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2012-10-23 Assigned to HEART FAILURE TECHNOLOGIES, LLC reassignment HEART FAILURE TECHNOLOGIES, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PHI HEALTH, INC.
In one embodiment, there is disclosed a method for repairing a heart of a human, comprising introducing a collapsed shaping device through the skin into the vascular system of the human, delivering the shaping device into a left ventricle through the arteries, once inside the left ventricle, expanding the shaping device to an expanded shape, imbricating a wall of the ventricle over the shaping device, collapsing the shaping device, and removing the shaping device from the left ventricle such that the ventricle is restored to an appropriate size.
This application claims the benefit of the filing date of U.S. provisional patent application Ser. No. 60/317,197 entitled “DEVICE AND METHOD FOR ENDOSCOPIC SURGICAL VENTRICULAR REPAIR” filed on Sep. 5, 2001 and U.S. provisional patent 60/327,221 entitled “METHOD AND DEVICE FOR CLOSED CHEST PLACEMENT OF SEPTUM” filed on Oct. 5, 2001, the disclosures of both of these applications are incorporated herein by reference.
This invention relates generally to surgical methods and apparatuses for performing surgical ventricular repair endoscopically or through a minimally invasive incision.
The shape and volume of the normal heart are of particular interest as they combine to dramatically affect the way that the blood is pumped. The left ventricle which is the primary pumping chamber, is somewhat elliptical, conical or apical in shape in that it is longer, long axis longest portion from aortic valve to apex, than it is wide, short axis widest portion from ventricle wall to septum, and descends from a base with a decreasing cross-sectional circumference, to a point or apex. The left ventricle is further defined by a lateral ventricle wall and a septum, which extends between the auricles and the ventricles.
Two types of motion accomplish the pumping of the blood from the left ventricle. One of these motions is a simple squeezing motion, which occurs between the lateral wall and the septum. The squeezing motion occurs as a result of a thickening of the muscle fibers in the myocardium. This compresses the blood in the ventricle chamber and ejects it into the body. The thickening changes between diastole and systole. This is seen easily by echocardiogram, PET and MRI imaging and can be routinely measured.
The other type of motion is a twisting or writhing motion, which begins at the apex and rises toward the base. The rising writhing motion occurs because the heart muscle fibers run in a circular or spiral direction around the heart. When these fibers constrict they cause the heart to twist initially at the small area of the apex, but progressively and ultimately to the wide area of the base. These squeezing and twisting motions are equally important, as they are each responsible for moving approximately one-half of the blood pumped. The contractility or stiffness of these fibers are major determinants in how well the ventricle pumps.
The amount of blood pumped from the left ventricle divided by the amount of blood available to be pumped is referred to as the ejection fraction of the heart. Generally, a healthier heart has a higher ejection fraction. A normal heart, for example may have a total volume of one hundred milliliters and an ejection fraction of sixty percent. Under these circumstances, 60 milliliters of blood are pumped with each beat of the heart. It is this volume in the normal heart of this example that is pumped with each beat to provide nutrients including oxygen to the muscles and other tissues of the body.
As the ischemia progresses through its various stages, the affected myocardium dies losing its ability to contribute to the pumping action of the heart. The ischemic muscle is no longer capable of contracting so it cannot contribute to either squeezing or twisting motion required to pump blood. This non-contracting tissue is said to be akinetic. In severe cases the akinetic tissue, which is not capable of contracting, is in fact elastic so that blood pressure tends to develop a bulge or expansion of the chamber. This muscle tissue is not only akinetic, in that it does not contribute to the pumping function, but it is in fact dyskinetic, in that it detracts from the pumping function. This is particularly detrimental to the limited pumping action available, as the heart loses even more of its energy to pumping the bulge instead of the blood.
The body seems to realize that with a reduced pumping capacity, the ejection fraction of the heart is automatically reduced. For example, the ejection fraction may drop from a normal sixty percent to perhaps twenty-percent. Realizing that the body still requires the same volume of blood for oxygen and nutrition, the body causes its heart to dilate or enlarge in size so that the smaller ejection fraction pumps about the same amount of blood. As noted, a normal heart with a blood capacity of seventy milliliters and an ejection fraction of sixty percent would pump approximately 42 milliliters per beat. The body seems to appreciate that this same volume per beat can be maintained by an ejection fraction of only thirty-percent if the ventricle enlarges to a capacity of 140 milliliters. This increase in volume, commonly referred to as “remodeling”, not only changes the volume of the left ventricle, but also its shape. The heart becomes greatly enlarged and the left ventricle becomes more spherical in shape losing its apex.
On the level of the muscle fibers, it has been noted that dilation of the heart causes the fibers to reorient themselves so that they are directed away from the inner heart chamber containing the blood. As a consequence, the fibers are poorly oriented to accomplish even the squeezing action, as the lines of force become less perpendicular to the heart wall. This change in fiber orientation occurs as the heart dilates and moves from its normal elliptical shape to its dilated spherical shape. The spherical shape further reduces pumping efficiency since the fibers which normally encircle the apex facilitate writhing are changed to a more flattened formation as a result of these spherical configurations.
Of course, this change in architecture has a dramatic effect on wall thickness, radius, and stress on the heart wall. In particular, it will be noted that absent the normal conical shape, the twisting motion at the apex, which can account for as much as one half of the pumping action, is lost. As a consequence, the more spherical architecture must rely almost totally on the lateral squeezing action to pump blood. This lateral squeezing action is inefficient and very different from the more efficient twisting action of the heart.
What is needed therefore is a reliable method and apparatus to allow a surgeon to perform surgical ventricular repair, preferably without having to do a full sternotomy and/or make large incisions in the chest. Additionally, such methods could be performed on a beating heart eliminating the need for lengthy full bypass circuit runs.
In response to these and other problems, an improved apparatus and method is provided for endoscopic surgical ventricle repair which allows a surgeon to perform a surgical ventricular repair procedure through a closed chest or through a small thoracotomy on a beating, fibrillating or an arrested heart. In one embodiment, there is a method for repairing a heart of a human, comprising introducing a shaping device percutaneously into a vasculature of the human, wherein the shaping device is in a collapsed state, delivering the shaping device into a left ventricle through the vasculature, expanding the shaping device to an expanded shape, imbricating a wall of the ventricle over the shaping device, collapsing the shaping device, and removing the shaping device from the left ventricle such that the ventricle is restored to an appropriate size.
FIG. 1—illustrates a process used by an embodiment.
FIG. 2 a—illustrates an embodiment of a shaping device.
FIG. 2 b—illustrates another embodiment of a shaping device in an expanded condition.
FIG. 2 c—illustrates the embodiment of FIG. 2 b in a collapsed condition.
FIG. 2 d—illustrates another embodiment of a shaping device in an expanded condition.
FIG. 2 e—illustrates the embodiment of FIG. 2 d in a collapsed condition.
FIG. 3 a—illustrates one embodiment deployed within a human heart.
FIG. 3 b—illustrates a human heart before remodeling.
FIG. 4—illustrates one embodiment deployed within a human heart.
FIG. 7—illustrates one embodiment deployed within a human heart.
FIG. 8 a—illustrates one embodiment deployed within a human heart.
FIG. 8 b—illustrates one embodiment deployed within a human heart.
FIG. 8 c—illustrates one embodiment deployed within a human heart.
FIG. 8 d—illustrates one embodiment deployed within a human heart.
Turning to FIG. 1, there is presented an overview method 100 for performing and using one embodiment. The method 100 may use the following components: a shaping device, a patch, and a stapling device.
The shaping device may be pre-shaped to generally model the appropriate volume and shape of the left ventricle, such as illustrated in FIG. 2 a. Such a shaping device 200 may be used as a guide in reforming the left ventricle so that the reconstructed heart may be formed closer to the size and shape of the pre-enlarged heart. Consequently, the heart performs better post operatively than with conventional methods. As illustrated in FIG. 2 a, the shaping device 200 is generally conical or “tear drop” in shape. The length of the shaping device 200 may vary with each patient and will typically be a function of the volume selected for the shaping device. Depending on the patient, the length may be in the three to four inch range to generally match the length of the pre-enlarged left ventricle. A doctor may select the appropriate volume for the shaping device by estimating the volume of the pre-enlarged left ventricle. Such selection procedures and shaping devices are discussed in a U.S. patent application Ser. No. 09/864,510, filed on May 24, 2001 by the inventors, which is hereby incorporated by reference into this application.
In some embodiments, such as illustrated in FIG. 2 a, the shaping device may be an inflatable balloon 202 coupled to a filler tube 204. Such tubes are well known in the art, and illustratively may be made of plastic-type materials such as PVC. A proximal end of the filler tube 204 may be connected to a fluid reservoir (not shown) which may be used to fill a pre-specified amount of fluid into the balloon 202 through the filler tube 204. The injection of fluid through the filler tube 204 inflates the balloon 202 to an inflated condition.
The shaping device could also be a wire skeleton or frame, as illustrated in FIG. 2 b. The wire frame could be made from surgical grade stainless steel, titanium, tantalum, or nitinol, which is a commercially available nickel-titanium alloy material that has shape memory and is superelastic. Nitinol medical products are available from AMF of Reuilly, France, and Flexmedics Corp., of White Bear Lake, Minn.
The shaping device 210 illustrated in FIG. 2 b is in an expanded condition. In this embodiment, a main wire 212 could run through the center of the shaping device 210. Coupled to the main wire may be a series of back ribs 214 a though 214 d. The back ribs 214 a through 214 d are coupled to a collar 216.
FIG. 2 c shows the shaping device 210 in a collapsed position. In a collapsed position, back ribs 214 a-214 d surround the main wire 212. In operation, once the shaping device 210 is inserted into the left ventricle, a doctor may cause the collar 216 to slide along the main wire 212 towards the distal end 218 of the wire. The force exerted on collar 216 will cause the ribs to buckle radially outward as illustrated in FIG. 2 b to a predetermined shape.
Other embodiments may include a wire mesh system such as illustrated in FIG. 2 d. The wire mesh shaper 218 is formed of a tubular fabric made from a plurality of wire strands having a predetermined relative orientation between the strands. Those skilled in the art will appreciate that the pick and pitch of the braided wires may be varied depending upon the desired density of the fabric. The tubular fabric may have metal strands which define two sets of essentially parallel generally spiraling and overlapping strands, with the strands of one set having a “hand”, i.e. a direction of rotation, opposite that of the other set. This tubular fabric is known in the fabric industry as a tubular braid.
The pitch of the wire strands (i.e. the angle defined between the turns of the wire and the axis of the braid) and the pick of the fabric (i.e. the number of turns per unit length) as well as some other factors, such as the number of wires employed in a tubular braid, the size or diameter of each wire in the braid, and the diameter of the braid are all important in determining a number of important properties of the device. For example, the greater the pick and pitch of the fabric, and hence the greater the density of the wire strands in the fabric, the stiffer the device will be. Also, the greater the diameter of each wire of the braid, the stiffer the device will be.
The wire strands of the tubular metal fabric are preferably manufactured from so-called shape memory alloys. Such alloys tend to have a temperature induced phase change which will cause the material to have a preferred configuration which may be fixed by heating the material above a certain transition temperature to induce a change in the phase of the material. When the alloy is cooled back down, the alloy will “remember” the shape it was in during the heat treatment and will tend to assume that configuration unless constrained from so doing.
Without any limitation intended, suitable wire strand materials may be selected from a group consisting of a cobalt-based low thermal expansion alloy referred to in the field as ELGELOY, nickel-based high temperature high-strength “superalloys” (including nitinol) commercially available from, for example, Haynes International under the trade name HASTELLOY, nickel-based heat treatable alloys sold under the name INCOLOY by International Nickel, and a number of different grades of stainless steel. The important factor in choosing a suitable material for the wire strands is that the wires retain a suitable amount of the deformation induced by a molding surface when subjected to a predetermined heat treatment.
When the tubular braid, for example, is in its preformed relaxed configuration 218 as illustrated in FIG. 2 d, the wire strands forming the tubular braid will have a first predetermined relative orientation with respect to one another. As the tubular braid is compressed along its axis 222, the fabric will tend to flare out away from axis 222 conforming to the shape of the mold. When the fabric is so deformed the relative orientation of the wire strands of the metal fabric will change. After undergoing the shape memory process, the resulting medical device has a preset relaxed configuration 218 as illustrated in FIG. 2 d and a collapsed or stretched configuration 220 as illustrated in FIG. 2 e which allows the device to be passed through a catheter or other similar delivery device.
In alternative embodiments, the shaping device may also have mechanisms by which the epicardium may be grabbed and conformed to the shape of the shaping device. As will be explained below, in such an embodiment, the clasping instrument may be placed along the outer surface of the ventricle at precise locations and closed to take a bite out of the ventricle, reshaping the ventricle around the shaping device.
A delivery device or catheter (not shown) may take any suitable shape, but desirably comprises an elongate flexible metal shaft having a threaded distal end. The delivery device may be used to urge the wire mesh shaper 218 through the lumen of a catheter for deployment in a channel of a patient's body. When the device is deployed out the distal end of the catheter, the device will still be retained by the delivery device. Once the wire mesh shaper 218 is properly positioned, the distal end of the catheter may be pressed against the medical device and the metal shaft or guidewire can be rotated about its axis to unscrew the medical device from the threaded distal end of the shaft. The catheter and guidewire are withdrawn.
As will be explained below, a patch is also used in the method 100. In one embodiment, the patch may be made from sheet material and may be a variety of shapes, including circular, elliptical, or triangular in shape. The sheet material for the patch may be formed from a biocompatible synthetic material, for example, from polyester, Dacron (Hemoshield) manufactured by the DuPont Corporation, or polytetrafluoroethylene (Gortex). The sheet material may also be autologous pericardium, or some other fixed mammalium tissue such as bovine pericardium or porcine tissue. The biocompatible synthetic material patch may be collagen impregnated to assist in hemostasis, or it may be sprayed with a hemostatic sealant to achieve better and instantaneous hemostasis.
On one side of the patch, there may be a means of adhering the patch to the endocardium or inside of the heart. Additionally, the patch may have markings that enable the movement and position of the patch to be post-operatively observed and analyzed under imaging systems, such as Magnetic Resonance Imaging (“MRI”), x-ray machines, fluoroscopy or other external visualization methods, for post-operative clinical evaluation. Such markings will allow identification of the patch and allow for analysis of the heart's contractility in future post-operative evaluations. The markings may also be radiopaque. Such radiopaque markings are discussed in U.S. patent application Ser. No. 09/864,510, filed on May 24, 2001 by the inventors, which has been incorporated by reference into this application.
In some embodiments, the shaping device may be coupled to the patch or have a mechanism, which couples to and releases the patch.
An imaging system may also be used preoperatively to take MRI, PET or echocardiography imaging data of the ventricle to determine what the appropriate areas of the ventricle to exclude are and to determine what the appropriate volume of the ventricle should be.
Turning back now to FIG. 1, the method 100 will now be discussed. For purposes of illustration only and not by way of limitation the method 100 will now be discussed as part of a bypass procedure. The procedure may begin by the surgeon positioning an endoscopic camera into the patient to view the infracted area of the patient's heart. Preoperatively, the surgeon may determine the size of the shaping device by selecting a shaping device that matches the volume of the ventricle desired for the particular patient.
When the shaping device is in a collapsed state, in 102, the shaping device may be introduced into the vasculature or vascular system of the patient. From the vascular system, in 104, the shaping device is guided into the left ventricle.
In a bypass procedure, the femoral vein and artery are cannulated to connect the patient to the cardiopulmonary bypass machine. After the bypass machine is running, the shaping device is manipulated to deploy from a collapsed state to an expanded shape. In some embodiments, markings on the controlling handle will provide feedback to the surgeon on how the shaping device is positioned, so that he knows where the patch is in relation to the ventricle. A positioning device on the shaping device will align with an anatomical landmark inside the ventricle, like the aortic annulus, to provide another reference location for the shaping device. In 106, the shaping device may be deployed into an expanded condition, as shown in FIG. 3 a.
In 108, the wall of the ventricle may be imbricated over the shaping device, as shown in FIG. 3 b. The term “imbricating” as used in this application means to bring together two edges of the ventricle wall that have non-viable tissue between them and excluding this portion of the ventricle wall will which will basically reshape the ventricle. The shaping device may help determine which edges should be brought together. However, some non-viable tissue may be left in the ventricle in order to reshape the ventricle to the appropriate size and shape.
In order to imbricate or reform the ventricle wall over the shaping device, a molding instrument may be inserted into the chest through a small opening in an intercostal space to reach the epicardium. This molding instrument will allow the surgeon to press the ventricle wall against the shaping device to help reshape the ventricle, as shown in FIG. 3 b. This molding instrument will be withdrawn and a clasping instrument may be inserted. The molding instrument and clasping instrument may be one device. This clasping device will take portions or “bites” out of the ventricle wall starting at the edges of the area of non-viable tissue that needs to be excluded to restore the ventricle to its correct shape, size and contour. The bites may be made with suture type devices, stapling devices, or clip type devices, for example. The clasping instrument may be partially closed to allow the surgeon to ensure that he is properly shaping the ventricle onto the shaping device. If the surgeon determines that he has the clasping instrument placed properly, the device will allow for full closure. The implements placed by the clasping instrument when closed will have pulled the ventricle wall over the shaping device and will maintain the ventricle's shape. Turning back to FIG. 1, once the shaping is complete, in 110, the shaping device will be collapsed and removed from the ventricle (112). Additionally, intraoperative imaging may be used during this procedure to aid the surgeon's view of the mandrel and ventricle interface.
Alternatively, the method 100 may be performed on a beating heart. Referring back to 102 of FIG. 1, the collapsed shaping device may be inserted into a femoral artery. In 104, the shaping device is passed through the femoral artery to the left ventricle as illustrated in FIG. 4. Once in the ventricle the shaping device is expanded briefly and the surgeon checks the alignment indicators to ensure that the patch is in the correct position. He collapses the mandrel and allows the heart to beat normally. This procedure minimizes the heart's contractions for a very brief period of time while the shaping device is deployed, but allows the heart to beat when the shaping device is collapsed. Once the surgeon has determined that the patient may tolerate another low flow period, the shaping device will be expanded again (106), and the wall of the ventricle is imbricated over the shaping device (108). The imbrication is performed with the placement of clasping mechanisms. The placement of the clasping mechanisms may be determined from analysis of the. preoperative imaging. A small opening is made in an intercostal space and the clasping device is placed through this opening. Clasping mechanisms are now placed on the ventricle and partially closed. The shaping device is deployed again briefly and the surgeon assesses the progress of the procedure and collapses the shaping device. If the clasping mechanisms are in the correct position the shaping device is expanded again and the clasping mechanisms are closed fully. The deployed shaping device ensures that the ventricle is of the intended volume. In 110, the shaping device is collapsed and removed from the ventricle and the femoral artery (112).
The method 100 could also be done as part of a thoracotomy, where the chest is opened in an intercostal space to allow greater access to the ventricle. The surgeon could use the intercostal space opening to position the clasping instrument. If the surgeon chooses, he could do revascularization of the lateral anterior descending artery along with the procedure. A cannula may be placed in the jugular vein to deliver cardioplegia to the coronary sinus, if the surgeon desires to do the anastomosis on an arrested heart.
Turning to FIG. 5, a method 500 will now be discussed. The method 500 may be used as either part of a bypass procedure or a beating heart procedure. As discussed in relation to method 100, the surgeon may determine the location of the ventricle to be excluded (i.e., “the excluded portion”). Thus, the surgeon may cut a patch to a size that covers the excluded portion or select a presized patch to match the excluded portion. Alternatively, the patch may also be a predetermined size that corresponds to the size of the shaping device and where the patch would be preattached to the shaping device. Once the size of the patch has been determined, the surgeon selects a shaping device that matches the volume of the ventricle desired for the particular patient. In one embodiment, the patch is secured to the shaping device and the shaping device is collapsed into/onto a delivery catheter.
When the shaping device is in a collapsed state, in 502 the shaping device and patch may be introduced into the vasculature or vascular system of the patient. From the vascular system, in 504, the shaping device and patch is guided into the left ventricle.
In some embodiments, markings on the controlling handle will provide feedback to the surgeon on how the shaping device is positioned, so that he knows where the patch is in relation to the ventricle. A positioning device on the shaping device will align with an anatomical landmark inside the ventricle, like the aortic annulus, to provide another reference location for the shaping device. In 506, the shaping device may be deployed into an expanded condition, as illustrated in FIG. 7.
Once the molding instrument has been deployed, in 508, the patch may be attached to the epicardium of the heart. Once the shaping is complete, in 510, the shaping device will be collapsed and removed from the ventricle (512).
Alternatively, the wall of the ventricle may be imbricated over the shaping device. In order to imbricate or reform the ventricle wall over the shaping device, a molding instrument may be inserted into the chest through a small opening in an intercostal space to reach the epicardium. This molding instrument will allow the surgeon to press the ventricle wall against the shaping device, to ensure that the patch gripping mechanism attaches to the ventricle wall that is to be excluded. This molding instrument will be withdrawn and a clasping instrument may be inserted. The molding instrument and clasping instrument may be one device. This clasping device may take portions or bites out of the ventricle wall starting at the edges of the area of non viable tissue that needs to be excluded to restore the ventricle to its correct shape, size and contour. The bites may be made with suture type devices or clip type devices, for example. The clasping instrument may be partially closed to allow the surgeon to ensure that he is properly shaping the ventricle onto the shaping device. If the surgeon determines that he has the clasping instrument placed properly, the device will allow for full closure. The implements placed by the clasping instrument when closed will have pulled the ventricle wall over the shaping device and will maintain the ventricle's shape. Intraoperative imaging may be used during this procedure to aid the surgeon's view of the mandrel and ventricle interface.
Similarly, the method 500 may be performed on a beating heart using intraoperative imaging. The shaping device, with the patch attached, may be passed through a femoral artery to the left ventricle. Once in the ventricle the shaping device is expanded and an image is made of the ventricle and the shaping device is collapsed. This stops the heart for a very brief period of time while the shaping device is deployed, but allows the heart to beat when the shaping device is collapsed. Once the image is analyzed to ensure that the patch is in the proper place, the shaping device will be expanded again and the patch secured with the assistance of the molding instrument and the shaping device collapsed. The placement of the clasping mechanisms on the clasping device is done from analysis of the preoperative imaging. A small opening is made in an intercostal space and the clasping device is placed through this opening. Clasping mechanisms are now placed on the ventricle and partially closed. The shaping device is deployed again and another image taken of the ventricle and the shaping device collapsed. This image is analyzed to ensure that the positioning of the clasping mechanisms is creating the desired shape of the ventricle over the shaping device. If the clasping mechanisms are in the correct position the shaping device is expanded again and the clasping mechanisms are closed fully. The deployed shaping device ensures that the ventricle is the correct volume. The shaping device is collapsed and withdrawn from the ventricle and the femoral artery.
Another alternative is to place the patch into the ventricle separately from the shaping device. This procedure may be accomplished by having the patch introduced into the ventricle with a catheter across the aortic valve and secured in a fashion similar to the method 500. The patch could also be placed across the septal wall from the right ventricle. In this embodiment a cannula is advanced into the right ventricle and a small hole is made in the septum between the right and left ventricles. Another cannula with the proper shaped patch is advanced into the right ventricle and through the hole in the septum where one half of the patch is deployed. The cannula is pulled back into the right ventricle where the second half of the patch device is deployed. The deployment of the patch on both sides of the ventricle holds the patch securely in place.
In yet another alternative procedure, the patch may be placed on the shaping device and introduced into the ventricle. The patch is attached to the wall of the ventricle and a device on the patch is tightened to cause the patch to reshape the ventricle over the shaping device. Once the desired shape is achieved the shaping device is removed and the patch left in place to hold the desired shape.
Turning now to FIG. 6, there is one embodiment for a method of reinforcing a dilated portion of an endocardial surface of a human heart. In this embodiment, a surgeon preoperatively determines the location, size and shape of the area of the septum to be reinforced. The surgeon determines which appropriate reinforcing element will match the patient needs. Such reinforcing elements may be made from biocompatible materials and may take many forms. For instance, a patch material (discussed above) could be used. Such materials could be encapsulated within a deploying and securing mechanism that would allow them to be attached to the septal wall. Another example of a reinforcing element could be a device made from shape memory metal that has the shape of the area to be reinforced and has biocompatible material covering the metal framework. As discussed above, the metal frame could be made of memory shape materials and would provide a means to secure the material and the material would give substance to the metal frame to resist the pressure in the left ventricle. Additionally, the reinforcing element may also have radiopaque markings in a pattern that allow them to be viewed and analyzed postoperatively and may have a shape that matches the area to be reinforced. The reinforcing element may be shaped to match the patient anatomy and extent of injury. The securing device may have a mechanism by which the reinforcing element may be secured to the septum along the border zone between viable and non-viable tissue. In yet another embodiment, the reinforcing element could have a first surface and a second surface, where the first surface is adapted to match the dilated portion of the endocardium, and the second surface is adapted to match an appropriate shape of the left ventricle. Thus, the reinforcing element could also be used to reshape the ventricle.
Turning back to FIG. 6, in 602, the surgeon inserts a first catheter with a distal and proximal end percutaneously into a vasculature or vascular system (such as the jugular vein or the femoral vein) of the patient. The surgeon may route a guidewire through vein into the right ventricle in the vicinity of the area to be reinforced. With the guide wire in place, in 604, the surgeon may guide the first catheter into the right ventricle, as illustrated in FIG. 8 a. Once the first catheter is in place, in 606, an incision may be made into the septal wall. In one embodiment, this may be accomplished with the aid of a trocar. The trocar may be advanced along the guide wire and positioned at the point in the septum that is generally the central point of the thinned septal region. The trocar is pushed through the thinned septal wall to create a path between the right and left ventricles.
In 608, the guidewire is advanced into the left ventricle from the right ventricle and, if a trocar is used, it may be withdrawn. In 610, a second catheter may be inserted over the guidewire such that the second catheter is introduced into the left ventricle. However, the second catheter is coupled to a reinforcing element, as described above. In 612, the reinforcing element is deployed in order to reinforce the portion of the endocardial surface, as illustrated in FIG. 8 b. For instance, in the left ventricle side of the septum, one portion of the reinforcing element is deployed with the edges of the device and securing mechanism resting on viable tissue of the septum at the border zone of the non-viable septal tissue. A second part of the securing mechanism is deployed in the right ventricle and secured to the septal wall, as illustrated in FIGS. 8 c and 8 d. A securing mechanism could be a type of mechanism used to occlude ventricular septal defects. NMT Medical (Massachusetts), W.L. Gore (Arizona) and AGA Medical Corporation (Minnesota) manufacture such devices. In 614, all components are withdrawn from the right ventricle and the procedure is complete.
Alternatively, the method 600 could include inserting a patch into the left ventricle using the reinforcing element. The patch could be positioned such that the patch aligns with a non-viable region in the heart. The reinforcing element is expanded to an expanded shape. In the expanded shape the patch may be attach to the dilated portion of the heart. Additionally, the expanding could anchor the reinforcing element to the septal wall in the right ventricle.
Another embodiment may be where the reinforcing element and securing mechanism are deployed on either side of the ventricle without creating a hole in the septum. In this embodiment a guidewire would be placed in the jugular or femoral veins and advanced to the proper location at the septum. The reinforcing element and securing mechanism may be advanced along the guidewire and the reinforcing element secured to the septum at the border zone of the non-viable septal tissue. The securing mechanism may be secured to the viable tissue at the edge of the border zone. An example of a type of securing mechanism that may be used are those similar to securing devices used to secure thoracic aortic aneurysm grafts. Medtronic (Minnesota), W.L. Gore (Arizona) and Boston Scientific (Massachusetts) make these securing mechanisms. In this embodiment the reinforcing element could also be placed in the left ventricle side of the septum. The guidewire may be advanced through the aortic valve from the femoral artery or through one of the three great vessels coming off the aortic arch. The reinforcing element may be placed in a fashion similar to that used to place the device on the right ventricle side of the septum.
Another embodiment could have two reinforcing elements being placed on either side of the septum in both the right and left ventricles without being connected through the septum. The placement of both reinforcing elements would be done as described for the individual placements in the right and left ventricles.
This procedure could also be done as part of an endoscopic surgical ventricular repair, when the ventricle wall as well as the septum have been damaged due to ischemia. The placement of the reinforcing element will be as described in one of the methods above. The endoscopic surgical ventricular repair procedure consists of inserting a ventricular shaping device into the left ventricle via the femoral artery. A molding instrument may be inserted into the chest through a small opening in an intercostal space to reach the epicardium. This instrument will allow the surgeon to press the ventricle wall against the shaping mandrel, to ensure that ventricle is pressed against the mandrel. This pressing device will be withdrawn and a clasping instrument may be inserted. The molding instrument and clasping instrument may be one device. This device will take bites out of the ventricle wall starting at the edges of the area of non viable tissue that needs to be excluded to restore the ventricle to its correct shape, size and contour. The bites may be made with suture type devices or clip type devices, for example. Such devices are currently used in an endoscopic surgery procedure and commonly referred as GIA. In which a portion of the patient's stomach is excluded from the remainder of the stomach. These devices are manufactured by USSC (Connecticut), and Ethicon Endosurgery (Ohio). The clasping instrument may be partially closed to allow the surgeon to ensure that he is properly shaping the ventricle onto the shaping mandrel. If the surgeon determines that he has the clasping instrument placed properly the device will allow for full closure. The implements placed by the clasping instrument when closed will have pulled the ventricle wall over the shaping mandrel and will maintain the ventricle's shape. Once the shaping is complete, the shaping mandrel will be collapsed and taken from the ventricle. Intraoperative imaging may be used during this procedure to aid the surgeon's view of the mandrel and ventricle interface.
If needed, revascularization during the beating heart method may be done either with stents alone or with a LIMA to LAD graft using a small thoracotomy and stents on any other vessel that needs to be opened. All other aspects of surgical ventricular restoration may be performed.
It is further understood that other modifications, changes and substitutions are intended in the foregoing disclosure and in some instances some features of the disclosure will be employed without corresponding use of other features. Accordingly, it is appropriate that the invention be construed broadly and in a manner consistent with the scope of the disclosure.
removing the shaping device from the left ventricle.
2. The method of claim 1 further comprising substantially reforming the wall of the ventricle over the shaper.
3. The method of claim 2 further comprising excluding at least the portion of the non-viable tissue from the ventricle.
securing the wall of the ventricle through the opening.
5. The method of claim 4 further comprising stapling the ventricle with a stapling instrument to secure the wall of the ventricle.
6. The method of claim 1 wherein the shaping device comprises a wire mesh structure, and further comprising expanding at least a portion of the wire mesh structure.
7. The method of claim 1 wherein the shaping device comprises a balloon, and further comprising expanding at least a portion of the balloon.
cutting the patch to be of the assessed size and shape.
9. The method of claim 1, wherein the portion of non-viable tissue in the heart comprises akinetic tissue.
removing the securing mechanism from the left ventricle.
11. The method of claim 10, further comprising expanding the securing mechanism.
12. The method of claim 10, further comprising collapsing the securing mechanism.
modifying the reinforcing element to be the assessed size and shape.
14. The method of claim 10, wherein the securing mechanism comprises a shaping device.
15. The method of claim 14, wherein the securing mechanism comprises a wire mesh structure, and further comprising expanding at least a portion of the wire mesh structure.
16. The method of claim 14, wherein the securing mechanism comprises a balloon, and further comprising expanding at least a portion of the balloon.
removing the catheter from the left ventricle.
18. The method of claim 17, wherein the reinforcing element comprises a patch.
19. The method of claim 17, further comprising positioning the reinforcing element in the left ventricle using a securing mechanism.
coupling the reinforcing element to a part of the heart.
22. The method of claim 17, wherein the reinforcing element comprises nitinol.
23. The method of claim 17, further comprising coupling the reinforcing element to the septal wall separating the left ventricle and a right ventricle.
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text:
The economic loss rule is a rule frequently invoked in construction disputes that operates to limit the types of damages that can be recovered. Understanding the limits of the economic loss rule requires a party to examine (1) the source of the duty at issue and (2) the nature of the property damage claimed.
Fundamental differences exist between contract and tort law. Obligations in tort generally arise from duties imposed by law to protect citizens from physical harm or damage to their property. And certain tort theories carry the possible imposition of punitive damages. In contrast, contractual obligations arise from promises the parties have made to each other, with the intent that their expectancy interests—created by such promises—are enforced.
Courts created the economic loss rule to enforce the parties bargained-for economic expectations and limit liability to those damage arising from contractual promises. This limit on tort damages allows contracting parties to more accurately allocate risks and build cost considerations into a contract.
But some creative parties wishing to bring tort claims are pleading damages to secondary or “other property” to avoid application of the economic loss rule. The key is to determine the source of the duty owed by the alleged tortfeasor. Does the duty of care flow from the contract, or does the duty truly arise independently of any contractual duty existing between the parties?
The economic loss rule provides, “a party suffering only economic loss from the breach of an express or implied contractual duty may not assert a tort claim for such breach absent an independent duty of care under tort law.” BRW, Inc. v. Dufficy & Sons, Inc., 99 P.3d 66, 72 (Colo. 2004). The focus is not on the professional status of the parties, but rather on the contractual relationship between them to determine whether there is an independent duty of care. But see Flagstaff Affordable Housing Ltd. Partnership v. Design Alliance, Inc., 212 P.3d 125 (Ariz. App. Div. 1 2009 (economic loss rule did not bar professional negligence claim against architect due to architect’s independent duty of care).
Courts generally define “economic loss” as damages other than physical harm to persons or property. If damages—for the cost of repair and replacement of property, structural damage, diminution in value of a damaged structure not repaired, loss of use or delay in utilizing property for its intended purposes—and related lost profits, revenue, and costs were the subject of the contract, such damages constitute economic loss damages. If no independent duty exists, the economic loss rule bars recovery in tort for such economic losses.
One frequently recognized exception to the economic loss rule applies in situations where the court finds that a party had a duty to the other party that was independent from the duties stated in the contract. If a duty exists, then a party can recover a damage award in tort based in tort. See e.g. Parr v. Triple L & J Corp., 107 P.3d 1104, 1108 (Colo. App. 2004).
The phrase “economic loss rule” is a bit of a misnomer and implies a primary focus on the type of damages. But the relationship between the type of damage suffered and the availability of an action in tort is inexact at best. At least one court has suggested the more accurate designation for the “economic loss rule” would be “independent duty rule.” The key is to focus on the source of the duty. If a duty has been breached that is independent of any contractual obligations, the economic loss rule has no application and does not bar a plaintiff’s tort claims because such claims fall outside the scope of the rule. But if a contract specifically imposes relevant duties of care—such as those concerning the contractor’s skill and workmanship in performing its services—those contractual duties of care will provide the basis for a cause of action, and may trump other independent common law duties of care not contemplated in the contract.
While the proper focus is on the source of the duty, the type of damages suffered may assist in determining the source of the duty underlying the action. A Utah court stated that under the economic loss rule “economic damages are not recoverable in negligence absent physical property damage or bodily injury.” SME Indus., Inc. v. Thompson, Ventulett, Stainback & Assocs., Inc., 28 P.3d 669, 680 (Utah 2001) (emphasis added) (finding that application of the economic loss rule is particularly applicable in the construction setting where all parties to a construction project resort to contracts and contract law to protect their economic expectations. Id. at 681.).
But damage to property that is the subject of the contract is an economic loss—and does not qualify as “damage to other property”—while damage to secondary property is not an economic loss. Hughes Custom Building, LLC v. Davey, --- P.3d ---, 2009 WL 1260171 (Ariz. App. Div. 2 2009). Determining secondary property damage is unclear. In some construction cases, and for the purposes of the economic loss rule, courts have treated the house and its component parts as a single property. Id.
Consequently, when a defect of a particular part of the house results in damage to the whole, no negligence action is permitted for that additional property damage. Id.; see also Steineke v. Russi, 190 P.3d 60, 66 (Wash. App. 2008) (holding that persuasive authority and common sense dictate that a building constitutes a single “product” or “property,” not a series of component parts, for the purposes of the economic loss rule).
Court declined to apply economic loss doctrine to bar claim for damage caused to home by defective installation of stone façade.
In other words, property that was not encompassed in the bargain, i.e., not the subject of the contract, constitutes “other” or “secondary” property. Damages to such other or secondary property is not an economic loss.
And when the nature of the defect is sudden, accidental, calamitous, and exposes others to harm, the economic loss rule will likely not bar tort recovery for resulting damages to property outside the scope of the contract. See e.g. Valley Forge Ins. Co. v. Sam’s Plumbing, LLC, 207 P.3d 765, 766-67 (Ariz. App. 2009). But when the duty not to cause damage to the property, or the duty to pay for damage caused is derived from the contract, the economic loss rule operates as a bar to tort claims seeking relief for those damages.
Although the economic loss rule generally does not apply where other property damage is proven, courts have tended to focus on the circumstances and context giving rise to the injury in determining whether alleged losses qualify as “other property” damage. Specifically, in the context of a commercial transaction between sophisticated parties, injury to other property is not actionable in tort if the injury was or should have been reasonably contemplated by the parties to the contract. In such cases the failure of the product to perform as expected will necessarily cause damage to other property, rendering the other property damage inseparable from the defect in the product itself. Id. at 129-30. While the above analysis from the Fourth Circuit stemmed from a sale of goods, its application and reasoning may be even more suited to a construction project particularly when defects to the work would lead to foreseeable and inseparable damages that were contemplated and bargained for—or should have been—in the underlying contract.
Property damage will be subsumed as an economic loss if such property was the subject of the contract at issue. Courts will honor the terms of the parties’ bargain to accept and allocate risks associated with the construction project. If the damage to the property was unforeseeable or not properly addressed in the contract, it would likely be categorized as “other” or “secondary” property damage to which relief for such damages would be available in tort.
The proper inquiry focuses on whether the source of the duty alleged to have been breached is derived from the contract (or derived from inter-related contracts of a construction project) or derived from a duty imposed by law that arises independently of any duties imposed under the contract. If the duty derives from the contract, the economic loss rule should work to bar tort claims for such resulting property damage.

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049 Pa. Code § 35.201. Definitions.
Accredited collegeA college, university or institute of higher learning recognized by the Council for Higher Education Accreditation or the United States Secretary of Education.
ActThe Real Estate Licensing and Registration Act (63 P. S. § § 455.101455.902).
Agency relationshipA fiduciary relationship between a broker or licensees employed by a broker and a consumer who becomes a principal.
Associate brokerAn individual broker who is employed by another broker.
Branch officeAny fixed location in this Commonwealth, other than the main office, maintained by a broker or cemetery broker, devoted to the transaction of real estate business.
(i) Negotiates with or aids a person in locating or obtaining for purchase, lease or acquisition of interest in real estate.
(ii) Negotiates the listing, sale, purchase, exchange, lease, time share and similarly designated interests, financing or option for real estate.
(iv) Represents himself or itself as a real estate consultant, counsellor or house finder.
(v) Undertakes to promote the sale, exchange, purchase or rental of real estate. This subparagraph does not apply to an individual or entity whose main business is that of advertising, promotion or public relations.
(vi) Undertakes to perform a comparative market analysis.
(vii) Attempts to perform one of the actions listed in subparagraphs (i)(vi).
Broker of recordThe individual broker responsible for the real estate transactions of a partnership, association or corporation that holds a brokers license.
(i) List for sale, sell or offer for sale real estate of the builder-owner.
(ii) Negotiate the sale or exchange of real estate of the builder-owner.
(iii) Lease or rent, or offer to lease, rent or place for rent, real estate of the builder-owner.
(iv) Collect or offer, or attempt to collect, rent for real estate of the builder-owner.
BureauThe Bureau of Professional and Occupational Affairs of the Department.
Buyer agentA licensee who enters into an agency relationship with a buyer/tenant.
Campground membershipAn interest, other than in fee simple or by lease, which gives the purchaser the right to use a unit of real property for the purpose of locating a recreational vehicle, trailer, tent, tent trailer, pickup camper or other similar device on a periodic basis under a membership contract allocating use and occupancy rights between other similar users.
Campground membership salespersonAn individual holding either a standard or reciprocal license, who, either as an employee or an independent contractor, sells or offers to sell campground memberships under the active supervision of a broker. A licensed broker, salesperson or time-share salesperson does not need to possess a campground membership salespersons license to sell campground memberships.
(i) A place for the disposal or burial of deceased human beings, by cremation or in a grave, mausoleum, vault, columbarium or other receptacle.
(ii) The term does not include a private family cemetery.
Cemetery associate brokerAn individual cemetery broker employed by another cemetery broker or by a broker.
Cemetery brokerAn individual or entity holding either a standard or reciprocal license, that is engaged as, or carrying on the business or acting in the capacity of, a broker exclusively within the limited field or branch of business that applies to cemetery lots, plots and mausoleum spaces or openings.
Cemetery companyAn individual or entity that offers or sells to the public the ownership, or the right to use, a cemetery lot.
Cemetery salespersonAn individual holding either a standard or reciprocal license, employed by a broker or cemetery broker exclusively to perform the duties of a cemetery broker.
CommissionThe State Real Estate Commission.
Comparative market analysisA written analysis, opinion or conclusion by a contracted buyers agent, transactional licensee or an actual or potential sellers agent relating to the probable sale price of a specified piece of real estate in an identified real estate market at a specified time, offered either for the purpose of determining the asking/offering price for the property by a specific actual or potential consumer or for the purpose of securing a listing agreement with a seller.
ConsumerAn individual or entity who is the recipient of any real estate service.
CreditA period of 15 hours of instruction.
DepartmentThe Department of State of the Commonwealth.
Designated agentOne or more licensees designated by the employing broker, with the consent of the principal, to act exclusively as the agent or agents for the principal to the exclusion of all other licensees within the brokers employ.
Distance educationReal estate instruction delivered in an independent or instructor-led format during which the student and the instruction are separated by distance and sometimes time.
Dual agentA licensee who acts as an agent for the buyer/tenant and seller/landlord in the same transaction.
Hour of instructionA period of at least 50 minutes.
Independent learningAn interactive educational program, including computer-based technology courses, that provides no contact with an instructor.
Initial interviewThe first substantive discussion between a licensee and a consumer about the consumers real estate needs.
Instructor-led learningAn interactive educational program, including a classroom or simulated classroom, that provides significant ongoing contact from the instructor to the participant during the learning process.
LicenseeAn individual or entity holding either a standard or reciprocal license, under the act. For purposes of the consumer notice in § 35.336(a)(relating to disclosure summary for the purchase or sale of residential or commercial real estate or for the lease of residential or commercial real estate when the licensee is working on behalf of the tenant), the term means a broker or salesperson.
Listing brokerA broker who has entered into a written agreement with a seller/landlord to market property as a sellers agent, dual agent or transaction licensee.
Main officeThe fixed location other than a branch office of the broker or cemetery broker in this Commonwealth or another state devoted to the transaction of real estate business.
Manager of recordThe individual rental listing referral agent responsible for the rental listing transactions of a partnership, association or corporation that holds a rental listing referral agents license.
Nonexclusive buyer agency agreementA nonexclusive agreement governed by a memorandum or contract wherein the buyer retains the right to employ multiple brokers to purchase or lease a property.
Open listing agreementA nonexclusive listing agreement governed by a memorandum or contract wherein the seller retains the right to employ multiple brokers to sell or lease a property.
PrincipalA consumer who has entered into an agency relationship with a broker or another licensee employed by the broker.
Principal place of businessThe fixed location of the broker or cemetery broker in the state where the licensee holds the equivalent of a standard license.
Real estateAn interest or estate in land-whether corporeal or incorporeal, whether freehold or nonfreehold, whether the land is situated in this Commonwealth or elsewhereincluding leasehold interests and time share and similarly designated interests.
Real estate education providerA person or institution who offers real estate education regardless of whether the learning is instructor-led or independent, excluding colleges, universities or institutes of higher learning accredited by the Middle States Association of Colleges and Secondary Schools or equivalent accreditation.
Reciprocal licenseA license issued to an individual or entity whose principal place of business for the provision of real estate services is outside of this Commonwealth and who holds a current license to provide real estate services from a state that either has executed a reciprocal agreement with the Commission or has qualifications for licensure which are substantially comparable to those required by the Commission.
(i) An individual or entity that owns or manages a business which collects rental information for the purpose of referring prospective tenants to rental units or locations of rental units.
(ii) The term does not include an official or employee of a public housing authority that is created under State or Federal law.
(i) Sell or offer to sell real estate, or list real estate for sale.
(ii) Buy or offer to buy real estate.
(iii) Negotiate the purchase, sale or exchange of real estate.
(iv) Negotiate a loan on real estate.
(v) Lease or rent real estate, or offer to lease or rent real estate or to place real estate for rent.
(vi) Collect rent for the use of real estate, or offer or attempt to collect rent for the use of real estate.
(vii) Assist a broker in managing property.
(viii) Perform a comparative market analysis.
Seller agentA licensee who enters into an agency relationship with a seller/landlord.
Standard licenseA license, other than a reciprocal license, issued to an individual or entity who has fulfilled the education/experience and examination requirements of the act.
SubagentA licensee, not in the employ of the listing broker, who acts or cooperates with the listing broker in selling property as a sellers/landlords agent and is deemed to have an agency relationship with the seller.
(i) The right, however evidenced or documented, to use or occupy one or more units on a periodic basis according to an arrangement allocating use and occupancy rights of that unit or those units between other similar users. As used in this definition, the term unit is a building or portion thereof permanently affixed to real property and designed for separate occupancy or a campground membership or portion thereof designed for separate occupancy.
(ii) The term does not include a campground membership.
Time-share salespersonAn individual who, either as an employee or an independent contractor, sells or offers to sell time shares.
The provisions of this § 35.201 issued under the Real Estate Licensing and Registration Act (63 P. S. § § 455.101455.902); amended under sections 402, 404, 404.1, 513, 602, 606606.6 and 608608.3 of the Real Estate Licensing and Registration Act (63 P. S. § § 455.402, 455.404, 455.404a, 455.513, 455.602, 455.606455.606f and 455.608455.608c); amended under sections 201, 501, 601, 602 and 604 of the Real Estate Licensing and Registration Act (63 P. S. § § 455.201, 455.501, 455.601, 455.602 and 455.604).
The provisions of this § 35.201 adopted February 24, 1989, effective February 25, 1989, 19 Pa.B. 781; amended June 10, 1994, effective June 11, 1994, 24 Pa.B. 2904; amended January 7, 2000, effective January 8, 2000, 30 Pa.B. 228; amended November 17, 2000, effective November 18, 2000, 30 Pa.B. 5954; amended March 29, 2002, effective March 30, 2002, 32 Pa.B. 1644; amended December 10, 2004, effective December 11, 2004, 34 Pa.B. 6530; corrected April 29, 2005, effective December 11, 2004, 35 Pa.B. 2630; amended August 19, 2005, effective August 20, 2005, 35 Pa.B. 4711; amended November 14, 2008, effective December 15, 2008, 38 Pa.B. 6282; amended December 21, 2012, effective December 22, 2012, 42 Pa.B. 7647. Immediately preceding text appears at serial pages (339406) to (339410).
This section cited in 49 Pa. Code § 35.271 (relating to examination for brokers license); 49 Pa. Code § 35.272 (relating to examination for salespersons license); 49 Pa. Code § 35.273 (relating to examination for cemetery brokers license); 49 Pa. Code § 35.275 (relating to examination for rental listing referral agents license); 49 Pa. Code § 35.308 (relating to relationship with educational institution); 49 Pa. Code § 35.341 (relating to approval of real estate education provider); 49 Pa. Code § 35.354 (relating to prohibited forms of advertising and solicitation); and 49 Pa. Code § 35.385 (relating to continuing education providers).


text:
Between August 2008 and June 2009, Tarla Makaeff attended approximately seven real estate investing and finance seminars, workshops, and classes hosted by Trump University and spent a total of approximately $60,000 on the programs. Although Trump University asserted Makaeff was satisfied with the services Trump University provided to her, noting that Makaeff frequently provided excellent reviews of the programs, Makaeff stated the Trump University programs she attended were unsatisfactory. Specifically, Makaeff alleged the programs were shorter than advertised, she was provided only a toll-free telephone number instead of a one-year mentorship of “expert, interactive support,” and her Trump University mentors were largely unavailable and offered no practical advice when she did speak with them.
In addition, Makaeff alleged she was told by Trump University staff to raise her credit card limits to purchase real estate, but once she did, she was pressured by Trump University staff to instead use her elevated credit to purchase the Trump Gold Elite seminar for $34,995. Makaeff also claimed she was told by Trump University staff that her first real estate transaction after signing up for the Trump Gold Elite program would earn her approximately the amount she spent on the Trump Gold Elite program, which it did not. Additionally, Makaeff alleged Trump University instructed her to engage in illegal real estate practices, such as posting advertising “bandit signs” on the sides of roadways. On June 18, 2009, Makaeff received a letter from the Orange County District Attorney’s Office informing her that posting bandit signs in California without lawful permission could subject her to fines, a misdemeanor charge, and up to six months in jail.
Makaeff brought a class action lawsuit against Trump University on April 30, 2010. On May 26, 2010, Trump University filed a defamation counterclaim against Makaeff, alleging Makaeff “published statements to third parties about Trump University orally, in writing and on the Internet that are per se defamatory, including many completely spurious accusations of actual crimes.” Trump University alleged Makaeff’s defamatory statements were a substantial factor in causing actual and significant economic damages amounting to or exceeding $1,000,000. Madaeff responded with an anti-SLAPP motion, which was originally denied, but on appeal the Ninth Circuit determined that Trump University was a limited public figure, and send the case back to the District Court for a determination as to whether Trump University could still state a prima facie case, given the higher “actual malice” standard.
How was the case decided? Listen to the podcast to find out.
To prove actual malice, a defamation plaintiff must show by clear and convincing evidence that the defendant knew her statements were false at the time she made them, or that she acted with reckless disregard of the truth or falsity of the statements made. Gertz v. Robert Welch, Inc., 418 U.S. 323, 328, 94 S. Ct. 2997, 41 L. Ed. 2d 789 (1974). The clear and convincing standard “requires that the evidence be such as to command the unhesitating assent of every reasonable mind.” Rosenaur v. Scherer, 88 Cal. App. 4th 260, 105 Cal. Rptr. 2d 674, 684 (Ct. App. 2001). “A defamation plaintiff may rely on inferences drawn from circumstantial evidence to show actual malice.” Christian Research Inst. v. Alnor, 148 Cal. App. 4th 71, 55 Cal. Rptr. 3d 600, 612 (Ct. App. 2007) (citing Reader’s Digest Assn v. Superior Ct., 37 Cal. 3d 244, 208 Cal. Rptr. 137, 145-46, 690 P.2d 610 (1984)).
Actual malice is a subjective standard. See St. Amant v. Thompson, 390 U.S. 727, 731, 88 S. Ct. 1323, 20 L. Ed. 2d 262 (1968). “[R]eckless conduct is not measured by whether a reasonably prudent man would have published, or would have investigated before publishing. There must be sufficient evidence to permit the conclusion that the defendant in fact entertained serious doubts as to the truth of [her] publication.” Id.
Actual malice “has nothing to do with bad motive or ill will,” and “may not be inferred alone from evidence of personal spite, ill will or intention to injure on the part of the writer.” Harte-Hanks Commc’ns, Inc. v. Connaughton, 491 U.S. 657, 666 n.7, 109 S. Ct. 2678, 105 L. Ed. 2d 562 (1989). However, in appropriate cases, factors such as “[a] failure to investigate, anger and hostility toward the plaintiff, reliance upon sources known to be unreliable, or known to be biased against the plaintiff . . . may . . . indicate that the publisher [herself] had serious doubts regarding the truth of [her] publication.” Reader’s Digest, 208 Cal. Rptr. at 145-46 (citations omitted).
The Court finds Nguyen-Lam distinguishable from the present matter. In that case, the California Court of Appeals considered a defamation defendant who had learned about the defamation plaintiff, then a candidate for a public position, only through media reports yet accused her of being a Communist. 171 Cal. App. 4th at 868-69. The evidence in Nguyen-Lam indicated the defamation defendant had no personal knowledge of the defamation outside of the media reports, none of which had mentioned Communism, and thus had no basis for his claim that the defamation plaintiff was in fact a Communist. Id. at 869.
Trump University points to evidence of Makaeff’s anger and hostility toward Trump University, as well as a motive to get a refund, as evidence of actual malice. (Dkt. No. 300 at 17) (citing Christian Research Institute v. Alnor, 148 Cal. App. 4th 71, 84-85, 55 Cal. Rptr. 3d 600 (2007) (“anger and hostility toward the plaintiff . . . may, in an appropriate case, indicate that the publisher himself had serious doubts regarding the truth of his publication”); Harte-Hanks Commc’ns, Inc., 491 U.S. 657, 669, 109 S. Ct. 2678, 105 L. Ed. 2d 562 (“it cannot be said that evidence concerning motive or care never bears any relation to the actual malice inquiry”); Widener v. Pacific Gas & Elec. Co., 75 Cal. App. 3d 415, 436, 142 Cal. Rptr. 304 (1977) (finding an engineer’s motive of wanting to suppress the making of a film and his anger with the film’s producer “sufficient evidence from which the jury could have found that [the engineer] knew [his libelous statement about the producer] was false, or was recklessly indifferent as to whether his statement was accurate or not”)).
Ninth Circuit Opinion finding that Trump University was a limited public figure.

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