Growing Controversy Over Safety of New Oral Anticoagulant Pradaxa

Pradaxa is a novel oral anticoagulant designed to reduce the risk of stroke in patients with atrial fibrillation. From the day it was approved for sale in the United States an unprecedented number of serious adverse events and deaths attributed to the drug that were reported to the FDA. In response, the FDA launched an investigation into the safety of Pradaxa announcing that “the FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected…” Less than a year later, in November 2012, the FDA concluded that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.” The FDA based their conclusion on an analysis of data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The approach utilized by the FDA was immediately criticized by health care professionals as “problematic” and described the conclusions reached by the FDA as “tantamount to a guess.” It appears the FDA did nothing more than ineffectively attempt to provide itself political cover for approving such an unsafe drug.

The problem with Pradaxa, and its hasty approval, lies in the fact that, unlike warfarin – the drug it is compared to in both its clinical trials and television advertisements – is that it cannot be reversed. Or to put another way, it has no antidote. When a warfarin patient experiences a bleeding event or is in need of emergency surgery, health care providers have a host of options available to them to reverse the blood thinning effects of warfarin and stop or slow the bleeding event or allow for safe surgical invention. Pradaxa has no such reversal agent or antidote. What does this mean in the real world use of Pradaxa? Are more Pradaxa patients bleeding to death than warfarin patients as a result of this lack of antidote? If you look to the pivotal clinical trial, the Randomized Evaluation of Long-Term Anticoagulation Therapy (“RE-LY”) you won’t find the answer. It’s a pretty simple question. Did more patients bleed to death on Pradaxa than they did on warfarin?

More than five years since the RE-LY trial was completed and more than two years since Pradaxa was approved, we are only just now beginning to answer this question. Rather than provide an answer to this important question in the original analysis and publication of RE-LY, the makers of Pradaxa waited until December 2012, after hundreds of lawsuits had been filed on behalf of Pradaxa patients who suffered a major or fatal bleed, and released data at a medical conference in a poster abstract. Amazingly, their “new” analysis of five-year-old data showed that Pradaxa patients were 44% less likely to die as a result of a major bleed than warfarin patients. Amazing in that if this were true, why not include it in the original analysis and publication? Perhaps the answer lies in the fact that poster abstracts are not peer-reviewed or subjected to scientific or regulatory scrutiny.

Less than a month after these “amazing” results were released by the makers of Pradaxa, on January 9, 2013, the Institute for Safe Medication Practice (“ISMP”), an independent research organization, published their own analysis of this very same question: are more patients bleedings to death on Pradaxa than warfarin? Amazingly, the ISMP reached a radically different answer than the makers of Pradaxa. ISMP determined that “reported [Pradaxa] bleeds were about 5 times more likely than warfarin to result in death…” 500% more likely to die as a result of a major bleed if you are on Pradaxa instead of warfarin. This really shouldn’t come as a surprise based on what we know about the availability of a reversal agent for these two drugs. What is surprising is the total disconnect between these two studies that reportedly addressed the same question.

Simply put: One of these two new studies got it wrong. Way wrong. Is this a matter of sloppy science or perhaps is this a deliberate effort by someone, for whatever rea$on, to mislead prescribers and users of Pradaxa? Only time will tell. Stay tuned.

Florida Court Refuses To Dismiss Claim For Pregnant Woman’s Death

An appellate court in Florida refused  today to dismiss a claim for the wrongful death of a young pregnant woman while she was in the care of a mental health facility known as Park Place.  The Defendant, Osceola Mental Health, Inc., sought to have the case thrown out because the woman’s family did not sue under the Florida Medical Malpractice laws.

The patient, 25 year old Farrah Krystle Jean, went to the hospital with complaints of pain.  While there, she was transferred involuntarily to Park Place.  The involuntary commitment was done under Florida’s Baker Act, a law that allows patients to be held against their will when a court, police officer or healthcare provider believes the patient poses a serious risk of imminent harm to herself or others.

Jean complained of severe abdominal pain and other problems over the two days following her confinement. Tragically, she died at the beginning of the third day.  The family filed suit against the facility, alleging that the acts and omissions of the staff caused the death.  The court rejected the facility’s arguments that the Medical Malpractice laws had to be complied with and ruled that the case could go forward.  The court stated that mental patients have rights under the Baker Act, and the facility was not a healthcare provider as defined under the Medical Malpractice statutes.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Wind Tax Credit Avoids Fall Over Fiscal Cliff

The U.S. government has managed to postpone financial calamity for a few months with the passage of a so-called “fiscal cliff” deal.  But hidden within the bill was tax credit that was considered dead on arrival – The wind energy production tax credit.

The credit has been in jeopardy since it was first introduced, with Republicans in Washington threatening to kill the tax credit, citing its estimated cost of $12.1 billion over the next decade as too costly.  However, the credit breaks down to a mere 2.2 cents per kilowatt hour of wind energy produced in America, making it one of the cheapest subsidies approved for energy projects.

The extension of the credit comes at the perfect time, as the United Nations recently released a report detailing the ways in which climate change could cause financial disasters across the globe.

Among the more dire warnings in the U.N. report is the threat of water scarcity, which could devastate commodity markets, as agriculture would take a massive hit and crops would be decimated.  So while the United States might have postponed the drop over the fiscal cliff, the threat of the environmental cliff is very real, and very much in need of addressing.

The wind production credit extension will keep the tax credit alive for the year 2013, and its fate after that remains unclear.

Farron Cousins is the executive editor of The Trial Lawyer Magazine, a contributing writer at DeSmogBlog, and the producer of Ring of Fire.  Follow him on Twitter @farronbalanced.

Medical Malpractice: “Never Events” Occur At Least 4000 Times Per Year

“Never Event” is a universally recognized term in the medical profession referring to something that should never happen during surgery, such as a retained-foreign-body (an instrument or sponge left in the body) or a wrong-site, wrong patient, or wrong procedure surgery.

According to a recently released Johns Hopkins’ medical malpractice study, “never events” occur approximately 4000 times per year in the United States:

–  retained-foreign-body occurs 39/week;

–  wrong procedure occurs 20/week; and

–  wrong-site/patient occurs 20/week.

This astonishing number only further substantiates a fact that we all should already know:  physicians, just like the rest of us, are capable of negligence.  And, just like the rest of us, when their negligence causes injuries and damages to others, physicians should be held financially accountable.

From 1990 to 2010, the study, based upon information from the National Practitioner Data Bank (NPDB), identified 9,744 paid malpractice judgments and claims resulting from “never events” with death reported in 6.6 percent of the patients and permanent injury reported in 32.9 percent of the patients.  The total compensatory payout amount of the 9,744 claims was approximately $1.3 billion.

To think, this data only accounts for “never events”.  It does not even begin to consider and account for medical malpractice claims resulting from the less egregious forms of medical negligence that occur each and every year.  Make no mistake, medical malpractice is a prevalent and unavoidable consequence of medical treatment in our society, and injured patients and their families deserve just compensation.

Cameron Stephenson is a lawyer with the Levin, Papantonio law firm in Pensacola, Florida, and handles medical malpractice and other wrongful death cases.  He has devoted his legal practice to fighting for the rights of Florida’s injured patients.

More information on medical malpractice lawsuits.

Surgical Malpractice Associated With Surgeon’s Inexperience

Although it comes as no surprise that an inexperienced surgeon may be more likely to commit medical negligence in the performance of a surgical procedure, the surprising thing is that it happens at all, given the stringent training, licensing and credentialing requirements for surgeons.  Nonetheless, surgical inexperience continues to be associated with poor patient outcomes.

Researchers have identified a number of factors associated with bad surgical outcomes. In addition to inexperience, they cite low hospital volume for some surgeries, excessive workload, fatigue, lack of optimal technology, poor supervision of staff and trainees, poor communication, emergency circumstances and even the time of day.  Fortunately, these issues can be addressed, as they are “system” problems rather than unavoidable and inherent ones.  Unfortunately, though, we have not yet found a way to require these system issues to be adequately addressed.

Just last week, a claim against a Veteran’s Hospital in Ohio was settled after a 59 year old veteran died following a simple hernia surgery.  The patient’s family discovered that the surgeon had never performed this type of surgery on his own and had only been licensed a few months when the patient had his surgery.  The claim was settled for $500,000.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Obama Foregoing Chance To Change Federal Court By Inaction

The President has an opportunity to affect the makeup of the federal judicial branch through his power of appointment, yet he may not be using that power to the fullest.  There are 874 federal judicial slots which are filled upon appointment by the President and confirmation by the Senate.  That number includes all the judges who serve at the district trial court level, the circuit courts of appeal, the Court of International Trade and the nine members of the United States Supreme Court.  According to the Administrative Office of the U.S. Courts, there are currently 75 judicial vacancies, which is about 10% of the total federal district and appellate court positions.  The President has nominated people for 32 of those available slots, and they are awaiting Senate confirmation.  However, 43 of the slots are open.  27 of the existing judicial vacancies have presented what has been described as “judicial emergencies.”

Chief Justice John Roberts has expressed concern about the consequences of long term reductions in funding for the judiciary.  In the Chief Justice’s annual report to the President and Congress, he cautioned that the courts need vital resources, including an adequate number of judges, to keep up with pending cases.  He warned that a delay or denial of justice could occur if the court does not have sufficient judges and staff to do its work.

Virginia Buchanan is a shareholder at Levin, Papantonio.  She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.

Robert Reeves named one of South Carolina’s Top Trial Attorneys

South Carolina attorney Robert Reeves, founding partner of Reeves, Aiken & Hightower LLC, has been listed as one of the state’s Top 100 Trial Lawyers by The National Trial Lawyers (NTL).

NTL is a professional, educational and business organization of trial attorneys. Its membership is limited only to those it selects on its top 100 trial lawyers list. These spots are offered to those attorneys that the NTL believe have demonstrated superior qualifications of leadership, reputation, influence and profile as civil plaintiff or criminal defense trial lawyer.

Reeves accepted the invitation to become an elite member of NTL with great appreciation and excitement.

“I love being able to help people everyday that I come to work,” Reeves said. “It’s an honor to be recognized by The National Trial Lawyers for helping people understand their legal rights and finding them to solutions to their problems.”

The office of Robert J. Reeves PC is located in Fort Mill yet has a limited liability partnership with Aiken & Hightower PA located in Columbia. Together the firms represent clients in both South Carolina and North Carolina who come to them for help in either personal injury or criminal matters. The firm focuses primarily on DUI / DWI and workers compensation cases.

Reeves is part of the less than one percent of lawyers in the country who has attained a personal injury settlement worth more than $1 million. This rare achievement has made him a member of the Million Dollar Advocates Forum.

Reeve’s partner, Arthur Aiken, is also one of the few members of the Million Dollar Advocates, making Reeves, Aiken & Hightower an impressive and reputable team of personal injury lawyers.

The firm also has a successful record in criminal cases.

Reeves’ civil litigation skills have helped him aggressively defend countless DUI/DWI cases. Such convictions have an enormous negative impact not only on the person charged, but his or her family members as well. That is why Reeves, and the attorneys at Reeves, Aiken & Hightower, conscientiously fight against these charges on behalf of their clients.

As a new member of The National Trial Lawyers, Reeves will gain extensive networking resources as well as engage in open dialogue between the finest trial lawyers in the country.



DATE: March 21, 2011



CASE NO.: 09C0053

COURT/COUNTY: Superior Court of the State of California, Kings County

JUDGE: Hon. James T. Laporte, Dept. 4

MEDIATOR: Michelle Reinglass, Esq.

SETTLEMENT: $2,500,000.00


Brian Panish and Thomas Schultz – PANISH, SHEA & BOYLE, LLP (Los Angeles, California)

Michael Silvers – Las Offices of Michael Silvers (Los Angeles, California)


Kamala Harris, Attorney General; and Alberto Gonzalez, Supervising Deputy Attorney General, State of California


On January 5, 2008, April Macias (37 years old) was driving her two minor children Korin Macias (16 years old) and Michael Macias (14 years old) home from school in her 2005 Ford Excursion.  April was travelling westbound on Highway 198.  At the same time, a 75 year old employee of the State of California driving a State vehicle, was travelling eastbound on Highway 198.

Inexplicably, the State employee turned left directly in front of Plaintiff’s vehicle causing her to collide with the broadside of the State vehicle.  The brunt of the impact was felt in the left front of the vehicle where April was sitting.  April lost consciousness and had to be carried out of the car through the rear window by her two minor children.

After the accident, April, Michael and Korin were transported by ambulance to a local hospital for medical treatment.



At the scene of the accident, Plaintiff complained of head, neck, shoulder, hips, legs and back pain.  She was later diagnosed as having suffered a concussion as well as a cervical sprain/strain with radicular symptoms, a left AC joint tear, left shoulder internal derangement and positive impingement sign, lumbar sprain/strain, rib contusion and coastal chondritis.  In addition, she underwent six surgeries to treat neuropathy in her left wrist and upper extremities. Even after the surgeries, Plaintiff suffered chronic pain in her hands, back and neck.

Michael and Korin suffered abrasions and contusions to their face and bodies.  Korin was also diagnosed with bursitis in her left tricep.


As a result of her injuries, Plaintiff was unable to return to work.  At the time of the accident, Plaintiff worked in a deli as a food preparer.  She had taken this job in order to have more time to raise her children.  Prior to working as a food preparer, Plaintiff worked as an administrative assistant/secretary.  Due to the injuries to her hands, Plaintiff’s secretarial abilities were severely limited.

Plaintiff claimed past and future lost income, loss of earning capacity and past and future medical expenses.

Michael and Korin claimed damages for negligent infliction of emotional distress both as bystanders and as direct victims.


In February of 2011, shortly after Brian Panish and Thomas Schultz of Panish, Shea & Boyle were associated in, Defendant admitted liability in this action.  Defendant further stipulated that their driver was solely responsible for the accident and that he was working within the course and scope of his employment at the time of the collision.  The only issues to be determined at trial was the nature and extent of the injuries and damages to Plaintiffs.


The case settled for $2.5 million during mediation before Michelle Reinglass, Esq., on March 21, 2011.

Bea Hightower Joins University of South Carolina as an Adjunct Professor

Having spent seven years of undergraduate and law school education at the University of South Carolina, Bea Hightower has decided it’s time to return. Except this time, she is going to be sharing knowledge instead of gaining it. Ms. Hightower will be serving in an adjunct teaching position, and her primary responsibility will be to teach the university’s course on Criminal Courts. It will explore the structure, organization and functions of the federal and state court systems.

Bea Hightower is a founding partner of the SC law firm, Reeves, Aiken & Hightower, LLP. She has an extensive criminal and litigation background, and has worked at the Berkeley County Deputy Attorney’s Office, the Richland County Public Defender’s Office and the Richland County DSS Child Support Enforcement Office.

Serving as a South Carolina attorney, Ms. Hightower focuses on cases involving clients who have been accused of DUI, DUAC, drug charges, credit card fraud, domestic violence, bad financial transactions, and other similar offenses. These experiences, coupled with her activity in various law associations and committees, give her the expertise needed to serve as an adjunct professor within the USC’s Department of Criminology and Criminal Justice.

About Reeves, Aiken & Hightower, LLP

Reeves Aiken & Hightower LLP is a limited liability partnership between Robert J Reeves PC (Fort Mill/Charlotte) and Aiken & Hightower PA (Columbia). They are full-service personal injury and criminal defense law firms that employ personal injury lawyers and criminal defense attorneys who have over 70 years of combined legal experience.

About the University of South Carolina Department of Criminology and Criminal Justice

The University of South Carolina Department of Criminology and Criminal Justice offers state-of-the-art programs grounded in both research methods and criminological theory. These programs focus on the causes of and societal responses to crime and other deviant behavior. Students are provided with a strong foundation in both liberal arts and social sciences, and they are prepared to address the challenges of crime in society from the viewpoint of criminal justice professionals, researchers, educators and more.

The National Trial Lawyers President Speaks Out on Sanford, Florida Fatal Shooting

By Andrew Findley and Niki Pierce

Mike Papantonio, the president of The National Trial Lawyers, talked about the recent killing of a young black man in Florida on MSNBC’s The Ed Show on Wednesday, March 21, 2012.  Papantonio criticized the National Rifle Association’s (NRA) involvement in passing the “Stand Your Ground” law passed in Florida.  The “Stand Your Ground” law is getting attention after the recent fatal shooting of Trayvon Martin in Sanford, Florida.  Police say George Zimmerman shot Martin February 26 while acting as a neighborhood watchman.  Zimmerman, who has not been arrested, says he shot Martin in self-defense.  The Justice Department is investigating the shooting.

To watch video of Papantonio’s appearance, please click the link below: