The DePuy Debacle

Johnson & Johnson, the world’s largest pharmaceutical company found itself facing yet another set of expensive lawsuits after its subsidiary company, DePuy Orthopedics, reportedly misrepresented the features and abilities of its line of ASR Hip Replacement Implants, namely ASR XL Acetabular System and ASR Hip Resurfacing System, leading over 93,000 people worldwide to undergo hip replacements with the ASR implants.

Although the company promised reliable safety standards and longevity of the implants, the National Joint Registry of England pointed out that several patients undergoing these implants had to opt for revision surgeries within a span of just 5 years. Soon, a connect could be made between thousands of such cases, where people undergoing these implants complained of inexplicable pain.

Initially, it was rather thought that mistakes were made by surgeons in placing the implants in the patients. However, on further research it was discovered that the devices were defective and were responsible for symptoms like groin pain, allergic reactions, muscle and nervous damage due to metallic debris shed from the device; in many cases leaving the patients permanently disabled. Thus, bringing in a wave of litigation suits against the company.

The American Ambiguity

In the US, the Food and Drug Administration (FDA) gave clearance to only one of the two models of hip implants of DePuy for sale in the US. However, according to the law, there existed a provision that unlike new drugs, critical implants didn’t need to undergo too many clinical trials before getting an approval from the FDA.

This was a noble provision which allowed the manufacturer to rapidly make improvements to such devices but DePuy used this provision to jump the regulations set by the FDA and minimize the tests required to get the product approved. This loophole allowed the company to bundle a component from an unapproved device into an existing design of the approved device and sell it with minimal testing.

Since similar devices were already in the market, it was easy for DePuy to start selling these modified implants without a separate model being introduced after seeking proper permission. In this case, there was a common cup which formed an important part of both the devices, but due to lack of any form of independent monitoring system or any specific regulation barring companies from using parts of a banned product in other approved product, this cup was allowed to be used.

This cup, which was way shallower than the ones used in other hip implants became the nemesis of the product, as it turned out to be the main source of the trouble. Several well-seasoned doctors who were initially the ones advising their patients to use the given product, later admitted that the design of the product was highly prone to various types of problems.

With a revenue over $1.4 Billion from the sale on hip implants in 2018 alone, it isn’t very surprising that Johnson & Johnson has agreed to pay over $4 Billion to settle about 9000 law suits in the US regarding these faulty implants. In majority of the cases related to this product, the case hinged primarily on the fact that DePuy misrepresented the survivorship rate of the product rather than on the threats that it posed to the well-being of the patients.

Furthermore, the damages being awarded were only punitive in nature. Since many states limit the amount of punitive damages the jury may award, most of the damages were cut down later. Thus, this case exposed a major loophole in the American legal system which left the law unable to adequately safeguard the interests of the citizens.

Although, we can see that several patients got a reasonable compensation and others were offered attractive settlement offers, it wasn’t until 2013 that the strengthened regulations of the FDA ensured a complete ban on the sale of this line of ASR implants. Yet, the same implant, though manufactured with other material combinations, continues to be sold in the US.

The Indian Insufficiency

India too faced a similar problem with the issue of faulty hip implants due to its lack of strong regulations to control these pharmaceutical multinationals. Initially, DePuy apparently started selling the hip implants illegally in India way back in 2005, before actually applying and obtaining the Import License for these implants under Drug Act, 1940 from the Drugs Controller (India), Directorate General of Health Services in the month of December 2006 only.

However, evidence suggest that DePuy ASR Hip Implant surgeries were carried out much prior to issuance of the license, in gross violation of Indian laws by Johnson & Johnson. In the year 2005 these Implants were unofficially and without approval introduced and sold in Indian market without obtaining necessary and mandatory Import License.

It can be corroborated from the fact that even though the device was officially licensed in 2006, the ASR India Patient Assistance Program (ASR IPAP) strangely provides assistance to patients who have undergone a hip replacement with their implant from 2004 onwards, as listed in the official site of Johnson & Johnson. According to official reports, the implant was carried out on around 4700 people in India over a period of 5 years from 2005-10.

After multiple complaints, the Drug Controller General of India finally took a step in 2017 in trying to resolve the issue. Two expert committees were formed under the chairmanship of Dr. Arun Kumar Agarwal and Dr. RK Arya. While the Agarwal Committee examined the issues relating to faulty ASR hip implants, the Arya Committee determined the quantum of compensation.

The formula was based on the percentage of disability, age and risk factor, and was accepted by the Government of India, as per a press release dated November 29, 2018. The Supreme Court too accepted the formula suggested by the committees and rejected the paltry compensation of 25 lakhs was agreed upon by Johnson & Johnson after a prolonged negotiation.

Furthermore, the court rejected the plea that the payment wouldn’t be construed as the acceptance of any liability and any future costs of compensation would have to been included in the payment already made.

An Easy Evasion

The main problem in this case is that the most important stakeholders are not party to this litigation. One of the fundamental tenets of law is that no order, not even one that is perceived to be a favorable order, should be passed by a court of law without hearing the parties who are going to be impacted by the order. The only way patient interests can be protected is to invite patients to be part of the process.

This is not merely an issue of abstract theory but one of practical implications. For instance, if there was even one lawyer for the patients present in court, he or she would have informed the court that most patients have not approached the expert committee of the government because it was very clear that the committee did not have any legal powers to award damages. Instead, most patients moved consumer courts seeking compensation.

Thus, dealing with the claims of only the 289 who contacted the committee out of the thousands those were affected is pointless.

Herein, the government could have used the provision given in sub-section 1(d) Section 12 of the Consumer Protection Act which states that “the Central or the State Government, as the case may be, either in its individual capacity or as a representative of interests of the consumers in general. the Central or the State Government, as the case may be, either in its individual capacity or as a representative of interests of the consumers in general.”, to take up all the consumer court cases being filed by the aggrieved parties against DePuy with a common interest into a single case in order to represent a more complete image of the severity of the issue and put the progress of the case on fast track while allowing the litigation costs of the aggrieved parties to be minimized.

Another problem here is that the paltry settlement offers a chance to both the DCGI and Johnson & Johnson cover up for their failure to take care of the patient interests with the help of a deal brokered under the guidance of the Delhi High Court.

The irony of the situation can be clearly seen in the situation when we compare the amount of money the company is compensating for the patients in USA and India respectively. In the U.S, Johnson & Johnson has agreed to pay an average compensation of about $300,000 to the patients affected in the US while in India they are being asked to provide a basic compensation of about $27,000 per patient, which is in sharp contrast to the American situation.

Also, Johnson & Johnson has agreed to pay only the ones who are willing to undergo a revision surgery. This posed as a problem since many people were either not able to undergo a revision surgery due to old age or medical complications while others were unwilling to undergo the same due to personal reasons. Thus, they don’t qualify for the compensation provided by the company.

Hence, we can see that this was easily the most controversial medical tort case in modern Indian legal history that has helped in shedding light on the loop holes that plague the system of drug regulation. However, it is through mistakes that we all learn and even in this case, the Judiciary has taken concrete steps in ensuring that this loophole gets repaired by taking recourse to stringent actions in order to teach the defaulting company a good lesson.

Yet, we can see that there is a lot that needs to be done in order to ensure that there are stronger medical regulations and lesser companies daring to breach it in the future.

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