Gabriele Shaw (suing as the personal representative of the estate of William Ewan (Deceased)) v Medtronic Corevalve LLC (a company incorporated in the USA) and Others

JurisdictionEngland & Wales
JudgeMr. Justice Lavender
Judgment Date20 January 2017
Neutral Citation[2017] EWHC 54 (QB)
Date20 January 2017
CourtQueen's Bench Division
Docket NumberCase No: HQ15C05279

[2017] EWHC 54 (QB)



Royal Courts of Justice

Strand, London, WC2A 2LL


Mr. Justice Lavender

Case No: HQ15C05279

Gabriele Shaw (suing as the personal representative of the estate of William Ewan (deceased))
(1) Medtronic Corevalve LLC (a company incorporated in the USA)
(2) Jean Claude Laborde
(3) Medtronic Inc (a company incorporated in the USA)
(4) Medtronic Limited
(5) Medtronic Plc

David Berkley QC (instructed by Pearson Solicitors and Financial Advisers LLP) for the Claimant

Toby Riley-Smith QC (instructed by CMS Cameron McKenna LLP) for the First, Third and Fourth Defendants

Hearing date: 12 January 2017

Mr. Justice Lavender

(1) Introduction


This action arises out of the death of William Ewan on 26 September 2007, following an operation at Glenfield Hospital in Leicester when a heart valve ("the Valve") was implanted. The Valve was manufactured by the First Defendant, Medtronic Corevalve LLC (then known as Corevalve Inc). The Claimant, Mrs. Gabriele Shaw, is the late Mr. Ewan's daughter.


There are three applications before me:

(1) The First Defendant applies for an order setting aside the service on it of the Claim Form out of the jurisdiction.

(2) The Third Defendant, Medtronic Inc, (which has since April 2009 been the parent company of the First Defendant) makes a similar application.

(3) The Fourth Defendant, Medtronic Limited, (which is part of the same group of companies as the Third Defendant) applies for either an order striking out the Particulars of Claim (under CPR 3.4) or summary judgment against the Claimant (under CPR 24.2)).

(2) The Inquest


This is the second action brought by the Claimant in connection with her father's death. Moreover, it follows an inquest which was held over 13 days in 2011, when the Claimant and other family members were represented by leading counsel. The inquest jury answered a series of questions. By their verdict, they decided, in particular, that the Valve which was implanted in the operation was of what had been referred to as the small, rather than the large, type of valve manufactured by the First Defendant.


The Claimant applied for judicial review of the jury's decision, including their decision that the Valve was of the small type. Her application was heard in February 2013 by Burnett J and HHJ Peter Thornton QC, the Chief Coroner. They decided to dismiss her application. The reference to their judgment is [2013] EWHC 386 (Admin). It runs to 32 pages.


The Claimant then applied for permission to appeal to the Court of Appeal. The application was refused by Sir Richard Buxton, but two aspects of it were subsequently referred to the full court. The Court heard her application on 11 February 2014. The reference to their judgment is [2014] EWCA Civ 294.

(3) The First Action


On 23 September 2010 the Claimant commenced an action against the late Mr. Ewan's cardiologist, Dr. Kovac, and the University Hospitals of Leicester NHS Trust. I will refer to this as the First Action. As with the present action, the First Action was brought by the Claimant as personal representative of her late father's estate, pursuant to the Fatal Accidents Act 1976 and the Law Reform (Miscellaneous Provisions) Act 1934 ("the 1934 Act").


The Defendants to the First Action submitted to judgment, which was entered on 2 July 2015. On 28 October 2015 HHJ Platts assessed the amount of damages. The reference to his judgment is [2015] EWHC 3335 (QB). In paragraph 6, he said as follows:

"Although the defendants have never made any admission of liability and, indeed, Mr Spilsbury expressly indicated during the trial that there was no such admission, there is no issue that the factual basis for the judgment to which both defendants have submitted, and which they have chosen not to challenge, was that set out in paragraphs 9 to 15 of the Re-amended Particulars of Claim. In short, the claimant's complaints are, first of all, that her father never gave proper or informed consent to the TAVI procedure. In particular it is alleged that he was never informed that the procedure was newly developed and still the subject of clinical trials; that the prosthetic valve used in the procedure was not approved for public use, nor fully or adequately evaluated in terms of its safety and performance; or of the alternatives of either open-heart surgery or conservative treatment. Secondly, there is an allegation that the defendants failed to care for him properly once it was realised that there was damage to the aorta."


HHJ Platts assessed damages for pain, suffering and loss of amenity, loss of life, cost of treatment and funeral costs. These damages have been paid. HHJ Platts also recorded that claims for damages in respect of the costs of the inquest, the application for judicial review and the application to the Court of Appeal were abandoned.

(4) The Present Action


The present action was commenced by a Claim Form issued on 21 December 2015. That is over 8 years after Mr. Ewan's death. In those circumstances, these Defendants say that they have a good limitation defence. However, they do not rely on that as a ground for the present applications.


The brief details of claim set out in the Claim Form (as subsequently amended) state as follows:

"The claim is for damages arising from the death of the Claimant's father, Mr William Ewan ("the Deceased") who died on 26 September 2007 upon implantation and use upon him of the Defendant(s)' medical devices and as a result of the conduct and/or omissions of the Defendant(s), their servants or agents including during the course of the advice to and treatment of the Deceased at Glenfield Hospital in 2007 until his death. The Claimant claims damages for:

— for personal injury and loss on behalf of the Estate of the Deceased pursuant to the Law Reform (Miscellaneous Provisions) Act 1934 and/or pursuant to the Fatal Accidents Act 1976 as amended and/or pursuant to the Consumer Protection Act 1987 and/or the Product Liability Directive and/or

— negligence and/or in restitution (unjust enrichment and/or wrongful act)

— misrepresentation and/or deceit

— aggravated/exemplary damages

— and the Claimant seeks an account of profits

and interest thereon pursuant to Section 35A of the Senior Courts Act 1981."


As set out in the Particulars of Claim, the Claimant's case is that, contrary to the jury's verdict, the Valve implanted in the operation was of the "large" type. The Claimant makes a number of allegations as to the manner in which valves of both the small and the large type were developed and tested by "Corevalve" (which it was accepted means the First Defendant).


As for causes of action, it was common ground that:

(1) There is no claim under the Fatal Accidents Act 1976, because the late Mr. Ewan had no dependants.

(2) The causes of action pursued by the Claimant pursuant to the 1934 Act arise:

(a) in negligence (as set out in paragraph 43 of the Particulars of Claim); and

(b) under the Consumer Protection Act 1987 (as set out in paragraph 42 of the Particulars of Claim); and

(c) (according to the Claimant) unjust enrichment; but

(d) not in misrepresentation or deceit: although these are referred to in the Claim Form, Mr. Berkley acknowledged that the Particulars of Claim does not plead a case in misrepresentation or deceit.


As for the remedies sought, the prayer for relief includes claims for:

(1) Damages, including aggravated and/or exemplary damages.

(2) An account of profits.

(3) Damages in restitution.


A Preliminary Schedule of Loss and Damages dated 15 April 2016 identifies 3 heads of loss, against each of which appears, not a figure, but the letters "tba". The heads of loss are:

(1) General Damages.

(2) Restitutionary Damages.

(3) Aggravated and/or Exemplary Damages.


The Claim Form was served on the Fourth Defendant within the jurisdiction. It was served on the First and Third Defendants in Minnesota, pursuant to permission granted by Master McCloud on 2 June 2016 at an ex parte hearing. As to that application:

(1) Contrary to CPR 6.37(1)(a), the Claimant's application notice did not set out which ground in paragraph 3.1 of Practice Direction 6B was relied on.

(2) The Claimant's counsel's skeleton argument mentioned ground (9), which concerns claims in tort, but made no mention of ground (16), which is the ground applicable to claims for restitution. Nor did it mention the Claimant's alleged cause of action in unjust enrichment.

(3) The skeleton argument asserted that the Third Defendant (and others) were the successors in title of CoreValve.

(4) The skeleton argument did mention (as does the Particulars of Claim) that the Claimant had successfully brought the First Action, but did not mention the potential defence to which this gave rise, and to which I will refer.

(5) The Fourth Defendant


It is common ground that the Fourth Defendant had no involvement with this matter until April 2009, about 18 months after Mr. Ewan's death. The Claimant's pleaded case against the Fourth Defendant is set out in paragraph 4 of the Particulars of Claim, which provides as follows:

"The First, Third, Fourth and Fifth Defendants are collectively referred to as " Medtronic"; the Fifth Defendant being the parent company located in Ireland. In 2009 Medtronic acquired...

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