An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of September. The selections feature topics ranging from changes in misuse and abuse of prescription opioids following implementation of REMS programs, to the determinants of market exclusivity for prescription drugs, to the fate of FDA post-approval studies. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in misuse and abuse of prescription opioids following implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017;26(9):1061-1070.
  2. Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, integrity, and the FDA: An ethical framework. Science. 2017;357(6354):876-877.
  3. Kashoki M, Lee C, Stein P. FDA Oversight of Postmarketing Studies. N Engl J Med. 2017;377(12):1201-1202.
  4. Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Sep 11. [Epub ahead of print]
  5. Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017;358:j3837.
  6. Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017;377(12):1114-1117.
  7. Zeitoun JD, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study. Int J Cancer. 2017 Sep 20. [Epub ahead of print]