US$3B Fine Against GlaxoSmithKline LLC for Off-Label Marketing

US$3B Fine Against GlaxoSmithKline LLC for Off-Label Marketing

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.

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

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.