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Internal Continuous Evaluation

Law of Torts,
Case Study
Semester I (2018– 2023 Batch)
(July to December (2017-2018)



2001 EWHC QB 446

Name of the Student: Puneet Mathur

Class: 1st semester BBA LLB
Division: B
Registration Number: 18B093
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A and ORS.



2001 EWHC QB 446





Royal Courts Of Justice

Strand, London,WC2A 2LL

26TH March 2001


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In this case various claimants claimed damages after they were infected with Hepatitis C
from blood and blood products through blood transfusions from the Timeframe of March
1988. All of the claims in this case were filled under the Consumer Protection Act1 which
implements the European Product Liability Directive .2

The claimants in this case submitted that national blood authority the defendants were
strictly liable under article 6 of the directive because they were the ones who had taken up
responsibility for the administration of blood transfusions. The claimants contended that by
abiding the article 6, the blood was defective and the defendants had no basis to claim the
development risk within article 7(e) of the Directive. Both the parties agreed that Hepatitis C
virus had not been discovered or identified when the date of claims were commenced and
no screening test was available to discover such type of virus in donor’s blood. The
defendant submitted that while such types of risk were known to medical profession, the
general public could not be entitled to receive 100% clean blood3.


This trial has been limited to consideration of the case brought by those Claimants infected
with Hepatitis C from blood and blood products who are making claims under the
Consumer Protection Act 1987 . The 114 Claimants received blood transfusions or blood
products usually in the course of undergoing surgery, whether consequent upon having
suffered an accident or otherwise, or immediately after childbirth or in the course of
treatment for a blood disorder. The earliest date of infection in respect of which claimants

Consumer Protection Act 1987 (CPA)
European Product Liability Directive (Council Directive 85/374).
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can make such claims is 1 March 1988, being the date when the CPA was brought into


The National Health Service bodies responsible for the production and supply of blood and
blood products prior to 1 April 1993 in England (and also covering northern Wales) were
fourteen regional blood transfusion centres ('RTCs'), controlled and administered by
Regional Health Authorities. From that date, by the National Blood Authority
(Establishment and Constitution) Order 1993 (SI 1993 No. 583), the National Blood
Authority ('NBA') was established, with responsibility for the RTCs and both central blood
laboratories (the Central Blood Laboratory Authority ('CBLA'), which itself had
responsibility for the Blood Products (later Bio Products) Laboratory ('BPL') and the Blood
Groups Research Laboratory ('BGRL')). Subsequently the National Blood Authority
(Establishment and Constitution) Amendment Order 1994 provided that all rights
enforceable by or against a Regional Health Authority in respect of the exercise of functions
which became exercisable by the NBA were to be exercisable against the NBA


The group action effectively commenced with a generic Order for Directions on 1 May 1998
made by Master Eyre, who was assigned Master, which set out the basic rules for the
conduct of the Hepatitis Litigation, gave leave to issue an omnibus writ and provided for the
maintenance of a Hepatitis Register. The omnibus writ was issued on 1 May 1998. Justice
burton was appointed as assigned Judge in February 1999. Each Claimant has been entitled
to have his or her own solicitor, but the generic aspects of the action have been handled and
the individual cases co-ordinated, on the Claimants' behalf by Messrs Deas Mallen,
instructing Michael Brooke QC, Stuart Brown QC, Ian Forrester QC and Jalil Asif. The
Defendants' solicitors have been Messrs Davies Arnold Cooper, instructing Nicholas
Underhill QC, Philip Brook Smith and Louise Merrett. By the third Generic Order of 26

National Blood Authority (Establishment and Constitution) Amendment Order 1994 (SI 1994 No. 589)
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February 1999 justice Burton ordered that the generic trial of issues to be agreed and/or
determined take place in October 2000. The generic issues effectively amounted to whether
the Defendants are liable to the Claimants under the CPA, i.e., whether the Claimants as a
whole can prove that (assuming injury, causation and loss can be proved in respect of each
Claimant) the Defendants are liable under Section 3 (Article 6) and not exonerated within
Section 4(1)(e) (Article 7(e)). All the Claimants have, by an unopposed order in May 1998,
been entitled to remain anonymous and the six lead Claimants have been known by the
codes of Mr S, Miss T, Mr U, Ms V, Mr W and Mrs X


The claims the subject matter of this trial are not in negligence, but are put against the
defendants by way of 'strict' or 'objective' liability by virtue of the CPA, which implemented
in the United Kingdom the European Union (then the EEC) Product Liability Directive of
1985:Council Directive (EEC) 85/374

Strict liability differs from ordinary negligence because strict liability establishes liability
without fault. In other words, when a defendant is held strictly liable for harm caused to the
plaintiff, he is held liable simply because the injury happened. The fact that the harm that the
plaintiff suffered is not the defendant’s fault makes no difference.

Strict liability for negligence typically involves cases where the plaintiff was injured either by
the defendant’s animal or by an abnormally dangerous activity that the defendant had
undertaken. The elements required to establish a case for strict liability are similar to those
for negligence, except that there is no requirement of fault. Therefore, there is no
requirement that a duty to the plaintiff is breached.

The Directive is not, in any event in this action, said to be directly enforceable against the
Defendants by the Claimants, who rely for their cause of action on the CPA. However, as
below appear, the European Commission complained, by application lodged at the
European Court on 20 September 1995, that the United Kingdom Government had not
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fulfilled its obligations under the Directive and under the EC Treaty by implementing the
CPA in the terms it had. Although the European Court dismissed that application, it is
apparent from the judgment of the European Court, reported as European Commission v
United Kingdom ('Commission v UK') 5 , that, there not at that stage having been any
decisions of the English courts,nor indeed any facts before the European Court, the
European Court was concluding that, whatever be the precise terms of the CPA, the United
Kingdom would so implement and construe the CPA as to be consistent with the Directive -
not least by virtue of Section 1(1) of the CPA, which reads as follows:

"[Part I] shall have effect for the purpose of making such provision as is necessary in order
to comply with the Product Liability Directive and shall be construed accordingly."

As will be seen, the arguments were directed mainly to the true and proper construction of
Article 6 of the Directive (the equivalent being Section 3 of the CPA) and Article 7(e) (the
equivalent being Section 4(1)(e)) and consequently it is with those Articles and not the
relevant Sections, with which this judgment will be primarily, if not exclusively, concerned. It
is conceded for the purpose of these proceedings that the blood or blood products by which
the Claimants were infected are products within the meaning of the CPA and the Directive
and that the Defendants' production of blood was, for the purpose of the Directive, an
industrial process.


Consumer Protection Act 1987

Product Liability Directive 85/374/EEC6

European Commission v United Kingdom ('Commission v UK') [1997] AER (EC) 481
Product Liability Directive 85/374/EEC

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Abouzaid v Mothercare (UK) Ltd7

Commission v UK8

German Bottle Case9

Richardson v LRC Products Ltd10

Smedleys Limited v Breed HL11

Morris v West Hartlepool Steam Navigation HL 12

Worsley v Tambrands13

Richardson v LRC Products Ltd14

Graham Barclay Oysters Pty Ltd. v Ryan15


(1)Whether the blood was defective within Article 6 of the Directive

(2)Whether the public's legitimate expectation of the product was that it would not be
Abouzaid v Mothercare (UK) Ltd [2002] CA Transcript 2279

Commission v UK, Case C-300/95 [1997] All ER (EC) 481, [1997] ECR I-2649, ECJ

German Bottle Case, The (9 May 1995) NJW 1995, 2162, Bundesgerichtshof

Richardson v LRC Products Ltd [2000] Lloyd's Rep Med 280

Smedleys Limited v Breed HL ([1974] AC 839)

Morris v West Hartlepool Steam Navigation HL ([1956] AC 552)

Worsley v Tambrands [2000] PIQR 95\
Richardson v LRC Products Ltd [2000] PIQR 164
Graham Barclay Oysters Pty Ltd. v Ryan (2000) 177 ALR 18, Aust FC.
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(3)The true construction of the term 'all considerations' in Article 6 of the Directive

(4)Whether the alleged defect in the blood product was a manufacturing or design defect

(5)Whether the Directive's Article 7(e) defence could be used by the defendant Blood

(6)The quantum of damages in respect of infection


(1)Whether the blood was defective within article 6 of the Directive

The Court expressed that, in the appraisal of a case under article 6 of the Directive, the
underlying advance was to recognize any hurtful qualities which caused the damage. Thus, to
build up that a deformity existed in an item, the subsequent stage is finish up whether the
item was "standard" or "non-standard". Burton J. stated that this could be done by
comparing the product with other products of the same type or series, produced by that
producer. Where an item varied from the arrangement so that included unsafe qualities, at
that point it was held that it was non-standard for the motivations behind Article 6 of the

Further, the essential issue for non-standard items was whether the general population
everywhere acknowledged its non-standard nature. In this way, the Court held that an item
was probably going to be risky if any mistake in outline or defective framework existed. The
unsafe trademark must be recognized, in spite of the fact that the essential inquiry for the
Court would be the item's security for its predictable utilize. Since the Court found that
testing of the blood ought to have been set up by March 1988, and along these lines
screening ought to have been presented by 1 March 1990, it held that blood tainted after
March 1988 did not give the wellbeing that people were by and large qualified for anticipate.
The court was fulfilled that the blood provided to the Claimants was blemished inside

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Article 6 of the Directive. The item's imperfection was the infection in the blood and the
harm was the infection in the patient.

(2)Whether the public's legitimate expectation of the product was that it would not be

It was stated that the producer was under an obligation to meet the level of safety that the
public at large was entitled to expect, as determined by the Court, and not the safety actually
expected. The genuine desire for general society everywhere was not that tests had been
completed, or safety measures embraced. Unexpectedly, the Court found that general
society's solitary real desire was the wellbeing of the item. In this manner, the litigant Blood
Authority couldn't contend that the buyer had a genuine desire that the blood being
provided was 100% clean, nor would it be able to be presented that he had information that
it was, or liable to be, tainted by Hepatitis C. As a result of such a finding, the blood couldn't
be viewed as an item that conveyed an innate hazard by its exceptionally nature, to which
purchasers had uncovered themselves. The Court thus held that the legitimate expectation of
the public at large was the safety of the blood.

(3)The true construction of the term "all considerations" in Article 6 of the Directive

It was held that the term "all considerations" in Article 6 of the Directive meant "all relevant
circumstances". It was accepted by both parties that the Directive's aim was to eliminate
proof of fault or negligence in order to make life easier for Claimants to prove their case.
Thus, a consumer would neither have to prove the producer failed to take reasonable steps
to comply with his duty of care, or the producer failed to take all legitimately expectable
steps. Furthermore, it was stated that avoidability, impracticality, benefit to society, utility of
the product, cost and difficulty in taking precautionary measures were not relevant
considerations to be taken into account under Article 6 of the Directive. This was on the
grounds that such contemplations did not line up with the reason for the Directive; on the
off chance that they were so then they would have been incorporated into disparagement
from it. Thus any issues of fault, negligence or conduct of the producer were for
consideration under the limited Article 7(e) development risk defence of the Directive.

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(4)Whether the alleged defect in the blood product was a manufacturing or design defect

The infected blood products were deemed non-standard products, the Court stating that the
primary issue for such a product was to whether the public at large accepted its non-standard
nature. It was found however to be immaterial as to whether such products would have been
categorised as manufacturing or design defects, as they were in any event, different from the
norm which the producer intended for public use. Moreover, it was stated that even in the
case of standard products like drugs, some side effects were capable of being "socially
acceptable" where they were made known to the customer.

(5)Whether the Directive's Article 7(e) defence could be used by the Defendant

Section 47 onwards of the court's judgment points of interest the arrangement and
contentions of the two gatherings under article 7(e) of the Directive. It expresses that gave a
deformity was known, or ought to have been known, in the light of "non-Manchurianly
open data", at that point the maker kept on delivering and supply at its own hazard. Burton J
expressed that it would be conflicting with the motivation behind the Directive if, on
account of a known hazard, the maker kept on providing items essentially on the grounds
that he was not able recognize in which of his items that deformity would happen, or where
he was obliged to supply, kept on providing without tolerating the obligation regarding any
wounds coming about. In any case, he attested that the motivation behind Article 7(e) was
not to demoralize advancement and prohibit improvement chances, that being the
motivation behind why a maker was shielded from the obscure. Consequently in actuality,
non-standard items were not prohibited from falling inside Article 7(e) since they could
qualify where the issue was not known.

The Court expressed that once an issue was anyway known, a non-standard item couldn't be
ensured by Article 7(e). It was held that the Claimants were qualified for recoup harms since
the items were damaged, and Article 7(e) of the Directive couldn't be utilized as a resistance
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as it was known to the litigant Blood Authority that the presence of a deformity was
conventional, there being a known danger of the infection emerging in any item. The
National Blood Authority had kept on providing such items, and that must be at its very
own hazard, as people in general were qualified for expect that the blood items transfused to
them would be free from contamination.

(6)The quantum of damages in respect of the infection

In the evaluation of harms in regard of the disease, the Court expressed that it was important
to recognize the condition, finish up whether there had in truth been a freedom of the
infection, and if so at what organize, and to choose, in like manner, regardless of whether
such appraisal ought to be based on temporary harms. After this underlying phase of
evaluation, the court expressed that it would then be important to survey the forecast,
treatability and treatment indications recognized and persevering. The quantum reason for
the contamination was held to bar a particular liver malady related side effects, or identifiable
mental turmoil, however would incorporate weakness. Where the petitioners could build up
torment, or some partiality emerging out of their condition, it could frame some portion of
their harms


Liability under the Act for a defective product was established where the defect was known,
despite the fact that the present condition of information did not make it conceivable to
recognize which of the items was influenced. The Act was to be understood to be
predictable with the Directive. In the event that the level of security was underneath the level
customers could legitimately expect, the item was flawed, and the provider obligated, despite
the fact that there may be nothing which should be possible. The buyer's genuine desire was
for wellbeing. The expectation of the Directive was to dispense with the requirement for a
complainant to need to demonstrate blame


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This is the seminal case on the CPA and the Directive and the judgment gives a thorough
analysis of the central provisions. It confirms that blood and blood products fall within the
definition of "product" and the distinction between standard and non-standard products is
significant and likely to be followed . This is an important decision for a number of reasons.
It has for some time been imagined that the Product Liability Directive was actualized in the
United Kingdom through the Consumer Protection Act in a way that favored makers by
receiving models that were more similar to carelessness, especially when it went to the idea
of imperfection and the advancement dangers guard. The Consumer Protection Act has
dependably been viewed as more positive to makers than the mandate itself. On the off
chance that Burton's methodology of going directly to the order (and viably disregarding the
terms of the Consumer Protection Act) is received all the more generally, defendants will be
deprived of the more favourable wording of the Consumer Protection Act.

Burton took a particularly strict approach to determining whether a product contained a

defect, excluding considerations that would appear to have been contemplated by the
directive as well as the Consumer Protection Act. For example, he ruled out questions of the
benefit that the product provided to society as a whole and what the medical profession
knew at the time of its risks. The exclusion of the knowledge of a 'learned intermediary' is
perhaps one of the most controversial aspects of his decision. This is likely to have far-
reaching consequences for manufacturers of pharmaceutical products that are known within
the medical profession to have certain side effects but that the consumer nonetheless
expects will be safe. In the words of one of the lawyers acting for the National Blood

"One wonders whether it is really in the public's interest for a manufacturer of a life-saving drug with known
side effects to have to wait for a retrospective subjective assessment of a court of whether the product is as safe
as can be legitimately expected."

Burton's judgment has been hailed as a landmark decision for consumer rights. What is clear
is that any suggestion that there should be a 'negligence-style' interpretation of the directive
has been rejected.

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A v The National Blood Authority16 is the principal choice of an English judge to survey
exhaustively the arrangements of the UK enactment offering impact to the Product Liability
Directive, the Consumer Protection Act 1987. Burton held that 114 individuals tainted with
hepatitis C following blood transfusions were qualified for remuneration from the National
Blood Authority assessed to be in overabundance of £6 million.

In a lengthy judgment, Burton ruled that in determining whether the product was defective,
the crucial question was the level of safety that persons generally are entitled to expect.
Significantly, he held that the question of whether a harmful characteristic of the product
was avoidable was irrelevant, and that it was therefore wrong to consider what tests a
producer could or should have used to minimize or reduce the risk.

The judge also ruled that the National Blood Authority could not rely on the development
risks defence (Article 7(e) of the directive). Once the possibility of contamination was or
ought to have been known to the producer, the producer supplied the product at its own
risk. This was the situation paying little respect to whether it would have been feasible for
the maker to recognize in which (assuming any) of a progression of blood items
contamination would actually occur.

A v The National Blood Authority [2001] ALL ER (D) 298
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