Articles Posted in Drugs & Medical Devices

Stryker Corporation has issued a voluntary recall of yet another product used in orthopedic surgeries. In July of 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems used in conjunction with hip replacement surgeries. More recently, Stryker Corporation has acknowledged defects with its ShapeMatch Cutting Guides used to assist in the positioning of total knee replacement components. On April 10, 2013, Stryker issued an urgent medical device recall of the ShapeMatch Cutting Guides. This was classified as a Class I recall by the U.S. Food and Drug Administration, which means that there is a reasonable probability the product can cause serious adverse health consequences or death.

The ShapeMatch Cutting Guides were used with the Triathlon Knee System. The recalled products are single use, disposable cutting guides used as surgical instruments to assist the surgeon in positioning the total knee replacement components and guiding the marking of bone before the surgeon begins cutting. The product was recalled due to a software defect that resulted in wider cutting ranges. Additionally, Stryker determined that a separate software defect resulted in displayed parameters for the depth of resection or the angle of cut not matching the cutting guides produced. It was determined that these defects could result in injuries, including joint instability, fracture, chronic pain, limited mobility of the knee and the need for revision surgery.

Patients who have had knee replacement surgery during which the ShapeMatch Cutting Guides were used and who feel their knee is not functioning properly should contact their orthopedic surgeon. If it is determined that the patient is experiencing joint instability, fracture, chronic pain, or limited mobility in the knee, any of which could necessitate revision surgery, he or she should contact the experienced defective medical device attorneys at Suthers & Harper on our toll free number, 1-800-320-2384, for a free consultation. Suthers & Harper is presently representing numerous individuals in pending lawsuits against the manufacturers of defective hip replacement and knee replacement products, and has the experience and resources necessary to hold the product manufacturers accountable for their defective products.

DePuy Orthopedics has issued a Class I recall of the DePuy LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component when exposed to normal physiologic loads while walking. The DePuy LPS Lower Extremity Dovetail Intercalary Component was manufactured and distributed from February 2007 through May 2013 and was used to replace the mid-shaft portion of the femur, top, bottom or total femur, and top tibia. The component was frequently used in cases that required extensive resection, such as those involving tumors, severe trauma and serious infection. DePuy has advised surgeons, hospitals, and medical distributors to immediately discontinue use of the device as a result of the severe risks associated with its use.

Class I recalls are the most critical as they involve products deemed to be dangerous enough to cause serious adverse health consequences or death. Known injuries involving the DePuy LPS component recall include serious infection, loss of limb function, loss of limb, need for additional surgery, and in some cases death. Further, according to the Food and Drug Administration, those patients weighing more than 200lbs who were implanted with the DePuy LPS are at an increased risk for fracture and injury.

The recalled DePuy components include lot numbers: 130896, A2AGS1, 132131, A2AGT1, 132133, A2AGV1, 209461, B2VAL1, 209466, B43G11, 219843, B43G1A, 232972, B43G1B, 295965, B43G1C, 310189, B43G1D, 336843, B69HV1,349283, B69HVA, 352878, BK1BB1, 374125, BW7DX1, 379089, BW7DX1A, A1TAR1, E3SJD1, A2AGN1, and EN4KJ1.

The da Vinci robot surgical system, manufactured by Intuitive Surgical, is a telesurgical device that has been FDA approved for a range of minimally invasive procedures. During these procedures, the patient is on the operating table while the doctor sits several feet away at the control area of the machine, where he or she can maneuver the robotic arms while watching the procedure through a 3-D viewfinder. Many surgeons feel the robot makes it easier to see and navigate places in the body normally difficult to reach with traditional surgical methods. Doctors advocating the use of the da Vinci also point to the potential benefits for patients, such as small incisions, minimal bleeding, minimal scarring, and speeding post-surgery recovery time. As a result, surgical procedures using the da Vinci robot are becoming increasingly popular in the United States, with close to 400,000 of the procedures performed in the United States in 2012, and more than 1.5 million procedures since Intuitive Surgical received its initial FDA approval of the device.

Unfortunately, as the da Vinci procedures have grown in popularity, so have the reports of injuries associated with their use. In the last 5 years, the U.S. Food and Drug administration has received more than 4,600 complaints from patients associated with robotic surgeries, including reports of serious burns, cuts, infections, including 89 deaths. Surgeries performed with the da Vinci have also been connected with damage to organs, harm to body tissue, and bleeding and internal scarring that can lead to chronic pain and dysfunction. Causing even greater concern is the fact many patients have been discharged from the hospital following a da Vinci robotic-assisted surgery only to discover the injury days later, thus requiring a prolonged hospitalization, and in some cases, additional surgery.

Many medical experts worry the high-tech, futuristic nature of the machine is driving surgeons’ decision to use the da Vinci, rather than an actual medical need, and they are not adequately considering the risks associate with its use. This fact, coupled with the lack of adequate training by surgeons using the device, has resulted in patients being subjected to surgical complications that may have been avoided if other safer surgical methods were chosen. Moreover, there is evidence the design of the da Vinci surgical robot is known to lead to injury even without any error on the part of the surgeon. As a result, there have been numerous, serious injuries attributed to the use of the da Vinci surgical robot, and lawsuits are being filed across the country against both Intuitive Surgical and negligent surgeons.

A jury heard opening statements last week in the first Federal Court trial involving manufacturer CR Bard, Inc.’s Avaulta transvaginal mesh products. The case of Sisson v. CR Bard, Inc., in the United States District Court for the Southern District of Virginia, is one of approximately 3,600 cases pending against Bard in which women allege that erosion of the mesh products have caused organ damage, made sexual intercourse painful, and caused women to have to undergo additional surgical procedures to remove the mesh products. Most of the cases against Bard have been consolidated before U.S. District Court Judge Joseph Goodwin in what is known as the Multidistrict Litigation Court in Charleston, West Virginia for pretrial workup and the exchange of evidence. The Sisson trial was expected to last 2 to 3 weeks. However, on July 10, 2013, Judge Goodwin declared a mistrial because of a witness’ testimony. The Federal Judge stopped the trial in its second day after expert witness Lennox Hoyte, a gynecological expert, testified about the vaginal mesh devices’ marketing. Judge Goodwin had ruled previously that the Plaintiffs could not mention the fact that Bard had withdrawn the products from the market last year. After the witness’ testimony, Bard’s attorney moved for a mistrial. Judge Goodwin stated that it would be difficult for the jury to disregard such testimony and as a result, granted the Defendant’s motion for a mistrial. However, the trial on behalf of Donna Sisson and her husband is expected to begin again soon before a new jury, perhaps as early as July 29, 2013.

Donna Sisson was experiencing problems with control of her bladder, a condition known as stress urinary incontinence (SUI). When her problems became worse, she turned to a specialist who diagnosed her as suffering from pelvic organ prolapse (POP), a condition that can cause urinary incontinence and/or pain, including pain during sexual activity. In 2009, a transvaginal mesh product manufactured by Bard was surgically implanted in Ms. Sisson, purportedly to solve her problem of urinary incontinence. Instead of solving the problem, she began experiencing significant bleeding, pain during sex, bladder spasms, and as a result, had to undergo 2 additional surgeries to remove the mesh device. Ms. Sisson and her husband sued the product manufacturer, CR Bard, Inc., claiming that Bard knew about the problems associated with these mesh products but failed to warn doctors and consumers. Plaintiffs’ lead counsel, Henry G. Garrard, told the Federal Court jury last week that Bard officials knew that these transvaginal mesh devices were made of a material that was unsuitable for human implantation, and they covered up that flaw from doctors and women who were being surgically implanted with the products. Garrard told jurors that Bard made these implants, which were designed to shore up pelvic muscles, out of a type of plastic that carried a warning saying it should not be permanently implanted in humans. Bard’s lawyers have denied that these vaginal mesh devices were defective.

The litigation involving these transvaginal mesh products which were designed to treat SUI and POP has expanded and accelerated after the United States Food & Drug Administration issued a safety warning in 2011 stating that “Serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” Other manufacturers of vaginal mesh products, such as Ethicon, a division of Johnson & Johnson, Boston Scientific Corporation, American Medical Systems, Inc., Coloplast Corporation, and Cook Medical, Inc. are facing lawsuits claiming that their vaginal mesh devices are defective. In addition to the cases pending in the MDL Court before Judge Goodwin in Charleston, West Virginia, there are thousands more cases pending in State Courts across the country, 2 of which resulted in jury verdicts for the Plaintiffs within the past year. The outcomes of the Sisson case and other cases scheduled for trial in the MDL Court could put pressure on these manufacturers to try to settle the pending cases.

A number of victims throughout the United States have filed lawsuits against Johnson & Johnson and its subsidiary, McNeil-PPC, after suffering severe liver damage, liver failure and, in some cases, death after taking Tylenol or Acetaminophen. The lawsuits allege that the Defendant manufacturers failed to provide adequate warnings about the risks associated with the side effects of Acetaminophen, which is the active ingredient in Tylenol. The victims suffered serious and life-threatening injuries, even when the medication was taken as directed. Liver damage can lead to prolonged hospitalizations and potentially, the need for a liver transplant. The average cost for a liver transplant in the United States exceeds $500,000.

In April of 2013, the United States Judicial Panel on Multidistrict Litigation issued an order consolidating and centralizing all of the Tylenol liver damage lawsuits pending in Federal Courts throughout the United States in the U.S. District Court for the Eastern District of Pennsylvania. Any Tylenol liver injury lawsuits filed hereafter in the Federal Court system will be transferred into the Multidistrict Litigation (MDL) Court for the purpose of coordinated pretrial proceedings. This is not a class action. Any case transferred to the MDL Court remains an individual lawsuit throughout the process. The consolidation of such cases is more common in complicated product liability cases, where there are a significant number of lawsuits filed regarding similar injuries allegedly caused by a common medication, medical device or defective product. If a settlement agreement is not reached after the pretrial proceedings are completed in the MDL Court, the individual cases may be sent back to the U.S. District Courts where they were filed or could have been filed originally, and they are assigned dates for trials.

When the Tylenol lawsuits were consolidated in the MDL Court recently, there were only 27 Tylenol lawsuits filed against various manufacturers in Federal Courts throughout the United States. I believe this is only the tip of the iceberg, and that the Tylenol litigation will increase over the next few years as more victims discover that their liver damage or liver failure was caused by Tylenol manufacturers’ failure to provide adequate warnings about the risks associated with this over-the-counter medication. Acetaminophen is the leading cause of acute liver failure in the U.S., and has been for the past ten years. This fact has been reported by the FDA, and is well known to the makers of Tylenol. It has been estimated that more than 50,000 emergency room visits, 25,000 hospitalizations, and between 400 and 600 deaths occur annually as a result of liver damage or liver failure associated with Acetaminophen. Consequently, the FDA and other health organizations have been studying the association between Acetaminophen overdose and liver damage.

Generic drugs comprise 80% of all of the prescriptions filled in the United States. These generic drugs generate approximately $53 billion dollars in revenue. Unlike brand manufacturers, generic drug manufacturers have no duty to disclose new safety risks pertaining to their drugs when such risks become known. Brand manufacturers are required to update their warning labels upon learning of new safety risks or hazards associated with their drugs. Why should generic drug manufacturers be treated any differently?

In 2011, the United States Supreme Court ruled in Pliva v. Mensing that generic drug manufacturers cannot be held responsible for injuries caused by their failure to warn about safety risks associated with their generic drugs. Sometimes, these generic drug manufacturers are the biggest or only manufacturer of a particular drug. The Mensing decision protects generic drug manufacturers from being held accountable for failing to warn about potential hazards associated with the use of their drugs.

A young lady named Kira Gilbert is one of many examples of why generic drug manufacturers should be held accountable. Kira, who was 22 years old at the time, took a generic pain medication prescribed by her doctor for a few days prior to undergoing knee surgery. The drug was the generic version of Darvocet, which was eventually removed from the market because it posed a significant safety hazard. Kira Gilbert died from cardiac failure caused by her taking the generic drug. Unfortunately, her family was unable to hold the manufacturer of the generic drug responsible for Kira’s death because of the Mensing decision.