Defective Products

$500 Million Pinnacle Hip Verdict

Published on: May 2, 2016 | by Hollis Wright

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 Hit with Fourth Million Dollar Verdict on Risperdal Failure to Warn Claims

Published on: November 18, 2015 | by Hollis Wright

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.”

C.R. Bard Inc.’s IVC Filter Litigation

Published on: September 16, 2015 | by Hollis Wright

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.

Zofran: Birth Defects Caused by Anti-Nausea Drug?

Published on: April 7, 2015 | by Hollis Wright

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.

Pharmaceutical Companies Hit Hard Recently

Published on: March 5, 2015 | by Hollis Wright

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.

HIP IMPLANT MANUFACTURER AGREES TO $1.43 BILLION SETTLEMENT

Published on: November 7, 2014 | by Hollis Wright

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 products. Complex 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.

2014 GM Ignition Switch Recall & amp; Settlement Fund

Published on: September 25, 2014 | by Hollis Wright

Have you been injured while driving or riding in a GM manufactured vehicle? As of August 2014, GM has set up a settlement program to compensate persons injured in several recalled cars. The problem noted in the recall is an ignition defect which cuts power to the airbags, power steering, and brakes. In these cases, the ignition switch moves out of the “run” position, resulting in a partial loss of electrical power and turning off the engine. These issues can cause an accident or make an accident far worse. As of September 22, 2014, the official death toll from the ignition defect stands at twenty-one (21). 143 alleged death claims have been filed, out of 675 total filed claims.

The affected models include:

Buick	Cadillac	Chevrolet	Oldsmobile	Pontiac	Saturn
Lacrosse (2005-2009)	CTS(2003-2014)	Camaro(2010-2014)	Alero(1999-2004)	G5(2007-2010)	Ion (2003-2007)
Lucerne (2006-2011)	Deville(2000-2005)	Cobalt(2005-2010)	Intrigue(1998-2002)	Grand Am(1999-2005)	Sky (2007-2010)
	DTS (2006-2011)	HHR(2006-2011)		Grand Prix (2004-2008)
	SRX (2004-2006)	Impala(2000-2014)		Solstice (2006-2010)
		Malibu (1997-2005)
		Monte Carlo (2000-2007)

If you were injured while driving or riding in one of these vehicles, it is important to consult with an attorney as soon as possible. The compensation expert hired by GM to manage the recall settlement has stated that GM will only accept claims until December 31, 2014. The settlement manager has also stated that GM has not placed a cap on the payments, so anyone with an eligible claim has an opportunity to recover damages. Those with an eligible death claim will automatically receive $1 million in addition to the awarded amount.

Eligible claims must meet the following criteria:

The injured party must have been a driver of or passenger in one of the car models (and years) listed above;
There must be a physical, personal injury—GM is not compensating for property damage;
The airbags must not have deployed—if the airbags deployed, then this ignition defect was not the cause of the accident.

Finally, the compensation program will not consider driver negligence in determining eligibility for a settlement award. The law firm of Hollis Wright is currently representing numerous clients with potential GM claims. Complex litigation against large pharmaceutical companies demands specialized legal experience. If you or a loved one believe you have been harmed by a transvaginal mesh device, contact the firm of Hollis Wright for more information and evaluation.

Additional authors: Alison Almeida

TRANSVAGINAL MESH MAUNFACTURER AGREES TO $830 MILLION SETTLEMENT

Published on: June 3, 2014 | by Hollis Wright

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.

ACTOS: $9 Billion Awarded in First MDL Bladder Cancer Trial against Manufacturers Takeda & Eli Lily

Published on: April 25, 2014 | by Hollis Wright

On April 7th, a jury in the first federal court Actos bladder cancer trial returned a verdict for almost $9.15 billion dollars against co-defendants, Takeda Pharmaceuticals USA Inc. and Eli Lilly & Co. Inc. (In Re: Actos [Pioglitazone] Products Liability Litigation, MDL Docket No. 2299, No. 6:11-md-2299, Allen v. Takeda Pharmaceuticals North America Inc., et al., No. 12-62, E.D. La.), the seventh largest verdict in U.S. history.

The plaintiffs in the case, Terrence and Susan Allen, were awarded $1,475,000 in compensatory damages (i.e., damages for medical bills, lost wages, pain and suffering, emotional distress, and/or mental anguish), and $9 billion in punitive damages. The jury found that Takeda was 75% liable and Eli Lilly was 25% liable, and split the punitive award accordingly – $6 billion against Takeda and $3 billion against Lilly. The plaintiffs’ case was premised on the theory that the drug manufacturers had marketed Actos knowing it could cause cancer, but failed to disclose this information to doctors and failed to warn consumers about the risks associated with taking the drug. The plaintiffs alleged that the pharmaceutical companies failed to disclose this information in order to reap the substantial profits Actos supplied. For example, in 2011, Actos sales revenue was $4.5 billion and accounted for nearly 27% of Takeda’s total revenue for that fiscal year. Since its release in 1999, Actos has generated more than $16 billion in sales for Lilly and Takeda, who partnered together to produce and market the drug in the United States.

Actos was originally approved by the FDA in 1999 as an oral medication for type 2 diabetes blood sugar control. According to the original drug applications and approval literature, it was recommended for patients who have been unsuccessful at regulating blood sugar levels through diet and exercise alone. However, at the heart of this litigation was an FDA mandated 10-year safety study which was required at the time of approval, to assess whether Actos had any link to bladder cancer. That study was concluded in 2011, and found that the use of the drug for more than one year continuously might be associated with an increased risk of bladder cancer.