Articles Posted in Featured Lawsuits

pradaxa maker fine

Boehringer Ingelheim hit with a million dollar fine

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.

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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 that could lead to a substantial jury award.  So the stakes are high.  (The Humira claims are rarely involving HIV patients and infections, to be precise.  But the point is a large verdict, and Humira will set off the Pavlovian dogs.)

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da vinci recall

Da Vinci Recall

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.

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stryker rejuvinate claims

The number of lawsuits nears 1,000

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 will intensify.  This post talks about where these cases are going and makes a prediction of how and when these cases will settle.

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pradaxa reversal agent

Could a Pradaxa reversal agent be approved soon?

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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da vinci robot problems

Problems on the increase

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 believe they will try to put together a global settlement that will resolve more than just the cases with pending trial dates.  But in the meantime, Bard will 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 will settle.

avaulta vaginal mesh lawsuitsBard is not only fighting the new cases, it is fighting the battles it has already lost.  The most recent battle was a verdict against the company for over $1.4 million.

Bellwether Verdict

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, the 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.

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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. vaginal mesh bellwetherAmerican 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 multi-district 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

da vinci robot settlements

NoteGreat technology… if it works

Victims and attorneys have been complaining about da Vinci robotic surgery pr0blems and have made their voice heard by filing lawsuits.  The financial exposure of these suits is, I’m sure, a concern of Intuitive Systems.  But, I think the voices they listen to the most are those on Wall Street.

What is Wall Street saying?  There is a concern now that all of these complications with these da Vinci robots are not yet baked into Intuitive System’s stock price which, despite a surge today,  has already taken a beating this year.

These robots are not being purchased or bragged about by hospitals as they have been just last year.  The company has blamed the drop in sales on the lack of hospital dollars for new technologies.

But so far this year, there have been 4,603 adverse event records that have been posted for da Vinci.  Sure, it is a big country.  But let’s put this in context.  There were 4603 reports about this technology over the last 12 years.

It gets worse.  In August, the number of injury or death events rose to 103, which is the triple that of any other month.

Wall Street is a bit slow in figuring all of this out, but now it is asking the same question lawyers have been asking for a few years.
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