South African firm and Johnson & Johnson strike vaccine deal South

 Johnson & Johnson would be responsible for supplying the vaccine in large batches and Aspen would put it into vials and package it for individual doses, pending a final commercial agreement, said the statement issued by Aspen.

Aspen chief executive Stephen Saad said the company has invested more than 3 billion rand ($184 million) in its South African facility and has a track record of supplying drugs for the treatment of HIV/Aids and multi-drug-resistant TB.

The 7-day rolling average of daily new cases in South Africa did not increase over the past two weeks, going from 2.73 new cases per 100,000 people on Oct. 18 to 2.64 new cases per 100,000 people on Nov. 1.

The country has a total of 726,823 cases, representing more than 40% of all cases recorded in Africa, according to the Africa Centers for Disease Control and Prevention.

In July protesters demonstrated in Johannesburg against vaccine trials of a vaccine being tested by the University of Oxford, in which about 2,000 people were expected to participate.

The protesters told The Associated Press then that people chosen as volunteers for the trials were from impoverished backgrounds and not fully aware of the potential risks associated with clinical trials. However, academics running the trials said that all those participating were given considerable information about the trial and had to take an examination about the trial and pass with a rate of 80% Experts told a United Nations webinar in June this year that misinformation about testing fueled anti-vaccine sentiment in Africa.

J&J ordered by Florida jury to pay $9 million in talc-cancer case

Johnson & Johnson was ordered by a Florida jury to pay $9 million to an 82-year-old woman who blamed asbestos-tainted talc for her cancer, the latest court loss for the company in US litigation over its iconic baby powder.

Jurors in Miami concluded on Thursday that asbestos in baby powder used by Blanca Mure-Cabrera over her lifetime contributed to the development of her mesothelioma, said David Jagolinzer, one of her lawyers. That type of cancer has been specifically linked to asbestos exposure.The trial loss is the second for J&J this year over claims the company knew some of its talc-based products were laced with asbestos and hid it from consumers. Earlier this month, a jury in J&J’s hometown of New Brunswick, New Jersey, ordered the company to pay $750 million in punitive damages to four people. A judge later reduced that award to $186.5 million.J&J -- the world’s largest maker of healthcare products -- said it will appeal the jury’s liability finding and damage award.

“Today’s verdict is at odds with the decades of evidence showing the company acted responsibly and was guided by sound science,” Kim Montagnino, a company spokeswoman, said in an emailed statement.J&J still faces almost 18,000 lawsuits over the 135-year-old baby powder. A majority of the cases allege women who used the product got ovarian cancer, while a smaller number claim links to mesothelioma.

The talc litigation may eventually cost the company as much as $10 billion, according to Bloomberg Intelligence. Though baby powder accounts for only a small fraction of J&J’s annual revenue, it’s been a core brand for the company for more than a century.

Plaintiffs’ lawyers claim internal J&J documents show executives knew since the late 1960s that talc mined in places such as Vermont and Italy contained trace amounts of asbestos but failed to alert consumers or regulators. Asbestos is often found in mined talc, but the company says it is removed when processed. The listed ingredients in J&J’s baby powder are talc and fragrance.J&J -- which contends there’s never been any asbestos in its baby powder and that it marketed the product properly -- has steadfastly fought the claims at trial and on appeal, only settling a small number of lawsuits.Earlier this week, J&J agreed to settle a 62-year-old woman’s mesothelioma claims just before a trial in state court in Manhattan was set to begin. In court filings, lawyers for Laura Shanahan said she used baby powder daily starting as a young child. She was diagnosed with the asbestos-linked cancer in October. Terms of the settlement weren’t made public.

“The decision to resolve any particular case in no way changes our overall position that our talc is safe, is asbestos free and does not cause cancer,” Montagnino said in an emailed statement. “We do not have any organized program to settle Johnson’s baby powder cases, nor are we planning a settlement program.”

Johnson & Johnson to expand its anti-TB programme in India

Johnson & Johnson said today that it is expanding its tuberculosis (TB) programme in India ahead of the 50th Union World Conference on Lung Health in Hyderabad.

According to the company, the expanded India programme aims to broaden access to treatment for multidrug-resistant TB (MDR-TB), improve detection of undiagnosed cases, build critical health systems and raise awareness about TB at the community level. The intitiative is part of Johnson & Johnson's 10-year goal of achieving a world without TB.

"TB is a devastating disease that claims nearly half a million lives in India every year," said Sarthak Ranade, managing director, Janssen India, a Johnson & Johnson subsidiary.

Ranade added that the company is collaborating with the Central government and with several multilateral and non-governmental organisations to support the country's efforts to root out the disease by 2025, as outlined in its National Strategic Plan for TB Elimination.

Johnson & Johnson's TB programme in India includes technical assistance to build capacity and establish new TB culture and drug-susceptibility testing facilities in at least seven sites across India. The focus would be on high-burden TB states of Maharashtra, Himachal Pradesh and Tamil Nadu. The company will also launch a pilot initiative to expand TB-control efforts in the private sector, where most patients initially seek care.

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.

"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.

J&J tries to use supplier bankruptcy to fight 2,400 baby-powder lawsuits

Johnson & Johnson wants a federal judge to take over more than 2,000 baby-powder lawsuits it faces instead of allowing the cases to be heard by state-court juries, where the company has a mixed record.

The world’s largest maker of health-care products seeks to invoke legal protections available to J&J’s bankrupt talc supplier Imerys Talc America Inc. to collect suits accusing its baby powder of causing asbestos-related cancers before a single judge in Delaware. Imerys sought Chapter 11 protection in bankruptcy court there in February after being swamped by talc suits.

Because it hasn’t filed for bankruptcy protection, J&J would normally not be entitled to demand state-court litigation be halted or transferred to a federal court. But a special bankruptcy law provision allows Imerys creditors with significant financial ties to the talc miner to make the request to promote “expeditious resolution of claims,” according to Thursday’s filing.

“Because the claims raise common questions of fact, law, and science, the current nationwide” round of pre-trial information exchanges “is duplicative, unpredictable, and wasteful,” J&J said in court papers.

J&J is facing more than 14,000 claims its talc products caused ovarian cancer or mesothelioma, a rare cancer linked to asbestos exposure. The company denies its products ever contained the carcinogen and argues talc on its own doesn’t cause the life-threatening illnesses.

Mixed Record

More than 11,000 of those suits filed in federal courts around the U.S. already have been consolidated before a federal judge in New Jersey for pre-trial information exchanges. J&J’s request aims to set up a similar -- but smaller -- concentration of the state court cases in Delaware.

J&J faces more than a dozen trials, primarily in California, over the next five months, according to data compiled by Bloomberg. The company has a mixed record when juries have weighed the talc cancer cases. J&J prevailed in a New Jersey trial last month, two weeks after a jury in Oakland, California, hit it with $29 million in damages.

“I think the chances a judge in Delaware is going to add another 2,400 cases to that court’s docket are pretty remote,” said Chuck Tatelbaum, a Florida-based lawyer who’s been involved in mass tort cases that wound up in bankruptcy court. “This move is a bit of a stretch,” said Tatelbaum, who isn’t involved in the J&J litigation.

J&J’s lawyers noted in their filing they aren’t seeking to bring to Delaware cases that have already gone to trial or are in the jury-selection process. They also aren’t seeking to include any verdicts on appeal as part of the requested transfer.

$4.7 Billion Verdict

That would include a nearly $4.7 billion verdict against J&J last year in state court in Missouri on behalf of 22 women who blamed their cancers on baby powder use and a $117 million verdict on behalf of a male user of the talcum powder in state court in New Jersey.

Because Imerys was a co-defendant in most of the talc suits lodged against J&J, the health-care company is a significant creditor in the talc suppliers’ bankruptcy case, according to the company’s filing. The companies have disagreements about $2 billion in insurance coverage and indemnity agreements covering talc litigation, J&J noted.

Sweeping the remaining talc cases to Delaware would help U.S. Bankruptcy Judge Laurie Selber Silverstein more efficiently decide how to cover Imerys’s talc liability and relieve the litigation burden on state courts across the U.S., J&J said.

The claims are “overwhelming” state courts nationwide, “to the detriment” of Imerys, its creditors and talc plaintiffs, J&J’s lawyer said. A Delaware consolidation would “further judicial economy and the prompt, fair and complete resolution” of all the claims.

Nate Finch, a South Carolina-based lawyer for talc plaintiffs, dismissed J&J’s filing as another attempt to avoid having state-court juries “look at their internal documents and hear other evidence” of their effort to hide baby powder’s health risks.

Lawyers for women suing J&J over its familiar powder have unearthed documents they say show the company knew in 1970 that asbestos had been found in talc used in the product and could cause cancer in users.

J&J moves Delhi HC, says willing to pay only Rs 25 lakh to victims

Pharmaceutical giant Johnson & Johnson (J&J) has approached the Delhi High Court against a Central Drugs Standard Control Organisation (CDSCO) order asking it to pay Rs 65 lakh and Rs 74 lakh to two of the victims of faulty Articular Surface Replacement (ASR) hip implants.

The company said it was willing to pay Rs 25 lakh as compensation to those affected but could not agree to the arbitrary amounts being imposed by the government.

Other than the CDSCO order, J&J has also challenged the Agrawal committee report and a release issued by the Union health and family welfare ministry asking it to pay compensation to the victims. The compensation was based on the report submitted by two committees, under the chairmanship of Arun Kumar Agarwal and R K Arya, respectively. While the Agarwal committee report had examined the issues related to faulty implants and the reasons behind it, the Aryan panel had come out with the quantum of punishment, which varied from Rs 10 lakh to Rs 1 crore.

Hearing J&J’s plea, a single judge bench of Justice Vibhu Bakhru, while issuing notice to the government, also sought to know as to what procedure had been followed by the government while arriving at the formula for compensation.

“The question here is of the procedure. What is the power of the Committee (to frame the formula). There was Bhopal gas tragedy...there was a legislation to enforce the compensation. Can an Executive Authority do so? Where is the provision under law?” the court observed. The court will now hear the matter on May 2.

The CDSCO had on March 11 asked J&J to pay Rs 74 lakh to a Mumbai-based victim within 30 days of the order. Of the total 4,700 hip implant surgeries conducted in India using J&J subsidiary DePuy’s ASR hip replacement system, only 882 patients (accounting for 1,056 implants) could be traced through the ASR helpline. DePuy set up a helpline and initiated the reimbursement process for ASR patients in India.

After Rajasthan, Gujarat to test J&J's baby shampoos

After Rajasthan's state drugs controller found that Johnson & Johnson (J&J)'s baby shampoo products were not of standard quality, the Gujarat Food and Drugs Control Authority has turned its eye on the healthcare major.

The state FDCA has now ordered tests on samples of J&J's baby shampoo results, which could take at least couple of weeks.

Gujarat took it upon itself to test the products following media reports on results in Rajasthan.

"We randomly and arbitrarily take up products for test. Close to 15,000 samples of drugs and cosmetics every year are tested in Gujarat. However, we have now ordered tests on Johnson & Johnson's baby shampoos on a priority basis after we saw the results declared by Rajasthan," H G Koshia, Food and Drugs Commissioner of Gujarat told Business Standard.

Recently, Rajasthan Drugs Control Organisation termed J&J's baby shampoo products as non-standard quality after the state drug controller found carcinogenic contents in two batches of the samples tested. Having discovered formaldehyde, a carcinogen, in the samples tested, Rajasthan's drug controller has asked its officials to ensure that J&J's baby shampoo stocks were not consumed anymore. Responding to the findings, J&J has contested the interim test results of the analysis that were based on “unknown and unspecified methods.” Further, it added, “the application before the relevant authority is pending for re-testing of samples at Central Drugs Laboratory.”

As for tests in Gujarat, Koshia said that test results are likely to be out in the next 2-3 weeks.

However, Gujarat's move to test the baby shampoo product is not driven by any larger steps being taken by the Drug Controller General of India (DCGI) at the Centre.

"We have taken the step suo moto and have not heard or received any notification from the DCGI," Koshia added.