Archive for the ‘Catastrophic Wrongful Death’ Category

Guidant’s Guilty Plea for Failure to Notify FDA of Defective Defibrillators Takes New Twist – Will Plea Agreement be Accepted by the Court?

April 24, 2010

Just over two weeks ago, the newswires were advising the public that Guidant LLC, a unit of Boston Scientific Corp, had been implicated in short circuiting failures of three models of their implantable cardioverter defibrillators (ICD’s). At issue in the charges brought last November by the Department of Justice were 20,146 devices identified as the Ventak Prizm 2 and Contak Renewal 1 and 2 defibrillators. It was also reported that Guidant pleaded guilty to the criminal charges. Guidant’s defibrillators became available to the public in 2005.

Dr. Ananya Mandal, the author of one of the lead articles relating to the case at that time, provided the following information about the devices:

The implantable cardioverter defibrillator (ICD) is a life saving battery operated device much like a pacemaker that is placed near the heart in a minor surgical procedure. This device detects abnormal heart rates and rhythms in the patient and delivers an electric shock to make the heart beat normally again. These save millions of people in the US and all over the world from sudden death.

As a result of the proposed plea agreement, Guidant has agreed to pay a combined criminal penalty of more than $296 million, which, according to a report in Reuters, is “the largest criminal penalty against a medical device company.”  In essence, the charges stemmed from Guidant’s withholding information from the U.S. Food and Drug Administration regarding catastrophic failures in some of the devices. According to this same Reuters report, “Boston Scientific reached a settlement with defibrillator patients in 2007 covering the 2005 product issues and additional issues the following year. It agreed to pay up to $240 million to cover up to 8,550 claims, including ones collected in a multi-district litigation case.”

This plea agreement is currently being considered by U.S. District Court Judge Donovan Frank, who announced at a hearing on April 5, 2010, that he would make his decision as to whether or not to approve the plea agreement within three weeks of that last hearing.  If he stays within the self-imposed time limit, his decision should be announced this coming week.

Photo of Ventak Prizm 2 by mindfully.org

Last week, however, a new twist to the case was reported by several news sources, including one posted by Reuters this past Thursday, April 22, 2010 – “two cardiologists who cared for a 21-year-old college student who died when his implantable defibrillator made by Guidant failed to deliver a life-saving shock are urging a federal judge to reject a plea agreement with the company.” These physicians are identified as Dr. Robert Hauser and Dr. Barry Maron.

The doctors’ comments in a letter to Judge Frank bear quoting:

“We are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act.

“On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.

“To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.”

Whether the judge heeds the words of these physicians or not remains to be seen. What is absolutely laudatory is the fact that these physicians have expressed their outrage as to this manufacturer’s conduct.  Are they not correct – the money paid both through civil settlements and, if approved, by virtue of the criminal charges will be “entirely borne” by the company’s shareholders? Where is the personal accountability for this outrageous conduct?  Our system of justice is one not only of compensation to the victims of such heinous conduct but also should serve to deter other individuals from taking the same life-threatening conduct in the future.  There is nothing like a good long jail sentence for those involved in this horrible scheme to deter other corporate executives from going down the same path of profit at all costs – even to human life.

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Dental Malpractice: Wisdom Teeth Removal Leads to Death and Verdict in Excess of $10million – NJ

April 24, 2010

Francis Keller, 21, presented to Dr. John S. Madras complaining of pain in his gums. Mr. Keller was told he needed a routine cleaning and that his wisdom teeth would need to be removed.

Mr. Keller returned a few days later for his cleaning, but, having informed Dr. Madras of his angioedema condition (a genetic immunity disorder with severe risk for swelling from incurring trauma to the hands or face), the cleaning was deferred. The dental hygienist contacted Dr. Richard Goldstein and was informed that Mr. Keller could not undergo any dental procedure until medically cleared.

Dr. Madras referred Mr. Keller to Dr. George Flugrad for wisdom teeth removal, and the procedure was performed on August 4, 2005. The following day, Mr. Keller awoke with difficulty breathing. Within the next fifteen minutes, his throat swelled causing suffocation.

Doctors Madras, Goldstein and Flugrad were all named as defendants in the case. During the trial, there was apparently great debate over whether Dr. Flugrad had been informed of Mr. Keller’s condition, and whether the patient had actually been cleared for surgery. The following is from the report of the case provided by Verdict Search.

Counsel for Flugrad and Madaras both argued that Keller was comparatively negligent, as he had been well advised of the risks of surgery. Counsel for Flugrad also contended that Keller claimed he had been cleared for surgery.

Counsel for Flugrad also claimed that Madaras telephoned him during the evening of Aug. 4 and they discussed Keller, but Madaras never mentioned that Keller’s physician had not given him medical clearance for dental surgery. Counsel also argued that Keller claimed he had been cleared for surgery.

Madaras admitted to speaking to Flugrad on the telephone on Aug. 4, but claimed there was no discussion about Keller, rather that the call was simply to wish Flugrad well on a two-week vacation he was commencing on Aug. 5.

The jury appears to have resolved the conflict in the patient’s favor – Dr. Goldstein settled with the family for a sum of $250,000; a New Jersey jury awarded Mr. Keller’s family a verdict of $10,200,00.00.

Fetal Pain and Suffering: New Nebraska Abortion Law Sparks Debate – When Does a Fetus Feel Pain?

April 17, 2010

An online article posted yesterday in NewScientist raises some interesting issues that will no doubt be the subject of much debate in days, months and years to come – does a fetus feel pain and if so, when? The true focus of this article was the recent (April 13, 2010) passage of new legislation in Nebraska, which essentially prohibits abortions after 20 weeks.  Ostensibly, Nebraska has become the first state to ban abortions on the basis that fetuses feel and appreciate pain.

The law, according to a report in LifeSiteNews.com, goes into effect on October 15, 2010, and has, at a minimum, the following legal implications:

Abortionists who break the law would face a Class IV felony charge, which carries a penalty of a five year maximum prison sentence, $10,000 fine, or both. Women who obtain abortions of their unborn children would face no criminal penalties.

The bill would allow women and even the fathers of aborted unborn children to sue and seek damages from abortionists who violate the law.    

I say “at a minimum” since there are other civil law implications arising from  the rationale behind this legislation. One of those issues often litigated throughout the various courts of the United States is a parent’s right to sue for conscious pain and suffering for fatal or non-fatal injuries to a fetus.  That analysis is beyond the scope of this blog. What is of present importance is the so-called ‘science’ behind this legislation and the response of the scientific community that may well have far-reaching implications in the field of civil litigation.

Before engaging in this discussion, note well: it is not my intention (or desire) to become embroiled in the abortion issue.  That is not what we do in our firm.  It is the state of  science that intrigues me in terms of how that may have relevance to what we do – litigate civil cases involving matters such as fetal death in utero or death or injuries sustained by fetuses due to the negligence of third persons (e.g. medical malpractice, catastrophic automobile accidents and the like).

Apparently, the ‘scientific basis’ for this Nebraska legislation is the research of Kanwaljeet “Sunny” Anand, a professor at the University of Arkansas for Medical Sciences.  Dr. Anand testified in 2004 on the federal partial birth abortion ban.  He provided his opinion testimony that after 20 weeks gestation, an unborn child would experience “severe and excruciating pain” from an abortion.

Dr. Anand’s opinions are not without numerous critics.  What is significant, however, is that even many scientists, who challenge Dr. Anand’s opinions that 20 weeks of gestation is the point at which a fetus can feel and appreciate pain, do accept the proposition that there is a point in the life of fetus where they can and do appreciate pain and suffering.

Dr. Mark A. Rosen, the Director of Obstetrical Anesthesia at UCSF’s Fetal Treatment Center, in 2005 co-authored an article in JAMA (abstract) that some refer to as the ‘seminal review on fetal pain.’

One of the opinions expressed in that paper defines what is at the center of this discussion – what is meant by ‘perception of pain’?

Pain perception requires conscious recognition or awareness of a noxious stimulus. Neither withdrawal reflexes nor hormonal stress responses to invasive procedures prove the existence of fetal pain, because they can be elicited by non-painful stimuli and occur without conscious cortical processing.

In the NewScientist posting, Dr. Rosen provided rebuttal statements to the premise inherent in the Nebraska legislation that fetal pain occurs at 20 weeks of gestation.

Dr. Rosen states, “The first brain pathways associated with pain perception “are not complete before approximately 29 weeks of gestation”, so although fetuses develop brain wiring from about 23 weeks onwards, the connections are not there to enable them to experience pain.”

Whether it is at 20 weeks or 29 weeks, one common principle exists – according to a number of scientists, there is a point prior to birth that a fetus can appreciate pain from a medical-scientific standpoint – the ‘wiring’ is in place. If this is true scientifically, how does this affect the right of recovery by a parent or the estate of an injured fetus in those jurisdictions permitting conscious pain and suffering damages for injuries to a fetus?

For instance, if a fetus is at 35 weeks gestation and by all other accounts is totally viable with ‘the wiring in place,’ does that fetus and/or the parents have a claim for conscious pain and suffering should injury to the fetus occur?

Does any jurisdiction recognize the right of a fetus to recover for injuries sustained in utero?  Absolutely – it just depends which jursidiction(s) you are considering.  For example, the District of Columbia, in 1946, was the first jurisdiction to recognize the right of a fetus to bring a separate cause of action (Bonbrest v. Kotz). This was an action for damages being brought on behalf of a fetus allegedly injured ‘in the process of being removed from its mother’s womb.’ “Under the civil law and the law of property, a child en ventre sa mère is regarded as a human being from the moment of conception.”

In 1984, the D.C. Court of Appeals, relying in large part on Bonbrest, stated:

Although this court has never considered this question, we note that every jurisdiction in the United States has followed Bonbrest in recognizing a cause of action for prenatal injury, at least when the injury is to a viable infant later born alive.

Note the key conditions: “…when the injury is to a viable infant later born alive.

This posting is already perhaps too long – this topic is multi-faceted and more the subject of a treatise, white paper or a law review article, not a blog.  What is apparent (at least to me) is that this new Nebraska legislation will undoubtedly rekindle the fires of fascinating litigation about fetal rights, fetal and parental causes of action and fetal pain and suffering claims. Stay tuned – there will undoubtedly be much more to come.


FHA Announces New “Toward Zero Deaths” Initiative

April 13, 2010

The Federal Highway Administration has launched a new initiative called ‘Toward Zero Deaths,’ a national strategy on highway safety, aimed at ELIMINATING, not reducing, all highway deaths.  The strategy is explained in a new article just posted by USA TODAY:    

The approach is called Toward Zero Deaths, based on a philosophy that even one road death is morally and ethically unacceptable. The goal: to alter behaviors that cause fatalities, such as speeding, drunken or distracted driving, and lack of seat belts. Speeding is a factor in more than 31% of road deaths, drunken driving in 32%, and distracted driving in about 16%. And 55% of those killed in passenger vehicles are not wearing seat belts, according to the National Highway Traffic Safety Administration.

More details regarding the purpose of the initiative are found within the announcement on the Federal Highway Administration’s website:

Toward Zero Deaths: A National Strategy on Highway Safety will be a data-driven effort focusing on identifying and creating opportunities for changing American culture as it relates to highway safety. The effort will also focus on developing strong leadership and champions in the organizations that can directly impact highway safety through engineering, enforcement, education, emergency medical service (EMS), policy, public health, communications, and other efforts. The national strategy will be utilized as a guide and framework by safety stakeholder organizations to enhance current national, state and local safety planning and implementation efforts. The intent is to develop a mechanism for bringing together a wider range of highway safety stakeholders to work toward institutional and cultural changes.

One of the most significant needs is to change Americans’ attitudes toward highway safety. There are already programs and technologies that can result in substantial reductions in fatalities; however, those benefits will not be realized as long as the public and elected officials are not willing to pass laws or take the actions needed to implement them.

Sound like a grassroots effort?  In part, it is.  A lot also has to do with technology, and several states have already implemented state versions of the national campaign.  As an example, Utah has already implemented the initiative, and has seen clear, convincing results in just four years.  Robert Hull, the director of traffic and safety at the Utah Department of Transportation, explains:

Since launching a zero traffic deaths program in 2006, the state’s traffic deaths have fallen almost 15%, from 287 to 245 last year, Hull says. The state already had cut road deaths by 24% from 2000 to 2005, partly by implementing engineering changes such as rumble strips and median separations, he says. He acknowledges that the economic downturn likely accounted for some of the recent decline as people drove less.

The next steps, in regard to the national effort led by the Federal Department of Transportation, are “to identify and understand challenges and opportunities in reducing highway fatalities.”  In addition, “the impact must include projections of lives saved as well as the health care costs of highway injuries and deaths, best practices, effective means of creating a cultural change, and other issues,” as stated by the Department.

To date, there are members of over 30 organizations interested in participating in the Stakeholder Group.  With over 35,000 deaths ocurring on the Nation’s highways every year, assistance from more highway safety stakeholder organizations may certainly be put to good use within the initiative.

Is this possible?  Can it be done?   Think about how difficult that would be, all of the challenges involved.  Having said It is a noble but impossible cause .  We will continue to monitor this initiative and will report on its progress.

Bicyclist Dies in Collision With DC Guard Truck

April 13, 2010

In recent weeks, we have discussed bicycle and pedestrian safety within blogs on our firm website.  Unfortunately, the tragedies continue to mount, and the most recent DC bicycle fatality is related to the traffic issues surrounding the DC Nuclear Security Summit, that is now taking place here in the District.  As NBC News has just reported:

A woman was killed Monday night when her bicycle collided with a five-ton truck doing security work for a motorcade for the Nuclear Security Summit in Northwest Washington.  

The accident happened around 6 p.m. at the intersection of 12th Street and New York Avenue, NW.

The vehicle that collided with the woman was a five-ton truck with the D.C. National Guard.

“It was moving forward to block as a procession was coming through,” said Major Gen. Errol Schwartz of the D.C. Guard.

At this time, it is still unclear who is at fault.  Regardless, we again urge all motorists , pedestrians, and cyclists to obey all applicable traffic laws.  Currently, the road situation in DC is, for lack of a better word, a mess.  A significant section of NW is currently completely inaccessible, and it is taking a very, very long time to get around anywhere in downtown DC.

The NBC article also details the current road closures, which continue all day today.  Click here for a complete list, and to view real-time traffic maps.

Now, I can tell you first-hand from living in the District, that traffic has been just miserable to deal with over the past several days!!  Having a tremendously increased security presence at this time is needed, I know.  However, I can ALSO tell you first-hand that this past Saturday, my wife and I were almost plowed into by an unmarked police escort in Georgetown, as we attempted to leave the area.  This was only one four car motorcade.  Imagine what forty plus motorcades for the various heads of state are doing right now as we speak…BE CAREFUL OUT THERE!

Aging Motorcyclists Hit the Road, But at Greater Risk of Injury, Death

April 7, 2010

Yes; Spring is upon us.  With the warmer, sunny weather comes more outdoor activity, including motorcycle riding.  The University of Rochester has just released a new study in regard to a noticeable increase in motorcycle injuries in the older population .  This study was the subject of a recent article, as published on the University’s website.  The study also details why older riders are injured more severely in motorcycle mishaps:

The increase in injury severity for older riders may be related to the reduced capacity to withstand injury as the body ages. Age-related changes, such as decreases in bone strength and brain size, may make older riders more susceptible to injury. Other factors associated with aging, such as impaired vision, delayed reaction time, and altered balance contribute to motorcycle crashes in this population, explaining in part the researchers’ finding that older riders crashed more often as a result of loss of control than younger riders.    

The figures regarding the increase in severity of injuries were compared to the younger population.  A short summary of those findings were listed in the article:

Between 1996 and 2005, researchers found the average age of motorcyclists involved in crashes increased from approximately 34 to 39 years, and the proportion of injured riders above the age of 40 increased from around 28 percent to close to 50 percent. Of all injured riders included in the study, 50- to 59-year-olds represented the fastest growing group, while 20- to 29-year-olds were the most rapidly declining.

The article also details the unfortunate use of alcohol by motorcycle riders, and the fact that intoxicated riders are less likely to wear a helmet.  The combination of alcohol and the lack of a helmet may prove to be a deadly combination:

The younger and older riders did have two things in common: helmet use and alcohol use. Overall helmet use was around 73 percent for both groups, and alcohol use was seen in approximately one third of injured motorcyclists, with no significant difference between the older and younger riders.

Alcohol use and helmet use have been linked in prior reports, with intoxicated drivers less likely to be wearing a helmet and therefore at greater risk for injury and death. It is not surprising that the researchers at the University of Rochester found that riders who tested positive for alcohol use were two-and-a-half times more likely to not be wearing a helmet at the time of injury. Despite abundant evidence that helmets reduce mortality, brain injury, length of hospital stay and economic burden, only 20 states have universal helmet laws.

The complete study can be found in the March 2010 issue of The American Surgeon.

Malpractice Wrongful Death Lawsuit by Couple Falsely Accused of Abusing Their Child Filed Against Children’s Hospital

April 1, 2010

Are there many things in this life worse than losing your child?

What if you lost two children?

What if you lost two children, you were wrongly accused of causing both of their deaths through child abuse, and one of the accusers in one of the deaths was the hospital that may have been able to prevent the death from ever even occurring?

The Dayton Daily News reports that may be what happened in the tragic case of Landen Shawen.  Before we get to that case, we will first briefly detail the death of ANOTHER one of the same parents’ children, approximately 3 years ago.  As reported previously back in October of 2006 by the Dayton Daily News in an article:

A Kettering baby whose death this summer was labeled suspicious by the Montgomery County Coroner’s Office died from natural causes, a coroner’s report shows.

Ethan Alan Shawen, who was 2 months old when he died Aug. 20 at Children’s Medical Center of Dayton, died from meningitis caused by an unknown organism, according to the report released Oct. 4. An autopsy showed no signs of child abuse.

As if this tragedy was not enough grief for parents Amber and Preston Shawen to have to suffer with, their second child, Landon, died a tragic death on March 31, 2009 at Children’s Medical Center in Dayton, Ohio, at 6 weeks of age, the very same hospital where their first child died.  The cause?  Here is a quote from the article:

On March 31, 2009, the couple’s 6-week-old son Landon died at Children’s Medical Center. Doctors accused the couple of abuse, and Children Services took custody of their 19-month-old daughter.

On June 5, the coroner’s office ruled that Landon died from venous thrombosis coagulopathy disorder, an easily treatable genetic disorder, which the lawsuit states is the same disorder that killed Ethan. Had the family been told of the neuropathologist’s report, Landon’s death could have been prevented, the lawsuit states.

The hospital’s current position, as posted in the article, goes as follows:  

Vicki Giambrone, a hospital vice president, said the hospital has a legal duty to report suspected cases of abuse.

“Dayton Children’s does not investigate these cases, nor do we accuse people or pass judgment,” Giambrone said. She declined to comment on the specifics of the lawsuit.

Note that the article states that the Shawens’ THIRD child, a 19 month old little girl, was taken into custody by Children Services after the hospital’s allegations.  How much more loss can one family take?  What a tragedy!

Time nearly up on malpractice suit against missing doctor -Texas style

March 30, 2010

In an article recently published online through the Austin-American Statesman website, one of the many harsh realities of our legal system is exposed.  The significance of procedural deadlines, and what may ultimately happen if such a deadline is not met (despite best efforts) is highlighted in this tragic story.  The following is a very brief summary, as taken from the article:

Debbie Stockton didn’t know her obstetrician was a drug addict when her son William was born in 1989 with extensive nerve damage to his left arm.

But when the boy grew into a teenager and his atrophied arm didn’t improve, Stockton sought legal advice and learned that Dr. Howard Offenbach had checked himself into a drug treatment center within a week of William’s birth to kick a years-long Valium and hydrocodone habit.

So in 2007, Stockton sued for an unspecified amount, claiming that Offenbach caused William’s injury by failing to order emergency surgery when the boy’s shoulder became pinned beneath his mother’s pubic bone during a difficult delivery.    

The Stocktons, however, ran into a legal roadblock that derailed their lawsuit before it went to trial.

Texas malpractice law gave them 120 days after filing suit to serve Offenbach with their medical expert’s report and résumé, but Offenbach couldn’t be found. After losing his medical license in 2000 for drug abuse, Offenbach had moved from his Dallas house, been evicted from two apartments and disappeared from public records.

Even Offenbach’s lawyers — acting on behalf of the former doctor’s insurance company — have been unable to locate their client and say that Offenbach is “not findable.” Still, they asked the trial court to throw out the Stocktons’ lawsuit for blowing the 120-day deadline.

The case has traveled its way up through the Texas court system over the past several years, before ending up at oral argument last week before the Texas Supreme Court.  The article also details the extent to which the Stocktons’ lawyer went to attempt to serve Dr. Offenbach with the lawsuit.

Sadly, Debbie Stockton passed away last fall from cancer.  The injured victim, William Stockton, is fighting for his cause, as the case has been continued under his name.  The Court now has the case under review.  We do not know what the Court will hold.  The article leaves us with this:

Justice Dale Wainwright mused aloud about the court’s dilemma.

The language of the law clearly directs judges to dismiss any lawsuit that exceeds the 120-day deadline, he noted: “On one hand, we don’t want defendants dodging or hiding to let the 120 days lapse. On the other hand, we don’t want claimants to be lax in any way when the Legislature used this kind of strict rule.”

Earphones Connected to More Injuries and Deaths

March 22, 2010

A report last week, as published on http://www.myfoxdc.com, states that there is an increase in the number of both pedestrians and bicyclists being killed or seriously injured, as a result of wearing earphones.  The article refers a warning issued by the American Automobile Association (AAA), whose officials state that this troubling trend is occurring across the United States:

Local officials are seeing a rise in the number of pedestrians and bicyclists who are being killed or seriously injured while wearing earphones.              

Transportation officials say several people have been killed in the Washington, DC area. Recently, a 51-year-old jogger was killed by a tractor-trailer truck while crossing Constitution Avenue. DC police say the woman was wearing headphones.

AAA officials say across the United States the number of pedestrian injuries and deaths are increasing because people wearing earphones are not aware of their surroundings.

This is a good time to remind everyone of the rules of the road, as cherry blossom season is upon us, and our local traffic significantly increases.  Please remember, regardless of whether you are a pedestrian, bicyclist, or operator of an automobile, be safe and follow all applicable safety and traffic laws.

Serious flaws in D.C.’s paramedic system

March 17, 2010

So says an editorial in last week’s The Washington Post.  The editorial details multiple deaths, allegedly caused by the inadequacies of  DC emergency response units.  One of the cases is the tragic story of Stephanie Stevens:

Responding to a call of a child with trouble breathing, emergency personnel went to Stephanie’s home on Feb. 10. But instead of taking her to a hospital, they advised her mother to run a hot shower to clear the child’s congested lungs. Less than 24 hours later, after another 911 call, she was dead, reportedly from complications of pneumonia.

This horrible set of circumstances follows other deaths in recent years – one with striking similarities:

Yet another problematic case was that of Edward L. Givens, who died in December 2008 after complaining of chest pains and being advised by emergency medical personnel to take Pepto-Bismol for what was likely acid reflux.

According to The Washington Post, a task force has been formed and has made some limited progress.  However, some of the main goals involve equal pay for medical personnel and to unify operations.  To date, this has not been accomplished.  An in-depth exclusive was featured by The Washington Post last year, regarding DC EMS problems.  A very concerning assessment of the quality of the training and performance of D.C.’s emergency response units was the subject of a Washington Times report of April 2009, which contains a ‘must see’ interview of Paul Werfel, Stony Brook University’s EMT/paramedic program director conducted by NBC 4, Washington, D.C.