BOOMSAUCE !!!

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Vaginal Mesh Litigation

According to court documents, Ethicon is named a defendant in more than 30,000 transvaginal mesh lawsuits pending in courts nationwide, including more than 21,000 that have been filed in the Southern District of West Virginia. Jeffrey S. Grand, a partner with Bernstein Liebhard LLP, is serving on the Plaintiffs' Steering Committee for the federal Ethicon proceeding. (in re:Ethicon)(in re:Inc.)(in re:pelvic Repair Systems Products Liability Litigation - MDL No. 2327)

Court records indicate that Ethicon has lost two other transvaginal mesh cases that have gone to trial on the state level. In March 2013, a New Jersey Superior Court jury awarded more than $11 million in compensatory and punitive damages to a woman who was injured by the Gynecare Prolift device. Mr. Grand is currently serving as Co-Liaison Counsel in the Ethicon mesh litigation underway in New Jersey, and was a member of the Plaintiff's trial team. (Gross v. Gynecare Inc., Atl-L-6966-10)

In April 2014, juror hearing a case in Texas awarded $1.2 million to another victim of TVT-O mesh. (Batiste v. McNabb, No. 12-14350, District Court for the 95th Judicial District, Dallas County Texas)
 












Anonymous said:
Reasons Behind Intuitive Surgical's Financial Disturbances And Growth Opportunities 10/21/2014


Summary

1. This year so far, Intuitive Surgical hasn't managed to keep up with its usually excellent financial performance. Revenue, net income and EPS suffered a year-on-year decrease.

2. The company has had to face a lot of negative publicity, along with significant costs, owing to a number of lawsuits that had been filed against it.

3. There has been a growing concern lately around whether robotic surgery is even essential for certain procedures. Intuitive has reported there are over 76 product Liability lawsuits currently pending against them.

REF: The whole article


Negative publicity due to lawsuits:

ISRG has had to face a lot of negative publicity, along with significant costs, owing to a number of lawsuits that had been filed against it. In a report filed with the Securities and Exchange Commission in February, the company revealed that it was named as a defendant in around 76 product liability lawsuits. On April 8, the company announced that a total of $67 million charge was made against its earnings in 2014 to settle an "unspecified" number of product liability lawsuits. This amount is a significant amount as compared to its net income for the second quarter, which was $140 million. This negative publicity, along with the significant costs that the company had to incur as a result of these lawsuits led to a deterioration in its overall performance.
Its sales have also been impacted:

Lately, there has been a growing concern regarding whether robotic surgery is even essential for certain procedures. The American Congress of Obstetricians and Gynecologists raised concerns regarding the limited expertise available for the operation of da Vinci Systems, and that the surgeons learning how to operate this technology may have higher complication rates. Apart from this, concerns regarding the cost-effectiveness of the technology were also raised. According to critics, there are more cost-effective alternatives to minimally invasive surgery that can be chosen over the extremely costly da Vinci Systems. These factors, combined with the impact of the Affordable Care Act on the spending priorities of hospitals in the U.S. have been significantly affecting the company's overall sales. Sales fell, as a result of which it saw an 11.5% y-o-y decline in revenues. The revenue from Instruments and Accessories fell from $265 million in 2013 to $213 million in 2014, while Systems revenue fell from $216 million in 2013 to $144 million in 2014. The Services segment was the only one that saw an increase in revenue of around 9% from the same quarter in the previous year. The second-quarter operating income operating income decreased to $143 million from $219 million in the second quarter of 2013. This fall in sales, therefore, means a fall in the overall revenue generation of the company, leading to all the financial problems mentioned earlier. For ISRG to be able to increase its sales once again, it is of paramount importance that it expands to new markets.
Click to expand...

This same type of article is always written at least once/year. You can look on this site and find them all, and we've always rebounded. Will we hit $600 again? Doubtful. Here's why, Intuitive has grown at the pace of a successful start-up. Once all the hospitals finally acquired systems, the company growth finally leveled off a bit, and now we grow like most typical established large companies. We were growing at an average of 30% every year...show me another large established company that has that growth! It's unrealistic to assume we would grow like that once we penetrated so much of the market.
Look at Apple's stock it is very similar to Intuitive's highs and lows. You think they're going anywhere??
Intuitive and robotic surgery isn't going anywhere. Will it have record year growth again, no way. A big reason for getting JA out was that JA was a barbarian...Intuitive loved calling themselves barbarians. Now that business has leveled off, we are bureaucrats...it's hard for everyone at the top to stomach that. This is why the culture needs an overhaul.
Like one of the other posters said, if robotics was so dangerous and unsafe, don't you think every existing robotic surgeon would quit for liability purposes?? We're still training new surgeons everyday...
 






"Like one of the other posters said, if robotics was so dangerous and unsafe, don't you think every existing robotic surgeon would quit for liability purposes?? We're still training new surgeons everyday..."


Then why would Intuitive say this, "after an extended mediation process with plaintiffs’ counsel, it “determined that in light of the costs and risks of litigation, settlement of certain claims is appropriate.” It said its estimate is based on negotiations with plaintiffs’ counsel covering about 3,000 claims submitted beginning in October 2012.".... LexisNexis

To date that's 77 million dollars and climbing... All for a defect you people seem to blame on the doctors...
 






Anonymous said:
"Like one of the other posters said, if robotics was so dangerous and unsafe, don't you think every existing robotic surgeon would quit for liability purposes?? We're still training new surgeons everyday..."


Then why would Intuitive say this, "after an extended mediation process with plaintiffs’ counsel, it “determined that in light of the costs and risks of litigation, settlement of certain claims is appropriate.” It said its estimate is based on negotiations with plaintiffs’ counsel covering about 3,000 claims submitted beginning in October 2012.".... LexisNexis

To date that's 77 million dollars and climbing... All for a defect you people seem to blame on the doctors...
Click to expand...

I don't understand how your rebuttal justifies anything. Just b/c they reserve $77M to settle suits, doesn't mean they're accepting fault. I'm not saying that the issues w/ the MCS don't justify law suits, but the majority of the suits are probably surgeon error. How much did Ethicon reserve for all of their mesh lawsuits? If the robot was that bad, the FDA would have forced a mandatory recall on the robot.
 






Anonymous said:
I don't understand how your rebuttal justifies anything. Just b/c they reserve $77M to settle suits, doesn't mean they're accepting fault. I'm not saying that the issues w/ the MCS don't justify law suits, but the majority of the suits are probably surgeon error. How much did Ethicon reserve for all of their mesh lawsuits? If the robot was that bad, the FDA would have forced a mandatory recall on the robot.
Click to expand...

You say, "the majority of the suits are probably surgeon error." Why would Intuitive settle? And why would any doctor use Da vinci knowing they are going to blamed by the manufacture.

Intuitive's not going to have the luxury of arguing both side of the coin in the forthcoming litigation. When the manufacturers start blaming the customers, the customers will soon stop being customers don't you think? hell, wouldn't you?

Another question Intuitive is unable to answer is, "why are all these doctors making the same mistakes"? I believe this ship is sinking and once a celebrity or politician, or politicians family gets hurt with one of these machines we will see congressional hearing.

Now, let me address this simple minded and naive claim submitted by the previous poster.
This stupid bitch keeps asking, "If the robot was that bad, the FDA would have forced a mandatory recall on the robot". Lets hears what the educated people say about that.


Dear (Friend),

Thanks for your note and for trying to help your friend. I don’t know if you saw me quoted in the NY Times a while ago regarding the Da Vinci system, which research shows has a much higher rate of causing problems than has been reported. Apparently, surgeons don’t like to report problems with the Da Vinci system because they are afraid they will be blamed, and since the reporting system is voluntary for physicians, they don’t have to report. I can also tell you that the FDA never required any testing on human beings before they allowed the system to be sold. Instead, it was cleared for the market as “substantially equivalent” to scalpels and other surgical tools that were not part of a robotic system – which is obviously not an appropriate standard.

I can tell you is that the inadequate testing of potentially dangerous medical devices is the fault of Congress and companies like Intutitve, which have repeatedly pressured the FDA to not require human testing because it is too “burdensome” for device companies. (And Congress, in turn, gets lots of donations from device companies.) If you or others you know think this is outrageous, I can help you have your voices heard to try to turn this situation around. I hope you will consider joining our efforts, because until this situation is changed, millions of patients will continue to be harmed.

Sincerely,

Diana Zuckerman, Ph.D.
President
National Center for Health Research is our new name!
Formerly National Research Center for Women & Families
Cancer Prevention and Treatment Fund is our major program
1001 Connecticut Ave., NW, Suite 1100
Washington, DC 20036
202 223-4000


Call her and ask her, I did.



Lets see its about money honey...

.....(And Congress, in turn, gets lots of donations from device companies.)
 






... "FDA inspection between April 1 and May 30 at the company’s Sunnyvale, California production facility. Investigators reportedly found that in several cases Intuitive Surgical sent out field correction letters to doctors and hospitals in order to correct or prevent da Vinci problems. Federal regulations require that the FDA be informed within 10 working days of such a notification, but the FDA investigators say the agency got no such notifications.

One of the notifications appears to show that Intuitive Surgical knew that the da Vinci had problems with electricity arcing from the tools as early as October 2011. The FDA says that at that time the company have initiated a field correction by sending letters on the proper use of the Tip Cover Accessory and that generators should be used with the robot’s monopolar instruments. According to the agency, the company sent out the letters in response to complaints and medical device reports (MDRs) that doctors had experienced electrical arcing through damaged tip covers that resulted in patient injuries."
-
 






Hmm there's more...


"That appears to contradict statements the company made in a prior da Vinci robot recall issued earlier this year, when Intuitive Surgical announced that it was replacing some of its monopolar scissors, known as “hot shears” because they may be prone to develop microfractures that allow electrical arcing. At that time, the company implied it was unaware of any injuries associated with the defective da Vinci hot shears caused by electrical arcing.

According to a report in June, Intuitive Surgical received at least 1034 complaints and 802 MDRs involving the problem just between January 2010 and December 2012.

The FDA also indicated that Intuitive Surgical sent a notice to clients in October 2011 about issues with use of the da Vinci robot for thyroidectomy, indicating that the device was not cleared for that indication after the manufacturer received at least 103 complaints and filed 50 MDRs related to thyroidectomies with da Vinci robots between July 2009 and October 2011. This action was also not reported to the FDA, according to the letter.

That same month the company issued a third field correction letter instructing da Vinci users on proper inspection of instrument cannulas and proper flushing of the instruments and transporting the da Vinci from one facility to another.

A fourth letter was sent out by Intuitive Surgical in January 2013, changing the user manual to warn surgeons not to use the da Vinci on certain types of patients, including children. The FDA letter notes that had it known about the field corrections it would have considered the actions class II da Vinci surgical robot recalls because they all involved reducing or preventing a health risk posed by the surgical robot."
-
 






Anonymous said:
Hmm there's more...


"That appears to contradict statements the company made in a prior da Vinci robot recall issued earlier this year, when Intuitive Surgical announced that it was replacing some of its monopolar scissors, known as “hot shears” because they may be prone to develop microfractures that allow electrical arcing. At that time, the company implied it was unaware of any injuries associated with the defective da Vinci hot shears caused by electrical arcing.

According to a report in June, Intuitive Surgical received at least 1034 complaints and 802 MDRs involving the problem just between January 2010 and December 2012.

The FDA also indicated that Intuitive Surgical sent a notice to clients in October 2011 about issues with use of the da Vinci robot for thyroidectomy, indicating that the device was not cleared for that indication after the manufacturer received at least 103 complaints and filed 50 MDRs related to thyroidectomies with da Vinci robots between July 2009 and October 2011. This action was also not reported to the FDA, according to the letter.

That same month the company issued a third field correction letter instructing da Vinci users on proper inspection of instrument cannulas and proper flushing of the instruments and transporting the da Vinci from one facility to another.

A fourth letter was sent out by Intuitive Surgical in January 2013, changing the user manual to warn surgeons not to use the da Vinci on certain types of patients, including children. The FDA letter notes that had it known about the field corrections it would have considered the actions class II da Vinci surgical robot recalls because they all involved reducing or preventing a health risk posed by the surgical robot."
-
Click to expand...

Don't let the facts get in the way of your fucking ass-sauce, ops boomsauce
 












Anonymous said:
down again... third straight day after the Q3 report.

short this bitch....


NASDAQ: ISRG - Oct 27 1:12 PM ET
475.76 -2.25 (-0.47%)
Click to expand...


Investors Buy Intuitive Surgical on Weakness Following Insider Selling (ISRG)
Director Floyd D. Md Loop sold 15,209 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The stock was sold at an average price of $475.71, for a total value of $7,235,073.39


More rats jumping ship we see.

http://www.sec.gov/Archives/edgar/data/1035267/000103526714000105/xslF345X01/edgardoc.xml
 






there seems to be a pattern here:


Intuitive Surgical (NASDAQ:ISRG)

SVP Colin Morales sold 4,105 shares of the company’s stock in a transaction that occurred on Tuesday, August 26th. The stock was sold at an average price of $478.66, for a total value of $1,964,899.30. Following the sale, the senior vice president now directly owns 102 shares of the company’s stock, valued at approximately $48,823.


SVP Salvatore Brogna who unloaded 12,626 shares of Intuitive Surgical stock on the open market in a transaction that occurred on Tuesday, September 2nd 2014. The stock was sold at an average price of $472.06, for a total transaction of $5,960,229.56.

EVP Jerome J. Mcnamara sold 15,000 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The shares were sold at an average price of $473.76, for a total value of $7,106,400.00. Following the transaction, the executive vice president now directly owns 2,849 shares of the company’s stock, valued at approximately $1,349,742.

Director Floyd D. Md Loop sold 15,209 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The stock was sold at an average price of $475.71, for a total value of $7,235,073.39.


Damn, everybody is selling... I bet they know something is coming.
 






Anonymous said:
there seems to be a pattern here:


Intuitive Surgical (NASDAQ:ISRG)

SVP Colin Morales sold 4,105 shares of the company’s stock in a transaction that occurred on Tuesday, August 26th. The stock was sold at an average price of $478.66, for a total value of $1,964,899.30. Following the sale, the senior vice president now directly owns 102 shares of the company’s stock, valued at approximately $48,823.


SVP Salvatore Brogna who unloaded 12,626 shares of Intuitive Surgical stock on the open market in a transaction that occurred on Tuesday, September 2nd 2014. The stock was sold at an average price of $472.06, for a total transaction of $5,960,229.56.

EVP Jerome J. Mcnamara sold 15,000 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The shares were sold at an average price of $473.76, for a total value of $7,106,400.00. Following the transaction, the executive vice president now directly owns 2,849 shares of the company’s stock, valued at approximately $1,349,742.

Director Floyd D. Md Loop sold 15,209 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The stock was sold at an average price of $475.71, for a total value of $7,235,073.39.


Damn, everybody is selling... I bet they know something is coming.
Click to expand...

Lets not forget about this one:

CFO Marshall Mohr unloaded 2,500 shares of Intuitive Surgical stock in a transaction dated Monday, October 27th. The stock was sold at an average price of $473.50, for a total transaction of $1,183,750.00. Following the transaction, the chief financial officer now directly owns 1,383 shares of the company’s stock, valued at approximately $654,851
 


















Anonymous said:
there seems to be a pattern here:


Intuitive Surgical (NASDAQ:ISRG)

SVP Colin Morales sold 4,105 shares of the company’s stock in a transaction that occurred on Tuesday, August 26th. The stock was sold at an average price of $478.66, for a total value of $1,964,899.30. Following the sale, the senior vice president now directly owns 102 shares of the company’s stock, valued at approximately $48,823.


SVP Salvatore Brogna who unloaded 12,626 shares of Intuitive Surgical stock on the open market in a transaction that occurred on Tuesday, September 2nd 2014. The stock was sold at an average price of $472.06, for a total transaction of $5,960,229.56.

EVP Jerome J. Mcnamara sold 15,000 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The shares were sold at an average price of $473.76, for a total value of $7,106,400.00. Following the transaction, the executive vice president now directly owns 2,849 shares of the company’s stock, valued at approximately $1,349,742.

Director Floyd D. Md Loop sold 15,209 shares of the company’s stock on the open market in a transaction that occurred on Monday, October 27th. The stock was sold at an average price of $475.71, for a total value of $7,235,073.39.

CFO Marshall Mohr unloaded 2,500 shares of Intuitive Surgical stock in a transaction dated Monday, October 27th. The stock was sold at an average price of $473.50, for a total transaction of $1,183,750.00. Following the transaction, the chief financial officer now directly owns 1,383 shares of the company’s stock, valued at approximately $654,851


Damn, everybody is selling... I bet they know something is coming.
Click to expand...


Here is a claim from the City of Birmingham (Ala.) Relief and Retirement System that sued the company's nine-member board of directors and its chief financial officer, alleging unjust enrichment and breach of fiduciary duty.

The shareholders claim that defendants CEO Gary Guthart, CFO Marshall Mohr and Chairman of the Board Lonnie Smith knew that "Intuitive's long run of fraudulently concealing 'adverse events' from the MAUDE system was about to come to an abrupt end" and sold thousands of shares of stock from Feb. 6, 2012 to July 18, 2013, for almost $113 million.


Intuitive is facing at least 76 (now 93 individual product liability lawsuits filed in various state and federal courts by plaintiffs who allege that they or a family member underwent surgical procedures that utilized the da Vinci Surgical System product liability lawsuits),
lawsuits from its insurers and a securities fraud class action, the complaint states.

The Courthouse News database
 


















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