PATTEN v. GAYLE
CHARLOTTE M. PATTEN, ET AL., Plaintiff-Appellant,v.CHRISTOPHER GAYLE, M.D., Defendant-Appellee.
No. 46,453-CA.
Court of Appeals of Louisiana, Second Circuit.
June 22, 2011.
NELSON & HAMMONS, A Professional Law Corporation, John L. Hammons, James Paul Lambert, Annis Cornell Flournoy, Counsel for Appellant.
WATSON, BLANCHE, WILSON & POSNER, Peter T. Dazzio, Garrett S. Callaway, Counsel for Appellee.
Before GASKINS, PEATROSS and DREW, JJ.
--------------------------------------------------------------------------------
DREW, J.:
The primary issue is whether the jury erred in finding the doctor's negligence during surgery did not cause any injury to the patient. Charlotte Patten and her husband, Rodney L. Patten, appeal the judgment rejecting their demands and dismissing the action with prejudice. They also seek review of the trial court's denial of their motion for judgment notwithstanding the verdict ("JNOV"). For the reasons discussed herein, the judgment1 is reversed in part and affirmed in part and rendered, awarding plaintiffs a portion of the damages sought.
FACTUAL AND PROCEDURAL BACKGROUND
Charlotte Patten became a patient of Dr. Christopher Gayle, an OB-GYN at Willis-Knighton Pierremont, in 1997 when Dr. Gayle performed a total abdominal hysterectomy, leaving her ovaries in place. In early 2001, Mrs. Patten began suffering from pain in her lower right abdomen which Dr. Gayle suspected was a cystic lesion on her right ovary. On August 14, 2001, at Willis-Knighton Pierremont, Mrs. Patten was admitted for laparoscopic2 evaluation and possible removal of her ovaries.
Dr. Gayle, assisted by Dr. Mary Taylor, began the procedure by inflating the abdominal cavity with carbon dioxide in order to create space between the abdominal wall and internal organs. Once the cavity was inflated, Dr. Gayle inserted an operative trocar3 through the umbilicus.
The operative trocar blade is covered with a protective sheath. When the doctor applies pressure to the trocar, the blade is unsheathed, allowing the trocar to penetrate the skin, muscle, and fascia. Once the trocar encounters "empty space" in the body cavity, the sheath re-covers the blades and locks in place. Since the initial trocar insertion is performed blind, most laparoscopic injuries occur during this part of the procedure.4 In this case, Dr. Gayle inserted the first trocar without complication.
After removing the blade from the trocar tube, Dr. Gayle inserted a laparoscope into this first trocar to allow him to see the inside of the abdominal cavity. Dr. Gayle noted adhesions of the small bowel to the abdominal wall. Because he was unable to determine whether he would be able to proceed laparoscopically, Dr. Gayle intended to insert a second trocar so he could better visualize the ovaries and abdominal cavity.
After using the laparoscope in the first trocar to find an area that was free of adhesions, Dr. Gayle testified he tried to angle the second trocar so it would enter the abdominal cavity in a particular direction. The second trocar unexpectedly entered the patient's abdomen. The doctor claimed the amount of force he applied should not have been sufficient for the trocar to enter the abdomen. The second trocar entered the abdomen in a different direction than Dr. Gayle intended and came out near a bowel adhesion.
Although Dr. Gayle could see the tip of the trocar, he could not determine whether the trocar had penetrated or avoided the bowel. Dr. Gayle left the second trocar tube in place but removed the blade. He then inserted a third trocar (without incident) and placed the laparoscope into the third trocar to evaluate the bowel. Dr. Gayle observed no bleeding or bowel content but was still unable to determine whether the bowel had been punctured.
Dr. Gayle decided he needed to open the patient's abdomen because there were numerous adhesions of the bowel to the abdominal wall. The doctor also concluded that the right ovary, which was cystic and densely adhered to the pelvic wall, needed to be removed, a procedure that could not be performed laparoscopically. Finally, he was still concerned about the possibility of bowel injury by the second trocar.
After making a Pfannenstiel incision5 and lysing6 some of the adhesions of the bowel from the abdominal wall, Dr. Gayle saw the second trocar had penetrated Mrs. Patten's small bowel "through and through." Dr. Gayle brought approximately 20 inches of bowel out of the abdominal cavity and called for Dr. Craig Bozeman, a general surgeon, to perform emergency surgery to remove the trocar7 and repair the bowel.8
Dr. Bozeman decided to connect the two holes to facilitate the surgical repair. He did so by cutting across the circumference of the bowel between the two holes. After sewing up the bowel, Dr. Bozeman "ran the bowel"9 to inspect it and found the repair was effective (not leaking) and that no further injuries could be seen. Dr. Gayle and Dr. Taylor then finished the surgery by removing Mrs. Patten's right ovary, placing the bowel back inside the abdomen and closing the incisions.
After the operation, Mrs. Patten was kept under observation by Dr. Bozeman to ensure her bowel was causing no further problems. Over the next few days, she showed some signs of improvement in her gastrointestinal functions but also had indications of trouble, most notably swelling. Five days after the operation, Mrs. Patten was examined by Dr. Schwalke, who was on call for Dr. Bozeman. That morning, Mrs. Patten's abdomen was distended. Later that day, feculent material began exuding from her incision.
Dr. Schwalke performed emergency exploratory surgery, which required him not only to reopen her horizontal incision but to make a vertical "midline" incision up to the sternum. He discovered a 3mm perforation of the bowel two inches from where the bowel had been repaired by Dr. Bozeman five days earlier. Also, approximately three liters of feculent material was in Mrs. Patten's abdominal cavity, necessitating extensive cleaning and drainage.
As a result of the feculent material having leaked into her abdominal cavity, Mrs. Patten developed peritonitis (an abdominal infection) and pneumonia. She was hospitalized until August 30. Mrs. Patten has subsequently suffered from abscesses (some of which ruptured) and herniating of her incisions, both of which have required further surgeries, and additional medical problems.
On June 6, 2002, Mrs. Patten and her husband filed a petition for a medical review panel against Dr. Gayle, Dr. Taylor, and Dr. Bozeman. The Pattens alleged negligence against the three doctors with respect to the August 14 surgery performed by Dr. Gayle and Dr. Taylor, in which Mrs. Patten's bowel was penetrated by a trocar, and Dr. Bozeman's emergency surgical repair.
The medical review panel (composed of Dr. Daniel Carroll, Dr. Edwin Byrd, and Dr. Timothy Hart) ruled that the evidence did not support the conclusion that Dr. Gayle, Dr. Taylor, or Dr. Bozeman failed to meet the applicable standards of care. Specifically, the panel found no evidence indicating the perforation discovered by Dr. Schwalke was present on August 14 and missed by Dr. Bozeman during his repair. The panel concluded that this perforation was most likely the result of undetectable microvascular damage that was unrelated to the trocar injury. Further, the panel opined that Dr. Gayle did not "lose control" of the trocar because there are many factors10 outside of the surgeon's control that can affect the passage of the trocar through the abdomen.11
On February 6, 2004, Mrs. Patten, together with her husband, filed a medical malpractice suit against Dr. Gayle.12 Following a four-day jury trial on the merits in May 2010, the jury returned a verdict that Dr. Gayle had deviated from the applicable standard of care and had committed malpractice.13 The jury, however, found Dr. Gayle's negligence had not caused any injury that would otherwise not have been incurred by Mrs. Patten. Finding a lack of causation, the jury awarded no damages to Mrs. Patten or her husband. At the request of counsel, the jury was polled, revealing the jury was split 10-2.
Following entry of the judgment denying plaintiffs' recovery and dismissing the action at their cost, Mrs. Patten and her husband moved for a JNOV, arguing the jury's finding that Dr. Gayle's negligence caused no injuries was manifestly erroneous. Following a hearing, the trial court denied the motion, finding the jury's verdict was reasonable, and entered judgment accordingly on August 27, 2010.
Mrs. Patten and her husband appealed, arguing: (1) the jury manifestly erred in finding a lack of causation; (2) the trial judge manifestly erred in denying the motion for JNOV; and (3) the jury erred in failing to award damages.
DISCUSSION
In a medical malpractice action, the plaintiff has the burden of proving: (1) the applicable standard of care, (2) that the standard of care was breached, and (3) that as a proximate result of the breach the plaintiff sustained injuries that would not otherwise have been incurred. La. R.S. 9:2794(A). The third element, causation, is subject to the manifest error standard of review. Lovelace v. Giddens, 31,493 (La. App. 2d Cir. 2/24/99), 740 So.2d 652, writ denied. Under the manifest error standard, an appellate court cannot substitute its own inferences and conclusions about the facts. Johnson v. Morehouse GeneralHosp., 2010-0387 (La. 5/10/11), 2011 WL 1759932; Wooley v. Lucksinger, 2009-0571 (La. 4/1/11), 2011 WL 1205136. Findings of fact cannot be set aside or overturned by the appellate court unless they are clearly wrong. Johnson, supra. Factual conclusions are not clearly wrong when the factfinder chooses a view of the evidence that an appellate court disagrees with as long as the factfinder's view is permissible. Id. Manifest error occurs only when there is "no reasonable factual basis for the [factfinder's] conclusion[.]" Johnson, 2010-0387 at p. 6. In a medical malpractice claim, great deference should be given to the factfinder when medical experts express different opinions relevant to causation. Lovelace, supra.
Initial Trocar Injury
While recognizing that Mrs. Patten suffered injuries, the Medical Review Panel unanimously found that Dr. Gayle was not negligent. In its written reasons, the panel stated there were other factors outside of Dr. Gayle's control that could have caused the second trocar to become misdirected, including scarring of the abdominal wall, defects from her prior surgeries and differences in the degree of sharpness of trocars.
Dr. Robert Zurawin, a board-certified OB-GYN and an associate professor at Baylor Medical School, testified by affidavit, deposition, and at trial on behalf of Mrs. Patten. Disagreeing with the medical review panel, Dr. Zurawin believed Dr. Gayle was negligent. Dr. Zurawin stated the factors mentioned by the review panel were relevant only to a blind trocar insertion. Since Dr. Gayle had already inserted one trocar, he should have been able to see (and thus avoid) any problems inside the abdominal cavity. At trial, Dr. Zurawin testified the trocar must have penetrated bowel that was adhered to the abdominal wall. Otherwise the protective sheath would have covered the blade after entering the abdomen and the through-and-through puncture never would have occurred.
Dr. Zurawin also noted that Dr. Gayle had apparently been holding the second trocar improperly. In his deposition, Dr. Gayle indicated he was not yet holding the second trocar in the proper position when it penetrated the abdomen. Dr. Zurawin testified the way Dr. Gayle was holding the trocar contributed to the trocar penetrating the abdomen without Dr. Gayle intending it to as well as how deep it penetrated. Further, Dr. Zurawin believed the second trocar should never have been inserted because Dr. Gayle should have converted to an open surgery once he saw the numerous, dense adhesions through the laparoscope in the first trocar.
Dr. Gayle admitted the puncture of the bowel by the second trocar was an injury. In his original answer to the complaint, Dr. Gayle stated that Dr. Bozeman was called in for "repair of a bowel injury." Moreover, at trial, Dr. Gayle admitted on cross-examination that Mrs. Patten "was injured and she suffered as a result of that injury[.]" Dr. Gayle claimed that the trocar injury was insignificant as far as the medical malpractice claim was concerned.
Dr. Gayle relied upon the testimony of Dr. Taylor, Dr. Schwalke, and Dr. Byrd, each of whom testified the initial bowel injury from the second trocar was insignificant. Both Dr. Taylor and Dr. Byrd testified the only harm done to Mrs. Patten was having approximately an extra hour of surgery by Dr. Bozeman to repair the bowel. Dr. Schwalke testified similarly, stating the injury was insignificant because it was immediately recognized and repaired and there were no further damages resulting from that injury.
Dr. Gayle also relied upon two consent forms that Mrs. Patten signed prior to the surgery. When obtaining consent from a patient for any treatment or procedure, physicians have a duty to advise the patient of associated risks. Roberts v. Cox, 28,094 (La. App. 2d Cir. 2/28/96), 669 So.2d 633; Broadway v. St. Paul Ins. Co., 22,433 (La. App. 2d Cir. 1991), 582 So.2d 1368. A physician does not have to inform a patient of "every conceivable possibility" but only "those that can reasonably be anticipated." Steinbach v. Barfield, 428 So.2d 915 (La. App. 1st Cir. 1983) (reversed on other grounds); see also, Roberts, supra; Broadway, supra.
A risk of bowel injury was among the risks listed on the consent forms signed by Mrs. Patten. Dr. Hart testified at trial that this risk would include bowel injury due to a misdirected trocar. Dr. Hart also testified, however, that a patient never consents to negligent treatment. This court agrees. Consent forms should not shield physicians and other healthcare providers from liability for injuries caused by their negligence simply because the injuries are a known risk of the procedure. While patients can be held to reasonably anticipate that procedures carry certain risks that may occur without any fault from their physician, patients should also reasonably anticipate a physician will not negligently injure them. Being injured as a result of negligence by one's physician is not a reasonably foreseeable risk of receiving medical treatment.
The through-and-through perforation of Mrs. Patten's bowel was undoubtedly an injury. Downplaying the significance of the injury is a defense to damages but not a defense to the injury actually having occurred. The two consent forms signed by Mrs. Patten do not exonerate Dr. Gayle for negligently injuring her by puncturing her bowel with the second trocar. Therefore, the jury's finding that Dr. Gayle's negligence caused no injury to Mrs. Patten is manifestly erroneous with respect to the trocar's penetration of the bowel. As a result, this court reviews the merits of this issue de novo.
De Novo Review of the Merits — Initial Trocar Injury
Dr. Gayle negligently punctured Mrs. Patten's bowel with a trocar, necessitating the emergency repair by Dr. Bozeman. According to Dr. Gayle, aside from the repair of the punctured bowel, all other surgical steps taken on August 14 would have been required even if there had been no bowel injury.
First, Dr. Gayle stated in his deposition that Mrs. Patten had to be "opened up" in order to remove her ovary. Therefore, the decision to open her abdomen would have been made even if there were no bowel injury. This view was shared by Dr. Taylor. Even Dr. Zurawin agreed, stating in his affidavit that Mrs. Patten should have been opened up after Dr. Gayle viewed Mrs. Patten's numerous abdominal adhesions through the laparoscope in the first trocar.
Second, Dr. Gayle testified the bowel adhesions had to be lysed from the abdominal wall in order to remove the right ovary. Both Dr. Schwalke and Dr. Hart agreed that lysing the adhesions would have been necessary without the trocar injury. Moreover, even had the trocar injury been the sole reason for lysing the bowels, Dr. Zurawin testified that Dr. Gayle did not breach the applicable standard of care by lysing the bowel adhesions to prepare for the surgical repair of the bowel injury by Dr. Bozeman.
Third, Dr. Zurawin stated in his deposition that it is within the applicable standard of care to run the bowel after lysing any bowel adhesions to ensure it has not been injured. Therefore, the bowel would necessarily have been run whether or not the trocar repair was performed.
Fourth, Dr. Gayle stated in his motion in limine to exclude medical expenses that, even without the trocar injury, Mrs. Patten would have stayed in the hospital a few days following the surgery for observation. Dr. Gayle stated this was necessary because having to lyse her bowel adhesions created a possibility of a perforation developing.
In contrast, Dr. Zurawin stated in his affidavit that, but for the trocar injury to the bowel, Mrs. Patten would not have undergone the repair procedure which placed her at a greater risk of a subsequent bowel perforation. However, Dr. Zurawin acknowledged that Dr. Gayle had to open Mrs. Patten up and lyse the bowel adhesions to complete his surgery whether or not there had been a bowel injury.
Aside from the repair of the through-and-through bowel puncture, all other treatments and steps taken (opening her up, lysing the adhesions, etc.) would have been necessary even had there been no bowel injury and therefore were not causally related to Dr. Gayle's negligence. The only injuries Mrs. Patten suffered on August 14, 2001, that were causally connected to Dr. Gayle's negligent handling of the second trocar and would not otherwise have been incurred are: (1) the puncture of the bowel; and (2) the time and expense of Dr. Bozeman repairing the bowel.
Subsequent Perforation
The cause of the subsequent perforation that was discovered by Dr. Schwalke five days after Mrs. Patten's first operation was the primary topic throughout this case. In Dr. Gayle's opinion, this subsequent perforation was most likely the result of a microvascular injury that was undetectable at the time of Dr. Bozeman's repair. The medical review panel had a similar opinion, finding the perforation was unrelated to the initial trocar injury and most likely the result of microvascular damage.
Dr. Zurawin stated in his affidavit that while the cause of the perforation was "not clear," he believed it was most likely caused directly by the second trocar striking a loop of bowel after making its through-and-through puncture. Dr. Hart, Dr. Bozeman, and Dr. Schwalke all testified that the trocar tip could have directly harmed another section of bowel, causing damage that eventually led to the subsequent perforation. Dr. Hart qualified his testimony, stating this scenario was highly unlikely.
Both Dr. Gayle and Dr. Taylor testified the trocar penetrated the abdomen in an area where there was an upside-down "U-shaped" section of bowel hanging from the abdominal wall. Thus, according to the only two people who saw the location of the bowel before Mrs. Patten was opened up, there was no other portion of bowel for the trocar to damage. Assuming the bowel was adhered in this position, Dr. Byrd testified it would have been "spectacular" for the tip of the second trocar to have directly injured another part of the bowel.
Moreover, the bowel was run and inspected by Dr. Bozeman after he repaired the initial puncture. This inspection was done in the presence of both Dr. Gayle and Dr. Taylor. Dr. Bozeman testified he examined a significant portion of the surrounding bowel. The perforation that was found five days later was only two inches from the repair site. Dr. Hart testified it would be almost impossible for Dr. Bozeman, Dr. Gayle, and Dr. Taylor all to have missed any visible injury to the bowel that was only two inches away from the site of the trocar puncture.
In addition, the opinion of the review panel was that the timeline indicated the perforation was not present on August 14. The panel opinion was supported by both Dr. Hart's and Dr. Schwalke's testimony that the perforation likely opened two or three days after Dr. Gayle's operation, based on when Mrs. Patten began having swelling problems and the amount of feculent material found in her abdominal cavity. Dr. Zurawin disagreed, stating in his deposition that a small perforation might have taken five days to manifest and therefore the timeline was not definitive.
In view of all the evidence presented, it seems unlikely the trocar tip directly caused damage to the bowel that led to the subsequent perforation. However, Mrs. Patten also presented evidence of another theory: that the trocar injury indirectly caused the perforation because it led to the bowel sustaining a partial thickness injury14 which ruptured in the days following Dr. Gayle's surgery. This partial thickness injury could have been caused either when the adhesions were lysed from the abdominal wall or when Dr. Bozeman was performing his repair of the initial trocar injury.
Dr. Carroll stated in his deposition that any partial thickness injury caused by Dr. Bozeman repairing and running the bowel should have occurred immediately adjacent to the original injury. Since the perforation was two inches away from the original injury, Dr. Carroll stated it was highly unlikely Dr. Bozeman's repair caused the perforation. Additionally, none of the medical experts who testified believed that either repairing or running the bowel indirectly caused the perforation
Dr. Schwalke testified that the most likely cause of the perforation was a partial thickness injury that occurred when the bowel adhesions were lysed from the abdominal wall. Both Dr. Hart and Dr. Byrd also agreed the cause of the perforation was most likely a partial thickness injury due to lysing adhesions. According to Dr. Gayle, the portion of bowel where the perforation occurred was adhered to the abdominal wall, making it more susceptible to a partial thickness injury. Dr. Bozeman testified that a partial thickness injury is a known risk of having to lyse bowel adhesions.
In his deposition, Dr. Zurawin stated it was within the applicable standard of care for Dr. Gayle to lyse the bowel adhesions. Dr. Zurawin also noted that it was unclear whether Dr. Gayle or Dr. Bozeman lysed the bowel that was two inches away from the trocar injury. Therefore, assuming the lysing of the bowel caused a partial thickness injury, it would be impossible to know to whom to attribute it. Moreover, even if the lysing caused an undetectable injury, Dr. Zurawin testified there would not have been a breach of any standard of care by Dr. Gayle.
The medical experts were in agreement that the bowel adhesions necessarily had to be lysed in order to remove Mrs. Patten's right ovary. Therefore, had no trocar injury ever occurred, the bowel adhesions would nonetheless have been lysed. This possibility was explicitly supported in the deposition testimony of all three members of the medical review panel (Dr. Byrd, Dr. Hart, Dr. Carroll) as well as the trial testimony of both Dr. Schwalke and Dr. Byrd.
Mrs. Patten had to be opened up and her adhesions had to be lysed. The evidence did not show that, more likely than not, the initial trocar injury was either a direct or indirect cause of the subsequent perforation and the resulting peritonitis and pneumonia which kept Mrs. Patten hospitalized until August 30, 2001. As Dr. Zurawin testified, the cause of this perforation is simply not clear "within a reasonable medical probability." Therefore, the jury finding no causation of damages with respect to the subsequent perforation is not manifestly erroneous.
Injuries Suffered by Mrs. Patten Since August 30, 2001
Mrs. Patten has suffered from many medical problems following her release on August 30, 2001, after recovering from peritonitis and pneumonia. She alleges that these subsequent injuries are traceable to Dr. Gayle's negligence. Among the injuries Mrs. Patten has suffered, according to her First Supplemental and Amending Petition:
abscesses . . . excruciating pain and suffering, mental anguish and embarrassment . . . extensive scarring, abdominal adhesions and extensive internal adhesions . . . and repeated surgical procedures[.]
Mrs. Patten also claims hernias of her incisions as an additional injury attributable to Dr. Gayle.
According to Mrs. Patten's own testimony, she had a history of abdominal pain and discomfort ever since the birth of her second child. Her first laparoscopic procedure was performed in 1993. She also had multiple abdominal surgeries performed prior to the surgery on August 14, 2001. As Dr. Zurawin stated in his deposition, the more surgeries a person has, the more likely she is to have bowel adhesions in the future that could lead to the injuries Mrs. Patten has suffered. Mrs. Patten also testified she had off-and-on undergone treatment for depression prior to Dr. Gayle's 2001 surgery.
In the months following the surgeries by Dr. Gayle and Dr. Schwalke, Mrs. Patten was treated by Dr. Bozeman for multiple abscesses of her surgical wounds. In his deposition, Dr. Bozeman stated these abscesses were likely not related to Mrs. Patten's peritonitis but rather a reaction to the sutures used by Dr. Schwalke.
In 2002, Mrs. Patten was treated by Dr. Charles Black for hernias of her incisions. Dr. Black's deposition was read at trial; he was unable to testify in person because he was suffering from health problems and subsequently died. In his deposition, Dr. Black stated that incisional hernias occur around 5% of the time even in the absence of negligence. Dr. Black further stated that, considering Mrs. Patten's history of abdominal surgeries, there was no reason to attribute her hernias in 2002 to either Dr. Gayle's or Dr. Schwalke's surgeries in 2001.
Dr. Dale McGinty treated Mrs. Patten for abdominal adhesions sporadically between 2005 and 2008. In his deposition, Dr. McGinty stated he had no reason to connect those adhesions to Dr. Gayle's surgery. Further, Dr. McGinty stated there was no way to know whether the adhesions he treated were caused by Dr. Gayle's surgery, any of Mrs. Patten's prior or subsequent abdominal surgeries.
Dr. Hart testified that hernias of the midline incision are traceable to Dr. Schwalke's surgery, as this was the first time such an incision had been made on Mrs. Patten. Hernias of any other incisions, though, are not necessarily connected to Dr. Gayle's surgery because any of Mrs. Patten's pre-2001 surgeries could have been the underlying cause.
After sitting on the medical review panel, Dr. Byrd testified in his deposition that it is hypothetically possible none of the injuries Mrs. Patten suffered are causally connected to Dr. Gayle. In other words, even had there been no trocar injury, it is possible that the subsequent bowel perforation would have occurred, that Mrs. Patten would develop an abdominal infection from the material leaking from the perforation, and that all of her hernias, abscesses, and adhesions might have occurred as anticipated risks of the surgeries performed by Dr. Gayle and Dr. Schwalke.
Having failed to show the subsequent perforation of her bowel was causally connected to Dr. Gayle's negligence, Mrs. Patten did not establish that injuries she has suffered since August 30, 2001, were caused by Dr. Gayle. Thus, the jury finding no causation of any damages with respect to Mrs. Patten's medical problems since August 30, 2001, is not manifestly erroneous.
Damages
The only injuries that Mrs. Patten has suffered as a result of Dr. Gayle's negligence are the puncture of her bowel by the second trocar and the time and expense of Dr. Bozeman repairing the bowel injury.
Dr. Gayle claimed the trocar injury itself was insignificant. Three medical experts (Dr. Taylor, Dr. Schwalke, and Dr. Byrd) also testified the injury was insignificant because it was immediately recognized, repaired, and no future harm resulted from it. Mrs. Patten presented no evidence showing the bowel injury from the second trocar caused any significant harm after its repair.
In his motion in limine to exclude certain medical expenses, Dr. Gayle argued the only medical expenses that were related to his August 14 surgery on Mrs. Patten are as follows: Dr. Gayle ($3,331.20); Willis-Knighton Pierremont ($18,546.85), Pierremont Anesthesia Consultants ($1,647.00), and Dr. Bozeman ($1,803.00), totaling $25,328.05.
Dr. Gayle's fee for the operation would have been incurred even without a bowel injury. Therefore, these expenses ($3,331.20) are not recoverable as damages.
Most of the expenses owed to Willis-Knighton Pierremont also would have been incurred even if there were no bowel injury. Some of the expenses, however, are causally connected to Dr. Gayle's negligence. Upon review of the Willis-Knighton medical bills, this court awards $1,726.00 owed to Willis-Knighton as damages attributable to Dr. Gayle negligently puncturing Mrs. Patten's bowel.
Mrs. Patten was placed under anesthesia for Dr. Gayle's surgery. However, additional anesthetic gases were necessary due to the extra time required for Dr. Bozeman to perform his repair. This court awards $1,281.00 in damages recoverable against Dr. Gayle for services performed by Pierremont Anesthesia Consultants.
The services performed by Dr. Bozeman were necessitated by the bowel injury and would not otherwise have been required. All expenses owed to Dr. Bozeman ($1,803.00) are causally connected to Dr. Gayle's negligence and recoverable as damages.
Accordingly, Mrs. Patten is awarded $4,811.00 in medical expenses attributable to injuries resulting from Dr. Gayle's negligence.
There is next the issue of general damages, such as pain and suffering, which cannot be definitively measured in monetary terms. See McGee v. A C and S, Inc., 2005-1036 (La. 7/10/06), 933 So.2d 770. Mrs. Patten claimed general damages for pain and suffering, mental anguish, disfigurement, and decreased quality of life. In closing arguments, counsel for plaintiff recommended general damages totaling $800,000 to Mrs. Patten as well as $250,000 to Mr. Patten for decreased quality of life and loss of consortium.
These claims all are connected to the perforation discovered by Dr. Schwalke and Mrs. Patten's subsequent medical problems, not the initial trocar injury. Because the jury did not manifestly err in finding Dr. Gayle's negligence was not the cause of the subsequent perforation, no general damages are warranted for these claims.
The claims for pain and suffering and mental anguish are compensable. While the majority of Mrs. Patten's pain and suffering and anguish are attributable to the subsequent perforation, the initial trocar injury also caused some general damages. Mrs. Patten testified at trial that the day of Dr. Gayle's surgery was her daughter's first day of school. Rather than going home that afternoon, as she expected, Mrs. Patten was hospitalized for a total of 16 days. When she awoke after the first surgery and was told by her husband that there was a problem, Mrs. Patten thought she had cancer. Mrs. Patten also testified she is now somewhat paranoid because Dr. Gayle was unable to explain what went wrong.
Accordingly, Mrs. Patten is awarded $10,000 in general damages for pain and suffering and mental anguish.
CONCLUSION
The portions of the final judgment concluding plaintiffs suffered no injuries from Dr. Gayle puncturing Mrs. Patten's bowel are manifestly erroneous and are reversed. Judgment is rendered awarding her special and general damages. In all other respects, the judgment is affirmed.
DECREE
The judgment of the trial court is REVERSED IN PART and AFFIRMED IN PART, and judgment is rendered in favor of appellants, awarding them the amount of $14,811.00. Appellee is cast with all costs of the appeal.
--------------------------------------------------------------------------------
Footnotes
--------------------------------------------------------------------------------
1. As a result of partially reversing the first judgment, consideration of the second judgment is unnecessary. The denial of the JNOV would, however, be affirmed and reversed along the same grounds.
Back to Reference
2. Laparoscopic surgery involves inserting small, hollow tubes, known as trocars, into the patient and operating by inserting scopes and instruments down the tubes. A small camera (laparoscope) can be inserted into these tubes for evaluation. Surgical instruments can also be inserted into trocars. A laparoscopy is a minimally invasive procedure because it does not involve "opening the patient up."
Back to Reference
3. An operative trocar is a trocar with a sharp blade at the tip. It is used for initial penetration of the trocar into the abdominal cavity.
Back to Reference
4. Dr. Robert Zurawin, medical expert for Mrs. Patten, testified that 95-98% of trocar-related injuries occur during insertion of the first trocar.
Back to Reference
5. A Pfannenstiel incision is a long horizontal abdominal incision, also called a "bikini" incision.
Back to Reference
6. Lysing is a term used to describe the detachment of bowel adhesions from the abdominal wall by cutting it with specialized surgical scissors.
Back to Reference
7. Dr. Gayle testified he left the trocar in place to allow Dr. Bozeman to remove it. Dr. Bozeman testified the trocar had already been removed when he arrived. This point is of no consequence to the disposition of this appeal.
Back to Reference
8. All medical experts and the medical review panel agreed that calling in a general surgeon for the purpose of repairing the bowel injury was within the applicable standard of care.
Back to Reference
9. Running the bowel is the inspection of the bowel by hand, moving it back and forth in one's hands, squeezing and applying pressure to check for leaks, bruises, cuts, and other damage.
Back to Reference
10. These factors explicitly included "fascial scarring or defects from prior surgery and differences in the degree of sharpness of disposable trocars." (Opinion of Medical Review Panel, p. 2)
Back to Reference
11. Members of the panel admitted to placing greater weight on Dr. Gayle's operative note than on his sworn deposition, in which he admitted to losing control "in a generic sense." (Deposition of Dr. Gayle, p. 67-68; Deposition of Dr. Hart, p. 18-19; Deposition of Dr. Carroll, p. 23)
Back to Reference
12. On October 23, 2007, Mrs. Patten amended her complaint and added Dr. Bozeman as a defendant. Dr. Bozeman filed peremptory exceptions of prescription and peremption, which were granted, and Dr. Bozeman was dismissed from the suit.
Back to Reference
13. Dr. Gayle has not contested this finding on appeal so we will not discuss the issue in depth.
Back to Reference
14. The bowel has multiple layers. A partial thickness injury is when some of the layers have been damaged. A partial thickness injury can later develop into a perforation due to pressure within the bowel.
http://www.leagle.com/xmlResult.aspx?page=2&xmldoc=In LACO 20110622396.xml&docbase=CSLWAR3-2007-CURR&SizeDisp=7
Thursday, June 30, 2011
Amniotic membrane transplant a viable treatment option for restrictive strabismus
Amniotic membrane transplantation should be considered when treating difficult cases of restrictive strabismus because it helps prevent adhesion recurrence, a study found.
"Because amniotic membrane has anti-inflammatory and anti-fibrosis characteristics, it may reduce secondary scarring and help prevent recurrence of restrictive strabismus and the diplopia and pain that often accompany this type of strabismus," the authors said.
The retrospective, interventional case series included eight eyes of seven consecutive patients who had developed restrictive strabismus after periocular surgery due to conjunctival scarring, fat adherence syndrome or rectus muscle contracture.
After failed additional standard surgery to remove the adhesions, patients underwent amniotic membrane transplantation.
Six of seven patients experienced improved ocular motility, with no recurrent scarring. Their motility remained stable for the 5- to 13-month follow-up period, according to the study.
One patient had recurrent scarring with persistent diplopia.
http://www.osnsupersite.com/view.aspx?rid=85142
"Because amniotic membrane has anti-inflammatory and anti-fibrosis characteristics, it may reduce secondary scarring and help prevent recurrence of restrictive strabismus and the diplopia and pain that often accompany this type of strabismus," the authors said.
The retrospective, interventional case series included eight eyes of seven consecutive patients who had developed restrictive strabismus after periocular surgery due to conjunctival scarring, fat adherence syndrome or rectus muscle contracture.
After failed additional standard surgery to remove the adhesions, patients underwent amniotic membrane transplantation.
Six of seven patients experienced improved ocular motility, with no recurrent scarring. Their motility remained stable for the 5- to 13-month follow-up period, according to the study.
One patient had recurrent scarring with persistent diplopia.
http://www.osnsupersite.com/view.aspx?rid=85142
Saturday, June 25, 2011
Seprafilm death goes unreported to FDA
I am Mrs. Heisner's daughter. I realize that this is not the proper forum to discuss what happened to my mother and our family. A proper forum would be in a court of law, however, because we have been denied that forum, I would like to take this opportunity to tell my mother's story and, by doing so, illustrate just how confused our legal system has become.
My mother died after experiencing what we suspect was a massive reaction to Seprafilm. Seprafilm is a class 3 medical device. It is a bioresorbable membrane manufactured and sold by Genzyme to prevent adhesions following surgery. It is absorbed into the body several days after being placed. My mother didn't ask that Seprafilm be placed in her nor did our family. During routine gynecological surgery, it was discovered that she had adhesions in her small bowel area and so the surgeons “took care of it” while they had her in the operating room. After removing the adhesions, Seprafilm was placed on her small bowel to prevent the formation of further adhesions. It appeared that the surgery had gone well. After four days, she was sent home from the hospital. Within 24 hours, she was unable to keep down any food and became severely dehydrated. She was readmitted to the hospital a week after her surgery and, when the doctors re-opened her to discover what was going on, they found that her small bowel had entirely matted together. The doctor described it as looking and reacting like a bowl of left over spaghetti. We were also told that her intestines were “concrete” or, in other words, dead. The doctors had never seen this reaction and had no idea what to do. My mother spent three weeks in intensive care. Her system totally failed. Ultimately, we made the painful decision to remove her from life-support and she passed away.
I am describing this because we later learned that other people have reacted in a very similar way after receiving Seprafilm. Although most people didn't die as a result of their reaction, they did appear to be fine after Seprafilm was placed and then, within a few days, the reaction became apparent. We know this is the case because we have read adverse event reports on the FDA's MAUDE database that appear to mirror my mother's reaction. MAUDE, in fact, has 302 adverse event reports for Seprafilm, 14 of which are reports of deaths.
My mother's doctor reported her reaction while she was in intensive care. Genzyme provided their report to the FDA during that time, as well. They stated that the event type was “injury” and the patient outcome “required intervention”. There are no reports from Genzyme on the MAUDE database that state that my mother's outcome was death. I suspect that they reported to the FDA so quickly because they wanted to avoid having to file such a report.
My family decided to bring a lawsuit against Genzyme because we want them to figure out why people are reacting in this way after Seprafilm is used. We also want them to tell doctors about the possibility of this reaction and let them know what to do if it happens. We consider that to be Genzyme's responsibility, not ours. And yet, in order to be granted the privilege of standing before a judge and telling him or her our situation, we feel as though we have to tell the judge what exactly went wrong. We don't know why our mother reacted like she did, we only know that she reacted and died and there is no doubt in our minds that the reaction was caused by Seprafilm.
10:33 AM
Laura (cont) said...
So now, what seems like such a basic right, our right to a day in court, has been taken away from us because of what we consider “loopholes” that lawyers have discovered and made law. Even though we suspect that Genzyme has not reported properly to the FDA, because of Buckman, we can't claim it. Even though we suspect that Genzyme is not providing the warnings that they should on Seprafilm's labeling, because of Riegel, we can't claim it. We are left with absolutely no recourse. Jayne Heisner's life has been taken and the only thing that we can do is to let people know what happened on this blog.
Ultimately, I hope that someone from the FDA reads this and discovers why Genzyme has been allowed to sell a product that can possibly cause such catastrophic outcomes and not warn people of this possibility. I hope that someone from Congress reads this and decides that the Medical Device Safety Act needs to be passed quickly. I hope that someone from Genzyme reads this and decides that something should be done. If anyone from the FDA , Congress or Genzyme would like to contact me, my email is Lauras6320@yahoo.com. I would be happy discuss this with them and then, possibly something good will come from this horrible situation.
10:36 AM
ARTILCLE THIS COMMENT WAS FOUND WITH
Friday, March 12, 2010
Heisner - Strike 3
Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration. Now at the "third amended" stage, it's been dismissed again. See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010). As you'll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn't pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren't parallel). Heisner has now been around for some two years and the plaintiffs haven't mustered a decent complaint yet.
Strike three and you're out? Yes. This time the court dismissed the complaint with prejudice. Slip op. at 8.
Anyway, the latest decision, which we'll call "Heisner III," found essentially more of the same. Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance. There doesn't seem to be any way around preemption in this case, as much as plaintiff has tried. You can't have a "parallel" claim that isn't really parallel - or as the court puts it, "state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements." Slip op. at 5 (citation omitted).
This time the plaintiff tried to equate the FDA's CBE warning update regulations with a common law claim for post-sale duty to warn. But that didn't fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory. Slip op. at 5-6.
Everything else in the plaintiff's, longer complaint remained too vague and devoid of facts. "Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations." Slip op. at 7.
A claimed failure to file adverse reaction reports didn't constitute a product defect. Slip op. at 6 ("failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect"). Negligence per se claims still couldn't possibly be causal, since they postdated the alleged injury. Id.
We thank another of our anonymous (by request) readers for passing Heisner III along.
http://druganddevicelaw.blogspot.com/2010/03/heisner-strike-3.html
My mother died after experiencing what we suspect was a massive reaction to Seprafilm. Seprafilm is a class 3 medical device. It is a bioresorbable membrane manufactured and sold by Genzyme to prevent adhesions following surgery. It is absorbed into the body several days after being placed. My mother didn't ask that Seprafilm be placed in her nor did our family. During routine gynecological surgery, it was discovered that she had adhesions in her small bowel area and so the surgeons “took care of it” while they had her in the operating room. After removing the adhesions, Seprafilm was placed on her small bowel to prevent the formation of further adhesions. It appeared that the surgery had gone well. After four days, she was sent home from the hospital. Within 24 hours, she was unable to keep down any food and became severely dehydrated. She was readmitted to the hospital a week after her surgery and, when the doctors re-opened her to discover what was going on, they found that her small bowel had entirely matted together. The doctor described it as looking and reacting like a bowl of left over spaghetti. We were also told that her intestines were “concrete” or, in other words, dead. The doctors had never seen this reaction and had no idea what to do. My mother spent three weeks in intensive care. Her system totally failed. Ultimately, we made the painful decision to remove her from life-support and she passed away.
I am describing this because we later learned that other people have reacted in a very similar way after receiving Seprafilm. Although most people didn't die as a result of their reaction, they did appear to be fine after Seprafilm was placed and then, within a few days, the reaction became apparent. We know this is the case because we have read adverse event reports on the FDA's MAUDE database that appear to mirror my mother's reaction. MAUDE, in fact, has 302 adverse event reports for Seprafilm, 14 of which are reports of deaths.
My mother's doctor reported her reaction while she was in intensive care. Genzyme provided their report to the FDA during that time, as well. They stated that the event type was “injury” and the patient outcome “required intervention”. There are no reports from Genzyme on the MAUDE database that state that my mother's outcome was death. I suspect that they reported to the FDA so quickly because they wanted to avoid having to file such a report.
My family decided to bring a lawsuit against Genzyme because we want them to figure out why people are reacting in this way after Seprafilm is used. We also want them to tell doctors about the possibility of this reaction and let them know what to do if it happens. We consider that to be Genzyme's responsibility, not ours. And yet, in order to be granted the privilege of standing before a judge and telling him or her our situation, we feel as though we have to tell the judge what exactly went wrong. We don't know why our mother reacted like she did, we only know that she reacted and died and there is no doubt in our minds that the reaction was caused by Seprafilm.
10:33 AM
Laura (cont) said...
So now, what seems like such a basic right, our right to a day in court, has been taken away from us because of what we consider “loopholes” that lawyers have discovered and made law. Even though we suspect that Genzyme has not reported properly to the FDA, because of Buckman, we can't claim it. Even though we suspect that Genzyme is not providing the warnings that they should on Seprafilm's labeling, because of Riegel, we can't claim it. We are left with absolutely no recourse. Jayne Heisner's life has been taken and the only thing that we can do is to let people know what happened on this blog.
Ultimately, I hope that someone from the FDA reads this and discovers why Genzyme has been allowed to sell a product that can possibly cause such catastrophic outcomes and not warn people of this possibility. I hope that someone from Congress reads this and decides that the Medical Device Safety Act needs to be passed quickly. I hope that someone from Genzyme reads this and decides that something should be done. If anyone from the FDA , Congress or Genzyme would like to contact me, my email is Lauras6320@yahoo.com. I would be happy discuss this with them and then, possibly something good will come from this horrible situation.
10:36 AM
ARTILCLE THIS COMMENT WAS FOUND WITH
Friday, March 12, 2010
Heisner - Strike 3
Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration. Now at the "third amended" stage, it's been dismissed again. See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010). As you'll see from our device preemption scorecard, previous versions were dismissed at Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008) (plaintiff didn't pleas any parallel claims), and Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009) (negligence per se claims weren't parallel). Heisner has now been around for some two years and the plaintiffs haven't mustered a decent complaint yet.
Strike three and you're out? Yes. This time the court dismissed the complaint with prejudice. Slip op. at 8.
Anyway, the latest decision, which we'll call "Heisner III," found essentially more of the same. Each time plaintiff gets told to go back to the drawing board, he comes back with more words and less (or at least no more) substance. There doesn't seem to be any way around preemption in this case, as much as plaintiff has tried. You can't have a "parallel" claim that isn't really parallel - or as the court puts it, "state and federal requirements are not equivalent if a manufacturer could be held liable under state law while complying with federal requirements." Slip op. at 5 (citation omitted).
This time the plaintiff tried to equate the FDA's CBE warning update regulations with a common law claim for post-sale duty to warn. But that didn't fare any better (even after plaintiff belated discovered that the CBE regulation for devices was different than the one for drugs), because the CBE regulation is voluntary, whereas the tort claim would make it mandatory. Slip op. at 5-6.
Everything else in the plaintiff's, longer complaint remained too vague and devoid of facts. "Plaintiff utilizes more words, but verbosity cannot substitute for factual allegations." Slip op. at 7.
A claimed failure to file adverse reaction reports didn't constitute a product defect. Slip op. at 6 ("failure to report adverse events to the FDA may violate the FDCA, but does not constitute a product “condition” or defect"). Negligence per se claims still couldn't possibly be causal, since they postdated the alleged injury. Id.
We thank another of our anonymous (by request) readers for passing Heisner III along.
http://druganddevicelaw.blogspot.com/2010/03/heisner-strike-3.html
Wednesday, June 22, 2011
Robotic One-Port Gallbladder Surgery Feasible
By John Gever, Senior Editor, MedPage Today
June 21, 2011
MedPage Today Action Points
•Explain that outcomes were just as good with robotic single-port cholecystectomy as with conventional laparoscopic procedures in a pilot study of 10 patients.
•Note that mean operating room time was nearly identical with the robotic procedure and conventional multiport laparoscopy.
Review
Outcomes were just as good with robotic single-port cholecystectomy as with conventional laparoscopic procedures in a pilot study, researchers said.
The robotic surgery was attempted in 10 patients and completed in nine, with the same average operating room time as in 10 standard laparascopic gallbladder removals, according to Sherry Wren, MD, and Myriam Curet, MD, of Stanford University and the Palo Alto VA Health Care System.
No serious adverse events were seen after the robotic procedures, the first such single-port surgeries conducted with Intuitive Surgical's da Vinci Si system, the researchers wrote online in Archives of Surgery.
Both physicians were affiliated with Intuitive Surgical -- Wren as a consultant and Curet as chief medical advisor.
In their Archives report, they explained that single-port laparascopic surgery has attracted interest in recent years because of the possibility of reduced pain, faster recovery, and less scarring.
They cited a recent review that counted more than 4,500 patients having received single-port procedures for a variety of purposes.
But, Wren and Curet noted, "there has not been a large clinical trial comparing [single-port] surgery versus standard multiport laparoscopy, so the clinical benefits of this new technique are purely speculative.
They did not have the resources to conduct such a study themselves, but they were able to compare outcomes in the first 10 cholecystecomies they attempted with the da Vinci Si system with the last 10 multiport laparoscopic procedures Wren had performed at the Palo Alto VA hospital.
Seven of the patients undergoing single-port surgery were male and were otherwise representative of the usual VA population, Wren and Curet indicated.
The one single-port procedure that could not be completed involved a patient with significant adhesions of the omentum to the diaphragm, such that it was necessary to use, first, multiport laparoscopy and then open surgery to finally remove the diseased organ, the researchers explained. That patient was not included in the analysis of procedure time.
Among the nine patients with completed single-port surgeries, the mean operating room time was 105 minutes (SD 18), compared with 106 minutes (SD 24) for the control group. "There did not appear to be a significant learning curve for the [single-port] procedure," Wren and Curet wrote.
The presence of inflammation, seen in six of the nine patients included in the analysis, tended to prolong the procedure. Operating room time for the patients without inflammation was 82 to 88 minutes, whereas in two patients with empyema and hydrops the procedures took two hours or more.
The surgeon spent an average of just over one hour (range 38 to 99 minutes) at the operative console during the procedure.
Other tasks adding to operating room time included preparing the port (mean 17 minutes from skin incision to cannula insertion), docking the robotic arms (mean 5 minutes), and port removal and closure (mean 18 minutes).
No intraoperative complications were reported, and with follow-up ranging from five to 10 months, Wren and Curet saw no serious adverse events.
Two male patients had postoperative urinary retention requiring a urinary catheter during the first night. One was discharged with a catheter, which was removed a week later.
One patient in the control group developed atrial fibrillation, and two male patients had urinary retention, the researchers reported.
During the first few robotic procedures, there were two cases in which part of the access port device tore off as the specimen extraction bag was placed and the pieces needed to be retrieved. Wren and Curet indicated that they then revised their technique for inserting the specimen bag and the problem did not recur.
On a standard 10-point scale, patients rated pain at discharge with a mean score of 2.5. The mean score at a postoperative visit two to three weeks later was 0.67.
Asked their opinions 30 days after surgery, the robotic surgery patients told the researchers they were highly satisfied with the robotic surgery and would recommend it to others.
"The da Vinci single-site platform performed equivalently to traditional multiport cholecystectomy in this human use study," Wren and Curet wrote.
However, they noted, "additional trials would need to be performed to directly compare it with current single-port surgery."
The study had no external funding. Intuitive Surgical provided the instrumentation used in the study.
Wren reported serving as a consultant to Intuitive Surgical.
Curet reported serving as the company's chief medical advisor.
Primary source: Archives of Surgery
Source reference:
Wren S, et al "Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform" Arch Surg 2011; DOI: 10.1001/archsurg.2011.143.
--------------------------------------------------------------------------------
Disclaimer
The information presented in this activity is that of the authors and does not necessarily represent the views of the University of Pennsylvania School of Medicine, MedPage Today, and the commercial supporter. Specific medicines discussed in this activity may not yet be approved by the FDA for the use as indicated by the writer or reviewer. Before prescribing any medication, we advise you to review the complete prescribing information, including indications, contraindications, warnings, precautions, and adverse effects. Specific patient care decisions are the responsibility of the healthcare professional caring for the patient. Please review our Terms of Use.
© 2004-2011 MedPage Today, LLC. All Rights Reserved.
Saturday, June 18, 2011
The inpatient burden of abdominal and gynecological adhesiolysis in the US
Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden.
This study examines the inpatient burden of adhesiolysis in the United States (i.e ., number and rate of events, cost, length of stay [LOS]).
Methods: Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system.
Results: We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis.
The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling $2.3 billion ($1.4 billion for primary adhesiolysis; $926 million for secondary adhesiolysis).
Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and $220 million in attributable costs.
Conclusions: Adhesiolysis remain an important surgical problem in the United States.
Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.
Author: Vanja SikiricaBela BapatSean CandrilliKeith DavisMalcolm WilsonAlan Johns
Credits/Source: BMC Surgery 2011, 11:13
Wednesday, June 15, 2011
FDA Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Ummm do you mean like Sprayshield too???????Does Kruschinski know about this...another way to maim his poor patients. Is Carl aware of this too? I'm betting he does not!
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Date Issued: July 9, 2010
Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room
Products:
Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressure regulator and a source of compressed air or gas. Air- or gas-pressurized sprayers can be used to mix and apply hemostatic drug or biological products (products that help control bleeding from blood vessels during surgery) including fibrin and non-fibrin sealants.
They include devices such as:
EasySpray and spray set used with Duploject system(Baxter Healthcare Corporation)
Tissomat and spray set used with Duploject system (Baxter Healthcare Corporation)
Evicel application device (Omrix Medical)
FibriJet Aerosol Applicator (MicroMedics)
HemaMyst Surgical Applicator System (Heamacuare Corporation)
MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)
Vitagel Hemostat Spray Set (Orthovita, Inc.)
Summary of Problem and Scope:
FDA has received reports of air or gas embolisms occurring during or immediately after application of hemostatic drug or biological products using air- or gas- pressurized sprayers. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.
Recommendations/Actions:
Given the life-threatening consequences of an air or gas embolism, FDA is recommending that clinicians using air- or gas- pressurized spray devices for application of hemostatic drug or biological products:
Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use (IFU) of the hemostatic agent.
Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
Monitor blood pressure, pulse, oxygen saturation and end tidal CO 2 for signs of an air or gas embolism.
Make sure the regulators are maintained properly and checked for safe performance regularly.
FDA Activities:
In cooperation with the FDA, Baxter Healthcare Corporation and Omrix Pharmaceuticals, the manufacturers of all fibrin sealants licensed in the U.S., have updated the Warning and Precautions sections of the labels of EVICEL, T isseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance.
The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.
Report Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of fibrin sealants and/or air or gas pressurized fibrin sprayers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program1. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements2 should follow the reporting procedures established by their facilities.
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV or 800-638-2041.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218523.htm
FDA Safety Notification: Risk of Air or Gas Embolism When Using Air- or Gas- Pressurized Spray Devices
Date Issued: July 9, 2010
Audience: Surgeons, Operating Room Nurses, and other support personnel in the Operating Room
Products:
Air- or gas-pressurized sprayers are dual syringe products that simultaneously mix and apply two non-homogeneous liquids within a single spray head that is connected to a pressure regulator and a source of compressed air or gas. Air- or gas-pressurized sprayers can be used to mix and apply hemostatic drug or biological products (products that help control bleeding from blood vessels during surgery) including fibrin and non-fibrin sealants.
They include devices such as:
EasySpray and spray set used with Duploject system(Baxter Healthcare Corporation)
Tissomat and spray set used with Duploject system (Baxter Healthcare Corporation)
Evicel application device (Omrix Medical)
FibriJet Aerosol Applicator (MicroMedics)
HemaMyst Surgical Applicator System (Heamacuare Corporation)
MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)
Vitagel Hemostat Spray Set (Orthovita, Inc.)
Summary of Problem and Scope:
FDA has received reports of air or gas embolisms occurring during or immediately after application of hemostatic drug or biological products using air- or gas- pressurized sprayers. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site.
Recommendations/Actions:
Given the life-threatening consequences of an air or gas embolism, FDA is recommending that clinicians using air- or gas- pressurized spray devices for application of hemostatic drug or biological products:
Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use (IFU) of the hemostatic agent.
Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
Monitor blood pressure, pulse, oxygen saturation and end tidal CO 2 for signs of an air or gas embolism.
Make sure the regulators are maintained properly and checked for safe performance regularly.
FDA Activities:
In cooperation with the FDA, Baxter Healthcare Corporation and Omrix Pharmaceuticals, the manufacturers of all fibrin sealants licensed in the U.S., have updated the Warning and Precautions sections of the labels of EVICEL, T isseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance.
The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.
Report Problems to FDA:
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical products. If you suspect problems with the use of fibrin sealants and/or air or gas pressurized fibrin sprayers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program1. Healthcare personnel employed by facilities that are subject to FDA's device user facility reporting requirements2 should follow the reporting procedures established by their facilities.
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV or 800-638-2041.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm218523.htm
Ceftriaxone Injection
Ceftriaxone Injection(sef try ax' one)
Last Revision: March 16, 2011.
Why is this medication prescribed?
Ceftriaxone injection is used to treat certain infections caused by bacteria such as gonorrhea (a sexually transmitted disease), pelvic inflammatory disease (infection of the female reproductive organs that may cause infertility), meningitis (infection of the membranes that surround the brain and spinal cord), and infections of the lungs, ears, skin, urinary tract, blood, bones, joints, and abdomen. Ceftriaxone injection is also sometimes given before certain types of surgery to prevent infections that may develop after the operation. Ceftriaxone injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics will not work for colds, flu, or other viral infections.
How should this medicine be used?
Ceftriaxone injection comes as a liquid to be injected intravenously (into a vein) or intramuscularly (into a muscle). It is sometimes given as a single dose and sometimes given once or twice a day for 4-14 days, depending on the type of infection being treated. You may receive ceftriaxone injection in a hospital or doctor's office, or you may administer the medication at home. If you are using ceftriaxone injection at home, use it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ceftriaxone injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You should begin to feel better during the first few days of your treatment with ceftriaxone injection. If your symptoms do not improve or get worse, call your doctor.
If you will be using more than one dose of ceftriaxone injection, use the medication until you finish the prescription, even if you feel better. If you stop using ceftriaxone injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicine
Ceftriaxone injection is also sometimes used to treat endocarditis (infection of the heart lining and valves), chancroid (genital sores caused by bacteria), Lyme disease (an infection that is transmitted by tick bites that may cause problems with the heart, joints, and nervous system), relapsing fever (an infection that is transmitted by tick bites that causes repeated episodes of fever), shigella (an infection that causes severe diarrhea), typhoid fever (a serious infection that is common in developing countries), salmonella (an infection that causes severe diarrhea), and Whipple's disease (a rare infection that causes serious problems with digestion). Ceftriaxone injection is also sometimes used to prevent infection in people who have been sexually assaulted or who have been bitten by humans or animals. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using ceftriaxone injection,
•tell your doctor and pharmacist if you are allergic to ceftriaxone injection, other cephalosporin or penicillin antibiotics, or any other medications.
•tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any intravenous medications or feedings that contain calcium such as total parenteral nutrition (TPN, a liquid feeding that is given intravenously to people who cannot eat or digest food).
•tell your doctor if you have or have ever had problems with your digestive system, especially colitis (inflammation of the large intestine), malnutrition (you do not eat or cannot digest the nutrients needed for good health), or kidney or liver disease.
•tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ceftriaxone injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
Ceftriaxone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
pain, tenderness, hardness, or warmth in the place where ceftriaxone was injected
headache
dizziness
sweating
flushing
diarrhea
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
rash
bloody, watery stools
fever
stomach cramps
stomach pain or bloating
nausea and vomiting
heartburn
chest pain
Ceftriaxone injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine?
If you will be injecting ceftriaxone injection at home, your health care provider will tell you where you should store it and how long you may keep it. Follow these directions carefully. Be sure to store ceftriaxone in the container it came in and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ceftriaxone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
American Society of Health-System Pharmacists, Disclaimer
AHFS® Consumer Medication Information. © Copyright, 2011. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
The following brand names are from RxNorm, a standardized nomenclature for clinical drugs produced by the National Library of Medicine:
Brand names
•Rocephin
Last Revision: March 16, 2011.
Why is this medication prescribed?
Ceftriaxone injection is used to treat certain infections caused by bacteria such as gonorrhea (a sexually transmitted disease), pelvic inflammatory disease (infection of the female reproductive organs that may cause infertility), meningitis (infection of the membranes that surround the brain and spinal cord), and infections of the lungs, ears, skin, urinary tract, blood, bones, joints, and abdomen. Ceftriaxone injection is also sometimes given before certain types of surgery to prevent infections that may develop after the operation. Ceftriaxone injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics will not work for colds, flu, or other viral infections.
How should this medicine be used?
Ceftriaxone injection comes as a liquid to be injected intravenously (into a vein) or intramuscularly (into a muscle). It is sometimes given as a single dose and sometimes given once or twice a day for 4-14 days, depending on the type of infection being treated. You may receive ceftriaxone injection in a hospital or doctor's office, or you may administer the medication at home. If you are using ceftriaxone injection at home, use it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ceftriaxone injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You should begin to feel better during the first few days of your treatment with ceftriaxone injection. If your symptoms do not improve or get worse, call your doctor.
If you will be using more than one dose of ceftriaxone injection, use the medication until you finish the prescription, even if you feel better. If you stop using ceftriaxone injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Other uses for this medicine
Ceftriaxone injection is also sometimes used to treat endocarditis (infection of the heart lining and valves), chancroid (genital sores caused by bacteria), Lyme disease (an infection that is transmitted by tick bites that may cause problems with the heart, joints, and nervous system), relapsing fever (an infection that is transmitted by tick bites that causes repeated episodes of fever), shigella (an infection that causes severe diarrhea), typhoid fever (a serious infection that is common in developing countries), salmonella (an infection that causes severe diarrhea), and Whipple's disease (a rare infection that causes serious problems with digestion). Ceftriaxone injection is also sometimes used to prevent infection in people who have been sexually assaulted or who have been bitten by humans or animals. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using ceftriaxone injection,
•tell your doctor and pharmacist if you are allergic to ceftriaxone injection, other cephalosporin or penicillin antibiotics, or any other medications.
•tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any intravenous medications or feedings that contain calcium such as total parenteral nutrition (TPN, a liquid feeding that is given intravenously to people who cannot eat or digest food).
•tell your doctor if you have or have ever had problems with your digestive system, especially colitis (inflammation of the large intestine), malnutrition (you do not eat or cannot digest the nutrients needed for good health), or kidney or liver disease.
•tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ceftriaxone injection, call your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
Ceftriaxone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
pain, tenderness, hardness, or warmth in the place where ceftriaxone was injected
headache
dizziness
sweating
flushing
diarrhea
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
rash
bloody, watery stools
fever
stomach cramps
stomach pain or bloating
nausea and vomiting
heartburn
chest pain
Ceftriaxone injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine?
If you will be injecting ceftriaxone injection at home, your health care provider will tell you where you should store it and how long you may keep it. Follow these directions carefully. Be sure to store ceftriaxone in the container it came in and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ceftriaxone.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
American Society of Health-System Pharmacists, Disclaimer
AHFS® Consumer Medication Information. © Copyright, 2011. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
The following brand names are from RxNorm, a standardized nomenclature for clinical drugs produced by the National Library of Medicine:
Brand names
•Rocephin
Monday, June 13, 2011
Tuesday, June 07, 2011
Friday, June 03, 2011
Adhesiolysis in Repeat Caesarean Delivery Common, Costly
Medscape Medical News from the:
American Congress of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting
May 20, 2011 (Washington, DC) — Adhesions from previous Caesarean deliveries severe enough to require adhesiolysis during repeat Caesarean delivery have clinical and economic implications, according to a retrospective review of a large database with discharge data from 60 hospitals in the United States. The data were reported here at the American Congress of Obstetricians and Gynecologists 59th Annual Clinical Meeting.
The matched cohort study found that for patients who required adhesiolysis, the cost per patient was $300 more, operative length was longer, hospital stay was longer, and postoperative complications were more frequent.
Read the rest: http://www.medscape.com/viewarticle/743097
Subscribe to:
Posts (Atom)