Heparin is a blood-thinning drug that had become practically ubiquitous in hospitals by 2008, especially as part of a regimen for a host of cardiovascular-related conditions. But in the intervening months since, this particular pharmaceutical has been blamed for as many as 100 patient deaths and perhaps thousands of injuries caused by contaminated ingredients and confusing labeling that led to overdoses.

“It used to be considered safe without reservations,” says attorney Michael Stratton of Stratton Faxon based in New Haven, Connecticut, “not anymore.”

In Delaware, the maker of the drug, Baxter International Inc., has confirmed the deaths of a 71-year-old man and a 64-year-old woman who received the drug at Beebe Medical Center in Lewes, Delaware. A third patient who suffered medical complications at the same hospital after receiving the drug survived. “These are tragic cases, but probably only the tips of the proverbial iceberg,” Stratton says, “Cases involving heparin are seldom easy to prove.”

In 2008, Baxter heparin contaminated with a counterfeit active ingredient supplied by a Chinese company was blamed for about 100 deaths and hundreds of injuries to patients receiving the drug. Based on those injuries, the FDA ordered a recall of heparin made by Baxter before the year ended. It later was determined that the FDA had failed to inspect the Chinese plant where the contaminated heparin was made, prompting calls to improve the agency’s monitoring of foreign drug manufacturers.

Baxter was also criticized for labeling that failed to adequately distinguish between full-strength heparin and a lower-dose form of the drug, called HepLock, which is used in newborns.

Confusion between the size of the vials and similar labeling for heparin and HepLock was blamed for mix-ups in which newborns were given multiple doses of full-strength heparin instead of HepLock, causing deadly internal bleeding. In one high-profile case, the newborn twins of actor Dennis Quaid and his wife were critically injured when a nurse at Cedars-Sinai Medical Center in Los Angeles mistakenly administered several doses of heparin to the twins instead of HepLock. “Such mistakes are inexcusable,” Stratton concludes.

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It happened at a restaurant called Knickerbocker’s in Middletown, Connecticut, in December 2003. A disc jockey was setting up a lighting display for a show. An 80-pound lighting fixture on an adjustable tripod came out of its socket and landed on Angela Wilson’s head. She was briefly knocked unconscious, and was treated by emergency medical technicians at the scene.

Shortly after the incident, Wilson began experiencing memory loss, headaches, gait disturbance and unexplained tremors in her leg. In time, a diagnosis of traumatic brain injury was applied to her situation, and she filed a civil action with the help of Connecticut’s firm for trial law, Stratton Faxon, based in New Haven. “Establishing liability and proving damages proved difficult in this case,” said Joel Faxon, “Special challenges existed.”

Faxon explained further. “They never found the Chinese company [that made the tripod]. We knew who it was, and brought a third-party action, but they never appeared,” Faxon said. The defendant was a Bronx importer called Visual Effects Inc., which sold the device.

The tripod was adjustable, but had no internal stop mechanism to keep sections from separating. Stratton Faxon retained engineer John R. Manning, of San Francisco, to analyze the tripod, which he deemed defective in its design.

Unlike ordinary negligence cases, products liability cases allow introduction of evidence that the defect was subsequently repaired or improved in a later design. “That provision of the Connecticut products liability statute was valuable in proving our case,” Faxon asserted. In subsequent versions of the tripod, a safety stop was built in.

The case was mediated by Superior Court Judge Theodore Tyma, in Derby, Connecticut, and the parties agreed to a settlement of $1.35 million.

The most controversial part of the case was proving that Wilson was actually injured, Faxon said. Because the objective tests of brain damage yielded no proof, the defense contended that she was simply malingering, and that the debilitating medical symptoms she claimed were simply faked.

Faxon retained psychologist Robert A. Novelly, of Branford, Connecticut, who testified that Wilson had suffered impairment of “executive functions” making it impossible for her to work or to function fully as a homemaker and mother. Novelly was recently disciplined by state licensing officials, but according to Faxon his firm was happy to rely on Novelly’s testimony, and would do so again.

“We are aware that Mr. Novelly has had disciplinary action in the past related to his delay in providing written reports to lawyers concerning his patients,” Faxon acknowledged. The disciplinary probation, which ended January 1, 2009, “has no impact on his qualifications as an expert, his quality as a persuasive witness or his ability to be a resource for his patients,” Faxon concluded.

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In 1976, U.S. Army recruit Private David Lewis was based at Fort Dix, N.J., and suddenly felt very sick. Within a day he was dead. The cause of his death was given as “swine flu,” otherwise known as the H1N1 influenza virus. As a consequence of this single death, approximately 45 million Americans were inoculated against H1N1 between October 1, 1976, and December 16, 1976.

Shortly after the 1976 vaccinations began, recipients of the vaccine began developing Guillain-Barre syndrome, a rare neurological illness associated with loss of muscle control, leg and arm paralysis, tingling and weakness.

According to Dr. Walter Rocca, now one of two co-directors of the Rochester Epidemiology Project, “The Rochester Epidemiology Project helped uncover that there were more cases of Guillain-Barre syndrome. The vaccine was given and there were no foreseen issues – and then a number of neurologists started to notice people coming in with Guillain-Barre.” Out of prudence, the 1976 vaccinations were stopped.

In Olmsted County, New Jersey, where Fort Dix is located, between 1935 and 1980, 48 residents of Olmsted County (29 male and 19 female) met the criteria for a diagnosis of Guillain-Barre syndrome. Twenty persons, an increased risk that was limited to the initial five or six weeks after being immunized, showed a small but significant vaccine-attributable rise in Guillain-Barre risk.

Is the 2009 new vaccine against H1N1 pandemic influenza risky?

“No vaccine is without risk,” said Claudia Vellozzi, acting deputy director for the Immunization Safety Office at the Centers for Disease Control and Prevention. Keeping such prudence in mind, the CDC staff will continue to watch for Guillain-Barre and other risks this year. Federal officials say that the H1N1 vaccine includes a smaller portion of the virus, thus making it much safer than the 1976 vaccine.

But this is small consolation to those who were adversely affected thirty-three years ago. Guillain-Barre syndrome can drastically affect a person’s quality of life, even if the illness is rarely fatal. Michael Lindstrom was a New Jersey-based minor league baseball player with hopes of making it to the Major Leagues when he was inoculated in 1976. Afflicted with Guillain-Barre that same year, he never played another game.

Alexandra Reed writes for Connecticut personal injury law firm, Stratton Faxon.

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Much discussion has recently surfaced about the mandated administration of H1N1 “swine flu” vaccines to millions of Americans, especially those included in so-called “high risk” groups such as children, the elderly and pregnant women. But if these groups are at risk for contagion of the relatively rare influenza strain – they may also be at risk for adverse consequences received from the vaccine itself.

How safe is this vaccine? What are its potential hazards?

In fact, one of the special groups currently being targeted for vaccination is healthy pregnant women. This group, while at risk for the “swine flu,” may be at direct risk of experiencing adverse affects attributable to the vaccine itself, including but not limited to mercury poisoning. On July 23, 2009, the U.S. Food and Drug Administration’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) confirmed that the H1N1 vaccine will contain significant amounts of mercury containing the preservative thimerosal. This mercury-laden concoction has not been proven yet to cause adverse health consequences, but concerns about fetuses being harmed have arisen. To stretch the vaccines, certain adjuvants may also be added to the concoction prior to its being administered. These compounds have yet to be specifically approved for use in the United States and some studies have shown they cause immune disorders in mice. In fact, the proposed adjuvants (AS03 and MF59) are squalene oil-based. Exposure to squalene is associated with production of auto-antibodies and auto-immune disease. Squalene adjuvant in vaccines may well have been responsible for Gulf War Syndrome among U.S. military personnel.

Although six deaths occurred among pregnant U.S. women believed to have the H1N1 flu between April 15 and June 16, 2009, how many deaths and adverse consequences may occur if healthy pregnant women in mass numbers are exposed to the vaccine? An epidemic of auto-immune disease or Gulf War Syndrome among otherwise healthy, pregnant women would almost certainly trigger a rash of related lawsuits, as liability may be provable in varying degrees.

These potential hazards may already have been lost in the politically-motivated public safety arguments which have advocated for mass immunization of relatively untested vaccine concoctions in recent months.
Alexandra Reed writes for Connecticut personal injury law firm, Stratton Faxon.

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When Mark Hirschbeck began his career as an umpire, right after high school, he never thought that three failed hip replacements would lead to a disastrous end of his dream career. After 23 years of being an umpire, the majority of that time spent in the Major Leagues, he began to have pain in his right hip. This would cause him to require frequent cortisone shots.

In June 2003, Hirschbeck went to John Keggi, a physician based in Waterbury Connecticut, to seek out a hip replacement. Upon being informed that he was going to receive the “Rolls Royce” of hip replacements, Hirschbeck underwent the surgery in hopes of returning to the Major Leagues. While in recovery from the surgery, the ceramic hip shattered. “Pain shot right through my side,” stated Hirschbeck.

Hirschbeck returned to the same physician and replaced the artificial hip with an exact duplicate of the previously shattered one. This would lead to a staph infection, one month later. After undergoing a 3rd surgery with the same brand artificial hip, the infection returned again.

This led Hirschbeck to Dr. Charles Cornell of New York who removed the pieces of ceramic and metal from inside Hirschbeck’s hip. He also administered antibiotics to clear up the infection. After spending eight weeks in recovery, a non-ceramic hip was surgically implanted. Hirschbeck has said that he is much better now, but still requires pain medication because it hurts him to stand or sit for any extended period of time.

Hirschbeck has a pending lawsuit against John Keggi and Wright Medical Technology, Inc, the original equipment manufacturer of his first three artificial hips. Stratton Faxon’s Eric P. Smith is representing Hirschbeck in his case. Hirschbeck just wants his day in court, which is why he’s lobbying federal lawmakers in Washington, D.C. for the initiation of The Medical Device Safety Act. This would allow individual consumers of medical devices to be able to hold the manufacturers responsible when injury or death occurs from their products. “He’s a fighter,” concludes Smith, “an extremely courageous man whose quality of life has been altered forever. We’re hoping that he can win his case, not just for his sake, but in order to set a precedent for other victims.”

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Connecticut’s firm for trial law, Stratton Faxon, helped to win Karen Smith’s case of negligence at Dairen Health Care Center. Her mother had been admitted there after suffering from fractured ribs caused by a minor automobile accident. Less than a week after her admission she died. A jury awarded a $1,450,000 verdict to the plaintiff, Karen P. Smith, Administratrix of the Estate of Margaret Miller, against the Darien Health Care Center and 599 Boston Post Road Operating Company II, LLC.

Margaret Miller repeatedly called to the nurse’s station because she required assistance in going to the restroom. These calls were ignored by the health care facilities’ staff. Having given up on waiting for help from the nurses, Ms. Miller attempted to use the restroom on her own accord. Before she made it she slipped, further injuring herself by breaking her hip and shoulder.

At Norwalk Hospital, where Ms. Miller was taken after her fall, the orthopedics department deemed it necessary to operate on these injuries. During surgery major complications arose. Due to these complications, Ms. Miller died.

While in trial it was argued by the defense that their client was not neglectful, it was Ms. Miller who was at fault for attempting to use the restroom on her own. It was also argued that due to the fact that she was 80 years old, her life expectancy was already shortened.

Eric P. Smith, of Stratton Faxon, provided some observations in retrospect. “Of course not every fall can be prevented, but standard practices of care dictate that skilled nurse professionals should assess new patients and provide appropriate care. Ms. Miller was virtually left alone in a room for several hours, her calls for help seemingly ignored. This is what led to her fall and truly an undignified death that she did not deserve. I am glad the jury could recognize that and I hope, with the five-year anniversary of Ms. Miller’s death upon us, her family can now gain some peace.”

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Mark Hirschbeck reached the pinnacle of his profession in 2001 when he umpired in the 2001 World Series. But in the nearly a decade since, he’s experienced a nightmare of dashed dreams and never-ending pain.
Hirschbeck, 48, began umpiring right after high school. It took him eight years to rise through the ranks to the Major Leagues. His umpiring career at the highest level lasted fifteen years. By then, years of squatting, bending, and running had made pain and cortisone shots regular features of his life. In June 2003, following hip replacement surgery, he heard a “pop.” The hip, a ceramic one, had shattered. “Pain shot right through my side,” Hirschbeck said.

His physician had supposedly given him the “Rolls Royce” in artificial hips, and told him that he’d soon be able to resume his coveted umpiring career. It never happened.

A second surgery by the same doctor replaced the original artificial hip with the identical brand. By August, severe pain redeveloped and Hirschbeck was diagnosed with a staph infection. A third hip replacement surgery, again with the same brand of artificial hip, led to the same result.

Eventually, he sought out a different physician, Dr. Charles Cornell of New York, who removed all the ceramic and metal from his hip and administered antibiotics to clear the infection. Months later, he’d recovered to some extent, but his recovery has been limited. “I can’t run anymore, I can’t play golf, I can’t do yard work, and I can’t be an umpire,” Hirschbeck says.

When he first underwent surgery at age 42, he’d anticipated an additional 15 years of working as a Major League umpire.

In 2008, the U.S. Supreme Court ruled that manufacturers of class III medical devices attaining U.S. Food and Drug Administration approval, like Hirschbeck’s artificial hip, are immune from claims challenging these products’ safety or effectiveness. Hirschbeck, like many other victims of similar corporate negligence, is trying to change this outcome via the legislative route.

U.S. Rep. Rosa DeLauro, D-3, supports the Medical Device Safety Act. “Stories like that of Mark’s demonstrate the need for modernizing and strengthening the Food and Drug Administration’s drug and device safety responsibilities, including reforming the approval process for medical devices, increasing transparency, and enhancing post-market surveillance.”

Alexandra Reed writes for Connecticut personal injury law firm, Stratton Faxon.

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On July 29, 2004, Margaret Miller was admitted to Darien Health Care. She had fractured ribs as a consequence from an automobile accident. At Darien, while needing assistance to use the restroom, her repeated calls to the nurses went ignored. As a result of this negligence, Ms. Miller slipped and sustained additional injuries. A fractured hip and shoulder on her right side caused her to be rushed to an emergency room at Norwalk Hospital. The orthopedic department determined surgery to be the most viable option to heal these injuries. Regrettably there were complications from the surgery. These complications would lead to her untimely death in the incredibly short period between July 29th and August 4th of 2004.

It was argued in the case that because Margaret Miller was 80 years old, she couldn’t have been expected to live long anyway. The plaintiff’s attorney counter-argued that standard operating procedures were not observed at the health care facility when Margaret Miller had initially been admitted. If these procedures had been conducted properly, her tragic accident might have been prevented. “Of course not every fall can be prevented,” said Eric P. Smith, attorney for the plaintiff, “but standard practices of care dictate that skilled nurse professionals should assess new patients and provide appropriate care. Miller was virtually left alone in a room for several hours, her calls seemingly ignored. This is what led to her fall and truly an undignified death that she did not deserve. I am glad that the jury could recognize that and I hope, with the five-year anniversary of Ms. Miller’s death upon us, her family can now gain some peace.”

Five years to the day after this nightmare of a trial began, the jury in Karen P. Smith, Administrator of the Estate of Margaret Miller vs. Darien Health Care Center and 599 Boston Post Road Operating Company II, LLC awarded the plaintiff one million and four hundred fifty thousand dollars in compensation. Even with this amount of money nothing can ever replace the loss of a loved one to unwarranted negligence.

Alexandra Reed writes for Connecticut personal injury law firm, Stratton Faxon.

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Beverly Eckert, a widow since the death of her husband, Sean Rooney, on September 11, 2001 – in the attacks on the World Trade Center on that date – was among 50 passengers and crew aboard Continental Connection flight 3407 departing Newark’s Liberty International Airport on February 12, 2009, that crashed less than 100 yards from its destination of Buffalo-Niagara International Airport. Her sister, Margaret Eckert, has filed a wrongful death suit against three airlines, including Houston-based Continental.

The flight was operated by Continental Airlines contractor Colgan Air, a wholly-owned subsidiary of Tennessee-based Pinnacle Airlines Corp.

Margaret Eckert, the executor of her deceased sister’s estate, appeared in federal district court in Connecticut to file suit. She alleges that the plane was operating on autopilot with its wings loaded with ice, a condition that caused the aircraft to slow and stall immediately prior to the crash.

Just a week prior to her death, Beverly Eckert was at the White House with Barack Obama, part of a meeting the president had with relatives of those killed in the 2001 attacks and the bombing of the USS Cole to discuss how the new administration would handle terror suspects.
Spokespersons for Continental and Pinnacle declined comment pending litigation.

Colgan operates an average of 173 daily flights for Continental, serving 28 cities, according to Mary Clark, a Continental spokeswoman, a statistic representing 6.5% of the parent airline’s average daily flights systemwide.

From Continental’s Houston hub Colgan flies to a dozen destinations in Texas and Louisiana. From the Newark hub, Colgan flies to 16 East Coast destinations, including Boston, Pittsburgh, and Toronto.

Since the crash, there have been no changes in Colgan’s two contracts with Continental, one of which expires in 2010 and the other in 2018, according to Pinnacle spokesman Joe Williams. Margaret Eckert is represented by Stratton Faxon Law Firm in New Haven, Connecticut.

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In Hartford on June 17, 2009, a Superior Court jury in Michael Santopietro vs. Elizabeth Lach-Pasko, M.D. awarded $1.56 million to the plaintiff, 67-year-old Canton resident Michael Santopietro, finding that Dr. Elizabeth Lach-Pasko, director of the Department of Pathology at Charlotte-Hungerford Hospital, was negligent in her pathology findings, misdiagnosing the plaintiff with cancer requiring immediate resection and removal of a lobe of his lung when there was actually no cancer present.

Santopietro had recently retired from his job driving a handicap van for children with special needs in 2005 when he underwent a needle aspiration (biopsy) of his lung, which was submitted to the Department of Pathology at Charlotte-Hungerford Hospital where Lach-Pasko was a staff pathologist and pathology department director. Lach-Pasko issued a report the same day stating that the specimen of Mr. Santopietro’s lung was malignant and dangerously cancerous. Santopietro was immediately transferred to a cardiothoracic surgeon who quickly removed a portion of the left lung that Lach-Pasko had reported as cancerous.

While Santopietro was in recovery at Saint Francis Hospital after his surgery, their pathology department issued an updated report indicating that the lung specimen submitted from surgery showed “no evidence of malignancy.” Upon reviewing the findings, Santopietro’s primary care physician agreed: there was no tumor and no cancer. The amount of lung tissue removed was described during trial by Lach-Pasko’s own colleagues as “nearly half the size of a tennis ball in surface area.”

At trial, the jury listened to arguments posed by both sides for several weeks. It was determined that the plaintiff needlessly underwent a painful surgery and is now without a significant portion of a lung for no reason whatsoever. Charlotte-Hungerford Hospital had also refused to provide the lung tissue slides in question showing the misdiagnosis was withdrawn prior to trial. After the lung tissue was removed, Santopietro required constant supplemental oxygen and is now primarily confined to a wheelchair.

Santopietro was represented by Paul T. Edwards of Stratton Faxon Law Firm in New Haven, Connecticut.

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