Last week, the Department of Justice Announced a record $1.5 Billion settlement with Abbott Laboratories over their mislabeling of the drug Depakote.

“Global Health Care Company Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today.  The resolution – the second largest payment by a drug company – includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million.  Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.

Fox 4 in Dallas did a great story on the Texas Medical Board and their contribution to physician discipline since tort reform in 2003.  According to the report serious disciplinary actions are down and the time taken to conduct investigations has risen.  Further, Doctor confidentiality and secrecy is maintained until a final disciplinary action is completed, leaving patients unaware of allegations of malpractice by doctors.

Check the Fox 4 page for a video.  Some of the images are graphic and the stories are truly tragic.  Its a shame our state has fallen so far in protecting patient rights.  Still, there are ways to make health care providers and even doctors accountable for malpractice or negligence.  Don’t hesitate to call if you may have been a victim.

Many 18-wheeler accidents become more difficult to investigate due to missing or incomplete information concerning hours-of-service compliance. Electronic Logging Devices could assist in safety and compliance with federal laws by more closely tracking hours 0f service and other important metrics.

The American Trucking Associations, along with other law enforcement and advocacy groups, recently signaled support for such a measure by sending a letter to members of the House and Senate who are currently negotiating safety regulations.

“The Federal Motor Carrier Safety Administration has estimated the annualized cost to be between $525 and $785 per truck over a 10-year period. This is a reasonable cost to help improve compliance with and enforcement of important truck safety rules,” the letter said.

“ATA believes that this technology can be beneficial to our industry by encouraging compliance with the hours-of-service rules,” Graves said. “That increased compliance translates into safer highways not just for the thousands of professional truck drivers on the road each day, but for every American who travels our highways.”  See the ATA’s article about this story here, see their letter to Congress here.

A new study by  David A. Hyman, Charles Silver, and Bernard Black shows that Texas Tort Reform measures have not increased the number of doctors in Texas since 2003.

“Does state tort reform affect physician supply? Tort reformers certainly believe so. Before Texas adopted tort reform in 2003, proponents claimed that physicians were deserting Texas in droves.

After tort reform was enacted, proponents claimed there had been a dramatic increase in physicians moving to Texas due to the improved liability climate. We find no evidence to support either claim. Physician supply was not measurably stunted prior to reform, and did not measurably improve after reform. This is true whether one looks at all patient care physicians in Texas or at high-malpractice-risk specialties.”

Undoubtedly, victims will continue to be blamed and accused of being “money-grubbing” and “litigious,” but studies like this should provide some solace to those who seek redress for the injuries they’ve suffered.  Demanding compensation after suffering medical malpractice does not harm our medical community.

The Dallas Morning News reports that a soon-to-be-released study shows Texas Appellate Courts reverse judgments for plaintiffs with alarming regularity, and at a dramatically higher rate than judgments for defendants:

“The study, conducted by two appellate lawyers at Haynes and Boone, found the Texas appellate judges have an overall reversal rate of 49 percent when they review cases that the plaintiff won in the trial court and the defendant appealed. But those same judges reversed only 25 percent of the cases in which the defendant prevailed at trial and the plaintiff appealed.

The Texas courts of appeals reversed 50 percent of the jury verdicts that favor plaintiffs in consumer fraud and general tort cases, but the judges overturned only 11 percent of the jury verdicts that favored defendants, according to the study, titled “Reasons for Reversal in the Texas Courts of Appeal.”

In personal injury cases, including allegations of wrongful death, the disparity was even larger. Appellate judges reversed 7 percent of the jury verdicts that favored defendants, but they reversed 44 percent of the jury verdicts that decided for plaintiffs”

When victims face such a hostile legal environment it is even more important that they seek experienced lawyers so the parties at fault cannot avoid paying for the damages they cause.

Distracted driving is a real scourge in our society.  Secretary of Transportation, Ray LaHood, has declared today #StopTheTextsDay asking Twitter for ideas on how best to fight this menace and convince people to put down the phone and drive.   Celebrities like Kasey Khane have even released public service announcements with the National Highway Traffic Safety Administration urging drivers to “STOP THE TEXTS STOP THE WRECKS.”

Unfortunately, distracted driving isn’t just a problem amongst consumers.  Many employers still have policies that allow, or even encourage employees to use their cell phones while driving.  The National Safety Council released a report today about the danger caused and the liability faced by employees with such misguided policies.  According to the NSC:

“In 2010 motor vehicle crashes killed nearly 33,000 people in the United States.  Motor vehicle crashes are the No. 1 cause of work-related deaths and account for 24% of all fatal occupational injuries.  On-the-job crashes are costly to employers, incurring costs of more than $24,500 per property damage crash and$150,000 per injury crash. Driver distraction is a significant factor in crashes, and cell phones have played an increasing role as cell phone use has grown rapidly in the past 15 years, from a small percentage of the population using cell phones to virtually everyone. Today there are more U.S. cell phone subscriptions than there are people living in the United States. The National Safety Council estimates that at least 24% of crashes in 2010 involved drivers using cell phones, including 1.1 million crashes where drivers were talking on cell phones and a minimum of 160,000 crashes where drivers were texting. These estimates include property damage, injury and fatal crashes. Several research studies found that the risk of a crash is four times as likely when a person is using a cell phone – handheld or hands-free.”

In one example, the NSC cites the case of a fatal accident caused by a distracted truck driver:

“In March 26, 2010, a semitrailer traveling southbound on I-65 near Munfordville, KY, crossed the grass median and entered the northbound lanes where it was struck by a 15-passenger van. The crash killed 11 people. NTSB determined the probable cause of the crash was the truck driver’s failure to maintain control of his vehicle because he was distracted by the use of his cell phone.”

These accidents are tragic and the public should not be left to foot the bill for the havoc that distracted driving causes.  That’s why the National Safety Council recommended that all employers create policies prohibiting the use of cell phones while employees are behind the wheel.  An experienced personal injury attorney will discover cell phone records from the driver to determine if distracted driving caused the accident.  If an employer fails to heed the NSC’s advice, and their distracted employee injures one of our clients while working, you can rest assured we will make them pay for the damage they caused.

This is a great article by Dr. Kevin Karlson about the effects of family violence on the victim’s cognitive health, and what that means for a family law case.  If you have been the victim of family violence, call the police and get safe.  If they won’t help, call me and I will do everything I can to get you a protective order.  Remember, in Texas the courts cannot charge a protective order applicant with any fees, and attorney fees are often recoverable from the losing party.  If you are in serious danger I want to help, or at least refer you to organizations like Friends of the Family, so you can get safe and move on with your life.  Here’s Dr. Karlson’s article:

fMRI Research Update: Spousal abuse causes physical changes in the brains of victims

In many high conflict divorce cases, the pattern of conflict that began as a verbal disagreement escalates in a predictable way until one partner is physically assaulting the other. In a previous post, I reviewed the fMRI research that documented the brain changes in the children from merely witnessing domestic violence (DV) in their families. This post is devoted to the spouse/victims of domestic violence and what we know about the effects of DV and treatments for its symptoms.

Few family lawyers would be surprised to learn that many victims of domestic abuse suffer from post-traumatic stress disorder (PTSD), the same malady that afflicts many combat veterans. The experience of talking with one domestic violence victim is usually enough to sensitize most family lawyers to the resulting anxiety and fear-driven symptoms and behaviors that can result from prolonged exposure to the cycle of abuse (most abusive relationships last an average of 7 years before the victim gets out). What we now know is that the damage is not just emotional–domestic abuse, just like combat, causes identifiable and measurable changes in the brain’s structure and function that are evident in fMRI scans of victims. That means the damage is physical and the abuse changes both the physical shape of the brain AND affects the way it functions.

Just as the treatment of combat-related PTSD has proven to be challenging and frequently ineffective, the treatment of domestic violence-related PTSD is less than optimal in its effectiveness. A reasonable summary of the available research, using the latest and most effective cognitive behavior therapy (CBT) for trauma for battered women (CTT-BW) suggests that treatment is about 50% effective. It is this documented lack of treatment success in nearly half the victims that led to the fMRI studies to try to identify underlying brain pathology that was interfering with CBT effectiveness.

What the fMRI scans of these traumatized women revealed was identifiable changes in structure and function of three areas of the brain: the amydala, the insula, and the prefrontal cortex. These 3 regions are the same ones identified in the research of the combat PTSD victims and the kids from violent families, and they are dysfunctional in the same ways in all these victims. Brain centers for identifying danger are hyper-activated, and the brain center responsible for self-control and logical thinking (executive functions, as they are called) is not working like it does in normal people. This latest research noted that other brain areas (the anterior cingulate and posterior cingulate) were more active in people who were successfully treated, suggesting that the CBT was successful in activating these brain areas which led to reducing the fear-driven anticipation of something bad happening to them, leading to reductions in anxiety and other PTSD symptoms.

There are clearly family law implications for this growing body of research. Victims of domestic violence have scientifically verifiable physical brain injuries resulting from their abuse. These brain injuries affect how, and how well, the brains of these people function, and how well state of the art treatments will work to return them to normal functioning.  These findings have both child custody and property division implications which should be considered in cases involving document domestic violence.

Victims of domestic violence, both the adults and the children, are more like the victims of car accidents with head injuries than most of us would like to believe. Domestic violence doesn’t just make its victims “nervous”; domestic violence causes brain damage to its victims that is very difficult to repair even with the best available treatments. And by the way, there is NO evidence that this kind of damage will “heal itself” when the victims are removed from the violence.

A number of practice tips come to mind as a consequence of these findings:

1. Longer exposure to abuse means greater brain damage for both the adults and the children. There is no “grace period”. Getting away from the abuse is the first step, so the abused spouse and children must either leave or be protected by a protective order–now.

2. Effective treatment for the victim is available, may work, and takes a few (3-4) months. Get the victim into a program which offers CBT or CTT-BW as soon as possible while the litigation proceeds. An effectively treated victim is a much more rational and well functioning client (and parent).

3. Emphasize the physical brain damage effects of DV in settlement discussions about property division and visitation.

4. Insist on treatment for the perpetrator before allowing unsupervised visitation to prevent further “brain damage” to the children. (See my earlier post for details.)

Great story by NPR on the continuing problems faced by patients who have recieved All-Metal Hip Implants.

Implants Need To Be Removed Early

by Richard Knox

EnlargeRichard Knox/NPRYoung-min Kwon of Massachusetts General Hospital holds the metal-alloy ball of Susy Mansfield’s faulty artificial hip joint. The yellowish tissue on top is dead muscle caused by a reaction to the metal debris produced by the defective hip implant.

When Susy Mansfield needed a hip replacement in 2009, her orthopedic surgeon chose a relatively new and untested kind of artificial hip made entirely of metal.

“He said, ‘You’re young. Metal is good for younger people. It’s going to last a lot longer,’ ” says Mansfield, who was 57 at the time.

Older-model artificial hips are usually made of a tough plastic and metal. But they can wear out after 10 or 15 years, especially in people who are physically active like Mansfield. She runs a recycling facility and likes to hike, kayak and even windsurf.

So manufacturers of the newer all-metal hips have touted them as the right choice for younger patients. But for Mansfield, and thousands of other artificial hip patients, they’ve been a bad choice.

Recently she found herself in an operating room at Massachusetts General Hospital in Boston undergoing major hip surgery for a second time to remove the all-metal device she got more than three years ago. It was eating away at the surrounding bone and soft tissue.

Since her original implant, Mansfield has suffered from constant, worsening pain. “It’s terrible,” she said a few days before the so-called revision surgery over a cup of elderberry tea in her New Hampshire kitchen. “It’s a hot pain … that’s there all the time. Every step is agony.” She says she can’t sleep without painkillers.

The first implant also became loose. “At one point, the doctor said, ‘OK, I’ll hold your hands … now stand on that leg.’ And I stood and it went kuh-CHINK, like that, and he said, ‘What the hell was that?’ ”

Later Mansfield read a newspaper article about problems with all-metal hips and called the surgeon’s office to ask if she had one. The secretary assured her she didn’t. But she did some research and found out that she did.

In fact, she subsequently learned that the model she had, made by a subsidiary of Johnson & Johnson called DePuy, had been recalled. She says she didn’t see the recall notice until a year after the fact.

Doctors had favored metal for its longevity, but it turns out shavings can enter the bloodstream.

At the time Mansfield got her all-metal hip, about 1 in 3 artificial hip patients across the nation was getting this kind. Since there are about 250,000 hip implants a year, that means around 80,000 of them involved the all-metal implants when they were most popular. Far fewer are believed to be implanted now, though they’re still being marketed.

More than a half-million Americans are thought to have all-metal artificial hips. More than 5,000 of them have filed lawsuits against manufacturers. (Mansfield is not among them.)

Fortunately, Dr. Joshua Jacobs says, most patients who got all-metal implants don’t suffer the kind of problems Mansfield did. He’s chairman of orthopedics at Rush University Medical Center in Chicago and an officer of the American Academy of Orthopedic Surgeons.

“Most patients who have metal-on-metal bearings are doing fine,” Jacobs says. “They have good clinical results. Even the implant that’s been recalled, the majority of patients still have well-functioning implants. However, it does have a failure rate that is unacceptably high.”

A recent study from Britain found a five-year failure rate of 6.2 percent — 1 in 16 patients. But the rate could be higher. Nobody really knows because the U.S. has no system for keeping track of how many were implanted or what happened to the patients. Jacobs says the orthopedic surgeons’ group is trying to get such a clearinghouse off the ground.

After talking to Mansfield, I was interested in seeing for myself what kind of damage was going on around her first hip implant, and what was involved in replacing it. Orthopedic surgeon Young-min Kwon at Mass General allowed me to watch the operation.

Dressed in a kind of moon suit, Kwon hovers over Mansfield as he slices through skin and muscle until he exposes the faulty hip joint.

“You can see here the yellowish discoloration of the tissue that is no longer functioning,” he says. That yellow tissue used to be Mansfield’s muscle. The all-metal hip implant has been killing it.

Next, assisting surgeon David Anderson takes up a big mallet and, after several sharp blows, knocks off the implant’s steel ball at the top of her thigh bone.

The surgeons find more dead tissue than they expected, although Kwon says he has seen much more severe damage than Mansfield has. “You see that staining? Black staining of the tissue?” Kwon says. “We call that metallosis.”

Metallosis is the buildup of metal debris — tiny pieces of cobalt and chromium that have flaked off the implant and worked their way into surrounding tissue. It often causes swelling, tissue death and the kind of burning pain that kept Mansfield awake at night.

Researchers have found high levels of cobalt and chromium in the blood and organs of many patients with all-metal hip implants. But they aren’t sure what risk that poses.

Many surgeons monitor blood levels of these metals in patients with all-metal hips, but Kwon and Jacobs say high blood levels alone don’t justify removing the old implant if the patient is not having pain or other symptoms.

Next Kwon takes the mallet, removes the implant’s metal cup from Mansfield’s hip bone and holds it up for me to see. “There’s actually no bone that’s grown into this,” he says. “It should be covered with the bone.”

Kwon decides to do a bone graft to beef up the hip bone under the implant. It has grown thin, another effect of the all-metal joint. He sprinkles white pieces of bone from a cadaver donor into the hollow where the old implant used to be. The pieces will grow together and fuse with her own bone.

After several hours, the operation is finished. Kwon predicts “a reasonably good prognosis.”

The original hip implant Susy Mansfield got wasn’t tested extensively in humans before it went on the market. It was cleared for sale by the Food and Drug Administration after it was deemed “substantially equivalent” to those already on the market.

Kwon says that shouldn’t happen in the future. “I think there are lessons for all of us — that you need to have scientific data to support any introduction of any new technology,” Kwon says. “One might argue that [this one] didn’t have enough.”

The FDA says patients with all-metal implants should be monitored for problems.

Four days after her surgery, Mansfield is almost ready to go home. Remarkably, she has already passed a crucial test — going up and down stairs, on crutches.

She is still woozy from pain meds, but she is full of hope. “I’m going to actually be able to — I think, and fairly soon — have no pain

Originally posted at the Dallas Morning News:

http://www.dallasnews.com/business/health-care/20120327-u.s.-judge-upholds-texas-cap-on-medical-malpractice-awards.ece

The following article by Mark Hollmer at FierceMedicalDevices.Com reports how the Johnson & Johnson (Dupuy Orthopaedics) hip implant is being treated in courts and by regulatory agencies in the U.K, Australia and New Zealand. Read below.

Johnson & Johnson  is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia.

Both countries’ regulatory agencies issued a recall of the MITCH TRH hip components made by J&J’s Finsbury Orthopaedics unit.

In New Zealand, the problem involves a loosening and movement of part of the joint. The warning notes that patients will need annual checkups as long as they have the implant, according to Radio New Zealand online. Some even may need a replacement, depending on what doctors find. In Australia, the country’s Register of Therapeutic Goods removed the MITCH TRH modular head from its listing, so it can no longer be used there, according to news.com.au. About 400 patients are affected by the Australian recall, and they’re being advised to ask their surgeon whether they need to have the device removed or just be closely monitored.

Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency issued a warning urging surgeons to stop using the MITCH TRH cup/heads, as well as the Accolade femoral stems made by Stryker  that are intended for use with the MITCH TRH system. The warning takes into account an unusually high 10.7% revision rate for the product combo compared with rivals.

J&J is facing other metal-on-metal hip problems. Its DePuy Orthopaedics unit is one of many companies now facing lawsuits over apparent safety problems with a joint implant that faced a global recall in 2010. The FDA plans a two-day hearing in June to solicit risk-benefit data from manufacturers and others regarding the implants.

- read the Radio New Zealand story
- check out the Australian coverage