Last year, first-of-a-kind drug approvals by the FDA reached their highest level in 19 years. The annual total of first-of-a-kind drugs increased to this level because of the drug industry’s focus on drugs designed to treat rare and hard-to-treat diseases. In 2015, the Food and Drug Administration (FDA) approved 45 drugs with never-before-sold ingredients.

The FDA’s approvals are considered innovative in the treatment of rare and hard-to-treat diseases. This should be considered big news for the pharmaceutical companies as well as patients. However, specialty drugs on the market are accompanied by controversy over the enormous increase in drug costs to patients.

In fact, one of the most expensive drugs of the year was produced by Vertex Pharmaceuticals. The drug, Orkambi, is appropriate for treatment of cystic fibrosis. It is one of the most expensive drugs on the market and sells for $259,000 per year. The drug has been proven to iincrease lung function in patients with the deadly inherited lung disease. Cystic fibrosis is a disease that causes the buildup of sticky mucus to develop throughout the body.

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The law firm of Williams, Bax & Saltzman, P.C. represented Cole Goesel and his parents in a personal injury lawsuit that settled before trial. Because Cole was a minor, the law firm needed judicial approval to finalize the settlement. The parties’ contingent-fee agreement entitled the law firm to one-third of the gross settlement, while all litigation expenses would be covered by the Goesels’ share.

The U.S. District Court judge refused to approve the settlement unless litigation expenses were deducted off the top and one-third of the net settlement was allocated to the firm. The judge also rejected the firm’s attempt to count the cost of computerized legal research as a separately compensable litigation expense rather than rolling it into the fee recovery. The law firm appealed the judge’s order limiting its fees. The Goesels declined to participate.

The U.S. Court of Appeals reversed the district court judge’s decision. The appeals panel stated that although the district court enjoys substantial discretion to safeguard the interests of minors in the settlement of litigation, this discretion is not boundless. In this instance, the trial judge criticized aspects of the firm’s contingent-fee agreement that have received the expressed blessing of Illinois courts. The trial judge’s analysis of what the Goesels would receive, that being 51% of the gross settlement amount rather than 42%, was insufficient to justify discarding a reasonable contingent-fee agreement.

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Andrea Larkin, 25, suffered from vertigo. When tested, she was shown to have a large venous varix on the left side of her brain and an aneurysm on the right side. A varix is an enlarged vein, artery or vessel. Larkin received her medical care from Dr. Jehane Johnston. A year or so later, she stopped seeing Dr. Johnston. She became pregnant. Her prenatal care was provided by the same medical association as Dr. Johnston.

After the vaginal delivery of her child, Larkin suffered a hemorrhagic stroke. As a result, Larkin has cognitive and speech difficulties and paralysis requiring 24-hour care.

Larkin’s husband, individually and on her behalf, filed a lawsuit against Dr. Johnston and her practice, alleging that the doctor chose not to properly treat the venous varix and alert the obstetrician about Andrea’s medical history.

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On Sept. 17, 2009 Crystal McFadden was admitted to Northwestern Memorial Hospital in full-term labor. Her care was managed by a team of resident obstetricians under the direction of the defendant, Dr. Jeffrey Dungan, the supervising attending obstetrician.

During the course of her labor, the residents and nursing staff documented late and variable decelerations on the fetal heart monitor with periods of minimal or undetectable variability, but they described the fetal heart tracings as being reassuring overall.

Around 3 a.m. on Sept. 18, 2009, after McFadden had been trying to push for 1.5 hours, the fetal heart tracings became non-reassuring and the senior obstetrician resident called Dr. Dungan to perform delivery. By then the baby’s head was crowning, so the delivery was accomplished with a vacuum extractor. However, the infant was born with no signs of life. The neonatologist in the delivery room stated that the baby appeared to be hydropic with generalized swelling, ascites (accumulation of fluid in the peritoneal cavity), and pleural effusion.

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Iala Suarez was 24 weeks pregnant when she went to her obstetrician, Dr. Michael Coffey, for a regularly scheduled appointment. During that visit, testing showed that she had protein in her urine and high blood pressure. The next day, she went to the Peace River Medical Center, where she underwent a 24-hour urine test and a blood pressure evaluation. Suarez was discharged. The urine test results came back about 30 minutes later showing that she had preeclampsia.

Preeclampsia is a pregnancy condition considered a complication that comes with high blood pressure and signs of damage to another organ system, often the kidneys.

Over the next several days, Suarez saw Dr. Coffey during this time and went to Peace River Medical Center for an evaluation. She continued to experience high blood pressure, increased protein in her urine and restricted fetal growth. She eventually returned to the hospital where she underwent an emergency Cesarean section.

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Stacy Maxberry attempted a vaginal birth after a Cesarean section birth. This is often referred to as “V-back.” During the delivery, the fetal monitor showed repetitive decelerations, a dangerous sign for the unborn child. The obstetrician in charge of the birth was Dr. Matthew Whitted, who was contacted about the repetitive decelerations showing on the fetal monitor. However, Dr. Whitted did not come to the hospital to look at the fetal monitoring strips. Maxberry was told to continue pushing.

When the fetal heart rate patterns worsened, Dr. Whitted was called again. This time he ordered a Cesarean section, which was done 30 minutes later. Stacy Maxberry’s son was stillborn.

She sued Dr. Whitted claiming that he chose not to call for a timely Cesarean section after the first phone call and chose not to evaluate the fetal monitoring strips more closely. In the hour between the first and second telephone call to Dr. Whitted, Maxberry argued that her unborn baby suffered a fatal hypoxic event. The jury agreed and entered its verdict in favor of Stacy Maxberry for the wrongful death of her unborn child at $1.5 million.

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During Tristan Hamilton’s delivery, his mother was given Pitocin to induce labor. The treating obstetrician instructed attending nurses to give no more than 20 milli-units of Pitocin to allow only four contractions every ten minutes. The nurses did not follow those instructions.

Because of the excessive amount of Pitocin given (hyperstimulation) and numbing effect of the epidural, Tristan’s mother was unable to push, prompting the obstetrician to attempt a forceps delivery. The baby then became stuck in the birth canal and the physician completed the delivery using a vacuum extractor.

At birth, Tristan had Apgar scores that were one at one minute and three at five minutes. He suffered brain damage in the delayed delivery. He is now 8 years old and has severe motor dysfunction and is unable to walk or talk.

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Alice Sodjago was in labor when she was admitted to a hospital. The nurse who treated her performed a vaginal exam and noted the presence of heavy meconium. The fetal monitor revealed fetal distress. The nurse contacted a midwife who did not call the on-call obstetrician. About 20 minutes later, the midwife arrived at the hospital and called the obstetrician. Sodjago’s daughter was delivered by Caesarean section almost 40 minutes later.
As a result of oxygen deprivation, the baby, now 8 years old, suffers from cognitive impairment and cortical blindness.

Sodjago and her husband, individually and on behalf of their 8-year-old daughter, filed a lawsuit against the hospital and the midwife claiming that they chose not to perform a timely emergency Caesarean section delivery, which would have saved the baby and prevented the devastating brain damage caused by the delay in delivery.

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On Sept. 5, 2015, Jaclyn Pena-Prather arrived at Sherman Hospital in Elgin, Ill., for an elective induction of labor. She was more than 41 weeks’ pregnant. She was a patient of Dr. Carol Korzen, who practiced obstetrics and gynecology in Elgin.

After admission, an external monitor was applied, and the fetus was continuously monitored throughout labor. At 2:15 a.m. on Sept. 6, 2015, she received an epidural for pain. At 4:45 a.m., a nurse contacted Dr. Korzen to update her on the patient’s progress. Dr. Korzen was present at 7:20 a.m. Pena-Prather was coached to begin pushing. At 8:21 a.m., the baby, Gianna, was delivered vaginally, weighing 6 lbs., 4 oz.

However, Gianna’s Apgar scores were very low. One minute after birth, Gianna’s score was zero. At 5 minutes, her score was 1. At ten minutes, her score was 3. The umbilical cord was described as “thin and shoe-string-like,” and was coiled seven times. Gianna was diagnosed with hypoxic-ischemic encephalopathy (HIE) and metabolic acidosis.

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During the delivery of Gwendolyn E., her shoulder became stuck or she encountered shoulder dystocia. Shoulder dystocia is a term used when the baby’s shoulder gets stuck behind the pelvic bone of the mother during delivery. Because of the shoulder dystocia involving Gwendolyn’s delivery, the attending obstetrician, Dr. Miguel Carbonell, applied traction.

As a result of the traction, Gwendolyn suffered a brachial plexus injury, which required many surgeries. She is now 6 years old but has limited use of her left hand because of the nerve injuries to the brachial plexus. The brachial plexus is a network of nerves that runs from the spine to the neck to the shoulders. During a shoulder dystocia delivery, the baby can have those nerves stretched or torn, which results in very serious mobility injuries to the shoulder, arms and hands.

Gwendolyn’s mother filed a lawsuit against Dr. Carbonell and the employer, Associates for Women’s Health of Southern Oregon, alleging use of excessive traction.

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