Alabama Litigation Review

Alabama Litigation Review

Insights & Commentary on Developments in Alabama Litigation

Were Clinical Trials For Xarelto Tainted By Misconduct?

Posted in Defective Products, Personal Injury

What is Xarelto?

Xarelto (Rivaroxaban) is a relatively new coagulant (blood thinner). The FDA first approved Xarelto in 2011. It is distributed in the United States by Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Healthcare. Xarelto was released as a replacement for Coumadin (Warfarin), a blood thinner effectiely used for decades.

Xarelto is used to treat or prevent deep vein thrombosis which can lead to blood clots in the lungs (pulmonary embolism). It is also used to treat atrial fibrillation (heart rhythm disorder) to lower the risk of stroke due a blood clot. A Huffington Post article in 2012 detailed concerns of top heart doctors related to new blood thinners Xarelto and Pradaxa.

Were the Clinical Trials Tainted?

Slate article asks the important question — Are Your Medications Safe? It’s a question I’ve raised about several drugs and medical devices allowed by the FDA. According to Slate:

We didn’t have to search very hard to find FDA burying evidence of research misconduct.

The Slate article details two large clinical trials used to support FDA approval of Xarelto. According to the article, the studies were tainted by falsified data and the discarding of medical records.

What Problems Are Potentially Related to Xarelto?

Since its inception, Xarelto has been the subject of many adverse event reports to the FDA. Numerous claims have been filed as a result of personal injuries and deaths by patients taking the medication. Primary problems associated with the medication are:

  • Deaths Due To Uncontrolled Bleeding
  • Gastrointestinal Bleeding
  • Hemorrhaging
  • Strokes

Our FDA should protect patients from dangerous drugs and defective medical devices. Too often it does not. It’s all too common for dangerous and defective drugs to be approved for use. I’ve written past posts about the failed FDA approval process as well as research bias for drugs and medical devices. We are investigating Xarelto and potential injuries or deaths from it. In the future, the FDA should act first so needless injuries and deaths can be prevented.

The Lobby To Gut Workers’ Compensation

Posted in Workers' Compensation

An interesting article discusses the quiet lobbying effort to gut workers’ compensation laws bankrolled by Walmart and several other large retailers. According to the article, these companies have supported and funded a behind the scenes lobbying effort to dramatically change workers’ compensation laws in many states. My state, Alabama, is on the group’s target list.

The changes come quietly. In state legislatures, the group’s lobbyists work to promote legislation which limits or diminishes basic benefits to injured workers. One of the major efforts of this business group is to create an opt-out system for workers’ compensation. How would such a system work? Workers’ compensation benefits in Alabama are already extremely limited. Yet, although limited, the system does mandate certain basic medical and disability benefits for workers.

Under an opt-out system, a business could choose to opt-out of the workers’ compensation system and write its own benefit plan. The employer could be allowed to write its own rules governing benefits. If this ever became a reality in Alabama (and it already has in a couple states), here’s what injured workers and their families could possibly see —

  1. Plans that limit or cut-off medical benefits. Our current workers’ compensation law requires an employer to provide medical care for work-related injuries. Under some opt-out systems, the employer can choose to arbitrarily limit medical benefits to a set dollar amount or set time period in its plan. While this might save an employer like Walmart a few dollars, the overall cost to affected communities and taxpayers would be tremendous.
  2. Plans that limit or cut-off disability benefits. A proposal to cut-off disability benefits has already been tried in past Alabama legislative sessions. And, we are likely to see the proposal again in the future. If enacted, employers like Walmart might save a few dollars. Yet, the reality is that the cost of the disability would simply be shifted to the workers’ family, the local community, and the taxpayers.
  3. Plans that limit or deny benefits for many work-related activities. I recently completed a workers’ compensation case where the worker suffered paralysis following an injection at work. The employee was a healthcare worker who underwent additional vaccinations at her employer’s urging to save the employer from potential costs of blood-borne diseases. Yet, when injured, the employer tried to deny benefits arguing the injection was not mandatory. Do we want employers like Walmart to write plans arbitrarily limiting benefits to certain narrow activities? Do we want employers writing plans that exclude specific risks and exposures that are part of their employees’ actual work?

If this group was lobbying for real safety measures that prevented costly accidents and illnesses, it would be a good cause. But, the group is not engaged in that effort. Instead, this lobbying group is engaged in an effort to shift the costs of injuries in its workplaces. The group wants to shift those costs to the families of its workers, the communities where those workers live, and the taxpayers who pay for government services. The quiet lobbying efforts to gut our workers’ compensation laws should be stopped.

How Much Is An Arm Worth In Alabama? Not Much.

Posted in Workers' Compensation

ProPublica recently published an in-depth series detailing the demise of workers’ compensation benefits in many states. Journalist Michael Grabell did an excellent job researching the changing issues faced by injured workers and their families. Grabell’s articles relate stories like those I hear daily from injured workers in Alabama. If you want to understand the terrible toll of work-related injuries in our communities, I urge you to read his articles:

     The Demolition Of Workers’ Compensation

     How Much Is Your Arm Worth? Depends On Where You Work

     The Fallout Of Workers’ Comp ‘Reforms': 5 Tales Of Harm

Hopefully, Grabell’s research and writing will spotlight these troubling issues and lead to real reforms protecting our workers. While I’m hopeful, recent years have seen significant efforts in the Alabama Legislature to roll-back and eliminate even the minimal protections provided in our State. Just three years ago, in 2012, one Alabama State Senator proposed a “false” reform that would cut-off medical benefits to injured workers. I discussed that proposal in a prior post.

Now, two Alabama State Senators have proposed a new reform for workers’ compensation benefits. This new Alabama proposal follows ProPublica’s series and seeks to raise benefits for injured body parts. Is this proposed law an improvement? I certainly intend to study it. I hope it is not similar to prior proposed ‘reforms’ that offer one benefit but reduce or eliminate other important benefits in exchange.

Court Secrecy Harms The Public

Posted in Business Litigation, Defective Products, Personal Injury, Uncategorized

It’s been almost two months since my last post. Although not writing here, I have been busy writing – including a number of briefs in an ongoing products’ liability case and a separate case involving a public contract in Alabama. Both cases share a common (and troubling) issue. Both involve serious public issues shrouded in secrecy by confidentiality orders. One case involves a medical device marketed and implanted in women despite huge dangers known by the manufacturer. The other involves a company with a public contract affecting health benefits for thousands of beneficiaries across Alabama.

In the medical device case, patients and their doctors should have access to important information concerning research, testing, and FDA approval. Yet, they do not. Many of these documents are shielded from disclosure by court order. How many women could have been saved from the chronic pain and disabling injuries of this product? If only important information had been disclosed.

In the public contract case, Alabama’s citizens should have access to information concerning how a company spends their money. Yet, they do not. Why should any company ever be allowed to spend public money in secret? Yet, much of this information is shielded from disclosure by court order.

The New York Times calls it – Secrecy That Kills. A proposed law would change this. It’s called the “Sunshine in Litigation Act.” If passed, this law would prevent courts from restricting disclosure of information important to public health or safety. It would also prevent courts from enforcing some secrecy provisions in settlement agreements. The proposal is an important step for justice. This law could prevent many needless injuries and deaths. Yet, it is not enough. The proposal includes issues of public health and safety. It should also include cases involving the use of public money.

Secrecy in our judicial process harms all of us. Broad confidentiality orders allow defendants to continue their wrongful conduct and hurt more people. It’s time for a real discussion on the role of our courts in promoting the wrongful conduct of defendants through secrecy. A change is needed.

Public Contracts — A Call For Transparency

Posted in Business Litigation

A recent article discusses an important issue in public pension and health plans — a lack of transparency. I realize this topic is a change from my normal posts discussing personal injury, products’ liability, and Alabama court issues. However, it’s an important issue. It’s one important to Alabama. And, it’s one I’ve explored in a recent case representing a local healthcare business in Alabama with significant damages.

While the article discusses public plans in Kentucky, the issues also apply in Alabama. Some of our public plans have similar problems. What are two of the transparency problems we discovered in our case? They are:

  1. Conflicts Of Interest:  Let’s face it – health and pension plans involve complex issues. So, the State often employs consultants with expertise in the field. That’s OK. It’s important these plans provide long-term benefits to our valued public employees. Here’s the problem. In our case, the State’s consultant managed the entire bidding process. He even scored the bids of companies competing for the contract. Yet, while handling the bidding process, he also accepted thousands of dollars from one bidder. And, no surprise, that bidder won the contract. Although he accepted thousands of dollars and provided the winning bidder with important pricing information, neither consultant nor bidder disclosed their relationship. The bidding process should be fully transparent and beyond ethical question.
  2. Use Of Public Money To Favor Some Firms:  Health and pension benefits need specialized management. These plans need a contractor to administer benefits fairly between providers. Does anyone think it fair for the contractor administering state funds to choose one healthcare provider and pay it more for the same service than others? And, shouldn’t the use of the State’s money be transparent so everyone knows service providers are all being treated fairly and equally? When the contractor favors one company over another with the State’s money, it negatively affects competition and service for all.

These are important issues. Conflicts of interest and favoritism in government contracts should be a public concern. Most disappointingly, our public officials seemed more concerned with keeping obvious conflicts quiet than fixing them upon discovery. Maybe it was simply embarrassment arising from ethical concerns occurring on their watch? Regardless, we should expect better from our public officials and the companies handling public money.

Failed FDA Process Opens Door To Dangerous Medical Devices

Posted in Defective Products, Personal Injury

Power morcellators. Transvaginal mesh. Both are examples of the FDA’s faulty 510(k) process. I’ve written several times about transvaginal mesh – products that have caused tremendous personal injury to women in Alabama and throughout the United States. Last week, I sat through the deposition of our expert witness in one mesh case. This medical specialist has treated many women suffering from implanted mesh. He has seen first-hand the impact of these products. His testimony was a gripping account of the pain and suffering seen in so many patients.

Yet, the list of dangerous medical devices marketed through the 510(k) loophole is much longer than simply power morcellators and transvaginal mesh.

What is the 510(k) process and why is it a safety loophole for medical devices? In 2013, a Professor at the UCSF medical school explained “all you have to do is show that your device is substantially similar to a number of other devices.” But, here’s the real safety loophole. “And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those ‘predicate devices’ that claimed ‘substantial equivalence.'” In other words, a device may be approved although earlier versions have been pulled off the market due to patient safety risks. This is unacceptable.

A recent post in The Wall Street Journal sums up the issue related to power morcellators:

Regulator Didn’t Study Morcellator’s Cancer Risk Until 18 Years After Approving For Gynecology

Morcellators have been utilized in surgeries to remove uterine fibroids. The devices cut up larger tissue into smaller pieces that can be removed through smaller incisions. Sounds like a good idea – until researched and tested. About 1 in 350 women have cancerous tissue around these fibroids. Morcellators also cut up this cancerous tissue into many smaller pieces which can then migrate to other areas. This increases greatly the risk of cancer spread. The devices create a potentially fatal risk in patients.

On November 24, 2014, the FDA issued a new warning concerning power morcellators. This new FDA announcement begins:

Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.

The FDA announcement then discusses the new box warning added to morcellators. It informs medical providers:

Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of     patients. This information should be shared with patients when considering surgery with the use of these devices.

Hopefully, this new warning will save lives. However, it is too little too late for many patients. These patients trusted that devices used on them had been studied and tested. They were misled by a system that too often rushes dangerous and defective products to the market. This loophole puts profit over safety. And, it is wrong.

Walmart Seeks To Delay Justice

Posted in Personal Injury, Supreme Court of Alabama, Workers' Compensation

In June, a Walmart driver slammed his truck into the limousine carrying comedians Tracy Morgan and James McNair. Morgan suffered severe personal injury. The collision killed McNair.

The crash generated media discussion related to highway safety and, particularly, the safety of large commercial trucks on our roads. Morgan filed suit against Walmart seeking to recover damages as a result of the truck driver’s negligence. In his suit, Morgan contends the truck driver had not slept in 24 hours prior to the accident. Truck drivers suffering fatigue and being pushed to make quick deliveries are real and far too common dangers on our highways.

I have represented individuals in cases against Walmart in the past. I always expect Walmart to fight as hard as possible to avoid accountability or liability. Walmart even takes a hard line when its own employees are hurt on the job and simply need workers’ compensation benefits. Maybe Morgan’s case, being in the public spotlight, will eventually be different? Maybe Walmart will treat Morgan better than others in an effort to avoid bad publicity? I don’t know what course the retailer will eventually take in his case. However, it sounds as if Walmart began defending the claims as it does most others.

In its initial response to Morgan’s suit, Walmart attempted to blame Morgan himself for the injuries. The effort by a defendant to avoid responsibility and shift blame back to the injured victim is a topic I wrote about recently. However, this is not the only tactic Walmart is apparently using to avoid or delay justice in Morgan’s case.

According to ABC News:

The truck driver charged in a New Jersey highway crash that injured comedian-actor Tracy Morgan and killed another man filed a request Friday to delay a federal lawsuit while his criminal case proceeds in state court.

The defense tactic of trying to delay civil justice due to pending criminal charges is one I’ve seen in past cases. A couple years ago, I represented the family of a local paramedic who was struck and killed while helping someone on the side of an Alabama highway. The defendant in that case was speeding in icy conditions, drove past a law enforcement officer waving for him to slow down, lost control, and ran off the highway. Law enforcement arrested the defendant driver because of his reckless conduct and pursued criminal homicide charges against him. When we filed a wrongful death suit for the Decatur family of this paramedic, the defendant immediately moved the Court to stop our proceedings until his criminal charges were resolved. The defendant in our case argued our civil proceedings could violate his right under the 5th Amendment to the U.S. Constitution not to incriminate himself.

Was the defendant entitled to a stay of our Alabama civil damages case? The answer is, not necessarily. The Alabama Supreme Court has previously ruled:

The United States Constitution does not automatically require a stay of civil proceedings pending the outcome of parallel criminal proceedings or potential criminal proceedings.

. . .

There are situations where the right against self-incrimination can be adequately protected while the civil case proceeds in some limited way.

Should an injured plaintiff simply agree to completely stop or stay his damages case? No. Our justice system already works slowly. Serious cases involve a number of issues. While the U.S. Constitution certainly protects the defendant from being forced to testify against himself in a criminal matter, this protection does not necessarily mean the entire civil case process should stop. The parties can often continue with other discovery issues or the depositions of witnesses and doctors. The parties can continue to move forward with some trial preparations. In Alabama, our Court has developed a number of factors aimed at balancing a defendant’s Constitutional right against self-incrimination with the important private and public interests in moving damage cases forward. Hopefully, in Morgan’s case, the Court will continue to move the wheels of justice forward.

Boston Scientific Suffers Another Trial Loss Over A Mesh Product

Posted in Defective Products, Federal Courts, Personal Injury

Last week, a Federal Court jury in Florida found Boston Scientific liable for the severe personal injuries caused by one of its transvaginal mesh products. The Florida case involved four women suffering tremendous problems from implanted mesh. The jury assessed $26.7 Million in damages against the company. This was not the first trial loss suffered by Boston Scientific over one of its implanted transvaginal mesh products.

Our office represents a number of Alabama women suffering personal injury as a result of defective and dangerous mesh implants. Across the U.S., thousands of product liability claims have been filed against mesh manufacturers. These manufacturers include Boston Scientific, Coloplast, Ethicon, and American Medical Systems. I’ve discussed the pain and problems caused by these defective products in prior posts.

I followed last week’s trial closely. The lawyers involved in that case worked hard to obtain some justice for their clients. The Judge assigned to oversee all claims pending in Federal Court selected a small number of these claims for initial trials. We have one of the selected cases and are currently in the process of taking depositions of expert witnesses. Medical experts who routinely treat women suffering from defective mesh implant problems know these injuries can cause severe disability. And, they know how difficult it is to help treat these injuries.

As these cases slowly wind their way through the legal process toward trial, Boston Scientific and other mesh manufacturers face significant decisions. Will these companies now accept responsibility and accountability for the thousands of women harmed by their defective products? These companies sold products for implant in women without adequate testing. These companies continued to market these products even after women began to report injuries. These companies refused to accept responsibility for years prior to these recent trials. Now, the companies finally face jury verdicts assessing damages against them. The women injured by these products have difficult stories of pain, disability, and altered lives. It’s time for these companies to accept responsibility.

Too often, the drug and medical device industry sells products that cause substantial harm. Rather than focus on patient health and safety, companies rush dangerous products to market. In addition to cases against transvaginal mesh manufacturers, we are currently pursuing or investigating claims for consumers injured by other defective drugs and medical products, including:

  • ACTOS
  • MIRENA IUD
  • POWER MORCELLATORS
  • BENICAR
  • RISPERDAL
  • TESTOSTERONE REPLACEMENT THERAPY
  • XARELTO
  • LEVAQUIN / AVELOX / CIPRO

What Can Be Learned From Walmart And The Blame Game?

Posted in Personal Injury

A recent blog post from a personal injury firm in our nation’s capitol begins by saying “Tracy Morgan Shocked By Walmart’s Accusations.” The post is an interesting read. The crash that injured Tracy Morgan generated media headlines for months. Just in case you’ve avoided all news for the last few months – A Walmart truck driver crashed his truck into the limousine carrying Tracy Morgan. Morgan suffered severe injuries. Another passenger, comedian James McNair, was killed in the collision.

Months later, Morgan filed a lawsuit against Walmart claiming its truck driver had not slept in 24 hours before the accident. Did Walmart take responsibility for the collision which caused so much injury and damage? No. Walmart, like other defendants seeking to avoid accountability and responsibility, played the blame game. Incredibly, Walmart answered the lawsuit by blaming Tracy Morgan for his own injuries. I have represented clients in the past with claims against Walmart. I’m not surprised Walmart tried to blame an innocent victim of its driver. Sadly, Walmart’s actions are not unusual. Instead of accepting responsibility or even considering accountability, too many defendants respond by attempting to blame the victim.

In many cases, insurance companies hire IME doctors simply to generate a medical record raising questions about the injured person’s motives or condition. Many of these injured individuals spent a lifetime working, are deeply depressed about their injury, and desire to return to work more than anything in the world. These individuals have worked hard with their doctors to recover. So, why is it acceptable to allow the insurance carrier to generate a report calling the plaintiff’s motives into question? Why is it acceptable for an IME doctor who often has no real medical practice to sit in an office and generate such questionable reports? Often, the IME doctor simply uses the same form report, changing only the patient name. In prior posts, I’ve written about these biased and inappropriate IMEs. Yes, we even have a couple of these biased IME doctors in both Huntsville and Birmingham who make a lot of money simply raising false doubts about hurt people. In his book, Polarizing the Case, attorney Rick Friedman has some great advice on how to handle these doctors who try to raise issues about the victim.

Yet, false efforts to blame the injured victim usually don’t start with a biased IME doctor. They start much earlier. Like Walmart in the Tracy Morgan case, many defendants make these accusations in their initial Answers to the lawsuit. In a recent workers’ compensation case, my client suffered severe internal organ and orthopedic injuries which left him unable to perform any physical labor. Despite these very limiting injuries, he begged his employer to let him return to work. When his boss would not let him return, he applied for 30 different jobs within months. He wanted to work but physically could not. Yet, when he filed his workers’ compensation claim, the insurance carrier initially and falsely accused him of refusing to work. For some defendants and lawyers, blame is a game. It should not be. These issues are very personal. For people who care deeply about their families and their work, it is devastating to face such an accusation. As the old expression goes, the defendant added “insult to injury.” It is wrong. We should not accept it.

Too many personal injury lawyers run from these accusations. Why? By ignoring false accusations you give them credibility. Instead, you should counter them head-on. Highlight that the defendant is not just avoiding responsibility but is also doing the unacceptable by trying to blame the victim. Don’t allow your client to suffer twice – first by being needlessly injured and second by being blamed for simply seeking justice.

Did The Uninsured Driver Have First Class Legal Representation — Courtesy Of Your Insurance Carrier?

Posted in Personal Injury, Uncategorized

Another driver crashed into you on an Alabama highway. You suffered personal injury. The other driver does not have enough insurance to pay for your damages. Naturally, the other driver also has no money, assets, or other hidden treasure, that can pay for your damages. Thankfully, you have uninsured / underinsured coverage on your policy. You can make a claim against both the negligent driver and your own insurance carrier for your damages.

What happens next? Your uninsured insurance carrier has a choice. It can choose to stay in the case and assist in defending the claim – in other words, to argue against your claim. If the uninsured or underinsured driver also has his own counsel, the injured plaintiff now faces multiple lawyers. Or, the insurance carrier can opt out and allow you to proceed just against the negligent driver, with the understanding it will pay damages beyond the other driver’s insurance. It’s a simple choice. Yet, Alabama’s Supreme Court has allowed this simple choice to evolve into one completely unjust to you as the injured plaintiff.

Your uninsured carrier can opt, in or out, of the claim. And, Alabama law says it has a “reasonable time” to make the choice that is in its best interest. If the insurance carrier opts “in” then it is an active defendant with lawyers actively working against you. If it opts “out” then it does not defend your claim at trial and you cannot mention the insurance company. How has our Court taken a simple choice and made it completely unfair to the injured driver? The recent case of Ex parte Electric Insurance Company is a perfect example. In that case, the uninsured carrier actively participated in the case for almost two years. During that time, the insurance company’s lawyers served discovery on the injured plaintiff, took the plaintiff’s deposition, and participated in depositions of four different medical doctors. After participating in the case – practically to the eve of trial – the insurance carrier attempted to opt out. The trial court understood the insurance company’s late effort to opt out was unfair and denied the request. However, our Supreme Court thought differently, concluding such a long delay was “reasonable.”

It is difficult to imagine how or why our Court thought this two year delay was reasonable. Instead, it prejudiced the plaintiff. If extra attorneys are allowed to participate in discovery and depositions for this length of time, then they should also be present and seen by the jury at trial. You should not be allowed to prepare the defense and then hide at trial.