The case stems from an off-label spinal fusion procedure. Plaintiff sued Medtronic and his surgeon claiming that Infuse bone graft was used in a manner that had not been approved by the U.S. Food and Drug Administration, and was therefore an unauthorized off-label use.
Approximately five days prior to trial, and one day after a judge denied Defendants’ attempt to dismiss, a settlement was reached in a pending Wright Profemur lawsuit. This is one of at least two Wright Profemur hip settlements that have been reached just before trial. The terms of the settlement were not disclosed.
I don’t know what they are, either. But let me tell you how much I think this case settled for: more than the market value for the claim. Why? Because the attorneys handling these case for Wright are pretty smart. They know full well the best way for the settlement value of these cases to get completely out of hand is to let plaintiffs start seeing jury verdicts. Right now, Wright can pretend that they are someone situated different than DePuy. Everyone who is in these cases – on both sides – knows the real score. But the last thing Wright needs at this point is a big verdict to get plaintiffs’ expectations soaring through the roof.
As the result of litigation wrongdoings a federal judge called egregious, Pradaxa manufacturer, Boehringer Ingelheim, was hit with a fine in the amount of $931,500, approximately $500 per case. Let me tell you: this does not happen every day. This is a harsh sanction and it underscores that this company is either negligently or intentionally failing its discovery obligations. Will this benefit Boehringer Ingelheim more than the measly, in the general scheme of things, million bucks? It might.
Many product liability cases have a medical malpractice component to them. Certainly, in the mass tort world, the da Vinci robotic surgery claims come to mind. In those cases, patients often blame the manufacturer of the robot and the doctor who performed the operation. The question in these cases is whether jurisdiction for the claim is in state court or federal court, assuming the plaintiff prefers state court as we often do.
In Larson v. Abbott Laboratories, a new federal court decision in Baltimore, Maryland, the plaintiff, who was an HIV positive space engineer, alleged that the prescription drug Humira caused him an infection that left him with permanent brain damage. So we have real stakes for everyone. A big selling pharmaceutical drug – with billions of dollars in sales a year – that is on the verge of being the subject of a big time mass tort and a plaintiff who has a brain injury which could lead to a very large jury award. So the stakes are high. (The Humira claims are rarely involving HIV patients and infections, to be clear. But the point is a large verdict and Humira is going to set off the Pavlovian dogs.)
Add one more issue to the mounting problems that Intuitive Surgical is facing with its da Vinci Surgical Robot. The FDA has announced that the mechanical arms on some of the da Vinci robots could stall during robotic surgery, resulting in short-term or medically reversible health problems, or even serious injury. The recall affects 1,386 Patient Side Manipulators on da Vinci S, Si and Si-e Surgical Systems.
The FDA announced yesterday that Onfi (clobazam), an anti-seizure drug, can cause rare but serious skin reactions that can result in permanent harm and death. Two such skin reactions are Stevens-Johnson Syndrome (SJS) and Toxic Epidural Necrolysis (TEN). The FDA has identified 20 cases of SJS/TEN associated with the medication and at least five children have been seriously injured by this product.
The numbers continue to grow. The number of complaints filed in state and federal courts by those who have experienced problems with the Stryker Rejuvenate hip replacement is nearing 1,000. With DePuy hip cases reaching a settlement last month, the focus on these claims is going to intensify. This post talks about where these cases are going and makes a prediction of how and when these cases will settle.
Janssen Pharmaceuticals got hit with an $11 million verdict in a Topamax cleft lip lawsuit. This is the second big verdict against this epilepsy drug. Janssen, a Johnson & Johnson subsidiary, took a $4 million verdict in October. There are not many of these claims, thankfully. Right now, there are 134 cases pending although you can expect a lot more to be filed in the near future after these verdicts.
What do these two verdicts mean for the future of the Topamax litigation? It means what you think it means. The value of these cases are going up and up.
Great news may be just around the corner – great news for everyone. According to the results of an early trial presented this week, researchers may have identified a reversal agent for Pradaxa. Although not yet approved, a study was conducted in which men were given this medication for four days, then provided with an IV drip containing either the potential new reversal agent or a placebo. Those receiving the new antidote had a complete reversal of Pradaxa’s anti-coagulation effects following a five-minute infusion of the agent.
This is huge. Many thought Pradaxa would almost completely replace Warafin (Coumadin). It was being promoted as a superior alternative to warfarin for stroke prevention, as it was easier to take and required less medical monitoring. The problem? The effects of Warfarin were easily counteracted by administration of vitamin K, whereas Pradaxa had no known reversal agent. There was no way to control bleeding that may have unexpectedly occurred following emergencies such as trauma or emergency surgery. Lawsuits have been filed alleging exactly this – the drug caused excessive bleedings without warning cause serious injuries and the deaths of many innocent people.