PA Law Blogs

Why are Metal on Metal Hip Joints Dangerous?

Michael Monheit — Sat, 04 Feb 2012 02:17:37 +0000

Metal on metal hip replacements were designed to decrease the number of fractures suffered by hip replacement patients and to avoid other potential problems. However, in the past few years reports of potentially serious metal on metal hip replacement complaints have been reported.

The primary concern about metal on metal hip replacements is that tiny particles of metal may be released into the body as the metal parts of the replacement hip joint rub together when the patient moves. These metal particles can damage the bones and joints around the replacement which can then cause the replacement to fail and/or cause the patient pain. Additionally, it is possible that metal may be released into the bloodstream which may affect different parts of the body such as the heart.

So, are metal on metal hip joints dangerous? For some patients they may be and that is why you should talk to your orthopedic surgeon about your hip replacement options or about how to monitor the metal on metal hip replacement you already have implanted.

7 Serious Vaginal Mesh Side Effects That Could Change Your Life

Michael Monheit — Sat, 04 Feb 2012 02:15:02 +0000

You consent to vaginal mesh surgery with the expectation that it will improve your life. Yet, after surgery you find that you are suffering from problems you didn’t anticipate.

Not every patient experiences vaginal mesh side effects, and not every patient who does experience side effects from trans-vaginal mesh has the same problems. Yet, the following side effects are common and are important to know about if you have had, or if you are considering, transvaginal mesh surgery:

Dangerous Infections.
Internal bleeding.
Vaginal scarring or wall narrowing.
Mesh erosion through the vaginal tissues.
Significant Pain.
Painful sexual intercourse.
Recurrence of the prolapsed or incontinence or both.

If you have had transvaginal mesh surgery, please talk to your doctor about the symptoms you should report and about your risks. Additionally, contact an experienced medical device attorney who can advise you of your legal rights and help protect your recovery.

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.

Risky business: Diabetic Clinical Trial Ends Abruptly

Michael Monheit — Mon, 30 Jan 2012 21:09:51 +0000

Late last year Novartis announced termination of ALTITUDE study with Rasilez®/ Tekturna® in high-risk patients with diabetes and renal impairment; 8,609 patients from 36 countries were involved.

There was an increased incidence after 18-24 months of non-fatal stroke, kidney complications, hyperkalemia (high potassium levels) and hypotension (low blood pressure) in the diabetic high-risk study population.

According to the press release put out by Novartis, following the seventh interim review of data from the ALTITUDE study with Rasilez®/Tekturna®, a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC).

The DMC noted that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial.

As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.

Patients involved in the ALTITUDE study should have contacted their study site for guidance on medication but should not stop treatment until they have seen a doctor who can help control high blood pressure.

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?

Reasons To File A Lawsuit After A Car Accident

Jackie Fedeli — Wed, 25 Jan 2012 19:57:23 +0000

Every Five seconds, there is an automobile accident somewhere in the United States. Half involve some sort of injury. Your First thought after an auto accident might be to call your insurance company and let them handle all of the details. For some this may be the best option. Others may contact an attorney to file a lawsuit against the negligent driver on their behalf. If you were involved in an auto accident, you may want to ask yourself what are the reason to file a lawsuit after a car accident?

The main reason to file an auto accident lawsuit is death or permanent or catastrophic injuries that render one incapable of working or performing daily activities permanently or a significant period of time.

One of the reasons to file a lawsuit after a car accident is a lack of insurance by the responsible party. The victim would need to file either an Uninsured or Underinsured Motorist claim.

Automobile and truck accident cases also may involve other complex issues, including dangerous highway design, dangerous design of an automobile, an airbag failure or truck, as well as liquor liability claims against bars that serve drivers to the point of intoxication. If any of these factors caused or contributed to your auto accident, you may want to consider contacting an attorney to review your accident report. Some of these more complex cases can involve multiple defendants, including state and local governments, the Department of Transportation and automobile manufacturers.

Hiring a Personal Injury Attorney to represent you may also increase your chances of getting a larger settlement.

To find out more about automobile accident cases, please visit: http://www.anapolschwartz.com/practices/auto_accidents.shtml

Is Actos Off the Market? The Answer May Surprise You

Michael Monheit — Fri, 20 Jan 2012 11:48:04 +0000

The answer to the question, “is Actos off the market” is dependent on which market you are talking about. Despite warnings, the FDA has allowed Actos to remain on the market in the United States. Yet, several European countries including France and Germany have taken Actos off the market at least in part because of the possible connection between Actos and bladder cancer. Additionally, the FDA has warned physicians not to prescribe Actos to patients who have active bladder cancer or who have a history of bladder cancer.

While the answer to the “is Actos off the market” question may differ from country to country, there is only one answer to the question “does Actos cause bladder cancer”. According to the FDA, the use of Actos for more than one year may be associated with an increased risk of developing bladder cancer.

Thus, if you are taking Actos to treat your Type 2 Diabetes then it is important to speak to your doctor about this risk and about how best to protect yourself.

When Did Actos Come on the Market?

Jackie Fedeli — Thu, 19 Jan 2012 15:54:38 +0000

Actos is a prescription drug containing Pioglitazone Hydrochloride. This medication, manufactured by Takeda pharmaceuticals was approved by the FDA in July 1999 to treat diabetes. Since its introduction to the market, Actos was the subject of a 10 year study to measure the safety and side effects. At the 5-year interval, results showed that although there was no overall increase of bladder cancer from Actos – there was an increased risk of bladder cancer noted among patients who had the longest exposure to Actos and were exposed to the highest cumulative dose of Actos. However, following the completion of the 10 year study, on June 15, 2011, the FDA issued a safety alert informing the public that using the diabetes Actos for more than one year may put patients at a higher risk for bladder cancer.

In Europe, a French Study also suggested an increase risk of bladder cancer from Actos. France has suspended the use of Actos as a result.

As per the safety alert, the “FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.”

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.

Anapol Schwartz’s Larry Coben takes on the NFL

Michael Monheit — Thu, 12 Jan 2012 19:57:16 +0000

Imagine that you worked many years for an employer — for good pay — only to find after retirement that your job exposed you to long-term health risks, including brain injury. Your former bosses protest that you were compensated well enough during your professional years that you need no additional compensation. Where do you turn?

A December 2011 New York Times story considers just that issue. At stake: the future care for over a hundred retired National Football League players and their spouses, who assert in a series of lawsuits that team owners, helmet manufacturers, and the NFL itself knew about the dangers of concussions during play — or, at least, they should have known about those dangers, yet looked away.

Larry Coben, an attorney with Anapol Schwartz, represents seven retirees, including famed Chicago Bears quarterback Jim McMahon. In the New York Times article, he makes the case against the league in stark terms: “We believe that the long-term medical complications that have been associated with multiple concussions — such as memory loss, impulse anger-control problems, disorientation, dementia — were well documented, and that factually the N.F.L. knew or should have known of these potentially devastating neurological problems, and yet it didn’t take any active role in addressing the issue for players.”

The science of head trauma

The Times hints that the NFL’s defense against these lawsuits will be to claim that the NFL has always placed a high emphasis on safety. The evidence of this is mixed, however. The players and their attorneys argue that the NFL rejected conventional medical advice on head trauma, and in 2007 even informed players that “Current research with professional athletes has not shown that having more than one or two concussions leads to permanent problems if each injury is treated properly.” They also claim the league’s doctors produced research — later discredited — that minimized the risks to players.

In fact, medical studies over the last decade have shown that football concussion injuries are associated with severe challenges later in life. Retired NFL players who had received concussions in their careers “reported more problems with memory, concentration, speech impediments, headaches and other neurological problems than those who had not,” as determined by a 2000 survey. A 2007 study found that multiple career concussions was linked to depression in NFL retirees at triple the rate of uninjured players. In 2009, a study found that Alzheimer’s disease and similar memory impairments may affect former NFL players at a rate of 19 times the normal rate for men ages 30 through 49.

The changing climate of public opinion

The Times report suggests that public opinion may have a huge influence on these lawsuits. Certainly the NFL would like to dismiss the suits as mere nuisances, but the potential danger to the league’s image probably makes that impossible.

Recent legal controversies dealt with arcane issues — such as merchandising and antitrust exemptions — that were unlikely to stir the passions of everyday sports fans. A parade of retired football heroes testifying how NFL neglect lead to their mental disabilities would be different.

It would be a public relations disaster for the NFL. “The notion of retired players telling a jury the league is at least partly liable for their dementia and other cognitive disabilities is an entirely different matter, legal experts say, because the players’ testimonies are bound to get a sympathetic audience and cast a shadow over the league,” reports Ken Belson in the New York Times.