Ethicon nov 6

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

1. Ethicon Stapler Suit Belongs Outside US, 6th Circ. Told

   Nov 5, 2015 | Law360

   By Emily Field
   
   
   Johnson & Johnson subsidiary Ethicon Endo-Surgery Inc. asked the Sixth Circuit on Wednesday to affirm a lower court’s order tossing an ex-pat’s suit over a surgical stapler he says misfired and injured him, saying the suit doesn’t belong in an American court but in Germany, where he lives.
2. Canada: Product Liability Defence Review 2015

   Nov 5, 2015 | Who's Who Legal

   By Peter J Pliszka
   
   
   In my article, “As the Pendulum Swings: Shifting Fortunes Between Plaintiffs and Defendants in Product Liability Class Actions in Canada”, which appeared in the 2014 edition of Who’s Who Legal: Canada, I reviewed some recent product liability class action certification decisions by Canadian courts which were conspicuous by their results...

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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

1. Ethicon Stapler Suit Belongs Outside US, 6th Circ. Told

   Nov 5, 2015 | Law360

   By Emily Field

   Johnson & Johnson subsidiary Ethicon Endo-Surgery Inc. asked the Sixth Circuit on Wednesday to affirm a lower court’s order tossing an ex-pat’s suit over a surgical stapler he says misfired and injured him, saying the suit doesn’t belong in an American court but in Germany, where he lives.
   
   Ethicon said that the Ohio federal judge who dismissed the case didn’t abuse his discretion in concluding that Germany would provide an adequate forum for American citizen Brandon Hefferan and his German wife Sabine’s suit, since virtually all the witnesses and many relevant documents are in that country. None of the legal or procedural differences that the Hefferans cite establish that a German court would provide a relief so inadequate that it wouldn’t amount to any relief at all, Ethicon said.
   
   “Germany has the primary interest in deciding claims involving a German resident and a German citizen, allegedly caused by the sale and use of a defective medical device in Germany— also implicating the actions of German doctors in surgery in that country,” Ethicon said.
   
   Brandon Hefferan had sued the companies, saying the staples used in his hemorrhoid removal in July 2012 came loose and caused his rectal wall to leak, resulting in infections and injuries that required 20 additional surgeries. His wife also brought loss of consortium claims in the suit.
   
   Ethicon also said that the fact that German law doesn’t provide for loss of consortium claims is a false issue, since German law would apply regardless of where the case would be tried.
   
   The Hefferans’ argument that Ohio has the more significant relationship to the suit fails because Brandon Hefferan was injured in Germany, where the product was sold, and the Hefferans are still living in that country, Ethicon said.
   
   U.S. District Judge Timothy S. Black dismissed the case for lack of jurisdiction in May, and rejected arguments by the plaintiffs that the German court is inadequate for various reasons.
   
   The judge said that differences between the rights and remedies offered by the foreign and U.S. courts did not render the foreign venue inadequate.
   
   The only suggestion that Ohio has a meaningful relationship to the case is the Hefferans’ argument that the surgical stapler was designed there, Ethicon said.
   
   “But it remains to be seen what conduct caused the injury; it may have been the result of how the surgery was conducted in Germany, and of course, plaintiffs also pleaded a manufacturing defect claim while acknowledging that the stapler was made in Mexico,” Ethicon said.
   
   Ethicon recalled the PPH 03 surgical stapler along with two other stapler products in August 2012 because “users had difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation,” the complaint says. Hefferan notes that the company announced in the U.S. Food and Drug Administration recall that the device’s failure to complete the firing stroke could result in severe pain, rectal wall damage, sepsis, bleeding and other conditions.
   
   In September, the Hefferans told the circuit panel that the case belongs in the U.S., since that is where the primary evidence for their design and manufacturing defect claims is located. Brandon Hefferan's rights as a U.S. citizen, the inability to pursue pre-trial discovery under German law and other factors also weigh in their favor, the couple told the appeals court.
   
   "Mr. Hefferan is an United States citizen and veteran who was injured by a product designed in the United States by a United States company," Adam E. Deutsch of Morelli Alters Ratner LLP, Hefferan's counsel, told Law360 on Thursday. "We feel that he should be entitled to bring his case in the courts of this country and believe the law permits him to do so."
   
   Representatives for the parties didn't immediately respond to requests for comment on Thursday.
   
   The plaintiffs are represented by Joseph M. Lyon of The Lyon Firm and Adam E. Deutsch of Morelli Alters Ratner LLP.
   
   Ethicon and Johnson & Johnson are represented by David F. Abernethy of Drinker Biddle & Reath LLP.
   
   The case is Hefferan et al v. Ethicon Endo-Surgery Inc. et al, case number 15-3619, in the U.S. Court of Appeals for the Sixth Circuit.

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2. Canada: Product Liability Defence Review 2015

   Nov 5, 2015 | Who's Who Legal

   By Peter J Pliszka

   In my article, “As the Pendulum Swings: Shifting Fortunes Between Plaintiffs and Defendants in Product Liability Class Actions in Canada”, which appeared in the 2014 edition of Who’s Who Legal: Canada, I reviewed some recent product liability class action certification decisions by Canadian courts which were conspicuous by their results – the courts dismissed the plaintiffs’ applications for certification of product liability class actions – and I queried whether those defence victories were merely a pleasant coincidental anomaly or portended a much-needed reverse swing of the judicial pendulum towards the centre of the certification arc between plaintiffs and defendants.

   Further judicial rulings over the past year fortify the view that those decisions were not mere anomalies. Rather, three more defence victories on product liability certification motions over the past year – from courts of three different provinces – suggest that a significant shift in how Canadian judges apply the class action certification test has occurred. There is now a critical mass of legal precedents to support the position that Canadian courts are to apply the certification test, and in particular the “some basis in fact” evidentiary standard, in a much more robust and balanced manner between plaintiffs and defendants.

   The British Columbia Court of Appeal ushered in 2015 with a resounding bang for the defence bar. In January, the BCCA’s decision in Charlton v Abbott Laboratories Ltd, 2015 BCCA 26, reversed a motion court’s decision which had granted certification of a class action relating to Sibutramine, the active ingredient in a weight-loss drug (Meridia).

   The plaintiffs had brought a proposed class action on behalf of all persons who had used or purchased Sibutramine. The plaintiffs alleged that the ingestion of Sibutramine caused or contributed to an increased risk of adverse cardiovascular events, such as heart attacks and strokes, increased blood pressure and heart rate, and irregular heartbeat. The plaintiffs relied upon a study that showed that Sibutramine should not be used in patients with existing cardiovascular disease. However, the available statistical evidence suggested that there was no measurable increase in the risk of cardiovascular events for patients without a diagnosed history of cardiovascular disease, and the plaintiffs’ expert acknowledged that he was unable to quantify that risk.

   Further, the contraindications in the product monograph for Meridia made it clear to doctors that Meridia should not be prescribed to patients who had a history of cardiovascular disease. Consistent with that, the defendant adduced expert evidence from cardiologists who testified that they, and other cardiologists, well understood that Meridia ought not to be prescribed to patients with a history of coronary artery disease, and the product monograph specifically referred doctors to that fact and recommended regular monitoring of blood pressure and heart rate because cardiovascular disease is a known complication of elevated blood pressure.

   Despite that evidence, the motion judge had found that the plaintiffs had adduced sufficient evidence – ie, they had met the minimal and undefined “some basis in fact” evidentiary threshold – to establish a common issue of whether Sibutramine causes or contributes to heart attacks, strokes and arrhythmia.

   On appeal, the defendant argued that the certification judge had erred by failing to consider whether there was any evidence of an available methodology to effectively determine that common question that was certified. The Court of Appeal adopted the principle from some recent antitrust class action decisions that the plaintiff has an onus to provide some evidence of a workable methodology that will enable the plaintiff to prove causation on a class-wide basis, and thereby advance the litigation for the entire class. Given that the hallmark of a common issue is that success for one member of the class must mean success for all, the representative plaintiff must adduce some evidence to show how the answer to a question raised by a common issue for one plaintiff will be capable of extrapolation to each member of the class.

   In essence, each common issue certified required a finding that Sibutramine increases the risk of cardiovascular events for all class members – ie, including those who had no prior cardiovascular condition. The Court of Appeal looked at the evidence adduced by the plaintiffs on the certification motion, and observed that there was no evidence of a methodology for establishing that the class as a whole, as opposed to those members who had a pre-existing history of cardiovascular condition, were affected or put at risk by using of Sibutramine. The expert witnesses were uncertain about whether there even was a risk to the class members who did not have a pre-existing cardiovascular condition, and they could not describe a methodology for addressing that question. In other words, the plaintiff had failed to present any evidence to establish that this question of general causation for the class as a whole was capable of resolution. Accordingly, the Court of Appeal reversed the order of the motion judge and denied certification of the class.

   One month later, in February 2015, the Court of Queen’s Bench of Alberta dismissed a motion for certification of a proposed class action for damages allegedly resulting from a hip resurfacing system in Warner v Smith & Nephew Inc, 2015 ABQB 139. In Warner, the court found that the plaintiff failed to establish that a class action would be the preferable procedure for resolving the claims because of the absence of a common issue that could materially advance the class-wide claim, and also failed to establish the existence of an identifiable class of two or more persons.

   The plaintiff had been implanted with the Birmingham metal-on-metal hip resurfacing system in 2005. About three months after the procedure, the plaintiff noticed the system beginning to “pop and click”. A blood test showed elevated metal ion levels, and her doctor then began to monitor her blood. By 2012, the plaintiff was told by her doctor that the levels of cobalt ions in her system were considered toxic. In April 2012, the plaintiff had a revision surgery to remove the Birmingham hip system and replace it with a total hip implant system.

   The plaintiff commenced a class action on behalf of all persons in Canada who had been implanted with the defendant’s Birmingham metal-on-metal hip resurfacing system. The second element of the certification test in Canada is that the plaintiff must show that there is an identifiable class of two or more persons. Specifically, there must be evidence of at least one person other than the representative plaintiff who shares the same complaint and wants that complaint prosecuted in a class proceeding. In her supporting affidavit for certification, the plaintiff testified that she had been informed by someone in the law firm that was representing her that the law firm had been retained by nine other class members, and that these class members had experienced problems with the Birmingham hip system similar to those which the plaintiff had experienced. However, the plaintiff had not communicated with any of those individuals, and she did not know the identities of those individuals, the nature of their complaints or why they had retained counsel.

   The motion judge held that the undetailed hearsay information provided to the plaintiff by her law firm was insufficient and inadmissible evidence to meet this element of the certification test. There was no identification of any other individual member of the class nor any evidence that such person wished to pursue his or her claim in a class action. Similarly, the description that the other nine individuals had “similar problems” was considered so brief and generic as to defeat any attempt to evaluate whether there was some basis in fact of this allegation. In essence, it was double hearsay – information being passed from the anonymous nine people, through an unnamed person at the law firm, to the plaintiff. For this reason, the judge found that the plaintiff had failed to establish that there was an identifiable class of two or more persons.

   Beyond that, the judge held that the plaintiff also failed to demonstrate that a class action was the preferable procedure for this litigation because the plaintiff did not establish that the root common issue could materially advance the litigation on a class-wide basis. At the hearing, the plaintiff proposed that the common issue at the root of all claims was whether the Birmingham resurfacing system should have been made available for implantation in patients at all. Yet the plaintiff failed to adduce even minimal evidence to establish that this common issue had any realistic prospect of succeeding. Among other things, the Birmingham system is federally licensed and regulated, and had never been the subject of a recall in Canada. The judge noted that while not definitive, that fact makes it less likely that the system is so deficient that it should not be used for any application a surgeon might recommend. Further, the Birmingham resurfacing system had been the subject of an extensive, ongoing study by the Alberta Hip Improvement Project. The preliminary report of that Project indicated that current information supports the Birmingham system remaining available as recommended by surgeons, within existing practice guidelines. Moreover, evidence showed that many qualified surgeons continued to recommend and use the Birmingham system for patients considered appropriate; the revision rate experienced by patients with the Birmingham system was comparable with, and in some cases better than, that experienced by patients with total hip replacements; the metal-on-metal aspect of the Birmingham system was an improvement on the materials that were used for other resurfacing systems; and not even the plaintiff’s expert suggested that the Birmingham system was so deficient that it should be removed from the list of available products. Consequently, the court denied certification.

   Before the winter of 2015 had ended, a judge of the Ontario Superior Court of Justice added a third defence certification victory to the list in O’Brien v Bard Canada Inc, 2015 ONSC 2470, released in March 2015. There, the plaintiff had moved for certification of a class action on behalf of women who were implanted with 19 different pelvic mesh medical devices manufactured by the defendant, 10 of which were used to treat pelvic organ prolapse (POP) and the other nine of which were used for treating stress urinary incontinence (SUI).

   POP and SUI are medically distinct phenomena with a broad range of severity. The defendant began making and selling products to treat POP and SUI in 2002, and produced a variety of pelvic mesh products with different designs and intended surgical uses. The products are designed to provide different approaches to the treatment of POP and SUI respectively. While all the products used surgical mesh, there are distinct design features which differ among the 19 products.

   The plaintiff filed a report of a medical doctor as an expert witness. The plaintiff’s expert opined that there are very serious issues regarding the safety of pelvic mesh products, and that the warnings and information of the dangers of using the products that were provided to surgeons, patients and the general public were inadequate. The expert acknowledged that there are differences among the defendant’s 19 pelvic mesh products, but in his view the similarities made the pelvic mesh products collectively unfit for their intended purpose. In this regard, the plaintiff’s expert did not go so far as to say that surgical mesh products should never be used. Rather, he acknowledged that there is a role for device-assisted pelvic repair surgeries, but the plaintiff’s expert did not have the requisite expertise to opine on whether design changes could be made to pelvic mesh products to make them safer.

   The judge found that the plaintiff failed to establish the common issue element of the certification test. In brief, the judge found that the plaintiff failed to adduce evidence to show a singular or common design defect in the defendant’s 19 pelvic mesh products. The judge observed that the commonality of surgical mesh in the 19 products conveyed only a false impression of commonality among these 19 products because: the evidence showed that the 19 medical devices for the treatment of two very different medical ailments were different in materials, shape, size, weight, density, weave, porosity, flexibility, configuration, fixation methodology, design purposes and product warnings;patients diagnosed with these conditions will have idiosyncratic symptoms, side effects and responses to treatment; andthe choice of the type of surgical intervention will be guided by patient-specific factors, surgeon-specific factors, and factors related to the mechanical and functional design and intended use of the various products available for surgical intervention.

   Further, the judge found that the plaintiff had failed to show that any significant element of her claim is capable of proof on a class-wide basis. Citing the above-noted BCCA decision of Charlton v Abbott Laboratories Ltd, the judge noted that where a plaintiff seeks to address questions of general causation as the foundation of a class action, there must be some evidence of a methodology that will enable the plaintiff to prove causation on a class-wide basis. Where no such methodology is put forward by the plaintiff, there is not sufficient evidence before the court to show that the resolution of the proposed general causation common issue will efficiently advance the claim of the class as a whole. Here, the judge found that the plaintiff had failed to propose any methodology to show that a finding of causation of the multitude of injuries, conditions and complications from the use of the 19 different mesh products for POP and SUI surgery can be extrapolated across the class. Consequently, the judge held that the plaintiff had failed to meet the certification test, and he dismissed her motion.

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