Is Soriatane the Next Accutane?

Soriatane is a drug used to treat sever psoriasis in adults. It is manufactured by Roche Holding, AG, (Hoffman-La Roche), and the generic name is Acitretin. It is a retinoid compound and is similar to Accutane. Soriatane was launched in 1997.

Soriatane has been linked to several dangerous side effects including serious birth defects, depression and suicidal thoughts.

Birth Defects: A pregnancy prevention program has been implemented since the drug first came to the market. There are stringent guidelines in place that must be followed before a doctor can prescribe the drug to a woman. They must present two negative pregnancy tests, use two or more birth control methods one month prior to treatment, and they must continue their birth control treatment for three years after discontinuing use of the drug. Women must also sign an informed consent agreement before treatment.

Depression/Suicide: In May 2003, Roche added a warning to Soriatane’s label, alerting the public of the drug’s link to depression, aggression and thoughts of self-harm. Similar to Accutane, common Soriatane side effects include depression, aggressive feelings, mood swings, suicidal ideation, and self-harm.

Other Side Effects: Increased intracranial pressure, alteration in lipid levels, eye problems, cardiovascular effects, bone spurs, and pancreatitis.

There has not been an MDL formed to consolidate Soriatane lawsuits. There are too few cases to merit an MDL at this time. 

Pittman, Dutton & Hellums, P.C., is not currently pursuing lawsuits for this drug, but we will continue to monitor any new FDA warning label changes which could affect the legal landscape.

Two Pelvic Mesh Juries Give Two Differing Results

Over the last two weeks, two strikingly different results have occurred involving transvaginal mesh trials.

A jury in a West Virginia federal court slammed Johnson & Johnson subsidiary Ethicon Inc., with a $3.27 million verdict last Friday in a bellwether trial. The jury found Ethicon's transvaginal sling was defectively designed and the company failed to warn of its potential risks. 

It was reported that the jury returned the compensatory damages verdict after deliberating for just three hours and found for the plaintiff on all counts. The trial lasted two weeks.

Johnson and Johnson faces nearly 33,000 similar lawsuits.

On August 29, the previous Friday, a Massachusetts jury sided with Boston Scientific Corp., in the second bellwether trial involving the company’s pelvic mesh devices. The jury found that a transvaginal sling was not defectively designed and the company adequately warned of risks associated with the device. That trial lasted two weeks and the jury deliberated for over two days. This trial was heard in state court.

These bellwether trials illustrate the multitude of different outcomes in transvaginal mesh litigation on both the state and federal level. On one hand, we have seen summary judgment granted for the defendants, while on the other we have seen near Billion dollar settlements (see my previous blog posts regarding such). The MDL system and bellwether trials are designed to help both sides of the aisle evaluate their positions reasonably. These latest bellwether trials will probably do little to help either side assess their positions and instead push them to keep trying cases.                                         

First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.