Maidstone and Tunbridge Wells NHS Trust Cleared of Manslaughter

A major NHS manslaughter case has collapsed after a judge ruled that there was no legitimate case to answer.

Maidstone and Tunbridge Wells NHS trust had been accused of corporate manslaughter in connection with the death of schoolteacher Frances Cappuccini.

This had been the first prosecution of a health body since the new law was introduced in 2008.

Errol Cornish, 68, a locum consultant anaesthetist, was accused of gross negligence manslaughter.

Cappuccini was anaesthetised following a Caesarian section at Tunbridge Wells hospital at Pembury in Kent, but unfortunately never awoke from the procedure.

Another doctor, Dr Nadeem Azeez, had managed to avoid prosecution by returning to his native Pakistan.

Azeez and Cornish failed in the “elementary task of protecting Cappuccini’s airway” contributing to her passing away, according to evidence that was presented to the court.

Yet the trial judge, Mr Justice Coulson, instructed the jury at Inner London crown court to acquit both defendants.

Although the judge acknowledged that “there is no question that Frances Cappuccini should not have died at the trust hospital on 9th October,” legal technicalities seem to have blighted the case.

Flaws in the prosecution case, including evidence that indicated that some of the actions of the defendant had been “about as far from a gross negligence manslaughter case as it is possible to be” caused the case to collapse.

A spokeswoman for the CPS acknowledged that the correct verdict have been arrived at.

“We appreciate that Mrs Cappuccini’s family will be understandably upset by this outcome, but we respect the decision made by the judge that there was insufficient evidence to continue with the trial.”

The defendant was naturally relieved by the verdict of the court, and took time to commend the family of the deceased for their conduct.

“I would like to pay tribute to the family of Mrs Cappuccini for the restraint and dignity they have displayed throughout this trial.”

The NHS trust was also adamant that the trial should never have taken place, also taking time to sympathise with the feelings of the family of the deceased.

“The allegation of corporate manslaughter has been consistently denied by the trust and now also comprehensively rejected by the court. The trust regrets that the Crown Prosecution Service saw fit to pursue the charge in the first place, given the additional stress this will have caused all involved.”

The NHS statement continued:

“Patient safety remains of paramount importance and it has been shown during the trial that a number of compassionate and highly skilled clinical teams were involved in caring for Frances. The trust has, however, recognised from the start that there were aspects of Frances’s care that fell short of the standards that the trust would expect and they have already apologised to the family for this.”

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European Court of Justice Makes Key Pharma Ruling

A European Court ruling is expected to have a significant influence over the pharmaceutical industry.

The decision of the of Court of Justice of the European Union in favour of Seattle Genetics will be welcomed by pharmaceutical companies all over the world.

Seattle Genetics went before the European court regarding the duration of supplementary patent protection afforded to the pharmaceutical industry.

EU legislation provides the possibility of a supplementary protection certificate to compensate a patent holder.

This is necessary due to the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation.

However, it is currently European law that no medicinal product may be commercially exploited before the relevant authority has issued marketing authorisation.

Prior to the Seattle Genetics case, there was confusion regarding the duration and calculation of a supplementary protection certificate.

EU legislation suggests that the certificate should be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”.

But confusion reigned regarding what constitutes the date of the first authorisation.

The ruling thus addresses this issue and creates a president in European law.

The Court of Justice ruled that “Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.”

Although this may seem an extremely technical and obscure issue, the ruling is nonetheless expected to have a significant influence over the pharmaceutical industry in the foreseeable future.

The court decision puts an end to any uncertainty faced by both innovative and generic pharmaceutical industry companies regarding the duration of effective patient protection, which will have potentially significant effect on the industry.

This is due to the fact that the marketing of medicinal products will often reach its peak towards the end of the patent term.

When one considers the vast number of pharmaceutical products that this ultimately relates to to, the potential delays involved are certainly not insignificant.

Additionally, following the Court of Justice’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation.

This will enable patent holders to be certain of a uniform duration throughout the EU.

Commenting on the court ruling, Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, was naturally pleased with the decision:

“The CJ’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJ on this matter.”

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