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$72mn Fine Slapped as J&J Products Tied to Ovarian Cancer

26,February, 2016

MUMBAI: Former Maharashtra Food and Drug Administration (FDA) commissioner Mahesh Zagade was at the centre of a nationwide debate on how foreign companies were being harassed in India, when he revoked the licence of a city plant of Johnson & Johnson in June 2013 after complaints that its product Baby Powder contained hazardous particles. Zagade, a senior IAS official, was on Wednesday relieved after a US jury ordered J&J to pay $72 million to the family of a woman who claimed her death was linked to the use of the Baby Powder she had used for decades.
A resident of Alabama, Jacqueline Fox, 62, had died of ovarian cancer in 2015. Her family had argued in court that the company knew of talc risks and failed to warn users. J&J denied the family’s claim. A company spokesperson told BBC: “We’ve no higher responsibility than the health and safety of consumers, and we are disappointed with the outcome of the trial. We sympathise with the plaintiff’s family, but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence.”
“I am hearing about the court’s verdict from you. It shows my stand vindicated,” Zagade told Express from Pune where he is currently posted. In 2007, FDA officials discovered that J&J had used an unauthorised process for sterilising Baby Powder. The company had conducted the sterilisation process at another organisation in Thane which did not have the licence. The FDA probe revealed that the company had used ethylene oxide, a substance used to produce industrial chemicals and sterile medical equipment, to kill bacteria in Baby Powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder.
According to rules, it is mandatory for a company to inform the FDA on what process they are going to adopt for sterilisation.
An FDA official said that J&J had not informed that they are going to sterilise the product using ethylene oxide, which can cause cancer. The FDA officials did not take any action in spite of the test results revealed the possible danger. The first action was taken by Zagade in 2011 when he assumed the charge of FDA Commissioner.
“He came to know about the complaint against J&J when he was taking a stock of the complaints his office had received inlast couple of years. By the time he took initiative the company had sold around 50-60,000 packs of Baby Powder,” the source said.
Zagade formed another enquiry team after the company refused to call back its sold product. The other inquiry also revealed that there were hazardous particles in the product. “He (Zagade) sent them a showcause notice after the enquiry report was out. Little he knew that he will be put under tremendous pressure from the higher authorities to go slow in this case. However, he got a go ahead from the government and the plant was closed down,” the source said.
The company had approached the Bombay High Court against the FDA action.
Case History

  • First-ever penalty by a US jury on Johnson & Johnson
  • Charged with failing for decades to warn consumers that its talc-based products could cause cancer
  • Jurors awarded the family of Jacqueline Fox $10 mn in actual damages and
  • $62 mn of punitive damages
  • Fox used Baby Powder and Shower to Shower for feminine hygiene for more than 35 years before being diagnosed three years ago with ovarian cancer; died in October last
  • In October 2013, a federal jury in South Dakota found another petitioner Deane Berg’s use of J&J body powder products was a factor in her developing ovarian cancer. It, however, awarded no damages
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