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Letter to the Irish Medicines Board seeking MHRA report on PIP Breast Implant contents

The following is a letter sent today from our office to the Irish Medicines Board today seeking a copy of a report drafted by Covance Laboratories of Harrogate, North Yorkshire analysing the composition of faulty PIP breast implants.

This link leads to the Daily Star article referred to in this letter.

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Our Ref: EMcG Your Ref;   21st May 2012

 

The Chief Executive

Irish Medicines Board

Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.
Fax: 676 7836

 

Re: PIP Breast Implants

Dear Sir,

We write this as an open letter to you and will put it on our website.

We are instructed by a number of women that have been fitted with defective breast implants manufactured by Poly Implant Prothèses (PIP) and in connection with their claims for personal injuries arising therefrom.

We understand that Covance Laboratories of Harrogate, North Yorkshire have completed a report into the constituent parts of the PIP breast implants. This is recorded in a newspaper report of the UK “Daily Star” of 13th May 2012. The report quotes a spokesman for the UK Medicines and Healthcare Products Regulatory Agency as saying that the report is published on the website of the Agency.

We have been unable to locate the report on that website and would be obliged if you would use your good offices with the Medicines and Healthcare Products Regulatory Agency to get a copy for us. Publishing it on your website or providing a web link would be very acceptable.

We await hearing from you in due course.

 

Yours faithfully,

___________________

McGarr Solicitors

Newspaper Licensing Ireland Ltd asks Women’s Aid for money to link to newspaper websites

The following letter was sent on behalf of Women’s Aid to Newspaper Licensing Ireland Limited today. Our office is grateful to Fergal Crehan BL for his pro bono assistance in drafting counsel’s opinion.

Women’s Aid have agreed to allow us to publish their response in the hope that it may prove helpful to other non-profit bodies who may receive similar requests.

We have not charged any fee but if you feel like it, you can donate to Woman’s Aid to assist them in providing services to women who have suffered domestic violence

*****

Newspaper Licencing Ireland Limited

Clyde Lodge

15 Clyde Road

Dublin 4

;

Re: Women’s Aid

Dear Sirs,

We write further to the email of Ms. [redacted] of your office of the 2nd April and subsequent emails and letter of the 3rd April 2012.

We act for Women’s Aid in this matter. Women’s Aid is a registered charity, being a non-profit organisation dedicated to working against violence against women. Our client received, on or about the 27th day of March, 2012, correspondence from Newspaper Licensing Ireland Limited, proposing that our client sign and return a licence agreement giving our client “permission to scan clippings for 16 national titles and 90 regional newspapers plus some foreign newspapers”

The letter continued by warning our client that should they fail to comply in circumstances where a licence was required;

“You will be breaking the law; you risk exposing your company to expensive litigation. Reproducing copyright content without permission is theft”

We understand that Newspaper Licensing Ireland Limited (“NLI”) is a not-for-profit, limited liability company established in 2002 to collect licence fees for the use of copyrighted newspaper material in Ireland. NLI states that it has been mandated by a number of national and regional newspaper titles to collect licence fees on their behalf.

Our client is a stranger to any such mandate, or any relationship between NLI and any news publication or other copyright owner. In the circumstances, we write seeking some further clarification on a number of matters.

Our client has confirmed that it does not scan or clip newspaper articles. However, as is common with organizations of this type, our client will often link, via its own website, to online publications which have given coverage to it or its campaigns. Such use of media coverage is a vital component of our client’s advocacy mission.

Upon entering into correspondence with NLI, and after it had sought to clarify the status of such links, our client was told that

“a licence is required to link directly to an online article even without uploading any of the content directly onto your own website”.

We would be grateful if you would specify the statutory basis of this claim by return of post.

We note that you have supplied a schedule of rates, depending on the number of stories accessible online from a licencee’s website. Under the heading Website Republishing you list the following

Bundle / Annual Fee

1-5 / €300

6-10 / €500

11-15 / €700

16-25 / €950

26-50 / €1,250

50+ / Negotiable

Can you please confirm by return of post that this is the payment schedule for the licence you have claimed is required to “link directly to an online article even without uploading any of the content directly onto your own website”?

As you are doubtless aware, Section 39 of the Copyright and Related Rights Act 2000 provides for a “Reproduction Right”:

—(1) References in this Part to copying shall be construed as including references to all or any of the following, namely:

(a) in relation to any work—

(i) storing the work in any medium,

(ii) the making of copies which are transient or incidental to some other use of the work;

(b) in relation to an artistic work, the making of a copy in three dimensions of a two dimensional work and the making of a copy in two dimensions of a three dimensional work;

(c) in relation to a film, television broadcast or cable programme,

making a photograph of the whole or a substantial part of any image forming part of the film, broadcast or programme;

(d) in relation to a typographical arrangement of a published edition, making a reprographic copy of the arrangement.

(2) There shall be a right of the owner of copyright to copy a work or to authorise others to do so which shall be known and in this Part referred to as the ‘‘reproduction right’’”

As is made clear in subsection (d), the scanning or transcribing and reposting of an article is encompassed within this right. However, nothing in this provision grants any right to a copyright owner in respect of linking to an article appearing on the copyright owner’s own website.

Furthermore, it should be noted that our client has been granted access to the articles linked to from its own site on the basis of the Terms and Conditions of the respective publications. Each of these publications has its own specific terms and conditions of use. However, as a number of the publications are part of the INM Group, they share a standard set of Terms and Conditions. These state:

“You are granted a limited licence solely for your own personal, non-commercial use to refer to, bookmark or point to any page within this website”

Linking is clearly intended by reference to “pointing” to web pages. This conclusion is strengthened by the text which follows, detailing the uses of material which are not permitted under the licence:

“Any other use of the Materials on this website, including any form of copying or reproduction (for any purposes other than those noted above) modification, distribution, re-publication, extraction, re-utilisation, incorporation or integration with other materials or works or re-delivery using framing technology”

Another publication, The Offaly Express, states the following in its Terms and Conditions (these are in fact the Terms common to publications of the Johnston Press, a UK-based newspaper group):

 

“1. Ownership. Except in the case of the Forums and any other content you create, the copyright in the Website and its contents belongs to the Publisher, or has been included with the consent of other copyright owners. Reproduction in any form, printing or downloading of part or all of the contents is forbidden save in accordance with the licence granted below.

2. Licence to copy for personal use: You may print copies of any item in hard copy provided that you do not edit alter amend or delete any part of it or combine it with other material. You may recopy the material to individual third parties for their personal information only if you acknowledge the Website as the source of the information by including such acknowledgement and the address of the Publisher and the Website in the copy of the material AND you inform the third party that the material may not be copied or reproduced in any way. You may not supply the material to any third party for commercial gain.

3. Web Aggregation: If you are a paid for web aggregator you require a licence to redistribute the content of this site. Licences can be obtained through the Newspaper Licensing Agency (http://www.nla.co.uk).

4. No Transmission. No part of the Website or the contents thereof may be reproduced on or transmitted to or stored in any other web site or other form of electronic retrieval system.”

The specific reference to paid-for web aggregators appears to exclude the requirement of a licence to link to stories on the part of persons or organisations such as our client.

The Irish Examiner states in its Terms & Conditions:

 

“you are granted a limited non-exclusive and personal licence strictly for your own non-commercial and private use to bookmark, refer to or point to any page within the Site, and to download the Content (with the exception of music) to a single personal computer and to print a single copy of the content.”

No right, title or interest in any downloaded materials or software is transferred to you as a result of, any such downloading or copying and Examiner Publications (Cork) Ltd reserves all rights in respect of the Content for itself, its subsidiaries, affiliates and advertisers. You must not alter or delete any copyright, trademark or other proprietary notices in or on any of the Content. You must not reproduce, publish, transmit, distribute, display or otherwise provide access to (including framing or linking to any Content or the Site), modify, create derivative works from, sell or participate in any sale of, or exploit in any way, in whole or in part, any of the Content, the Site, or any related software for any commercial purpose whatsoever. If you wish to use any of the Content for any commercial purpose (including any framing or linking to any Content on the Site) you must obtain the express prior written permission of the Irish Examiner or obtain an appropriate licence from Newspaper Licensing Ireland Limited (www.newspaperlicensing.ie ).”

Regardless of whether or not linking of any kind is protected by copyright, linking for non-commercial purposes is specifically permitted by the Terms & Conditions of all the newspapers in question.

Our client is a non-commercial entity and any and all links to online coverage which it may post on its own website are for the promotion of its non-commercial purposes.

In addition to the explicit licences contained within the Terms of Use of these publication’s websites, there is also the question of the implicit licence they have granted through the use of social sharing buttons and services.

In Ryanair Ltd v Billigfluege.de GMBH [2010] IEHC, Mr. Justice Hanna determined that certain clauses were binding on users of a website where they were “contained in the Terms of Use on the plaintiff’s website, highlighted by way of a hyperlink. In such circumstances, the Terms of Use on Ryanairs’s website were “fairly brought to the attention of the other party”. It seems that the Terms of Use were clearly accessible by way of a hyperlink which was at all times clearly visible to users of the plaintiff’s site. The Terms were not hidden in an awkward part of the screen or in any way concealed or difficult to find.”

Where the publications linked to from our client’s website have Terms of Use, they tend to be displayed via a hyperlink in small type at the bottom of each page. In a number of publications, this hyperlink is far less prominent than the social media and sharing buttons which increasingly are to be found in online publications.

By way of example, Independent News and Media plc publications generally display, under each story, a number of icons, clicking on which allows the story to be linked to on social media. Stories in The Irish Independent can be shared via almost 100 different internet platforms. The Irish Times offers over 300 ways to link to articles. In each case, the “sharing” takes the form of a hyperlink, often including the headline of the article, and a short abstract. This abstract generally runs considerably longer than the 11 words the subject of the European Court of Justice’s decision in Infopaq International A/S v Danske Dagblades Forening (Case C-5/08).

Given the prominence of these sharing and social media buttons on the websites of publications, they can be taken to form part of (if not to entirely supersede) the Terms of Use of the websites and their content. It should be noted that these social media buttons allow sharing not only via personal social media sites such as Facebook and Twitter, but also via website design platforms such as WordPress. In all cases, these platforms can be, and increasingly are used for commercial as well as personal purposes.

We note that in your email of the 2nd April at 10:02 am, Ms. [redacted] of your office states

“Everything as it appears in a newspaper (both hard copy and online) is the copyright of the publisher not the author.”

We would again be grateful for your assistance in this matter, as our client is a stranger to the specific contractual agreements between the author of any specific article and the publisher of same. It is therefore impossible for our client to know which articles may have been written by an employee of a newspaper and which by a freelancer.

We are mindful in raising this question of Section 23 of The Copyright and Related Rights Act, 2000, which provides

“23.—(1) The author of a work shall be the first owner of the copyright unless—

(a) the work is made by an employee in the course of employment, in which case the employer is the first owner of any copyright in the work, subject to any agreement to the contrary,

(b) the work is the subject of Government or Oireachtas copyright,

(c) the work is the subject of the copyright of a prescribed international organisation, or

(d) the copyright in the work is conferred on some other person by an enactment.

(2) Where a work, other than a computer program, is made by an author in the course of employment by the proprietor of a newspaper or periodical, the author may use the work for any purpose, other than for the purposes of making available that work to newspapers or periodicals, without infringing the copyright in the work.”

Our understanding has been that the effect of this provision is that Newspapers are the first owners of copyright in the materials they publish, but only where the author of the article is an employee. Where, as is very often the case, an article is written by a freelance journalist, our understanding has been that the journalist retains copyright unless she specifically waives it. We assume the publishers on whose behalf you act have supplied you with such waivers in relation to all articles under discussion in this correspondence and we would be grateful if you would supply our office with a copy of same.

In the alternative, if your organisation also acts as a collection agent for freelance journalists, we would be grateful if you could confirm that this is the case, and identify those who have made such an agreement with NLI.

Our client is committed to working within the law in all that it does and we would request that you might set out clearly in your reply those statutory provisions requested so that our client may clearly assess whether it requires to purchase a licence from your agency.

In the alternative, you may wish to confirm that our client’s activities are not those for which a licence of the sort you are empowered to provide is required.

Yours faithfully,

;

________________

McGarr Solicitors

Open letter to Dr. Tony Holohan, the Chief Medical Officer re PIP Breast Implants

Letter to Dr. Tony Holohan, the Chief Medical Officer

Our Ref: EMcG Your Ref;   8th May 2012

 

Dr. Tony Holohan

Chief Medical Officer

Department of Health

Hawkins St.

Dublin 2

Fax:

 

Re: PIP Breast Implants

Dear Dr. Holohan,

We write this as an open letter to you and will put it on our website.

1. Representation

We are instructed by a number of women that have been fitted with defective breast implants manufactured by Poly Implant Prothèses (PIP) and in connection with their claims for personal injuries suffered in connection therewith.

Our clients, generally, consider that the injuries occurred through breach of duty of the hospitals/clinics whereby they were fitted with those defective implants.

We note that you are in discussion with the said hospitals/clinics on the same issue (we expect). Consequently, we write to ask that you keep us informed of the details of those discussions and to seek our suggestions on the form of any proposals advanced by the state to the hospitals or our comments on any proposals advanced by the hospitals.

We would be particularly pleased for a briefing on the current position.

We say this in the light of the recent declaration of the Irish Medicines Board that independent clinics (not owned by the state), furnishing cosmetic surgical services, were and are beyond the regulation of the state.

We believe that statement not to be accurate, for several reasons.

As justification for our position we recite Section 11 of the Sale of Goods and Supply of Services Act 1980:

“11.—(1) Subsections (2) and (3) apply to any statement likely to be taken as indicating that a right or the exercise of a right conferred by, or a liability arising by virtue of, section 12, 13, 14 or 15 of the Act of 1893 is restricted or excluded otherwise than under section 55 of that Act.

(2) It shall be an offence for a person in the course of a business to do any of the following things in relation to a statement to which subsection (1) refers:

( a ) to display on any part of any premises a notice that includes any such statement, or

( b ) to publish or cause to be published an advertisement which contains any such statement, or

( c ) to supply goods bearing, or goods in a container bearing, any such statement, or

( d ) otherwise to furnish or to cause to be furnished a document including any such statement.

(3) For the purposes of this section a statement to the effect that goods will not be exchanged, or that money will not be refunded, or that only credit notes will be given for goods returned, shall be treated as a statement to which subsection (1) refers unless it is so clearly qualified that it cannot be construed as applicable in circumstances in which the buyer may be seeking to exercise a right conferred by any provision of a section mentioned in subsection (1).”

It is our clients’ consistent position that the PIP breast implants are defective and therefore not merchantable and therefore their supply by the hospitals was in breach of Section 14 of the 1980 Act.

That being the case, refusals by the hospitals, in writing, even to you, to replace the implants or to refund our clients’ costs of their implantation are, we believe, in criminal breach of Section 11 of the Sale of Goods and Supply of Services Act 1980. In the event that you are in possession of evidence of such we urge you to refer the evidence to the Director of Consumer Affairs for prosecution.

You will notice that the 1980 Act mandates replacement of defective goods, not just their “recall”.

We urge you therefore, not to discuss any proposals from the hospitals, limited to removal as opposed to replacement. To do otherwise would be to undermine our clients’ statutory rights.

2. Injuries and loss

We should like to give you a brief insight into the consequences of the fitting of these implants.

Currently, we can only summarise, under broad heads, the nature of our clients’ claims.

(1) General damages

Our clients have suffered personal injury, of varying degrees. They have the prospect of a surgical operation to remove the implants or, in some cases, have already undergone the operation. Some have suffered rupture of the implants; all, we believe, suffer from seepage. This is, however, just a summary and should not be regarded as a comprehensive description of the injuries pending receipt of expert medical opinion.

They all are victims of breach of contract.

(2) Expenses and losses

We expect the claim for expenses and losses will include the following heads.

(i) Refund of the cost of implantation;

(ii) Recovery of the cost of removal and replacement;

(iii) Medical expenses;

(iv) Loss of earnings;

Further details would relate to individual cases and are not pertinent to this letter.

3. Conflicts of Interest

We wish to alert you to the inadvisability of referring claimants to the surgeons who performed the operations of implantation. Without wishing to impugn them in this letter, it is surely not appropriate that those surgeons should advise claimants?

There are many surgeons in Ireland qualified and available to give the necessary advice and, importantly, make the necessary assessments of the claimants’ injuries and who have not been employed by the defendant hospitals in the supply of PIP implants.

We particularly advise against any proposal that the defendant hospitals should arrange the removal of the PIP breast implants.

We look forward to receiving your response to this letter.

 

Yours faithfully,

 

___________________

McGarr Solicitors

The above letter was sent from our office today, following our attendance at the PIP Action Group Information Day.

It sets out the concerns we have regarding the current reported discussions between the Chief Medical Officer, Dr. Tony Holohan, and hospitals who provided women with PIP breast implants.

PIP Action Group Information Day Presentation

PIP Action Group Information Day slides

 

We will be attending at the PIP Action Group Information Day on Saturday the 5th May in the Red Cow Hotel, at the organisers’ invitation.

Attendance is free, but subject to application for an e-ticket from the organisers’ website. We’ll be wearing name badges, so please do make yourselves known to any of us if you’re attending also and would like to discuss any matter arising from the above presentation or if you have any other legal queries about the faulty PIP Breast Implants.

PIP: A Mind Map

Between 2001 and 2010 (possibly even before that period), a former salesman, the owner of a business in the south of France, engaged in a fraud. He did it because of a crisis, a money crisis, in his business. His business was the manufacture of a particular form of “medical device”. His speciality was the manufacture of “prostheses”, artificial body parts. The name of his company was Poly Implants Prothèses, PIP for short and he was particularly focused on the manufacture of breast implants.

His crisis had arisen in 2000. That year, the Food and Drug Administration of the USA (“FDA”) had inspected his French factory and revoked his license to sell, in the USA, a breast implant he was manufacturing. The breast implant had saline as a filler. Being an American public body, the record of (and reasons for) this revocation were publicly accessible, under Freedom of Information laws, to any person making inquiries.

His American licence had a corresponding European licence or licences because the manufacture and distribution of medical devices is closely regulated in law. Not only ought a manufacturer to comply with legally established standards, it must also submit to inspection from a certifying body. In the USA, the FDA, the certifying body, is both the certifier and the government regulator. This is not necessarily the case in Europe and in the case of France was not the case. There, the French regulator left the function of certifying the production process to private bodies. PIP used the services of a German company to certify its production process and compliance with standards. The German company would inspect the PIP factory by appointment.

This arrangement gave the PIP owner an idea. He would ramp up his sales figures outside the USA and increase his profit margins in those markets. That way he would offset the loss of the USA as a market for his breast implants and save his company. The key to this plan required that he avoid compliance with legal standards in his manufacturing process.

He decided to do this with respect to a silicone filler for his breast implants. Silicone was an alternative to saline as a filler. It was widely manufactured but was relatively expensive when required to meet the standard for use as a filler in a medical device. That use dictated that it have a certain consistency, for instance. Speaking loosely, it had to be closer to a jelly than to a soup.

The PIP owner could buy soup-like silicone at one fifth the price of jelly-like silicone, so he did and made his own mixture.

This was a radical deviation from standards and required that he conceal what he had done from the regulator and the German certifier.

He also concealed it from his customers. His customers were doctors and hospitals. They were the people who delivered the breast implants to the ultimate consumers. Some, possibly many, of his customers were heavy buyers of breast implants; they were in the business of promoting their use in a “cosmetic” context rather than a “medical” context. They were quite price conscious. The owner of PIP could and did undercut his competitors in price in selling his breast implants to his customers.

His breast implants were, potentially, lethal. Desirable consistency was not the only attribute of medical-grade silicone; it also had to be free of impurities. The industrial silicone the PIP businessman had bought was manufactured without regard to impurities; why worry about impurities if the silicone is destined for use in mattresses, say?

The danger arises from a simple fact; accidents happen. If a breast implant is inserted into you it may rupture.

Inevitably, that did happen to PIP implants. In 2006 Ms. Rachel Walters, a UK plastic surgeon encountered such a case. Because of the unusual and unexpected consistency of the silicone in the PIP implant, the rupture and its consequences presented Ms. Walters and her patient with serious and difficult problems. She was so concerned that she wrote a letter to the British Journal of Plastic Surgeons recording the problem and alerting the profession and anyone interested or concerned.

The following year, in 2007 another UK plastic surgeon, Mr. Brook Berry, encountered another case. He also wrote a letter to the British Journal of Plastic Surgeons recording the problem and alerting the profession and anyone interested or concerned.

The British Journal of Plastic Surgeons is published in English. It was available to be read by any doctor or regulator or hospital/clinic proprietor in the UK and Ireland.

It would appear not to have been read, because the use of PIP implants continued.

In 2010 the French medical devices regulator received an anonymous tip-off about PIP. It launched an investigation and discovered the fraud. It then notified other government regulators, including the British and Irish regulators. They issued a medical alert and a “recall”.

What was recalled was the stock of PIP implants in the hands of any doctor or regulator or hospital/clinic proprietor in the UK and Ireland.

The stable door was now shut but the horse had bolted.

In Ireland the authorities are in denial. The Irish Medicines Board is the regulator for medical devices. It recommends that women fitted with PIP breast implants consult the doctor that fitted them, presumably to privatize the decision to take them out or leave them in. Its recommendation ignores the clear potential for a conflict of interest resting with such a doctor. Did the doctor not know of the FDA licence revocation and if not, why not? Did the doctor attend any continuous professional development courses since 2006 or 2007? If not, why not? Why did such a doctor not read a, presumably, leading professional journal in his/her specialised field?

The same questions can be directed to the Irish Medicines Board and the hospital/clinic proprietors or managers fitting PIP breast implants.

No doubt the hospital/clinic proprietors feel they are between a rock and a hard place. In Ireland, almost universally, the PIP breast implants were fitted pursuant to a contract with the patient. Those contracts contained some implied terms. The terms are implied by law; that means that the parties making the contract don’t have to express the terms, for them to form part of the contract. Firstly, it was a term that the person or persons fitting the implants would have the required skill and knowledge to do so properly. Secondly, it was a term that the implants would be merchantable. “Merchantable” means that they were fit for their purpose.

At a minimum PIP breast implants were not merchantable. Consequently the hospitals/clinics breached their contracts and the patients are entitled to be compensated for any losses arising from that breach.

Currently, only some lawyers are using language like this. The hospitals/clinics are, effectively demanding that patients produce, at their own expense, a scan. The scan is presumed to show if there is a rupture or not. (It has been suggested that it does not, necessarily).

The hospitals/clinics are, by implication, defining “breach of contract” to mean “rupture”. Probably, if pressed they would even deny that a PIP breast implant rupture is evidence of a breach of contract. They could cite the fact that all breast implants are at risk of rupturing, and argue that a ruptured implant is also a merchantable implant.

These ideas ignore the fact that the evidence of lack of merchantability is in the “recall”. Why recall merchantable goods? If a PIP implant ruptures nobody knows what the consequences will be, save that they will constitute a medical emergency, the same medical emergency that Ms. Rachel Walters and Mr. Brook Berry wrote about in the British Journal of Plastic Surgery.

But there will be a difference; those doctors did not know that the silicone that leaked into their patients was not pure. Now, the profession does know that. The regulator knows that. The patients know that.

Only the patients, some of them, are acting to deal with this crisis.

Disclaimer
Please note that no solicitor/client relationship or duty of care or liability of any nature shall exist or be deemed to exist between McGarr Solicitors and you until you have received a written letter of engagement from us in which we confirm our appointment as your Solicitors. The contents of this website are not intended to constitute legal advice and should not be taken as such.

See our other websites HERE and HERE.

 

The DePuy hip scandal; Your questions answered

Who are the Defendants?

The parent company of “DePuy” is Johnson & Johnson Inc. There is more than one “DePuy”. The principal companies of that name are DePuy Inc. and DePuy Orthopaedics Inc. DePuy Orthopaedics Inc., a subsidiary of DePuy Inc., is the principal company manufacturing the hip replacement products. It is the company licensed to do so in the USA. For the rest of the world, “DePuy” transacts its manufacturing business through DePuy International Limited, a UK company based in Leeds. This is the entity recorded by the Irish Medicines Board as the “producer”. A factory controlled by DePuy Orthopaedics Inc. is located in Ringaskiddy in Cork. It exports its products to the USA. In addition, there is a distribution arm in Dublin called Johnson & Johnson (Ireland) Limited. For the purposes of the Liability for Defective Products Act 1991, there can be more than one “producer” pursuant to that Act; a person importing a product into the European Union is also a “producer” under the Act.

The hospitals fitting DePuy hips are liable, generally, under the Sale of Goods and Supply of Services Act 1980 for breach of contract.

What is the damage?

Currently, it is believed that 49% of DePuy recalled hips will fail. This figure is not intended to count persons with elevated cobalt and chromium ions in the bloodstream. It means that the implant has broken down and forced ex-plantation. If bloodstream contamination is the issue, the failure rate is much higher, possibly 100%. Bloodstream contamination is potentially serious; it damages local tissues and itself undermines the implant, besides being a poison. If the implant “breaks down”, so too will a person’s bone and that is not replaceable.

What are the causes of action?

“DePuy”is a “producer”; it is liable under the Liability for Defective Products Act 1991. Under this act it is not necessary to prove negligence on the part of the producer. It is necessary to prove the defect and the damage. “DePuy” was negligent; there were reliable technologies for the manufacture of hip implants; it was negligent to get it wrong. The Irish hospitals that fitted the hips did so under contract with patients; they are liable in contract, because the hips are defective.

What is the forum for disputes?

Ireland is the place of jurisdiction. It is the location of the commission of the torts and breaches of duty and contract of the defendants.

Is it necessary to wait?

No, not if it is possible to obtain all necessary medical reports on the current and prospective condition of the hip implants.

Is it desirable to wait?

Definitely not. The limitation periods applicable to the causes of action are now running against potential plaintiffs.

Can I join a class action?

Not in Ireland. We do not have provision for such actions. They are permitted in the UK, in Canada and in the USA. The people with immediate responsibility for failing to make such provision in Ireland are sitting on the Superior Courts Rules Committee.

Is it necessary to apply to the Personal Injuries Assessment Board?

No. Although the principal claim is for, inter alia, personal injury, the claims fall under exceptions to the Personal Injuries Assessment Board Act 2003.

What must be proved?

A plaintiff must prove the defect and damage. The fact of the DePuy “recall” is useful to prove the defect, but it would be necessary to engage an expert in the issue. The damage would vary from case to case, but it is difficult to see how any plaintiff with a DePuy hip would avoid ex-plantation before the expiration of the expected use life of the hips, 10 to 15 years. That means the claim is for metal contamination and an unnecessary medical operation and all the losses that would imply.

Disclaimer
Please note that no solicitor/client relationship or duty of care or liability of any nature shall exist or be deemed to exist between McGarr Solicitors and you until you have received a written letter of engagement from us in which we confirm our appointment as your Solicitors. The contents of this website are not intended to constitute legal advice and should not be taken as such.

See our other websites HERE and HERE

 

Faulty DePuy Hip Implants: How to litigate the issue

A) Hire a solicitor. Give all your information to him/her. The important information is; the date of the hip implantation; the date you were notified you had a DePuy hip; the date you learned it was defective, if that date was different.; the identity of the surgeon who fitted the hip; the hospital where it was fitted; the price you paid for the operation and the method of payment.

B) Get a medical report confirming your injury, or your prospective injury. (The solicitor does this.)

C) Get a medical report confirming the negligence of the surgeon and the hospital and an opinion on the behaviour of DePuy. (The solicitor does this.)

D) Discuss the heads of claim and the identities of the proposed defendants with the solicitor. The defendants will be; DuPuy; the Hospital; the HSE, possibly; the surgeon, possibly;

E) The heads of claim will be; Liability for defective product. (DePuy is liable on this head); Breach of Contract. (The hospital and the surgeon and the HSE are liable on this head of claim); Negligence. (DePuy and the hospital and the surgeon are liable under this head);

F) Calculate, with the solicitor, the various periods of limitations for the various heads of claim. They are; 3 years for a claim under the Liability for Defective Products Act (never exceeding 10 years); 6 years for breach of contract; 2 years for negligence resulting in personal injury. Two or more of these periods are coming to an end. This is a crisis for victims who have not issued proceedings.

G) (From the perspective of a lawyer planning the production of evidence, proving breach of contract is the easiest claim to prove. The other heads of claim offer creative possibilities to defence lawyers.)

H) Decide, with the solicitor, to issue proceedings immediately to stop time running. Seek leave of the High Court to issue proceedings against the DePuy entity that manufactured the defective hip product/s. (That entity is in the USA. To litigate a claim against it here requires leave of the High Court.)

I) Issue the proceedings and serve them, or notice of them, on the defendants.

Disclaimer
Please note that no solicitor/client relationship or duty of care or liability of any nature shall exist or be deemed to exist between McGarr Solicitors and you until you have received a written letter of engagement from us in which we confirm our appointment as your Solicitors. The contents of this website are not intended to constitute legal advice and should not be taken as such.

See our other websites HERE and HERE

Faulty PIP breast implants: The Time Problem

What is the “time problem”?

Every claim lodged in a court, to be successful, must be lodged within a “window” of time. That window is defined by the Statute of Limitations, or some other statute of similar effect. Missing the window will result in a bar on successfully bringing a claim.

Depending on the basis of the claim, or the kind of claim, the window may be long or short; it may be rigid or flexible in its point of commencement.

If it is inflexible, the knowledge of the woman is irrelevant. Time just starts to run. If it is flexible, time does not start to run in the absence of knowledge by the woman that she has been injured or could reasonably have found out that she was injured.

Irish women with PIP breast implants normally learned that they had been fitted with them when they received a letter from a clinic or a doctor confirming that that was the case. This happened belatedly because PIP implants were not marketed to the women, the ultimate consumers, by brand name; the implants were “brandless” when they were fitted. Of course the clinic or doctor that fitted them was aware of the brand, even to the extent of keeping records (in most cases) about the individual implants.

This fact of belated learning by the women means that, in relation to any proceedings based on allegations of negligence, the limitation period of two (2) years for such actions (under the Statute of Limitations) will not begin to run before they are so informed. The two-year period will, generally, begin to run from the day they receive the letter.

The clinics may argue that time began to run before that date. They may point to the so-called “controversy” arising from the “recall” of the PIP breast implants and try to suggest that the controversy put, or ought to have put, the women on notice to actively make inquiries from a date early in 2010. Such arguments are without merit, particularly in circumstances where the clinics, or one or more of them, were not promptly forthcoming with the written alert to the individual patients.

Is “negligence” the only basis to make a claim?

No. Each Irish PIP victim entered into a contract with the clinic fitting the implants. A claim based on breach of contract must be lodged before the expiry of six (6) years from the date of the breach. “Breach” here must mean the fitting of the implants and time runs from that date.

Is there any other basis for PIP victim claims?

Yes. The breast implants are “defective products” within the meaning of Ireland’s Liability for Defective Products Act 1991 and Council Directive No. 85/374/EEC. Claims under the 1991 Act must be lodged within three (3) years of the occasion on which time starts to run, and never later than ten (10) years after the product was put into circulation. In the case of Irish PIP victims, that is the date they received the letter from the clinic informing them that they had PIP breast implants.

What is the interaction between the two-year (or three-year) period and the six-year period?

There is none. The two-year (three-year) period begins to run from the knowledge or imputed knowledge of PIP implants having been fitted. The six-year period begins to run on the date of the operation to fit the PIP implants. For the six-year period, knowledge or ignorance is irrelevant; time just starts running. After six years the action, for breach of contract, is barred.

So, one right of action might become barred and the other survive?

Yes. The individual facts of each woman’s circumstances will show what her rights are.

What are the actual relevant dates from which time is running?

For negligence claims the date is the date the woman received a letter from the clinic informing her she had PIP breast implants.

For breach of contract claims the date is the day of the operation fitting the implants.

Disclaimer
Please note that no solicitor/client relationship or duty of care or liability of any nature shall exist or be deemed to exist between McGarr Solicitors and you until you have received a written letter of engagement from us in which we confirm our appointment as your Solicitors. The contents of this website are not intended to constitute legal advice and should not be taken as such.

See our other website HERE.

 

Text of Minister Sean Sherlock’s email sent this week to some opponents of SOPAireland

Re: Enactment of the European Union (Copyright and Related Rights) Regulations 2012

A Chara,

I would like to update you regarding the enactment of the European Union (Copyright and Related Rights) Regulations 2012.

I fully acknowledge the concerns that have been expressed by you regarding the introduction of the European Union (Copyright and Related Rights) Regulations 2012 which were signed into law on 29th February, 2012. I wish to re-emphasise that it has been necessary to introduce this legislative measure to restate the position that was thought to exist in the Copyright and Related Rights Act, 2000 regarding injunctions against intermediaries prior to the High Court Judgement of Justice Charleton in the case of EMI & others –v- UPC and to ensure that Ireland is compliant with our obligations under EU law.

I am satisfied that the High Court now has significant guidance in the implementation of this legislative measure arising from the underpinning EU Directives, as interpreted by the recent Court of Justice of the European Union case law, to ensure that any remedy provided will uphold the following principles:

• Freedom to conduct a business enjoyed by operators such as ISPs;
• The absolute requirement that an ISP cannot be required to carry out general monitoring on the information it carries on its network;
• Any measures must be fair and proportionate and not be unnecessarily complicated or costly;
• The fundamental rights of an ISPs’ customers must be respected, namely their right to protection of their personal data and their freedom to receive or impart information.

I am determined to ensure that Ireland will be a premier location where innovation can flourish and where innovation is facilitated by our copyright laws and data protection regime. In this regard, I am committed to reviewing and updating the Copyright legislation currently in place in order to strike the right balance between encouraging innovation and protecting creativity.

In this context, I am particularly anxious that the Consultation Paper of the Copyright Review Committee, which was launched on 29th February, 2012, is carefully studied by all interested parties to stimulate a constructive and well informed debate on these issues. This is a wide-ranging Consultation Paper which examines the current copyright legislative framework to identify any areas of the legislation that might be deemed to create barriers to innovation. The Consultation Paper is available to download at the following link: http://www.djei.ie/science/ipr/crc_statement.htm.

I would like to encourage the deepest engagement by all interested parties in the consultation process which has been launched in order to stimulate a constructive and well informed debate on all of the issues raised in this rapidly evolving area.

I am confident that the work being carried out by the Copyright Review Committee together with the interaction and input of all of the interested parties will result in establishing Irish copyright law on a firm footing to encourage innovation, foster creativity and meet the challenges of the future with confidence.

Yours sincerely,

Seán Sherlock TD
Minister for Research and Innovation

Imprisonment for Life

To a lay person, hearing that somebody has been sentenced to life imprisonment, it might appear that the prisoner will never be released. This will rarely be the case.

A life sentence is an indeterminate sentence.

The constitutionality of this particular indeterminate sentence was endorsed in Lynch v Minister for Justice [2010] IESC

McGarr Solicitors represent a client, in his challenge to a variety of indeterminate sentence, before the High Court, and will report the outcome of the case in due course.

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