PA Law Blogs » Deborah Forrister

What is the Status of Biomet Metal on Metal Hip Replacements

Deborah Forrister — Tue, 20 Mar 2012 14:27:12 +0000

As of February 2012 Biomet M2a-Magnum Metal-on-Metal Hip replacement (Biomet hip replacement) has not been recalled. Yet, the absence of a medical device recall does not mean that patients and surgeons should accept a product’s safety without further examination.

Biomet Hip Replacement Has Similarities to Other Metal on Metal Hip Replacements

The FDA is currently reviewing the safety and effectiveness of all metal on metal hip replacements. As with other manufacturers’ metal on metal hip replacements, Biomet MoM devices work with metal balls that moves against metal cups. While metal on metal devices were designed to improve wear and extend the life of a hip replacement device, there is some concern that metal on metal hip replacements may fail earlier than other types of hip replacements and put patients’ health at risk.

Concerns About Biomet Hip Replacements Have Been Raised

The safety of metal-on-metal hip replacement by Biomet has been questioned. The number of adverse reports concerning Biomet hip replacements has increased over the past few years. Additionally, lawsuits have been filed alleging that these metal on metal hip replacements are prematurely failing and putting patients in pain and/or at risk.

While the FDA and others continue to investigate the safety of Biomet hip replacements, and other types of metal on metal hip replacements, it is important to talk to your surgeon about the device that is right for you and about what to do if you experience any complications.

What is the FDA Doing About Metal on Metal Hip Replacements?

Deborah Forrister — Fri, 09 Mar 2012 15:21:28 +0000

With some metal on metal hip replacements recalled and others causing concern, patients and members of the public may question what the FDA is doing about the potential problem of metal on metal hip replacements.

FDA Actively Working on Metal on Metal Hip Replacement Issues

According to the FDA, the agency is actively working to assess the safety and effectiveness of metal on metal hip replacements by:

Reviewing: risk-benefit profiles, utilization trends, patient selection criteria, pre-operative patient screening, surgical technique, follow up, revision rates, published literatures, adverse reports filed with the FDA, post approval study reports, data from orthopaedic device registries around the world, and retrieval analyses from hip system manufacturers.
Ordering: post market surveillance studies. 145 such orders were sent to 21 metal on metal hip replacement manufacturers in the spring of 2011.

The results of the FDA’s review have not yet been disclosed. Patients who have metal on metal hip replacements are encouraged to talk to their physicians about the risks, to promptly seek treatment for suspected complications, and to report any adverse events to the FDA so that the agency has all of the necessary data with which to make a safety and effectiveness determination for metal on metal hip replacements.

Everyone’s talking: hip replacement complaints

Deborah Forrister — Wed, 08 Feb 2012 21:19:33 +0000

Hip replacements are major surgery. What could be worse than going through a debilitating and painful hip replacement and then finding out the hip implant is being recalled?

What could be worse than finding out the hip replacement surgery you had a few short years ago requires another hip replacement now vs. the dozen or 15 years that was originally predicted?

These are some of the hip replacement complaints that victims of hip implants are coping with today.

Widespread hip replacement complaints include:

Crippling injuries caused by tiny particles of cobalt and chromium in the bloodstream and joints. These particles shed as they wear from metal on metal implants.
Limping, swelling in groin, swelling
Lack of general well-being

Hip implants are held in place by cement, plastic, or metal. Friction of joint surfaces wears away implant surfaces, creating tiny particles which loosen or destroy the bond holding the implant.

Bacteria may adhere to metal or plastic implants and serve as a breeding ground for infection.

A hip implant can migrate or pop out of its normal position affecting one in 50 patients.

Hip replacement surgeries are invasive and with anesthesia are always risks.

How and why does the FDA approve hip implants before testing them over the long term?

Why are people human guinea pigs for the hip implant manufacturers?

What are your hip replacement complaints?

Is Actos safe to use?

Deborah Forrister — Thu, 02 Feb 2012 17:43:02 +0000

Is Actos safe to use? That is a question you should be asking your doctor. That is a question you should be asking yourself as well. Sometimes doctors do not have all the answers.

Most diabetics have to be on medication long term unless perhaps they lose a lot of weight, diligently exercise, and change their lifestyle drastically. Most people are unable to do that.

So, most diabetics are on Actos long term. It’s the nature of diabetes. But is Actos safe to use?

On June 15, 2011, the FDA alerted the public that using Actos for more than one year may be linked with an increased risk of bladder cancer. Information about this risk would be added to the Warnings and Precautions section of the label for medicines containing Actos. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

Also in June 2011, the European Medicines Agency (EMA) was informed by the French Medicines Agency of its decision to suspend the use of Actos-containing medicines in France, while awaiting the outcome of the ongoing European review on the risks and benefits of some anti-diabetic medicines.

So there are precautions. But is Actos safe to use? This is the conversation you should be having with your doctor and healthcare team. Your doctor may say that the risk is small and the benefits outweigh the risk. Perhaps, except for those people who have been diagnosed with bladder cancer from taking Actos for more than one year, Actos was not safe to use.

Topamax & Pregnancy

Deborah Forrister — Mon, 30 Jan 2012 15:47:24 +0000

You’re pregnant. You’re having a baby. Congratulations abound. The first thing you should be asking yourself before painting the nursery or baby names is – Are the prescription drugs that you’re taking safe while being pregnant? Is the medication that you take to control epileptic seizures or migraine headaches safe to take while pregnant?

Is it possible to get pregnant while taking Topamax? Yes. Topamax has no effect on fertility.

However, if you were taking Topamax while pregnant, it may increase your baby’s chances for birth defects. Most women don’t even know they are pregnant right away and continue to take their medications as prescribed.

Do doctors who prescribe Topamax do their due diligence to inform women of childbearing age or women who are trying to get pregnant that taking Topamax while pregnant may cause birth defects like oral cleft palates?

Does the Topamax black box labeling sufficiently emphasize the taking Topamax while pregnant risk?

In March 2011, the FDA issued a statement that new data suggested the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy.

Before prescribing Topamax which is approved to treat certain types of seizures in people who have epilepsy, healthcare professionals should warn women of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug.

Do the benefits of taking Topamax while pregnant exceed the risks for oral birth defects?

Shocking News: DePuy hip replacement problems

Deborah Forrister — Wed, 18 Jan 2012 01:52:12 +0000

According to a recent article in the New York Times, experts estimate that the cost of hip implant failures will likely cost insurers, employers, taxpayers and others billions of dollars in the years to come.

DePuy hip replacement problems are included in the cost of hip implant failures although the makers of other hip implants have problems too.

Metal on metal or MoM hip implants have high rates of failures. Meant to last 15 years or more, some are lasting a few years. Worse, the wear and tear of metal on metal causes metal debris to go into the bloodstream and body tissues. The wear and tear of metal causes excessive pain and cobalt poisoning.

What are some DePuy hip replacement problems?

Receiving a letter from your doctor that you have a DePuy hip that is being recalled and needs replacement is frightening.
Surgical procedures are always risky as far as doctor error or medical malpractice, anesthesia error, bacterial infections, nursing and pharmaceutical errors as for dosing the wrong medications. Being in a hospital is a risk in itself.
The initial surgery was bad enough. What makes you the patient feel assured that the second one or replacement surgery will be better?
Last time the hip rehabilitation was longer and more painful than you thought possible. What will happen after the replacement surgery?
Will your employer give you more time away from work? What if you are no longer employed and no longer have health insurance?
The first time you had a DePuy hip replacement, your family went through much sacrifice caring for you. Are they willing to do that again? Does your spouse have to take time off work again?
Who is going to pay for high cost of medical bills and prescription drugs? Health insurance companies are not exactly standing in line to dole out money for medical procedures.
If health insurance doesn’t pay and DePuy doesn’t pay all the bills or all the bills in their entirety or in a timely manner, will you have to declare bankruptcy or lose your house and belongings?

These are just some DePuy hip replacement problems facing people who must have an implant remove and replaced. Medical device makers of hip implants are negligent and you the patient (or your loved one) must be compensated accordingly.

Death by Texting: Auto Crash Danger

Deborah Forrister — Mon, 12 Dec 2011 15:20:44 +0000

Too many people die in auto crashes involving texting.

Texting is an extracurricular activity that should never be done while driving a car. Texting while driving is avoidable.

Auto crashes involving texting happens because of stupidity.

Due to advancements in technology and inexpensive cell phone contracts/cheap prepaid phones—texting while driving is on the rise and increases day by day. A study by Virginia Tech Driving Institute revealed that those who resort to texting while driving are 23 times more likely to have an auto crash.

Texting while driving is about six times more likely to result in an accident than driving drunk.

How many people die in auto crashes involving texting?

Studies have found that texting while driving causes a 400% increase in time spent eyes not looking at the road.

On November 9, 2011 Pennsylvania Governor Tom Corbett signed into law a bill that bans drivers from sending or receiving text messages in Pennsylvania. This bill brought the total number of states with a texting while driving ban to 35. The new law makes texting behind the wheel a primary offense, meaning that police can pull over motorists for that violation alone. The ban takes effect on March 8, 2012; the fine is set at $50.

Will the texting while driving ban have an effect on auto crashes?

Pittsburgh Materials Technology Inc. Becomes Part of Thermacore

Deborah Forrister — Tue, 18 May 2010 21:23:49 +0000

When two companies share several common interests within their market, the potential of success in reaching a larger clientele often presents itself in the opportunity of combining both businesses. The sale of a Pittsburgh business should not always be associated with debt or inefficient management. Businesses in Pittsburgh thrive on growth and providing quality products and services to consumers. While not every PA business will agree to being sold to another company, these types of unions take place relatively frequently in Pennsylvania and throughout the United States to keep up with demand and competition.

A Pittsburgh Business Times article recently announced the sale of Pittsburgh Materials Technology, Inc. (PMTI) based in Jefferson Hills, PA, to Thermacore, Inc. in Lancaster. Based on the article, PMTI concentrates on the development of high-temperature metallic alloys, intricate metal joining, and other specialty materials for markets relating to aerospace, military, manufacture of electronic, production of metals, and energy.

In becoming a part of Thermacore, Inc., PMTI will play a role in the company providing high performance thermal management solutions to customers. Senior vice president and PMTI general manager noted in a written statement that the “union will allow us to reach customers on a global scale, and add our industry expertise to an already robust solution set.”

The United States Bureau of Labor Statistics notes that from 1995 to 2007, there were 31 union mergers that took place on a national level. When learning of a company’s union with another large business, concerned individuals often wonder if employment will be affected. While company mergers sometimes involve employee termination, this has reportedly not been the case for PMTI or Thermacore.

Pennsylvania Faces Same-Sex Legal Divorce Issues

Deborah Forrister — Tue, 18 May 2010 18:38:15 +0000

While the debate over same-sex marriage has not dissipated, even in states that have legalized the union of gay couples, the challenge of same-sex divorce seems to be on the rise. Some family law attorneys in Pennsylvania and throughout the United States have encountered several issues relating to same-sex couples that were married in one state and wish to divorce in another.

A CNN article discusses the frustration that two women have been experiencing in trying to get a divorce in Pennsylvania. Apparently, the women were married in Massachusetts, but had their petition for divorce filed in Pennsylvania, where a judge denied the divorce. This denial puts these specific women, and potentially several other same-sex married couples, in quite a challenging predicament. Since the two women are still legally married, neither one of them can remarry in the future, if they want to, until they are legally divorced. Some other issues of concern regarding the limitations of divorce for same-sex married couples relate to property rights as well as child custody and visitation.

Considering that only Washington, D.C. and five states have legalized same-sex marriage and permit divorces to take place when necessary, married same-sex couples who move to other states that do not recognize gay marriage or ban it altogether, may encounter various dilemmas if their marriage does not work out. Interestingly, Maryland does not permit gay marriage, but the state does acknowledge gay marriages that have been performed elsewhere. It has therefore been speculated that Maryland will be able to perform gay divorces.

To further complicate things in the U.S. regarding marriage and divorce for same-sex couples, courts in California are still addressing same-sex divorce cases from marriages that occurred during a brief period when gay marriage was legal in 2008.

While legally married gay couples do not receive the same recognition that all heterosexual marriages receive on a statewide level, this does not mean that gay couples do not encounter similar family law issues that heterosexual couples experience. Even though everyone may not agree on many of these family law subjects, a significant amount of citizens are being affected.

Harrisburg Employment Opportunities for Those with Disabilities

Deborah Forrister — Mon, 17 May 2010 19:27:21 +0000

Some individuals with disabilities in Harrisburg and throughout Pennsylvania sustained their debilitating injury while on the job. However, several of these afflicted individuals are highly motivated to find new employment or return to previous jobs despite their disability. The Pennsylvania Department of Labor & Industry recently announced that $4.2 million in grants is going towards the development of new plans and initiatives for bettering employment opportunities for those with major disabilities.

As a part of the American Recovery and Reinvestment Act, the new employment grant asks that vocational rehabilitation providers apply by June 11. The main goal of the initiative is for innovative and localized programs to be created based on successful and qualifying applicants’ proposals. A few programs that the Department of Labor & Industry hopes to create through additional funding include:

An expansion of employment readiness programs
Industry-integrated employment and training programs
Services for underserved/unserved Office of Vocational Rehabilitation customers who meet specific qualifications

As these programs begin to further develop, it will be interesting to see how opportunities for employment evolve for individuals with disabilities.

When a work accident in Harrisburg occurs, an employee may receive financial assistance through Pennsylvania workers’ compensation benefits. The type of benefits that an injured employee is entitled to greatly depends on the degree of the injury. For instance, if an injury results in permanent disability, such as paralysis or disfigurement, then a person may be able to obtain compensation for all necessary medical treatment, lost wages, and job re-training. An employee who is unable to work temporarily may be able to receive two-thirds of their average wage up to a determined amount. An employee who has sustained a catastrophic injury may want to consult with a Harrisburg workers’ compensation attorney who will ensure that accurate paperwork is filed appropriately and that the injured worker receives the benefits that he or she deserves to its entirety.