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supreme court.jpgIn 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.”

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The birth control drugs Yaz, Yasmin and Ocella are facing increasing litigation citing some serious complications. According to the San Francisco Chronicle, a recent study listed Yaz and Yasmin as the second worst drugs on the market for adverse events. Between Yaz and Yasmin alone, over 8,000 adverse side effects were reported to the FDA in 2011. A recent FDA study suggested that Yaz and other similar drugs could increase the risk of blood clots, deep vein thrombosis, and pulmonary embolism by up to 74%. Even though all oral contraceptives carry the risk for blood clots, these new and supposedly more advanced drugs may actually create a much higher incidence of blood clots and other related complications. Such strong experimental evidence and high rate of side effect complaints led the FDA to order stronger warning labels on Yaz, Yasmin and Ocella in April of this year.

What are deep vein thrombosis and pulmonary embolism? Deep vein thrombosis refers to a blood clot that forms in a deep vein. This usually occurs in the legs or pelvis and can cause swelling, pain, and even ulcers. This situation can become very serious when the blood clot dislodges and travels through the bloodstream, eventually blocking lung arteries; this is known as pulmonary embolism. Some symptoms include difficulty breathing, chest pain, and palpitations, but in extreme cases effects of pulmonary embolism can be collapse, extremely low blood pressure, and sudden death.

Drospirenone, an active ingredient in these contraceptive drugs, is the culprit of such adverse effects. It is a synthetic progestin that has been linked with forming blood clots, deep vein thrombosis, and stroke. Two 2011 studies reported finding a two-to-three times increased risk for blood clots when using drospirenone contraceptives.

Bayer, the manufacturer of these drugs, has already paid millions in settling lawsuits against their drospirenone oral contraceptive products. The company faces over 12,000 lawsuits. As of this April, Bayer pledged to pay out over $400 million to settle nearly 2,000 cases, at an average of around $200,000 per case. If you or a loved one has developed blood clots or even more serious related complications while using Yaz, Yasmin or Ocella, don’t hesitate to contact a lawyer about your case’s potential. Due to Bayer’s pledge, now could be a very good time to file your claim.

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A verdict has finally been reached in the first transvaginal mesh lawsuit to go to trial. C.R. Bard, a medical device company, has been ordered to pay a significant amount in damages for the horrific complications it caused one patient after being implanted with an Avaulta device. This woman suffered incapacitating complications as her implant began to cut into surrounding tissues and organs, leaving her with many painful corrective surgeries. After years of legal battle, her family may have finally found justice. The jury deemed that Bard was 60% liable for the damages caused by the product, and the operating doctor 40% responsible for faulty implementation of the device. However, the doctor will not be forced to pay in the settlement.

Surgeries involving transvaginal mesh have proven the risk for disastrous consequences. Some side effects include organ perforation, extreme pain, infection, bleeding, urinary problems, mesh contraction and mesh erosion through the vagina. After such complications ensue, multiple surgeries are often required to remove the device and reconstruct any damage it caused. These complications may leave a patient in severe and chronic pain for long periods of time. A patient may suffer for years after their original surgery from debilitating pain and discomfort.

According to the Legal Examiner, “On July 13th, 2011, the FDA released an updated safety concern that stated ‘serious complications associated with surgical mesh for transvaginal repair of POP are not rare'” It was ultimately decided that transvaginal mesh products are high risk and are not more effective than more traditional, non-mesh procedures. Across the United States, there are thousands of transvaginal mesh lawsuits being filed, against many different manufacturers. The Sacramento Bee states that over 47,000 women have received an Avaulta implant, and that there are currently over 650 lawsuits against Bard pending. Johnson & Johnson, another notable medical device manufacturer faces over 1,400 transvaginal mesh lawsuits.

What does all this mean? If you have suffered serious side effects due to a transvaginal mesh implant, you could be eligible to receive justice and compensation for your troubles. At least one jury has decided in favor of the victims of such defective medical devices. Don’t hesitate to contact a lawyer and find out what potential your case may hold.

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The DePuy metal-on-metal hip replacements have affected many citizens and often left them with serious and life-threatening complications. These implants suffer an extremely high failure rate, which is projected to be around 80% at just 8 years after surgery. The complications of a metal-on-metal hip replacement can be extremely severe. Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone. There have already been thousands of lawsuits filed citing the disastrous results of a DePuy metal-on-metal hip implant.

DePuy, a Johnson & Johnson company, issued a recall on these products in August of 2010. Due to Texas’ 2 year statute of limitations law, clients will no longer be able to file lawsuits against DePuy metal-on-metal hip replacements after August 23, 2012. A statue of limitations law is intended to put a specific length of time on certain lawsuits, so that future filings cannot be extended indefinitely. While this can help avoid clogging in the justice system, it may also leave many victims incapable of receiving compensation for their suffering.

If you or a loved one has been adversely affected by a DePuy metal-on-metal hip replacement, don’t let the sun set on your filing rights. Every patient should be entitled to proper care and certainly proper medical device implants. If you fail to file a lawsuit by the August 23 deadline, your claim could be lost forever. No one should have to live with life-altering complications from a defective medical device without retribution, so make sure you are one of the ones to have your voice heard. Contact Borchardt Law Firm now for a consultation about your case.

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The Stryker Corporation is a leading manufacturer of medical devices. However, even Stryker could not avoid blame in the ongoing metal-on-metal hip replacement issue. Earlier this month, Stryker stated that it is issuing a voluntary recall of two of its hip replacement products: the Rejuvenate Modular hip replacement and the ABG II Modular-Neck hip stem. While neither is strictly a metal-on-metal hip implant, both contain metal-on-metal components that may cause the same disastrous complications seen in the DePuy case. Both defective products can lead to metallosis and other serious damage.

After reports of trouble with Stryker hip implants began to mount, the FDA launched an investigation into one of its manufacturing facilities. The disappointing findings included inadequate quality control measures and even the presence of the Staphylococcus bacteria. In 2007, the FDA warned Stryker to rectify these problems immediately or face very detrimental consequences. These deficiencies are independent of the serious structural problems that plague the two recalled implants. The friction of its metal parts can lead to, according to Stryker, “…a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.” Such reactions include unbearable pain, swelling, and the development of metallosis. These products suffer from a very high early failure rate as well, working directly against their original marketing as a more long-lasting product for younger patients. Often patients implanted with defective devices must consequently undergo extremely costly and painful revision surgeries to correct the trouble.

Overall, the problems associated with these products warrant their immediate removal from the market and widespread public concern for patient safety, especially those patients who are still implanted with such devices and remain at risk for developing very severe complications. These medical devices can be extremely harmful, and no patient should have to carry such a risk.

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Although the recall on Johnson & Johnson’s metal-on-metal DePuy hip replacement was in August of 2010, the problems are far from over. Johnson & Johnson created the Pinnacle hip replacement as a second generation of DePuy, and it has already begun suffering similar results to its predecessor. According to Fox News, it is estimated that over 10% of Pinnacle hip replacements will fail within the next 2-3 years. At Borchardt Law Firm, we have seen many cases protesting the hazards of DePuy’s metal-on-metal hip replacement surgery, and it seems that litigation over this defective medical device still has a long road ahead.

After a costly $3 billion dollar recall on the DePuy product, Johnson & Johnson could still pay $5 billion dollars to cover revision surgeries for affected patients. There are 1600 lawsuits filed with the U.S. District Court for Northern Texas alone. The statistics on DePuy failure rates continue to look very grim. It is currently believed that DePuy will see a 49% failure rate after just 6 years, a number that is four times what DePuy cited when it decided to recall the product. Additionally, this failure rate is expected to rise to 80% at 8 years after surgery.

The complications of a metal-on-metal hip replacement can be extremely severe. Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone.

In light of the current situation, the FDA has recently stated that they see no reason to continue the usage of metal-on-metal products in hip replacement surgeries. Many doctors have begun to refuse using them altogether, because the extreme risk of exposure to dangerous substances can render any proposed benefits negligible. Ultimately, it has been proven that the DePuy hip replacement and other metal-on-metal systems can be very unsafe and potentially life-threatening to patients, warranting deep concern over the continuing presence of such products on the market and concern that manufacturers and physicians take responsibility for exposing patients to danger.

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With the Fourth of the July holiday still fresh in our minds, it is important not to overlook the potential danger of operating fireworks. Though a beloved tradition, by nature alone fireworks can be extremely hazardous. Some recent reports have shown that serious fireworks-related injuries are currently on the rise. Perhaps not surprisingly, nearly three quarters of such injuries take place in the month surrounding the Fourth of July. At Borchardt Law Firm, we’ve seen injury cases involving faulty or otherwise poorly functioning fireworks, often concerning workers of firework display companies. There are reports all over the nation of people sustaining serious injuries during this holiday weekend.

Firework injuries can range from small nicks and blisters to life-threatening burns. While sparklers injure many civilians and children every year, larger firework shows can be very unsafe for workers. Firework companies may be at fault when defective fireworks are allowed to be handled or when fireworks are handled in hazardous environments. Often such accidents involve prematurely firing mortars, the shells used to shoot fireworks into the air. When a mortar explodes near people or in unfavorable conditions serious damage can occur. The most common areas injured by firework explosions are the eyes, face and arms of victims.

In 2011, 9,600 consumers were injured and four were killed in firework accidents. This is an increase of over 1,000 injuries since the previous year. Fireworks are explosive devices, and their operation should not be taken lightly. Too often employers or individuals overlook proper safety precautions in handling such incendiary materials. While there are some ways to improve safety, including stricter usage of the appropriate electrical release methods (where an employee may simply press a button to detonate fireworks from a reasonable distance rather than manually light them), the responsibility falls on manufacturers and employers to ensure the safety of their products and those charged with using them.

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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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The FDA has recently proposed a new method of identifying and tracking medical devices. Under this system, most medical devices would be inscribed with a “unique device identifier”, or UDI. This code would contain product information including manufacturer, expiration and other device specifics. High risk medical devices are the first priority to receive UDI codes, whereas some less risky devices or over-the-counter devices may be exempt from the ruling. This information could be held in a database that is available to the public, greatly improving the transparency and accessibility of medical device implants.

The FDA is optimistic that continued post-market surveillance will help the medical community identify, isolate, and inform consumers about problematic devices. This proposal will be open to public comments for the next 120 days, and has already garnered much support for its potential to increase the safety of medical device implants.

This system will help manufacturers and hospitals to discern the problems of a given product faster and implement more efficient recalls. It is also suggested that UDI codes will make it easier to prevent counterfeit products from entering the market. This could greatly improve patient safety by limiting the amount of defective devices available and making it easier for consumers to learn when their safety may be at risk. FDA Commissioner Margaret A. Hamburg, M.D. is quoted in the Star Tribune: “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

Overall, this proposal may hold great promise to increase consumer safety and medical accountability. Medical device disasters like metal hip implants and transvaginal mesh could have been mitigated by a system that made recognizing and recalling dangerous products more effective. Consumers deserve accurate and timely information regarding their well-being and the well-being of any device implants they may have received.

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On June 8th, the Texas Supreme Court issued a ruling on the Centocor, Inc. v. Hamilton case. This case concerns Remicade, a drug used to treat Crohn’s disease, which is manufactured by Centocor, Inc, a subsidiary of Johnson & Johnson. The plaintiff argued that she developed a very serious syndrome as a result of taking this drug, and sued Centocor for failure to warn her of the risks. In the jury trial, she had been awarded up to $20 million in damages. But when the case reached the Texas Supreme Court, the court sided with big business and gave pharmaceutical manufacturers what may be a considerable buffer against future liability claims.

The ruling officially recognizes the usage of the “learned intermediary” rule in defective drug cases. This means that as long as pharmaceutical companies provide prescribing physicians with the information on risks and concerns of their drugs, they may have no real responsibility to inform the end consumers (patients). This may seem logical considering that patients receive drugs from their physicians who are considered the experts in determining the best course of treatment. However, the issue of “direct to consumer” marketing is crucially overlooked. This refers to drug manufacturers creating advertisements on television and other mediums in order to reach individual consumers. The court decided not to allow an exception to the learned intermediary rule in cases that involve direct to consumer marketing, thus allowing pharmaceutical companies to create incomplete or misleading advertisements.

This decision obviously favors the interests of pharmaceutical manufacturers. It may allow them to be shielded from an increasing number of charges and to continue making huge profits by advertising in a misleading manner. The interest of patients, who may now legally not always be warned of a drug’s risks, is clearly not a priority. In an environment where direct to consumer pharmaceutical advertisement is abundant, it seems wrong to hold back adequate information from the targets of such marketing. A patient should have the right to know a drug’s potential risks in their entirety before taking such a prescription.

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