Defective Implanted Defibrillator Leads

A common procedure for people with irregular or unusual heart rhythms often receive defibrillators implanted into their chest to provide a necessary shock to maintain a healthy heart rhythm whenever necessary. It was a big, and unwelcome, surprise when the manufacturer, Medtronic, announced last year that their Sprint Fidelis leads were malfunctioning at rates that were higher than other leads. These defective leads were pulled from the implant market but cannot be changed or removed without a real risk of harm to the patient. Numbers vary depending on the source, but in the range of 87.9% to 94.3% of the leads are still in place in patients.

In May of 2009, the Heart Rhythm Society, an American cardiac physicians’ group representing MDs who implant and extract defibrillators and their associated leads, issued policy statements calling for hospitals to better police the experience and training of the surgeons who extract defibrillator leads. This is especially important given the risk to the patient to remove or change these defective leads. HRS also issued a statement calling for companies that produce the leads to do be more accountable in the tracking the performance of their devices once they’re on the market.

A legal nurse consultant can provide information for a case where there may be a suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed. One of the questions that must be answered is the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to be determined in Canada, the training and experience of the physician may be relevant to the injury. Legal nurse consultants for the defence may be able to raise the level of experience as an avenue of defence of the doctor. Legal nurse consultants for the plaintiff will question the lack of experience of the physician as evidence of negligence.

The incidence of medical device failure is a serious one. And is definitely the type of case requiring the expertise of a legal nurse consultant.

What role could a nurse have in a law firm?

Canadian nurses have discovered a new area of specialty-- legal nurse consulting. It can be the best of both worlds for an experienced RN. She can use her established knowledge and skills in a whole new way. She can explore employment options outside of shiftwork. She can remain an important member of a professional team that can make a difference.

Here is how a nurse works within the team:

*Strategizes with the legal professional for successful resolutions between parties involved in health care-related litigation or other medical-legal or health care-legal matters;
*Educate attorneys and/or others involved in the legal process regarding the healthcare facts and issues of a case or claim;
*Research and integrate healthcare and nursing literature as it relates to the healthcare facts and issues of a case or a claim:
*Review, summarize, and analyze medical records and other pertinent healthcare and legal documents and comparing and correlating them to the allegations;
*Assess issues of damages and causation relative to liability within the legal process;
*Identify, locate, evaluate, and confer with expert witnesses;
*Interview witnesses and parties pertinent to the healthcare issues in collaboration with legal professionals;
*Draft legal documents in medically related cases under the supervision of an attorney;
*Develop collaborative case strategies with those practicing within the legal system;
*Provide support during discovery, depositions, trial, and other legal proceedings;
*Support the process of adjudication of legal claims.

Source: AALNC

Another Diet Pill Recall Alert

According to a May 1, 2009 news release by attorneys at Morgan & Morgan, the Food & Drug Administration (FDA) issued a warning to consumers to immediately stop using Hydroxycut products. Hydroxycut products, dietary supplements manufactured by Iovate Health Sciences, Inc., have been linked to serious liver injuries and at least one death. The products were sold in Canada as well.

This recent example in the product liability field is within the expertise of the legal nurse consultant as part of the legal team. Legal nurse consultants are not hired to know the law but rather to understand the injury, what caused it, its extent and how it could have been prevented. Once the free legal consultation has been completed, the legal nurse consultant can piece together vital pieces of information to assist the attorneys in evaluating the merit of each case.

Nurses have specialized knowledge and resources to assess the risks and benefits of a product, whether it was regulated and for what particular use, identify common off label uses of a product, explore the history of the product and the side effects that have been reported as well as personal patient histories which might have affected the outcome with this product. Then they can assist in the preparation of cases for legal teams faced with a large scale recall within the healthcare-related industry.

What is a legal nurse consultant?

The legal nurse consultant is a licensed registered nurse who performs a critical
analysis of healthcare facts and issues and their outcomes for the legal profession,
healthcare profession, and others, as appropriate. With a strong educational and
experiential background, the legal nurse consultant is qualified to assess adherence to standards of healthcare practice as it applies to the nursing and healthcare professions.
There is a diversity of practice settings and services performed by legal nurse
consultants nationwide.

The legal nurse consultant practices the art and science of this nursing
specialty in a variety of settings, including law firms, government offices, insurance
companies, hospital risk management departments, and as self-employed practitioners.
The legal nurse consultant is a liaison between the legal and healthcare communities and
provides consultation and education to legal, healthcare, and appropriate other
professionals in areas such as personal injury, product liability, medical malpractice,
workers’ compensation, toxic torts, risk management, medical professional licensure
investigation, and criminal law.