Let us help youDefective Medicines & Medical Devices
Medical devices have revolutionized healthcare. Severely arthritic or injured individuals have regained mobility from knee and hip replacements. People with heart problems can enjoy normal lives with the help of implanted pacemakers and defibrillators.
But when medical devices manufacturers ignore evidence that a device is failing or not working properly, they owe it to patients to let them know the danger they may be facing.
Unfortunately, as long as profits are at stake, there will be some companies which are willing to forgo certain safety advances in favor of increasing their corporate profits. The cost of developing, patenting, and obtaining government approval for a medical device can be staggering. Delays in approval can shave years off of the life of a patent, and after a patent expires the profits associated with a new medical device are severely diminished by competition from generic products. This can create a significant temptation to hide negative information about a potentially lucrative device, so as to obtain government approval and to bring the product to market.
Like pharmaceutical companies who continue to sell dangerous drugs, the manufacturers of defective medical devices often don’t respond as quickly as they should to negative results. In fact, they often don’t respond until forced to do so. Our attorneys have the experience, resources and strength to force these corporations to do the right thing.
At Lilly, O’Toole & Brown, we represent individuals and families whose lives have been harmed by a defective medical device. We will advise you on your right to recover compensation for all damages associated with a faulty medical product – from medical expenses to lost wages and pain and suffering.
We are committed to representing your interests while forcing those responsible for your injuries to take responsibility for their conduct.
How do defects happen?
Manufacturers do not design a device intending that it injure its users. What typically happens is the device is not adequately tested and once a large number of patients begin using it, problems are discovered.
Instead of recalling the device and compensating people for the damages suffered, some manufacturers cover up the problem, and pay claims only after the injured person hires a personal injury lawyer and sues. Once that happens, you need an experienced medical device attorney to evaluate and handle your claim.
Lilly, O’Toole & Brown has the knowledge, expertise, and resources needed to handle the most complex personal injury claims, including product liability cases involving defective medical devices.
We have represented clients in personal injury and other related areas: Product Liability, Wrongful Death
Mass Torts
Cases of widespread death, injury, damage, or loss that stem from negligence often fall into the category of the legal term mass torts. Mass tort claims arise when unscrupulous individuals or corporations disregard public health or safety and the consequences affect large groups of innocent victims.
A case in point is when big manufacturers in the health care industry put their profits before safety, and hundreds of people, sometimes thousands – fall prey to dangerous drugs and medical devices.
Mass tort cases are sometimes confused with class actions, since both kinds of claims are brought on behalf of groups of people who have suffered similar harm. In mass tort cases, however, each victim or family has its own distinct claim, while benefiting from the time and cost savings of individual claims that have been grouped together by the courts.
Kugel Hernia Mesh
Manufactured by Daval/Bard
Composix brand and dual mesh technology designs
This product is a synthetic mesh patch that is used during hernia surgery to close the hernia and help the tissue heal. It includes what is called a “memory recoil ring,” a small plastic ring embedded in the path that permits it to be folded over and then deployed once inside the abdomen. Certain sizes of the Kugel Hernia Mesh were recalled by the FDA in 2007 because the products have a tendency to break, causing bowel perforations, abdominal wall punctures and tears, and adhesions. Further, the mesh patch itself has shown a tendency to migrate within the body and sometimes grow into vital organs due to the dual mesh design.
Ortho-Evra Birth Control Patch
Manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson and Johnson
The critical difference between the Ortho-McNeil birth control patch and oral contraceptives is indirect versus direct delivery of the hormones. Birth control pills are first processed by the body’s digestive system, while similar drugs in a skin patch go directly into the blood stream. The high-dosage concentration delivered by the Ortho-Evra patch can cause blood clots which, in turn, can cause strokes and other life-threatening complications and death.
In January 2008, after thousands of complaints had been logged, the FDA strengthened its warning about the risk of serious blood clots among Ortho-Evra patch users. This product has not been recalled, however, and continues to be marketed as a “safe” option for birth control with the marketing being directed at the very youngest patients.
Vaginal Slings and OB Tape
Manufactured by Mentor Corporation
This device was produced by Mentor in 2003 for use in certain kinds of surgical procedures to treat stress incontinence, which is common among women. A vaginal sling reinforces muscles weakened by childbirth and other causes, and helps patients control urinary functions. Almost immediately after its introduction, design and manufacturing defects in the Mentor Ob Tape vaginal sling brand causing severe complications such as breakdown of vaginal tissue, chronic discharge, serious infections, and other injuries that my be permanent.
When the Journal of Urology in 2006 documented widespread injuries caused by the Mentor Ob Tape vaginal sling, the device was pulled from the market. By that time, however, an estimated 35,000 women had been fitted with the sling.
Pain Pumps
Manufactured by Stryker Corporation, I-Flow Inc., DJO Inc., and BREG Inc.
External automatic pain pumps are used frequently in shoulder and other joint surgeries to deliver pain medication directly into the joint. Recently, this direct delivery method has been found to cause serious cartilage destruction – a condition called postarthroscopic glenohumeral chondrolysis (PAGCL), medical terminology for death by cartilage. PAGCL can result in permanent disability and require total joint replacement surgery.
Victims of PAGCL suffer from narrowing or destruction of joint space, which can be diagnosed by x-ray. Patients should seek medical advice if they experience symptoms such as joint weakness stiffness, pain, decreased motion, or clicking, popping, or grinding when the joint is put in motion.
ACTOS, ACTOplus met, ACTOplus metXR, Duetact
Manufactured by and marketed by Takeda
Actos was approved by the FDA in 1999 and marketed by Takeda Pharmaceuticals, a Japanese company. Actos was promoted to Type II diabetics as being a safe alternative to Avandia (which causes heart attacks and strokes) and Rezulin (causes liver failure). The science linking Actos to bladder cancer continues to grow. A link has been shown with use for as little as 12 months. Actos has been recalled in some foreign countries and the FDA is analyzing safety data at this time. Litigation efforts in both state and federal courts involving the Actos family of drugs are in their early stages.
Yaz, Yasmin and Ocella
Manufactured by Bayer Health-Care Pharmaceuticals, Inc.
Yasmin, a birth control product, was approved by the FDA in 2001. Yasmin contains drospirenone, a progestin that can increase the body’s potassium levels. According to the drug’s label, the posatssium increase may put women with liver and kidney problems at higher risk for serious health problems. Currently, there is multi-district litigation ongoing with trials scheduled to begin in early 2012. The FDA recently held a hearing to evaluate safety concerns associated with these drugs which have been shown to cause two to five times more blood-clot related injuries, including deep vein thrombosis, pulmonary emboli, strokes, heart attacks, and sudden cardiac death. Additionally, these drugs have been associated with gallbladder injuries.
Fosomax
Manufactured by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Fosomax (alendronate) was approved by the FDA to prevent and treat the bone-thinning disorder osteoporosis and was one of several drugs classified as bisphosphonates which act to decrease cells that damage bones. Medical studies suggest that bisphosphonate compounds like Fosamax restrict blood flow to the bone and cause osteonecrosis of the jaw (ONJ) ; a progressively debilitating condition that results in actual bone death. ONJ is associated with minor jaw trauma such as tooth extractions that do not heal properly, typically leading to exposure of the bone, and complications such as extreme pain, virulent infections, tooth loss and disfigurement. Fosomax has also been linked to long bone fractures (e.g. femur fractures) and also esophageal cancer.
Pradaxa
Manufactured by Boehringer
Pradaxa is a blood thinner primarily prescribed for those with atrial fibrillation. With atrial fibrillation, patients have a higher risk of forming blood clots near the heart which can travel through the body and cause strokes. Pradaxa is used to lower the chance of blood clots forming. The drug had great promise and was quickly embraced by patients and prescribers as it eliminated the need for frequent blood tests, as required by traditional Warfarin and Coumadin therapy.
Within months of its introduction, however, physicians started reporting serious concerns about the safety of the drug. The blood thinning effects of Pradaxa are not easily reversed, so patients requiring surgery or who have suffered trauma have died or suffered serious injuries due to uncontrolled bleeding caused by Pradaxa. The drug remains on the market for now, but is likely to be recalled or its use severely curtailed as physicians and patients learn more about its significant risks.
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