Recently in Medical Devices Category

February 7, 2013

DePuy ASR Hip Implant Recall

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Over 10,000 lawsuits have been filed against the company Johnson & Johnson for their distribution of the DePuy ASR hip implant, since a recall was issued in August 2010. The DePuy ASR hip implant has a metal on metal design, which means that a metal head rotates within a metal cup. This design causes metal debris, caused from the metal parts rubbing against each other, to be released into the surrounding tissue and cause medical problems. The failure occurs within five years of replacement.

When the recall was first issued, Johnson & Johnson stated that the failure rate was only about 13%, but after documents were released as part of the litigation, it was estimated that the failure rate of the DePuy ASR hip implant is as high as 37%. This means that one out of every eight DePuy ASR hip implants were failing within five years of replacement surgery.

There is currently a case going on in California against Johnson & Johnson for the marketing, manufacturing and sale of the defective DePuy ASR hip implants. It is being said that the company failed to properly warn the public, as well as healthcare professionals, about the risk of loosening and other complications that may develop shortly after hip replacement surgery.

In testimony in the current case being heard in California, a DePuy engineer testified that Johnson & Johnson only tested one angle of implantation and that the company failed to use the right engineering controls when trying to assess potential problems. The engineer further stated that the testing conducted failed to predict how much wear the hip implants would experience and how much they could loosen.

The FDA released a new guidance for metal on metal hip replacements in January of this year. Doctors were advised that metal on metal hip replacement systems should only be used if other artificial hip implants were not appropriate for the patient, and called on all manufacturers to prove that their implants are safe enough to stay on the market. Also, future metal on metal hip designs will have to undergo extensive human clinical trials before being made available for sale to the public.

July 12, 2011

Basis for Product Liability Legal Claims

When consumers make purchases they expect them to function properly and safely. It is when the purchased defective item causes injuries and illnesses that there are basis for product liability lawsuits. Some of these items are: automobiles, prescription drugs, beauty products, frozen foods, automobile parts and tires, etc.

When Manufactures realize that a product is defective they issue out a recall of that item to consumers. However, recalls do not always keep the consumer safe.

Product liability claims are based on the theory of negligence. The manufacturer has a duty to exercise a reasonable standard of care for developing a particular product, and has failed to do so; thus resulting in harm to the consumer. When making a negligence claim, the injured consumer must prove that the defective product was the actual and proximate cause of the injury. One must show that had it not been for the defective product, the injury would not have occurred. The manufacturer should have foreseen the danger and risk when it sold the product.

Design defect, failure to warn/improper labeling and manufacturing defects are the most common scenarios that form the basis for a product liability claim.

Product liability claims can also be based on the following legal theories:
- Breach of Warranty - failure to fulfill terms of a promise or claim made regarding the quality and safety of a product. A manufacturer must guarantee certain warranties on products sold and needs to be held accountable when they are breached;

- Strict Liability - responsibility of the manufacturer to all consumers who might be injured by a product and does not require the injured consumer to prove negligence. The consumer only needs to prove that the product was defective and therefore cause the injury, therefore; making the product unreasonable defective and dangerous. The designer, manufacturer, distributor and seller of the defective product can and should be held liable for the injury and illnesses cause to the consumer.

- Misrepresentation - when a manufacturer gives the consumer false or misleading information on the safety and reliance of a product. When the consumer relies on this information and is harmed, they can recover money damages.

A consumer can also contact the Consumer Product Safety Commission for further details and advice.

May 17, 2011

To Prevent Hospital Infections the FDA is Proposing New Guidelines For Cleaning Medical Devices

Endoscopes.bmpThe U.S. Food and Drug Administration (FDA) is proposing new guidelines for the cleaning of reusable medical equipment, which if not done properly, can cause infections at hospitals and other medical facilities and doctors offices.

The new guidelines would require manufacturers to provide detailed instructions on how to clean any medical device that will be reused on multiple patients, properly. The guidelines would also provide cleaning instructions of those devices for health care professionals.

These guidelines are being implemented because when these instruments are not cleaned and/or sterilized properly, they could carry bodily fluids and other materials from one patient to the next and therefore; cause infections. These infections can be life threatening and should be avoided, and with these new guidelines, they could potentially be avoided.

A report released by the FDA, from January 2007 to May 2010, they received 80 reports of inadequate cleaning of endoscopes and 28 reports of hospital acquired infections that were most likely spread by endoscopes. Endoscopes are small cameras that are inserted into the body. They are most commonly used in colonoscopy procedures, but can also be used on ears, nose and throat procedures.

The FDA has a public workshop scheduled for June 8 and 9th of this year, to discuss the draft guidelines with manufacturers, health care providers and other government agencies, after which, the FDA would draft a final guidance. Guidance are recommended procedures that are recognized as federal standards.


March 14, 2011

What is the Real Cost of Health Care Fraud?

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The National Health Care Anti-Fraud Association (NHCAA) defines health care fraud as an intentional deception or misrepresentation that the individual or entity makes knowing that the misrepresentation could result in some unauthorized benefit to the individual, or the entity or to some other party.

In the United States, it is estimated that almost $226 billion a year are spent on health care fraud. That is 10% of the nation's health care expenditure. Therefore; consumers have higher premiums and out-of-pocket expenses, also reduced benefits and coverage. As for employers, they have increases in the cost of providing insurance benefits to their employees, as well as increasing the overall cost of doing business.

The Coalition Against Insurance Fraud claims that two out of five Americans want little or no punishment for insurance cheats. Consumers blame the insurance industry for its fraud problems because they believe insurers are unfair.
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The Journal of the American Medical Association, claims that almost one-third of doctors exaggerate the severity of a patient's illness to help the patient avoid early discharges from a hospital.

Categories of Fraud:
- Hard Fraud - this occurs when someone purposely plans or invents a loss. For example: staged automobile accidents. The "victim" obtains an attorney, who in turn refers the victim to a physician. The physician then submits charges to the insurance carrier and refers the victim for additional physical therapy. The physical therapy physician then also submits charges to the insurance carrier.
- Soft Fraud - this occurs when policy holders exaggerate a legitimate claim. For example: receiving treatment for a slip and fall accident on 2/1 and submitting that claim to insurance carrier and then changing that same service charge to 2/4 and resubmitting the claim.

The most common fraudulent acts are:
- The billing of late charges by a hospital
- False durable medical equipment claims (DME)
- Behavioral health fraud
- Medical identity theft
- Billing for services, procedures and/or supplies that were never provided or performed
- The condition treated or the diagnosis made
- The charges for services, procedures and/or supplies provided or performed
- The deliberate performance of medically unnecessary services for the purpose of financial gain

The cost of insurance fraud is factored in to the premiums we all pay. In order to lower these premiums, the laws against health care fraud must be tougher. Penalties must be instituted by both federal and state governments. As of the year 2010, only 40 state fraud bureaus exist. In order for health care fraud to be less common and less costly for each citizen in general, each state should have a fraud bureau. It is easier to prevent fraud than to recover payments once they have been made.

We, as consumers, can also do our part to lower health care fraud. We must never sign a blank insurance form. We must comprehend all claim forms we complete. We must request detail bills, or HICFA/UB 92 billing statements and we must always keep our insurance information confidential.

If you need to report health care fraud, please call your insurance company immediately. Also, contact your state insurance fraud bureau and file a complaint with the State Medical board.

April 29, 2010

Medical Errors Are Costly and On the Rise

Research has shown that medical errors may result most frequently from system errors. One out of 25 patients in hospitals are injured due to medical errors, and an estimated 48,000 to 98,000 patients die from these errors a year. Even if you consider the lower estimate of 48,000 errors a year, it is still higher than the annual mortality from motor vehicle accidents (43,458), breast cancer (42,297), or even AIDS (16,516), thus making medical errors the eighth leading cause of death in the United States. These errors, besides causing death, have also cost the economy from $17 to $29 billion each year and cost more that $5 million a year in large teaching hospitals, according to the Agency for Healthcare Research and Quality (AHRQ).

For Patients at Risk, Medical errors may result in the following:

- A patient being given the wrong medicine
- A clinician misreading the results of a test
- An elderly person that shows up to an emergency room with ambiguous systems, such as: shortness of breath, abdominal pain and dizziness, whose heat attack is not diagnosed by the medical staff

How Errors Occur:
- Medication Errors:
These are preventable mistakes in the prescribing and delivering of medications to a patient, these errors include: prescribing two or more drugs whose interaction is known to produce side effects or prescribing a drug to which the patient is allergic to.
- Surgical Errors
- Diagnostic Inaccuracies:
This leads to ineffective treatment and/or unnecessary testing, which is costly and can be invasive to the patient.
- System Failures:
This is the way health care is delivered and the way that resources are provided to the delivery system.

Medical Mistakes are also made by distracted nurses. It is believed that if medical facilities had more nursing staff that could focus their attention on fewer tasks at a time that medical mistakes would decrease, patient safety increase and it would reduce the risk of medical malpractice. When nurses are interrupted, it increases the chance of a procedural failure by 12.1%, and the chances of a clinical error by 12.7%, as indicated by the Archives of Internal Medicine study published in Australia in 2008.

April 20, 2010

Hospital Acquired Infections on the Rise

The Centers for Disease Control and Prevention (CDC), reports that there are over 2 million hospital infections acquired each year, resulting in almost 90,000 deaths annually. This number is much higher when dealing with nursing home infections.

It is because of this huge number of yearly deaths that Medical Malpractice lawsuits have increased in the United States. Experts believe that these potentially life threatening infections can be prevented if steps are taken by hospitals and their staff. The steps that need to be taken should include: improving the methods of handling catheters during insertion, leaving them in for shorter periods of time and improving hygiene. Also hospital staff should was their hands more frequently and make sure to keep areas more sterile and catheters clean.

The hospital acquired infections include Postoperative sepsis, catheter-associated urinary tract infections and other preventable infections. Hospital stays are prolonged because of these avoidable infections and patients are also more likely to die from these infections, according to the U.S. Department of Health and Human Services (DHHS) 2009 National Healthcare Quality Report released earlier this year.

The biggest increase of hospital acquired infections occurred in sepsis infections. Sepsis is when a full body inflammation occurs as a reaction to an infection. Symptoms of sepsis include high heart rate, high respiratory rate, high and/or low body temperature and elevated white blood cell count. All of these symptoms can cause organ damage and in some cases organ failure, which lead to death in about 20 to 35% of cases.

Hospitals in the Washington Metropolitan Area, such as Washington Hospital Center (WHC), George Washington University Hospital (GWUH), Sibley Memorial Hospital (SMH) and Georgetown University Hospital (GUH), are making much needed changes to try and reduce these infections and deaths in order to avoid Medical Malpractice Lawsuits. These medical facilities are devoting more attention to patient safety in order to ensure that health care does not result in patient harm.

April 7, 2010

Human Factors Experts Testimony in Product Liability Cases Is On the Rise

The Food and Drug Administration (FDA) has regulations, guidance documents and industry standards in relation to the use of human factors experts, which allow for more effective cross-examination and a strong defense in Product Liability Cases. With these regulations, human factors not only base their expert opinion on speculation, but also on facts.

You may be asking yourself, what are Human Factors, well it is the study of the relationships between humans, the tools they use, and the environment in which they live and work.

It is with these tools that human factors experts are allowed to testify in cases to provide opinions regarding the adequacy and efficacy of warnings and/or the impact of human factors in the design of products. The Expert must be able to identify a reliable scientific basis for his/her opinion to be used as testimony. It is the goal of the human factors professional to eliminate user error through proper product design and labeling.

Medical devices that are designed by the FDA are designed with the human factor principles in mind. According to the FDA manufacturers must use the following three device classes/guidelines when manufacturing a device for human use:

- The Manufacturer must consider human factors in the development of the device. Such things as what the user sees, feels and hears;
- The Manufacturer must test all devices for the potential in error use by the user;
- The Manufacturer, when conducting risk analysis of the device, must consider user error.

These three device classes must all be subject to good manufacturing practices (GMPs) and these can be found in its Quality System Regulations. It is imperative that the medical device withstand the actions and inactions of its intended user, in order to design an error-tolerant medical device. It is important that the developer consider the characteristics of the worst case user. It is this underlying philosophy that human factor experts are used for.

These Human Factors Principles are also embraced by the Association for the Advancement of Medical Instruments (AAMI), the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO)