Engineering and the law-products liability for medical devices:federal preemption of state lawsuits

The basis of product liability lawsuits and a trend in the law that can protect medical device manufacturers from these lawsuits are discussed. Section 402(A) of the Restatement of Torts, the basis for liability laws in most states, is reviewed. The King vs. Collagen Corp. case, in which King, diagnosed with an autoimmune disease, claimed that the disease was caused by Zyderm, a modified cow protein that is injected under the skin to correct wrinkles, is also reviewed. King sued Collagen Corp. for selling a defective product and for failure to properly warn her and her physician of the risks of using the product and lost the suit     

Engineering and the law. The Supreme Court rules on medical deviceliability-or does it?

In previous articles the author has discussed the evolution of federal preemption for state products-liability claims against medical-device manufacturers. This is a controversial approach, and federal district and appeals courts have made opposing rulings on cases that are legally identical. Some courts have refused to allow any products-liability claims for devices, some have limited claims against only some devices, and some courts refused to limit claims in any cases. The United States Supreme Court has now reviewed this law to resolve the conflicts between the lower courts. The Court rendered its decision in Medtronic, Inc., v. Lora Lohr, 116 S.Ct. 2240, June 26, 1996. The Court did not find preemption in the case it reviewed, but neither did it clearly eliminate the chance of preemption in other cases. Ruling in a split decision, it assured that confusion will still reign     

Engineering and the law. Science in the Supreme Court: round two

Since the United States Supreme Court's 1993 decision in the Daubert case, federal judges have been looking more carefully at the scientific basis of the expert testimony presented in their courtrooms. Medical-device litigation, especially that over the alleged harm caused by breast implants, has been at the center of this rethinking of the role of the court in assessing scientific evidence. Cases that were about to settle for a total of more than $4 billion are now being seen as potentially groundless. One judge in Oregon dismissed a group of breast-implant cases. Finding there was no scientific basis for the plaintiff's claims. Another court, overseeing a large group of cases, has appointed an independent panel of experts to determine if the plaintiff's experts will be allowed to testify. As in the Oregon breast-implant cases, the exclusion of a plaintiff's expert witness often means the court must also dismiss the plaintiff's case. Plaintiffs have appealed these decisions, arguing that since the trial court's exclusion of their expert's testimony ends their case, the appeals courts should strictly review the correctness of the trial court's decision. In GE vs. Joiner, decided December 1997, the United States Supreme Court established the proper standard for appellate review of decisions by trial courts to exclude evidence     

Engineering and the law: pillorying well-stocked scientists

Previously (ibid., March 1993, March 1994, May 1994) the authors discussed the conflict between headline-seeking reporters, and zealous scientists at the Office of Research Integrity seeking to convict high profile researchers of misconduct. The authors also discussed the rights of the researchers to a fair hearing on the charges against them. Here the following topics are discussed: responsibilities of the Director; responsibilities of the Policy and Education Division; responsibilities of the Research Investigations Division; misappropriation of NHS funds and the ALERT system; protecting whistleblowers; how to avoid trouble     

Engineering and the law [custodians of information]

The control of valuable technical information determines its beneficiaries. The “owner” may exploit the information for a profit or share it with colleagues and the general public. When used for a profit, benefits focus on monetary considerations and the narrower interests of the “owner” of the information. When information is in the public domain, benefits extend to everyone. Information, of course, exists whether there is an “owner” or not. Until discovered, information “belongs” to everyone but can be used by no one. After discovery, the ownership of the information does not change, but who can use it does. Thus, one who discovers information becomes its first custodian, but not its owner. In his thoughtful “GNU Manifesto” (1985), Professor Richard Stallman, a well-known computer scientist, points out that the desire to be rewarded for one's creativity does not justify depriving the world of that creativity, and that creativity is a social contribution only insofar as society is free to use the results. Indeed, if the initial custodians of valuable information deserve to be rewarded for their creativity, they also deserve to be punished if they restrict the use of it. Nevertheless, most legal systems recognize at least 3 methods for the control of information. Trade-secret law recognizes the right of the first custodian of information to keep the information secret and be protected from misappropriation by a subsequent custodian of the same information. The first custodian of information comprising a significant advance in a useful art is permitted to use the information as embodied in the specific advancement exclusively for a period of time in return for disclosing it promptly to the public in a patent     

Engineering and the law: the False Claims Act and scientificmisconduct

In previous articles, we have discussed the investigation and punishment of misbehaving scientists by the Office of the Inspector General (OIG) of the Department of Health and Human Services. While these were often characterized by the “Alice in Wonderland” notion of punishment before verdict, the actions of the Appeals Boards in overturning several egregious claims was heartening to many scientists. In this article, we discuss a new avenue for punishing miscreants/pillorying the innocent: The False Claims Act (FCA). Topics considered include: i) history of the FCA, ii) what is a claim? iii) when is a claim false? iv) but I did not mean to cheat, and v) what is the penalty?     

Engineering and the law: the Biomaterials Access Assurance Act of1998

Congress passed legislation protecting suppliers of bulk components and raw materials for implants from law-suits, The legislation is called the Biomaterials Access Assurance Act of 1998 (BAAA). The BAAA applies to all implant raw materials and components except the silicone gel and the silicone envelope utilized in a breast implant containing silicone gel. The new law supersedes otherwise applicable state laws and procedures by precluding any civil action, regardless of the legal theory upon which it is based, for harm, other than commercial loss or loss of or damage to an implant, caused by an implant. The BAAA was passed in response to a serious problem: the embargo by manufacturers of bulk biomaterials such as silicone gel and Teflon. This embargo arose from some legal decisions making the suppliers of bulk biomaterials liable for injuries allegedly caused by finished implants. Unfortunately, Congress and the President lost sight of the original goal in the flurry of lobbying by plaintiffs' lawyers and component-part manufacturers. The result is a bill that provides a much broader umbrella than is necessary to protect biomaterials suppliers, and no protection for suppliers of silicone gel, one of the bulk materials that led to the legislation     

An Internet-based system for the commerce of medical devices. A portal for improving communication between healthcare professionals and the medical device industry

The MEDIDEV service combines a central product catalog featuring basic information with Internet-connected websites and online catalogs hosting the detailed information. This approach is compatible with the manufacturers' requirement to maintain control over the detailed information of their products. At the same time, it allows the end user to efficiently choose from a potentially long list of products-those which mostly satisfy his requirements-and then to get more detailed information in the corresponding linked websites and on-line catalogs. The manufacturers have two alternative ways for updating the information stored in the Portal. They can use a human-operated and HTML-based interface or an automated and CORBA-based interface. Thus, the timeliness and consistency of the Portal information is ensured. The adoption of Internet standard technologies (Java, CORBA, XML) has maintained a high level of platform independence and interoperability. The current version has been developed for Windows NT, while the final version is currently ported to a HP UNIX machine. Special care has been taken to support both major Internet browsers: Internet Explorer and Netscape Navigator. The implementation of XML for the data presentation has led to a reduced and optimized transmission of data from the Portal to the user's browser. Only the new data are transmitted as XML documents each time, while formatting information is once loaded at the browser. The separation of data from the formatting information leads to another advantage. It is a common practice today for horizontal portals, which are targeting a wide variety of interests, to subcontract content from other, more specialized portals or sites (vertical portals). The MEDIDEV Portal can provide its data to other sites as XML documents that will be parsed and displayed with their own look and feel. This opens up new marketing opportunities.     

The medical device industry and the biomedical engineer: currentstatus and future trends

The role of new and existing technology in the development of medical devices is examined. The impact of competition and economic and regulatory pressures is assessed. The identification of clinical needs is discussed. These include the needs to reduce liability, find less invasive alternatives to surgery, improve the quality of life, and prevent disease. Career opportunities are considered in some detail.     

An overview of FDA medical device regulation as it relates to deep brain stimulation devices.

The United States Food and Drug Administration (FDA) is charged with assuring the safety and effectiveness of a variety of medical products and the FDA's Center for Devices and Radiological Health is responsible for premarket and postmarket regulation of medical devices. In this paper, we review--from device classification and clinical studies to the final marketing application--FDA's premarket requirements and postmarket requirements as they relate to deep brain stimulation devices.     

铅价格对铅供应与蓄电池企业的影响

几年来,铅价长时间居高不下并且保持稳定,使铅酸蓄电池生产商受到极大的影响,企业在容纳成本的同时不得不自己消化大部分由于铅涨价所造成的费用增长,利润几乎消失殆尽.由于近几年铅矿供应大大减少,而需求却依然旺盛,需要二次铅的生产也参与进来以平衡供应.许多发达国家的废铅回收设备已经在高速运行,只有在发展中国家例如:中国和印度的二次铅市场还有待加强.在这样的形式下欧洲蓄电池企业进行了并购与重组运作,同时也将生产企业迁移至低生产成本地区,我国蓄电池行业在重组并购的同时,着重进行提高生产技术和产品改进的运作.     

日本小型二次电池及主要厂商概况

综述了日本小型二次电池产业的发展概况；介绍了主要厂商三洋电机株式会社、索尼株式会社和松下电池工业株式会社近几年的经营状况、主要产品、产品发展策略、近期动向和投资情况；分析了主要厂商未来的发展及前景。     

Addressing myths of science and public policy in the United States.1

This is the first part of an essay on developmental trends in science, technology and technology policy as they appear at the onset of the 21st century. These subjects are first surveyed to depict recent changes in the structure of industry, university, and government (the three major players in this arena). These changes represent substantial shifts in the way we do business and in the very nature of the business we do. Other changes are the result of self-perception, or misrepresentation of the role of each of the three primary agencies in the science economy. This misrepresentation may be the result of competition for access to resources (such as access to the highest level of skilled staff, or enhanced government funding), or for reasons as mundane as simple ego gratification. In any event, these misperceptions seriously impede our ability to formulate programs addressing real societal needs.     

Expanding the scope of the IEEE Transactions on Rehabilitation Engineering to explicitly include Neural Engineering.

The original scope of this Transactions implicitly gave it wide latitude to include all aspects of biologically based Neural Engineering. The Transactions now has an additional explicit charter to target Neural Engineering and its links to rehabilitation, from the very basic science to the highly engineered design application. This Transactions will become a prime repository for the emerging field of Neural Engineering, without losing its rehabilitation roots.     

Comparison of Ampere's circuital law (ACL) and the law ofBiot-Savart (LBS)

Ampere's circuital law (ACL) and the law of Biot-Savart (LBS) are applied to the computation of the magnetic flux density at the center of the square loop. The results are compared and some common misunderstandings of students are clarified. It is seen that LBS is general and applies to closed or open circuits. In the case of open circuits, care must be exercised in applying the ACL. Here, two choices present themselves; one is to use a modified form of ACL appropriate to the problem at hand and the second is to use ACL in its generalized form, which takes into account the inevitable charge accumulations     

Engineering and the law-employment obligations. I. Duties of anemployee to his employer

Problems that arise in connection with duties to the current employer(s) are discussed. Current employment law evolved from the feudal relationship between lords and peasants. An employee has a fiduciary duty toward his employer; this is a common law duty deriving its name from the duty of fides, or fidelity, between the master and the servant. In the case of a scientist or engineer employed to conduct research and/or development for a company or university, fiduciary duties obligate the employee to offer all benefits of the work he conducts for the employer to the employer. A scientist or engineer with interests that are adverse to a potential employer must disclose the existence and extent of such interests. An employee has a duty not to compete with his employer concerning the subject matter of the employment; this duty has been documented extensively in legal cases. An employee also has a duty not to act, or agree to act, for third parties whose interest conflict with those of his employer.     

Engineering and the law-engineering obligations. III. Who is anindependent contractor?

For pt.II see ibid., vol.9, no.3 p.72 (1990). The following topics are discussed: implications of an employee's status; independent contractors; classifying employees.     

A simple device to monitor flexion and lateral bending of the lumbar spine.

Monitoring compliance with exercise and motivating patients with lower back pain to perform prescribed exercise regimens are considerable tasks. The objective of this study was to develop and test a low-cost device that can be used by a patient at home to both record and provide real-time biofeedback of lumbar position in the midsagittal and frontal planes during exercises. Our device utilizes strain gages on a thin stainless steel beam to measure lumbar flexion-extension and an optical mouse sensor attached to the end of the blade to measure lateral bending. In comparison tests with a standard electrogoniometer, our device was shown to be accurate within 3 degrees in both the sagittal and frontal planes in healthy subjects. Furthermore, users were capable of reapplying the device themselves and obtaining measurements that were repeatable within 4 degrees in both planes. The capability of this simple device to accurately measure lumbar spine position in a nonlaboratory setting makes it well suited as a tool for providing feedback on exercise performance to both patients and clinicians.     

Effects of lithography non-uniformity on device electrical behavior. Simple stochastic modeling of material and process effects on device performance

Understanding how lithographic material and processing, affect linewidth roughness (LWR), and finally device operation is of immense importance in future scaled MOS transistors. The goal of this work is to determine the impact of LWR on device operation and to connect material and process parameters with it. To this end, we examine the effects of photoresist polymer length and acid diffusion length on LWR and transistor performance. Through the application of a homemade simulator of the lithographic process, it is shown that photoresists with small polymer chains and small acid diffusion lengths form lines with low LWR and thus lead to transistors with more reliable electrical performance.     

推行岩土工程体制,降低工程造价与勘探成本

推行岩土工程体制,在确保给定的安全水平条件下达到综合造价最低的目的。