By Nihit Nagpal and Livya P. Lalu
A decade long battle of selling defective products through doctors and hospitals reached its finality. The Hon’ble National Consumer Dispute Redressal Commission in Mrs. Lalita Rajpurohit v M/s Johnson & Johnson Ltd & Ors.[1] addressed the issues of unethical marketing, professional misconduct, appropriate compensation, and the law for deciding compensation for injuries.
Factual Matrix:
The complainant asserted that despite having a hip osteoarthritis diagnosis and having a drilling operation in Ahmedabad in April 2005, she was unable to find any relief as she was perpetually in pain. The complainant then went to see the doctor (OP-4) as an outpatient at P.D. Hinduja National Hospital & Medical Research Centre (OP-5) (the hospital) on August 1, 2006, with a history of hip pain on both sides and worsening right side pain since 2005. The doctor recommended a total hip replacement and said that the best metal-on-metal, large-headed DePuy Acetabular System Resurfacing (ASR) procedure available was risk-free.
In June 11, 2007, the complainant was brought to the hospital for surgery on a right hip implant. After performing surgery on June 13, 2007, OP-4 implanted a massive, metal-on-metal ASR head, and on June 21, 2007, she was released. For the same, the complainant paid Rs. 3, 90,309/-. Additionally, OP-4 recommended a left hip replacement, which was carried out at the same facility from August 23 to August 31, 2007, for which the complainant paid Rs. 3,74,841.
The complainant began experiencing steadily worsened hip-related pain, discomfort, and mobility issues in January 2008. On July 21, 2009, she went to see OP-4 since the pain was unbearable, and her movement was restricted. He recommended a bone scan and medication and further advised her to use a slightly higher vehicle. In July 21, 2009, the complainant paid Rs. 22,02,580/- for a Toyota Innova car, which she began driving to keep her job. However, the discomfort was not alleviated, so on August 28, 2009, she went to see OP-4 once more. This time, OP-4 and his colleagues took no action and suggested sticking with the same medications and scheduling a follow-up visit three months later. The complainant’s condition deteriorated to the point where she was unable to visit OP-4 at the hospital. Thereafter she sought for an advice of another doctor, a local physician on July 9, 2012, who examined her and informed her that the ASR she had implanted was per se faulty and it was withdrawn from US markets in 2010 due to metal toxicity concerns.
The OP-4 sent her a letter dated July 7, 2012, asking her to fill a consent form for participation in the implant recall process. They introduced a website related to recall process of the said defective hip implants to deal tactfully with victims of the same. The complainant gave her consent on June 2012 and OP-6 informed OP-4 about her registration for revision surgery. But the complainant did not receive any information for the follow up, later she underwent some tests where it was reported that chromium level was within acceptable limit and cobalt was negative. Later she sent a legal notice and then filed a consumer complaint before NCDRC. In 2014, she chose to undergo revision surgeries at Mount Elizabeth Hospital, Singapore where she found high chromium levels in blood.
The opposite parties blatantly denied all the averments raised by the Complainant and raised the point of maintainability of the complaint filed.
Commission’s view on the Issue of Unethical Marketing of Defective Product and Dumping of Defective Product in India:
The present case was one of the matters in the batch matter before the Hon’ble National Commission, about the faulty implant. Due to the bunch of other complainants with regards to the faulty ASR hip implant, the Ministry of Health and Family Welfare constituted an Expert Committee to examine the various issues pertaining to faulty ASR Hip Implants.
- Expert Committee:
On due consideration of all the facts and details the Committee was of the view that the ASR Hip Implants manufactured by the Opposite Parties were per se faulty which resulted in higher instances of revision surgeries globally including India. Due to the faulty implant it leads to accelerated wear and tear which causes high level of cobalt and chromium in the blood which may lead to toxicity. Even though reimbursement programs were initiated however, it was seen that the complainants were not compensated as per the available records. - Arya Committee:
The OP challenged the Expert Committee report dated February 19, 2018, in Writ Petition (Civil) No.13395 of 2018 filed in the Delhi High Court. In response to the Expert Committee’s recommendations, the MoH & FW established a second technical committee, known as the “Arya Committee,” which is chaired by Dr. R.K. Arya. Its purpose is to investigate the problems surrounding the payment of compensation to patients who have ASR Hip Implants and provide recommendations to the MoH & FW regarding these matters. In a letter/order dated November 30, 2018, the MoH&FW directed the OP to provide compensation to patients who had received the ASR Hip Implant based on the Arya Committee’s recommendations. Based on the report, the OP filed Writ Petition (Civil) No. 3523 of 2019 and Writ Petition (Civil) No. 4691 of 2019, contesting individual compensation orders. In an order dated March 20, 2023, the Delhi High Court noted that the concerned court would consider the OP’s objection to the expert report if it were to be relied upon in any other court or forum.After series of meeting the following formula was prepared for determining compensation for the ASR victim patients:
“B*R*E+Rs. 10 lakhs towards pecuniary damages”
Where B is the basic amount
R is the Risk factor
F is the Age Factor
- California Court Order:
The Hon’ble NCDRC placed reliance on the Superior Court of the State of California dated March 22, 2013, in the case of Sandra Ellis, Loren Kransky, and Others vs. DePuy Orthopaedics Inc.[2] (Case No. BC 456086), as well as the Court of Appeal of the State of California’s ruling in CA/2/7, B249576 Kransky vs. DePuy Orthopaedics, dated July 21, 2016. The jury of the Superior Court of California issued its verdict on March 21, 2013, in the case of Loren Kransky vs. DePuy Orthopaedic Inc. DePuy Orthopaedics, Inc. filed an appeal against the Superior Court’s ruling in the Kransky case, which found DePuy strictly liable for the defective design of a Kransky hip implant, in the Court of Appeal of State of California’s CA/2/7, B249576 ruling dated July 21, 2016. While the appeal was pending, Kransky passed away on February 26, 2014. DePuy had contested several evidentiary decisions in the appeal, including the admission of some of Kransky’s expert witness and treating physician’s testimony and the exclusion of evidence pertaining to the FDA’s approval of the hip implant for sale in the US. However, the appellate court came to the conclusion that the trial court did not abuse its discretion in any of the evidentiary rulings, that the award of $8.3 million in compensatory damages was not so egregiously out of proportion as to shock the conscience, and that the trial court’s verdict was supported by substantial evidence that is evidence and not irreconcilable. Thus, the trial court’s decision was upheld.
Based on facts and circumstances the Hon’ble Commission partly allowed the Complaint with a cost of Rs. 1,00,000/- and directions for Opposite Party No. 1 to 3 to jointly and severally to pay Rs. 35,00,000/- as compensation with an interest @6% per annum from the date of complaint till the date of payment.
Court’s view with respect to Compensation:
In similar lines the Hon’ble Supreme Court has determined the quantum of compensation for a medical negligence. Further, in Nizam’s Institute of Medical Sciences v. Prasanth S. Dhananka[3] has observed the following:
“88. We must emphasise that the court has to strike a balance between the inflated and unreasonable demands of a victim and the equally untenable claim of the opposite party saying that nothing is payable. Sympathy for the victim does not, and should not, come in the way of making a correct assessment, but if a case is made out, the court must not be chary of awarding adequate compensation. The “adequate compensation” that we speak of, must to some extent, be a rule of thumb measure, and as a balance has to be struck, it would be difficult to satisfy all the parties concerned.
“89. It must also be borne in mind that life has its pitfalls and is not smooth sailing all along the way (as a claimant would have us believe) as the hiccups that invariably come about cannot be visualised. Life it is said is akin to a ride on a roller-coaster where a meteoric rise is often followed by an equally spectacular fall, and the distance between the two (as in this very case) is a minute or a yard.”
Similarly, the Hon’ble Supreme Court also gave emphasis on ‘just compensation’ wherein it was observed that the idea of compensating a receiver person is to bring back to a position, as if loss/injury suffered by them hadn’t occurred.[4] In plethora of judgments such as Sarla Verma v. DTC [5]; Balram Prasad v. Kunal Saha and Ors. [6]; V. Krishnakumar v. State of Tamil Nadu & Ors. [7] and Nand Kishore Prasad v. Mohib Hamidi and Ors. [8] observed that compensation awarded must by adequate, fair and equitable as per the facts and circumstances of each case.
The DePuy ASR metal-on-metal hip implant, manufactured by Johnson & Johnson was found to be defective and guilty of unethical and aggressive marketing of a product it knew to be unsafe, even after recall abroad. The court did not find direct negligence on the part of OP-4 and the Hospital in conducting surgery. The court cited Section 17 of Limitation Act, stating that limitation start from discovery of fraud/defect not the original transaction date therefore, the cause of action arose in 2012 when the complainant was informed about the recall and learned of the implant defect. The court rejected complainant’s claim of Rs. 107 crore and awarded just compensation of 35 lakhs along with 6% interest per annum from the date of complaint to till date which can be adjusted accordingly if 25 lakhs are already paid. Lastly, the court relied on Supreme court precedents on personal injury to affirm that when bodily injury is caused by defective goods, compensation can be granted under tort law, beyond refund or replacement.
Conclusion:
It is evident that the Consumer Protection Act being a welfare legislation all the foras along with the other courts have resolved the concept of just compensation for the betterment of the receiver who has suffered loss/injury. Moreover, from the above judgments it is clear that the Hon’ble Forums and the courts are inclined toward giving compensation for genuine complainants keeping in view the magnitude of loss/injury attained by them. In Lalita Rajpurohit (supra) the importance of implanting faulty implants and its unethical business shows us the level of scrutiny and vigilance that is required for a genuine person who is in need.
[1] Mrs. Lalita Rajpurohit v M/s Johnson & Johnson & Ors. C.C. No. 233 of 2013
[2] Sandra Ellis, Loren Kransky, and Others vs. DePuy Orthopaedics Inc. Case No. BC 456086
[3] Nizam’s Institute of Medical Sciences v. Prasanth S. Dhanaka in (2009) 6 SCC 1
[4] Jyoti Devi v. Suket Hospital & Ors. in Civil Appeal No. 5256 of 2024
[5] Sarla Verma v. DTC in (2009) 6 SCC 1
[6] Balram Prasad v. Kunal Saha and Ors. in (2014) 1 SCC 384
[7] V. Krishnakumar v. State of Tamil Nadu & Ors. in (2015) 9 SCC 388
[8] Nand Kishore Prasad v. Mohib Hamidi and Ors. in (2019) 6 SCC 512