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.
- 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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Transvaginal mesh lawsuits pending around the country were sparked when the FDA issued a Public Health Alert in October, 2008 revealing that it had received 1,000 reports of serious injuries associated with vaginal mesh products over a three year period. In July 2011, the FDA warned that complaints associated with transvaginal prolapse repair had grown five-fold since the 2008 alert. It stated that it no longer considered these types of injuries to be rare. This was a big deal because that is what women were sold: complications would be very unlikely. According to the FDA and what we have seen with the inquiries that have come to our law firm, the most common vaginal mesh complications included chronic infections, organ damage, and mesh erosion and shrinkage. Women have filed claims in massive numbers since then.
Every major manufacturer has been sued. American Medical Systems (AMS), based in Minnesota, is a major manufacturer of transvaginal mesh medical devices, support systems designed to correct pelvic organ prolapse, (POP) and stress urinary incontinence (SUI). Johnson & Johnson is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. Currently, of the six different vaginal mesh multidistrict litigations (MDLs) centralized before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia, the largest MDL is the American Medical System (AMS) mesh lawsuits. The products were manufactured by the subsidiary of Endo Health Solutions, Inc. As of September 2013, there were 9,930 cases filed against AMS.
Dangerous Side Effects of Transvaginal Mesh Patches Include
- Erosion of the vaginal epithelium
- Bladder or bowel perforation
- Serious infection
- Return of pelvic organ prolapse
- Urinary incontinence
There has been some speculation that AMS may attempt to settle cases before the first trial dates begin. Otherwise, according to a pretrial order issued in the beginning of October, it will be determined in December what four cases will be eligible for the first bellwether trials, to be heard in April and May of 2014. It is time to either settle these AMS cases or start hitting them with big verdicts that will make them settle on very different terms than AMS could get now.
Filing a Lawsuit
If you or a loved one has suffered any negative effects as a result of an AMS transvaginal mesh, or any of the other manufacturers, protect your rights. Call us at 800-553-8082 or talk to us online. There is no fee or cost for you in pursuing your claim unless you win a recovery.
In a status update two months ago, I told you that settlements in the NuvaRing cases may be imminent and I gave you my thoughts on the potential settlement value of these claims. Both parties spending less energy on getting these lawsuit ready for trial and instead focusing on whether these actions can be settled in massive number. So we can’t be surprised by the latest next that there has been yet another postponement for the first NuvaRing bellwether trial. Originally scheduled to be tried earlier this year, the MDL trial date has been postponed several times by the judge assigned to the class action proceedings.
What is NuvaRing and what is the problem?
NuvaRing, a flexible plastic ring that is inserted once a month by women, not their doctor. Once inserted, the ring gives off a continuous dose of hormones designed to prevent pregnancy. No appointment necessary, nice and convenient, right? Well, for some, convenience can come with a price. While all hormone-based birth control carry risks of blood clots, medical studies indicate that NuvaRing users are more likely to experience dangerous and can cause the the woman’s blood hardens from a liquid to a solid. Specific problems include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attack, and death. Compared to some types of birth control, NuvaRing doubles these risks—or more. The FDA examined and confirmed the problem in 2011; however, Merck & Co., manufacture of NuvaRing, failed to warn users of the increased risks in any of their advertisements. Since then, hundreds and hundreds of former users have filed NuvaRing lawsuits.
Where the cases are going
These case have multiplied like rabbits. It began with a scattering of cases, In May 2012, just under 900 cases were filed in the federal court system. Now, with over 1,400 cases brought in the U.S. District Courts, these cases have become part of a Multidistrict Litigation (MDL). These cases are brought together as part of coordinated proceedings for the purpose of common discovery and settlement talks. As part of the proceedings, a small group of cases go through case-specific discovery in preparation for early trial dates, known as bellwether trials. I’d love to see a bellwether case go to trial because I think plaintiffs’ would win it. A bellwether case is basically a test case, allowing the parties to see what a jury will do with average claim to help everyone figure out what the values of the case really are. But I think the defendant thinks the same way and they seem to be going out of their way to avoid a trial before these cases start to settle.
Originally scheduled for January 27, 2014, the first bellwether case scheduled for trial has been pushed back to April 7, 2014, just the most recent of several postponements. The judge has also put a hold on all discovery, motions, and rulings in any of the federal NuvaRing cases filed until the end of this year. The judge is looking for a more accurate “census” of the cases that are being pursued, whether they are pending in federal court, state court, or have yet to be filed. This desire for a “more accurate census” seems to jive with what I have been saying: a global resolution to settle the NuvaRing cases may get done in 2013.
If you or a loved one has been injured by a NuvaRing you need to talk to someone quickly because your rights may be expiring very quickly. Contact us at 1.800.553.8082 or online here. We can tell you the latest 411 on the these claims and help you figure out if you should bring a suit.
- NuvaRing | Are we close to a settlement?
- Punitive Damages – Go for it!
- What is the NuvaRing and What Damages Can it Cause?