Defective Medical Products. What happens when the defective product is a medical device or pharmaceutical product?

Recent defective medical product controversies regarding the DePuy hip replacement recall in 2010 and the French PIP silicone breast implants in 2011 along with increased instances of medical product recall has brought to the fore the interaction between Product Liability and Medical Negligence litigation*.A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).  Examples of medical devices commonly inserted include hip and knee prosthesis; metal plates or screws inserted to repair fractures; pacemakers; coronary stents; sutures; staples and breast implants.  A medical device may also include a device not surgically inserted such as a contact lens or a hearing aid.  Difficulties may also arise with a medical device which is used to carry out a medical procedure such as the instruments used in an angiogram.Medicinal products (or Pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, or thermal means.  The safety of both medical devices and pharmaceuticals is largely governed by the Liability for Defective Products Act 1991.  This legislation aims to safeguard consumers from products that do not reach a reasonable level of safety and cause foreseeable injury or damage through for example a manufacturing error, design defect or inadequate information on the appropriate use of a product.  The main effect of this legislation is to introduce into Irish law the principle of “strict” liability on the producer, and in certain circumstances, the supplier of a defective product.  Strict liability is the imposition of liability without fault, for damages, on the manufacturer or supplier.   This is different from medical negligence cases (not involving defective products).   There may also be a medical negligence aspect to litigation involving surgically inserted medical devices or pharmaceutical products if it can be established that the medical practitioner breached the duty of care i.e. the care afforded to the patient was not of the requisite standard and that “but for” the medical negligence/breach of duty of the treating medical practitioner the outcome would have been far different.  Breach of duty may relate to the surgical insertion of the device, the follow up care or indeed the selection of a particular medical device or pharmaceutical product itself over other similar products.Apart from there being a liability on the part of the manufacturer and/or supplier of the product, there may also be a liability for a Medical Practitioner / Hospital or the HSE if they supply defective medical products which are not of “merchantable quality” or “fit for their purpose” under the Sale of Goods and Supply of Services Act 1980.Defective Product litigation throws up a number of practical legal issues: Identifying the correct Defendant(s) for the purposes of legal proceedings.  There are often a number of parties involved in the process: (i)   The original manufacturer, (ii)  The European supplier and/or distributor, (iii) The medical facility that purchases and recommends the product to their patients, and (iv)  The physician who inserts the product. The manufacturers of medical products are often based outside the jurisdiction and even outside of the E.U.  If such is the case the permission of the Court must be obtained to issue legal proceedings against Defendants that are based outside of the E.U. Injuries Board – A defective product action involving personal injury must in the first instance be assessed by the Injuries Board.  However, if there is also a medical negligence aspect to the case the Injuries Board may not assess the claim and instead an Authorisation should be sought from the Injuries Board to proceed with the case through the appropriate Court. Statute of Limitations – The law in relation to time limits when a personal injury is involved is generally two years from the date of wrongdoing i.e. insertion of the defective device.  In some situations the time can be extended for those who did not have knowledge of the wrongdoing (or alternatively that the person did not have knowledge that the wrongdoing caused the injury). One should always move expeditiously with defective product/medical negligence cases and should contact a Solicitor as soon as possible for advise on the specific time limits applicable to their case.If you are a patient who has been affected by a medical device or pharmaceutical recall, or if you have concerns about a medical device surgically inserted, contact us at Cantillons Solicitors at +353 (0)21 -4275673 or info@cantillons.com if you would like more information.* In contentious business, a solicitor may not calculate fees or other charges as a percentage of any award or settlement.  Share on Social