Columbus, Ohio Attorney Blog - Robert W. Kerpsack Co., L.P.A.

Last week, federal health officials announced a new monitoring system called Sentinel Initiative for assessing drugs which have been FDA-approved and then marketed. The plan is to use Medicare claims information to determine how drugs are affecting people’s health.

The current system depends on reports coming in to the FDA from doctors and patients around the country who have problems in connection with specific drugs or medical devices. People are free to report problems or not according to their judgment. This creates uncertainty, since what appears as a problem worth reporting to one person may not appear that way to another. This system also requires a lot more time to pass, for people to notice possible problems and report them.

By using Medicare records, the FDA will be able to quickly learn what percentage of users of a given drug are suffering what specific effects.

Potential Problems

Sentinel Initiative has been developing since 2005. Many are delighted with its prospects, but there are potential problems too.

• Medicare only collects data when someone is applying for payment. Actual patient health records would give a lot more detail and be far more accurate.
• Some people experience problems while taking a drug not because of the drug, but just because they are ill people.
• People on Medicare use 28 prescriptions per year on average, whereas that average is only 12 prescriptions among all other Americans. So with 28 medications entering a Medicare recipient’s body, it might be hard to distinguish what one particular drug is causing.
• Government officials have given repeated assurances that the FDA would not have access to personal information about Medicare recipients. However, this possibility worries some.

Perhaps Sentinel Initiative will lead to better drug and device monitoring. Time will tell. Meanwhile, if you have been harmed by a prescription drug and are wondering if you might have a valid legal claim, please give us a call or send an email and we will arrange a free consultation for you.

Fen-Phen was withdrawn from the market in 1997 by request of the FDA. It was manufactured by Wyeth (previously known as American Home Products), a large pharmaceutical company based in New Jersey. They are the manufacturers of Robitussin and Advil, and many other often-used drugs.

Fen-Phen was offered as a weight-reduction aid. It was a combination of two drugs called fenfluramine and phentermine. It was found to sometimes cause problems with the heart valves, which led to its recall.

Heart Structure

The heart has four chambers (compartments) – two atria on top and two ventricles below. In the walls between each atrium and its ventricle beneath are valves which allow blood to flow from the atria to the ventricles with each heartbeat.

• Blood in the right atrium has come from the body, and moves through the valve into the right ventricle, which pumps it to the lungs.
• Blood in the left atrium has just come from the lungs, where it was divested of its load of carbon dioxide and given an infusion of oxygen. It moves through the valve into the left ventricle and from there is pumped to the rest of the body.
• When blood enters the right side of the heart from the body, and when it leaves the left side to flow back into the body, there are two more valves.

Drug Recall

So the heart has four valves, and if they become constricted, or stiff, and if there is any backup of blood, problems ensue. Doctors had been evaluating their patients taking Fen-Phen with echocardiograms, testing the heart valves, and finding that about 30% of patients had abnormal echocardiograms. The Mayo Clinic and Mayo Foundation reported 24 cases of heart valve disease and when the FDA asked all health care professionals to report any such cases nationwide, they received 66 reports.

By 2005, over 50,000 product liability lawsuits had been filed by Fen-Phen users claiming injury. You can read more about that on our Fen-Phen Attorney page.

New Research

However, Fen-Phen was very successful at reducing the appetite and many people used it to help them fight obesity. A team of researchers at the University of North Carolina are working on pinpointing why Fen-Phen caused heart valve problems. They have found a serotonin receptor in the heart that was affected by Fen-Phen and led to the problems. Now they are working to devise a drug which will bypass that receptor but affect the weight gain receptor.

They have competitors and one such drug is now in testing. Perhaps we will have a safer new version of Fen-Phen before long.

Our office serves Columbus, Ohio and nearby areas. If you would like a free consultation about any drug-related problem, including any related to Fen-Phen, please give us a call or send an email.

Nanotubes are microscopically tiny cylinders of carbon that are used to manufacture light and strong materials. They are used in tennis racquets, golf clubs and bicycles, for instance. They were discovered in 1991 and researchers have been investigating their properties and potential dangers since then.

There is strong similarity to the tiny fibers of asbestos which were used decades ago in many household and construction materials. They became embedded in the lungs of people exposed to air containing them, as in asbestos mines, construction sites, plumbing work, drywall, etc.

Nothing happened for 30 or 40 years, but now many of those people have been developing asbestosis and mesothelioma, two fatal illnesses caused by the continued presence of asbestos fibers in the body. Now researchers are wondering if nanotubes might present a similar danger.

But this time, as Anthony Seaton has said, a professor of environmental and occupational medicine at the University of Aberdeen in Scotland: “…we’re forewarned and forearmed now with respect to nanotubes.”

Macrophages normally save the day

We breathe in all kinds of particles in the course of everyday living, and normally it is not a problem. Cells known as macrophages have the job of scavenging such particles, engulfing them, and carrying them away in the bloodstream for excretion.

But asbestos is a remarkable substance. It one of Earth’s elements, and is a fibrous mineral. It is fire resistant, it blocks sound, and it resists chemical change. No wonder it was used in so many products for a long time. It also resists macrophages; in fact, it destroys them, and they linger at that site, building up and forming tumors. That is why asbestos fibers have been able to remain in the lungs for so many years. They are too long for macrophages to deal with.

Study comparing asbestos fibers and nanotubes

By injecting mice with different lengths of nanotubes and dissecting them either the next day or a week later, researchers discovered that only the mice injected with long nanotubes developed lesions. Those with short nanotubes were not harmed. The study did not look at airborne nanotubes however, and further research is planned to determine how easily they could become airborne, and if they could become stuck in the lungs.

One suggested action for right now is altered labeling on products using nanotubes, to inform users of their presence. It is thought that nanotubes should be subject to the same rules and regulations that govern asbestos use.

If you or a loved one have been diagnosed with asbestosis or mesothelioma, and are wondering if you might have any legal recourse, please call us or send an email, and we will set up a free consultation for you.

A New Mexico ophthalmologist is facing a civil suit which alleges that one of his patients, one Martha Cardon aged 72, died after her cataract surgery in July, 2004. The suit claims that Cardon was given inadequate monitoring in Dr. Donald Ham’s practice known as Alamogordo Eye Clinic Inc., and that nobody was present with training in how to resuscitate a patient. The person in charge of monitoring Cardon was an 18-year-old girl with no certification or formal training, just some on-the-job training.

Dr. Ham admitted in his deposition that the discharge summary in Cardon’s file was inaccurate, and that his employees gave inaccurate information to Cardon’s daughter, who was in the waiting room. Cardon was taken in an ambulance from the eye clinic, with a worsening medical status, but nobody told her daughter.

During her cataract surgery, Cardon moved around and after 10 minutes, sat up. She was breathing heavily and had high blood pressure. When she was placed in a chair, she slumped down and lost consciousness, as well as bladder control. To help her with breathing, Dr. Ham tried to insert a breathing tube, but failed. He had not intubated a patient for about 15 years. Cardon did not regain consciousness and later died from brain damage.

The wrongful death suit claims that Alamogordo Eye Clinic breached the standards of care laid down by the American Association of Ophthalmologists in their Preferred Practice Pattern Guidelines for cataract surgery. There was no anesthesiologist available during surgery and no drugs were used to treat Cardon’s condition. Further, there was no properly-trained staff person to monitor Cardon, and Dr. Ham failed to properly assess her health before the cataract surgery. He is charged with medical negligence and the suit is being heard this week.

If you have lost a loved one through medical negligence and are wondering what to do about it, please contact us for a free case evaluation.

In April of this year, the Ohio Supreme Court issued a ruling on a 1997 Workers’ Compensation claim where an injured worker had been given only $2000 after breaking his leg in a fall at his factory job. That man was one Robert Wise, who had not been represented by an attorney. Instead, his father helped him sign the settlement. Per the April court decision, Wise was tested to have an IQ of 72, reading at fourth-grade level, and on the borderline of mental retardation.

In 2002, a lawyer took Wise’s case and reopened it, beginning the series of events which led to the Ohio Supreme Court now overruling the 1997 settlement. It had been between Wise and the Bureau of Workers’ Compensation.

On April 29 that Bureau issued an internal order forbidding any destruction of past settlement records. The possibility looms that many past claims may now be reopened since the Ohio Supreme Court has overruled this one particular past case.

Between 1997 and 2007, the Bureau settled 255,266 claims. At present, it is not clear how many of them might be affected by the Ohio Supreme Court decision.

If you have suffered a workplace injury, please call or email us for a free consultation.

According to a posting this week on the National Highway Traffic Safety Administration (NHTDS) website, Ford Motor Co. is recalling over 655,000 pick-up trucks because of a faulty hose. The recall is scheduled to begin in July.

The trucks in question are the Ford F-150 and Lincoln Mark LT. They are 2005-2006 trucks with 5.4 liter, three-valve engines. The hose as is could interfere with the vehicles’ braking ability.

Most of the trucks being recalled are in the United States, although about 50,000 are in Canada and 1500 in other countries. So far there have been eleven small accidents tied to this hose issue, but no injuries. Ford dealers will replace the hose at no charge.

2005 Recalls

That same Ford F-150 pickup truck was recalled twice back in 2005, along with some SUVs. The first recall was in January, 2005 and the second one in September.

The reason on those occasions was fire risk. About 550 complaints had been made to the NHTDS about fires breaking out in unattended vehicles. In January, Ford recalled about 792,000 pickup trucks and SUVs for a faulty speed control deactivation switch that they suspected of causing the fires. The F-150 models were from 1995 to 1999, 2001 and 2002.

In September, after some delay, Ford recalled nearly four million trucks to replace that same switch. Again, the F-150 was one of the recalled vehicles. That was the fourth largest recall in Ford’s history. Brake fluid was leaking through that switch into the speed control system’s electrical components. That caused corrosion over time, leading to fires.

When we buy a new vehicle, we tend to assume that it is safe and in excellent working order. Most of the time that is true, but when it is not true, disasters can happen. If you have been hurt by a faulty vehicle, or if you have a loved one so injured, please call or email us for a free case evaluation.

Gourmet Boutique, a New York food company, is voluntarily recalling 143 tons of meat and poultry. Federal food safety inspectors and Florida agriculture officials discovered that some of it is contaminated with the Listeria monocytogenes bacterium.

Some of the products are chicken salads and sandwiches, sold under the name Gourmet Boutique. Others are frozen wraps and burritos which are sold as “Jan’s” or “Archer Farms”. The exact products are listed on the USDA webpage about this recall, dated May 3, 2008.

So far there are no reports of illness associated with this recall.

What is Listeriosis?

It is a bacterial infection caused by the monocytogenes bacterium. In 2004 and 2005, it occurred only 2.5 to 3 times for each million of U.S. population. Of those cases, about 70% occurred in people with a compromised immune system, for whatever reason – chemotherapy patients, elderly, or suffering from HIV, AIDS, a blood cancer, malnutrition, or a hereditary condition. The other 30% occurred in pregnant women.

The Listeria monocytogenes bacterium exists throughout our environment and typically enters the body through being ingested. It has been found in seafood, meat, dairy products (despite pasteurization), and vegetables.

Symptoms of Listeriosis

There are four separate ways Listeria can develop in the body, with four sets of symptoms. When ingested in contaminated food, symptoms may not occur for one or two days afterwards, and would typically be:

• Diarrhea
• Fever
• Aching muscles
• Nausea
• Headache
• Stiffness in the neck area
• Confusion
• Impaired balance
• Convulsions

Treatment is done with antibiotics, usually ampicillin and perhaps gentamicin. Gourmet Boutique has made a recorded phone message which states it has made some environmental changes at its food plants to prevent this problem arising again.

If you think you may have eaten any contaminated products, please see your doctor immediately. Please also contact us if you would like to know more about your legal rights and options.

The Supreme Court is sometimes referred to as SCOTUS, analogous to POTUS – Supreme Court (or President) Of The United States. It consists of the Chief Justice of the U.S. and eight Associate Justices (although Congress has the power to change that number). They tend to begin serving well into their law careers, after an acclaimed career and long experience as a judge. They serve for life, or until they decide to resign or retire, or are impeached. They meet in their own building in Washington, D.C.

Over the years since 1789, each change of Chief Justice has marked a new stage in the ongoing career of the Supreme Court, and in each stage, the court is named for whoever is Chief Justice at that time. In each stage, the court makes a series of important rulings which add up to a certain identity for that particular group of nine judges.

The Marshall Court ran from 1801 to 1836, and gave initial shape to the balance of power between the federal and state governments. It ruled that the Supreme Court could correct state supreme courts in their interpretations of the Constitution. It also set the practice which we see today of rulings being issued as one majority opinion with minority dissentions. That was a change from the inherited British tradition where opinions were issued separately by each judge.

The Taney Court from 1836 to 1864 ruled on the famous Dred Scott case, opining that people of African descent brought here as slaves, and their descendants, could not be citizens, could not bring a lawsuit against anybody, and could not be taken from their owners without due process. This decision is thought to have been a contributing cause of the Civil War, but it was overturned later by the Thirteenth and Fourteenth Amendments which abolished slavery and gave full rights and citizenship irrespective of race.

Closer to our own era, the Warren Court, from 1953 to 1969, made several rulings which expanded application of the Constitution to civil liberties. It opined that racial segregation was unconstitutional in public schools, that the Constitution gives (a) a right to privacy and (b) a right to have a court-appointed lawyer if you’re too poor to pay for your own. It ruled that public schools cannot have any mandatory prayer times or Bible readings (although they may have optional prayer).

The Burger Court from 1969 to 1986 made the controversial ruling that abortion is a constitutional right. It also opined that the death penalty is not unconstitutional, although its implementation at that time in some states was unconstitutional.

The Rehnquist Court from 1986 to 2005 put some restrictions on Congressional power, working with the idea of federalism. It put an end to the repeated electoral recounts in the 2000 presidential election, allowing George W. Bush into the White House. It also put some limits on picketing by labor unions and removed some from abortions.

The current Supreme Court is the Roberts Court, which began in 2005. Time will tell how it will be characterized by its rulings.

If you would like to schedule a free consultation, please call or email our office.

On August 1, 2007, the eight-lane Minnesota bridge known as Bridge 9340 crumpled and fell into the Mississippi river during the evening rush hour. Vehicles and construction equipment fell into the water, and some vehicles, including a school bus, clung precariously to the slanted bridge roadway.

It took nearly three weeks for divers to recover the bodies of the thirteen people who died. About 145 people were injured, and some are still having surgeries done. The National Transportation Safety Board has been investigating what caused this disaster, and focusing on a design flaw.

On April 25, 2008, Minnesota state lawmakers announced that they had reached a compromise agreement for compensating the injured victims. It’s expected to be signed by the governor, and it provides relief and support for victims and their families.

Negotiations had somewhat bogged down over the issue of whether to recognize the state’s limit of liability by capping awards made to individual victims. It appears that has been recognized, as victims may receive up to $400,000 each. However, there is still $12.6 million available for ongoing medical costs, uncompensated medical expenses, and lost wages.

Part of the agreement is that victims and their families would have to agree not to sue the state of Minnesota if they accept the settlement amounts of this compromise.

If you have been injured or have lost a loved one because of somebody else’s negligence, you may have a valid legal claim. Please call or email us if you would like to schedule a free consultation.