Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit

Aug 9th, 2012 | By | Category: Legal News

Mersilene Mesh, BiotecSA website

August 8, 2012 ~ An appeals court ruling in Mississippi has upheld a lower court dismissal of a $10 million vaginal mesh case against Johnson & Johnson’s Ethicon division.

The United States Court of Appeals Fifth Circuit filed the decision August 2, 2012 in the case against Ethicon by Deborah and Michael Smith.

Deborah Smith had a hysterectomy in 2001 along with pelvic organ prolapse which required additional surgery. Dr. Phillip Barksdale of the Women’s Hospital in Baton Rouge, Louisiana did the abdominal sarcoplexy April 12, 2002 using Mersilene mesh made by Ethicon, a division of Johnson & Johnson (J&J).

The court noted that the mesh had a package insert that said “No significant adverse clinical reactions to MERSILENE mesh have been reported. The use of nonabsorbable MERSILENE mesh in a wound that is contaminated or infected could lead to fistula formation and/or extrusion of the mesh.”

Dr. Barksdale said he was familiar with Mersilene mesh and had used it hundreds of times and was aware of the risks involved.

Deborah Smith experienced pain, vaginal discharge and by July of 2006 she was diagnosed with vaginal mesh erosion, sinus tract formation, pain, adhesions and rectocele. She was admitted to the hospital and stayed for five weeks. Smith became sick with sepsis (infection), renal insufficiency, pneumonia and respiratory failure.

The Smiths filed their complaint on October 16, 2007 in federal court in the Eastern District of New York which was later transferred to the Southern District of Mississippi. They claimed negligence, strict liability, breach of implied warranty of merchantability, breach of express warranty and loss of consortium.  They had requested damages in the amount of $10 million.

Strike the Experts

The court noted the Smiths submitted the names of three experts on the day of a deadline. The witnesses included the expert testimony of Drs. Stuart Hart, Kyle Wohlrab, Robert Lloyd Goldstein, and William A. Hyman.

Ethicon argued the names were not sufficient and that the reasons those persons had been chosen needed to be stated under federal law. Ethicon layers filed numerous motions to strike the Smith’s expert witnesses based on lack of timeliness. The court also concluded the expert witnesses did not provide “factual support or reasons for their conclusions.”

Drs. Hart and Wohlrab had stated they believed Mersilene mesh caused vaginal erosion.

“Dr. Hart’s medical report did not address the actual question at issue in this case, which is not whether the Mersilene mesh caused Smith’s injuries, but whether the warning provided by the manufacturer in the Mersilene mesh documentation was sufficient and whether any inadequate warning caused Smith’s injuries.”

The defective product lawsuit was dismissed by the lower court in favor of Ethicon. The Smiths filed an appeal of that order on the basis that certain experts were not allowed to testify on their behalf. In addition, the Smiths also appealed being ordered to pay some legal fees to Ethicon for the alleged late filings.

The appellate court found the lower court’s evidentiary rulings were not an abuse of discretion and the Smiths did not factually state the inadequacy of the Mersilene warning and whether an adequate warning would have prevented the doctor from using Mersilene mesh.

An inadequate warning or a failure to warn can be one additional component of a defective product or product liability case.

Learned Intermediary

The court granted Ethicon’s summary judgment dismissing the case based on the “learned intermediary” defense.

The Mississippi court cited the “learned intermediary doctrine” as “a manufacturer of a prescription drug has no duty to warn the end user of the drug’s possible adverse effects.” In other words, the physician is the end user, the “learned intermediary” between the patient and manufacturer and the duty to warn stops with him or her.

The Mississippi rule also applies to medical devices.

Mesh Complications

Since the product label said there were “No significant adverse clinical reactions to Mersilene mesh,” the Smiths dug into the FDA database and found that was not true. There had been eight adverse event reports prior to 2002 of injuries associated with Mersilene mesh, three of which resulted from tears in the mesh.   The Smiths had argued that information should have been on the mesh product warning on the package and if it had been, Dr. Barksdale would not have used Mersilene mesh.

Dr. Barksdale testified that he was aware of the risks of Mersilene but still thought the mesh was the best option for Mrs. Smith. If the doctor is the end user, that ends the argument if he was aware of some of the warnings.

The Smiths were ordered to pay the legal costs of Ethicon’s responses to late paperwork and ordered to pay costs to Ethicon.

Civil Action No. 3:08cv245 HTW-LRA

Mississippi Southern District Court
3:2008cv00245

Learn More:

U.S. Court of Appeals 5th Circuit:
http://www.ca5.uscourts.gov/opinions%5Cunpub%5C11/11-60624.0.wpd.pdf;  

CNN I report on Predicates and Mersilene:
http://ireport.cnn.com/docs/DOC-416625
;

Background on Mesh production, UC Denver:
http://www.ucdenver.edu/academics/colleges/medicalschool/departments/surgery/education/GrandRounds/Documents/GRpdfs/2011%20-%202012/Feb%2013%20Mesh%20Dr%20Montero.pdf

 


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7 Comments to “Mississippi Court Upholds Ethicon Win in Mesh Warning Lawsuit”

  1. I am disgusted this poor couple lost their case. I had a Mersilene Mesh implant in 2002 for a Sacrocolpopexy and I have suffered agonisingly since then. I have had to have several operations to remove the mesh- disfiguring me for life. I am still suffering despite a removal in March of this year – where they found more mesh, screws and staples. Also my bowel, ureter and right iliac artery had been stapled to the abdominal wall after one of the Mesh Removal Operations! I think Johnson and Johnson should be hauled over the coals for the suffering that Surgical Mesh Implants have caused to countless thousands of people. They have also ignored a basic duty of care to patients in the US and Canada by leaving patients suffering with NO access to Medical help because they are not covered for surgery by their insurance companies!!!!!! It is unbelievable and a disgrace that people are left to suffer and die in AGONY in todays so-called sophisticated society! …..SHAME ON ETHICON – AND SHAME ON JOHNSON & JOHNSON….

  2. Mark Are says:

    The definition of fascism is when corporations run the country. That is what we are suffering under these days. The psychopaths running the corporations are only interested in PROFIT at the expense of all of humanity. This mesh is obviously a product that shouldn’t be used the way it is being used. A 20% failure rate is NOT acceptable.

  3. anurse says:

    Disgusting and horrible that Ethicon and Johnson & Johnson can get off on a “technicality” when their product is defective and harmful to so many patients. Ethicon, J & J, and other companies just like them do not care about the lives they have destroyed. Their only concern is protecting their pocketbook! As a nurse with thirty years of experience, I am absolutely and completely appalled! My faith in healthcare and the medical field is shattered! Big Pharm is not there to improve the lives of people. It’s primary goal is to make big bucks and line it’s own pocketbooks…. At YOUR expense- especially if you happen to be one of the “unlucky” ones! Since this is happening with many medical devices, not only surgical mesh, DO NOT believe this cannot happen to you or a loved one. When it comes to any medical device… BUYER BEWARE!!!

  4. Jane Akre says:

    Again the end user is not you the patient, it is the doctor. So what if automakers had the same philosophy. Say the end user was the car dealer. That auto makes it to the dealer- no problem…. but for you, the user of the vehicle….. the car does not work. Does that make any sense? Am I missing something?

  5. David says:

    Its the same reason we cant get media attention…..look around what are 80 percent of the ads on TV they are Pharma ads. So why would a station run a story that made their paycheck look bad??? The same with congress taking steps to stop this madness look who the biggest contributors are to the economy. I read something earlier today………Antipsychotics were the #1 dispensed drug category and the #1 income grossing drug category in 2008, 2009 and 2010. Prescriptions in our children in 2009 grew at 4X the rate of the general population. Can you say “CASH COWS”? Because this is what your children are to Pharma! and if your interested in reading it here is the link:
    http://healthland.time.com/2012/08/09/antipsychotic-prescriptions-in-children-have-skyrocketed-study/

    Its so troubling when one really looks at reality! There are so many wrongs in this whole nightmare. I believe we need to start yelling to international organizations as The FDA and USA and Europe just are not stepping up and stopping this madness……HOW MANY MORE WOMEN HAVE TO DIE OR BE ROBBED OF THEIR LIVES????

  6. Amy G says:

    Important post David! The tragic overprescribing of antipsychotics and ADD drugs to Children makes them life long dependents of the pharmaceutical industry. The mutilation of a sacred space and big pharma’s effort to medicate every child must end.

  7. EH says:

    UNREAL! I just cannot believe what is happening in our world. I hurt all the time, NO SEX LIFE for over 3 years, been told so many things and had hope each step of the way. After 7 mesh removals I still have mesh eroding. Yes I’ve seen Dr. Raz 3 times, and I do love him and think he’s the best. That said – it shows how difficult it is to get mesh out. One of my friends told me “it’s a plan by the government to kill and maim it’s citizens-to open up more jobs, and have less to feed “, I don’t believe that and laughed. But we really do seem to be the un-politically correct. Mention mesh and the hole opens up – almost as if I had leprosy. They go running, I’m not accountable- I’m not getting involved.” There of course are some good Dr.’s (like Dr. Raz), but the average woman cannot afford to go to CA and just suffers under whatever she can get. The commercials are being minimalized, and mesh is still being sold to a public that basically trusts it’s Dr.’s. I heard so many excuses of why it’s not the mesh . . . now, I just walk out. On down the list. Even in the face of so many medical reports, it’s still being sold. It’s being put into women everyday. I don’t know how it will finally get caught – hopefully something will stop the MADNESS!!!

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