Source: http://jameskolka.typepad.com/international_regulatory_/competent-bodies/
Timestamp: 2018-06-21 18:07:33
Document Index: 248306817

Matched Legal Cases: ['art 820', 'art 820', 'art 21', '§ 201', 'art 807', '§ 48', '§ 48']

International Regulatory Compliance: Competent Bodies
Risk Management: How Might An Attorney View QMS Risks for Medical Device Manufacturers? #1
For purposes of this article, I am going to focus on FDA’s Quality System Regulation (QSR) 21 CFR 820. As a start it is useful to examine different FDA Warning Letters to see what type of critique is levied at medical device manufacturers in a regulatory inspection. It will provide the initial snapshot for a forensic legal analysis. When I review a company’s QMS for a plaintiff or defendant involved in a lawsuit, I look first at the clauses key to this case, the FDA regulatory assessment and the allegations of opposing counsel.
Next I review the Quality Manual and the Quality System Procedures, how well they are written, how well they were followed and whether the requirements of 21 CFR 820 were effectively implemented. It takes some time to digest the material and it takes intuition to guide the development of a legal strategy. What happens next will depend on the objectives of the legal counsel with whom I am working, e.g. affidavit, depositions, supporting research, reviewing similar warning letters, etc
Every lawsuit has its own rhythm as the lawsuit preparation unfolds. For example, in a previous blog I mentioned a supplier’s employee not following their QMS procedures for unloading a tank car of ethanol and failing to clean the hoses after a previous tank car of acetone had been unloaded. This mistake resulted in tainted ethanol being mixed with other chemicals that were used to manufacture diabetic test strips. After unraveling what had occurred, the medical device manufacturing company alleged that they had experienced a 1½ million dollar loss. The forensic accounting firm verified the loss.
In another lawsuit a Texas Medical Device Company was sued by a UK machinery manufacturer that alleged a breach of contract and asked for damages. The UK company alleged that they had completed manufacturing a medical machine to the Texas Medical Device Company’s specifications. In turn the Texas Medical Device Company countersued that they had not contracted for the machine manufactured.
In depositions we conducted in the UK, the officers of the machine manufacturer were asked why they had not followed the contracting procedure in their ISO 9001:2000 QMS. Basically the deposition revealed that they had failed to follow their own QMS contracting procedure, instead creating a new contact that was not mutually agreed upon by both parties. Both of the preceding examples illustrate how knowledge of a QMS can be used in a lawsuit. These are simple examples. Most QMS lawsuits are more complex.
Some background is in order. A few years ago I worked with two IT colleagues putting together questions that could be used to satisfy QSR 820.25 Personnel (a) General Each manufacturer shall have sufficient personnel with the necessary education, background, training and experience to assure that all activities required by this part are correctly performed. (b) Training Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented. (1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
We developed over 500 + questions addressing all of the subparts of FDA 21 CFR Part 820 Quality System Regulation addressing all of a Medical Device Manufacturer’s business functions, from top management on down to regulatory director, quality manager, design, production engineer, marketing and sales. The questions ranged from easy to medium to difficult and utilized True/False, Multiple Choice to Multiple/Multiple Choice questions. The source of the questions was FDA 21 CFR Part 820 Quality System Regulation, Guide To Inspectional Technique (QSIT), and various FDA Medical Device Guidance Documents. If a person missed a question they would be given the correct citation from the relevant FDA document and would not see the same question again in their next test. All of the performances were recorded.
Developing these materials was an effective way to become extremely familiar with FDA regulatory requirements and take a deep look at the regulations from a legal perspective. It was a very useful legal education.
Lessons From FDA Warning Letters
FDA warning letters are very specific identifying area where a manufacturer failed to follow a requirement(s) of 21 CFR Part 21 Quality Regulations. One way to better understand the focus of FDA inspectors is to read the various materials FDA has prepared on its Quality System Inspection Technique and the various QSIT Workshops. If the observations made in warning letters helps substantiate an injury to a patient, it can provide powerful information in a lawsuit:
Warning Letter 1
Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, no corrective and preventive action procedures were available for review on request by the investigator. Mr. Calvin Knickerbocker III indicated that Shasta does not have CAPA Procedures.
Your firm’s response is not adequate. Your firm provided the Quality Manual Doc. No QA-1001, which states that Quality Manual No. Doc. No QS-1001 session 14.0 Corrected in Sacramento’s Action describes as the Shasta Technologies CAPA activities in that it relies on its contractor’s CAPA procedures because all manufacturing and distribution is performed by the contract manufacturers. However, this is not adequate because this does not specify your firm’s involvement or responsibility for the corrective and preventive action procedure. Your firm did not provide evidence of a procedure that describes analyzing the corrective and preventive action processes, investigating the cause of nonconformities relating to the product, verifying or validating the corrective and preventive action, implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of the product and submitting relevant information on identified qualty problems and corrective and preventive actions for management review is required by the CAPA requirements of 21 CFR 820.100. Your firm did not provide evidence of a retrospective review of other procedures pertaining to the CAPA subsystem, such as complaint handling and nonconformance procedures, to ensure that they were documented as required.
Your firm failed to process complaints in a timely manner. Your procedure “Returned Material Authorization” (RMA) and Complain Processing Operating Procedure, “SAMA 2003 states “*** complaints are recorded and followed-up upon in a timely manner.”
Complaint # 0 – received on 12/4/12, complaint investigated on 7/23/13 (days lapsed: 231);
Compliant # 18 – received on 3/27/13, complaint investigated on 8/2/13 (days lapsed: 128);
Compliant # 21 – received on 5/30/13, complaint investigator on 8/1/13 (days lapsed: 63);
Complaint # 23 – received on 6/1/13, complaint investigated on 8/1/13 (days lapsed: 61);
Complaint # 26 – received on 6/6/13, complaint investigated on 8/1/13 (days lapsed: 56);
Complaint # 87 – received on 11/11/13, complaint investigation not started as of this inspection (days lapsed: as of 1/15/14).
We have reviewed your response did 2/4/14. We acknowledge your commitment to addressing your complaint procedures; however, the implementation of your corrective actions will require verification during our next inspection.
Warning Letter 3
Failure to establish and maintain procedures for identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation as required by 21 CFR 820.30 (i). For example:
a. Your firm has not established and maintained its procedure, PDG-02, Section 6.3.6 of the Change Control Process, which requires verification or validation testing of proposed design changes and an evaluation of the potential impact of such changes on the Risk Assessment records (RMF/URA). Specifically, your firm has not evaluated the decreasing of the sensitivity of the Leak Alarm for the Renasys Go Pump device, implemented under ECO # 12-0182, in order to ensure that the change would not adversely affect the finished device. Additionally, your firm has not evaluated the impact of this change on the Risk Assessment records for this device.
b. Your firm does not establish and maintain its User Evaluation Procedure, PDG-02, Section 6.1.1, which requires that a product built for the User Evaluation testing be “under a controlled build and GMPs”. The User Evaluation testing conducted under validation protocol PDG-13- 056, executed under ECO # 13-0074, did not use the canister filter installation instructions that were listed in the current Renasys EZ and EZ Plus Pump instructions for use.
The adequacy of your firm’s responses cannot be determined at this time. Your firm has not provided retrospective review documentation which was expected to be completed by February 26, 2014. {FDA letter dated June 11, 2014} Additionally, no documentation was provided to support that personnel have been trained on the new procedure. (emphasis added)
The preceding three warning letters all were written in 2014. What you have read are just three observations out of several FDA inspection observations for each Medical Device Manufacturer. While these observations may or may not be relevant to a particular lawsuit, they will provide relevant issues to be explored in future lawsuits. They not only show how personnel in a regulatory agency think, they also illustrate FDA’s concern about the issues device safety and patient safety.
As noted in previous, blogs I have joined a group of International colleagues to work with medical device companies in the US and in the EU where there is a fear of product liability litigation in the US market. We combine legal expertise in risk management, human factors, document control, insurance, loss control, preventive law, Product Liability Audits that can be applied to FDA’s Quality System Regulation, EU Medical Devices Directives, and ISO 13485 & ISO 9001 Quality Management Systems. We use a QMS as a platform for Product Liability Avoidance, including document management and “word control” training and the creation of a Product Management System. We are preparing new approaches to work with companies to address these concerns. In particular we focus on the legal aspects of Product Liability Exposure. In my next blog, I will examine FDA QSIT Workshops and their relevance for product liability litigation.
Posted at 03:44 PM in ABA, ANAB, Annex I Checklists, Ansi standards, ASQ, attorneys, Authorized Representatives, CE Marking, CE Marking Lawsuits, CE Marking Medical, CEN, CENELEC, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, EU Member States, European Commission, FDA Quality System Regulation, food machinery, Hazards Analysis, Healthcare Regulation, IEC standards, Insurance Companies, Insurance Underwriters, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, Medical Devices, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Risk Analysis, Risk Assessment, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
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Posted at 11:44 AM in ABA, ANAB, Annex I Checklists, Ansi standards, ASQ, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CEN, CENELEC, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, EU Member States, European Commission, False CE Marking, food machinery, Hazards Analysis, HSE, IEC standards, Insurance Companies, Insurance Underwriters, International Regulatory Compliance, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, New Approach Directives, Notified Bodies, plaintiffs attorneys, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, Risk Assessment, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Using A Legal Expert/Expert Witness in ISO 9001 and CE Marking Lawsuits
I have discussed this topic at various times in previous Blogs. Recently I have been reading responses to the topic, “Putting The Expert At The Planning Table” asking various legal experts and expert witnesses about the issue of having their input when a law firm is planning their approach to a lawsuit. The discussion revolved around whether it makes sense to bring an expert in early in the planning process when attorneys are formulating their litigation strategies.
Whether building a defense or preparing an attack attorneys should have an intelligent grasp of issues known to experts in specific areas such as (in my case) the relevance of ISO 9001 documents and records or CE Marking documents and records for a lawsuit. Even though on first blush these two areas might seem approachable, in fact they often are quite complex presenting veritable minefields for self-assured legal counsel who might charge ahead following their “instincts” resulting in serious legal problems for themselves and their clients. I was happy to see an active discussion of the issues and a general agreement that Experts are helpful when planning a litigation strategy.
I have served as Legal Expert/Expert Witness in seven cases involving ISO 9001 and have consulted on several others. In only one case involving ISO 9001 was I asked to serve as Legal Expert/Expert Witness prior to legal discovery. In all of the other cases the attorneys moved ahead with discovery prior to fully understanding what ISO 9001 was, what information they hoped obtain and how ISO 9001 might or might not help their case. In more than one instance the attorneys’ inability to communicate with the judge about ISO 9001, its relevance to their case and explain what they hoped to accomplish angered the judge and seriously compromised the information they hoped to obtain.
In other cases attorneys worked with ISO 9001 consultants who didn’t understand the legal implications of ISO 9001 and offered opinions about certification that confused legal counsel who weren’t conversant with the standard and whose opinions weren’t relevant to the case. In more than one instance opposing counsel representing a client with a certified ISO 9001 Quality Management System flooded my client with reams of process control records that were meaningless to the issues they were trying to understand. The magistrate wasn’t amused by this tactic and chastised the attorneys for wasting time attempting to obscure the discovery request.
In another case opposing legal counsel for a major corporation denied that they had any records and stated that they did not have a recall policy. When we filed an affidavit asking for specific records from their ISO 9001: 2000 Quality Management System (QMS) they complied stating, “Oh those records!” the Judge was furious that they were acting coy and attempting to evade the discovery request.
From their response to the discovery request, it was apparent that the corporation not only had a certified ISO 9001 Quality Management Systems at their various plants but also had a corporate ISO 9001 QMS covering their global manufacturing operations. When confronted with this observation, the corporate officers and their legal counsel stated that they did not have a corporate ISO 9001: 2000 Quality Management System. Two weeks later the corporate ISO 9001 QMS was produced. It also contained a recall policy. By this time the Judge was livid and willing to grant additional discovery and depositions.
From my experience with litigation counsel, I understand how it is possible to be confused by ISO 9001 and whether it has relevance to their case. An early discussion with a legal expert who also understands the legal implications of ISO 9001 and its possible relevance to their case could have helped to clarify whether ISO 9001 documents and records might be useful. I have worked in a few cases where legal counsel and their client thought that ISO 9001 documents and records would be helpful to their case. After reviewing the facts and examining the key issues it became apparent that there were other factors that were more important such as CE Marking documents and records.
CE Marking is a large complex topic covering over 26 new approach EU Directives and related EN harmonized safety standards. Each Directive contains Essential Health and Safety Requirements that must be satisfied in order to CE Mark a product. If a manufacturer uses an EN Safety Standard to address an essential requirement, the EU will presume conformity. Over 10,000 EN Harmonized standards have been created to implement the requirements of the Directives. If a company wishes to address an essential requirement without using an EN harmonized standard they will have to submit full proof to authorities demonstrating that they satisfy the essential health and safety requirements.
The objective of the EU new approach requires that each manufacturer review the essential requirements of the Directive or Directives that apply to its product or products. For example, I have worked with several machinery manufacturers where several Directives applied to their machine or machines – Machinery Directive, Low Voltage Directive, Electromagnetic Compatibility Directive (EMC), Pressure Equipment Directive (PED), Explosive Atmospheres Directive (ATEX). And starting on 1 January 2013, add the Restriction of the Use of Certain Hazardous Substances (RoHS) Directive.
The Machinery Directive has an excellent guide for applying the Directive to machines. It also has thousands of standards that apply to different kinds of machines. After reviewing the Annex I Essential Health and Safety Requirements to the machine or machines in question it is necessary to determine which EN harmonized standards apply, purchase the standards and consider what if any modifications must be made to the machine(s). This same step must be repeated for each Directive and a Part A Technical File created that contains all of the elements involved to CE Mark the machines. If you buy CE Marked components you should have an EC Declaration of Conformity or if they are partly completed components you should have a Declaration of Incorporation. The suppiers also must have used current standards
Finally it is essential that the new EN ISO Risk Assessment Risk Management standard be applied to the machine or machines. Sound good? It is except the weakest part of the Machinery Directive is that virtually all manufacturers can self certify to the Directive. That in itself isn’t bad, but if a manufacturer wants to be sloppy the door might appear to be open. Since I work with manufacturers implementing various Directives involving Machinery, Electronics, Medical Devices, Toy Safety, Telecommunications Terminal Equipment, EMC, ATEX, etc. I am aware of the requirements and what must be done to satisfy the Directives Requirements.
In lawsuits in US Courts involving CE Marked products it has been useful when serving as a Legal Expert/Expert Witness knowing what is supposed to exist when reviewing what is missing. In three cases I found what was identified as a Technical File was in my opinion a junk file that didn’t contain any of the required information. There was no risk assessment, EN harmonized safety standards were not followed and what was alleged to be an ISO 9001: 2000 QMS was not produced in discovery. The CE Marked machines had killed workers in the EU and injured workers in the US, one who needed 24/7 care for the rest of his life. Having helped companies satisfy the CE Marking requirements for their respective products (including a detailed risk assessment), conducting a forensic legal analysis of non-compliance is an interesting task.
In both ISO 9001 and CE Marking Product Liability Lawsuits the issue of timing is important. ISO 9001 has been visited and revised (in accordance with ISO requirements) four times. It is an important point that has confused attorneys in a several lawsuits. Likewise EU Directives have been revised as well as EN Standards. Following the Vienna and Dresden Agreements between the EU’s CEN and CENELEC with ISO and IEC, standards revisions increasingly conducted jointly, approximately every seven years. When an international body such as ISO and IEC participate, ANSI (American National Standards Institute) participates on behalf of the US resulting in the creation of ANSI standards, i.e. American Standards that have always been accepted in US Courts. Consequently, it further opens up the use of ANSI standards in US CE Marking litigation.
My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court or state courts. I focus on product safety, product liability and the steps necessary to create a safe product and serve as Legal Expert/Expert Witness where safety has been compromised or ignored resulting in damage and/or injuty. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com
Posted at 02:51 PM in ANAB, Annex I Checklists, Ansi standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, CEN, CENELEC, Competent Authorities, Competent Bodies, corporate counsel, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, European Commission, False CE Marking, food machinery, Forensic Law, Hazards Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
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Happy 2013, Are You Prepared For The New US Medical Device Excise Tax?
I have been working with several clients helping them prepare for implementation of the new US Medical Device Excise Tax that went into effect on January 1, 2013. In the process I contacted other clients to see if they were aware of the tax. Their responses have ranged from “Yes” to “I don’t think it applies to our type of medical device,” to “I have never heard of the tax!” Needless to say the first three months of 2013 should be interesting for many medical device manufacturers and importers.
It is astonishing that there is such a lack of awareness among US medical device manufacturers and importers concerning a tax that will have to be systematically collected and reported to the IRS. The best explanation of the tax was published by the IRS which you will find below:
A4. Generally, the manufacturer or importer of a taxable medical device is responsible for filingForm 720, Quarterly Federal Excise Tax Return, and paying the tax to the IRS.
Q6. Who is the manufacturer for purposes of the medical device excise tax?
A6. Generally, with regard to the medical device excise tax, the manufacturer is the person who produces a taxable medical device from scrap, salvage or junk material, or from new or raw material, by processing, manipulating or changing the form of a device or by combining or assembling two or more devices.
Q7. Who is the importer for purposes of the medical device excise tax?
A7. Generally, with regard to the medical device excise tax, the importer of a taxable medical device is the person who brings the device into the United States from a source outside the United States, or withdraws the device from a customs-bonded warehouse for sale or use in the United States.
Q8. What is the tax treatment of convenience kits?
A8. Notice 2012-77 provides interim guidance on the tax treatment of convenience kits. Under the interim guidance, a taxable medical device that goes into a domestically-produced convenience kit will be subject to tax upon its sale by the manufacturer or importer, but the sale of the convenience kit by the kit producer will not be subject to tax. Special rules apply to imported kits.
For purposes of the notice, a convenience kit is a set of two or more devices within the meaning of § 201(h) of the Federal Food, Drug, and Cosmetic Act that is enclosed in a single package, such as a bag, tray, or box, for the convenience of a health care professional or the end user.
Q9. What form will be used to report the medical device excise tax?
A9. The medical device excise tax is a manufacturers excise tax. Like other manufacturers excise taxes, the medical device excise tax is reported on Form 720. See Chapters 11 and 12 of IRS Publication 510 for additional information on filing, deposits, and payments.
Q10. When is the Form 720 due?
A10. Form 720 is filed quarterly. The first return to report the medical device excise tax will be due on April 30, 2013, for the quarterly period including January, February and March 2013. Quarterly return due dates are as follows:
Q11. Are tax deposits required for the medical device excise tax?
A11. Yes. Semi-monthly deposits will generally be required if tax liability exceeds $2,500 for the quarter. The first deposit of the medical device excise tax, covering the first 15 days of January 2013, will be due on Jan. 29, 2013. Notice 2012-77 provides transition relief from deposit penalties during the first three calendar quarters of 2013. For details on deposit requirements, see the Instructions to Form 720 and Chapter 12 of IRS Publication 510.
Q12. Should an entity that is disregarded for income tax purposes file Form 720 in the disregarded entity's name or the owner's name?
A12. An entity that is disregarded as an entity separate from its owner for income tax purposes is treated as a separate entity for excise tax purposes. Therefore, the entity, and not the disregarded entity’s owner, is responsible for filing Form 720 and paying of the tax.
Q13. Has the IRS issued guidance on the medical device excise tax?
A13. Yes. The IRS and the Treasury Department issued final regulations on Dec. 5, 2012. The IRS and the Treasury Department issued Notice 2012-77 on Dec. 5, 2012, to provide interim guidance on certain issues related to the medical device excise tax.
Q14. What is a taxable medical device?
A14. In general, a taxable medical device is a device that is listed as a device with the Food and Drug Administration under section 510(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 807, unless the device falls within an exemption from the tax, such as the retail exemption.
Q15. Are there any exemptions to the medical device excise tax?
A15. Yes. There are specific statutory exemptions for eyeglasses, contact lenses, and hearing aids. There is also an exemption for other devices that are of a type that are generally purchased by the general public at retail for individual use (the retail exemption).
Q16. How does a manufacturer determine if a particular type of device qualifies for the retail exemption?
A16. The regulations provide a facts and circumstances approach to determine whether a type of device meets the retail exemption. The regulations enumerate several factors that are relevant, but there may be relevant factors in addition to those enumerated in the regulations. The determination is based on the overall balance of factors relevant to a particular type of device. No one factor is determinative. See § 48.4191-2(b)(2) of the regulations for more information about the retail exemption. The regulations also provide a safe harbor for certain devices that will be considered to be of a type that falls within the retail exemption. See Q&A 18.
Q17. Do the regulations illustrate how the retail exemption facts and circumstances test should be applied?
A17. Yes. The regulations include examples that apply the facts and circumstances test to several types of medical devices. Based on the totality of the circumstances presented in the examples, the examples conclude that non-sterile absorbent tipped applicators, adhesive bandages, snake bite suction kits, denture adhesives, mechanical and powered wheelchairs, portable oxygen concentrators, and therapeutic AC powered adjustable home use beds are devices that fall within the retail exemption. Based on the totality of the circumstances presented in the examples, the examples also conclude that mobile x-ray systems, nonabsorbable silk sutures, and nuclear magnetic resonance imaging systems are not devices that fall within the retail exemption.
Q18. Is there a retail exemption safe harbor?
A18. Yes. The regulations identify certain categories of devices that qualify for the retail exemption so that manufacturers and importers do not have to apply the facts and circumstances test. Those categories are set forth in a safe harbor provision in § 48.4191-2(b)(2)(iii) of the regulations.
Q19. Are there any circumstances under which a taxable medical device can be sold tax-free?
A19. Yes. A manufacturer or importer of a taxable medical device may, in certain circumstances, sell a taxable medical device tax-free for use by the purchaser for further manufacture (or for resale by the purchaser to a second purchaser for further manufacture), or for export (or for resale for export). To make a tax-free sale for further manufacture or export, both parties to the sale must be registered with the IRS. Form 637, Application for Registration for Certain Excise Tax Activities, is used for the registration process. For more information on the Form 637 registration process, see the 637 Registration Program at IRS.gov.
Q20. I’m not familiar with manufacturers excise taxes. Where can I learn more?
A20. For more information about manufacturers excise taxes in general, see Chapter 5 of IRS Publication 510.
Posted at 04:48 PM in ABA, attorneys, Authorized Representatives, CE Marking Medical, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, Essential Health and Ssfety Requirements, Healthcare Regulation, Insurance Companies, Insurance Underwriters, International Regulatory Compliance, IRS, ISO 13485 -- Medical Devices, Loss Control, Medical Devices, MHRA, Notified Bodies, plaintiffs attorneys, risk management, trial attorneys | Permalink | Comments (0) | TrackBack (0)
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Posted at 02:24 PM in ABA, ANAB, Annex I Checklists, Ansi standards, ASQ, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, CEN, CENELEC, Competent Authorities, Competent Bodies, corporate counsel, defense counsel, EN harmonized standards, Essential Health and Ssfety Requirements, European Commission, False CE Marking, food machinery, Hazards Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
The accident occurred when the machine executed a movement and struck a worker who was unaware of how the machine operated. During the trial the jury learned that the manufacturer also made the same machine for Europe with a laser light curtain that would shut off the machine if it detected workers moving in the area of operation. It was a safety requirement of the Machinery Directive. The manufacturer had been shipping the “safe” machine into the EU for 6 years. Since it wasn’t required in the US, however, they didn’t add the light curtain.
The jury was furious when they realized that the company knew how to manufacture a safe machine but chose not to do so because there was no requirement in the US. The jury and court levied $35 million dollars in punitive damages against the machinery manufacturer, the largest judgment ever awarded in a Minnesota product liability lawsuit. The moral of the story is obvious, if you can make a safe machine for one market, you must do so for all markets – a long standing legal expectation in US product liability lawsuits.
This part of describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 1.7.4.1 apply.
How Does This Work In A US Federal Court?
The simple answer is that it does work but it must be presented in a fashion that is understandable to the Court. For example, in a recent lawsuit involving injury to a worker that will require 24-hour care for the rest of his life, his attorney demonstrated that the machinery manufacturer did not apply the EN Harmonized standard requirement for the thickness of a plexiglass shield that would have prevented a projectile from machine penetrating through the shield and striking the worker. Also, no meaningful risk assessment was applied.
My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court. I focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail jameskolka@gmail.com.
Posted at 01:14 PM in ANAB, Annex I Checklists, Ansi standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Toys, CEN, CENELEC, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, European Commission, False CE Marking, food machinery, Forensic Law, GAP Analysis, Hazards Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Tags: ABA, ANAB, Annex I Checklists, ANSI Standards, ASQ, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Toys, CEN, CENELEC, Competent Authorities, Competent Bodies, corporate counsel, defense counsel, EN Harmonized Standards.Enterprise and Industry, Essential Health and Safety Requirements, EU Member States, European Commission, food machinery, Forensic law, HSE, IEC Standards, Insurance Companies, International Regulatory Compliance, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO Standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, new approach directives, notified bodies, plaintiffs attorneys, preventive law, product liability audits, product liability lawsuits, product safety audits, registrars, risk analysis, risk assessment, risk management, Technical Files, trial attorneys
Auditing ISO 9001 For Liability Exposure to Lawsuits #1
This is the first of three blogs that will address Auditing for Liability Exposure to Lawsuits – (1) the first will focus on ISO 9001, (2) the second will focus on CE Marked products such as machinery, toys, etc., and (3) the third will focus on FDA’s Quality System Regulation (QSR).
The auditing for liability exposure to lawsuits theme isn’t new, but it continues to elude manufacturers and in the case of ISO 9001 it also eludes quality managers, top management, corporate counsel and the companies that insure manufacturers. In addition, ISO 9001 continues to befuddle defense attorneys, corporate counsel and trial attorneys, e.g., what is it and how do I attack or defend it in a lawsuit? (Note: These same observations can be applied to ISO 13485.)
In earlier blogs, I discussed how ISO 9001 has been at the center of lawsuits resulting in over a $100 million dollars of penalties brought by the US Department of Justice against Defense Contractors for defective products manufactured by failed ISO 9001 Quality Management Systems. Several of these products have resulted in military and law enforcement fatalities. In civil lawsuits, over $100 million dollars in punitive damages have been awarded by juries and in out of court settlements for failed products that caused extensive property damage and in some cases personal injuries. The losses now exceed $500 million for each category.
I have served as legal expert/expert witness in several lawsuits in US Federal Courts and continue to be amazed at how badly the ISO 9001 standard is approached by both plaintiffs and defendants in lawsuits. Too often in discovery trial attorneys make a blanket request or ask for ISO 9001 quality manuals, procedures, records, etc., without specifying which procedures and records. Defense attorneys are only too happy to provide boxes of production manufacturing records swamping plaintiff’s attorneys with reams of meaningless paper. When questioned by a Judge, Plaintiff’s attorneys often find themselves unable to specify what they are looking for and why. Defense attorneys often try to be evasive or don’t understand the purpose of ISO 9001. Few attorneys understand ISO 9001 and how it might relate to their lawsuit.
The day-to-day life of quality managers does not deal with the legal implications of an ISO 9001 quality manual, procedures, records and documents. If asked, they want nothing to do with legal issues, that is management’s responsibility. Consequently, the legal implications of quality procedures, records and documents does not receive any sort of intelligent legal scrutiny. Basically, quality managers audit their quality management system to make certain that the system is functioning according to their defined quality management system. Where problems are found by internal audits, those problems are addressed by identifying nonconformities, and determining what corrective and preventive actions might be needed to address the problem.
The fact that quality managers are not aware of the legal significance of quality records and documents should not be surprising. One of my first encounters with this dynamic was with a medical device company in Pennsylvania several years ago. (This was prior to FDA’s Quality System Regulation.) When I mentioned the possible legal implications of their ISO 9001 quality documents and records, he quickly said “that belongs to legal”, meaning their legal department. I subsequently learned he had been told by corporate attorneys that he should not get involved in any legal issues, that turf belonged to the attorneys.
How Attorneys Might Address The Problem
To begin, on the defense side, top management, corporate counsel, defense counsel and their insurance companies must become aware of the structure of ISO 9001, how it works and what the manufacturer hoped to accomplish with certification. On the plaintiffs’ side, trial attorneys need to better understand the ISO 9001 standard, how it might relate to their lawsuit and what information – quality manual, quality procedures, quality documents and records is important to make an intelligent request in discovery.
In the US, approximately 65,000 sites are certified, although the number has begun to decline in recent years. Internationally, the number exceeds 1 million with 500,000 in Europe alone and continues to grow. In many countries (including the US) and business sectors, ISO 9001 is a requirement for doing business. It is a DOD requirement for military contractors.
In addition to understanding the basics of the standard, it also would be prudent to understand ISO 9004, the Guidance Document because it offers some intelligent suggestions concerning issues that could make the QMS more legally defensible in a lawsuit. The impetus for such a move will not come from quality managers, however, because ISO 9004 is viewed as not required and therefore a nuisance. Unfortunately, such a response is both expedient and ignorant.
An area of particular weakness in ISO 9001 is the lack of safety built into product design.
The design requirements contained in 7.3 Design and development, 7.3.1 Design and development planning, 7.3.2 Design and development inputs, 7.3.3 Design and development outputs, 7.3.4 Design and development review, 7.3.5 Design and development verification, 7.3.6 design and development validation and 7.3.7 Control of design and development changes. Unless safety is specified and added as a design requirement by the manufacturer it will not be a significant factor in design. Also, unless Hazards Analysis, Risk Assessment, Risk Analysis and/or Risk Management (or some combination) is added to product design requirements by the manufacturer, it will not be added by ISO 9001.
Audits and Audit Training
All parties need to understand what audits are intended to accomplish in an ISO 9001 Quality Management System, especially Internal Audits. For an ISO 9001 Quality Management System to be effective the Internal Audit System must be effective. It is internal self-policing and magnificent when it works. Problems arise when nonconformities are discovered and ignored or incompetently resolved. Top management should be informed and participate in meaningful management reviews when nonconformities are discovered, denied or not resolved.
In one class action lawsuit, several machines (approximately 235 costing up to $240,000 apiece) were catching on fire, which was a nonconformity. The manufacturer sent an investigator into the field who had no experience with these types of machines and was not a fire expert. He declared that the fires were not a nonconformity, therefore no corrective or preventive action was needed. This finding was discussed and agreed to in a corrective action review.
Plaintiffs’ attorneys requested the corrective action review minutes, which was refused by the defense declaring that an attorney was present in the review and therefore the review was subject to attorney client privilege. Plaintiffs’ responded that while an attorney happened to be present in the meeting, there was no lawsuit at that time. The Judge denied the request, which made it all of the way to the US Supreme Court where Defendant’s Writ of Certiorari was denied. Eventually the matter was settled out of court. The Wall Street Journal hinted that the settlement was in the mid ten figures – $50 million dollars.
Documents and records are essential elements of ISO 9001 therefore document control is vital:
If you can’t prove it, it doesn’t exist!
Everything you write, e-mail, text or say verbally or electronically can and will be used against you in a court of law
Once legal action has begun, the destruction of documents is a criminal offense, including electronic and phone records (which can be retrieved by experts)!
All documents can be obtained in legal discovery by Plaintiff’s Request for Production of Documents!
Attorney client privilege cannot be used to withhold documents from Plaintiff’s Request for Production of Documents!
Certain words and phrases have legal consequences and should not be used in ISO 9001 documents and records!
I fleshed out several of these points in some of my earlier blogs in 2009. It appears it is time to revisit and update document control in a future blog.
Listed below are a few suggestions for addressing ISO 9001 and Liability Exposure,
Training is essential to understand the legal issues raised by ISO 9001. This includes training of Quality Managers, Top Management, Corporate Counsel, Defense Counsel and insurance personnel including underwriters. It also could be offered by insurance companies to their insureds for a fee – I have participated in such programs and they are well received.
Training also is essential for trial attorneys to better understand ISO 9001 and how to use it as a resource in a lawsuit.
Audit training also can be especially effective. I have also put together different training courses for conducting Product Safety Audits and Product liability Audits that can be conducted internally in companies or sponsored by insurance companies for a fee.
Hazards Analysis, Risk Analysis and Human Factor Analysis are essential to Product Safety and the integrity of any ISO 9001 QMS – Training is essential.
Finally, Document Control Training is essential in an era where documents exist in hard copy or electronically and where modes of communication have become more diverse.
My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court. I focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001, FDA’s Quality System Regulation or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com
Posted at 02:37 PM in ANAB, ASQ, attorneys, BIS, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, Competent Bodies, corporate counsel, Current Affairs, defense counsel, Enterprise and Industry, EU Member States, European Commission, FDA Quality System Regulation, Forensic Law, GAP Analysis, Hazards Analysis, Insurance Companies, Insurance Underwriters, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO 9004, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, Risk Assessment, risk management, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Tags: ANAB, ASQ, attorneys, BIS, BIS, CE Marking Lawsuits, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, Competent Bodies, corporate counsel, current affairs, Enterprise and Industry, EU Member States, European Commission, FDA Quality System Regulation, Forensic Law, GAP Analysis, Hazards Analysis, Insurance Companies, Insurance Underwriters, International Regulatory Compliance, ISO 13485, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO 9004, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, Plaintiffs Attorneys, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, Risk Assessment, Risk Management, Trial Attorneys
The Two Sides of Risk Management & Risk Assessment – Legal Protection Or Liability Exposure – The Choice Is Yours
I just finished working with a client helping them CE Mark their machine for entry into the EU. I enjoyed working with the EU’s new machinery safety standard, BS EN ISO 12100:2010, Incorporating corrigendum January 2011, Safety of machinery – General principles for design – Risk assessment and risk reduction. I tell my clients that a risk assessment will serve them well in the EU to respond to any questions from member state competent authorities and also will provide strong protection in a US court in the event of a product liability lawsuit. In turn, the absence of a solid risk assessment will open the doors to liability in the event of a product liability lawsuit.
Since I started this blog on February 26, 2009 I have written extensively about Risk Management, Risk Assessment, Risk Analysis and Hazards Analysis. They are essential elements for the design and manufacture of safe products, from medical devices and pharmaceuticals to machines and toys. In the EU’s new approach safety directives the European Union has done an excellent job of identifying product essential safety requirements in each directive and then asking companies to identify what EN harmonized standards they have chosen to demonstrate conformity to those requirements.
The EU’s Principles of Safety Integration spell out the classic design trilogy: (1) Design out hazards, (2) Guard against those hazards that can’t be designed out, and (3) Warn against those hazards that can’t be designed out or guarded against. Of course, as always, the devil is in the details. Since several new approach directives allow for manufacturer self-certification there is an opportunity to be sloppy.
Litigation Analysis – Since starting this blog, I have also written about the absence of Risk Management, Risk Assessment, Risk Analysis and the legal consequences of failing to be systematic in designing and manufacturing products. I was asked to examine the litigation records of a manufacturing division of a parent corporation that was losing so much money in lawsuits that it erased their profits. The absence of design records, hazards analysis, design changes, safety manuals, etc. was appalling. Had plaintiffs’ counsel been more competent and examined the company’s design records, the losses would have been far greater.
Next, I spotted caution and danger decals on the finished machines and asked what type of hazards analysis was used to determine what warnings and cautions were used and why. I was directed to a company that provided the decals. When I called the company they said they were a printing company that provided they deals ordered by the manufacturing company. After further inquiry, I discovered that no one working there had any idea about the origin of the warnings and cautions and how they were determined. They simply replicated what existed on existing machines. The concept of hazards analysis was completely foreign. Following my litigation analysis, corporate counsel and management decided to sell the division.
ISO 9001 Analysis – Several other blogs have discussed lawsuits where ISO 9001 records, documents, Quality Manuals and Quality Procedures provided key information concerning efforts by of opposing counsel and their clients to withhold information that would reveal the existence of records important to a lawsuit In a US federal court. In these cases the information (records, documents, quality manual and quality procedures) were obtained by an Affidavit or Declaration identifying key documents and records required to maintain a certified ISO 9001 quality management system. In more than one instance, the following response by opposing counsel and their clients revealed additional information that was obtained in a follow-up declaration. As new information was revealed, the judge became quite angry at the duplicity of opposing counsel that did not help their case during settlement.
CE Marking – In recent blogs I have described CE marking lawsuits in US Federal Courts. Thus far, these cases have involved industrial accidents and in one instance a defective machine at the center of a contractual suit. Just like ISO 9001 where requirements are contained in a document outlining the specifications for certification, CE Marked Machines are governed by the requirements set forth in the EU Machinery Directive and related Directives such as the Low Voltage Directive, Electromagnetic Compatibility Directive, and in some cases the Pressure Directive and Explosive Atmospheres (ATEX) Directive.
While the Machinery Directive allows companies to self-certify in most instances, a specific set of requirements exist such an Annex I Essential Health and Safety Requirements Relating To The Design and Construction of Machinery Checklist, identification of EN Harmonized Standards that will allow a manufacturer to demonstrate conformity to the Essential and Safety Requirements, and an Annex VII Technical File Part A (the index) and Part B (the actual file in paper or electronic form), including a description of the machinery, overall and detailed drawings, the documentation on a risk assessment demonstrating the procedure followed which apply to the machinery, including:
-- a copy of the EC declaration of conformity.
The Directive also specifies that the Technical File must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of machinery or, in the case of series manufacture, of the last unit produced.
Needless to say, it isn’t difficult to determine if a manufacturer honestly attempted to comply with the requirements of the Machinery Directive and related Directives. The issue of the particular Directive(s) in force when the machine was manufactured and specific the EN harmonized standards that were in force when machine was manufactured are minor technical issues easily resolved.
In a recent case settled out of court, I reviewed what at best could be called a “Junk File”, that didn’t meet any of the Annex VII Technical File requirements. Worse yet, the most relevant EN harmonized standard for this particular machine not only wasn’t followed, but the required protective shield did not meet safety specifications of the standard resulting in a fatality and two workers injured for life, requiring 24 hour medical care for the rest of their lives. Finally, there wasn’t anything remotely approaching a required risk assessment. Writing a Affadavit for the Court was not difficult.
Liability Exposure – The opposite of legal protection is liability exposure. The absence of a competent risk assessment provides an opportunity to examine what if any kind of Risk Assessment existed and counter with a detailed breakdown of what kind of Risk Assessment should have existed. This is made easier by following the EN Risk Assessment Standard that was in place when the machine was manufactured followed by reviewing the Directive(s) requirements and examining the EN Harmonized Standards adopted by the manufacturer to demonstrate conformity with the essential requirements to see if they were the correct choices and were actually followed.
Finally, if the manufacturer was certified to ISO 9001, additional records, documents and procedures are available, including the design requirements contained in 7.3 Design and development, 7.3.1 Design and development planning, 7.3.2 Design and development inputs, 7.3.3 Design and development outputs, 7.3.4 Design and development review, 7.3.5 Design and development verification, 7.3.6 design and development validation and 7.3.7 Control of design and development changes.
I enjoy working with clients helping them conduct a thorough risk assessment when CE Marking their machines to create safe products. I also enjoy using a thorough risk assessment along with other CE Marking Machinery and ISO 9001 requirements to attack unsafe products in a lawsuit. While a few EU manufacturers attempt to stonewall the discovery process by not providing requested material, when they chose to file a lawsuit or are sued in a US Federal Court they have to comply with US discovery requirements. By specifying documents, records and CE Marking requirements they can be forced to comply with US discovery requirements. Too often however, discovery requests are made by attorneys who don’t understand ISO 9001 and CE Marking and this results in an unfocused document fishing expedition often irritating the judge.
The improvement of product safety would be greatly helped if insurance companies better understood these products and asked for key information that could advise their judgments about exposure to risk. I would be happy to help create a screening process to aid in assessing their risk exposure.
My primary focus is on International Regulatory Compliance, which includes both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001 or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.
Posted at 01:29 PM in ANAB, Annex I Checklists, Ansi standards, ASQ, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Toys, CEN, CENELEC, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, EU Member States, European Commission, False CE Marking, food machinery, Forensic Law, GAP Analysis, Hazards Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Lawsuits, Product Safety Audits, Registrars, Risk Analysis, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Tags: ANAB, Annex I Checklists, ANSI Standards, ASQ, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Toys, CEN, CENELEC, Competent Bodies, corporate counsel, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Safty Requirements, EU Member States, European Commission, False CE Marking, food machinery, GAP Analysis, Hazards Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, New Approach Directives, Notified Bodies, plaintiffs attorneys, preventive law, product liability audits, product liability lawsuits, product safety audits, registrars, Risk Analysis, Risk Assessment, risk management, Technical File, trial attorneys
Holding Registrars And Notified Bodies Accountable In ISO 9001 Lawsuits
In several blogs I have mentioned the standard, ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems. In a previous blog, I reviewed working as Legal Expert in a lawsuit where ISO 9001: 2000 became a central focus of litigation between a US plaintiff and defendant. In this particular case, the opposing party stated that they did not have a recall or quarantine procedure for their products, further, they did not have records concerning the product in question.
The law student intern who first contacted me for the law firm said he thought that the opposing party was certified to ISO 9001. I replied that I could find out if they were certified and if they were, what records and documents could be obtained in legal discovery. After filing an Affidavit identifying the opposing party’s certification to ISO 9001 and identifying the records and documents we wanted to examine, their response was, “Oh those records!” The judge was not amused by their duplicity and ordered the company to produce the records and documents requested.
In their response, one of the corporations employees stated that he was the management representative and that he worked with all of the plants in question concerning this product. His statement resulted in a second Affidavit where I noted that his comment was interesting because management representatives usually report to a plant manager. However, since he worked with several plants involved in manufacturing the product in question, this meant that he was a management representative at the corporate level and reported to corporate management. It also meant that in addition to the plants being certified to ISO 9001 there was a corporate ISO 9001 certification.
The immediate response was no, we do not have corporate ISO 9001 certification, however, within a couple of weeks a full corporate Quality Manual, Procedures, Documents and Records were sent to our attorneys and “lo and behold”, there was a formal corporate recall and quarantine policy. By now the judge was approaching livid, not amused and quite angry.
Enter The ISO 9001 Registrar
The Registrar in this case was well known to me. I was familiar with their work as a notified body for the EU Medical Devices Directive and had recommended them to some clients who wanted to CE Mark their medical devices. They always acted professionally. I also was familiar with their work as a Registrar for ISO 9001 and had visited their US Registrar headquarters. Consequently, I was startled by their behavior vis-á-vis their client in this lawsuit.
ISO/IEC 17021: 2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems
To provide a basis for evaluating the behavior of the Registrar in this case, I wrote a Critique for the law firm to use in deposing the Registrar and consider bringing them into the lawsuit if their behavior could adversely affect the outcome of the lawsuit. The basis for such a move would derive from comparing their behavior with their client (the opposing party in this lawsuit) with the requirements of the International Standard (ISO/IEC 17021: 2006) that governs their behavior as a third party ISO 9001: 2000 Registrar.
In the Critique I stated my opinion that the Registrar violated its role as an impartial third party and instead:
1) chose to act on behalf of their client to deny access to information regarding the ISO 9001 certification status of their client;
2) chose to help their clients obtain a consultant to address the company’s certification to ISO 9001; and
3) chose retroactively to change the long standings certification status (seven years) of a company site during a lawsuit between the company and our client to help their client win their lawsuit.
This Registrar, along with all ISO 9001:2000 Quality Management System certification Registrars must abide by the requirements set forth in ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit and certification of management systems. This Critique will draw from the requirements of the standard to substantiate and highlight these points.
1.) When I called the US headquarters of the Registrar, I asked if the opposing party in this lawsuit was a client of theirs, if they had certified several plants and the corporate headquarters to ISO 9001:2000. I was told that they would have to consult with their attorneys to see if they could divulge such information. A few hours later I received a call stating that their attorneys advised them that such information could not be given without their client’s consent. (Basically, US attorneys are clueless about international compliance standards, unless informed of such standards by their clients.)
ISO/IEC 17021:2006, Clause 4.5 Openness
4.5.1 A certification body needs to provide public access to, or disclosure of, appropriate and timely information about its audit process and certification process, and about the certification status (i.e., the granting, extending, maintaining, renewing, suspending, reducing the scope of, or withdrawing of certification) of any organization, in order to gain confidence in the integrity and credibility of certification. Openness is a principle of access to, or disclosure of, appropriate information.
4.5.2 To gain or maintain confidence in certification, a certification body should provide appropriate access to, or disclosure of, non-confidential information about the conclusion of specific audits (e.g. audits in response to complaints) to specific interested parties.
2.) Certification bodies (e.g. Registrars) must maintain impartiality in their operations. Recommending an ISO 9001:2000 consultant to a client violates their duty of impartiality and creates a conflict of interest for the Registrar.
3.) The Registrar retroactively changed the long-standing corporate certification status of their client during the lawsuit to help the client win its case.
5.1 Legal and contractual matters
The certification body shall be a legal entity, or a defined part of a legal entity, such that it can be held legally responsible for all of its certification activities. A governmental certification body is deemed to be a legal entity on the basis of its governmental status.
5.2.1 The certification body shall have top management commitment to impartiality management system certification activities. The certification body shall have a publicly accessible statement that it understands the importance of impartiality in carrying out its management system certification activities, manages conflict of interest and ensures the objectivity of its management system certification activities.
5.2.5 The Certification body and any part of the same legal entity shall not offer or provide management system consultancy. This also applies to that part of government identified as a certification body.
5.2.1.2 All Certification by personnel, either internal or external, or committees, who could influence the certification activities, shall act impartially and shall not allow commercial, financial or other pressures to compromise impartiality.
5.2.13 Certification bodies shall require personnel, internal and external, to reveal any situation known to them that may present them or the certification body with a conflict of interests. Certification bodies shall use this information as input to identifying threats to impartiality raised by the activities of such personnel or by the organizations that employ them, and shall not use such personnel, internal or external, unless they can demonstrate that there is no conflict of interests.
What you have read is an abbreviated portion of my 16 page Critique of the Registrar for a lawsuit. We conducted some preliminary depositions and were preparing to return for more in depth depositions that would be used to bring the Registrar into the lawsuit, however, the opposing party signaled that they would like to settle the case. The results, of course, were sealed.
Most appalling in this case was the either the ignorance and indifference (or both) of the Manager of the Registrar who wanted to please a wealthy client, not realizing the liability exposure for his company. Further, the Registrar would face potential sanctions from ANAB (ANSI-ASQ National Accreditation Board), assuming that ANAB Registrar oversight is rigorous. Unfortunately, this is one of several times that I have watched third parties like Registrars or Notified Bodies demonstrate unethical behavior – the absence of a Moral Compass.
My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal Court. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding ISO 9001 or CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.
Posted at 05:29 PM in ANAB, ASQ, attorneys, Authorized Representatives, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, Competent Bodies, corporate counsel, Current Affairs, defense counsel, Enterprise and Industry, European Commission, HSE, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Lawsuits, Registrars, risk management, trial attorneys | Permalink | Comments (0) | TrackBack (0)
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The preceding four blogs discussed some of the problems I have observed with clients concerning private for-profit Notified Bodies and regulatory compliance with the three EU Medical Devices Directives. In the January 31, 2012 blog, I wrote the following paragraph concerning one possible alternative Notified Body approach to Medical Device approvals:
“Something akin to an FDA 510(k) also should be created with device efficacy built in as major requirement. It isn’t a perfect solution because the 510(k) predicate device requirement doesn’t always avoid device defects in design and materials, but it is overseen by FDA not a private third party.”
Presently, there is a move in the US House of Representatives supported by some Senators to ease medical device regulations for Medical Device Manufacturers, hypothetically to encourage innovation and speed devices to the market. Even though the US has just begun to emerge from the disaster of deregulation of the US economy that allowed financial institutions to run amuck and create the worst financial crisis since the Great Depression, a convoluted ideology continues to appeal, i.e., regulation is bad, deregulation is good! Political ideology is a powerful force, uninformed by scientific knowledge and intelligence. Teddy Roosevelt and Abe Lincoln would have been appalled.
The regulatory and enforcement problem afflicting CE Marking breast implant manufacturing and enforcement for the EU Medical DEvices Directives is different from the regulatory problem in the US, namely the weakness of the 510(k) approach. On February 1st my wife received the following correspondence from Jim Guest, the President of Consumer Reports.
“It's a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.
This isn't science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.
And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were "similar" to products already on the market.
Tell Congress we don't want to be guinea pigs anymore!
Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren't safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.
For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful 'revision' surgery.
It's time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!
The device industry has unleashed an army of lobbyists and they don't want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!
(Note: Consumer Reports is the largest and oldest independent non-profit testing and information organization in the US, serving only consumers since 1936.)
What are some of the problems with the 510(k)?
Today the 35 year-old 510(k) System is used by FDA to review 90 percent of medical device applications each year. After numerous problems and ongoing billion dollar lawsuits concerning 510(k) approved medical devices, in 2009 FDA commissioned the Institute of Medicine (IOM) to study the problem and report back to FDA, which they did in August 2011.
The [DePuy] ASR was constructed by borrowing a metal alloy cup from a different hip device known as the [DePuy] ASR Hit Resurfacing System and retrofitting it onto a standard hip implant. The manufacturer successfully made the case that the reengineered implant was “substantially equivalent” to a predicate device. Its marketing clearance was therefore based not on trials or other clinical data but on bench testing in a laboratory, which was inadequate to simulate the stresses that would be placed on it in patients’ bodies. It soon became clear that the device failed at the astonishing rate of at least one in eight. (Brett Emerson, Injury Board.com, October 20, 2011)
The metal-on-metal hip implants were found to shred minute metal particles into patients’ bloodstreams over time.
What Are The Institute of Medicine Recommendations?
To begin the IOM, recommended that the agency (FDA) ditch the program entirely and replace it with an “integrated pre-market and post-market regulatory framework. It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying again will not help, said David Challoner who chaired the committee that wrote the report. The 510(k) Process cannot achieve its stated goals – to achieve innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with statutes that govern how FDA must implement the process.
Eliminate clearance using multiple predicate devices, by which a new device can be cleared by demonstrating equivalence to device that was also cleared through equivalence, forming a chain of devices that were never clinically tested, and
Implement a formal post-market surveillance program.
The [IOM] report concluded that it was impossible for 510(k) clearance to assure safety and effectiveness, because it assesses neither, instead establishing only “substantial equivalence” to an existing device.
As anticipated, the medical device industry rose up to complain about the reforms even though billion-dollar product liability lawsuits are working their way through the courts right now and will cost medical device companies a substantial amount of money. Not to mention that patients who suffer pain from the existing device and need to have the devices explanted and a new device inserted with no clear indication of how the surgical costs will be covered.
My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in compromised product safety and product liability lawsuits. In particular, I focus on product safety, patient safety and the steps necessary to create a safe product. I would be happy to help. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.
Posted at 12:21 PM in Annex I Checklists, Ansi standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, Competent Bodies, corporate counsel, cosmetics, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, European Commission, False CE Marking, FDA Quality System Regulation, Forensic Law, GAP Analysis, Healthcare Regulation, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, pharmaceuticals, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, risk management, Technical Files, trial attorneys | Permalink | Comments (4) | TrackBack (0)
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In this blog I want to focus specifically on the Silicon Breast Implant controversy involving the breast implant manufacturer Poly Implants Prothèses (PIP) and the EU regulatory structure for CE Marking medical devices. In my preceding three blogs times I have noted several problems concerning medical device product quality. In the first blog I quoted former European Commission Vice President Martin Bangemen.
The idea of separating compliance into product quality and process quality seemed like a good and workable idea at the time. However, looking backward from 2012, the growth of the EU to 27 Member States and a population of 500 million people, the separation into product quality and process quality needs to be readdressed.
EU Medical Device Oversight Structure
Medical Device Product Quality
While 6 silicon breast implant manufacturers approved for 313 million people in the US might seem small, 80 to 120 silicon breast implant manufacturers for 500 million people in the EU is preposterous and beyond oversight. Further, FDA requires that US manufacturers must be able to continually demonstrate the efficacy of their medical devices. No such requirement exists in the EU.
Medical Device Product Quality Recommendations
All in all, Notified Bodies do a better job with process quality oversight, not perfect but better than their oversight of medical device product quality. Unfortunately, in their zeal to obtain business, some Notified Bodies could be accused of providing the best oversight money can buy.
Medical Device Process Quality Recommendations
Clearly it is time to revaluate the effectiveness of the approach for the manufacture of medical devices. I hope that some of my suggestions prove to be useful. As mentioned in my previous blog I would be happy to help. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits or medical device regulatory oversight you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.
Posted at 12:29 PM in Annex I Checklists, Ansi standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, European Commission, False CE Marking, FDA Quality System Regulation, food machinery, Forensic Law, GAP Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, pharmaceuticals, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, risk management, Technical Files, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Tags: Annex I Checklists, ANSI Standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical Devices, CE Marking Toys, CEN, CENELEC, Competent Bodies, corporate counsel, current affairs, defense counsel, EN Harmonized Standards, Enterprise and Industry, Essential Health and Safety Requirements, European Commission, False CE Marking, FDA Quality System Regulation, Forensic Law, HSE, IEC Standards, Insurance Companies, International Regulatory Compliance, ISO, ISO 13485, ISO 17021, ISO 9001, ISO 9001 Lawsuits, ISO Standards, Lawsuits, Litigation Risk ManagementLoss Control, Market Surveillance, MHRA, New Approach Directives, Notified Bodies, Pharmaceuticals, plaintiffs attorneys, preventive law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, QSR, Registrars, risk managementTechnical Files, trial attorneys
This is not to say that audits by Notified Bodies are treated lightly by medical device manufacturers rather it speaks to the legal authority of an FDA audit when compared to the legal authority of Notified Body audits. In addition to the audit example described in my previous blog where a Notified Body wrote good observations for a Class III medical device manufacturer but failed to issue non-conformities, did not serve their client well. Whether this was done to placate a client to retain their business isn’t clear. What it did accomplish was to prompt their client to ask me if I thought they would survive an FDA site inspection, to which I said no.
In contrast, FDA at the very least would have issued a Warning Letter and might even have shut down the facility until major changes were implemented. This is not the only case where I have observed a Notified Body conduct an “audit-lite.” A few other examples are listed below:
These are not idiosyncratic observations. While I have worked with several exceptional Notified Bodies administering CE Marking regulatory oversight for the EU Medical Devices Directives, they too have experienced glitches and these have been corrected when discovered. Clearly, strong Competent Body oversight is vital to the process.
As mentioned previously there also are Notified Bodies more motivated by making money than quality medical device regulatory oversight. A colleague of mine encountered one such Notified Body a few years ago when working with a company that manufactured active implantable medical devices. He helped the manufacturer meet with the FDA regional office and review their quality management system. He was then asked by the manufacturer if he would review their most recent Notified Body surveillance audit, which he did. They asked his opinion and he said it was inadequate, which angered the Notified Body.
The problem now is the immediate solution and the long-term solution. I understand the desire to create a strong EU structure while preserving national sovereignty. My political science and legal training tells me that it is possible, not easy but possible. I would be happy to help.
My next blog will conclude this series and specifically address the problem with the silicon breast implants and prospective solutions. My focus on International Regulatory Compliance has always included both the requirements of regulatory authorities and the legal implications of compliance, non-compliance, documentation and sloppy attention to detail that could result in a lawsuit in a US Federal courtroom. I also focus on product safety and the steps necessary to create a safe product. If you have questions regarding CE Marking lawsuits you can contact me for a free preliminary consultation at my e-mail address jameskolka@gmail.com.
Posted at 04:33 PM in Annex I Checklists, Ansi standards, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical, CE Marking Toys, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN harmonized standards, Enterprise and Industry, Essential Health and Ssfety Requirements, European Commission, False CE Marking, FDA Quality System Regulation, food machinery, Forensic Law, GAP Analysis, HSE, IEC standards, Insurance Companies, International Regulatory Compliance, ISO 13485 -- Medical Devices, ISO 9001, ISO 9001 Lawsuits, ISO standards, Lawsuits, Litigation Risk Management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, Preventive Law, Product Liability Audits, Product Liability Lawsuits, Product Safety Audits, Registrars, risk management, trial attorneys | Permalink | Comments (0) | TrackBack (0)
Tags: Annex I Checklists, ANSI Standards, attorneys, attorneys, Authorized Representatives, BIS, CE Marking, CE Marking Lawsuits, CE Marking Machinery, CE Marking Medical Devices, CE Marking Toys, Competent Authorities, Competent Bodies, corporate counsel, Current Affairs, defense counsel, EN Harmonized Standards, Enterprise and Industry, Essential Health and Safety requirements, European Commission, False CE Marking, FDA Quality System Regulation, HSE, IEC Standards, Insurance Companies, International Regulatory Compliance, ISO 13485, ISO 9001, ISO 900O Lawsuits, ISO Standards, Lawsuits, Litigation Risk management, Loss Control, market surveillance, MHRA, New Approach Directives, Notified Bodies, plaintiffs attorneys, preventive law, product liability audits, product liability lawsuits, product safety audits, QSR, registrars, risk management, trial attorneys