The federal right-to-try (“RTT”) adventure, which we chronicled here, and here, concluded not long ago with the final passage of S. 204, signed into law on May 30.  The final bill is not materially different from the house draft we analyzed earlier.  The final bill cleaned up some of the previous hastily-drafted language, such as tying the definition of “life threatening” to prior regulations dealing with that subject.  The two provisions of most interest to us – concerning RTT adverse events and immunity from civil suits – had been pretty good before, and stayed that way.  Reporting requirements became slightly less onerous.  A “sense of the Senate” section at the end ensures no resurrection of the Abigail Alliance foolishness regarding a constitutional right to medications.  So it’s done, but our basic skepticism remains unchanged – we don’t think that the entire exercise was worth the candle, given existing FDA compassionate use regulations, and we strongly doubt that many people, if anyone, will be helped.  Right to try was a right-wing shiny object, a distraction from the serious problems stemming from our chaotic approach to health care.

According to something we read recently on the FDA Law Blog, a “New Vermont Law Seeks to Allow Wholesale Importation of Drugs from Canada.”  We view that legislation similarly to RTT.  Canadian drug importation is a left-wing shiny object, also distracting politicians from the country’s serious health care problems.  Think about it.  California alone has a greater population than Canada.  Any large-scale importation of cheaper Canadian drugs to the United States would almost immediately cause shortages in Canada.  Given the current tit for tat, we would expect Canada to react by slapping an export tariff on prescription drugs to force United States consumers to continue paying for the inefficiencies in our health care delivery system.

But putting stupid, unnecessary trade wars to one side, let’s focus on our sandbox – product liability.  What would the product liability effects of the Vermont program, as created by the new legislation, be?

The legislation authorizes the state to design a program whereby, “a State agency that shall either become a licensed drug wholesaler or contract with a licensed drug wholesaler” in order to import prescription drugs from Canada to Vermont – all in supposed compliance with federal law. 18 Vt. S.A. §4651(a)(1).  The arrangement is to “use Canadian prescription drug suppliers regulated under the laws of Canada.”  Id. §4651(a)(2).  While the imported Canadian drugs are supposed to meet FDA “safety, effectiveness, and other” standards, id. §4651(a)(3), there is no requirement that their Canadian labeling be altered.  The Vermont state agency:

Shall . . . (1) become licensed as a wholesaler or enter into a contract with a Vermont-licensed wholesaler; (2) contract with one or more Vermont-licensed distributors; (3) contract with one or more licensed and regulated Canadian suppliers; [and] (4) engage with health insurance plans, employers, pharmacies, health care providers, and consumers. . . .

Id. §4655(1-4).  Nowhere in the statute are the ultimate manufacturers of the Canadian drugs even mentioned.  The statute does not envision any contact between the drug companies and the state importing agency.  How does Vermont expect to handle drug recalls?  Controlled substances?

The statute also raises interesting product liability questions.  This being Vermont, the statute has no provisions creating any sort of immunity from suit.  So it appears to us that, by inserting one of its agencies into the chain of drug distribution, Vermont has exposed itself to product liability suits should any of the drugs it sells cause injury.  Equally important, the statutory scheme probably makes the state the prime target of any such litigation.  In all likelihood, none of the drug manufacturers will be subject to personal jurisdiction in Vermont.  They will not be selling any drugs in Vermont.  They will have labeled their drugs in accordance with Canadian, not American, regulations.  They will have no notice of their drugs being diverted from Canada to Vermont.  In terms of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), and Daimler AG v. Bauman, 571 U.S. 117 (2014), the drugs will enter Vermont solely by virtue of the conduct of unrelated third persons.

Just as we pointed out flaws with the immunity provisions of various versions of right-to-try statutes, the immunity issues here also implicate the viability of the Vermont program, albeit in a different fashion. With no statutory immunity, and no ability to obtain jurisdiction over drug manufacturers for the Canadian market, the statute paints a great, big target on the back of the state importing agency, as the deepest pocketed potential defendant available to all potential plaintiffs who might take the drugs thereby imported into the state.  Sovereign immunity won’t help, since the Vermont scheme has the state engaging in commerce, not in any traditional governmental role.

Both sides of the political spectrum unfortunately share an affinity for largely meaningless, feel-good prescription drug-related schemes.  Importing drugs from the Great White North, like the Vermont program envisions, would be rife with problems, including saddling states with product liability.  Maybe that is inevitable where states seek to act as commercial entities.

What follows is a guest post about a recent favorable decision in Canadian drug/device litigation.  Unlike in the USA, product liability class actions cases are often certified in Canada.  Thus, any pro-defense decision is good news indeed.  Robin Linley and Jessica Lam of Blake, Cassels & Graydon LLP in Toronto have been good enough to provide us what they call a “brief and selective summary” of Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016), which in typical Canadian fashion, takes 85 pages to reach a result that our clients will like.  As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be, for what appears below.

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In a recent product liability class action decision, Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016) (“Wise“), the Ontario Superior Court of Justice (“Court”) granted the defendants’ motion for summary judgment in advance of the certification motion, concluding that there was no genuine issue requiring a trial because there was insufficient evidence of general causation.  The decision highlights the potential for defendants to use summary judgment to resolve a class action before certification in appropriate cases.

The representative plaintiff brought a proposed class action against Abbott alleging that its testosterone replacement product, for the treatment of hypogonadism (testosterone deficiency) in men, caused serious cardiovascular (CV) events.  The plaintiff further alleged that the drug had no therapeutic benefit and that class members should be compensated for their economic losses incurred in purchasing the product. The plaintiffs also sought recovery from the defendant based on allegations of failure to warn and the novel claim of “waiver of tort”.

Abbott submitted that the plaintiff’s claims should be dismissed on the grounds that they could not prove general causation, which was a constituent element in all of the plaintiff’s product liability claims, and that ultimately, there was insufficient evidence of a “genuine issue requiring a trial”.

Continue Reading Guest Post – Ontario Court Decision Highlights Summary Judgment as a Potential Tool in Class Proceedings North of the Border

What follows is a guest post about a recent favorable development in Canadian drug/device litigation.  We’re not Canadian lawyers, so we gladly outsource Canadian developments to those who are, such as these guys – Mike A. Eizenga, Gavin H. Finlayson and Ashley L. Paterson, of Bennett Jones LLP – who won the case in question.  As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be.  Here goes:

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Certification was denied in a recent proposed multiple-model product liability class action before the Ontario Superior Court of Justice in O’Brien v Bard Canada Inc

Class actions are more common in Canada than the US, due in large part to the low bar for certification of an action as a class proceeding in Canada.  Although all Canadian jurisdictions, with the exception of the three territories and the province of Prince Edward Island, have their own class proceedings legislation, the test for certification of an action as a class proceeding is substantially similar across all common law provinces. In Ontario, there is a five-part test under section 5(1) of the Class Proceedings Act, 1992, which must be met in order for an action to be certified:

(a) the pleadings must disclose a cause of action;

(b) there must be an identifiable class of two or more persons;

(c) the claims of the class members must raise common issues;

(d) a class proceeding must be the preferable procedure for the resolution of the common issues; and

(e) the representative plaintiff must fairly and adequately represent the class, have a workable litigation plan and have no conflicts with the other class members.

Continue Reading Guest Post − Product Liability Cases Are No Longer Quintessential Class Actions In Ontario

What follows is a guest post about a significant class action decision in Canada.  Our guest poster today is Chris Horkins of the Canadian firm Cassels Brock & Blackwell LLP.   We haven’t changed a thing, not even Canadian-style spelling, so as always our guest poster gets all the credit, and any blame, for what follows.

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Canadian courts may be taking a firmer stance against certification in pharmaceutical class actions. The recent decision of the British Columbia Court of Appeal setting aside the certification of a pharmaceutical class action in Charlton v. Abbott Laboratories Ltd. 2015 BCCA26 [Charlton] provides evidence of a growing trend in favour of defendants in prescription drug class actions in Canada. Although the certification test in most Canadian jurisdictions remains a
procedural question, it is clear that courts will require plaintiffs to show that causation is capable of being proven on a class-wide basis before giving the green light to a proposed class action.

History of the Proceedings

The Charlton class action against pharmaceutical manufacturers Abbott Laboratories, Ltd. (“Abbott”) and Apotex Inc. (“Apotex”) was commenced on behalf of patients across Canada who had used or purchased the prescription drug sibutramine, alleging that the drug increased the risk of cardiovascular events such as heart attack and stroke. The plaintiffs alleged that the defendants were liable in negligence, waiver of tort and for breaches of Canada’s Competition Act and British Columbia’s Business Practices and Consumer Protection Act.

Originally developed as an anti-depressant, sibutramine was found to suppress appetites in its use for that purpose. Subsequently, Meridia, a weight-loss drug was developed by Abbott and approved for use in Canada in late 2000. In 2009, Abbott’s exclusive right to distribute Meridia ended and Apotex began distributing a generic weight loss drug containing sibutramine under the name Apo-Sibutramine. In 2010, a US medical journal published a study suggesting that sibutramine was associated with an increased risk of serious cardiovascular events for patients with pre-existing heart conditions. Shortly afterwards, the drugs were voluntarily taken off the Canadian market by Abbott and Apotex.

Decision of the BC Supreme Court 

At first instance, the BC Supreme Court certified the action as a class proceeding under BC’s Class Proceedings Act. The certification judge noted that his role was not to test the merits of the action, but rather to focus on the form of the action and whether it was appropriately prosecuted as a class action. Applying the low threshold “some basis in fact” test from the Supreme Court’s leading decision in Hollick v. Toronto (City) [2001] 3 S.C.R. 158, 2001 SCC 68,
the court certified the proposed class action.

Decision of the BC Court of Appeal 

On appeal, the BC Court of Appeal overturned the certification order, finding that the plaintiffs had failed to adduce evidence of a workable methodology to determine the issue of general, class-wide causation – namely, that sibutramine actually increased the risk of cardiovascular events for all class members. Since the only evidence before the court was the study suggesting an increased risk for patients with pre-existing heart conditions, the court found there was no viable methodology for determining causation with respect to the wider class:

While there is no dispute that those with pre-existing cardiopulmonary disease are at a statistically increased risk of adverse cardiac events, this is not a case where the experts disagree on the extent of the risk, but rather, a case where the experts are uncertain whether there is a risk to the class as a whole and cannot describe a methodology for addressing that question.

This was found to be a necessary element of proof for each of the certified common issues. As such, the question of causation was incapable of resolution based on the evidence at the certification hearing. Accordingly, the Court of Appeal found it was an error for the certification judge to have certified the class action and set aside the certification order.

Implications Going Forward 

What can product liability class action defendants take away from this decision? It demonstrates how arguments relating to the merits can be imported into the certification test and used to defeat certification. As Justice Willcock stated: “The question that ought to have been asked at the certification hearing in relation to both types of claims, is not whether the resolution of the general causation question will advance the class claims, but rather, whether there is a reasonable prospect of doing so.”  The failure of plaintiff’s counsel to put forward viable evidence of class-wide causation can be considered a failure to
demonstrate causation on a class-wide basis and that a class action is the “preferable procedure.”

Viewed together with the Ontario Divisional Court decision in Martin v. Astrazeneca Pharmaceuticals PLC, 2013 ONSC 1169, the Charlton decision demonstrates a shift to a stricter and more thorough analysis of proposed class action claims.

Several years ago we vacationed in Toronto. Back then, the Drug and Device Law Son split his time between hockey and videogames. He was a goalie, so, like his dad, he was always on defense. We visited the Hockey Hall of Fame, tap-danced on the glass floor in the CN Tower, had dinner at Wayne Gretzky’s restaurant, took in a Maple Leafs game, and wandered around the huge underground mall. With the sort of weather that reigns in the True North, an underground mall (really an entire underground city) makes a lot of sense. We noticed that many of the stores had a slogan on the walls: “The World Needs More Canada.” It’s hard to argue with that. Canada has pretty much everything we like (a nice standard of living, cultural offerings, and poutine), and not so much of those things we don’t like (crime, arrogance, and crocodiles).   How can you not admire a country that has given us Joni Mitchell, Bobby Orr, and Pamela Anderson, as well as the inventors of the zipper, basketball, and Trivial Pursuit?  And we look back with fondness at a college road trip adventure, when we drifted across the border to empty the town of Magog of Molson Brador.  (Bexis points out that Canada is also responsible for the rock groups Rush and BTO.  Hmmmm.  That fact might prompt us to reconsider the whole premise of this paragraph.)

Every once in a while we have the opportunity to blog about drug and device developments north of the border, involving matters also being litigated in the USA. As we said above, there’s a lot to like about Canada.  But its class action law is usually something we don’t like so much.  Canada’s application of class action certification rules is considerably more liberal than the corresponding rules here — excepting, perhaps, certain rogue counties in Southern Illinois.  Nevertheless, we are pleased to relay some good news from the Canadian courts.  Our friends at Covington, specifically Michael Imbroscio, sent us a decision by the Quebec Superior Court rejecting certification (what they call “authorization” in Quebec) of a proposed class action alleging that Accutane (isotretinoin) caused inflammatory bowel disease (IBD), in Lebrasseur v. Hoffman – La Roche Limitee, (Quebec Superior Court file no. 500-06-000512-109). The decision is in French, which we cannot read (though the Drug and Device Law Son says he can, and even has the grades to prove it), so we are trusting Covington’s summary.  But for those of you who claim the ability to read Proust and Moliere in the original, here is a copy of the Quebec court’s opinion.

Continue Reading Quebec Court Denies Accutane Class Certification

Since we follow developments in Canada, and in particular Canadian class action litigation, we thought our readers would like to know about the significant defense win in Andersen v. St. Jude Medical, Inc., 2012 ONSC 3660, slip op. (Ont. Super. June 26, 2012).

However, because of ReedSmith’s involvement in the litigation, we’re limited to telling you what happened.  Then again, since they write opinions differently in Canada − Andersen weighs in at a whopping 215 pages (with a glossary) − maybe that’s not such a bad thing, for you or for us.

Andersen is significant because there are not many instances where a Canadian class action (about 1100 members) has been dismissed outright after a full trial (and we do mean full − 39 witnesses and 140 trial days over the course of nearly 1½ years).  The case involved a medical device, a type of heart valve, and at bottom the class simply alleged negligence.  The plaintiffs sought compensatory and punitive damages, medical monitoring, disgorgement of profits, and provincial insurers’ health care costs, and of course attorneys’ fees for eleven years of litigation.  What was that that Robert Harper said about the XYZ affair?

Proceeding under different, and more liberal, class action standards than in the United States, the Andersen opinion addressed the following “common” issues:

(1) Negligent design/testing/marketing (broken into two parts, pre- and post-marketing)

(2) General causation

(3) Increased risk of medical complications

(4) Medical monitoring

(5) Spoliation

(6) Disgorgement/waiver of tort

(7) Punitive damages (note, our issue numbering is different than the court’s).

Here are the results that the court reached on those issues:

(1a) The evidence did not establish negligence in the device’s pre-market design and testing.  A balance of foreseeable risks and harms favored the defense.  Andersen, slip op. at 20-63.  Plaintiffs’ claim of regulatory fraud was rejected.  Id. at 59-62.

An interesting holding, that lack of testing has no legal significance unless the test results would have made selling the product “unreasonable,” appears on page 42.  This is a Canadian variant of the argument underlying our duty to test cheat sheet − that failure to test by itself is not a separate cause of action.

(1b) The evidence did not establish negligence in the device’s post-market surveillance or failure to recall the device sooner. Andersen, slip op. at 64-76.

(2) Plaintiffs’ evidence of toxicity neither satisfied the Canadian version of Daubert, nor sufficed to establish general causation. Andersen, slip op. at 15-19; 76-107; 110-26.

A case series was insufficient scientific evidence to support a causation opinion.  Id. at 125-26.

(3) The design of the device increased the risk of one condition (paravavular leak within specific post-implant periods), that was not seriously disputed.  Evidence (epidemiology; the court declined to perform a Bradford-Hill analysis) failed to establish any material increased risk of any other condition, those being all the ones in dispute.  Id. at 127-93.

Doubling of risk (relative risk of 2.0) is the legal standard of materiality in toxic tort cases, but as a presumption, not an absolute bar.  Id. at 178-85.

(4) Since general causation was unproven, plaintiffs were not entitled to medical monitoring.  Id. at 193.

(5) There was no intentional spoliation of evidence that could give rise to an adverse inference.  Id. at 107-10.

(6) A theory of “waiver of tort,” basically a cause of action for negligence without proof of causation, was not adopted, because such a change is more proper for the legislature than the courts.  Id. at 193-201.

(7) Without separate discussion, punitive damages are denied.  Id. at 202.

Obviously, we’ve left out a lot of details.   That’s why you have a link to the 215 − page Andersen opinion.

We’ve blogged before, occasionally, about drug/device developments north of the border.  Most of these developments have involved class action practice, where Canadian law is considerably more liberal than the corresponding rules here in the USA.

But there’s a point at which class actions fail even under Canadian law.  That point was recently reached in the parallel Seroquel litigation pending in Ontario.  We’re pleased to report that, in Martin v. AstraZeneca Pharmaceuticals PLC, No. 06-CV-314632CP, slip op. (Ont. Super. May 7, 2012), the court flatly rejected class certification.

Unlike the Canadian judiciary (the opinion is 78 pages long, single spaced), we’ll try to keep this report brief.

The class was huge and undifferentiated – “all persons” in Canada who “ever used Seroquel.”  Slip op. at ¶5.  Likewise, the alleged injuries were everything under the sun.  Id. ¶¶7-9.  The claims are the same that we typically see in the USA, a hodgepodge of inadequate warning, off-label promotion, and fraud on regulatory agency allegations.  Id. ¶¶11-13.  Their experts were also eye-rollingly familiar to US litigators, Laura Plunkett and William Wirsching.  Id. ¶¶26-28.  As often happens in the US, Plunkett was ruled incompetent to offer any medical opinions.  Id. ¶¶50.  More interestingly, since it’s part of her schtick, Plunket was also held incompetent to testify about Canadian regulations, since her only background involved the American FDA.  Id. ¶¶65-66.  Contrary to the plaintiffs’ apparent position, Canada is not simply an appendage of the US.

Despite having sophisticated class action counsel, plaintiffs were really lousy pleaders.  “It is plain and obvious that the causes of action as pleaded will fail.”  Id. ¶108.  Among other things, they “lump” differently situated defendants “together as a group” and allege that everybody’s liable for everything.  Id. ¶109.  Maybe we should call these pleading rulings “Canadian TwIqbal” or “CwIqbal” for short.  Whatever it’s called, the plaintiffs couldn’t meet the standard and the entire complaint was pitched.

How can counsel who can’t or won’t satisfy the most basic pleading requirements possibly be considered “adequate” for class action purposes?

Just a thought.

Another interesting holding in Martin – at least to us, since we don’t know much Canadian substantive law – is that it’s essential in design defect cases to plead “a safer and economical alternative design.”  Id. ¶¶136-37.  That’s also the law in many US jurisdictions.  Of course plaintiffs can’t plead an actual alternative design in most drug cases, so they just plead that somehow some other drug is safer.  That didn’t cut it in Martin.  Id. ¶136.

Continue Reading Oh, Canada!

We’re feeling uncharacteristically magnanimous after last night’s USA Olympic hockey victory, so we’ll cheerfully report on a recent pharma innovator-liability case from the True North. In Goodridge v Pfizer Canada Inc., 2010 ONSC 1095 (Feb. 18, 2010), the plaintiffs claimed injuries from off-label use of Neurontin and its generic version. We tip the cyber hat to Nick Mizell at Shook Hardy for bringing the case to our attention.
Most of the Canadian opinion is as tasty as a maple glazed donut from Tim Horton’s. The court believed it was writing the first Canadian opinion on innovator liability for generic products, and as far as we can tell that’s true. One of the first things the court decided was that American precedents were interesting but useless. (Perhaps that’s how Canadian hockey fans felt about Rafalski and Miller — until last night. But we digress.) At first we thought that’s too bad, because, as the court observes, most American decisions “favoured the Defendants’ arguments.” (We admit it – we love the “ou” in “favour” and “colour.”  Why not “doctour”?) But the Canadian court goes on to reach the right result, holding that Pfizer Canada owes no duty to consumers of generic gabapentin.

Applying the first part of the duty test, the court acknowledged it was foreseeable to an innovator that people might be injured by the generic. But the rest of the test goes against the plaintiffs. The connection between the innovator — which simply “releas[ed] an idea that is copied” — is remote from the consumer of the generic. More important, the court thought it simply unfair to impose liability on an innovator that “cannot control, qualify, or stop” the conduct in question — off-label use of the generic.

Further, the Canadian court identified two policy reasons for not imposing a duty on the innovator: (1) such a duty would essentially impose strict liability for defective products, which would be “a radical change in Canadian law” (the court quotes from an earlier Canadian’s court’s observation that while many American courts imposed strict liability, it wasn’t necessary “in the Canadian context, where there is much greater social assistance available for those who are hurt” — ouch!); and (2) innovator liability would stifle — you guessed it — innovation. We uttered similar comments about innovator liability cases in the United States here. Interesting and useful — at least we think so.

The court addressed other issues, mostly in a sensible way. For example, the court refused to certify an off-label promotion class action. The plaintiffs tried to exploit the allegations of off-label promotion of Neurontin in the US, but the court saw no “basis in fact for the allegations about wrongful marketing activities in Canada.” The court also declined to accept the plaintiffs’ argument that Canadian doctors were necessarily “influenced by any promotional activities emanating from the United States.” The court did certify some common issues for class treatment, but ordered individual trials for individual issues (specific causation and injury, anyone?). It also deleted the question of punitive damages as a common issue.

We’re not yet ready to issue a gold medal, but the judge did a better than average job — certainly better than what we’ve seen in the figure-skating competition.

This post discusses a Vioxx case, and Bexis’ tongue is thus tied. The following post was written by Herrmann alone:

Earlier this year, in a post cleverly titled, “Oy, Canada,” we deplored the fact that apparently no Canadian trial court had ever denied a motion to certify a class action.

We’re pleased to report that the times they are a-changin’. Civilization has arrived in our neighbor to the north.

Last week, the Court of Appeal for Saskatchewan [it’s not just a blog; it’s a spelling lesson, too!] reversed a trial court’s decision to certify a class of certain Canadian consumers of Vioxx. Merck Frosst Canada Ltd. v. Wuttunee, 2009 SKCA 43, slip op. (Court of Appeal Mar. 30, 2009) (click here to read the opinion and weep for joy).

After some preliminary skirmishing, the Vioxx consumers were pursuing claims under Canada’s Consumer Protection Act, Competition Act, and common law of negligence, battery and deceit. The trial judge (who has since been elevated to the Chief Justice of Saskatchewan) certified a class of Vioxx purchasers or consumers who fell into one or more of eight subclasses and included those seeking restitution for alleged ineffectiveness of Vioxx, others seeking the difference in purchase price between Vioxx and less expensive drugs in its class, and those who claimed to have suffered cardiovascular or gastrointestinal injuries. For good measure, the court certified a nationwide Canadian class. Id. at 6-8.

The trial court certified as common issues the questions of general medical causation, Merck’s knowledge, product defect, failure to warn, misrepresentation, and punitive damages. Id. at 9. And here you thought American class action law was dangerous!

But the Saskatchewan Court of Appeal saw the light: “[T]he most intractable difficulty with this action lies in the diversity of claims sought to be advanced on a common basis, and in the related question of whether such an action is manageable as a class action.” Id. at 25.

The appellate court found that the trial court’s description of the certified issues did nothing more than give “the impression of commonality, where commonality does not in fact exist,” and that the issues presented “a myriad of questions, susceptible to different answers in relation to each of the risks or defects of Vioxx alleged” such that “all semblance of commonality is lost.” In short, “the fragmentation of the class into subclasses, together with the range and diversity of claims asserted by members of the subclasses against the appellant, have together posed an insurmountable challenge to the quest for commonality in relation to the proposed common issues.” Id. at 77.

In addition to thinking about what Americans would call “commonality,” the court also addressed what we’d call “manageability.” The “complexity would in this case defeat the requirement that a class action be a fair, efficient and manageable method of advancing the claims of class members.” Id. at 78.

Because the court had decertified the class on other grounds, the court chose not to address the question of the propriety of multi-province or nationwide class actions. Id. at 79-80.

This ruling does not eliminate all certified Vioxx class actions in Canada, because an Ontario-certified class (national in scope, but excluding Saskatchewan and Quebec) and a Quebec-only certified class action remain pending.

But this is a start.

God save the Queen!

As we’ve said before, we don’t do Canadian law here. We posted once on that subject, about a year ago, and we were quick to confess our ignorance.

But we were startled by what we heard about Canadian class action law at the ACI conference in New York City last month. One speaker said that, to date, no Canadian court has ever denied a motion to certify a class in a drug or device case. The accompanying course materials tell us that, in the past, “Class actions involving breast implants, diet drugs, pain medications, gastrointestinal medications, antipsychotics, cholesterol reducing drugs, pacemaker leads, tainted blood, TMJ implants, heart valves, and defibrillators, have all been certified in Canada.”

As you would anticipate in this environment, these types of claims are becoming increasingly popular. The course materials go on to tell us that, “In the past two years, pharmaceutical and medical class actions that await a certification hearing have been commenced in Canada with respect to an ever widening range of medications and medical devices including ICD and pacemaker leads, pain medications, anti-inflammatories, children’s cold medications, purgatives, a variety of contraceptive products, more antipsychotics, bisphosphonates, antibiotics, medications for irritable bowel syndrome and restless leg syndrome, epilepsy medication, and diabetes medication.”

That raises our question: How should a drug or device company respond to a consumer complaint about a product liability issue in Canada?

In the United States, responding to a consumer complaint is pretty easy: If the consumer may have a point, you engage in a discussion with the consumer, perhaps agreeing to pay what that particular complaint is worth. But if the consumer is a nutcase, you reject the claim, because the claim has no value. Respectable plaintiff’s counsel wouldn’t agree to file a lawsuit, and there’s basically no chance that a court would certify a class, so you’re on pretty safe ground.

If, in Canada, all putative classes to date have been certified, that changes the calculus. Any consumer complaint basically threatens the possibility of a certified class action. That’s a tough environment in which to operate.

We actually asked a Canadian lawyer how Canadians handle these issues, and we didn’t find much comfort there. We were told, first, that Canadians are generally less litigious than Americans. That might be true, but we suspect that opportunistic Canadian plaintiffs’ lawyers, guaranteed that their putative classes will be certified, will be overcoming their historical reticence pretty quickly.

We were told, second, that Canadian plaintiffs often misplead their cases, messing up the Canadian “waiver of tort” doctrine or otherwise pleading themselves out of a claim. Again, we’re not getting that warm and fuzzy feeling. Surely, over time, plaintiffs’ lawyers will figure out how to plead their claims correctly, and then the deluge will begin.

We understand that there are a fair number of Canadian drug and device cases now approaching trial. Although most American class actions settle before trial (because defendants generally prefer not to run even a small chance of a huge loss), we hope that some Canadian company will stand firm. Perhaps an industry victory at trial will convince courts that these cases should not routinely be certified, or will show plaintiffs’ counsel that these cases are not without substantial risk.

Otherwise, we suspect that the class action litigation environment in Canada will soon begin to resemble that of its southern neighbor.

Oy vey, Canada.