Required: Criminal investigation against Johnson and Johnson in the sealant case EVICE

According to the law, each commercial company required to provide the consumer with full information. When it comes to medical products, the expectation for transparency is even greater. Elisha Elitov argues against Johnson & Johnson that the drug company has hidden from the public the risk of incurable granulomatosis disease as a result of the use of biological sealant EVICEL

According to the law, each manufacturer or business is required to maintain Full Disclosure. This suggests that consumers should be provided with full information and avoid deception. From this, the consumer should receive all information that is defined as material, that is, without it a wrong decision may be made, or describe an inferiority of the product or an existing defect.

When it comes to a manufacturer of pharmaceuticals, medical preparations or medical devices, it is expected that these products will be tested in a timely manner and that every detail that poses a potential danger to users' health will be stated clearly.

In the case below, it is alleged that Johnson and Johnson violated this obligation and concealed - or at the least refrained from disclosing - material information that poses a danger to users' health of its products.

The surgery ended successfully; the patient's condition worsened

In 2014, Elitov had a laparoscopic bariatric surgery. During the operation, EVICEL biological sealant was used, which is used for jointing internal incisions - instead of stitching. This sealant was developed and manufactured by an Israeli company called Omrix Biopharmaceuticals LTD, which was bought by global Johnson and Johnson, which is currently the sole distributor of this sealant for hospitals around the world. 

Elitov's surgery was successfully completed and his goal - weight loss - was soon achieved. Unfortunately, with the weight loss, Elitov began to suffer from a long line of distressing phenomena such as fatigue, weakness and, later - imbalance, blurred vision, and intracranial pressure.

 

In 2015, a colonoscopy examination revealed a lump in Elitov's colon. When he was taken to a surgery to remove this lump, number of granulomas were observed in his abdominal cavity - inflammatory lesions likely to be developed into cancerous tumors. However, even after the lump was removed, the symptoms from which Elitov suffered remained the same and even it become worsen. Further tests showed that the granulomas spread and proliferated, reaching the abdominal cavity and brain, and even cancerous cells were found in his body.

 

During the operation, the surgeon, Prof. Osama from Ha'emek Hospital, photographed the abdominal cavity and explained to the family that the photograph shows that in the laparoscopic bariatric performed to Elitov a year earlier at Elisha Hospital, they did not clean the biological sealant used for closing the incisions and that they can't take out the sealant that has become granulomas.

Since there isn't any available granuloma removal treatment, Elitov has been recognized by the Bitowah Leumi (Social Security) as handicapped with 100% permanent disability.

Discovery at Ichilov Hospital

 

Since his condition got worsen, Elitov was hospitalized in the neurology department of the Surasky Medical Center in Tel Aviv. A brain biopsy was diagnosed with lymphoma.

In addition, samples of granulomas from the brain biopsy and Colon samples with the biological sealant were sent for microscopic examination at the Faculty of Agriculture, Food and Environmental Sciences of the Hebrew University of Jerusalem. After performing tests on 3 samples: Colon and brain samples taken from Elitov and analysis of the biological sealant components EVICEL, it was found at the conclusion of these tests: "Comparison of the sealant composition and the foreign body composition found in the biopsies determine a complete match to the composition of the foreign composition in part of the  foreign bodies." 

The laboratory's conclusion: "Very likely some of the foreign bodies source is the adhesive."

Attorney Pinhas Michael Or

Material information disappearance

 

Elitov's case was examined in depth by world-renowned medical experts. These have clearly stated that the appearance of granulomas is directly related to the use of EVICEL, and that lymphoma is also most likely to be a complication of the granulomatosis disease.

 

Elitov claims that there is an apparent suspicion that during the trials conducted by Omrix or on its behalf for the preparation prior to marketing, side effects of granuloma formation were observed, and these findings seemed to be hidden and not cited as possible side effects in the label of the preparation.

 

According to Attorney Pinhas Michael Or, who represents Elitov, "In recent years, a number of similar claims has been filed against Johnson and Johnson regarding the Talc marketed by the Company that have been proven to be carcinogenic. Even in these cases, there was no warning in the label attached to the preparation. As far as we know, the US court has awarded astronomers hundreds of millions of dollars to plaintiffs. 

This is a matter of concealing material information from the public for making money, and we require the company to take responsibility and order the non-use of EVICEL sealant in surgeries." 

 

Adv. Or adds: "We asked Johnson for a copy of the FDA application file, which includes the clinical trials performed on animals and humans, before the company received the approval of the preparation for use in surgery. So far, Johnson has not complied with this request. "

According to Elitov, "Apparently, many patients in Israel and around the world suffer from granulomas and even have cancer because of the use of EVICEL's biological adhesive, and they don't know about it. In my case, it was discovered by chance in the second surgery, after the abdominal shortening surgery. For that reason, I have instructed the attorney to consider a class action lawsuit, so that justice can be done not only with me but worldwide. "

 

Johnson & Johnson received a warning letter before taking any action. Omrix has appointed a local lawyer to represent the Manufacturing Company in Israel.

 

The response of Omrix Biopharmaceuticals Ltd.: "The claims included in the law firm's letter are lacking in a scientific basis and negate any element. Omrix's instructions for use comply with regulatory requirements and provide the information needed by healthcare providers, including known complications. Patient safety in our products is the top priority for Omrix. "

 

Johnson & Johnson Consumer's response to Talc case: "Johnson's Baby Powder is safe, contains no asbestos and does not cause cancer."

 

Elitov opened a Facebook group: Victims of EVICEL, Johnson & Johnson, and he call all the other victims to join him and to share their personal story.