Today the FDA has announced that it is looking into a possible connection between the allergy drug Singulair and suicide. The manufacturer, Merck, has updated the drug’s label four times during the past year, adding more information on side effects such as anxiety, tremors, depression, and suicidal behavior.

The FDA has asked Merck to examine its data on Singulair to see if there might be more on a possible link to suicide. This new FDA action in regard to Singulair is based on reports it has received regarding mood changes in people taking Singulair, suicidal behavior, and actual suicide.

Merck officials have pointed out that drug safety is not tested or evaluated by means of “reports”. It is done through long, large, and strictly-controlled research studies before FDA approval is obtained. None of the 11,000 patients in Singulair trials has committed suicide and none has reported any suicidal thoughts.

The FDA approved Singulair in August, 2005 for relief of indoor allergies in adults and children over six months of age. It is taken once a day and helps with a wide range of allergy symptoms for about 24 hours. It had previously been approved in 2003 for relief of seasonal allergies. It is also used to treat asthma.

An Asthma Study

Merck recently provided the FDA with the results of a study specifically on Singulair being taken for asthma, which included 3,900 adults treated with Singulair and 3,400 treated with other asthma medications. The study found one person on Singulair and three on other drugs who attempted suicide. The FDA is looking into related drugs such as Zyflo, Zyflo CR and Accolate. It expects to take about nine months to complete its evaluations.

Although pharmaceutical companies must put their new products through rigorous and extensive testing to obtain FDA approval, the marketing itself is another kind of testing, as it makes the drug available to the public. Among so many people, new side effects sometimes show up, and so drug labels are amended to warn of these new possibilities. In some cases, a drug is recalled pending further safety studies. It remains to be seen whether Singulair will be recalled.

If you have been taking it and noticing any mood changes or depression, even suicidal behavior, please contact your doctor immediately. Please also feel free to contact us to learn more about your legal rights and options.

In 1993 there was a case before the U.S. Supreme Court known as Daubert v. Merrell Dow Pharmaceuticals Inc. The Supreme Court issued guidelines to determine what scientific evidence can be admitted in court, and they became known as the Daubert Standards. They instruct judges to be “gatekeepers” in admitting only evidence which is relevant, reliable, and based on a testable peer-reviewed theory. Such theories must have known error rates and must be generally accepted by the scientific community.

As years went by and cases came before innumerable judges nationwide, some people began criticizing the Daubert Standards. They claim that some judges misinterpret them, looking separately at each component of a body of evidence and barring some while admitting others. Some judges apply the Standards too strictly, and some block all evidence if the medical experts in the case disagree about something.

Presumably some of these complaints stem from an attorney’s personal chagrin at having his evidence rejected and therefore losing his case. One can also assume that some are genuine.

Some states have laws based on the Daubert Standards which set criteria for admission of expert testimony in civil cases. This month the Supreme Court of Georgia rejected plaintiffs’ arguments brought forward to challenge part of Georgia law known as Senate Bill 3. This Bill is also known as the Daubert Bill, as it sets tighter standards for evidence admission. The Georgia Supreme Court upheld it. The plaintiffs’ lead lawyer, Ned I. Miltenberg (of the Center for Constitutional Litigation based in Washington D.C.) was disappointed but is considering a further challenge if a suitable case comes to his notice.

Some of the most complex lawsuits are medical malpractice. The evidence, being medical and obscure to most non-medical professionals, must be examined by qualified medical experts, who then give their testimony if the case goes to trial. This study of a person’s medical records and all related information, along with deposition of all relevant people, can take months and even years. It must be done with the Daubert Standards in mind, as a good medical malpractice lawyer will always build a case with a trial in mind.

If you have incurred injury while under medical care and are wondering if you might have a valid legal claim for medical malpractice, or if you have a loved one in that situation, please feel free to contact us for a free consultation.

At the Phoenix airport in September, 2007, an intoxicated woman was arrested for disorderly conduct. She was traveling alone from New York to Tucson to enter an alcohol treatment center. The claim is filed by her family because on September 28, the woman, Carol Anne Gotbaum, died while in a police holding cell at the airport. The autopsy report done by the Maricopa County medical examiner states that Gotbaum accidentally hanged herself on her shackles and that alcohol and prescription drugs were contributing factors in her system.

The claim is the required beginning of a lawsuit and seeks money for Gotbaum’s husband, children and estate. Her husband is the son of Betsy Gotbaum, a New York City Public Advocate.

It states that on September 28, Phoenix police “…used excessive and unreasonable force on Carol, as if she was a dangerous criminal, rather than as the sick, intoxicated, and vulnerable person she was.” The City of Phoenix replied to this claim with a letter denying that police had done anything wrong, and stating that Carol’s death was an accident. It states in part:

“…the Gotbaum family has publicly admitted, not only that Carol hid her medical and mental condition, but that the officers responded to Carol exactly the way her husband knew they would respond because they did not have critical information known only to the Gotbaum family."

The letter includes transcripts of phone calls made by Carol’s husband to the airport, in which he expressed concern as to her whereabouts because she was depressed and suicidal.

Painful situations like this happen often, leaving a grieving family wondering how their loved one died, and wanting clear and specific answers. If you have found yourself in a similar situation, having suddenly lost a loved one, please call or email us to set up a free consultation.

The March issue of Orthopedics has an interview with Andrew Cappuccino, who is the assistant team orthopedic surgeon for the NFL Buffalo Bills. Bills player Kevin Everett was injured while making a tackle and suffered complete paralysis below the neck. The injury was a fracture dislocation of the neck-area spinal vertebrae known as C3 and C4 (Cervical 3 and 4, with number 1 being the first vertebra below the skull).

Dr. Cappuccino is the surgeon who has operated on Everett and is supervising his recovery. His treatment is working very well, as he is now in rehabilitation, after three weeks of hospital treatment, and is lifting weights and working with a harness mechanism.

What is hypothermia?

Part of his treatment was moderate hypothermia during surgery. Hypothermia is a lower body temperature than normal – 98.4 degrees F. Taken too far, as someone might experience it after a skiing accident, hypothermia is fatal, as it slows down all body processes until the brain stops and the heart stops beating.

But used by skilled surgeons within strict parameters, it can help with recovery from trauma. Everett’s hypothermia started right on the football field after his injury, while he was being stabilized, given IV fluids and oxygen. He was given an iced saline infusion and ice packs in the armpits and groin.

In the emergency room he was given a complete workup with radiographs, MRIs and CT scans, and surgery to relieve pressure on the spinal cord at the neck where the bones were damaged. Throughout these procedures his body temperature was kept below 98.4 degrees F. Eight hours later a tiny movement was noticed in the legs. Cooling continued via an epidural catheter (cooling his spinal cord) until, 36 hours later, both his arms and legs moved a little. Then his body temperature was gradually raised to normal. He is now in recovery.

Why does hypothermia help?

Part of Everett’s recovery is due to the decompression on his spinal cord. But some is also due to the fact that a lower body temperature, by slowing body processes down, puts lower demands on the body’s nerves. This keeps them less active while surgery and healing occur, which helps speed recovery.

Little research has been done on use of moderate hypothermia and Dr. Cappuccino is in hopes that Everett’s recovery will inspire other spinal injury centers to give it more attention. New medical techniques are developed all the time, as are new medical devices and drugs. While there is undoubtedly some risk for patients receiving new drugs or treatments, there may also be great benefits as our medical skills expand. We rely on each surgeon’s best judgment to use only likely and appropriate techniques on each patient.

Most medical professionals are responsible and attentive, but there are times when unacceptable mistakes are made. If you have been injured by careless medical care and wonder if you might have a valid legal claim, please contact us for a free consultation.

In 2003, a baby was born in Akron in a home birth after the mother’s doctor advised against it. When a woman has a C-section, that weakens the abdominal muscles, since they have been cut and stitched; therefore it is not a good idea to have any vaginal births after that. Once you have a C-section, it’s best to have them for each subsequent child.

On the other hand, a home birth is so much more comfortable and one’s own home is a far more relaxing place to be during such an exciting and potentially stressful event as childbirth. So this mother, Kelly Moscarello, went ahead with the home birth despite her doctor’s warnings about her previous C-section, and about the baby being too large.

The Birth Outcome

The birth was attended by a midwife and it did not go well. EMS technicians were called, who clamped the baby’s umbilical cord as they sped her to hospital. The baby weighed in at ten pounds and was found to have cerebral palsy, caused by brain damage.

In her distress, Moscarello was convinced the damage was caused by the umbilical cord clamp being premature, reducing oxygen to the baby’s brain. She contacted over 100 lawyers to find one who would file criminal charges against the EMS technicians.

Finally, a court-appointed guardian for the baby brought a suit against Moscarello’s physician, Dr. Kristin Trump. The suit asks for $13 million for lifelong care. It claims that Dr. Trump did not warn Moscarello about the dangers of a home birth. However, a Moscarello deposition transcript quotes her as stating earlier that Dr. Trump did tell her of the risks, and that a nurse had also warned her about them at the time of her previous C-section.

The Doctor Cleared

The trial began on January 24, 2008. On February 1, the Summit County jury cleared Dr. Trump of any responsibility for the baby’s injury. Their decision was reached after three hours, with a 6-2 vote for the doctor.

Medical situations can be very complex. They require expert medical testimony on both sides and a great deal of preparation. In this case the jury exonerated the doctor, but in many cases, medical malpractice is found to have occurred. If you are dealing with a birth injury and wondering whether you might have a valid claim, please call or email us to schedule a free consultation.

Chelsey Cruz was a 15-year-old honors student at the Capital Prep Magnet School in Hartford. She died on March 11, of lupus complications.

Disputes over Chelsey’s care had begun six years previously, when she was first diagnosed with lupus. Lupus is an autoimmune disease, where the body attacks its own healthy tissue. Chelsey had a complication of lupus called lupus nephritis where severe kidney damage can cause death. She also developed an infection and probably died of cardiac arrest as a result of the infection’s spread. There will be an autopsy.

Complaints against mother

Doctors at the Connecticut Children’s Medical Center and Yale-New Haven Children’s Hospital had both filed complaints stating that Chelsey’s mother, Kimberly Castro, was harming her daughter. Castro had objected to the treatments they were giving to Chelsey and had withdrawn her daughter from their care. When Chelsey died, she was in treatment at Children’s Hospital in Boston, and Castro had disagreed with the treatments given there too.

Last August the Connecticut Department of Children and Families filed charges of medical neglect against Castro and took cusody of Chelsey. They placed Chelsey in her grandfather’s custody, as he agreed to follow the doctors’ orders.

Castro’s reason for disputing treatments was the side effects caused by the various drugs. When Chelsey died, the doctors blamed the lupus and its severe complications. Castro blamed the doctors.

Drugs are not always miracles

It’s very hard for a mother when her child is ill and in pain. One has to remember though that (a) no drug is without side effects, and (b) lupus is a difficult disease to treat. There is no cure, so it is treated symptomatically, meaning the symptoms are treated since the causes are unknown and therefore can’t be treated. Its course is unpredictable. It flares up, then sinks into remission, then flares up again.

Survival in the U.S. of patients who have had it for five years is 95%, but Chelsey’s treatments seem to have been continually interrupted as her mother withdrew her from each group of doctors. She refused to allow Chelsey to have Cytoxan or Cellcept, claiming that those drugs were killing her daughter. When she was in hospital, Chelsey had a uniformed guard outside her room to prevent her mother from taking her out of the hospital.

Castro is now considering filing a lawsuit against the State of Connecticut. She may or may not have a valid case.

If you have lost a loved one through what you perceive to be medical negligence or malpractice, please call or email us for a free consultation. Medical malpractice cases are usually complex, and the sooner you obtain some legal help, the more quickly your case can be assessed and we can determine how to proceed.

In January, 2008, a Cleveland hospital patient, one Edward Balcerzak, was recovering from surgery. He choked on the material regurgitated from his stomach, and this interfered with breathing to the point where his brain was damaged, and he later died.

The Balcerzak family has filed a lawsuit against two doctors and the University of Ohio (OU). The two doctors worked for the OU college of Osteopathic Medicine, teaching medical residents. Because of this, they may not be individually liable for Balcerzak’s death.

One of the doctors has been an OU faculty member since 1985 and the other since 2004. Under Ohio’s current system, they can be granted immunity because they are employed by the state. Therefore medical malpractice claims involving them must go the Ohio Court of Claims, where all legal action against state agencies is handled.

It was in 2007 that the Ohio Supreme Court introduced the concept of immunity for state employees. It places greater financial burdens on the state, since the doctors’ own malpractice insurance need not be drawn upon. Now the Ohio Court of Claims will confirm whether or not the two doctors are indeed immune, and if they are, the state of Ohio will be held responsible for Balcerzak’s death.

In case the doctors are declared not immune, the Balcerzak family has filed another claim against the doctors’ private practices.

Medical malpractice lawsuits are usually quite complex and time-consuming. In this particular case, the concept of immunity for state employees is adding another level of complexity. If you have a loved one who was injured or killed in a medical setting, and are wondering whether you have a legal claim, please contact our office for a free consultation. It’s our job to sort through complications like this immunity factor, and there can be many such hurdles in the course of a medical malpractice lawsuit. Give us the legal work, so you can focus on supporting your loved one, or recovering from injury yourself.

On February 15, 2007, in Wichita, Kansas, a three-year-old boy was hit and killed in a McDonalds restaurant drive-through lane. His name was Cody Schuber and he was catching up with his twin brother. He walked out of the restaurant into the path of an oncoming pickup truck. The two small boys were out having dinner with their grandparents.

This particular spot had been the scene of an accident about a year previously. Another small boy had sustained a broken leg when he ran out the McDonald’s door and into the side of a van traveling through that same lane.

Cody Schuber’s family brought a wrongful death lawsuit against McDonalds Corp. and the company that owns this restaurant. The lawsuit stated that the death had occurred in a blind spot caused by the design of the restaurant. An attached indoor play areas blocks the view so that drivers and pedestrians cannot see each other.

The lawsuit further stated that the restaurant was negligent because:

• It removed speed bumps that had previously been in place to slow down the parking lot traffic
• It refused to install signs to warn drivers and pedestrians about this blind spot
• It had allowed the painted crosswalk to fade and become hard to see for motorists

McDonalds has a duty to monitor the operations of its restaurants, said Larry Wall, who filed the lawsuit. It should have inspected the premises. The lawsuit seeks over $75,000 in damages each for Cody, for his twin brother, and also for the two-year-old child whose leg was broken in the 2006 accident at the same spot.

In our view here at Robert W. Kerpsack Co, unsafe premises should be exposed and any harm they cause should be compensated for. If you have been injured by the negligence of any property owner, please contact us for a free case evaluation.