Behind the Ethicon Endo-Surgery $70 million punitive damages award

What it takes to try a products liability case without the defective product

Nina Shapirshteyn
2016 February

I hate being lied to. When I say “hate,” I mean the emotion born in your stomach that spreads rapidly through your body, heating every cell as it travels past your heart and up to your brain, filling it, nearly paralyzing the brain with its overwhelming presence.

We rightfully give speeches about compassion: how to understand our clients and fight for them by putting ourselves in their shoes. It is a skill necessary to being a good advocate.

But we rarely talk about hate. What is embarrassing about this natural, basic, raw human emotion we feel toward someone who wrongs our clients? Who violates the most important concept that makes us human – the ability to care for another human being? And who does not care for human suffering but instead places profits above people’s lives?

That kind of hatred, born out of compassion, need not be suppressed. It should be channeled to fuel the fight, to never get tired, to never give up, and to grind it out to the end.

Let’s face it: there are some truly despicable lawyers out there who bully, lie, cheat, and conceal evidence. In the past, when I would get a case with an evil opposing counsel, I would sigh and begrudgingly go on, hoping to minimize all interaction. Now, I welcome an opponent who makes my life difficult with scorched earth litigation tactics and their client who puts profits over people. I welcome them because I know they will make me work harder, add passion, and pour through each document, depose every witness, and leave no stone unturned until I find what defendant is trying to hide through their deceitful or dilatory behavior.

The lessons from Ethicon

In December, 2015, a jury returned a verdict for our clients in the amount of $9.8 million in compensatory damages and $70 million in punitive damages against Johnson & Johnson’s subsidiary, Ethicon Endo-Surgery, LLC.

One year before that, I was convinced Ethicon and their attorneys concealed a vital piece of evidence. After several weeks of games, it became clear Ethicon’s subsidiary had the evidence; Ethicon and its lawyers knew it, and intentionally concealed it.

Ethicon manufactured a PPH03 Stapler for use in hemorrhoid surgery. The stapler stapled plaintiff’s upper rectum to the lower rectum, causing an occlusion, and requiring a diverting colostomy which plaintiff endures to this day. Despite numerous complaints by surgeons of the firing problems, Ethicon waited over a year to recall the stapler and seven months after our client’s

The product was discarded. From day one, Ethicon gloated in its defense that we could never prove the defect without the product. Ethicon insisted that
(1) plaintiff could not prove the subject device was one of the recalled lots;
(2) even if the device was one of the recalled lots, it was not necessarily defective because only a small percentage of the recalled devices was defective; and
(3) there was no way to test the device to prove the defect. I began gathering every piece of circumstantial evidence to show the defect.

Identify the missing product through shipping records

Frequently, medical devices come with a sticker identifying the specific device which is then affixed to the operating report. Months later, you can pull the operating report and use the sticker to trace and identify the device used.

There was no lot number or serial number recorded in the operative report identifying the medical device used. We subpoenaed the packing lists for all PPH03 staplers ordered by the surgery center. A packing list is a document shipped with the device which contains crucial identifying information about the device: the date shipped, the number of products shipped, the lot number of the product, and the expiration date. We also obtained the operating reports for all surgeries in which the PPH03 stapler was used.

Ideally, we then could match each surgery with the specific stapler based on the surgery date and delivery date. Especially with expensive devices, hospitals/ surgery centers only keep a few in stock and order them on an as needed basis. The devices are rotated according to “FIFO,” or the “First in, First out” policy, where the oldest device is used first. With these tools, you can usually figure out which device was used for your client’s surgery even if the device is missing.

Do not let incomplete discovery responses “off the hook”

In our case, the surgery center was missing one packing list which identified the staplers most likely used in our client’s surgery. Because the packing list is shipped by the distributor, we sent a request for production to Ethicon, asking for all packing lists. Initially, it appeared that Ethicon did not have them. But upon scrutinizing Ethicon’s response, it became clear that the response was evasive at a minimum. There was no statement of inability to comply. When I tried to pin down Ethicon’s counsel, the same evasive responses followed and Ethicon did not provide responses required by the Code.

It turned out that another subsidiary of Johnson & Johnson, JJHCS distributed the staplers for Ethicon. Of course, Ethicon knew that all along, but failed to state who had the packing lists. We obtained the packing lists and sued JJHCS as well. The jury ultimately found both Ethicon and JJHCS strictly liable.

Remember, there is no legitimate reason for a big-firm-trained attorney not to answer discovery as required by Code. They know how to provide a correct response. If they do not, it is by design. Never disregard long-winded responses that tell you nothing and leave you more confused than before reading them. Follow up and insist on the statement of compliance or inability to comply. These are protections written into the Code of Civil Procedure specifically to prevent egregious discovery abuses and concealment of the evidence.

Require strict adherence to the Code, especially the often ignored and relaxed view on the statement of compliance/inability to comply. If a party is complying with the request for production, a party must give clear statement of compliance stating the requested documents will be produced in whole or in part, and that all documents in possession/control of the party will be produced. (Code Civ. Proc., § 2031.220). If unable to comply, a party must give an unequivocal statement of inability to comply, affirming a diligent search and reasonable inquiry have been made; specifying if the inability to comply is because the item has never existed, has been destroyed, etc., or is not in possession/control of the responding party; and providing the name of person believed to have possession/control. (Code Civ. Proc., § 2031.230).

Defendant’s evasive responses and its attorney’s evasive responses, followed by the discovery that Defendant knew all along the location of the crucial evidence, were infuriating. Disgusted with the fact that members of our profession intentionally conceal and most likely guide their clients to conceal evidence, I was determined to find out what else they were hiding.

Circumstantial evidence: “Less is more” does not apply

The judge instructs the jury that circumstantial evidence is just as good as direct evidence. But we know that it is human nature not to see it that way. For that reason, when your only proof of defect is circumstantial evidence, “less is more” does not apply. Gather all circumstantial evidence and trickle it in one by one throughout the trial to continue to remind the jury that every piece of evidence makes it more likely than not that the device was defective.

The defect for which Ethicon finally recalled its PPH03 staplers was the lack of lubrication, which caused increased friction in the components, which in turn increased the force to fire the stapler. The excessive force-to-fire caused difficulty firing the stapler, resulting in incomplete firing strokes and damage to the rectal wall.

In addition to showing through the packing lists that the stapler used on our client was one of the recalled lots, we called everyone in the operating room to testify. The surgeon testified she thought she completed the firing stroke, but realized she had not and had to fire the stapler the second time to finish the stroke. The circulating nurse testified she heard the surgeon comment that the stapler was difficult to fire. The surgical technician testified she heard the same. Plaintiff’s husband testified the doctor told him after surgery that she had difficulty with the stapler.

The combined effect of several witnesses’ consistent description of how the product malfunctioned is very powerful.

We explained to the jury that the loose, partially formed staples found in Plaintiff’s lumen after the surgery indicated that the stapler fired an incomplete stroke, as the staplers with the force-to-fire defect have done. Over Ethicon’s motion to preclude me from doing so, I took a four-day video deposition of Ethicon’s corporate designee on complaints and asked her about every single complaint. The jury heard hours of other surgeons’ complaints describing similar firing issues.

Finally, I obtained the force-to-fire measurements for each stapler manufactured by Ethicon for the relevant lots. While Ethicon had claimed only a small percentage of the recalled staplers was defective, the measurements taken at the assembly line showed that one-third of the staplers fired in the tight-staple setting were defective. So, even without any corroborating testimony, we were able to show the jury that the chance of any stapler being defective based on the measurements alone was 33 percent. Compounded by the witness testimony and other circumstantial evidence described above, the scale was tipped heavily.

Take video depositions of manufacturer’s employees and persons most qualified

Video depositions can be boring to watch, but they can also be invaluable. Often, defense lawyers prepare their clients for deposition by teaching them how to give evasive answers. The deposition becomes an endurance contest with defense lawyer interposing objections to every question, coaching their client, and the client giving evasive answers. You are being given a party line. Every question you ask, you get the same talking points, the same script.

It is a frustrating experience, but in those hours of video you will inevitably find some gems. Aside from the admissions you extract from the witness, the jury will see defendant’s attempts to muddy the waters and to avoid direct answers at all costs. These slippery responses are often just as, if not more, valuable as the admissions would have been. The jury will see the defendant is wronging the plaintiff twice: first, by being negligent – as evidenced by the evasive circular response and then by being dishonest about it.

Human beings are forgiving. So is the law. “I am sorry” goes a long way. Until then, there are punitive damages…

Nina Shapirshteyn Nina Shapirshteyn

Nina Shapirshteyn of the Alexander Law Group (San Francisco, San Jose) was selected as a Trial Lawyer of the Year by the San Francisco Trial Lawyers Association for her work as lead counsel in the Kuhlmann v. Ethicon-Endo Surgery, LLC, Johnson & Johnson Health Care Services, et al. in which a jury awarded $79.8 million. She was honored as a Northern California Super Lawyers Rising Star, in 2013 and 2014. In 2015 and 2016 she was selected as a Northern California Super Lawyer. Ms. Shapirshteyn is admitted to practice in California and New York.

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