Fort Worth Injury Lawyer BlogArticles Posted in Miscellaneous
FDA Collaborates with New Medical Device Testing Group
“The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology,” reported CBS News last week.
A nonprofit group named Medical Device Innovation Consortium (MDIC) was formed to improve the approval process of medical devices. This process is currently slow, complex and sometimes doesn’t even require clinical trials. This organization’s mission aims to speed up, simplify and ensure the quality of medical device testing. Minnesota-based LifeScience Alley founded this new consortium.
Since most medical device companies are small businesses, their budgets and staff don’t allow for extensive research and testing. This new agency, the MDIC, will procure high quality information and research from the government, industry and academia.
The new group reported that 17% of Americans currently are living with an implanted medical device of some sort. That is too high of a percentage to take testing these implanted devices lightly.
So what does this mean for consumers? It means that with this new nonprofit in place, we may have easier access to more efficiently and thoroughly tested medical devices. This would save the pain of dealing with faulty transvaginal mesh procedures or complications with metal-on-metal hip replacements. This could save medical device consumers thousands of dollars in lawsuits and years of suffering and pain.
FDA Approves Generic Version of Diabetes Drug, Actos
The U.S. Food and Drug Administration approved the first generic form of the diabetes drug, Actos, on August 17, 2012. Actos (pioglitazone) is used for patients with type 2 diabetes; it is designed to help bodies effectively use the insulin it makes and stops the liver from making unnecessary sugar. Although regulating these processes is important, prospective and current consumers should be wary of the ties Actos has with increased risk of bladder cancer and heart failure.
Typically, the approval of a generic drug is to be celebrated because it allows greater, more affordable access to quality drugs for Americans. However, Actos has been accumulating lawsuits in recent years because of its ties with bladder cancer. The brand-name drug already has a Black Box Warning due to its ties with causing or worsening heart failure. In the words of patient advocate Trisha Torey, a “Black Box” or “Boxed” Warning is the strongest form of warning issued by the FDA about a drug, the step taken just short of removing the drug from the market.
So, if Actos has been proven to be harmful and lawsuits are continuing to be filed, why did the FDA follow through with this approval? In 2011 the FDA announced that prolonged use of Actos at a high dosage may increase risk of bladder cancer and the warning was added to the label. By definition, generic drugs are similar to brand-names “…in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” (FDA Website) The generic, Pioglitazone, has met all of the standards as the innovator drug and is assured by the FDA in having the same quality, strength, purity and stability as Actos.
Although generic prescriptions are less expensive, there is a hidden cost to consumers. Even though the two products are nearly identical, brand name drug manufacturers are able to be sued while generics are not in most cases. Because of the prevalence of this potentially dangerous drug, it is extremely important for consumers to be aware and informed.
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Court Rules Damage Caps Are Unconstitutional Infringement on Right to Jury Trial
In Texas, a medical malpractice case has limits on the amount of non economic damages that can be recovered, usually $250,000.00. So no matter how severe and devastating the damage, the limit on non economic damage may be $250,000.00. Even if a drunken or drug addicted doctor inflicts brain damage on a child, that is often the cap. That baby, and his or her family, faced with life long consequences can only recover $250,000.00 in most instances for his or her non economic damage.
Even if a jury awards more than that, the judge is required by law to reduce the amount of damages recovered. In other words, a victim’s right to a jury trial is essentially taken away.
The right to a jury trial is a constitutional guarantee. The right to a jury trial is found in both the United States Constitution (Seventh Amendment [“the right of trial by jury shall be preserved.”]) and the Texas Constitution (Article I, Section 15 [“The right of trial by jury shall remain inviolate.”]).
Almost every single day, juries are deciding whether to impose the death penalty in criminal cases, and we, as a free and civilized society, trust juries to make those most important decisions. Why then should juries not be allowed to determine the amount of damage that has been done in medical malpractice cases? Putting the question another way, why shouldn’t juries (which decide if people live or die) get to decide how much insurance companies should have to pay when somebody is wrongfully injured?
The answer – as found in our state and national Constitution – is that juries absolutely should be allowed to make these decisions.
In states other than Texas, the Courts are beginning to bravely defend the constitutional right to a jury trial. These Courts are striking down “tort reform” or laws that limit the amount of non economic damages.
Just weeks ago, the Missouri Supreme Court defended the right to trial by jury, declaring that the Missouri statute that limited recoverable damages was unconstitutional. In Watts v. Lester Cox Medical Center, Naython Watts suffered catastrophic brain damage when doctors failed to timely deliver him as a baby. During the delay in delivery, Naython suffered horrific brain damage because of a lack of oxygen. In Missouri, a law limited the amount of non economic damages to $350,000.00. The Missouri Supreme Court upheld the constitution and declared the cap on damages unconstitutional. The Court wrote: “The individual right to trial by jury cannot ‘remain inviolate’ when an injured party is deprived of the jury’s constitutionally assigned role of determining damages according to the particular facts of the case.”
Texas Supreme Court Consistently Sides with Big Business
The non-profit Texas Watch Organization has released the results of its Court Watch project, which reviewed the decisions of the Texas Supreme Court over the last decade. This study claims to have found major biases and flaws in the actions of the state’s highest court. Researchers noted that this trend seems to have begun when Governor Rick Perry entered office and began appointing justices to the court. Alex Winslow, director of Court Watch, commented on this phenomenon: “The Texas Supreme Court is an activist, results-oriented body that over the last 10 years has developed into a safe haven for corporate defendants at the expense of individuals, families, and small business owners … The statistics speak for themselves. The court’s pro-defendant ideology can not be disputed.”
Exactly how extensive is the Texas Supreme Court’s preference for the powerful? According to Court Watch’s findings, when corporate and government bodies are sued, they actually win 74% of the time. When consumers sue big business, they lose their case 79% of the time. These statistics show a significantly lopsided set of decisions. One of the most interesting components of these statistics is the fact that these cases had already been decided in lower jury courts; often the citizens win these cases, only to have their verdicts ultimately overturned by the Supreme Court in favor of the defendant. A notable example involves a woman who was granted up to $20 million in her jury case against a Crohn’s disease medication that left her with debilitating and lasting complications. However, once her case was brought to the Supreme Court, the court overturned the decision and actually used the opportunity to set up protections for drug manufacturers that may shield them from many future defective drug lawsuits (see full discussion here).
The Texas Constitution includes a provision that limits the Texas Supreme Court’s jurisdiction to matters of law, not the facts of a given case. This rule can be disregarded, as a purely factual basis has been known to be used to overturn a jury’s case. The court may be overstepping its boundaries in a way that negatively affects the citizens of Texas and promotes the interests of business. Court Watch states, “The jury is our smallest, most direct, and least corrupted form of government. … However, the Texas Supreme Court has displayed a fundamental disregard for juries.” In fact, the Texas Supreme Court has overturned the local jury’s decisions 74% of the time since 2004. These findings demonstrate an inequality in the decisions of the Texas Supreme Court, something that is certainly worthy of notice and concern.
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