High Court of Ireland Decisions

Neutral Citation No: [2005] IEHC 390

THE HIGH COURT

2002 No 9004P

BETWEEN

SARA HENDERSON

PLAINTIFF

AND AEI INC.

DEFENDANT

THE HIGH COURT

2002 No 11724P

BETWEEN

DEIRDRE HOUSE

PLAINTIFF

AND AEI INC. AND LIPOMATRIX INC.

DEFENDANTS

DECISION of the Master of the High Court 12^th May, 2005

Both these cases have been taken by consumer plaintiffs who have suffered personal injuries through the use of defective products manufactured by the defendant.

For the purposes of this decision regarding the plaintiffs' requests for discovery of documents these two cases can be dealt with together. The motions in the cases seek discovery in identical terms. Five categories of documents are sought as follows:

a) All documents relating to the state of the defendant's knowledge of the product up to an including 1995;

b) All documents relating to tests and research carried out into the safety of the product (i) before it was released into the market, (ii) up to and including 1995, and (iii) up to and including 1999;

c) All documents relating to the withdrawal of the product from the market in 1999 and 2000;

d) All documents relating to information or warnings as to possible defects or inadequacies or dangers in the product between (i) 1990 and 1995 and (ii) 1995 and 1999;

e) All correspondence relating to the product between the defendant or any of its subsidiaries or associated companies and the Medical Devices Agency in the United Kingdom between 1995 and 2001.

In Henderson's case the date 1999 in categories (b) and (d) is replaced by the date 2000.

In November, 1995 Sara Henderson underwent cosmetic surgery involving the insertion of Trilucent breast implants. Alerted to the risk of injury by a hazard notice issued by the Medical Devices Agency in June, 2000, the plaintiff arranged for the surgical removal of the implants but it was found that the Trilucent implants had already ruptured causing serious complications and distress, and necessitating two further operations.

Plaintiff Deirdre House records a similar history. She had Trilucent implants inserted in September, 1995 and removed in September, 1999 after the official withdrawal of these implants from sale and distribution in the UK earlier that year. Her post operative recovery was less traumatic but as with Sara Henderson, it was found that one of the implants had already ruptured leaking a hazardous filler material (a "dieldeyde compound understood to be genotoxic and carcinogenic" Statement of Claim par 10).

Both plaintiffs seek damages "for breach of statutory duty, negligence and breach of duty by the defendant(s) in and about the production, marketing and distribution of the Trilucent breast implants". The duty owed under Statute is alleged to be a "strict duty to ensure the safety of their product within the terms of the Liability for Defective Products Act, 1992". The plaintiffs plead a breach of (non Statutory) duty as an alternative basis of claim, alleging breach of that (Common Law) duty as well.

From what is pleaded and what I have been shown, the plaintiffs would seem to have little difficulty in showing that the implants were defective and dangerous to the health of the consumers or users thereof. This, in spite of the fact that the defendants have denied any breach of duty.

First things first. The Liability for Defective Products Act, 1991 does not create any new duty of care. It does exactly what it says on the tin: it fixes liability for defective products on the producer. Section 2 provides that:

"The producer shall be liable in damages in tort for damage caused wholly or partly by a defect in his product."

This provision creates a liability "in tort" in respect of damage or injury caused to, inter alia, the ultimate consumer (who, of course, enjoys no privity of contract with the producer) and the liability is in no way contingent upon proof of any want of care. It is a strict liability. There is no standard of care. There is no need to prove carelessness. Actually, Section 6 confirms this by providing that:

"The onus shall be upon the injured person concerned to prove the damage, the defect and the causal relationship between the defect and the damage."

A plaintiff can of course apply for discovery of documents if he feels he needs them to assist in the proof of any of the foregoing material facts. In this case none of the categories sought is on the basis of such a perceived need. The reasons for discovery as set out in the letter seeking voluntary discovery (14/10/04) are as follows:

"To enable the plaintiff to establish:

(a) What the Defendant knew about the benefits and risks associated with its Trilucent implant product prior to the date when the plaintiff had the product inserted in her breasts;

(b) Whether the plaintiff adequately tested or monitored the product to ensure its safety, (i) prior to placing it in the market, (ii) prior to the date when the plaintiff had the product inserted in her breasts, and (iii) prior to the date when the product was surgically removed from the plaintiff's breasts;

(c) Why and in what circumstances the product was eventually withdrawn from the market, and the extent of the defendant's involvement in this decision;

(d) The extent to which the defendant knew, or ought to have known, of the medical risks posed by the Trilucent implant product, (i) prior to the date when the plaintiff had the product inserted in her breasts and (ii) prior to the date when the plaintiff had the product surgically removed form her breasts;

(e) The extent to which the defendant cooperated with the Medical Devices Agency in the United Kingdom, and whether the Medical Devices Agency communicated to the defendant its concerns over the safety of the Trilucent breast implant."

The plaintiff has no need to concern herself with proof of the matters she lists in the foregoing. They are facts, but they are not material. She does not need to prove them to succeed under the Act.

Faced with this proposition is was submitted to me that the discovery might be needed if the defendant sought to avoid liability on the basis of Section 6(c) which provides that:

"A producer shall not be liable under this Act if he proves….that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered."

The Act certainly provides that this defence may be available to the producer, but in this case no such defence has been pleaded. The producer saw fit to plead volenti/contributory negligence (!) but has not pleaded any section 6 defence. Consequently, no issue arises which might justify discovery as sought.

Unable to sustain their applications by reference to and in the context of the claim under the Liability for Defective Products Act, the plaintiffs submit that the discovery application may have more fertile ground in the alternative claim for damages for breach of the Common Law duty of care. In the absence of the Act, of course, a consumer would have a much more uphill struggle to prove carelessness. The state of knowledge of the defendant producer might well be a pivotal material fact in that context.

But, given the current state of law, the alternative common law claim will never fall to be determined at the hearing. And for this very simple reason: if the plaintiff proves the necessary elements of her claim under the Statute (defect, damage, causal link) she will have succeeded. If any one of these elements is not proven, she will not succeed either in her Statutory claim or in her claim in Common Law. If she loses her action for damages under the Act the particular gap in her evidence which afflicts that claim will also, in simple logic, afflict and totally undermine her claim for damages for negligence. Without proof of each of these three material facts the plaintiff cannot succeed in her Common Law claim either! Strict liability is not a liability in negligence, it is a strict liability. Whether the strict liability claim is upheld or dismissed, the Court will never embark on an examination of the evidence of the other facts which are material in the Common Law claim. It would be a pointless exercise.

Consequently, and again in strict logic, discovery is not necessary. In effect, the plaintiff's alternative claim is surplus and of no practical benefit to her. If she cannot succeed under the Act she cannot succeed in Common Law. It's as simple as that.

Approved: Edmund Honohan