Product Stickers: The Gold Standard

It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

Hospital Records: Typed Identification of Specific Components

For some reason, not all hospitals and surgery centers keep product stickers. Some simply throw them out with the boxes. It is not a good practice, but it happens. In those cases the person responsible for identifying the components usually types in the specific lot and reference numbers and other identifying information for each device component used in the surgery.

Operative Report

In any surgery the surgeon always writes up (usually dictates) an Operative Report where he or she describes what occurred during the surgery. In this report the doctor will explain the procedure and will reference the components used and implanted. In another section of this report, titled something like “Implants,” the doctor will list the specific components, with complete names and actual sizes.

Explants: Preserving and Keeping the Actual Device Removed From Your Body

The actual gun used in an armed robbery is better evidence than a description or a photo of the gun. The same holds for a product liability case involving a failed medical device. That’s why you should do all that you can to “preserve evidence” by making sure your surgeon understands you want to preserve and maintain any components removed from your body (“explants”). I wrote extensively about preserving explants here, and I invite you to read that article, but in a nutshell you need to send a letter to your physician asking her or him to preserve all evidence, especially explanted medical devices following the surgery. With written notice in advance, the doctor and the hospital usually understand the drill and will preserve the removed components, usually by sending the explanted components to the pathology department to hold the components for the patient or the patient’s attorney.

Surgeon’s Affidavit

As you can imagine, lawyers representing companies that sell defective medical devices will use every advantage to derail your case. If defense lawyers can cast doubt on what device is in your body, then you as the injured person cannot win your case. In some instances the product stickers were not maintained with the hospital records and the explanted components were not preserved. In that case, even with the typed identification of the products (see Hospital Records, above), you may need to obtain a signed and sworn affidavit from the surgeon testifying to the exact components implanted in your body. I have used this technique in the past and it has worked well.

Get Help From a Good Product Liability Lawyer

I’ve written about this subject on this site so often I’m not even going to link you to the other articles (they are easy to find). But I will say this: you need to work with an experienced product liability lawyer on any defective medical device case, and preferably before you undergo revision surgery (for several reasons, but mainly so the attorney can communicate with the surgeon and the hospital in advance about preserving all relevant evidence).

Identifying your medical device is very important. Being legitimately injured by a defective product is not enough. You have to show what product injured you. If you can’t, you don’t even know which medical device maker to sue. Put obviously: you cannot sue DePuy Orthopaedics for a defective Smith & Nephew artificial hip. So it is vital that you identify the exact components that injured you, in as many ways as possible. Good luck.

By all accounts, each of the three bellwether trials in the DePuy Pinnacle artificial hip MDL has been contentious. In the fourth bellwether trial, which should wrap up this week, the litigants have been in a fierce battle again. The most recent skirmish has centered on allegations by plaintiffs suggesting that lawyers for DePuy Orthopaedics may have been trying to influence the testimony of a witness for the plaintiffs.

I want to share with you the affidavit submitted by Dr. David Shein, a surgeon who treated three of the six plaintiffs involved in the current trial. Dr. Shein was once expected to be called as a fact witness in the case by the plaintiffs.

Affidavit of David Shein, M.D.

1. On Friday, October 13, 2017, at approximately 11:00am while was scrubbing in for surgery at the Montefiore Hospital, I met with my DePuy sales representative Glen Swajger in connection with a procedure that required his involvement.
2. Mr. Swajger looked terrible and appeared stressed, so I asked him what was going on. He said the day before (October 12, 2017), he had been contacted by the DePuy lawyers and that discussion made him anxious. He said the lawyers were “on him like crazy.” They were putting “big time pressure” on him.
3. Mr. Swajger told me that as a result of the conversations with DePuy attorneys, he was worried there could be ramifications for me in my practice in connection with my upcoming Dallas testimony.
4. He indicated the lawyers were “peppering him.” He said the “business in Dallas was freaking [him] out.” He said he had a “terrible” day on Thursday as a result of this and my going to Dallas was driving him crazy. He said “I care about you.”
5. Mr. Swajger also told me on Friday that he knows as much about metal on metal as I do, and that he would still want metal on metal because the wear characteristics are better than metal on poly, and he would want me to do his surgery.

What Does All This Mean?

Frankly, this affidavit is astonishing. It suggests that lawyers for DePuy Orthopaedics may have reached out to a DePuy employee, medical device sales representative Glen Swajger, for the purpose of using Swajger to influence the testimony of Dr. Shein, who was scheduled to give testimony in the fourth DePuy Pinnacle bellwether trial.

In the affidavit Dr. Shein states under oath that the DePuy sales rep “looked terrible,” that the DePuy lawyers were putting “big time pressure on him,” and that Swajger stated “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial. Plainly, this would send up a huge red flag to any lawyer trying a case against DePuy. The implication is that the DePuy lawyers wanted to know what Dr. Shein was going to reveal at trial, and possibly wanted to alter what Dr. Shein intended to say. Granted, this affidavit represents hearsay statements attributed to a DePuy employee, and at this point it cannot be taken as anything more than an allegation. But it looks awful, and it suggests an attempt to intimidate a key witness.

The last paragraph may be the most alarming. In it Dr. Shein recounts that Swajger made unsolicited statements about the safety of metal-on-metal hip implants, and that if Swajger were to undergo hip replacement surgery he would want metal-on-metal “because the wear characteristics are better than metal on poly [polyethylene, or plastic] . . . .”

This is jaw-dropping.

If this statement were actually made by a DePuy employee to a surgeon who is preparing to testify in a case about the safety and effectiveness of the metal -on-metal Pinnacle hip, it is hard not to see it as anything other than an attempt to influence the witness’s testimony. Even the judge presiding over the DePuy Pinnacle MDL stated that the affidavit was “disturbing” and “disconcerting.”

If the allegations are proven to be true, a mistrial could be issued, and sanctions could be imposed on the defense team. Further, any lawyer found guilty of witness tampering could be prosecuted and/or disbarred. It is a very serious matter.

So What Did the Judge Do?

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. This means that FBI agents and federal prosecutors will question Dr. Shein, Swajger, and the lawyers involved in connection with the affidavit. Following a hearing on the issue yesterday, Judge Kinkeade denied plaintiffs’ request to introduce the allegation of witness tampering to the jury. The judge decided that there was insufficient evidence that tied DePuy and Johnson & Johnson to the actions of their lawyers. It also appears the Swajger backed off his most alarming comments reflected in the affidavit.

The Takeaway?

The FBI investigation has not been completed. The affidavit, however, is troubling, and the call for an FBI investigation is the right one. At the very least this incident underscores how aggressive cases can become on the national stage. Billions of dollars may be at stake, not only for the six plaintiffs in this trial, but also for the thousands of plaintiffs that still have not resolved their cases in the MDL. With so much at stake, the takeaway so far is that both sides must remain vigilant at every turn to possible wrongdoing.

I will keep you posted on the outcome of the DePuy Pinnacle bellwether trial. Closing arguments in the case begin today, and the jury could reach a verdict by the end of the week.

This article was written based on my review of court documents, several news reports, and my previous writing on the subject.