Anatomy of $79,860,000 Defective Product Verdict

Florence Kuhlmann is a 62-year-old woman, born on January 1, 1953, who lives in Pleasanton with her husband, John Perkins.  She earned a Bachelor’s degree in psychology, worked as a police officer for the San Jose Police Department for 20 years and retired in 2004.  Her husband is a physicist who works at the Lawrence Livermore National Laboratory.

Over the years, she had chronic hemorrhoid problems, which had become “more challenging.”  When she consulted with a surgeon, she was told her hemorrhoids were “at a stage” beyond which usual medication could help and that she required surgery.

Hemorrhoids are swollen veins that protrude from the anus.  When bleeding, painful or causing leakage, surgery is required.  Traditionally hemorrhoids have been removed by colorectal surgeons, who are specialists in colon and rectal surgery, including hemorrhoidectomies, which is a serious operation that causes considerable post-operative pain and a prolonged painful recovery.

Beginning in 2003, Johnson & Johnson’s wholly owned subsidiary Ethicon-Endo Surgery, Inc., manufactured and sold a new single use, disposable device to employ a procedure first developed in Italy in 1993, known as a hemorrhoidopexy, and approved in the U.S. in 2003, the PPH03 Proximate PPH Hemorrhoidal Circular Stapler.  

This disposable stapler was for use by all surgeons, as opposed to specialists, and required brief training of a general surgeon to perform a simplified 30-minute procedure, which has a much lower level of post-operative pain and recoveries of 2 to 3 days.

The PPH03 stapler and stapling procedure literally lifts the protruding hemorrhoids, “returns” them to their original anatomical position by gathering and lifting the walls of the anal canal which are trapped in the device.  The stapler is then hand fired to connect the healthy tissue located above and below the gathered wall of the canal.  A circular knife mounted in the stapler then cuts the trapped skin.  The stapler is used once and then discarded (referred to as “single use”).

The pressure to operate the stapler and the circular knife to cut the gathered wall of the anal canal is provided by the doctor squeezing a handle and applying “force to fire.”

Ethicon was required to have stringent quality control for products used in the human body.  Between 2003 and 2012, the company tested and recorded the data on the force to fire of every stapler gun it sold.  The pressure test proved the stapler would fire, but nothing more.  Every staple gun always passed inspection, even those that exceeded the 154 foot-pound specification because there was no specification for rejection, no stapler was ever rejected due to high force to fire. Staple guns that had an excessive force to fire, failed to meet design specifications and which were by definition defective, were packaged and sold by the thousands for use by general surgeons around the world.

Beginning in April 2011 the failure to reject defective staple guns was made worse by a change in the manufacturing process. Ethicon stopped submerging the stapler into a lubricant and began hand brushing the lubricant onto the stapler’s components.   

Ethicon admits the lubrication method is the primary factor that controls the force to fire the PPH03 stapler and knew that decreasing the amount of lubrication could potentially increase the force to fire and any changes in the operation of the stapler could be significant to surgeons and patients. Yet, Ethicon did not conduct any testing to evaluate whether the force to fire was in fact increased. 

Ethicon knew that any changes in the design or manufacturing process had to be carefully evaluated to ensure each of its disposable devices works as smoothly and as expected as all others previously used by doctors because of the need for near perfect performance.  That requires that every Ethicon stapler work just like every other disposable stapler previously used by the surgeon.

Ethicon admitted that this change in the lubrication process implemented in April 2011 caused the force to fire to increase. 

Throughout the manufacturing of the PPH03 numerous complaints were generated and reported to Ethicon regarding force to fire, incomplete firing and having the device get stuck in a patient. 

Although Ethicon thought it was conducting accurate “investigations,” its investigations were superficial and always blamed the surgeon, largely because Ethicon did not know that it had never rejected any staplers for excessive force to fire.  Therefore, all Ethicon could conclude was that the surgeon was to blame. 

Over nine years Ethicon operated in the blind.

In September 2011, reports of problems with the PPH03 staple gun increased very significantly, just six months after the lubrication change.

Ethicon’s chief design engineer for the PPH03, John Measamer, admitted in video taped deposition testimony taken by Shapirshteyn that dominated the trial for days the following:

• there were devices where we received customer complaints that were attributed to high force to fire;

• the product had a lack of lubrication, which did not meet Ethicon’s standard;

• some devices received less lubricant than others; resulting in higher variations for force to fire;

• the change in lubrication coincided with an increase in customer complaints;

• those that had lack of lubrication had too high a force to fire and in some surgeon’s hands would have been excessive;

• the customer complaints it received were indicative of incomplete firing strokes;

• surgeons reported second firings and repositioning of the device to free it when not performing near perfect performance; and that the device did not perform as intended

•  after April 16, 2011 the PPH03 stapler was sold and distributed with a manufacturing defect.

The increased force to fire presented a safety issue for patients, especially when used by surgeons whose physical strength was not enough sufficient to let them complete the firing stroke, resulting in a misfire.The primary complaints came from the Asian markets, where surgeons are generally of slighter stature.  

Dr. Rakhee Shah, who performed Ms. Kuhlmann’s surgery, is a slight woman of Indian origin.

As the surgeons began using the defectively lubricated staplers, Ethicon began receiving complaints that the staplers required a greater force to fire, were difficult to fire, did not fire a complete stroke, and were difficult to remove from the patient.  Not able to remove the device from their patients’ anal canal, the surgeons would realize the device had not fired completely and would fire it “again.”

Shapirshteyn uncovered the fact complaints which were received from experienced surgeons who had operated other disposable PPH03 staplers 100s of times. 

Numerous complaints were received before January 27, 2012, the date of the surgery that injured Florence Kuhlmann, including complaints that surgeons were not able to fire the stapler on the first try and not being able to remove the stapler. 

At no time before January 27, 2012 did Ethicon warn surgeons of these issues by letter or through its sales representative and it did not instruct doctors on what to do when the instrument became stuck inside a patient.

To the contrary, Shapirshteyn in reviewing thousands of documents found an email by Ethicon executive which confirmed that the company concealed the issues with the staplers and represented to surgeons at meetings there had been no problems had been identified in firing.  The email was circulated to critical.  Ethicon’s manager admitted to Ms. Shapirshteyn that there was no written procedure not to tell doctors about the problem, but it was understood by Ethicon employees that this topic was not to be discussed.

On August 2, 2012 Ethicon finally issued a worldwide Class 1 voluntary recall of 144,693 staplers. 

Class 1 is the most urgent recall designation where a medical device can cause serious injury or death.  Ethicon stresses that this was a voluntary recall and that it moved as fast as possible to determine if the stapler were defective once the problem started to come to light in September 2011.

On October 24, 2012, the U.S. Food and Drug Administration announced the recall was “because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation. Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence [gaping or bursting open] of the rectal wall staple line and bleeding.  The recalled staplers were manufactured from April 16, 2011 to July 23, 2012 and distributed from April 18, 2011 to July 24, 2012.” 

The recall came six months too late for Florence Kuhlmann, age 59.

On January 27, 2012, Florence Kuhlmann underwent a stapled hemorrhoidopexy, performed with a PPH03 staple gun used by Rakhee Shah, MD, and a general surgeon with no specialty training in colorectal surgery.  Dr. Shah was experienced in the operation of the PPH03 and previously had used the staple gun 20 times.

            According to Dr. Shah’s procedure note, she closed the stapler – which was tougher than usual to do – and fired it, then opened and attempted to remove it. However, it appeared that the stapler had not fired the first time and Dr. Shah could not bring it out.  It was stuck.  Dr. Shah closed the stapler and fired it again and was able to remove the stapler the second time. She noted there was an “issue with the stapler not firing the first time.”   A subsequent note by Dr. Shah reports that the hemorrhoidopexy was “complicated by staples misfire.” 

            Dr. Shah has testified it was more difficult than usual to close the stapler and it was hard to operate all aspects of the stapler.  She reported to an Ethicon sales representative that the force in closing the stapler was higher than usual and it was tougher than usual to close.

On January 27, 2012, Florence Kuhlmann underwent hemorrhoid surgery at Pleasanton Surgery Center.  Dr. Shah’s operation report states there was a misfire of a stapler used in the procedure and torn rectal tissue that required stitches to repair.  It was an outpatient procedure, and she was released with antibiotics.

The surgery took place on Friday afternoon.  After a full weekend of bloating and pain from having her anal canal stapled shut, Ms. Kuhlmann in the early morning hours of Monday January 30, 2012 came to a hospital emergency room.  Dr. Shah was unable to determine at bedside why Ms. Kuhlmann was not passing waste (i.e.; unable to poop).  Florence was taken to an operating room for general anesthesia and an unsuccessful attempt was made to open the anal canal.

            Tuesday morning a colorectal surgeon, assisted by Dr. Shah, also was unsuccessful in an attempt under general anesthesia to drain Ms. Kuhlmann’s obstructed bowel. 

            Tuesday afternoon the colorectal surgeon had permission to open Ms. Kuhlmann’s abdomen, performed a full laparotomy across her pelvis, and confirmed that the rectum had been stapled shut.  The surgeon then severed her colon from the remaining rectum for drainage into a colostomy bag.  Florence had suffered peritonitis and severe sepsis that required 20 days of hospitalization and massive infusions of antibiotics.  She was discharged with a colostomy bag attach to her abdomen, which she wears to this day. She underwent exploratory surgery and was diagnosed with massive peritonitis.  She was given a diverting colostomy and was intubated and put in a medically- induced coma for one week.  She remained in the hospital for another two weeks.  

Ethicon’s claimed there was no documentation in the surgery center records that the stapler used in the Kuhlmann surgery was part of a recalled lot of staplers and that both Florence’s claim and that of Dr. Shah are confused based on Dr. Shah’s errors.

            The actual stapler was discarded and the surgery center where the procedure was performed did not record the lot number of the actual stapler that was used. Normally a device that does not work properly is returned to the manufacturer.  That was not done in this case because Dr. Shah did not have any problems with the stapler itself and did not consider the stapler defective in any way because it was not defective.  If it was defective it would not have been discarded, was the claim.

Furthermore, the surgery center followed a well-established healthcare practice policy known as FIFO: first in, first out.  The first and the oldest items to arrive were used before the later or newer items.  The surgical center’s staff was required to follow this policy.  They knew that the oldest devices were to be used first.  To ensure the FIFO procedure was followed, the staff took the oldest “first in” staplers off the top and checked the expiration date to make sure the oldest was being used first.

            The surgery center did not maintain a written inventory record of the use of the staplers and the nurse’s notes did not record the specific stapler used in this particular surgery.  For these reasons it is impossible to know anything about the actual stapler that was used.  In other words Florence Kuhlmann cannot prove her claim because she cannot prove that the stapler used on her was one of the recalled staplers that are deemed defective.

As a result of Shapirshteyn’s dogged discovery efforts it was determined that of the18 Ethicon staplers purchased by the surgery center between January 1, 2010 and June 3, 2011, the first 15 staplers were not recalled.  The last three delivered on June 3, 2011 were identified as recalled units. The following table cross-references the deliveries of the staplers with the dates of the surgeries:

If FIFO was accidentally not followed, as Ethicon claimed, the oldest non-recalled stapler would have been bypassed on October 19, 2011, December 2, 2011, and again January 24, 2012. 

           It is unlikely that the surgery center nurses violated the FIFO policy three times in a row.

           Assuming that FIFO was not followed in the four surgeries beginning with October 19, 2011 and that the four Ethicon devices were used at random, the odds are three chances in four that a defective stapler was used on Ms. Kuhlmann.  It is highly improbable that all the three recalled devices were used before the oldest, unrecalled or non-defective device was used.

           The jury agreed.

Ethicon’s placed full responsibility for the plaintiff’s injuries on Dr. Shaw for failing to meet the standard of care in performing this surgery and when the staple gun was obviously difficult to fire, she had to conclude the procedure to avoid causing any harm.  If she was not able to remove the stapler from the patient she should have arranged for her patient to be admitted to the hospital on an emergency basis and secured a colorectal surgeon to provide appropriate care.  The failure to do so was a violation of the standard of care.

            Assuming she was able to stop and remove the stapler, being aware that there had been a very unusual event in the operation of the stapler, unlike the 20 previous times when she had successfully and appropriately used the stapler, it was her obligation to make a full and complete examination to determine if the staple gun had fired, confirm that the colon was open and conduct a thorough inspection of the anal canal to determine if the stapling had proceeded as expected. The failure to do so was a violation of the standard of care.

            If Ms. Kuhlmann was intact and without injury, the procedure should have been rescheduled.

The failure to do so was a violation of the standard of care.

              If there was bleeding or any issues with her physical examination in light of the problems that occurred in the operation of the stapler, Ms. Kuhlmann should have been transferred to a hospital for immediate care by a colorectal surgeon. The failure to do so was a violation of the standard of care.

Plaintiffs’ expert Daniel Feingold, M.D., professor of surgery at Columbia University, testified that starting the surgery with a defective staple gun set the stage for all that followed and the total harm that has been inflicted on Ms. Kuhlmann started with a defective surgical device that was recalled exactly and specifically for the same problems Dr. Shah had on January 27, 2012.

The October 24, 2012 the Food and Drug Administration recall announcement that the PPH03 stapler stated the reason for the recall was:

“difficulty users have firing the stapler device resulting in incomplete firing stroke and incomplete staple formation” with one of the adverse outcomes of using a PPH03 stapler from a recalled lot is “occlusion of the rectal canal.

           Dr. Feingold a board-certified general surgeon was carefully asked by Alexander if Dr. Shah had performed the surgery properly.  Dr. Feingold concluded there was no error in the procedure itself, except afterward Dr. Shah “failed to appreciate” that a portion of the rectum had been pulled down and sutured, closing off the rectum.  In order to keep the focus on Johnson & Johnson and to minimize down play an allocation of fault to the surgeon, as an aside Dr. Feingold was asked if this was a violation of the standard of care and then the direct examination quickly moved to a detailed discussion of the horrendous damages suffered by the patient and the future surgeries she was facing.

The stapler used by Dr. Shah was extremely hard to use which is consistent with her immediate reports that she had difficulty firing the stapler and, only after the second attempt, was able to fire it. The PPH03 stapler that “malfunctioned” during Ms. Kuhlmann’s surgical procedure was representative of the staplers involved in the recall because the characteristics of the incident involving Dr. Shah’s adverse incident clearly are substantially similar to complaints from other doctors with difficulty in firing, incomplete firing, misfiring and entanglement with body tissue, keeping in mind that this device requires “near perfect performance.”

           Dr. Shah has performed more than 20 previous surgeries with the PPH03 without problems.  Dr. Shah was never informed of the change in lubrication and the many complaints of other surgeons that the device after April 2011 was much harder to fire, would become stuck and that misfirings were to be expected.  Ethicon never provided any warning what should be done when the PPH03 became stuck to free it.  Had Ethicon fully advised Dr. Shah of what it knew before January 27, 2012 she would have been alerted to this specific defect and would have been in a much better position to avoid all that has happened to her patient. 

The defective stapler that injured Plaintiff is from lot H43U63.   The stapler has various settings.  Dr. Shah fired the injury stapler using the tightest staple setting.  

            The post-recall test measurements of the force to fire the defective batches on that setting show that 17 out of 40 were defective. That is a defect rate of forty-two (42) percent.  In another recalled batch, testing showed that 7 out of 32 or 22% had a force to fire greater than the specification and should have been rejected, scrapped and never sold.             

Florence Kuhlmann has suffered severe pain, sphincter dysfunction, rectal wall damage, sepsis, peritonitis, bleeding, and occlusion of the rectal canal and endured 21 days of emergency hospitalization for a massive abdominal infection. 

            After her hospitalization, she had a total of 12 follow-up procedures including various unsuccessful attempts to repair her colon.

            Florence consulted with colorectal surgeons at Stanford who in multiple attempts were unsuccessful in dilating her rectum. 

            Next followed two trans-anal micro surgeries at the University of San Florenceco, which failed to release the severe constriction of her rectum.

            Total medical expenses were $223,999.  The fact that these were paid by medical insurance was admitted into evidence.

            Today Florence has a double barrel colostomy, with one end to the top of the ascending colon and the other to the descending colon.  One end is herniated and protrudes more than it should, which may require surgery in the future.  She sometimes feels pain at the site.

            In general, she is able to manage her colostomy and discard the collection bags.  She usually does this at least once or twice a day.  Her husband helps change the collection bags when he is home in order to share the task.  She uses a two-piece system, and the patch, which sticks onto her skin, needs to be changed once a week.  Her husband helps with this.

            She has had frequent diarrhea, which causes a variety of problems.  If the bag fills when she is asleep, it becomes detached and leaks.  Leaks have occurred in the moments between removing an old bag and putting on a new one.

            She has always been happy with her figure but now cannot wear anything that shows her waist because of the collection bag.  She passes gas uncontrollably, regardless of where she is.  Her sleep is erratic.

            Ethicon’s board certified colorectal surgeon, admitted on cross-examination by Shapirshteyn that he had only read Ms. Kuhlmann’s medical records and never examined her.  He opined that Ms. Kuhlmann would have to live the rest of her life with a colostomy bag. 

            Dr. Dan Feingold plaintiffs’ colorectal surgeon on the other hand had performed a full physical examination of Ms. Kuhlmann and concluded:

1. Ms. Kuhlmann underwent elective stapled hemorrhoidectomy complicated by rectal occlusion requiring colostomy creation and she developed a rectal stricture.
2. The presence of the colostomy and her ongoing pelvic symptoms are directly due to the hemorrhoid surgery and its complications.  
3. Ms. Kuhlmann will have longevity typical for a healthy, Caucasian female to approximately age 83.
4. Further attempts at trans-anal management are unlikely to successfully address the abnormal anatomy.
5. Ms. Kuhlmann has two remaining options.  
6. Option # 1 is to leave the colostomy in place for the rest of her life.  This would permanently leave her with the disfigurement of the colostomy.  As time goes by, she may require revisional surgery to repair the prolapsing and herniating colostomy.
7. Option #2 is to undergo further abdominal surgery under general anesthesia to remove her rectum together with the stricture and attempt to restore continuity of the intestines by connecting the colon to the anus.  This is a major operation that would require two stages and the creation of a new temporary stoma (abdominal port) called an ileostomy.  The first stage typically requires 5 hours in the operating room and a 7 day hospitalization.  The second stage typically requires an hour in the operating room and a 4 day hospitalization.
8. Ms. Kuhlmann would hopefully have acceptable function after healing from these two operations.
9. She would most likely have fecal urgency, frequency and accidents, decreased sensation and pad use/dependence.

            The cost of the second option costs $310,943.61 as supported and reported by Carol Hyland.

Shapishteyn delivered a straight forward summary of 24 days of evidence to which Ethicon had no real response other than Ethicon had complied with all FDA rules and regulations. Summarizing all the evidence with detailed citations to the transcript for the jury to note was superlative.  

            Dr. Shah’s argument focused on the defective stapler that she was provided and the failure of Johnson & Johnson to warn her.

            Alexander’s rebuttal noted that Ethicon had betrayed not only doctors and patients, but also the FDA and its own employees by its management decisions.  Defense counsel attempted to defeat the claim of malice by arguing there was no malice in this case,  such as the public had seen in San Bernardino and Sandy Hook.  Alexander’s response: “shame on you.”

On December 10, 20115, after 24 days of trial, the jury of 7 women and 5 men retired for two days of deliberation and by votes of 12-0 found the manufacturer strictly liable for a defective stapler strictly liable for failure to warn and general negligence.  Dr. Shah was found not to be negligent. 

            Ethicon Endo-Surgery, LLC the manufacturer was found 90% at fault and Johnson & Johnson Health Care Systems, Inc. 10% at fault.  Buy 9-3 the jury found that Ethicon Endo-Surgery, LLC acted with malice.  The award for Florence Kuhlmann were $212,622.99 for past medical expenses, $310,943.61 for future medical expenses, past pain and suffering $4,000,000 and future pain and suffering $4,000,000.  The award for John Perkin for past loss of consortium was $400,000 and for future loss of consortium $900,000.

The punitive damages phase lasted only a few hours.

            Supported by the evidence of Ethicon-Endo’s net worth of $6.8 billion, produced during trial on a direct order of the trial judge, Shapirshteyn recommended the jury impose a penalty of 1-2% of Ethicon’s net worth, which would put the verdict within “ten times” the compensatory verdict.

            In less than two hours, the jury by a vote of 9-3 found punitive damages of $70 million against Ethicon-Endo Surgery. 

            A stunning call to reality for the defendant flowing from detailed video-taped depositions, admissions of senior managers and uncovering a plan to conceal known problems with the device from surgeons around the world.