Johnson's Conservatives lead Labour as campaign enters final stretch: Poll

Boris Johnson’s Conservatives hold a solid lead over Labour in a couple of key weekend opinion polls as campaigning enters the final stretch of what’s been a bitterly contested general election.
According to a Savanta ComRes poll for The Sunday Telegraph, the Tories’ lead fell to 8 percentage points, back to where it was shortly before the starting pistol was officially fired on the campaign. That would be enough to secure a parliamentary majority of 14, the report said.

An Opinium poll in the Observer suggests Jeremy Corbyn’s Labour Party failed to make any inroads in the past week, with the Conservatives amassing 46% of the vote for a 15-point lead. The left-leaning newspaper quoted Adam Drummond, head of political polling at Opinium, as saying the picture is “starkly negative.”
“Heading into the final week, a recovery is not impossible but doing so would require a turnaround even more spectacular than the one Mr. Corbyn achieved” in the 2017 election, Drummond said.
According to interviews with senior political officials on both sides of the divide, Johnson is heading for a majority of between 20 and 35 seats in the House of Commons, Bloomberg reported. All Conservative candidates have pledged to vote for Johnson’s Brexit deal, meaning even a small majority would in theory ensure the U.K. completes its divorce from the European Union by the Jan. 31 deadline.
Poll Breakdowns:
Savanta ComRes surveyed 2,034 British adults online Dec. 4-5.
Conservatives 41% (-1 point), Labour 33% (+1), Lib Dems 12% (unchanged) Brexit 3% (unchanged).
46% said they’d be worried if they woke up on Dec. 13, the day after the election, to find Corbyn was the new prime minister.
Opinium surveyed 2,003 adults online Dec. 4-6.
Conservatives 46% (unchanged), Labour 31% (unchanged), Lib Dems 13% (unchanged) Brexit 2% (unchanged).
A separate Savanta ComRes poll commissioned by Remain United showed the Conservatives with a 6 percentage point lead over Labour.
Gina Miller, who founded Remain United as part of a drive to stop Britain’s departure from the EU, said if people vote tactically then the U.K. could still be set for a hung parliament.
“Based on these findings, remain and soft leave voters should be very energized knowing that their votes have the power to defeat a Tory majority,” Miller said in a statement.

Will push for election if lawmakers reject Brexit timetable: UK PM

British Prime Minister Boris Johnson said on Tuesday he would end an attempt to win parliamentary approval for his Brexit legislation and instead press for an election if lawmakers reject his timetable.
Opening a debate before lawmakers are expected to vote on his deal for the first time, Johnson warned parliament: "I will in no way allow months more of this."

"If parliament refuses to allow Brexit to happen and instead, gets its way and decides to delay everything until January or possibly longer, in those circumstances ... with great regret I must say that the bill will have to be pulled and we will have to go forward ... to a general election." The prime minister would need to win a vote to trigger an early election because one is not scheduled until 2022.

Brexit: UK Parliament to decide the fate of Boris Johnson's deal today

Boris Johnson will put his Brexit deal to Parliament to accept or reject Saturday, knowing that his political future and that of the country he leads are on the line in the knife-edge vote.
The UK’s 650 members of Parliament will convene in Westminster for only the fourth Saturday sitting since World War II to decide whether to endorse the Brexit agreement Johnson struck Thursday with the European Union.

If the British prime minister wins the critical vote, the country will be on course to leave the EU at the end of the month in an orderly break-up. A status-quo transition period lasting until the end of 2020 will give businesses and citizens time to plan for life outside the EU.
But if Johnson loses, the UK will be hurled into an unprecedented political and constitutional crisis, with a potentially severe impact on trade, hitting supplies of food and fuel, and sparking civil disorder.
Johnson has vowed he will seek to force the UK out of the EU on Oct. 31 even if MPs reject his divorce accord Saturday -- without an agreement to soften the impact on the economy and society.
His opponents in Parliament are aiming to stop him by using a new law under which he is required to write to the EU by the end of the day Saturday seeking to secure an extension to the Brexit deadline, if he hasn’t won MPs’ backing for his deal, or for a no-deal split.
Johnson says he will keep fighting to exit the EU on time, whatever the cost.
The clash could end up with legal challenges against the government within days, potentially concluding in the UK Supreme Court.
An emergency 11th hour summit in Brussels, a general election, another attempt to pass a vote in Parliament, and even another referendum could all follow.
Without a majority in the Commons, and having alienated his Northern Irish allies, who prop up his government, Johnson faces a struggle to secure the votes he needs to prevail.
‘Long, Exhausting’
He spent Friday trying to woo skeptical MPs in his own party as well as opposition Labour politicians who represent pro-Brexit districts. The result looks set to be too close to call, and Johnson’s team believe they’re making progress, according to an official who asked not to be named.
“Imagine what it could be like tomorrow evening, if we have settled this, and we have respected the will of the people, because we will then have a chance to move on,” Johnson said in an interview with BBC TV on Friday. “This has been a long, exhausting and quite divisive business.”
Johnson received a boost from the EU when French President Emmanuel Macron said even if Parliament rejected the deal, there would be no further delay to Brexit day beyond the current deadline of Oct. 31.
That added to the pressure on MPs who would prefer another extension to the deadline to leaving the EU without a deal.
In other developments:
Opponents of Johnson’s threat to pursue a no-deal Brexit moved to reinforce their options.
Former Tory cabinet minister Oliver Letwin is proposing an amendment to the motion to approve Johnson’s exit accord that he says will act as an insurance policy to make sure the UK can’t an accidentally fall out of the EU with no-deal on Oct. 31.
Letwin’s amendment, which may be voted on before Johnson’s deal gets a chance to be put to MPs for approval, would withhold Parliament’s endorsement for the exit agreement until a new law is in place implementing Brexit.
A group of Labour MPs have put forward an amendment to Johnson’s motion that would give Parliament’s backing to a referendum on any deal agreed with the EU.
Johnson sought to woo Labour MPs with a promise to make commitments that ensure increased protection of workers’ rights and environmental standards in domestic law as the UK leaves the EU.
A separate new pledge from Downing Street would increase parliamentary scrutiny of the negotiations on the future partnership trade deal between the UK and the EU.

J&J's largest India plant idle for 3 yrs, hurts govt's employment campaign

It was supposed to be Johnson & Johnson's biggest manufacturing plant in India. It was to eventually employ at least 1,500 people and help bring development to a rural area near Hyderabad.
Yet, three years after the U.S. healthcare company completed construction of production facilities for cosmetics and baby products on the 47-acre site, they stand idle.

Two sources familiar with J&J's operations in India and one state government official told Reuters production at the plant, at Penjerla in Telangana state, never began because of a slowing in the growth in demand for the products.
One of them said that demand didn’t rise as expected because of two shock policy moves by Prime Minister Narendra Modi: a late 2016 ban on then circulating high-value currency notes, and the nationwide introduction of a goods and services tax (GST) in 2017.
J&J spokespeople in its Mumbai operations in India and at its global headquarters in New Brunswick, New Jersey, declined to respond to a list of questions from Reuters.
Modi's office did not respond to a call and an email with questions.
Aimed at rooting out corruption and streamlining the tax system, the double whammy of demonetisation and GST were two of Modi’s signature policy moves. But instead of encouraging economic activity as intended, they did the opposite, at least in 2016-2018, by sapping consumer demand, according to some economists.
Many businesses, especially small and medium-sized enterprises, complained publicly—some in their financial statements—that they suffered a drop off in orders. The suspended J&J project stands as one of the most vivid examples of the impact on the broader investment picture.
In the first month after demonetisation, some business surveys showed that sales of products such as shampoos and soap fell more than 20 percent.
Lack of jobs growth and a farm-income crisis because of low crop prices have hurt Modi in the current general election, according to several political strategists.
Still, Modi and his ruling Hindu nationalist Bharatiya Janata Party are expected by many of the strategists to be in a position to get a second term—probably with support of some other parties—when votes are counted on Thursday, partly because of his strong stance on national security issues.
Big investments, great expectations
A range of Modi's business policies, such as capping prices of medical devices, forcing tech companies to store more data locally and stricter e-commerce regulations have in the past two years hurt plans of American multinationals such as J&J, Mastercard, Amazon and Walmart-owned Flipkart.
The groundbreaking of the J&J facility in Penjerla, its third in the country, was carried out with much fanfare in 2014, attended by Telangana's Chief Minister Chandrashekar Rao, who hailed the foreign investment as a big win for local communities.
A document dated April 2017 that lists products the company planned to make at the facility, submitted to the Telangana government and reviewed by Reuters, names baby oil, baby shampoo, baby lotion, baby hair oil, face wash and creams.
Shaukat Ali, running a tea shop under a bamboo stall on barren land outside the plant, said local workers check in routinely for possible vacancies at the J&J site, but nothing has come up in years.
At the local pollution control board office, the member secretary Satyanarayana Reddy said the J&J plant had all the required approvals and he was not sure why it hadn’t started production.
“It is unusual for such a big plant to stay idle for so long,” he said. “But there is no problem from our side,”
Chandrasekhar Babu, an additional director at the Telangana industries department, said a J&J company official told him the plant hadn't started due to lack of demand.
GST and demonetisation were two key reasons the plan didn’t kick off, one of the sources said, adding that lack of consumer demand since then dented company's plans.
The second source familiar with J&J's plans said the company miscalculated Indian market demand.
On a recent visit by a Reuters reporter to the J&J plant, plush, furnished conference rooms and cubicles sat inactive; M. Sairam, who said he was the site manager, told Reuters production areas with machines were idle too.
Planned further expansion
Local officials had hoped the initial J&J plant would be only the beginning. After the groundbreaking in 2014, Pradeep Chandra, who was Telangana's special chief secretary of industries, told Business Today magazine that "based on the extent of land (J&J) have acquired we believe that they are looking at much larger expansion here."
Local media reports at the time said the J&J facility would employ some 1,500 people.
A J&J official, who was not identified by name, was reported subsequently in December 2016 in Business Standard as saying that the $85 million plant would be operational by 2018 after it had overcome procedural delays. The official was quoted as saying the company had earmarked an additional $100 million for expansion.
Vikas Srivastava, the managing director of J&J Consumer (India), who was at the 2014 groundbreaking, did not respond to calls for comment.
Reuters also talked to two workers outside a sprawling Procter & Gamble facility making detergents and diapers, which is next to the J&J plant. They said they were part of the P&G plant's production team and the plant had been running below capacity.
A P&G spokesperson denied that, saying the plant was "operating at full capacity in line with our business plans".
"India is a priority market for P&G globally and in recent quarters, P&G’s business in India has registered strong double-digit growth consistently," the company said.
The weak rural economy, where most Indians work, has also hurt growth in sales of basic items such as detergents and shampoo in the past year.
Hindustan Unilever Ltd, an industry bellwether that would compete with the likes of J&J and P&G in some categories, said its volume growth shrank to 7 percent in the quarter ended March 31, down from double-digit growth in the previous five quarters. The company warned that the daily consumer goods segment in India was "recession resistant ... not recession proof."

No formaldehyde in baby shampoo: J&J rejects Rajasthan govt report

Johnson & Johnson has strongly rejected findings of a Rajasthan government laboratory showing presence of "harmful" chemicals in the US-based company's baby shampoo, a popular product in India.
Based on the report of the Drug Testing Laboratory in Jaipur, the National Commission for Protection of Child Rights (NCPCR) has written to the chief secretaries of all states and Union Territories asking them to stop sale of Johnson & Johnson's (J&J) baby shampoo and remove it from the stocks.

The NCPCR said the test report found presence of formaldehyde in J&J's baby shampoo.
The company, in a statement, said it has not received any direction to stop the sale of its shampoo and that it was not accepting the interim results of the laboratory tests which were based on "unknown and unspecified" methods.
India is a major market for J&J globally, and its share in the country's Rs 4,000-crore baby care market is nearly three-fourths.
"We will await the results and conclusions of the re-testing process at the Central Drugs Laboratory. We are not aware of any directions from NCPCR. It must be noted that any such directions, under the law, can only be issued under certain prescribed conditions," the company said.
J&J said it is in full compliance with current Indian regulatory requirements and standards for manufacturing and testing of all its products.
"We have confirmed to the Indian authorities that we do not add Formaldehyde as an ingredient in our shampoo nor does Johnson's baby shampoo contain any ingredient that can release formaldehyde over time. Our products are safe to use and conform to all applicable standard under the D&C (Drugs and Cosmetics) Act and D&C rules," it said.
ALSO READ: Child rights body asks states to stop sale of Johnson's baby shampoo
"We unequivocally maintain that our products are safe, and our assurance process is amongst the most rigorous in the world, meeting or exceeding the safety standards in every country where our products are sold," the company added.
Officials said NCPCR has powers to recommend action, but it was for the state governments and union territories to take a call on implementation of the recommendation by the apex child rights body.
The NCPCR had sought sample test reports of J&J's baby shampoo and talcum powder from authorities of five states -- Andhra Pradesh (south), Jharkhand (east), Rajasthan (west), Madhya Pradesh (central) and Assam (North East) -- after reports of presence of asbestos and carcinogenic substance in them emerged.
The order by he NCPCR around a week back was issued after test reports of the baby shampoo came from Rajasthan. However, it is yet to receive the test reports from the other four states.
The NCPCR has asked the Drug Control Officer of Rajasthan to send the test report of the talcum powder at the earliest, officials at the child rights body said.
In December last year, India's drug regulator ordered laboratory testing of J&J's baby powder following international media reports it may contain cancer-causing asbestos. Months later, test reports showed that the talcum powder did not contain asbestos.

India orders Johnson & Johnson to stop using raw material for Baby Powder

India's drugs regulator has ordered Johnson & Johnson to stop manufacturing its Baby Powder using raw materials currently in two of its factories until test results prove they are free of asbestos, a senior official said on Thursday.
The official at the Central Drugs Standard Control Organization (CDSCO), who declined to be named citing the sensitivity of the matter, said a written order had been sent to the US company telling it to stop using the "huge quantities" of raw materials stocked in its plants in northern and western India.

The company said on Wednesday that drug authorities visited some of its facilities and took "tests and samples" of its talcum powder. It also said that the safety of its cosmetic talc was based on a long history of safe use and decades of research and clinical evidence by independent researchers and scientific review boards across the world.
The visits came as the CDSCO and state-based food and drug administrations launched an investigation into J&J's Baby Powder following a Reuters report last Friday that the firm knew for decades that cancer-causing asbestos could be found in the product. J&J has described the article as "one-sided, false and inflammatory".
The company didn't immediately respond to requests for comment on Thursday.
Asked if the order meant the company would have to stop producing its ubiquitous baby powder in India for now, the official at the drugs regulator said that was "the inference you have to take" at least as far as the stores of raw materials were concerned.
"We have told them until this investigation concludes, you should not use the raw material.
Test results will take time," the official said. "Testing for asbestos is not a routine procedure. It might be in traces. It will require us to develop a method and all those things."

J&J says talc powder in India safe, drug regulators visited plants

Johnson and Johnson said on Wednesday that Indian drugs authorities visited some of its facilities and it provided them with "tests and samples" of its talcum powder.
The visits come as the regulators in India launch an investigation into the company's Baby Powder following a Reuters report last Friday that the firm knew for decades that cancer-causing asbestos lurked in the product.

The company told Reuters in a statement that the facilities were visited by the Central Drugs Standard Control Organization (CDSCO) and some state-based food and drug administrations (FDAs).
"Today, a few of our facilities were visited by the CDSCO and local FDA authorities and we are fully co-operating with them by providing tests and samples," the J&J statement said.
"The characterization of these visits as "raids" or "seizures" is incorrect as has been reported in some instances. The tests have been conducted in the regular way that the FDA collects samples."
Johnson & Johnson added that the safety of its cosmetic talc was based on a long history of safe use and decades of research and clinical evidence by independent researchers and scientific review boards across the world.
It also said Indian FDAs and the CDSCO have in the past confirmed that its products "comply with Indian standards and are free of asbestos".

J&J faulty hip transplant: CIC directs RTI disclosure of crucial documents

A Johnson & Johnson subsidiary caught in a controversy over faulty hip replacement systems has opposed RTI disclosure of crucial documents it submitted to the country's drug regulator for seeking import clearance for these devices, the CIC has said.
The commission, however, said it has found no impediment in directing disclosure of these compliance documents.

Among the records whose disclosure the DePuy Medical Private Limited, the Johnson and Johnson subsidiary, has opposed was an indemnity clause, said Mukesh Jain, the RTI applicant who had sought the information from Central Drugs Standard Control Organisation (CDSCO).
The indemnity clause makes companies liable for compensation to patients globally in case equipment are found faulty.
The CDSCO, the drug regulator, did not apply the RTI clause of "larger public interest" to provide the documents, Jain told PTI.
Instead, he said, it sought the consent of DePuy Medical Private Limited applying the "third party" clause of the Act and the company rejected the request.
The company claimed that the information sought attracts exemption clauses of the RTI Act related to commercial confidence.
Even exempted information can be furnished by a public authority if it finds that the disclosure is in larger public interest, according to the RTI Act.
When the matter came before the Central Information Commission, the top appellate authority on RTI matters in the country, the objections raised by DePuy were rejected by Information Commissioner Yashovardhan Azad, who heard the matter.
Through his RTI application, Jain had sought documents submitted by DePuy Medical Private Limited Ltd, a subsidiary of Johnson and Johnson, for import and marketing clearance of "ASR XL Acetabular System" and "DePuy ASR Hip Resurfacing system" manufactured by DePuy International Ltd.
These replacements were marketed by Johnson and Johnson.
ALSO READ: Faulty hip implants: Have reached out to 50% affected patients, says J&J
When the matter was challenged by Jain, a pharmacist himself, before the CIC, the CDSCO tried to justify its stand, saying these medical implants manufactured by foreign firms are imported and marketed by Johnson and Johnson Ltd.
Accordingly, the manufacturer and marketing company Johnson and Johnson sign various agreements including the Power of Attorney by which the onus and responsibility of marketing the product and consequences thereof accrue on the marketing company, the CDSCO officials argued.
Jain challenged the contention of the CDSCO, saying the matter pertains to a large number of patients who had to suffer because of faulty products which were recalled by the United States.
On being tested and found defective these implants have been banned from usage worldwide. But patients, mostly senior citizens in India, are being freely recommended and implanted with these allegedly cancer-causing devices with far-reaching complications, Information Commissioner noted in the order, citing Jain's submissions.
Azad said none of the documents submitted by the CDSCO contains information of commercial confidence, trade secrets or intellectual property of the Drug manufacturer -- DePuy International.
"Neither the company nor the respondent has made out a case as to which portion of these documents contain such information disclosure whereof is likely to adversely affect the competitive position of the company- the third party in question," he said.
Azad said Jain has successfully made out his case that he needs this information in larger public interest on behalf of thousands of patients suffering in India waiting to get relief in the form of monetary compensation against the parent company.
ALSO READ: Redress for faulty Johnson & Johnson hip implant surgeries unlikely
Jain has said the imports have been detrimentally affecting the senior citizens who have been administered such implants, he noted.
The documents are required for proving the liability and onus of the companies in the case of artificial hip implants imported by DePuy, Azad said.
"The exemption under Section 8(1)(d) (related to exemption of information pertaining to commercial confidence) of the RTI Act 2005 does not extend a blanket cover nor are such bald assertions legally tenable, unless tested on the touchstone of facts," he said.
Azad said the commission found no impediment in directing disclosure of these compliance documents as submitted before the commission and sought by Jain.
He, however, added a caveat that in case the CDSCO feels that any particular document attracts clause of commercial confidence that can be withheld by it.
Recently, the CDSCO, which works under the Health Ministry, put out a report on its website stating the Johnson and Johnson "suppressed" facts on the harm caused by surgeries which were conducted on patients in India using "faulty" hip replacement systems.
A group of patients, who suffered due to alleged faulty hip replacement surgeries by a multinational firm, have written to Union Health Minister J P Nadda, saying it is surprising that the media has been able to get the report yet the persons directly affected have been kept in the dark.
The group said that in the last eight years, since the recall of this product, they have endured pain and become disabled while some of them have lost family members who died awaiting redressal.
Reports quoting the expert committee findings say that over 3,600 patients with faulty implants remain untraceable, and that at least four deaths have been reported among these patients.

Faulty hip implants: Have reached out to 50% affected patients, says J&J

While senior government officials claimed that Johnson & Johnson (J&J) had agreed, in-principle, to pay compensation to the patients affected by its faulty hip implants, the company maintained it had the global expertise to arrive at a compensation mechanism on a case-to-case basis for each patient.
The government has fixed a minimum compensation amount of Rs 2 million for each affected patient, but J&J wants to arrive at a ‘mutually agreeable’ figure that need not be the same as the government has recommended.

Meanwhile, J&J has also claimed that it has reached out to almost 50 per cent of patients, who had an ASR hip implant made by DePuy, a J&J subsidiary. Its aim is to have all the 4,700 patients (who underwent an ASR hip implant surgery in India) register on the ASR helpline soon with help from the government, the company said.
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Sushobhan Dasgupta, managing director, J&J Medical India, said, “We want to arrive at a compensation amount that is fair and equitable for each patient. We have the global expertise to arrive at a compensation mechanism for the same, and would work closely with the Indian government on this.”
DePuy set up a helpline and initiated the reimbursement process for ASR patients in India in September 2010.
He also said while 2,300 patients had already been reached out to and 277 revision surgeries had been conducted, not all patients were unhappy with the ASR hip implant. “There are happy ASR-hip implant patients too. My mother, an 87-year-old lady, had undergone an implant surgery (using ASR implant) about 11 years ago, and she is doing fine. In fact, she travelled alone from Kolkata to Mumbai recently,” Dasgupta quipped. The first hip implant (a locally made one and not a J&J product) that was administered to his mother had failed within three months, after which she had gone for a revision surgery and received an ASR hip implant, he said.
Faulty hip implants: Have reached out to 50% affected patients, says J&J
There has been a five-year revision rate of 12-13 per cent for ASR hip implants globally, which is higher than the expected rate. So far in India, the company has paid around $2 million to patients for revision surgeries, and around $250,000 in related diagnostic costs, under its ASR reimbursement programme.
“We are open to pay for revision surgeries, if needed, and diagnostic costs, loss of wages, physiotherapy and other needs. The patients can choose to go to surgeons of their choices. We are already running a reimbursement programme. As for compensation, we want to go on a case- to-case basis and arrive at a mutually agreeable figure,” Dasgupta said.
J&J tried to clarify that a voluntary recall did not imply that the product was ‘faulty’. “A voluntary recall doesn’t imply that the product is faulty nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the company spokesperson said.
The expert committee constituted by the Union health ministry had recommended that each patient be identified through regional and central committees, which would put out advertisements in newspapers, register patients, evaluate the disability suffered owing to ASR hip replacements, and accordingly arrive at a compensation amount. The base amount for compensation was fixed at Rs 2 million. The amount was decided such that if a patient keeps it in a bank by means of a fixed deposit (at 7 per cent interest), he or she would get a monthly interest amount equivalent to his/her minimum wages per month. For example, the minimum monthly wage of an unskilled worker based in Delhi as of March 2017 was Rs 13,350.To earn this, a deposit of over
Rs 2 million would be required to be kept in a bank account.
A senior government official said the company had already given an undertaking in which it had agreed, ‘in-principle’, to provide compensation to the affected patients.
“They have some issues with the protocol for arriving at the compensation amount for each patient. We have also asked them to share the details of the protocol that they had used in the other countries such as US and Australia,” the official said.
The apex drug regulator had sent a letter to the company on Tuesday, asking it to comply with the recommendations of the government-appointed expert committee.
A J&J Medical India spokesperson said, “In the light of the recent committee report, we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation to patients in need.”
The US-based medical devices maker has been under fire, off late, for the faulty ASR hip-implants and its failure to identify the affected patients, and offer a resolution. The artificial hip implants were recalled worldwide by the company in 2010. Around 93,000 patients were had received ASR implants globally.

Faulty hip implants: Have reached out to 50% affected patients, says J&J

While senior government officials claimed that Johnson & Johnson (J&J) had agreed, in-principle, to pay compensation to the patients affected by its faulty hip implants, the company maintained it had the global expertise to arrive at a compensation mechanism on a case-to-case basis for each patient.
The government has fixed a minimum compensation amount of Rs 2 million for each affected patient, but J&J wants to arrive at a ‘mutually agreeable’ figure that need not be the same as the government has recommended.

Meanwhile, J&J has also claimed that it has reached out to almost 50 per cent of patients, who had an ASR hip implant made by DePuy, a J&J subsidiary. Its aim is to have all the 4,700 patients (who underwent an ASR hip implant surgery in India) register on the ASR helpline soon with help from the government, the company said.
Sushobhan Dasgupta, managing director, J&J Medical India, said, “We want to arrive at a compensation amount that is fair and equitable for each patient. We have the global expertise to arrive at a compensation mechanism for the same, and would work closely with the Indian government on this.”
DePuy set up a helpline and initiated the reimbursement process for ASR patients in India in September 2010.
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He also said while 2,300 patients had already been reached out to and 277 revision surgeries had been conducted, not all patients were unhappy with the ASR hip implant. “There are happy ASR-hip implant patients too. My mother, an 87-year-old lady, had undergone an implant surgery (using ASR implant) about 11 years ago, and she is doing fine. In fact, she travelled alone from Kolkata to Mumbai recently,” Dasgupta quipped. The first hip implant (a locally made one and not a J&J product) that was administered to his mother had failed within three months, after which she had gone for a revision surgery and received an ASR hip implant, he said.
Faulty hip implants: Have reached out to 50% affected patients, says J&J
There has been a five-year revision rate of 12-13 per cent for ASR hip implants globally, which is higher than the expected rate. So far in India, the company has paid around $2 million to patients for revision surgeries, and around $250,000 in related diagnostic costs, under its ASR reimbursement programme.
“We are open to pay for revision surgeries, if needed, and diagnostic costs, loss of wages, physiotherapy and other needs. The patients can choose to go to surgeons of their choices. We are already running a reimbursement programme. As for compensation, we want to go on a case- to-case basis and arrive at a mutually agreeable figure,” Dasgupta said.
J&J tried to clarify that a voluntary recall did not imply that the product was ‘faulty’. “A voluntary recall doesn’t imply that the product is faulty nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the company spokesperson said.
The expert committee constituted by the Union health ministry had recommended that each patient be identified through regional and central committees, which would put out advertisements in newspapers, register patients, evaluate the disability suffered owing to ASR hip replacements, and accordingly arrive at a compensation amount. The base amount for compensation was fixed at Rs 2 million. The amount was decided such that if a patient keeps it in a bank by means of a fixed deposit (at 7 per cent interest), he or she would get a monthly interest amount equivalent to his/her minimum wages per month. For example, the minimum monthly wage of an unskilled worker based in Delhi as of March 2017 was Rs 13,350.To earn this, a deposit of over
Rs 2 million would be required to be kept in a bank account.
A senior government official said the company had already given an undertaking in which it had agreed, ‘in-principle’, to provide compensation to the affected patients.
“They have some issues with the protocol for arriving at the compensation amount for each patient. We have also asked them to share the details of the protocol that they had used in the other countries such as US and Australia,” the official said.
The apex drug regulator had sent a letter to the company on Tuesday, asking it to comply with the recommendations of the government-appointed expert committee.
A J&J Medical India spokesperson said, “In the light of the recent committee report, we are seeking to work with the Indian government to develop an appropriate process for providing further support and compensation to patients in need.”
The US-based medical devices maker has been under fire, off late, for the faulty ASR hip-implants and its failure to identify the affected patients, and offer a resolution. The artificial hip implants were recalled worldwide by the company in 2010. Around 93,000 patients were had received ASR implants globally.