Beta, a subsidiary of Alpha after spending years and billions of dollars, engineered a knee replacement device. The device used metal in both the ball and the socket. It became an instant hit amongst the doctors, who extensively used it in the US as well as all across the world. The device was cheaper in the US, and its prices were more in the developing countries, including India. Also, the device was initially used in developed countries and later on introduced to developing countries. Popularly known as “knee implant”, the device soon turned toxic due to the release of metal debris, resulting in inflammation, tissue damage and profound pain.

It is unclear as to when Beta first came to know about the issues facing the device. However, reports did start coming in from Australia in 2007 about failure of the device causing excruciating pain to the patients. The reports could gather a little press only. In April 2010, Beta renewed its Indian import licence by paying the licence fee to the Government. It was only in August 2010 that Alpha issued a global product recall, which was limited to the countries in which recall was mandated by the respective drug regulator. In 2013, Indian drug regulator (Central Drugs Standard Control Organisation, or CDSCO) took notice of various complaints about the device in India and issued a product alert, stating the reports of increasing complaints regarding the device. 

Beta reimbursed certain victims in India for their revision surgeries (to replace the “metal” with other materials such as ceramic or polyethylene). However, they refused to compensate. 

The Indian government finally constituted an investigative committee in 2017. It came up with the following statistics- 

  1. 15,829 knee implants were imported in India, 
  2. 4,700 surgeries were performed. 
  3. 1,295 unused implants had been returned to the company, 

rest remain untraced. 

Meanwhile, many patients came together and formed SOS Association. It is a registered body running a highly viral campaign against Beta and Alpha. The Association is pressuring the Government to investigate into the matter and hold Beta and Alpha criminally liable. At one of the agitations organized by the Association, the crowd swelled and caused damage to Beta manufacturing plant in Lucknow. Some of the crowd also looted the Alpha’s baby powder and shampoo manufactured there. Such was the extent of damage that the manufacturing plant was closed for weeks. 

Strangely, the government has been rather timid in taking on Alpha. It even blocked a potential CBI inquiry, despite a former drug commissioner recommending this. 

People have turned to Courts. Some actions are pending before Indian courts and consumer fora filed by patients or their next of kin. 

Alpha and SOS Association have agreed to sit down and attend mediation to come to an amicable agreement. 

 

CONFIDENTIAL INFORMATION ALPHA

The Company had the first reports of device turning faulty in 2005. However, it was just in 5 per cent of the overall cases then, and the Company willing fully took no action. 

In order to quell the news of devices turning faulty, the Company cut off the funding of doctors who wanted to take the issue public. It has also filled in the newspapers and media with a lot of advertisements over the years, and when the going got rough, threatened to stop advertisements. Stopping advertisements can cause closure of several media companies as Alpha is a major advertiser and a conglomerate. 

The Indian compensatory jurisprudence is rather young. In Glenmark Pharmaceuticals v. Galpha Laboratories, the court imposed ₹1.5 crore as damages. The Court in the judgment also said “Drugs are not sweets. Pharmaceutical companies which provide medicines for the health of the consumers have a special duty of care towards them... However, nowadays, the corporate and financial goals of such companies cloud the decision of its executives whose decisions are incentivised by profits, more often than not, at the cost of public health. This case is a perfect example of just that.”

Alpha suffered a data breach in 2010. It does not have the data regarding entities to which the devices were sold in India. 

 

CONFIDENTIAL INFORMATION: SOS ASSOCIATION 

Drugs and Cosmetics Act (DCA) is inadequate when it comes to victim compensation. 

Patients can invoke traditional tort law remedies and the Consumer Protection Act to claim damages.

The Indian compensatory jurisprudence is rather young. In Glenmark Pharmaceuticals v. Galpha Laboratories, the court imposed ₹1.5 crore as damages. The Court in the judgment also said “Drugs are not sweets. Pharmaceutical companies which provide medicines for the health of the consumers have a special duty of care towards them... However, nowadays, the corporate and financial goals of such companies cloud the decision of its executives whose decisions are incentivised by profits, more often than not, at the cost of public health. This case is a perfect example of just that.”

SOS Association is being funded by competitors of Alpha. It may be in violation of FEMA and FCRA. 

 

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