SlideShare una empresa de Scribd logo
1 de 10
Contract and Consumer law
   Thalidomide first appeared in Germany in October
    1957

   The drug was introduced to the UK
    in 1958 under its brand name
    Distaval.

   The drug was mainly given to pregnant women for
    morning sickness.

   On 27 November 1961 Thalidomide was withdrawn in
    the UK from the British manufacture Distillers
    Biochemical LTD.
   The first British thalidomide victim was born
    in January 1959.

   There are currently 455 thalidomide survivors
    in the UK.

   In 1976 it was revealed that Distillers had not
    met the basic testing requirements of the
    time.
   The victim's disabilities range from
    missing limbs and internal
    deformities.

   it is estimated around 40% of thalidomide
    victims died before their first birthday.

   The Thalidomide Trust was established in
    August 1973, to provide support
   Sue for tort of negligence – civil law

   High court – Queen’s Bench

   First case Donoghue v Stevenson 1932

   Must prove duty of care and breach of duty i.e.
    fault

   The Congenital Disabilities (Civil Liability) Act
    1976 – duty of care owed to unborn child
   Breach of duty hard to prove – what would other
    manufacturers have done? Had they taken all
    reasonable care?

   Daniels v White & Son – 14 year old girl sniffing
    bottles of lemonade – breach of duty not proved

   Difficult /impossible to prove breach – Distillers
    would claim they tested product as any other
    manufacturer would have done – drug was
    licensed

   Any compensation – out of court settlement
   Now strict tortious liability under Consumer
    Protection Act 1984 part 1

   No need to prove fault

   But state of art defence would allow manufacturer to
    escape liability

   State of scientific and technical knowledge –
    manufacturer would only have to carry out tests
    known at the time and those that other
    manufacturers would carry out

   Claim would still fail
   The parents of British Thalidomiders were forced to
    fight a protracted court battle for compensation.

   In 1968 a deal was negotiated with Distillers which
    gave 62 victims compensation in an out of court
    settlement (40% of what they might have won if court
    case had been successful)

   After 1968 many out of court settlements followed

   "Y-list“ - 98 children who were suspected of suffering
    deformities due to the drug, but who could not prove
    it and so were unable to claim compensation.
   In 1972, The Sunday Times published the first in a series of
    articles under the headline “Our Thalidomide Children: a Cause
    for National Shame”

   An injunction was issued to stop the campaign

   The Sunday Times then decided to fight the injunction on its
    investigation into the origins and testing of the drug.

 The case went right through the British legal system and up to
  the European Court of Human Rights, which decided that the
  injunction violated the right of “freedom of expression”.
http://www.hrcr.org/safrica/limitations/sunday_times_uk.html
   1973 after 11 year campaign Distillers agreed to pay
    £20 million and to set up a trust fund for victims

   In 2005 Distillers, now part of Diageo, agreed an
    extra one-off payment worth 70% of the annual
    payments

   In 2010 Government issues long-awaited apology
    and a new £20m compensation package to 466
    thalidomiders

   Currently in the UK victims receive, on average
    £18,000 a year

Más contenido relacionado

La actualidad más candente

Clinical Trials Introduction
Clinical Trials IntroductionClinical Trials Introduction
Clinical Trials Introduction
biinoida
 

La actualidad más candente (20)

History and progress of pharmacovigilance
History and progress of pharmacovigilanceHistory and progress of pharmacovigilance
History and progress of pharmacovigilance
 
ICH-GCP Guidelines
ICH-GCP GuidelinesICH-GCP Guidelines
ICH-GCP Guidelines
 
Investigator's brochure
Investigator's brochureInvestigator's brochure
Investigator's brochure
 
Pharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detectionPharmacovigilance signal and signal detection
Pharmacovigilance signal and signal detection
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
Clinical Trials Introduction
Clinical Trials IntroductionClinical Trials Introduction
Clinical Trials Introduction
 
1.2 Importance of safety monitoring of Medicine.pptx
1.2 Importance of safety monitoring of Medicine.pptx1.2 Importance of safety monitoring of Medicine.pptx
1.2 Importance of safety monitoring of Medicine.pptx
 
ICH GCP
ICH GCPICH GCP
ICH GCP
 
Vaccine safety surveillance
Vaccine safety surveillanceVaccine safety surveillance
Vaccine safety surveillance
 
Turacoz - Clinical Study Report
Turacoz - Clinical Study ReportTuracoz - Clinical Study Report
Turacoz - Clinical Study Report
 
Investigator brochure
Investigator brochureInvestigator brochure
Investigator brochure
 
Pharmacovigilance program of India (PvPI)
Pharmacovigilance program of India (PvPI)Pharmacovigilance program of India (PvPI)
Pharmacovigilance program of India (PvPI)
 
CIOMS (1).pptx
CIOMS (1).pptxCIOMS (1).pptx
CIOMS (1).pptx
 
Schedule Y
Schedule YSchedule Y
Schedule Y
 
Periodic Safety Update Report (PSUR)
Periodic Safety Update Report (PSUR)Periodic Safety Update Report (PSUR)
Periodic Safety Update Report (PSUR)
 
INVESTIGATOR’S BROCHURE (IB)
 INVESTIGATOR’S BROCHURE (IB) INVESTIGATOR’S BROCHURE (IB)
INVESTIGATOR’S BROCHURE (IB)
 
Pharmacovigilance Basics
Pharmacovigilance BasicsPharmacovigilance Basics
Pharmacovigilance Basics
 
Clinical research protocol
Clinical research protocolClinical research protocol
Clinical research protocol
 
Pharmacovigilance
PharmacovigilancePharmacovigilance
Pharmacovigilance
 

Destacado

Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
Govt Medical College & Hospital, Sector-32
 
Chiral Separation A pharma Industry Perspective
Chiral Separation A pharma Industry PerspectiveChiral Separation A pharma Industry Perspective
Chiral Separation A pharma Industry Perspective
Bhaswat Chakraborty
 
Propuesta rise thalidomide.ppt felix valles
Propuesta rise thalidomide.ppt felix vallesPropuesta rise thalidomide.ppt felix valles
Propuesta rise thalidomide.ppt felix valles
yanielisrodriguez
 
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
Chitta Chowdhury
 

Destacado (20)

Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
Thalidomide & its derivatives by Dr. Harmanjit Singh, Department of Pharmacol...
 
thalidomide
thalidomidethalidomide
thalidomide
 
Chiral Separation A pharma Industry Perspective
Chiral Separation A pharma Industry PerspectiveChiral Separation A pharma Industry Perspective
Chiral Separation A pharma Industry Perspective
 
Pharmacovigilance ppt
Pharmacovigilance pptPharmacovigilance ppt
Pharmacovigilance ppt
 
Who art & med dra
Who art & med draWho art & med dra
Who art & med dra
 
Propuesta rise thalidomide.ppt felix valles
Propuesta rise thalidomide.ppt felix vallesPropuesta rise thalidomide.ppt felix valles
Propuesta rise thalidomide.ppt felix valles
 
Devitalisation of Thalidomide
Devitalisation of ThalidomideDevitalisation of Thalidomide
Devitalisation of Thalidomide
 
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
Spatial distributiion mapping of drinking water fluoride levels in Karnataka....
 
Thalidomide The Irish Experience Presentation2
Thalidomide The Irish Experience Presentation2Thalidomide The Irish Experience Presentation2
Thalidomide The Irish Experience Presentation2
 
Pharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMSPharmacovigilance at Trauma Center, AIIMS
Pharmacovigilance at Trauma Center, AIIMS
 
Geriatr007
Geriatr007Geriatr007
Geriatr007
 
يصثيصيص ي
يصثيصيص ييصثيصيص ي
يصثيصيص ي
 
Assignment on isomerism
Assignment on isomerismAssignment on isomerism
Assignment on isomerism
 
Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014Ethics of scientific research rc d ec 2014
Ethics of scientific research rc d ec 2014
 
Shraddha pre on 3 r new presen 123
Shraddha pre on 3 r new presen 123Shraddha pre on 3 r new presen 123
Shraddha pre on 3 r new presen 123
 
How to present a poster (1)
How to present a poster (1)How to present a poster (1)
How to present a poster (1)
 
Pharmacotherapy considerations in elderly adults
Pharmacotherapy considerations in elderly adultsPharmacotherapy considerations in elderly adults
Pharmacotherapy considerations in elderly adults
 
Role of Enantiomers in Pharmacology
Role of Enantiomers in PharmacologyRole of Enantiomers in Pharmacology
Role of Enantiomers in Pharmacology
 
Receptor down regulation
Receptor down regulationReceptor down regulation
Receptor down regulation
 
Receptor regulation and diseases
Receptor regulation and diseasesReceptor regulation and diseases
Receptor regulation and diseases
 

Similar a Thalidomide

Reputation Management
Reputation ManagementReputation Management
Reputation Management
m_gill
 
Legal and Ethical Constraints in the Creative Media Sector
Legal and Ethical Constraints in the Creative Media SectorLegal and Ethical Constraints in the Creative Media Sector
Legal and Ethical Constraints in the Creative Media Sector
emilyaldredd
 
Cameron Diver Summary of International Arbitration Experience
Cameron Diver Summary of International Arbitration ExperienceCameron Diver Summary of International Arbitration Experience
Cameron Diver Summary of International Arbitration Experience
Cameron Diver
 
Concerns over national security and the environment led congress to .docx
Concerns over national security and the environment led congress to .docxConcerns over national security and the environment led congress to .docx
Concerns over national security and the environment led congress to .docx
ladonnacamplin
 
Federal hazardous substances act
Federal hazardous substances actFederal hazardous substances act
Federal hazardous substances act
Saurabh Mishra
 
Multiple-Choice 2 points each.Pick the best answer; put answers .docx
Multiple-Choice 2 points each.Pick the best answer; put answers .docxMultiple-Choice 2 points each.Pick the best answer; put answers .docx
Multiple-Choice 2 points each.Pick the best answer; put answers .docx
adelaidefarmer322
 

Similar a Thalidomide (20)

Breast Implants
Breast ImplantsBreast Implants
Breast Implants
 
Reputation Management
Reputation ManagementReputation Management
Reputation Management
 
1 gmp essentials
1 gmp essentials1 gmp essentials
1 gmp essentials
 
Tobacco Tort Litigation
Tobacco Tort LitigationTobacco Tort Litigation
Tobacco Tort Litigation
 
Global Harmonization Issues and the Protection of Intellectual Property
Global Harmonization Issues and the Protection of Intellectual PropertyGlobal Harmonization Issues and the Protection of Intellectual Property
Global Harmonization Issues and the Protection of Intellectual Property
 
NEGLIGENCE17[2].ppt
NEGLIGENCE17[2].pptNEGLIGENCE17[2].ppt
NEGLIGENCE17[2].ppt
 
Legal and Ethical Constraints in the Creative Media Sector
Legal and Ethical Constraints in the Creative Media SectorLegal and Ethical Constraints in the Creative Media Sector
Legal and Ethical Constraints in the Creative Media Sector
 
History & Evolution of GMP Regulations
History & Evolution of GMP RegulationsHistory & Evolution of GMP Regulations
History & Evolution of GMP Regulations
 
Tobacco conspiracy
Tobacco conspiracyTobacco conspiracy
Tobacco conspiracy
 
SOC 204 Goldberg ch 4 f2f Fall15
SOC 204 Goldberg ch 4 f2f Fall15SOC 204 Goldberg ch 4 f2f Fall15
SOC 204 Goldberg ch 4 f2f Fall15
 
Cameron Diver Summary of International Arbitration Experience
Cameron Diver Summary of International Arbitration ExperienceCameron Diver Summary of International Arbitration Experience
Cameron Diver Summary of International Arbitration Experience
 
Introduction to the regulatory affairs
Introduction to the regulatory affairsIntroduction to the regulatory affairs
Introduction to the regulatory affairs
 
8.advert.2020.online
8.advert.2020.online8.advert.2020.online
8.advert.2020.online
 
Concerns over national security and the environment led congress to .docx
Concerns over national security and the environment led congress to .docxConcerns over national security and the environment led congress to .docx
Concerns over national security and the environment led congress to .docx
 
James M. Cooper and Bashar H. Malkawi, The need to relax intellectual propert...
James M. Cooper and Bashar H. Malkawi, The need to relax intellectual propert...James M. Cooper and Bashar H. Malkawi, The need to relax intellectual propert...
James M. Cooper and Bashar H. Malkawi, The need to relax intellectual propert...
 
GSIPA2M, Parallel session 2, Making compulsory licenses routine - James Love
GSIPA2M, Parallel session 2, Making compulsory licenses routine - James LoveGSIPA2M, Parallel session 2, Making compulsory licenses routine - James Love
GSIPA2M, Parallel session 2, Making compulsory licenses routine - James Love
 
Federal hazardous substances act
Federal hazardous substances actFederal hazardous substances act
Federal hazardous substances act
 
Multiple-Choice 2 points each.Pick the best answer; put answers .docx
Multiple-Choice 2 points each.Pick the best answer; put answers .docxMultiple-Choice 2 points each.Pick the best answer; put answers .docx
Multiple-Choice 2 points each.Pick the best answer; put answers .docx
 
Liability round up - january 2010
Liability round up - january 2010Liability round up - january 2010
Liability round up - january 2010
 
Soc 204 Goldberg Chapter 4 Drugs & The Law
Soc 204 Goldberg Chapter 4 Drugs & The LawSoc 204 Goldberg Chapter 4 Drugs & The Law
Soc 204 Goldberg Chapter 4 Drugs & The Law
 

Thalidomide

  • 2. Thalidomide first appeared in Germany in October 1957  The drug was introduced to the UK in 1958 under its brand name Distaval.  The drug was mainly given to pregnant women for morning sickness.  On 27 November 1961 Thalidomide was withdrawn in the UK from the British manufacture Distillers Biochemical LTD.
  • 3. The first British thalidomide victim was born in January 1959.  There are currently 455 thalidomide survivors in the UK.  In 1976 it was revealed that Distillers had not met the basic testing requirements of the time.
  • 4. The victim's disabilities range from missing limbs and internal deformities.  it is estimated around 40% of thalidomide victims died before their first birthday.  The Thalidomide Trust was established in August 1973, to provide support
  • 5. Sue for tort of negligence – civil law  High court – Queen’s Bench  First case Donoghue v Stevenson 1932  Must prove duty of care and breach of duty i.e. fault  The Congenital Disabilities (Civil Liability) Act 1976 – duty of care owed to unborn child
  • 6. Breach of duty hard to prove – what would other manufacturers have done? Had they taken all reasonable care?  Daniels v White & Son – 14 year old girl sniffing bottles of lemonade – breach of duty not proved  Difficult /impossible to prove breach – Distillers would claim they tested product as any other manufacturer would have done – drug was licensed  Any compensation – out of court settlement
  • 7. Now strict tortious liability under Consumer Protection Act 1984 part 1  No need to prove fault  But state of art defence would allow manufacturer to escape liability  State of scientific and technical knowledge – manufacturer would only have to carry out tests known at the time and those that other manufacturers would carry out  Claim would still fail
  • 8. The parents of British Thalidomiders were forced to fight a protracted court battle for compensation.  In 1968 a deal was negotiated with Distillers which gave 62 victims compensation in an out of court settlement (40% of what they might have won if court case had been successful)  After 1968 many out of court settlements followed  "Y-list“ - 98 children who were suspected of suffering deformities due to the drug, but who could not prove it and so were unable to claim compensation.
  • 9. In 1972, The Sunday Times published the first in a series of articles under the headline “Our Thalidomide Children: a Cause for National Shame”  An injunction was issued to stop the campaign  The Sunday Times then decided to fight the injunction on its investigation into the origins and testing of the drug.  The case went right through the British legal system and up to the European Court of Human Rights, which decided that the injunction violated the right of “freedom of expression”. http://www.hrcr.org/safrica/limitations/sunday_times_uk.html
  • 10. 1973 after 11 year campaign Distillers agreed to pay £20 million and to set up a trust fund for victims  In 2005 Distillers, now part of Diageo, agreed an extra one-off payment worth 70% of the annual payments  In 2010 Government issues long-awaited apology and a new £20m compensation package to 466 thalidomiders  Currently in the UK victims receive, on average £18,000 a year