Articles Posted in Dangerous Drugs and Medical Devices

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The U.S. Judicial Panel (JPML), a separate body within the Federal Court System, has granted the plaintiff’s second motion for consolidating Proton Pump Inhibitor (PPI) drug claims to Multidistrict Litigation (MDL). This allows the plaintiffs to consolidate the cases that allege PPI drugs caused kidney disease in those who used them. The benefit for plaintiffs is that the consolidated action will expedite the overall process, prevent duplicate discovery, and reduce a backlog in the court system.

The PPI drugs at issue include four prescription drugs: Prilosec, Nexium, Protonix, and Dexilant; and three over-the-counter drugs: Prilosec OTC, Prevacid 24-hour, and Nexium 24-hour. Plaintiff’s allege these PPIs cause kidney injuries, which include acute interstitial nephritis, chronic kidney disease, and end-stage renal disease. This type of drug first received FDA approval in 1989.

The suits, citing a host of studies, claim the manufacturers of the PPI drugs (the defendants) should be held liable and accountable for the damage caused to patients while taking said drugs. Furthermore, the defendants should take financial responsibility for failing to warn consumers of the potential health issues related to PPIs.

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Medical devices, implants and tools are used daily by people and medical personnel all over the country and are intended to improve the overall health and quality of life in patients. These medical devices are often intended to prevent or protect against certain medical dangers or injuries during the course of performing medical treatment or surgery.

However, what happens when the medical device or implant causes an injury to the patient? Such an occurrence will likely result in the pursuit of a product liability lawsuit against the manufacturer by the injured patient. During the course of litigation, the issue of the U.S. Food and Drug Administration’s (FDA) 510(k) clearance process of the subject medical device will likely arise. The FDA’s 510(k) process is one way to introduce new medical devices or implants to the market. In pursuing the 510(k) approval route, the manufacturer will submit an application to the FDA seeking clearance under the 510(k) process. Among other items, the 510(k) application will include a description of the medical product and the intended use of the product. Further, the application will reference other similar products that are on the market being used in a substantially similar manner.

While we would like to believe that the FDA is conducting a thorough and complete analysis of each medical product that is on the market, this is not the case. The FDA was never set up in this manner and simply does not have the resources to conduct such an analysis on every product. This type of in-depth, thorough evaluation is reserved for a different class of medical devices and implants, which is known as Pre-Market Approval (PMA).

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Millions of Americans annually rely on medical devices to either save their lives or improve the quality of their lives. While most medical devices perform properly and provide doctors with the means to maintain their patients’ quality of life, many devices fail and, either do not help the patient, or actually cause further harm. According to a May 2016 article in The Expert Institute, the FDA each year receives thousands of reports of deaths, injuries, and malfunctions associated with medical devices.

Surgical mesh is a commonly used type of medical device that has, in some cases, had adverse effects on patients. Hollis Wright is currently reviewing claims involving complications with two types of flexible, composite surgical mesh devices. Both mesh devices that Hollis Wright is currently investigating were recalled by the products’ manufacturer, not the FDA. Both products also were introduced via the controversial 510(K) Premarket Notification Program, not the FDA’s more stringent Premarket Approval Process (PMA).

The two surgical mesh devices for which Hollis Wright is currently reviewing claims are as follows.

After hearing thirty-seven days of trial testimony and deliberating for four days, a Texas jury determined that Johnson & Johnson was liable for defectively designing their metal-on-metal hip implants. The lawsuit alleged that Johnson & Johnson aggressively marketed their Pinnacle metal-on-metal hip implants for use by younger, more active patients because the metal-on-metal implants were long-lasting, durable and safe despite being aware of the design flaws in the implants, which caused them to fail more frequently and quickly than expected, leading to injuries including tissue death, bone erosion and high levels of metal in their blood. The five Plaintiffs who brought the lawsuit collectively received a $502 million judgment which was comprised of $142 million in compensatory damages and $360 million in punitive damages. The verdict will be split amongst the Plaintiffs based on the severity and impact that each Plaintiff suffered as a result of their individual injuries.

Unfortunately, Johnson & Johnson has vigorously stated since the massive verdict was returned that they will appeal the result. One of the many issues that will certainly be raised on appeal is Texas’ law which caps punitive damages. This means that on appeal the $360 million punitive damage award could be reduced to as low as $10 million.

However, despite a pending appeal and a possible overall reduction in punitive damages, the recent verdict is still an overwhelming triumph for Plaintiffs who suffer from defective metal-on-metal hip implants. Most notably, the recent verdict marks Johnson & Johnson’s first trial loss regarding the use of metal on metal artificial hips. In a prior trial in the same multi-district litigation (“MDL”), Johnson & Johnson was successful in defending a single Plaintiff suit based on its argument that it was the surgeon who installed the implant’s fault instead of the defective implant itself. However, based on this most recent verdict it appears the tide has begun to change in favor of the Plaintiffs, and Johnson & Johnson will no longer be able to overlook its defective product and place blame on the implanting surgeons.

Johnson & Johnson has faced several lawsuits over the past year alleging that Johnson & Johnson knew there was a link between their antipsychotic drug, Risperdal, and abnormal breast growth. Risperdal is a very powerful antipsychotic drug that Johnson & Johnson peddled to pediatric doctors for use by children even though the drug lacked certain approvals from federal regulators. Thus far, Johnson & Johnson has been hit with four separate jury trials all alleging that Johnson & Johnson not only knew that children prescribed Risperdal could develop a condition known as gynecomastia, but also that Johnson & Johnson failed to properly warn and/or disclose the risks of abnormal breast growth in adolescent boys prescribed Risperdal.

The Previous Three Jury Trials

In February 2015 the first Risperdal case was taken to a trial by jury. The jury returned a $2.5 million verdict in favor of the plaintiffs determining that Risperdal did in fact cause the plaintiffs injuries and that Johnson & Johnson failed to provide proper warnings. In the second case, the jury was less convinced as to the causal link between the drug and the plaintiff’s adverse condition. While the jury did agree that Johnson & Johnson failed to provide adequate warnings, the jury was not convinced that Risperdal caused the plaintiffs to develop abnormal breast growth. As such, the second jury awarded no damages against Johnson & Johnson. The third case began October 15, 2015 and the trial is still ongoing. Lead counsel for the young man who developed female breasts after taking Risperdal as a child stated recently that “Risperdal [is] a powerful antipsychotic drug which was promoted and marketed even though it wasn’t indicated for children.”

picture from http://www.drugdangers.com/ivc-filter/lawsuit.htm

What are IVC filters and when are they used?

Intra Vena Cava (“IVC”) filters are small spider-like devices that are implanted in the veins of patients in the hope that the filters will stop blood clots from reaching the patient’s lungs and other vital organs. IVC filters are designed to capture blood clots that occasionally break free from the deep veins inside a patient’s body before the blood clots can reach the patient’s lungs and cause a decrease or a complete stoppage of blood flow to the patient’s lungs. However, hundreds of reports from across the nation indicate that the devices may fracture or break after implantation resulting in serious injuries and in some cases death.

IVC filters are usually implanted in patients who are at risk for having a sudden blockage of a major blood vessel, known as a pulmonary embolism, and are either unable to take anticoagulants or the patient has taken anticoagulants but they have failed to properly prevent the patient’s blood from clotting. The IVC filters are supposed to be a safe alternative which prevents blood clots from forming in a patient’s blood vessels. However, in April of 2015, the Journal of the American Medical Association published a study comparing the treatment of patients presenting with an acute pulmonary embolism and a high risk of recurrence using a retrievable IVC filter plus anticoagulants versus using anticoagulants alone. The study revealed that “the use of a retrievable inferior vena cava filters plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at 3 months.” Furthermore, the study suggested that patients with IVC filters may be twice as likely to suffer from a serious, and sometimes fatal, pulmonary embolism than patients who were prescribed anticoagulants alone. Therefore, the study suggests that IVC filters should not be used in cases where patients can be treated with anticoagulation.

In the past month, at least three new lawsuits have been filed over birth defects parents allege were caused by Zofran, the popular anti-nausea medication prescribed for off-label use during pregnancy by mothers.  This case, filed in California Superior Court on March 30, 2015, follows two others: one filed in the Eastern District of Pennsylvania on February 12, and another in the District of Massachusetts on February 16.  Each case alleges congenital abnormalities, including heart defects, after the mothers were prescribed Zofran for nausea and vomiting associated with pregnancy…a use not approved by the FDA when the drug was approved for market.

The court cases allege, among other things, that the maker of the drug, GlaxoSmithKline, has received more than 200 reports of birth defects in children who were exposed to Zofran during early pregnancy.  Glaxo is also being accused of improperly marketing Zofran to treat pregnancy-related nausea and vomiting, and one lawsuit even notes that Glaxo previously agreed to pay $3 billion to settle charges with the U.S. Department of Justice regarding the marketing of a number of other medications.  This prior settlement with the U.S. government included allegations that Glaxo had improperly marketed Zofran to treat morning sickness…the very same claim now asserted by the plaintiffs.

Recent research by scientists with the University of Colorado, Stanford University, and London’s Royal Free Hospital reveled that when taken during pregnancy, Zofran does in fact cross the placenta to reach the developing fetus, and remains longer with the baby than the mother due to a longer half-life (i.e., the elimination rate of the drug in the body).  This was not the first study done regarding these issues.  A previously published study from the journal Clinical Pharmicokinetics, showed that samples taken from 41 women given Zofran prior to surgical pregnancy termination procedures revealed much higher concentrations of the drug within fetal tissues than was anticipated.

Big Pharma has taken it on the chin recently in several trials across the country, with juries awarding millions in damages to individuals who’s health and lives were ruined by defective drugs rushed to market with “reckless indifference” to the health and safety of patients.  Amid growing concerns over FDA oversight, and lack of transparency in the testing and studies for new drugs, two juries in the last 30 days in Philadelphia have awarded $2.5 million against Johnson & Johnson for claims associated with use of its long marketed Risperdal medication, while Takeda Pharmaceutical Co. was hit with $2.3 million in damages to a former teacher who developed bladder cancer after using the company’s diabetes drug, Actos.

The Takeda award amounted to $300,000 in compensatory damages for the plaintiff’s medical expenses, as well as an additional $2 million for pain and suffering related to his cancer diagnosis.  This is the not the first case where Takeda has been accused of, and found liable by a jury, of endangering the health and welfare of potential patients and users of its drugs.  On April 7, 2014, Takeda and Eli Lily where hit with a $9 billion jury verdict related to the same drug, Actos, for failure to disclose and warn of the drug’s potential to cause cancer.  On appeal, that award was cut to $36.8 million; however, this recent award is the fifth jury award against Takeda related to Actos.  Juries in California and Maryland have also awarded a combined $8.2 million against Takeda for its handling of the drugs.

Another Philadelphia jury ordered Risperdal drug manufacturer, Johnson & Johnson, to pay $2.5 million to a 20-year old autistic man from Alabama who developed size 46 DD breasts as a young teenager due to his long time prescribed use the drug.  This condition, called gynecomastia, was never warned about the manufacturer, who now faces thousands more lawsuits in Philadelphia, California, Missouri, and other locations across the US.  Juries aren’t the only problem for J&J related to Risperdal however; in 2013, the company paid $2.2 billion to settle federal and state criminal and civil charges related to illegal marketing of the drug.  Gynecomastia is the growth or enlargement of male breast tissue. The psychological and social injuries can be devastating — especially when gynecomastia affects adolescent males. Many doctors recommend surgery to reduce breast tissue. In mild or moderate cases, liposuction may be an effective option. In severe cases, however, a surgical procedure called a mastectomy may be necessary to remove breast tissue and excess skin.

On Monday, November 3, 2014, a Kalamazoo, Michigan-based orthopedic device manufacturer, Stryker Orthopedics and Howmedica Osteonics Corp., agreed to pay at least $1.43 billion to settle lawsuits pending around the United States.  The lawsuits were filed by thousands of patients who received two (2) different defective hip implants, which were recalled by Styker in 2012 due to corrosion and other various problems.  Defective hip litigation has seen several large settlements over the past few years, with John & Johnson agreeing to a $2.5 billion settlement just last year to settle some 8,000 lawsuits from patiets alleging that the company’s metal ball-and-socket hip implant caused them injury or had to be replaced or removed entirely.

The Styker settlement will include all pending state and federal claims, and will include plaintiffs from 39 different states.  The claims include corrosion which occurred in the patients’ bodies causing illness, as well as removing and replacing the implant with a new device, a procedure known as a revision.  According to attorneys who lead the settlement negotiations,   “[t]he settlement represents one of the largest medical device settlements with an unlimited compensation fund.”  Stryker expects to make most of the payments under the settlement by the end of 2015.

The law firm of Hollis Wright is currently representing numerous individuals who have been injured by these Stryker productsComplex litigation against large medical device manufacturers demands specialized legal experience.  If you or a loved one believe you have been harmed by a defective medical device or product, contact the firm of Hollis Wright for more information and evaluation.

On April 30th, Endo International Plc (“Endo”) agreed to pay $830 million to resolve legal claims filed by women who have been injured by various transvaginal mesh devices.  In its annual report filed with the U.S. Securities and Exchange Commission, Endo reported that as of February 2014, the company and its American Medical Systems (“AMS”) subsidiary faced approximately 22,000 lawsuits over the devices, and that in 2013, Endo agreed to pay $54.5 million to settle an undisclosed number of the cases.

This most recent settlement is aimed at resolving all of Endo’s pending legal claims across the country related to these devices; however, several other manufactures, including C.R. Bard, Inc. and Johnson & Johnson’s Ethicon unit manufacturer, remain pending and are not part of the announced settlement.  At last count, nearly 44,000 cases filed by injured women were pending in the U.S. District Court for the Southern District of West Virginia, alleging varying injuries, including pain during intercourse, bleeding, and additional complications, many of which have required additional surgeries to remove the devices.

Transvaginal mesh devices are net-like implants used to treat various conditions, including pelvic organ prolapse and stress urinary incontinence – common conditions for women after a hysterectomy, menopause, or childbirth.  However, over time and beginning in 2008, the U.S. Food and Drug Administration (“FDA”) began notifying manufacturers of reports of complications linked to the devices.  This ultimately led to post-marketing safety studies mandated by the FDA to be conducted by AMS and other manufacturers to monitor the rate at which adverse events were being reported.  The effect of these reports has been that at the beginning of May, the FDA announced that it is considering proposals which would tighten safety standards for mesh devices used to treat pelvic organ prolapse.  These proposals, if adopted, would require manufacturers to submit data which proves the devices’ safety and efficacy before allowing the manufacturer to take the device to market.