Articles Posted in Defective Medical Products

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surgery scissors.jpgTransvaginal mesh devices are designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). According to the Food and Drug Administration (FDA), in 2010, of the 300,000 women who had surgery for POP, 1 in 3 used transvaginal mesh devices. At the same time, of the 260,000 women who underwent surgery for SUI in 2010, 80% involved transvaginal mesh.

Unfortunately, many women have suffered an array of injuries as a result of the use of these devices. More specifically, there are more than 3,600 cases against transvaginal mesh manufacturer CR Bard, Inc.’s Avaulta alone in the United States. Notably, Bard is not the only transvaginal mesh company being sued. Other companies named as defendants in suits nationwide include American Medical Systems, Johnson & Johnson, and Boston Scientific Corp. In total, one judge has been assigned to manage nearly 23,000 cases involving these companies, among others. In these cases, women allege that erosion of the mesh products caused intense pain, infection, organ damage, made sexual intercourse painful and caused women to have to undergo additional surgical procedures to remove the mesh products.

Many of these cases have been consolidated in the Multidistrict Litigation Court in U.S. District Court in the Southern District of West Virginia. One such of these cases is Cisson v. Bard, Inc. In Cisson, the plaintiff alleges that Bard executives ignored warnings from the company that manufactured the plastic placed in the devices that the plastic should not be permanently implanted in people. The Cisson trial, however, which began in early July 2013, was declared a mistrial after only two days of trial after a witness disobeyed the court’s order and testified about the devices’ marketing.

Meanwhile, according to Reuters, in June 2013, Endo Health Solutions, which owns American Medical Systems, Inc., agreed to pay more than $54.5 million to settle thousands of lawsuits in North America alleging its vaginal-mesh implants eroded and caused women pain. In addition, two women have received sizable verdicts after suing mesh manufacturers for their injuries. First, in July 2012, a California woman and her husband who sued C.R. Bard were awarded $5.5 million by a jury after she was forced to undergo nine revision surgeries. Next, in February 2013, a New Jersey woman won $11.1 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its vaginal mesh product. In that case, the plaintiff underwent eleven surgeries.

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prescription bottle.jpgAccording to the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research, a generic drug is a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use. Although generic drugs are generally cheaper, since the FDA requires that the warning labels of generic drugs be identical to their brand-name counterparts, generic drugs have essentially been granted immunity to civil action resulting from the use of their drugs.

Unfortunately for consumers of generic drugs, a recent U.S. Supreme Court decision furthered strengthened this generic drug manufacturers’ immunity, finding that design defect law claims in state courts based on the adequacy of a drug’s warning are pre-empted by federal law. As explained below, the ruling not only creates an inconsistency in product defect law, but it also all but ensures that generic drug makers will not be held accountable for product defects, marking a victory for both drug industry and the FDA.

In Mutual Pharmaceutical Co. Inc. v. Bartlett, Ms. Bartlett suffered a severe reaction to the generic pain reliever drug, sulindac, made by Mutual Pharmaceutical Co. Inc. (“Mutual”). Even though Ms. Bartlett’s doctor prescribed her the brand name of the non-steroidal anti-inflammatory drug (NSAID), Clinoril, for shoulder pain, her pharmacist dispensed the generic form of the pain reliever instead. The drug caused her to develop toxic epidermal necrolysis (TENS), which led to 60 to 65% of her skin to either burning off or becoming an open sore. The condition left Bartlett disfigured, disabled and nearly blind.

Bartlett thereafter filed suit against Mutual in federal court in New Hampshire alleging that the generic drug, sulindac, had a design that made it dangerous for use. Like Texas law, New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe. A drug’s safety is evaluated in part by the adequacy of its warnings. Notably, at the time that Bartlett was prescribed the drug, sulindac’s label did not specifically refer to TENS or Stevens-Johnson Syndrome, another form of TENS.

The New Hampshire state court agreed with Bartlett, finding the generic drug was unreasonably dangerous and awarded Bartlett $21 million in damages. The Court of Appeals for the First Circuit affirmed. Nonetheless, focusing on the fact that Bartlett was provided the generic version of the drug, the U.S. Supreme Court held that the Federal Food, Drug and Cosmetic Act preempts state-law design defect claims against manufacturers of generic drugs. As a result, the U.S. Supreme Court reversed the decision of the Court of Appeals. If, however, Bartlett had been dispensed the brand name version of the drug, she would have had a cause of action against the brand name drug manufacturer, and would have been able to recover damages for her injuries.

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stethoscope.jpgAs previously reported by Carabin & Shaw, there have been a number of hip replacement recalls in recent years, including recalls of the of the DePuy ASR Hip, the Biomet M2a Hip, the Stryker Rejuvenate and the ABG II, among others. These recalls brought attention to the potentially serious injuries that could be caused by metal-on-metal hip replacement implants.

The Food and Drug Administration (FDA) cites the following general risks for all types of hip devices:

• Hip dislocation
• Bone fractures
• Joint infection
• Nerve damage, including numbness/weakness
• Device breakage or loosening
• Differences in leg length
• Bone loss (osteolysis)

In addition, due to the friction caused between metal components, all-metal hip replacements may shed bits of metal, causing these additional specific injuries:

• Damage to the bone and tissue surrounding the hip joint
• Loose implants and loss of mobility
• Complications from metal in the bloodstream, including damage to the heart, kidneys, nervous system and thyroid
• Severe inflammation
• Pseudotumors
• Infections
According to The New York Times, manufacturers rarely tested metal-on-metal hip replacements before placing the devices on the market. Not surprisingly, the devices failed at high rates soon after being implanted. As a result, many patients were forced to undergo costly and painful procedures to replace the devices. Due in part to the high number of recalls and injuries, in January 2013, the FDA proposed a rule that would require that the manufacturers of metal-on-metal hip replacement implants prove that their devices are safe and effective before they could continue selling existing implants through the premarket approval (PMA) process. The proposal would also require that manufacturers obtain approval for all new metal-on-metal designs.

The new process differs from the current 510(k) approval process, which merely requires that a product be equivalent to another product already on the product. More specifically, the new pre-approval process will also require all-metal hip replacement manufacturers to submit clinical studies to the FDA prior to placing them on the market, something manufacturers are not required to do under the current approval process.

On April 18, 2013, Consumers Union sent a comment letter to the FDA signed by more than 11,000 consumers. The letter expressed support for the proposal’s requirement to necessitate all metal-on-metal to be reviewed through the FDA’s PMA process. At the same time, the letter also strongly urged the FDA to push all manufacturers of metal-on-metal hips to remove their products from the market.

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woman in hospital.jpgOne key product liability issue to watch for in 2013 is reportedly the continued adoption of the learned intermediary doctrine by states. In June 2012, Texas joined 35 other states in holding that a sufficient warning to a treating doctor (the “learned intermediary”) satisfies a manufacturer’s duty to warn in product liability cases involving medicine and medical devices. Adoption of this rule essentially means that pharmaceutical manufacturers are not responsible for conveying drug risks to patients, even when the drug makers advertise their products directly to consumers.

With the Texas Supreme Court’s decision in Centocor, Inc. v. Hamilton, Texas became the largest remaining state where the Supreme Court had not adopted the learned intermediary rule, which requires warnings only to prescribing physicians–not to any health care provider with which the plaintiff may happen to come into contact. Unfortunately for future victims of negligent misbranding, negligent marketing, and fraud in drug/medical device product liability cases, the court all but did away with the direct-to-consumer exception to the rule, making it more difficult for plaintiffs to successfully bring suit against drug manufacturers.

In Centocor, Inc. v. Hamilton, the product at issue was Remicade, a prescription drug manufactured by Centocor, Inc. Patricia Hamilton suffered from Crohn’s disease and sought treatment from her physician, who informed her that her only treatment options were steroids or Remicade intravenous infusions. After her physician informed her of the risks and benefits of each approach, Patricia opted for the Remicade infusions. Following the treatment, Patricia claimed that the Remicade infusions caused her to suffer a serious drug-induced side effect called lupus-like syndrome.

Patricia and Thomas Hamilton brought suit, contending that the informational video shown to Hamilton by her physician in the course of her prescribed treatments provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous.” More specifically, the couple alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries.

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Pradaxa was first released into the market in 2010 by German pharmaceutical giant Boehringer-Ingelheim. The drug immediately reached blockbuster status by notching over $1 billion dollars in sales. In its initial stages, Pradaxa was thought to be a next generation drug that would replace the most common drug used to prevent strokes and blood clots, Coumadin, better known as Warfarin.

Coumadin is a blood thinner that has been the primary drug of choice for nearly 60 years to treat atrial fibrillation, or irregular heart rate, and prevent strokes that are associated with atrial fibrillation. One of the disadvantages of Coumadin is that it requires patients to undergo continual blood tests so that dosage adjustments can be made, if necessary.

The optimum dosage will serve to prevent strokes by thinning the blood but not thinning it so much as to cause a bleed. If the dosage is too high and a bleed results, Vitamin K and fresh frozen blood plasma can be given to the patient to reverse the effects and slow the bleeding.

Pradaxa was supposed to be more effective than Coumadin, safer and easier for patients to use. It would also not require the continual blood work regime. Unfortunately, that proved not to be the case. Pradaxa turned out to be a more dangerous substitute for Coumadin.

If a bleed occurs while using Pradaxa, there is no reversal. Simply put, traumatic bleeding cannot be stopped. Often it is even impossible to perform life-saving surgery because excessive bleeding during the procedure might prove to be worse than the initial trauma. Tthe widespread use of Pradaxa is filled with high risk for the patients who use it.

Initially the health risks of using Pradaxa were not provided to the public, specifically that traumatic bleeding cannot be stopped since there is no available reversal agent. This was documented in an issue of the Journal of Neurosurgery in March of 2012, which concluded that once the internal bleeding begins there is not much that can be done to stop it.

The FDA launched an investigation regarding the safety of Pradaxa in December 2011. There was no recall of the drug mandated. However, in September 2012, the Journal for the American Medical Association initiated new demands for a Pradaxa recall, due to the fact that perhaps the FDA overlooked the side effects of internal bleeding as it rushed to approve the drug.

Unfortunately the many patients taking Pradaxa for their atrial fibrillation are exposed to this danger of internal bleeding. The safety of Pradaxa was called into question shortly after usage began in the U.S. Some 542 deaths and 3,781 side effect problems were linked to the drug in 2011.

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Hip replacement surgery is a relatively common procedure for baby boomers and older adults who are restricted from their normal activities due to pain associated with severe arthritis. Usually, this option is entertained only after all non-surgical treatment has failed.

Although the use of prosthetic hip implants date back into the 1960s, there has continued to be an effort by manufacturers to improve on their design. As a result, many implant designs have been around for decades and have long track records of success. Others are newer and have little or no track record.

For many years plastic and ceramic orthopedic implants were used exclusively. Over the last decade, metal hip replacements became more common. It was expected that those devices would be more durable, last longer and reduce the possibilities of dislocation. As a result, some 500,000 people underwent metal hip replacement surgery. Data now indicates that metal on metal hips may be failing earlier than expected, in addition to causing a multitude of other medical problems, such as pain, popping sounds, and the release of metal ions into the body.

British experts have reported that over six percent of the patients with metal hips needed to have them replaced after only five years or less, when they were expected to last 10 to 15 years. This was three times the two percent failure of ceramic or plastic joints.

Most metal hip prosthetic devices on the market in the United States were granted clearance by the FDA for the manufacturer to market the device without having conducted clinical trials. This is not unusual, since 90% of all medical devices marketed in the United States obtained approval under the FDA’s fast track system. That system, tagged the 510k system, waives clinical trials for devices that are similar to other products already being used. Since ceramic and plastic hips had been marketed since the 1960s, new devices were approved without testing.

While recent news reports and lawsuits have focused around the metal hip replacement devices manufactured by Stryker and Depuy that have since been recalled by the FDA, new concerns are reportedly beginning to circulate about metal hip replacement devices manufactured by Biomet. At least one lawsuit has alleged that the FDA had received numerous adverse event reports about Biomet metal hip replacement devices, but the company continued to market them. As with other metal hip replacement devices, reported concerns focus around the need for additional corrective surgeries, pain and discomfort, and the release of metal ions into the body.

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1183621_surgical_instruments sxchu username LesKZN.jpgJohnson & Johnson has announced it will phase out the sale of four mesh surgical products used to treat pelvic prolapse, hernia, and bladder control problems in women. Johnson & Johnson’s Ethicon unit will reportedly stop selling Gynecare Prosima, Gynecare TVT Secur, Gynecare Prolift, and Gynecare Prolift+M by the end of the first quarter of 2013. Although the company maintains that each of the products are safe for use, the nation’s Food and Drug Administration (FDA) has warned consumers in the past about potential health and safety issues related to the products.

Approximately 75,000 patients had surgical mesh implanted in order to prevent pelvic prolapse last year. Patients in several states have filed hundreds of products liability lawsuits over pain, infection, and scarring allegedly caused by the vaginal mesh products. The FDA previously warned that 10 percent of pelvic mesh consumers will experience exposure or erosion of the mesh within one year after surgery. More than half of those women require at least one follow-up surgery. Oftentimes, more than one surgery is required. Additionally, the FDA stated there was no reason to believe the implants are associated with a better outcome than traditional pelvic prolapse surgery.

Because other similar surgical mesh products were already approved for use by the FDA, vaginal mesh was approved via the FDA’s fast-track process. The process generally leads to faster approval because it requires less stringent safety testing than traditional approval routes. Earlier this year, the FDA ordered six companies, including Johnson & Johnson, to conduct a safety review of vaginal mesh products. In a public statement, Johnson & Johnson announced it would not recall the company’s pelvic mesh products. The company also stated its decision to discontinue the sale of the products was due to market conditions and was unrelated to safety or efficacy.

Potential pelvic surgical mesh lawsuits are currently being evaluated throughout the United States due to a reportedly higher risk for side effects such as infection, bleeding, urinary incontinence, vaginal scarring, and pain for patients who were implanted with the products. If you or a loved one experienced medical complications after receiving a pelvic mesh implant, you should contact a skilled San Antonio lawyer experienced with transvaginal surgical mesh cases to discuss your rights.

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