MEDICAL PRODUCT LIABILITY CLAIMS

The law regarding medical product liability claims involving pharmaceutical drugs and bio-medical devices sold in the UK is to be found both in national and European Community legislation and in case law otherwise known as common law. It is no longer necessary to show that a manufacturer has been negligent, merely that a consumer, who need not be the person who bought the item, has been injured by normal usage. Almost without exception, manufacturers are covered by insurance however for the larger multinational corporations, especially those based overseas, it may mean that they effectively self insure for more substantial or multiple claims especially involving group action which can, in certain circumstances, make companies bankrupt or cause them to file for bankruptcy protection thereby precluding payment of some successful claims made against them.

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Four Main Categories

Medical product liability claims generally fall into the following categories as follows :-

1. Defective Design
   In the case of pharmaceutical drugs this refers to the chemical composition where very slight changes in structure can have far reaching effects however these issues are usually resolved at the drug trials stage where pharmaceuticals go through rigorous testing. In the case of bio-medical devices it refers to inherent danger in the design of the item.

2. Defective Manufacture
   Even the safest articles can be subject to failure of quality control during the manufacturing process resulting in dangerous goods being put on the market either intermittently or in batches.

3. Defective Warnings
   Drugs in particular need detailed and lengthy testing to establish interactions with other medications that the consumer may be taking. Failure to establish these contra indications or failure to adequately warn of dangers already established can make drug products extremely dangerous. Bio-medical devices can suffer failures in certain unusual circumstances of which the consumer should be given adequate advance warning.

4. Negligent Surveillance
   This is a very dangerous area for the manufacturers of both pharmaceuticals and bio-medical devices and adequate warning must be given about defects discovered after manufacture and sale especially if the product is withdrawn. The UK government has a sophisticate system for warning of these dangers however there are occasionally problems when individual GP’s fail to heed warnings or fail to adequately check their patent lists and give appropriate warnings.

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Sub Standard

Medical product liability claims will arise when the safety is not of the standard that consumers are entitled to expect. Poor quality of manufacture or the fact that a better item comes along does not necessarily make a product defective. Courts decide this point after considering overall marketing, instructions on use and warnings of danger together with the date of sale and the purpose for which the item was sold and may have reasonably been expected to be used.

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Specialist Solicitors

Medical product liability claims is a niche area of the law which requires more than just general claims experience. Whilst our lawyers are all members of the Solicitors Regulation Authority panel of personal injury experts and are also recognised by the Association of Personal Injury Lawyers, they are also qualified by virtue of the experience they bring with them having handled complex, high value and high profile cases including some of the most infamous multi-party actions against some of the worlds largest multinational corporations both here and abroad. If you would like free advice from experts just complete the contact form or use the helpline and a solicitor will give you free advice with no further obligation.