Levaquin would not have made a material difference if the physician had been warned, a defense that is not available in

This defense favours the pharmaceutical companies and for that reason, many settlements in the US have been marginal.   Dull says drug companies tend to fight these cases and spend millions of dollars on legal fees, rather than chance paying individual awards, which in the US tend to be large.

In the US in 2013, the Minneapolis District Court alone had 1,879 cases filed against Johnson & Johnson with respect to Levaquin.  Of these, 1182 were settled out of court by the company and 153 were still in negotiations.

There were also 1228 active cases in New Jersey, 898  due for dismissal because of  settlement.

Johnson & Johnson is surprisingly quiet in its financial statements and its website about its various lawsuits, including Levaquin.   Bloomberg reported that “in a filing in federal court, the drugmaker said it had agreed to settle, for an undisclosed sum, 845 of the legal actions brought by patients who claimed the drug maker didn’t do enough to warn about the dangers of antibiotic Levaquin, which has been tied to tendon problems. It [the company] said it is in negotiations to settle another 190 of the cases.”

What this means for litigation in Nova Scotia

Statement of Claim (PDF)

Dull says approximately 30 people have contacted his firm and he believes that roughly half of them have a compensable injury.  Nearly all involve tendon ruptures or tendonitis in clients in their fifties or sixties.

But Wagner & Co. is also weighing the benefits of proceeding on an individual basis for a small number of clients who have suffered the most serious injuries and have the strongest cases, in the hope of receiving more appropriate compensation if they are successful.  The full extent of their losses are individually assessed in those cases and awards are generally much more beneficial.

Although Dull believes his firm has the makings of a strong class action suit, he says that the US settlements have tempered some of the enthusiasm in Canada and Wagner & Co. has yet to determine if the class action suit will proceed.

Dull explains that class action suits are more the norm in pharmaceutical cases in Canada because the cost of experts’ fees, and hiring one lawyer just to peruse millions of pages of documents about a drug’s development is normally just not going to happen.  A lawyer or law firm will not do that much work for say, a percentage of an $80,000 settlement. But they likely will if they can get a percentage of 80,000 people who are potentially worth that much money.

Dull believes his firm has the makings of a good class action suit,but he says there is no doubt that the US settlements have tempered the enthusiasm in Canada and Wagner & Co. has yet to determine if the class action suit will go forward.

Medical marijuana lawsuit could be groundbreaking for federal privacy lawsuits

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Lemon Kush by Mark/Flickr
Lemon Kush by Mark/Flickr

Medical marijuana users are suing Health Canada, in a case that could open doors for other privacy lawsuits against the federal government, and highlight shortcomings in Canada’s Privacy Act, experts say.

“If this case actually proceeded, and resulted in a court decision, it would be precedent-setting,” says Kris Klein, a lawyer at nNovation law firm who has been an advisor to the Privacy Commissioner of Canada.

But it still faces steep hurdles to get there.

Privacy compromised

The case started last November, after Health Canada sent letters to 40,000 medical marijuana users across the country. Rather than the usual discreet envelopes sent by courier, these went through regular post, and had “Marihuana Medical Access Program” and the patients’ names and addresses clearly displayed on the envelopes.

Patients say this violated their privacy by disclosing to an unknown number of people that they consume and possess marijuana, and that they have grave health conditions. They say it also put them in danger, as many patients in the program also grow marijuana at home, and the information could leave them vulnerable to break-ins and violence.

“That address on that piece of paper outed a lot of people, including designated growers,” says Jason Wilcox, a patient based in Vancouver. As the founder of the Cannabis in Canada Society and an avid social media user, Wilcox isn’t afraid to admit he smokes pot – but he is worried that people could now find out where he grows it.  He says for people living in small towns where everyone knows everyone, the problem is even worse.

Jason Wilcox on how he believes the letters endangered growers

Health Canada apologized for the gaffe in a statement on their website, saying it “deeply regrets this administrative error”.  But patients have slapped the organization with a class action lawsuit, which is now being waged by four law firms working together across Canada.

The Privacy Act: outdated?

The plaintiffs are seeking financial compensation from the federal government, which is a new and barely-explored territory in Canadian privacy law. That’s because Canada’s Privacy Act, which regulates how the federal government handles people’s personal information, doesn’t actually say if people have the right to claim damages if their privacy is invaded. In fact, the only remedy the Act explicitly states is to complain to the federal Office of the Privacy Commissioner.

Because of that, many courts have interpreted the Act to mean that “the legislation didn’t intend for there to be a remedy and that the court doesn’t actually have the right to award a remedy,” says Kate Saunders, a Vancouver lawyer with Branch MacMaster LLP who is handling the medical marijuana case.

Klein says this is one of the areas where he feels the privacy law desperately needs reform. “The Privacy Act right now gives these hollow rights,” he says. “You’re not really giving us rights if, at the same time, you can go ahead and violate them without any negative consequence.”

Listen to Kris Klein on why he thinks the Privacy Act needs reform

The Office of the Privacy Commissioner shares Klein’s concerns. In the watchdog organization’s most recent annual report, then-commissioner Jennifer Stoddart slammed the government’s continued failure to update the Privacy Act, calling it “troubling.” In a speech last November, Stoddart also called for a complete overhaul of the Act, and lamented the lack of penalties for ignoring privacy guidelines. “Wouldn’t it be better to have the force of law to motivate better practices so rather than focusing on reporting breaches, the emphasis would be on avoiding them altogether?” she said.

Privacy lawsuits on the rise

Saunders and Klein both say they’re seeing an increase in the number of people looking for legal recourse when their privacy is violated. Klein says in the digital age, people are becoming a lot more aware of their personal information, “and as people become more aware, they want to hold organizations accountable if they have that personal information.”

In the Privacy Commissioner’s annual report, Stoddart said that the number of complaints to her Office by citizens has hit a record high two years in a row, with an increase of 133% this past year. While that number was inflated by two significant incidents, Stoddart said it was still concerning.

On the flip side, she also said that data breaches reported by government were at an all-time high for the third year in a row, with 30% more breaches reported than the year before.

But without legal recourse, says Klein, complaining to the Privacy Commissioner is “the end of the road.”

A new avenue

In the absence of hard legislation, the Privacy Commissioner recommends a new, common-law avenue that could offer promise, known as intrusion upon seclusion. It’s borrowed from American case law, and can award damages for an intrusion into someone’s privacy, even if there is no physical loss. This argument will play a key role in the medical marijuana case.

Saunders says they owe a big debt to a ground-breaking 2012 case in the Ontario Court of Appeal, known as Jones v. Tsige. For the first time, a Canadian court used intrusion upon seclusion to award damages for a privacy breach.

“The Jones and Tsige case opened up an avenue that was very exciting for privacy lawyers,” says Saunders, because it meant that, at least in Ontario, there is a common-law right to privacy.  “It created a very strong argument that there is a right to privacy in the rest of Canada as well.”

Listen to Kate Saunders on how Jones v Tsige matters to privacy law

Since then, a number of privacy lawsuits in Ontario have relied on intrusion upon seclusion, but the medical marijuana case would be the first to bring it into the federal arena.

“This is why this case is very interesting,” says Saunders. “It provides an opportunity for the government to weigh in on the status of the common-law right to privacy, federally.”

 

The long road ahead

But there’s a long road ahead to get to that point. Saunders says they will be applying for certification next month, which means the court must determine whether it’s appropriate for the case to be treated as a class action.

And even to be certified, Klein says they’ve got an uphill battle. “Most people are not overly sympathetic to the plaintiffs,” he says, saying the incident is largely viewed as a relatively minor mistake.

On top of that, because the Privacy Act doesn’t give any guidelines on what warrants compensation and what doesn’t, he says there’s a lot of risk involved. “The plaintiffs’ lawyers who are taking this on now, they’re gutsy,” he says.

After certification, Saunders says, about 90% of cases will be settled out of court – which means they don’t set any precedent for future cases.

Whichever way this battle goes, there’s no shortage of privacy class actions that are headed for the federal arena right now, including several in Saunders’ office. “But as it stands, we don’t have a good read on which way the federal court is going to lean on them.”

 

 



Beals warrant bucks unsolved homicide trend

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Ten years after Kevin Bowser was shot to death on the steps of his ex-girlfriend’s home, his family might finally get some answers.

A Canada-wide arrest warrant was issued for 31-year-old Shilo Beals in the middle of July 2014. He's been charged in the 2004 death of Kevin Bowser and six weapons-related offences.  Police photo.
A Canada-wide arrest warrant was issued for 31-year-old Shilo Beals in the middle of July 2014. He’s been charged in the 2004 death of Kevin Bowser and six weapons-related offences. Police photo.

Shilo Beals, 31, is the target of a Canada-wide warrant issued in July and is charged with the first-degree murder of Bowser, along with six weapons-related offenses.

While the decade-old cold case might be on its way to closure, many similar cases are still unsolved in Halifax.

According to a University of King’s College analysis of Statistics Canada data, a higher percentage of homicides go unsolved in Halifax than in most cities across the country.

Halifax’s clearance rate – the percentage of homicides “cleared”, either by the laying of charges or “other means”, such as the death of a suspect – is the fourth lowest among cities with more than 50 homicides since 2004, the year of Bowser’s death.

Halifax’s homicide clearance rate for the past 10 years is 66 per cent, ranking it just above Vancouver (49 per cent), Edmonton (62 per cent), and Montreal (63 per cent) – three cities with larger populations – and behind Toronto (68 per cent), Calgary (69 per cent) and eight others.

Halifax’s clearance rate includes statistics from both the Halifax Regional Police and the RCMP.

Provincially, Nova Scotia also lags behind the average in the past decade, solving 74 per cent of the homicides committed, a higher rate than British Columbia (58 per cent), Alberta (71 per cent), and Quebec (73 per cent).

 

Until the arrest warrant for Beals, Bowser’s murder was one of at least 34 left unsolved since the start of 2004 (because of the way Statistic Canada’s data tracks clearances some cleared cases could from before 2004).

His shooting on July 12 was the fourth in Halifax since the beginning of that month, according to archived media reports, although Bowser’s was the only fatality.
Police knew both Beals and Bowser for the shooting.

Bowser was charged with weapons offenses after an incident with a sawed-off shotgun in 1997 and spent two years in prison, the Chronicle Herald reported at the time of his death.
Beals spent two years and nine months in federal prison for drug charges.

His parole hearing documents from 2009 also state he was a suspect in two attempted murders using firearms, had prior convictions including possession of a weapon and pointing a firearm, as well as weapons and uttering threat charges that were both withdrawn.

Beals was sent back to jail the same day he was released from custody in March 2011 for an outstanding assault warrant.

Prior to the Canada-wide arrest warrant issued last month, Beals’ was also involved in a civil suit against Halifax Regional Police for what he claimed to be an illegal execution of a search warrant.

According to a study by Statistics Canada, homicides involving gangs and firearms, similar to the Bowser’s case, are the hardest to solve.

Between 2000 and 2010, the report states, non-gang related homicides were cleared at twice the rate of gang-related homicides. Similarly, homicides committed with a firearm were less likely to be cleared by police than non-firearm related homicide.

Of the 18 listed homicides on the province’s Reward for Unsolved Major Crimes, which offers up to $150,000 for information leading to a conviction, 11 are shooting deaths.

The program, which started in 2006, has received information from the public that has led to three different arrests, according to Roger Merrick, the director of public safety at the provincial Department of Justice. One case is currently before the court.

Merrick believes the effectiveness of the program is “very high.”

“From a […] family’s point of view, it provides them a great deal of relief,” said Merrick. “They now have answers to who killed their loved ones and the people are now being brought to justice.”

The program lists 77 homicide or suspicious missing persons cases dating back to 1955.
While the Statistics Canada study mentions gangs and guns as the hardest cases to crack, Const. Pierre Bourdages of Halifax Regional Police says otherwise.

“The manner in which the homicide was committed, whether it be by blunt force, a gun, or a stabbing, they all present their own challenge,” he said. “One is not easier to solve than the other.”

Halifax Regional Police investigators are always looking for new leads on cold cases, he said.

Officers are assigned to an unsolved homicide for a period of time, then the case will switch to a “new set of eyes” to keep the investigation fresh.

When it comes to the Bowser case, Bourdages said the charges against Beals came from “hard work by the investigators that worked on this file and were able to bring it to a conclusion.”

But that doesn’t always do it.

“One problem we have with some of the unsolved homicides is that we have individuals that have information or that know exactly who’s responsible, who will not provide the information to police,” said Bourdages. “It becomes very hard to investigate and bring these investigations to conclusion when we have people with information that refuse to speak to police.”

A first national class action in Nova Scotia

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Ken Taylor broken Profemur Hip Implant System. Credit: David Komm affidavit.
Ken Taylor broken Profemur Hip Implant System. Credit: David Komm affidavit.

When Ken Taylor’s hip implant broke in 2009, he did not think that his injury would one day make history. However, five years later, he is leading the first national class action ever certified in Nova Scotia.

Taylor’s legal battle is taking place at the Supreme Court of Nova Scotia against the Tennessee based company Wright Medical Group (WMG) and its subsidiaries in Canada. The resident of Dartmouth claims that WMG knew that their Profemur Hip Implant Systems had a high risk of failure, but the company sold them anyway. After receiving one in 2007, Taylor had to overcome three surgeries and he is now asking for compensation.

This first national class action could make a precedent and bring hope for better justice access for Nova Scotians. Class action procedures allow the plaintiffs to share the expensive costs of a trial. They also permit the Court to rule one case for many members, instead of having several similar trials backlogging the judiciary system.

“Usually, a national class action is certified in Ontario, as if it’s the only place that it could be done”, explains Michael Dull, from Wagner law firm, who is Taylor’s lawyer. “What this case says is that there are provinces outside of Ontario. We are pleased that the Court of Nova Scotia recognized that and didn’t take a back seat to Ontario.”

However, the battle is not won yet. Judge Michael J. Wood from the Supreme Court of Nova Scotia certified the lawsuit on March 7, but WMG appealed of the decision on July 8. For the American company, each medical case is different. Therefore, the class action should not be allowed, says the Tennessean corporation, that would prefer to manage the situation with each plaintiff separately instead of having them fighting together. Between the two sides, the legal battle in the Halifax Court House could last for years to come.

Taylor’s multiple surgeries

On September 1, 2009, Ken Taylor was plugging an amplifier at the bottom of his TV. “I was trying to get myself up and then I could hear a crunch.” At first, the large build man – Taylor measures 6 feet 1 inch and weights over 200 pounds – thought he just pulled something.

However, a few hours later at the hospital, radiography showed that it was serious: the neck of his hip implant broke. “The doctor told me: ‘You’re not going anywhere. The only thing that is holding your leg right now is the ligament under your skin.’”

Three days later, Ken Taylor had his first revision surgery. He received a new hip implant. Unfortunately, his bone was not growing around the prosthesis and the WMG product was loosening.

Six months later, on February 24, 2010, he underwent a third surgery, this time with a bone graft.

“And because of all that, I had my other hip done too,” says Taylor. “I put so much weight on my good hip for so long. So I had four operations in total: three on my left hip and one hip replacement on the right.”

A faulty product?

The hip implant was supposed to improve the quality of life of Ken Taylor who was suffering of osteoarthritis. This inflammation of the joints affects one in ten Canadian adults. Before receiving the hip implant, the cartilage of Taylor’s left hip eroded with time and became painful.

His doctor, Dr. Gross from Halifax, had good hope with the WMG hip implant, as he wrote it in 2006: “we will be using a ceramic articulating surface which I am hoping will give him twenty/twenty-five years of pain free range of motion without wear.” However, the implant only lasted two years and three months.

To support Ken Taylor’s case, two affidavits from experts were filed. In his testimony, Dr. David Zukor, Chief of the Department of Orthopaedic Surgery at the Jewish General Hospital in Montreal, indicates that the prosthesis Taylor received has been reported “to have a much higher than normal rate of failure at a much earlier time.” Zukor quotes the 2009 report of the Australian Hip Registry indicating that the WMG implant has an expected revision rate of 11.2%, instead of less than 2.5% for conventional hip replacements.

The second expert is David Komm, a mechanical engineer living in Arizona who has over 29 years of experience in examination of product failures and personal injuries. For Komm, it is “well within the balance of probability” that the WMG hip system has manufacturing or design issues. He uses the Manufacturer and User Facility Device Experience Database (MAUDE) from the Food and Drug Administration to make his point. His review suggests that the most common issue with the WMG hip implant is the fracture.

Battle of numbers

Revision rate for Profemur Hip System

Although David Zukor and David Komm’s opinions were damaging for Wright Medical Group, the company did not throw in the towel. Ken Taylor and his lawyer presented their expert opinions in October 2012. WMG presented its version of the situation in February 2013.

WMG’s expert, Byron Deorosan, a biomedical engineer from California, claims that both David Zukor and David Komm are wrong in their analysis. They used the MAUDE database which was an error, says Deorosan, because the FDA does not review the MAUDE reports. Therefore, the information is not a reliable source, he thinks.

In the affidavit of Debby Daurer, the Senior Manager with Wright Medical Technology contradicts the high rates of failure of the Profemur Hip Implant System. Quoting WMG records, she indicates that the worldwide fracture rate is 0.13% for the prosthesis. This number is well below the statistics from the 2009 Australian registry, used by David Zukor and David Komm.

Next step

The class action has been certified but the Supreme Court of Nova Scotia will hear the appeal from WMG this upcoming October. If the appeal is received, it could mean the end of the lawsuit, but if the appeal is rejected, the class action will go on.

“Then it could end in two ways,” explains Michael Dull. “The defendants could settle at any time. Otherwise, we would go on trial. If we win, we win for the benefit of everybody that had a fracture. If we loose, we loose to the detriment of everyone. That could take at least a couple of years.”

Thirty Canadians already joined Taylor’s class action.

Contacted by email, Wright Medical Group refused to give us an interview. However, in its 2013 Annual report, the company indicates that they changed the material of their Profemur implants in 2009 to improve their solidity. It is also specified that management estimates the liability cost of the Profemur prosthesis related claims from $17 million to $26 million in North America.

Ontario couple claims testosterone replacement drug AndroGel nearly killed husband, sues maker Abbott for $60M

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National class action lawsuit adds to growing number of similar court procedures in the United States, after study finds testosterone replacement products for older men can increase chances of heart attacks and death.

Androgel good picture
(Credit: Nate Gilman, Flickr)

For Norman Wise, it all started with an ad on television talking about “Low-T”, or low testosterone syndrome, and its blockbuster drug AndroGel. The commercial promised to help older men who suffer from low sex drive, erectile dysfunction, decreased energy, reduced muscle mass and anemia.

“The commercial was describing something called Low-t and my symptoms were very similar to what was being expressed, just low energy, general apathy. What I was feeling fit what was advertised.”

– Norman Wise, plaintiff

His family doctor prescribed him the testosterone-replacement drug manufactured by Abbott Laboratories. The topical gel contains male hormone testosterone, which is absorbed by the body through the skin.

After using AndroGel for about a month, Norman says he did not feel any different. Until the evening of October 9th, 2013, when he felt a searing pain across his body during his regular workout routine.

Within hours, he was rushed to the ER and underwent emergency surgery. Doctors told Monika that her fit 68 year-old husband, with no family history of heart disease, was having a heart attack.

After months of painful recovery, life will never be the same for the once happily-retired snowbirds. Their days are now filled with doctors’ appointments and constant naps for Norman. The many adventures that he and his wife had planned are cancelled, and they can’t get travel insurance because of his condition.

 “My heart was damaged so badly that I was diagnosed twice with congestive heart failure. Doctors are telling me my heart was damaged substantially.”

– Norman Wise, plaintiff

“Misrepresentation and disease-mongering”

The Wises allege that AndroGel-maker Abbott Laboratories is responsible for Norman’s heart attack on October 9th, 2013.

In a 45-page class action lawsuit filed June 25th, they claim neither they nor their family doctor was aware of the risks of heart damage associated with the use of the drug.

They claim Abbott Laboratories “misrepresented that AndroGel is a safe and effective treatment for so-called ‘low-T’ when in fact the drug causes serious medical problems, including life-treathening cardiac arrest.”

The lawsuit demands half a million dollars in damages for each plaintiff that was prescribed AndroGel, plus $60 million in exemplary damages to be paid by Abbott Laboratories. There is also mention of compensation for family members.

A growing trend 

This case is part of a growing trend involving many pharmaceutical companies behind the controversial marketing campaign “Low-T”, that has made testosterone replacement drugs more popular than ever in Canada and the United States.

Launched in 2011, the AndroGel campaign urged older men to get their testosterone tested if they lacked energy or had a low sex drive. It also included mailouts to doctors and a new website. Soon, men were flocking to their family doctors and the number of prescriptions increased substantially.

One study estimated the number of American men being treated for “Low T” more than tripled from 2001 to 2011, with results similar for Canadians.

The “Low-T” wave hit a wall in January 2014, when a study published by the Journal of American Medical Association found that older men taking testosterone replacement drugs have up to 30 per cent more chances to suffer heart attacks, blood clots and death.

Underdiagnosed and overprescribed?

In a safety announcement, the U.S. Food and Drug Administration (FDA) announced it was investigating the use of these drugs and stipulated that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

That’s precisely the problem, says Norman and Monika Wise’s lawyer, Matthew Bear. He explains that Norman was never properly diagnosed with hypogonadism, the medical condition drugs like AndroGel are supposed to treat. “Low-T is really just a disease that the drug companies made up, which stands up for low testosterone,” adds Bear.

“Because of the very aggressive marketing that they [pharmaceutical companies] do, most of the men who take these drugs don’t even have the health condition [hypogonadism] these products are suppose to treat. So not only do most of the men taking it don’t really need it, but the warnings are also inadequate.”

– Lawyer Matthew Bear, McKenzie Lake Lawyers LLP

 

Dozens of lawsuits in the US

AndroGel might soon become part of many lawyers’ vocabulary as class actions multiply. In the United States, 45 cases have been filed against Abbott Laboratories (and its new research-based pharmaceutical division AbbVie) by men who claim they suffered strokes, heart attacks and blood clots after using the drug.

In Canada, Lawyer Matthew Bear says he has received “dozens of calls” from men who want to join the first class action lawsuit in the country against the makers of AndroGel.

Meanwhile, Abbott Canada confirmed they have received the lawsuit and issued the following statement:

AndroGel has more than 10 years of clinical and post-marketing data, with therapeutic risks documented in the prescribing labels. Abbott encourages discussion between physicians and patients that leads to proper diagnosis based on symptoms, lab tests and a patient’s other health needs.”

– Abbott Canada statement (August 6th 2014)

In its Second-Quarter 2014 Financial Results, AbbVie notes that AndroGel sales in the United States are down 15.6 percent from the prior year quarter, telling investors this is a “notable slowdown in the market, with overall prescriptions down more than 20 percent in recent months. We expect these market trends to continue.”

The lawsuit must first be certified by a judge, which could take up to a year according to lawyer Matthew Bear.

The allegations have yet to be proven in court.

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Medical device company sells business division amid pending class-action lawsuit

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A Tennessee-based global orthopaedic medical device company sold its money-losing hip and knee replacement business to a Chinese company in January.

The deal earned Wright Medical Group, Inc. $287.1 million – almost the exact same amount as its net loss in 2013.

However, a national class-action lawsuit filed in Nova Scotia three years ago against Wright’s hip implant products might cause the company more trouble with its bottom line.

Story of a failed hip implant

Ken Taylor still remembers that evening in September 2009, when he was at home sitting on the floor, trying to hook up an amplifier to his TV, and by the time he turned to get on his knee to get himself up, he heard a crunch – his hip implant fractured.

This happened two years after the Dartmouth resident got an implant on his left hip at the Queen Elizabeth II Hospital in Halifax. Ideally, a hip implant should last around 10 to 15 years.

After Taylor was rushed to the Dartmouth General hospital that night, the doctor had to keep him hospitalized because the only thing that was holding his leg on him was the skin.

The next day he was transferred to the QE II hospital and got a revision surgery to correct the broken neck of the implant. His doctor who performed the surgery told him the broken device was a faulty product.

However, the story doesn’t end there. It turns out the second surgery didn’t go well either – the device was loose, and the stem and Taylor’s femur bone didn’t adjust well so less than half a year later he had to undergo a third operation.

Taylor says the nurse told him if he was to have a fourth implant, there’s no room left in his femur bone for the stem to go down.

The surgeries have weakened Taylor’s left hip – if he sits for a while and gets up, he limps. After the third surgery, Taylor had to retire from his job.

He says if he knew the implant was going to cause him this much pain before his had the first surgery, “it would have been stupid for me to do it.”

Taylor’s doctor told him the first implant device that was put into him was defective and suggested him to see a lawyer. At first, Taylor was only filing for his own case. But two months into the legal procedure, his lawyer convinced him to switch to a class-action because the lawyer said there were other people who have similar implant fractures.

In September 13, 2011, Taylor and another Dartmouth resident Judy Rowter filed the class-action lawsuit at the Supreme Court of Nova Scotia against Wright Medical Group, Inc. and two other sub companies, Including one based in Ontario, who’s in charge of selling Wright’s products in hospitals across Canada.

Taylor says before he decided to take the legal action, he got in touch with Wright. And they offered him $30,000 to settle the case. And even the company staff, who talked to him admitted that amount was low. So Taylor turned to resolve the case in court.

But his interaction with the company provided him with the knowledge that the company knew their products were problematic, but kept selling them.

In fact, studies have being done as early as 2006, suggesting the Profemur Hip Implant System that Taylor got had a relatively high failure rate during the first few years after surgery.

Pending class-action case

The court has already certified Taylor’s case as a class-action, but the company appealed, accusing the judge of making an error and Taylor’s case doesn’t classify as a common issue, and incidents like this should be settled individually.

However, Raymond Wagner from Wagners Law Firm in Halifax, who’s Taylor’s lawyer, says this will discourage other patients like Taylor from coming forward because a lot of people couldn’t afford the $30,000 to $150,000 litigation fee.

Wagner says there are 15 to 20 people in Nova Scotia alone whose Profemur implants have fractured. And 30 others have signed up to join the class-action case too.

He says lawsuits on hip implant failures have been on the rise in recent years following medical device companies started making the metal-on-metal model, Wright’s Profemur products is one example. The medal parts rub against each other and release toxic particles in the patients’ body and the parts themselves gets fragile and become easier to break. Studies by medical journal Lancet suggest a higher failure rate of metal-on-metal models compared to metal-on-ceramic or metal-on-plastic models.

There are class-action lawsuits against the metal-on-metal products in the U.S. prompting companies, such as DePuy Orthopaedics, to withdraw their metal-on-metal models. And earlier this year, the U.S. Food and Drug Administration had asked 21 manufacturers to conduct safety studies on their metal-on-metal hip implants.

Still liable despite selling troubled business

From 2007 to 2013, Wright’s hip products have experienced growth and then decline (starting 2011). And the company’s net income had a same trend with the products success and failure because of an increase on the number of fracture complaints from its customers.

 

In January of 2014, Wright sold it’s hip and knee business to a Shanghai-based medical device company, called MicroPort Scientific Corporation. 

MicroPort is hoping the deal could help it expand its portfolio and get a presence in North America. And the company can take advantage of the growing hip implant market in Asian to sell Wright’s hip and knee products. The location of the business remains in Tennessee, U.S., only the name changed from OrthoRecon under Wright to the now MicroPort Orthopedics, Inc.

However, lawyer Wagner says the deal doesn’t free Wright from any potential liabilities from the lawsuit.

He says the court will make a decision by March on Wright’s appeal. “If Wright loses the appeal, it may encourage the company to resolve the case, which may take a couple of years,” says Wagner. Individual cases may vary, but Wagner estimates Wright will have to compensate each plaintiff who signed up to the class-action with $100,000 to $300,000.

If the court rules Wright winning the appeal, Wagner is planning to take the case to the Supreme Court of Canada, which may take over five years to resolve.

But he hopes the case can bring attention to relevant government organizations, such as Health Canada to ban the defective products from the market.

However, Wagner says Health Canada is an under-funded organization, who relies on manufacturers and physicians to provide all the information. “And with the budget they had it’s hard for them to do the policing,” says Wagner.

Eric Morrissette, Senior Media Relations Advisor with Health Canada says, “Profemur Hip System with the Long, Titanium Profemur Modular Neck component are no longer licensed for sale in Canada.”

He says in 2009, Health Canada investigated reported failures of the Profemur stems at the request of a surgeon. And the investigation concludes that “patients’ weight and activity level” are potential causes of neck fracture for the Long, Titanium Profemur Necks. “Health Canada’s findings were consistent with those of the manufacturer,” says Morrissette.

According to Ken Taylor’s class-action lawsuit, Profemur Hip Implant System first received licensing approval from Health Canada in 2011.

And so far this year, Health Canada has issued 373 new licenses to Profemur series products, the highest number since 2001. And a few of those products were the ones causing trouble to Ken Taylor and other plaintiffs.

 

A class action for inappropriate access of medical records is moving forward

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Both sides are getting ready to discover witnesses in a class action against South West Health for an employee accessing patients’ medical records without a medical reason

The class action case against South West Health for an employee accessing personal medical records was put into motion over two years ago. Photo: Ocean-Leigh Peters
The class action case against South West Health was put into motion over two years ago. Photo: Ocean-Leigh Peters

A class action against South West Health for inappropriate access to personal medical records is moving forward next week. The case is at the discovery phase where both sides will questions each other’s potential witnesses to get an idea of how they will proceed from there.

In 2011, 707 people received letters from the South West Nova District Health Authority saying their medical records were accessed by an employee without a medical reason. Among those people were Alicia Hemeon and Willa Magee, who are the representatives for the class action and will be questioned next week. “To know that an employee of South West Health inappropriately accessed my private

The class action against South West Health was certified last August after a judge reviewed statements and affidavits from Alicia Hemeon, Willa Magee and Janet Wile, the privacy officer and manager for the health authority. Photo: Ocean-Leigh Peters
The class action against South West Health was certified last August after a judge reviewed statements and affidavits from Alicia Hemeon, Willa Magee and Janet Wile, the privacy officer and manager for the health authority. Photo: Ocean-Leigh Peters

medical records is humiliating, distressing and heart-wrenching,” said Hemeon in an affidavit. In June of 2012, Blaise MacNeil the CEO of South West Health, released a statement saying “We sincerely apologize to all patients and the community that this breach of confidentiality has occurred. The confidentiality of patient information is of vital importance in South West Health.”

The class action certification states that the class consists of anyone who received a letter, including those who were later informed that that their records were accessed for legitimate reasons.

In the amended statement of claim, the class claims intrusion upon seclusion, vicarious liability and negligence.

“One of the elements to a successful intrusion upon seclusion is that the breach of privacy is highly offensive to a reasonable person,” says Mike Dull a lawyer from Wagners law firm who represents the class. “We say that the mere act of going into a person’s medical records inappropriately is highly offensive to a reasonable person.”

Since the case is ongoing South West Health was unable to comment at this time, but in their statement of defence they claim no intrusion upon seclusion because they deny that it is a free-standing tort in Nova Scotia.

Intrusion upon seclusion became a binding president in Ontario in 2012 says Hilary Young, a law professor at the University of New Brunswick in Fredericton. She says that with new technology, claims such as trespassing may not be enough to cover all forms of privacy breach.

“I think there’s a good chance that the courts will recognize it in Nova Scotia,” says Young. “If I were betting, I would bet that they would adopt it because there’s no good reason not to.”

South West Health has asked for this claim to be dismissed in their statement of defence because it is not recognized. If not, “South West Health specifically denies that there was a significant invasion of private records… as many individuals’ records were viewed on only one occasion and/or for less than one minute.”

The class is also claiming vicarious liability against South West Health. “Vicariously liability is when you hold someone, usually an employer, legally responsible for someone else’s act,” says Young.

She says the plaintiffs would have to prove two things for this to apply. That the relationship was employee and employer, and that the actions were within the scope of the employee’s employment.

Mike Dull, lawyer for the plaintiffs, says the class members have sympathy for the employee who accessed their medical records. "Our clients don't want to rub salt in her wounds or kick her while she's down, whereas the health authority are big boys and they can handle it." Photo: Ocean-Leigh Peters
Mike Dull, lawyer for the plaintiffs, says the class members have sympathy for the employee who accessed their medical records. “Our clients don’t want to rub salt in her wounds or kick her while she’s down, whereas the health authority are big boys and they can handle it.” Photo: Ocean-Leigh Peters

“I think clearly the employee is liable,” says Dull, “but she, you understand, is a young girl now unemployed living in the south shore who doesn’t have of course the resources to compensate the 700-and-some people… so we turn of course to her employer.”

In their statement of defence South West Health claims they are not vicariously liable because “any actions alleged by the Plaintiffs and Class Members were unauthorized, deliberate and intentional actions taken by (the employee), unrelated to the work assigned to her.”

They also say that they have policies and procedure in place to managed personal medical records and that their employees are trained how and when to appropriately access them.

“They say she acted on an isolated, kind of rogue basis,” says Dull. “So the case really will turn on that question.”

Young says that it may be tricky for South West health to prove that the employee’s actions were not related to her job at the hospital.

Negligence on the part of South West Health is also being claimed in the class action against them. “Negligence means that… you acted unreasonably and because you acted unreasonably in a certain way someone was injured as a result,” says Young.

In this case, the injury to Hemeon and Magee, as well as the other class members, is not physical but rather emotional because their records were accessed by a health authority that they trusted.

Dull says when class members started contacting the firm their main complaint was that South West Health supposedly knew this breach of privacy was happening for a while and did not address it. This fits into their claim of negligence.

They also claim that because the employee was put in a position where she could look at patients’ medical records for what Dull says is “way to long a period”, they were being negligent.

South West Health denies any negligence on their part because they claim they “operated in accordance with the standards and practices generally known, and in place at the relevant time.”

They also say that they have policies and procedures that were made know to all staff members stating that they are responsible for protecting the privacy of patients’ personal information. This Thursday the case moves into what is called discovery where both sides will be able to question potential witnesses.

“They basically get to interview them to get a sense of what their answers will be to certain questions,” says Young, “and that will help them decide what their strategy will be for any trial. So no surprises.”

Dull is hoping for a trial early next year. “I suspect the health authority wants to delay this as long as possible, it’s big liability for them.”

Case timeline

Massive class action progressing against drug causing breasts in boys

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Gynecomastia causes enlarged breasts in men. Photo: Wikimedia Commons
Gynecomastia causes enlarged breasts in men. Photo: Wikimedia Commons

Two Canadian law firms are teaming up and combining their class actions against Janssen inc. over an antipsychotic medication that caused gynecomastia (male breasts) in patients.

 

The drug, Risperdal was not approved for treating minors. It is a potent antipsychotic, but has been prescribed for treating ADHD in youths.

 

The product label only mentions gynecomastia as a side-effect for adults, but does suggest that metabolic side-effects were more prevalent in minors during testing.

 

To put it simply, Toronto lawyer Bryan McPhadden says, “We allege that they (the patients) were not warned correctly about the risks of gynecomastia.”

 

McPhadden’s firm is teaming up with Joseph Prodor’s Vancouver based firm in what now appears to be a unified class action against Janssen inc., a branch of Johnson and Johnson.

 

As recently as July, 24 McPHadden had been pursuing class actions separate from Prodor’s in a number of Canadian Provinces, most recently in Nova Scotia where a class action was launched on behalf Ryan Hanna, an 18 year of man from Sydney NS that had breast reduction surgery to reduce the breasts he developed after taking the drug for nearly a decade. The legal filings allege that the breasts were a direct result of years of prescribed Janssen inc. ADHD medications: Risperdal and Invega.

 

The drugs have a long legal history that has resulted in class actions across the globe, most notably in The United States where both citizens and States have sought and received financial compensation on behalf of boys who developed breasts as a result of taking the drug.

 

These lawsuits have centred around two key arguments: 1) the product labels did not indicate the risks associated with the drug and 2) the pharmaceutical representatives that sold and promoted the drugs acted unlawfully in their promotion of the drug for off-label purposes.

Risperdal comes in may forms, but is commonly prescribed as an injectable. Photo: Wikimedia Commons
Risperdal comes in may forms, but is commonly prescribed as an injectable. Photo: Wikimedia Commons

 

In Canada it’s a bit of a different case. Risperdal was never approved for treating minors; though in Canada doctors are allowed to prescribe any medication that they feel will help a patient. The Canadian cases our based upon the notion that patients were not warned of the risks of developing gynecomastia.

 

McPhadden's class action is not yet certified in Nova Scotia courts. Photo: David Lostracco
McPhadden’s class action is not yet certified in Nova Scotia courts. Photo: David Lostracco

Court documents show that weight gain was a known side effect of the drugs, but the plaintiffs argue that weight gain actually made it more difficult to detect the enlarged breasts.

For over a decade Philadelphia attorney Steve Sheller has brought and won several actions over the same drug. The cases are at various stages, but some have resulted in multi-million dollar payouts to the plaintiffs. The total paid out thus far in the US has been over an estimated 1.6 Billion dollars.

Sheller’s cases were strengthened by proving that J&J engaged in off-label promotional activities such as financial rewards for prescribing the drugs.

 

Sheller’s class actions took in many cases over five years to resolve and many remain in courts yet unsettled.

 

It remains to be seen how the cases in Canada will play out, but the McPhadden and Prodor’s consortium is encouraging to the plaintiffs’ cause.

 

The medical side

Risperidone3Dan.gif
Risperdal as a molecule. Grapic: Wikimedia Commons

Dr. Steve is an American physician who did not want to be fully identified due to the controversial nature of this case, he sympathizes with the plaintiffs, but also sees the ambiguous proof that the judgments rely on.

 

“Teenagers and young adults are very body-conscious and gynecomastia at that age comes at the worst possible time. It can be a huge blow to one’s self-esteem.  Although it is correctable, the treatment can be very invasive and carries some risk itself.“

 

Risperdal can cause an increase in a hormone called Prolactin, this is the cause most lawyers use for gynecomastia (male breasts) in Risperdal users.

 

However, patients with prolactin secreting tumors rarely get gynecomastia,but high prolactin levels have been blamed for gynecomastia for years.

 

A recent review of the medical literature said that Risperdal was “probably” associated with gynecomastia.  Dr. Steve says “probably” doesn’t by any means mean it does definitively cause gynecomastia.

 

Some doctors prescribed risperdal despite some early warnings in the literature.

 

“So as always, it’s not a slam-dunk.  The kids who were on this medication were pretty mentally ill to be put on it in the first place.”

 

Financial Implications

 

In their 2013 annual financial filings Johnson and Johnson acknowledges the numerous legal actions facing them.

 

Despite the 1.6-billion USD the company paid out to satisfy Risperdal legal proceedings in the United States in 2013, the company does not foresee ongoing legislation impacting their cash flow going forward.

 

The company does note that a large one-time payment could have an adverse temporary financial effect in a given quarter or period’s financial statement.

 

The company has extensive insurance against potentially catastrophic legislation or liabilities against them.

 

The Canadian and UK class actions against Johnson and Johnson over Risperdal are significantly smaller in the number of plaintiffs in the class and therefore the payouts are expected to be smaller.

 

Annual sales of Invega were up 6-million USD in 2013, but sales for Risperdal fell 7.5-million USD in 2013 and 17.5-million USD since 2011. The company lists competition from generic drugs as the reason for the decline and not the litigation surrounding the product.

 

The company’s earnings per share were up nearly 1 USD in 2013 and nearly 1.5 USD since 2011 and the company’s overall stock price increased 33 per-cent in 2013.

Interactive Map: Major Risperdal Related Legal Cases