Alabama Injury Law Blog

Evidence of FDA’s 510(k) Clearance. Admissible or Not?

Published on: June 7, 2017 | by Hollis Wright

Medical devices, implants and tools are used daily by people and medical personnel all over the country and are intended to improve the overall health and quality of life in patients. These medical devices are often intended to prevent or protect against certain medical dangers or injuries during the course of performing medical treatment or surgery.

However, what happens when the medical device or implant causes an injury to the patient? Such an occurrence will likely result in the pursuit of a product liability lawsuit against the manufacturer by the injured patient. During the course of litigation, the issue of the U.S. Food and Drug Administration’s (FDA) 510(k) clearance process of the subject medical device will likely arise. The FDA’s 510(k) process is one way to introduce new medical devices or implants to the market. In pursuing the 510(k) approval route, the manufacturer will submit an application to the FDA seeking clearance under the 510(k) process. Among other items, the 510(k) application will include a description of the medical product and the intended use of the product. Further, the application will reference other similar products that are on the market being used in a substantially similar manner.

While we would like to believe that the FDA is conducting a thorough and complete analysis of each medical product that is on the market, this is not the case. The FDA was never set up in this manner and simply does not have the resources to conduct such an analysis on every product. This type of in-depth, thorough evaluation is reserved for a different class of medical devices and implants, which is known as Pre-Market Approval (PMA).

Fires and Burn Injuries

Published on: March 9, 2017 | by Hollis Wright

Fires are a leading cause of burn injuries, death and property damage in the United States and in the world. According to the World Health Organization, some 265,000 people die worldwide due to fire-related incidents. Lower-income areas are more prone to fire accidents, injuries and deaths than higher-income demographics. In the same vain, lower-income countries see far more fire-related deaths than the United States.

The American Burn Association in 2016 recorded 486,000 burn incidents in the United States that required medical attention, 3,275 of which resulted in fire or smoke inhalation deaths. Some 40,000 Americans are hospitalized each year due to burn injuries, 30,000 of those are admitted to specialized burn units. Most burns, a whopping 73 percent, in the U.S. result from in-home accidents. And while most burns are a result of fire or flame, many occur due to scalding, contact, chemicals, and electrical episodes.

If you are burned, the American Burn Association indicates the following:

When Your Medical Device is Defective: Surgical Mesh

Published on: February 28, 2017 | by Hollis Wright

Millions of Americans annually rely on medical devices to either save their lives or improve the quality of their lives. While most medical devices perform properly and provide doctors with the means to maintain their patients’ quality of life, many devices fail and, either do not help the patient, or actually cause further harm. According to a May 2016 article in The Expert Institute, the FDA each year receives thousands of reports of deaths, injuries, and malfunctions associated with medical devices.

Surgical mesh is a commonly used type of medical device that has, in some cases, had adverse effects on patients. Hollis Wright is currently reviewing claims involving complications with two types of flexible, composite surgical mesh devices. Both mesh devices that Hollis Wright is currently investigating were recalled by the products’ manufacturer, not the FDA. Both products also were introduced via the controversial 510(K) Premarket Notification Program, not the FDA’s more stringent Premarket Approval Process (PMA).

The two surgical mesh devices for which Hollis Wright is currently reviewing claims are as follows.

Good News for Victims of Elder Abuse

Published on: December 12, 2016 | by Hollis Wright

Placing a loved one in a nursing home or long-term care facility is one of the toughest decisions a family will face. Sadly, abuse and neglect occur far too often in nursing homes. The National Center on Elder Abuse puts the average number of yearly cases of elder abuse at more than 2-million. 60% of those are due to neglect, and the Center found that over 90% of nursing homes were not adequately staffed to take care of their patients. Unfortunately, most all of these elder abuse cases never see the inside of a courtroom because, until recently, most nursing homes required their residents to consent to binding arbitration, which would decide a claim if it arose. Arbitration is an alternative method of resolving disputes without court intervention. Parties to the dispute submit their claims to an arbitrator, who reviews the evidence submitted by both parties and issues a decision. Unlike the court system, a party to an arbitration dispute has little to no redress in the event they disagree with the arbitrator’s decision.

Recently, a move was taken that will make it easier for families to seek justice against elder abuse. The Department of Health and Human Services has issued a new rule to prevent long-term care facilities that accept Medicare or Medicaid from forcing residents into arbitration. The changes on arbitration were thrust to the forefront after officials in 16 states and the District of Columbia insisted the government eliminate funding to nursing homes that use arbitration clauses. The primary allegation was that arbitration kept patterns of wrongdoing hidden from would-be residents and their families because arbitration proceedings and decisions are confidential and do not take place in a public forum like a courtroom. The changes are part of an overhaul by the by the Center for Medicare & Medicaid Services (CMS) of consumer protections at long-term care facilities.

“We are requiring that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties,” reads the rule. “Thus, we are prohibiting the use of pre-dispute binding arbitration agreements.”

The Admissibility of “Absence” Evidence

Published on: October 31, 2016 | by Hollis Wright

Evidence is the foundation of any successful lawsuit – a single piece of evidence can make or break an entire case. Not all evidence, however, can be presented to the jury. There are strict rules that the courts use to determine whether a specific piece of evidence will be admitted. Given the effect a single piece of evidence can have, these rules attempt to provide the appropriate balance in as many cases as possible. Courts may therefore allow a piece of evidence in one trial, but disallow that same piece of evidence in another based upon the individual factual scenarios of each trial. One area of evidence which highlights this dichotomy is the use and application of “absence evidence.”

“Absence evidence” is evidence that there are no prior documented occurrences of a certain event. Attorneys use “absence evidence” to argue that because there are no prior documented occurrences of said event, it is not likely that said event would have occurred on this occasion. One of the primary uses of absence evidence is in products liability cases. For example, manufacturers of an older product might want to show the jury that their product has not caused any accidents over the last twenty-years and thus it is less likely that their product is defective in the current lawsuit. When a party wishes to use absence evidence, particularly in these kinds of cases, the court must determine whether evidence that a prior event has not occurred is accurate and if so, is it fair to present such evidence to the jury.

1. Does the lack of a prior occurrence accurately reflect the prior history of the occurrence?

Can you be liable for texting the driver of a vehicle?

Published on: June 7, 2016 | by Hollis Wright

Everyone has seen the advertising campaigns geared against texting and driving. Moreover, numerous states have enacted legislation which makes it illegal to text on your phone while you drive. While those ads and laws have certainly helped curb distracted driving on our roads, is their focus too limited? Should we consider not only the conduct of the person receiving the text, but also the conduct of the person sending the text?

The Ruling

In a recent opinion from the New Jersey Court of Appeals, three judges agreed with the general proposition that you can be liable if you text someone who you know is driving a vehicle and that person is subsequently distracted and gets into a wreck. In September 2009 a young man was driving down the road as he and his girlfriend were exchanging text messages. The plaintiffs, a married couple, were driving in the opposite direction on their motorcycle. As the young man drove down the road, he became distracted from the flurry of text messages and he allowed his truck to drift across the double center line and hit the plaintiffs’ motorcycle head-on. Seventeen seconds elapsed from when the young man received the last text message until he dialed 911 to report the incident.

$500 Million Pinnacle Hip Verdict

Published on: May 2, 2016 | by Hollis Wright

After hearing thirty-seven days of trial testimony and deliberating for four days, a Texas jury determined that Johnson & Johnson was liable for defectively designing their metal-on-metal hip implants. The lawsuit alleged that Johnson & Johnson aggressively marketed their Pinnacle metal-on-metal hip implants for use by younger, more active patients because the metal-on-metal implants were long-lasting, durable and safe despite being aware of the design flaws in the implants, which caused them to fail more frequently and quickly than expected, leading to injuries including tissue death, bone erosion and high levels of metal in their blood. The five Plaintiffs who brought the lawsuit collectively received a $502 million judgment which was comprised of $142 million in compensatory damages and $360 million in punitive damages. The verdict will be split amongst the Plaintiffs based on the severity and impact that each Plaintiff suffered as a result of their individual injuries.

Unfortunately, Johnson & Johnson has vigorously stated since the massive verdict was returned that they will appeal the result. One of the many issues that will certainly be raised on appeal is Texas’ law which caps punitive damages. This means that on appeal the $360 million punitive damage award could be reduced to as low as $10 million.

However, despite a pending appeal and a possible overall reduction in punitive damages, the recent verdict is still an overwhelming triumph for Plaintiffs who suffer from defective metal-on-metal hip implants. Most notably, the recent verdict marks Johnson & Johnson’s first trial loss regarding the use of metal on metal artificial hips. In a prior trial in the same multi-district litigation (“MDL”), Johnson & Johnson was successful in defending a single Plaintiff suit based on its argument that it was the surgeon who installed the implant’s fault instead of the defective implant itself. However, based on this most recent verdict it appears the tide has begun to change in favor of the Plaintiffs, and Johnson & Johnson will no longer be able to overlook its defective product and place blame on the implanting surgeons.

Lawsuit Lending, Easy Money Now BIG Consequences Later

Published on: February 10, 2016 | by Hollis Wright

If someone were to walk up to you and offer you $1,000 today, with the expectation that you pay them $3,000 in a month or a year you would likely look at them with shock and dismay. Why should I pay 200% in interest on my original loan, you might ask. However, you might take a second look at this offer if you are under the duress and financial hardship that many plaintiffs find themselves in when they are out of work and unable to pay their medical bills and living expenses after an accident. Your tune may change if you are faced with default notices and collection creditors are calling your house non-stop. This is exactly what the lawsuit lending industry is betting on, that you will overlook their astronomical interest rates and fees based on your dire financial situation. The lawsuit lending industry has been able to skirt federal and state regulations in this area by labeling their lending practice as “nonrecourse financing.” Essentially, lawsuit lenders bet on the final outcome of a case by loaning money to plaintiffs and as a result are able to operate within Alabama without a license, and without regulation or oversight by the Alabama Banking Department.

The lawsuit lending scheme is relatively simple. Lawsuit lenders give cash advances to individual plaintiffs that are facing financial hardships in order for the plaintiffs to cover medical and living expenses while their case is being litigated. It sounds like a pretty great deal when you’re down on your luck. However, lawsuit lenders are anything but a plaintiff’s white knight. These lawsuit loans typically come with sky-high interest rates, fees, and charges which can amount to as much as 200 percent of the original loan value. By attaching these massive fees and interest rates to the original lawsuit loan, plaintiffs are often left with little to no recovery from the personal injury claim. In fact, in some situations, plaintiffs actually lose money in an effort to resolve their personal injury claims.

In addition to adversely affecting the individual plaintiff, lawsuit loans also distort the litigation process. A lawsuit loan plaintiff faced with a settlement offer must not only consider the amount they will have to re-pay to their health insurance for any medical treatments the plaintiff may have received as a result of the accident, but they must also factor in the cost of paying off their high-interest lawsuit loan. The result is that the plaintiff may reject a reasonable settlement offer on the off chance that they may obtain a higher verdict in court in hopes that they can pay off their medical expenses and high-interest loan and possibly break even. This choice can jeopardize the chance of any recovery and put the plaintiff’s attorney in a precarious situation, because litigating their case may result in a verdict that is lower than the pre-verdict settlement offer or a judgment in favor of the defendant. Therefore, by injecting a third party into the litigation process, plaintiffs often forgo reasonable compensation in an effort to get out from under their impending lawsuit loans.

Johnson & Johnson Hit with Fourth Million Dollar Verdict on Risperdal Failure to Warn Claims

Published on: November 18, 2015 | by Hollis Wright

Johnson & Johnson has faced several lawsuits over the past year alleging that Johnson & Johnson knew there was a link between their antipsychotic drug, Risperdal, and abnormal breast growth. Risperdal is a very powerful antipsychotic drug that Johnson & Johnson peddled to pediatric doctors for use by children even though the drug lacked certain approvals from federal regulators. Thus far, Johnson & Johnson has been hit with four separate jury trials all alleging that Johnson & Johnson not only knew that children prescribed Risperdal could develop a condition known as gynecomastia, but also that Johnson & Johnson failed to properly warn and/or disclose the risks of abnormal breast growth in adolescent boys prescribed Risperdal.

The Previous Three Jury Trials

In February 2015 the first Risperdal case was taken to a trial by jury. The jury returned a $2.5 million verdict in favor of the plaintiffs determining that Risperdal did in fact cause the plaintiffs injuries and that Johnson & Johnson failed to provide proper warnings. In the second case, the jury was less convinced as to the causal link between the drug and the plaintiff’s adverse condition. While the jury did agree that Johnson & Johnson failed to provide adequate warnings, the jury was not convinced that Risperdal caused the plaintiffs to develop abnormal breast growth. As such, the second jury awarded no damages against Johnson & Johnson. The third case began October 15, 2015 and the trial is still ongoing. Lead counsel for the young man who developed female breasts after taking Risperdal as a child stated recently that “Risperdal [is] a powerful antipsychotic drug which was promoted and marketed even though it wasn’t indicated for children.”

Volkswagen’s Emission Defeat Devices are subjecting the Automaker Giant to Class Action Litigation

Published on: October 12, 2015 | by Hollis Wright

Volkswagen has recently been hit by a wave of skepticism as news of the company’s emissions scandal shocked the United States. Volkswagen Group, also known as Volkswagen Aktiengasellschaft, is the second largest car manufacturer in the world. In addition to the well-known Volkswagen brand, the company also sells cars under its subsidiary brands such as Bentley, Bugatti, Lamborghini, Audi, and Porsche. As of May 2015, Volkswagen Group was valued at a substantial $126 billion, ranking 67^th on Forbes’ list of the World’s Most Valuable Brands.

What cars are affected by the emissions scandal?

In early 2014, two students and two professors at West Virginia University received a $50,000 grant to study the emissions tests on three diesel cars: the VW Passat, the VW Jetta, and the BMW X5. The studies revealed that the BMW X5 performed at or below federal emissions standards. However, the Volkswagen test subjects did not fare so well. The VW Passat exceeded U.S. emissions standards by a factor of 5 to 20, while the VW Jetta exceeded U.S. emissions standards by a factor of 15 to 35. In May of 2014, the West Virginia scientists reported their findings to the EPA.