Recently, Johnson & Johnson has been besieged by lawsuits alleging that its talc powder causes cancer. Research is demonstrating that the presence of asbestos in the talc powder has caused mesothelioma and ovarian cancer. As a result, juries have issued large verdicts against the company that have assessed a high amount of punitive damages. As the evidence begins to mount that talc powder is a dangerous carcinogen the question arises as to what, if anything, the Food and Drug Administration has done about the issue. News reports have shown that the FDA did nothing about the issue, acceding to the viewpoint of industry. In the past several months, the FDA has finally begun to take some action after nearly half a century of skirting the issue.
The FDA’s Long History of Silence
Questions about talc powder have been raised as far back as 50 years. Talc and asbestos occur naturally near each other in the ground, and talc deposits have tested positive for traces of asbestos. Numerous studies have claimed that talc powder contains asbestos. However, Johnson & Johnson has vehemently denied this contention and has responded with studies of its own that have claimed that talc powder is safe and contains no asbestos.
This issue has certainly been in the public realm for the FDA to issue some sort of comment or issue a warning about it at any point in the last 50 years. However, the FDA has largely remained silent and has not made any public statement about the risk of asbestos contaminating talc powder. The FDA had not recently performed any tests of talc powder nor had it ordered Johnson & Johnson to test the product itself. This lack of action has spanned numerous administrations and several decades. Instead, the agency simply took Johnson & Johnson’s word for it when it promised that its product was safe.
The Industry Seemed to Control the Agency’s Viewpoint
At that point, the agency apparently backed off and let industry conduct its own tests. This was notwithstanding the fact that the test administered by Johnson & Johnson was not able to even detect the most common type of asbestos that has been found in its talc powder. Every point after that when there were calls for the FDA to get regulate the dangerous product, the agency relied on Johnson & Johnson’s own opinion in declining to step in and take any action. The company’s opinion was that even if the talc powder contained asbestos, it was not a sufficient amount to cause cancer.
However, records show that there was an FDA testing sample of a Johnson & Johnson product in 1973 that showed that the powder contained asbestos. However, after that, what happened is still murky. There were no other records of positive tests after that and the company apparently convinced the FDA that it was capable of regulating its own product. The FDA did not issue a recall of the product, seemingly because it did not find the powder to be dangerous.
One of the issues that are at play is that the agency had long felt that it lacked the power to regulate cosmetics and force manufacturers to pull them from the shelves. The FDA has recently come under enormous pressure after a string of jury verdicts against the company for the alleged linkage between talc powder and cancer. Now that the agency is under fire from the media and members of Congress, the FDA has finally begun to take some action.
The FDA Takes Action and Then Backs Off
The FDA did not perform any tests of talc powder on its own until 2009. This was after the South Korean regulator found traces of asbestos in the talc powder. Still, the test did not reveal any asbestos in talc powder. However, the lab that was hired to conduct the tests did not have any experiencing in asbestos testing and the methods that it used to conduct the testing were subject to scientific dispute.
Even after the FDA’s tests came back negative, several juries still found Johnson & Johnson civilly liable in court for injuries suffered by consumers. In 2016, the company lost a case in Missouri which spurred the FDA to take some action in requesting testing data from Johnson & Johnson. Still, the company presented the agency with its opinion that the product was completely safe.
Even as recently as 2018, the FDA was paying attention to talc powder in an industry-friendly manner. It held a symposium on talc safety behind closed doors in front of many professionals with industry backgrounds and it reached out to Johnson & Johnson for recommendations of product testers. Reports from the symposium still presented viewpoints that were closely aligned with those of the industry.
The Changing Tide of FDA Regulation of Talc Powder
The tides began to shift when the 2018 elections resulted in a change of control of the House of Representatives. Now, House committees began to investigate talc safety and placed pressure on the FDA to change its approach to talc powder.
At a certain point, the publicity from the jury verdicts and political pressure became too much for the FDA to resist. With the company facing a criminal investigation, the FDA finally ordered its own tests of Johnson & Johnson’s talc powder as well as several other cosmetic products. These tests revealed asbestos in many cosmetic products, including Johnson & Johnson’s talc powder. This resulted in the recall of 33,000 bottles of the product from the tainted lot. Now, the FDA promises public hearings into the matter to be held next year. This represents a change from the secretive and closed-door approach that the FDA had previously taken.
Predictably, the company has commissioned its own tests on the lot that the government concluded was tainted. True to form, Johnson & Johnson has claimed that its own tests have shown that the government was wrong and that the talc powder was not tainted.
At this point, Johnson & Johnson is facing more than 15,000 lawsuits from plaintiffs who claimed that they were sickened by talc powder. The number of lawsuits continues to grow and the company is facing sizable legal liability. The Law Offices of Sadaka Associates handles talc cases. If you believe that you have been injured from the use of talc contact them today for a complementary evaluation of your case.