“The Second Defendant was the proctor on behalf of CoreValve who was the lead operator responsible for the procedure under which the Deceased received the Valve.”
“The Second Defendant is an interventional cardiologist who, at all material times, was based in Toulouse, France and worked as Director of the Clinique Pasteur and who had assisted Jacques Seguin and thereafter CoreValve in the development of the Valve and acted as proctor on behalf of CoreValve.”
“The Second Defendant is sued as agent for CoreValve and Medtronic.”
“CoreValve failed to comply with the Directive and the Regulations and announced in May 2007, within weeks of regulatory approval for the 5 years clinical investigation, that its devices had been CE Marked and which they intended to be relied on and put into circulation devices which they, together with the Second Defendant, knew were unsafe and untested and which thereafter caused the death of the Deceased.”
“43. Further or in the alternative, CoreValve was [“negligent” is deleted] knowingly dishonest in:- (1) representing and supplying the valve as CE Marked when the same was dangerous per se, and its safety and performance not having been established, and/or likely to cause injury; (2) failing to disclose to the deceased the known dangers of injury to him from the insertion of the valve; (3) failing to warn the Deceased of the risks associated with the insertion of the Valve; (4) failing to warn the Deceased that the valve was in its experimental stage in being used upon him.” “45. In the event, on27 April 2007 a Declaration of Conformity for the 2 valves was signed notwithstanding that CoreValve knew one of which was not ever approved for clinical investigation and that the clinical investigation of its devices was in its infancy and proceeded to launch the devices on the market.” (1) representing and supplying the valve as CE Marked when the same was dangerous per se, and its safety and performance not having been established, and/or likely to cause injury; (2) failing to disclose to the deceased the known dangers of injury to him from the insertion of the valve; (3) failing to warn the Deceased of the risks associated with the insertion of the Valve; (4) failing to warn the Deceased that the valve was in its experimental stage in being used upon him.”
“Responsibility for the acceptance of a patient lay also with CoreValve and the Second Defendant: the documents evidence that they had all patient imaging and medical records, including for the Deceased sent to them for approval of rejection.”
“In the premises, the Claimant contends that the Defendants carried out an experimental procedure upon the Deceased which they knew was neither suitable nor necessary for him.”
“Further, the operating and experimentation upon the Deceased with experimental devices for a condition which he did not have by the Second Defendant without his consent constituted a battery for which the Deceased is entitled to damages.”
“53. By putting into circulation as CE Marked its experimental devices including the larger and untested valve and by supplying the same for use upon the public and causing or permitting the same to be implanted into the Deceased CoreValve, the Second Defendant and now Medtronic have sought to gain substantial gains such as to unjustly enrich themselves.” “56. CoreValve is now a subsidiary of Medtronic. The Claimant contends that Medtronic, and the Second Defendant upon the acquisition of CoreValve by Medtronic, have unjustly been enriched from the knowing, dishonest and cynical use of the Deceased for the purposes of developing the valve and equipment for commercial exploitation for which the Claimant seeks an account of profits made.”
“In this section a new claim means any claim involving either: (a) the addition or substitution of a new cause of action.”
“For the purposes of this Act any new claim made in the course of any action shall be deemed to be a separate action and to have been commenced: (a) in the case of a new claim made in or by way of Third party proceedings on the date on which those proceedings were commenced; and (b) in the case of any other new claim on the same date as the original action.” (a) in the case of a new claim made in or by way of Third party proceedings on the date on which those proceedings were commenced; and (b) in the case of any other new claim on the same date as the original action.”
“(3) Except as provided by section 33 of this Act or by Rules of Court neither the High Court nor any County Court shall allow a new claim within sub-section 1(b) above other than original set-off or counterclaim to be made in the course of any action after the expiry of any time limit under this Act which would affect a new action to enforce that claim. (4) Rules of court may provide for allowing a new claim to which sub-section (3) above applies to be made as they are mentioned, but only if the condition specified in sub-section (5) below are satisfied and subject to any further restrictions the rules may impose. (5) The conditions referred to in sub-section 4 are the following: (a) in the case of a claim involving a new cause of action if the new cause of action arises out of the same facts or substantially the same facts as are already in issue on any claim previously made in the original action.”
“(3) The purpose of the requirement at stage 3 is to avoid placing the Defendant in a position where he will be obliged, after the expiration of the limitation period, to investigate facts and obtain evidence of matters completely outside the ambit of and unrelated to the facts which he could reasonably be assumed to investigate for the purpose of defending the un-amended claim. (4) It is thus necessary to consider the extent to which the Defendants will be required to embark upon an investigation of facts which they would no previously have been concerned to investigate (Ballinger, paragraph 38). At stage three the court is concerned at a much less abstract level than at stage 2. It is a matter of considering the whole range of facts which are likely to be adduced at trial (Finlan at paragraphs 56 and 57 citing Smith v Henniker-Major at paragraph 96.”
“This section applies to proceedings which include a claim for damages; (a) for personal injuries; (b) under theFatal Accidents Act 1976 ; or (c) which arises out of death or personal injury and survives for the benefit of an estate by virtue of section 1.1 of theLaw Reform (Miscellaneous Provisions) Act 1934 .” (a) for personal injuries; (b) under theFatal Accidents Act 1976 ; or (c) which arises out of death or personal injury and survives for the benefit of an estate by virtue of section 1.1 of theLaw Reform (Miscellaneous Provisions) Act 1934 .”
“Subject to rules 44.15 and 44.16 orders for costs made against the claimant may be enforced without the permission of the court, but only to the extent that the aggregate amount in money terms of such orders does not exceed the aggregate amount in money terms of any orders for damages and interest made in favour of the claimant.”
“Orders for costs made against the claimant may be enforced to the full extent of such orders without the permission of the court where the proceedings have been struck out on the grounds that: (a) the claimant has disclosed no reasonable grounds for bringing the proceedings; …”
“Orders for costs made against the claimant may be enforced up to the full extent of such orders with the permission of the court and to the extent that it considers just where: … (b) a claim is made for the benefit of the claimant other than a claim to which this section applies.” … (b) a claim is made for the benefit of the claimant other than a claim to which this section applies.”