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.
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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.
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According to the FDA, problems involving the da Vinci Surgical System are increasing prompting new recommendations for surgeons and calling for more robot surgery training. The problems continue to involve serious injury such as burns, tears, bowl perforations and even death.
An independent investment analysis firm issued a report on October 3rd regarding the increased da Vinci complaints, warning investors about the impact these incidents may have on the stock price for Intuitive Surgical, manufacturer of the da Vinci robot. The report involved figures such as the 2,332 da Vinci complaints received in the first eight months of 2013 as compared with the 4,603 complaints received over the past twelve years from 2000 through 2012. Here is what is even more disconcerting: another study suggests that these problems are often unreported. Who knows that the real data would show?
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C.R. Bard has been in the transvaginal mesh cases from the very beginning. I really do believe they are going to try to put together a global settlement that will resolve more than just the cases with pending trial dates. But in the meantime, Bard is going to do what it has done from the beginning of this litigation: wage war. But facts are stubborn things which brings us back to the same theme: these cases are going to settle.
The case was a good test case although it was a case that was actually pretty favorable to the defendant because the injuries were not as serious as they are in some other cases. It is the classic design defect/failure to warn claims against Bard’s Avaulta Plus, a synthetic mesh product designed to treat pelvic organ prolapse. The woman’s lawsuit claimed that that the arms contained in the mesh device, the small pore size used in the mesh, and the use of polypropylene to make the device were design defects. On their failure to warn claim, plaintiff argued that Bard inadequately warned about the risk and severity of the complications Plaintiff eventually experienced. Plaintiff also argued the obvious: Bard did not adequately warn of the risks. (Does anyone really disagree with this premise? I don’t know how they argue that one.)
Bard sought a new trial after the verdict arguing the case never should have gone to the jury. Comically, defense counsel actually conceded that many of these issues appropriately went to the jury. But they did a takesey-backsie (is that how you spell it?) on it arguing that there was not enough design defect evidence to go to the jury.
The history of the Lipitor diabetes cases has followed the usual mass tort path:
- Plaintiffs seek “class action” type consolidation
- Defendant opposes it even though it would actually save them litigation costs
- The court agrees with the Defendant because there are not enough lawsuits to justify pulling the claims together
- More and more cases are filed
- Plaintiffs refile their motion citing all of the new cases
- The court agrees with plaintiffs and creates Multidistrict Litigation (a MDL)
Right now we are at Stage 5 in the process in the atorvastatin calcium (known as Lipitor) cases.
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