Actor Dennis Quaid sues drug maker

Last month, we reported in a blog through our website, how actor Dennis Quaid is involved as a patient advocate, after his newborn twins nearly lost their lives back in 2007, from a medical error that could have very easily been prevented.  Put simply, the precious twins were given two doses of Heparin instead of Hep-lock (an anti-coagulant medication widely used for children).  Why is this significant?  Heparin is a drug one thousand times stronger than what the twins were supposed to have received.

Earlier this week, it was reported in the Contra Costa Times, that Mr. Quaid has filed a lawsuit on behalf of his children.  As far as the extent of his children’s injuries, the article states “The children suffered internal injuries and shock, but the extent of what happened to them will probably not be known for years, according to the suit.”  The lawsuit alleges that vials of the 10,000 unit Heparin should have been recalled previous to what happened to his children, because other infants had already died from similar medication errors.  The suit also claims that the company responsible for making the drug, Baxter Healthcare, “was obligated to warn healthcare providers of the previous medication mistakes.”

We wish the best for the Quaid family, and hope that the discovery in this case shines a light on not only finding out exactly what happened in this case, but also makes information available that may be able to save the lives of other children from future similar medical errors.  We will continue to monitor the course of this case.

Another Child Dies. Will DC EMS Improve Now?

We reported back in mid-March on our blog site on the issues surrounding an investigation of the District of Columbia’s Emergency Medical Services. Since then, DC EMS has represented that they have made positive changes to their department.  In a headline article posted on MSNBC.com at the end of this past week, D.C. Fire and Emergency Medical Services Chief, Dennis L. Rubin, represented positive changes are being made:

Rubin said he is working to drive home a key point: providers never decline transport.

His staff is developing a “patient’s bill of rights” to be posted in every ambulance and producing a new  training video underscoring that message. In addition, the policy has been expanded to cover instances in which a patient refuses to be transported, including the requirement that responders get an OK from a supervisor and have a witness, such as a police officer, confirm the patient’s decision.

We certainly hope this is the case.  Our prior post cited a troubling report from April 2009, wherein it was found that there were serious training and performance issues relating to DC EMS.  The article posted at the end of  this past week also details another tragic event that unfolded after the report in April 2009:

Stephanie Stephens died after paramedics refused to take her to the hospital Feb. 10 in the first of two visits to her home after she experienced breathing problems. Her death has prompted a rare criminal investigation and raised questions about ambulance policies in Washington and emergency care for children nationwide.

After the paramedics recommended she be taken into a bathroom to inhale steam from a running shower, Stephanie’s family called back hours later and an EMS crew took her to a hospital. The child died from pneumonia the next day.

Anyone have issue with this?  How many tragedies must we endure before there is ZERO TOLERANCE for such costly delays?!  The citizens and guests of DC are dependent upon DC EMS to provide assistance immediately; not to give bad medical advice, try to play doctor, or decide that they will just simply not transport someone.  Read the report from last year cited above, along with the relevant articles.  Then, you decide.  I wonder what Stephanie’s family thinks…

Facts You May Not Know, but Should!- Hidden Dangers of Trampolines

Well, it looks like it will be 80 plus degrees and sunny outside for the first weekend of May here in the Nation’s Capital.  This means lots of outdoor activities; pool parties, lawn games, playing in the park…some will even have trampolines on their property, with the neighborhood kids coming over to use them.  CBS News reports on some of the hidden dangers of trampolines, as posted in an article today:        

Last year alone, an estimated 98,000 people were treated in emergency rooms for trampoline related injuries. 82 percent of them were children under the age of 15.

Trampoline safety expert Marc Rabinoff, of Metropolitan State College of Denver, Colo., calls trampolines “quad machines” because they can turn you into a quadriplegic in four seconds.”

Warnings on trampolines say no flips, no jumpers younger than 6 and only one jumper at a time, but those warnings are often ignored. Koeppen pointed out videos from YouTube that show children jumping and falling from trampolines.

Rabinoff says people don’t realize trampolines are a danger in their backyard. Rabinoff demonstrated to Koeppen how jumping with more than one person can throw you off.

The article goes on to state that ‘safety nets’ placed around the trampoline can reduce accidents by up to 50%.  However, they are not required by law.  In addition, and take note – insurance companies may not necessarily cover trampoline accidents on their policies.  Coming from Florida last year, where I practiced plaintiff personal injury law, I can tell you that I was contacted on more than one occasion by families who had a loved one injured as a result of a trampoline accident.  Each time I would check the homeowner’s policy of the responsible homeowner, (if they even had homeowner’s insurance; some didn’t) there was the EXCLUSION for such accidents!  No coverage!

The article also suggests that trampoline owners should erect fences around their property, to prevent others from wandering on the property and injuring themselves on or around the trampoline.  I, for one, will not be allowing my first-born son on any trampoline anytime soon.  In this line of work, you really do get to see the worst of what can happen, when a chain of events causes something to go terribly wrong.  Why ask for trouble?

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

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.

FHA Announces New “Toward Zero Deaths” Initiative

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.

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

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!

Study Finds Stents as Effective as Surgery to Prevent Strokes; European Study Finds Otherwise

A few weeks ago, the NY Times published a story about a recent North American study designed to examine the efficacy of stenting versus surgery of the carotid artery for the prevention of strokes. Known as the Crest (Carotid Revascularization Endarterectomy versus Stenting Trial) Study, the project was designed to determine if the less invasive procedure known as stenting (i.e. placing a small tube inside the carotid artery) was an equally safe and effective treatment option to surgery for the prevention of stroke.  

Strokes are reported to be “the third leading cause of death in the United States and a major cause of disability among adults. Each year, almost 800,000 Americans suffer a stroke, and more than 140,000 die.”

Of concern, however, is a European study published online in the Lancet the day before the announcement of the Crest Study results.  According to Dr. Martin M. Brown, chief investigator for the European trial, the International Carotid Stenting Study, their investigation showed “dismal results” from stenting versus surgery in their study group population of 1,173 randomly selected patients (the Crest study involved 2,502 patients from more than 100 hospitals in North America).

Dr. Brown said that although differences in the groups studied might explain the disparate results, “nobody has really shown stenting is better than surgery, so why choose a stent?”

Dr. Brown added, “Even if Crest shows little difference between the two, there are three other trials that suggest surgery is safer.”

On the other side of the debate, however, are the statements of the lead author of the Crest Study, Dr. Thomas  Brott, who is quoted in the NY Times article as saying:

“We had outstanding results, and our study, we think, is representative of these treatments in the United States and Canada. Prior to the Crest trial, we really did not have the best evidence, but these results indicate that we have two very safe and effective methods to prevent stroke.” Though there are differences in risk between the two procedures and individual variations, he said, “the results from stenting are very comparable to those for carotid surgery.”

The differences in the two studies in terms of mortality and morbidity are summarized in the Times article.

What to make out of all this remains the question.  Hopefully further studies will provide a clearer answer.

I am not a doctor, and I suspect, you, the reader, are probably not either.  What I can say is this – and it is what I have been advocating throughout many of our blogs – be an educated patient.  Ask questions if you find yourself or a loved one presented with this option of surgery versus stenting and ask the right questions of your doctor.  Why is one option being suggested by your doctor over the other?  What are the risks of each procedure?  While one procedure may be “less invasive” than the other, there are still risks associated with each.  “Less invasive” is not always the answer.   I further encourage you to ask your doctor what his or her experience is in performing carotid artery stenting.  Remember, the Crest Study had one key element – “carefully screened … doctors doing the stenting procedure, including only highly skilled physicians with a lot of experience.”  Make sure your doctor fits that description.

Serious flaws in D.C.’s paramedic system

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.

St. Joseph tells 169 more patients they may have had unneeded surgery; total notified at now at 538

The Baltimore Sun reports today that another 169 patients have been notified by St. Joseph Medical Center in Towson, Maryland, that the coronary stent implants they received may well have been (read – were) unnecessary.  The total number of patients so far notified by the hospital has now reached 538.

Stents, mesh tubes that are threaded into damaged arteries to prop them open, are generally considered appropriate when vessels have at least a 70 percent blockage. But hospital officials say their review uncovered stents implanted by Midei in patients with insignificant blockage. And attorneys representing some patients say the amount of blockage was often overstated in their medical records.

Dr. Mark Midei, a cardiologist at the center of this storm, was terminated by St. Joseph Medical Center after the hospital came under investigation by federal authorities last year.  He at one time was an employee of one of the leading cardiology group practices in the area, MidAtlantic Cardiovascular Associates, but left that group when he was recruited by St. Joseph Medical Center to head its cardiovascular laboratory in 2008.  His departure from his group was apparently not peaceful.

[Dr. Midei’s] departure helped scuttle a deal MidAtlantic had to merge with St. Joseph rival Medstar Health, and prompted the practice’s chief executive to tell Midei: “I will spend the rest of my life trying to destroy you personally and professionally,” according to court records.  

A class action lawsuit has been filed by the the Murphy Firm in Baltimore, Maryland, working in conjunction with another Baltimore legal powerhouse, The Law Offices of Peter Angelos. These firms have been involved in many class action lawsuits across the country.  The current lawsuit has been filed in Circuit Court for Baltimore City, Maryland.  On January 28, 2010, the Murphy firm posted an announcement regarding this class action.  A similar press release detailing some of the relief being sought in the class action is posted on Peter Angelos’ firm’s website.

In February of this year, according to the Sun’s report today, “two senior members of the U.S. Senate Finance Committee called on St. Joseph to turn over records of its financial relationships with stent manufacturers, including records of how the $10,000 procedures were billed to federal and private insurers.”

“In addition to putting patients’ lives at risk, unnecessary medical procedures amount to wasteful spending of precious federal health care dollars,” they wrote in a letter to the hospital.

As for Dr. Midei’s comments or reaction to today’s article, the Sun reports:

A spokesman for Midei declined to comment. He reiterated a statement the doctor issued in January, which read: “I am confident that I have always acted in the best interest of my patients, and when all the facts are presented, I will continue providing quality medical care to my patients.”

Man Dies After Ten 911 Calls

According to an article published by the Associated Press, Curtis Mitchell, a 50-year-old Pittsburg steel worker, died on February 6 after numerous ignored 911 calls. Mitchell had pancreatitis for some time, for which he was hospitalized in January.  About a week after his hospital discharge, his abdominal pain returned. This is when the 911 calls began.

Mitchell did not have a car. His abdominal pain progressed and he was in no condition to walk to a hospital or a medial clinic as the snow storm covered Pittsburg under two feet of snow. The first 911 call was made around 2:00 a.m. on February 6, as the storm knocked out the power to his house.  At 11:15 a.m., he called 911 yet again:

My stomach man, it’s real messed up. It’s killing me.

As Mitchell and his girlfriend, Sharon Edge, continued to call 911, his pain worsened and he began to develop shortness of breath. At around 8:00 a.m. on February 7, Edge called 911 for the tenth time:

I think my husband’s dead. Oh God, oh God.

After a short while, firefighters arrived at the residence. They found Mitchell unresponsive and without a pulse. Another five hours had passed before officials from the medical examiner’s office took Mitchell’s body out of the house.

According to the article, Pittsburg officials undertook an investigation of the circumstances surrounding Curtis Mitchell’s death in an attempt to reform the city’s emergency response system. The investigation revealed the following:

Details of Mitchell’s calls weren’t passed on from one 911 operator to another as shifts changed, so each call was treated as a new incident.

Twice, ambulances were as close as a quarter-mile from Mitchell’s home but drivers said deep snow prevented the vehicles from crossing a small bridge over railroad tracks to reach him. Mitchell was told each time he’d have to walk through the snow to the ambulances; in neither case did paramedics walk to get him.

Once, an ambulance made it across the bridge and was at the opposite end of the block on the narrow street where the couple lived — a little more than a football field’s length. Again, paramedics didn’t try to walk.

Sharon Edge put this tragedy in prospective when she said:

I’m very angry, because I feel they didn’t do their job like they supposed to. … My man would still be living if they’da did they job like they was supposed to. … They took somebody that I love away.

Contributing author: Jon Stefanuca