Tag: lawsuit

Fight Not Yet over as Case Against Vertex is Dropped After Cystic Fibrosis Medicine Price Cut

Cheri Nel launched a court case against Vertex to force them to allow their generic cystic fibrosis drug to be imported into South Africa. Credit: Spotlight

By Catherine Tomlinson

Last year a South African woman took a multibillion-dollar United States pharmaceutical company to court with the aim of securing access to life-changing cystic fibrosis medicines. That case has now been dropped following a reduction in the price charged for the medicines in South Africa.

Cheri Nel, a Johannesburg-based investment banker, has dropped a potentially landmark court case against Vertex Pharmaceuticals. Nel was asking the Gauteng Division of the High Court in Pretoria to grant a compulsory licence to allow generic versions of a cystic fibrosis medicine called Trikafta to be imported into South Africa. No such compulsory licences on medicines have ever been granted in South Africa.

Trikafta, which was registered in the United States in 2019, has been hailed as a “miracle” treatment for cystic fibrosis, which causes severe damage to the lungs, digestive system and other organs in the body. The medicine is effective in treating around 90 percent of people living with the condition. It significantly improves the quality of life of people living with cystic fibrosis, eliminating many of its debilitating symptoms, while also slowing the disease’s progression and extending survival.

In February 2023, when Nel launched her lawsuit against the Boston-headquartered pharmaceutical company, the only way people in South Africa could access Trikafta was by travelling to Argentina to buy it from an Argentinian company selling a generic version of the medicine.

This is because Vertex, the company that holds the patents on Trikafta in South Africa, refused to register the medicine with the South African Health Products Regulatory Authority (SAHPRA) or identify a local distributor that could import unregistered Trikafta via Section 21 authorisations – a mechanism allowing importation of unregistered medicines.

The United States list price for Trikafta is currently over $300 000 (around R5.5 million at the current rand/dollar exchange rate) per person per year, which South Africans feared they would also have to pay if or when Vertex finally started supplying its medicine in the country. Researchers in the United Kingdom have estimated that Trikafta can be produced for under $6000 (around R110 000 at the current rand/dollar exchange rate) per person per year.

When Nel filed the case, generic Trikafta from Argentina – called Trixacar – was much cheaper than Vertex’s product (but still prohibitively expensive for many) at around $60 000, or almost R1 million per person per year. But the Argentinian company selling generic Trixacar faced potential patent infringement challenges if it shipped Trixacar to South Africa. Thus, the only way to get the medicine into South Africa at the time was to travel to Argentina to collect it. People living with cystic fibrosis in South Africa learnt how to do this through an informal network or Buyers Club of people around the world that were reliant on the Argentinian product.

Launching a legal case

Nel argued that Vertex was abusing its patents in South Africa by refusing to make Trikafta available in the country on reasonable terms, while also blocking other manufacturers from supplying the medicine in the country. If successful, Nel’s case would have allowed generic Trikafta to be shipped directly to South Africa, removing the need for travel to Argentina to access the medicine.

According to Nel, Vertex argued in the company’s answering documents to her legal filing that, as she was the only named applicant in the case, a compulsory licence for importation could only be considered for her.

Nel then worked with the South African Cystic Fibrosis Association (SACFA) to get other people living with cystic fibrosis admitted as co-applicants in the case. This process of seeking more people to join her case, she said, was time-consuming, difficult, and expensive, but more than 100 people were working towards being admitted as co-applicants before the case was dropped.

Under pressure, Vertex starts providing Trikafta in South Africa

As the case gained momentum and made headlines around the world, Vertex finally opened the door to allow some people living in South Africa to access their product.

In May 2024, Vertex identified Equity Pharmaceuticals as the local company through which Trikafta could be imported into South Africa via Section 21 authorisations. These authorisations are granted by SAHPRA to enable importation of an unregistered medicine and are meant to be used in exceptional circumstances to remedy the need for an unregistered medicine, such as when there is a shortage of the registered product.

While Vertex has not confirmed to Spotlight or stated publicly the price of Trikafta for people living in South Africa, Nel and Doctors Without Borders’ Candice Sehoma told us that the company is charging around R400 000 ($22 000) for a year’s supply of the medicine.

While still unaffordable for many and much higher than the estimated cost of manufacturing, the R400 000 price is drastically lower than the R5.5 million price charged in the United States and originally feared for South Africa.

It seems improbable that Vertex would have offered the much reduced price to people living in South Africa had Nel not launched the court case

Some medical schemes now paying for Trikafta

As emerged in April this year, Vertex reached an agreement with some medical schemes in South Africa to provide the medicine for people on top-end plans.

“Four private healthcare providers are currently funding Trikafta for eligible patients and we are open for conversations with more insurance companies,” Vertex’s spokesperson Daria Munsel confirmed to Spotlight.

The exact nature of the conversations and/or agreements between Vertex and medical schemes in South Africa however remains somewhat unclear.

Discovery Health‘s CEO, Dr Ron Whelan, told Spotlight it has engaged Vertex about the “benefits available” and “affordable access” of the class of medications that Trikafta falls in but there is “no specific commercial agreement in place” in South Africa.

He noted that Discovery Health Medical Scheme members on the comprehensive and executive plans have a suite of benefits available for the treatment of cystic fibrosis with medicines like Trikafta “of up to R400 000 per annum” for eligible people.

According to Vertex, uptake of its product has been swift and is already starting to make a difference in the lives of people living with cystic fibrosis in South Africa. “Over 100 South Africans with CF [cystic fibrosis] have been prescribed our triple combination treatment in just the first two months of the medicine being available,” said Munsel.

The cystic fibrosis registry, an initiative which seeks to identify and collect data on the outcomes of people living with cystic fibrosis in South Africa, identified 525 people living with cystic fibrosis in the country as of December 2020. Experts believe there are many more undiagnosed cases.

Why did Nel drop the case?

Not only is Vertex’s price for people in South Africa now lower than the 2023 price of Argentinian generics, but the cost of a year’s supply of generic Trikafta from Argentina have increased from around $60 000 to around $100 000 due to hyperinflation in that country.

With Vertex now offering a price lower than the cost of Argentinian generics, Nel decided that her legal case was no longer the best avenue to enhance access to the medicine. The aim of the case “was to get access to the medication… to put pills in patients’ mouths”, she told Spotlight.

Nel said it is now probably better to redirect efforts to getting government at national or provincial levels to buy the medicine for patients in the public sector.

“There is a lot of work still to be done… my efforts are still there, it’s just being redirected,” she said.

“The fact that Trikafta will now be available in South Africa at a much lower price compared to generic versions globally, certainly undercuts the legal case for a compulsory license,” said Tendai Mafuma of SECTION27, a public interest law centre. The Treatment Action Campaign and Doctors Without Borders, represented by SECTION27, were admitted as friends of the court in the case.

Why won’t Vertex register its product in SA?

While much has changed because of Nel’s legal action, Vertex has held fast on its refusal to register Trikafta with SAHPRA.

When asked about Vertex’s plans to register Trikafta in South Africa, Munsel said: “We strongly believe that this [Section 21 Authorisation] is the fastest and most efficient route to sustainable access in South Africa, which does not require a regulatory filing.”

While registering medicines can be onerous and time consuming, it is a routine practice required for pharmaceutical companies to operate around the world. Full registration also typically requires that safety, effectiveness and quality is more closely scrutinised than is the case with Section 21 authorisations.

Nel believes that Vertex has chosen not to register Trikafta in South Africa because of the price transparency requirements embedded in South African law. If other countries know what price South Africa is paying then they may also demand a lower price, she said.

The law requires that there is a transparent pricing system for medicines sold in the private sector, but these requirements do not extend to unregistered medicines imported through Section 21 authorisations, explained Mafuma.

Note: SECTION27 was involved in the court case that is the subject of this article. Spotlight is published by SECTION27, but is editorially independent – and independence that the editors guard jealously. Spotlight is a member of the South African Press Council.

Republished from Spotlight under a Creative Commons licence.

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Court Finds Netcare Failed to Protect Employee Against an Abusive Surgeon

Operating theatre manager wins her case

Photo by Bill Oxford on Unsplash

By Tania Broughton

The former manager of an operating theatre at Universitas Hospital has successfully sued Netcare for failing to protect her and take action against an abusive surgeon because, she claimed, it was well known that he was a “money spinner” for the company.

Tilana Alida Louw also sued Dr Stephen Paul Grobler but, following his sudden death in June 2022, entered into a confidential settlement agreement with the executor of his estate.

She then pursued her case against Netcare Universitas Hospital.

In a ruling this month, Bloemfontein High Court Judge Ilsa van Rhyn directed Netcare to pay her R300 000 for damages, past and future medical expenses, and to pay part of her costs on a punitive scale.

Louw was appointed as surgical theatre manager at the hospital in 2005. Her role was to oversee and manage operating theatres and theatre staff and monitor patient care.

At that time, she was warned by the then hospital manager, and others, that Grobler had an “aggressive type personality”.

She said she soon experienced first hand his temper tantrums.

In her claim, she said he had verbally abused her continually, hurling profanities, insults, using blasphemous language and obscenities at her in the presence of other operating theatre staff and even members of the public.

She said Netcare had failed to come to her assistance, in spite of her numerous requests and complaints.

Netcare had also failed to act against Grobler, even though it was common knowledge that he behaved this way.

Louw alleged that Netcare had failed in its legal duty to create a work environment free from verbal abuse and intimidation and to take reasonable care of her safety and protect her from psychological harm.

As a result she was humiliated, degraded and suffered shock, anguish, fear and anxiety. She experienced post-traumatic stress syndrome.

She wanted to be compensated for this. And she wanted Netcare to publish a written apology in a local newspaper.

Netcare defended the action. It denied that it had breached its duty to Louw and said it had taken action against Grobler.

After Louw and her witness, labour law expert Professor Halton Cheadle, testified, Netcare offered to pay her for damages and to apologise.

Louw accepted the financial offer, but she was not happy with the wording of the apology and the scale of costs tendered.

And so the trial continued.

Read the judgment

Judge van Rhyn said Louw had testified that her complaints and those of others had been largely ignored by management.

“She explained that several of the scrub nurses refused to work with Dr Grobler and she would step in and assist him during surgeries. Her sense of duty and pity for the patients, many of them being cancer patients who were in dire need of urgent and timeous surgeries, caused her to bear the brunt and endure the constant abuse.”

Louw had said she and other personnel were “not allowed” to lay complaints against Grobler because he was a “so-called money-spinner for Netcare”.

Cheadle, in his evidence, said given the number of grievances lodged against Grobler and given Netcare’s professed zero-tolerance approach to harassment, a reasonable employer would have warned Grobler about his behaviour after the first complaint and would have terminated his contract at the very least, after the third complaint.

Judge van Rhyn said Netcare’s offer of damages during the trial had been made after Louw had endured years of abuse at the hands of Grobler and eight years of litigation.

“I also agree with argument on behalf of the Plaintiff (Louw) that Netcare evidently allowed its employees to be abused by Dr Grobler for its own financial interests. Netcare was acquainted with Dr Grobler’s disgusting behaviour even prior to her (Louw’s) appointment as the unit manager,” she said.

This conduct was deserving of a punitive costs order, the judge said.

Louw had rejected the proposed apology because it contained the words “we apologise sincerely that you felt that Netcare did not sufficiently support you”.

The judge said she agreed with Louw’s perception that this did not, in its plain and ordinary meaning, convey a sincere regret and remorseful apology.

She said she had been informed during argument that Netcare had published the apology in the local newspaper.

However, she said, she would not make any order regarding the apology, because it would not be lawful in a case which was not based on defamation.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

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High Court Ruling Paves the Way for Affordable Medical Scheme Benefits in South Africa

Photo by Bill Oxford on Unsplash

The recent judgement by the Pretoria High Court in favour of the Board of Health Funders (BHF) carries substantial implications for medical schemes in South Africa. This follows BHF’s court application, which sought to compel the Council for Medical Schemes (CMS) to give a complete record, providing light on the LCBO’s decision-making process thus far.

The Court ordered the Minister of Health and the CMS to provide all of the papers listed in Rule 30A within 10 days of receiving the applicant’s notice of motion. The completion of this crucial milestone hinges on the provision of several documents, which we eagerly await.

This significant victory brings us closer to the ultimate goal of granting Medical Schemes exemptions to offer Low-Cost Benefit Options (LCBOs), which aim to provide greater access to affordable medical scheme benefits for low-income earners. The BHF’s success aligns with the mission of improving
healthcare accessibility and advancing progress towards universal healthcare coverage (UHC) in the country.

In the main application lodged on 8 August, the BHF requested the High Court to:

  • Lift the moratorium that prevents medical schemes from offering LCBOs when the Council for Medical Schemes (CMS) refuses to grant applications for exemptions to medical schemes, pending the finalisation of LCBO guidelines.
  • Declare the failure by the respondents to develop and implement LCBO guidelines as irrational, unreasonable, and unlawful, as per Section 6 of the Promotion of Administrative Justice Act and Section 1(c) of the Constitution.

The BHF represents the majority of the country’s medical schemes and healthcare funders, encompassing schemes and administrators serving nearly 4.5 million individuals.

According to Charlton Murove, the protracted process of crafting a framework for Low-Cost Benefit Options has taken over seven years and is yet to be finalised. Many policymakers have criticised medical schemes for their lack of affordability. The proposed solution aims to address these concerns and move closer to the principles of UHC, ensuring that the healthcare system grants everyone access to quality and affordable healthcare.

Murove stated, “This application seeks to drive a progressive agenda for the public and private healthcare sectors, fostering collaboration to alleviate the current challenges in our healthcare system. The Council for Medical Schemes and the Minister have pivotal roles in implementing policies that enhance access to healthcare. However, progress with LCBOs has been hindered by the CMS’s failure to take the necessary steps for reform, despite the publication of demarcation regulations in 2016.”

The BHF’s victory in the High Court represents a significant step forward in the pursuit of affordable and accessible medical scheme benefits. By addressing the current burdens faced by the state and ensuring that medical scheme premiums remain affordable, we can strive towards a healthcare system that benefits all South Africans.

US Supreme Court Snubs Johnson & Johnson Talc Lawsuit Appeal

Photo by Bill Oxford on Unsplash

On Tuesday, the US Supreme Court declined to hear Johnson & Johnson’s appeal challenging a $2.12 billion ruling in favour of 20 women who developed ovarian cancer which they alleged was linked to the company’s talcum powder. 

The company was appealing a 2018 court ruling in favor of 22 women who alleged asbestos-contaminated talcum powder was linked to their cases of ovarian cancer. The women had said the company did not provide adequate warning of the risks associated with using their products. The initial settlement amount had initially been over $4 billion before being cut down.

The judge in that case ruled Johnson & Johnson had “misrepresented the safety of these products for decades” and the evidence shown at the trial demonstrated “particularly reprehensible conduct on the part of Defendants.”
Johnsons & Johnson has dominated the talcum powder market for over a century.
While there is no established link between talcum powder exposure and cancer, but talcum powder is often mined close to asbestos, a known carcinogen for which there is no safe level of exposure, and which can have a long latency period between exposure and cancer development.
Some studies have shown an increase in lung cancer risk for miners working underground when exposed to raw talc, which can be contaminated with asbestos, while others have found no effect. Use of talcum powder in the genital or perineal area is thought to contribute to ovarian cancer risk, but results are also mixed.
Companies have been directed not to use asbestos in cosmetic products since the 1970s, according to the American Cancer Society. According to the National Cancer Institute, “the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.”


A 2018 investigation by Reuters uncovered documents showing that Johnson & Johnson was not only aware of the asbestos contamination problem, the company covered it up. It even tried to influence US regulatory policy over asbestos in cosmetic products. Lawyers representing the company have argued in court that the tests were unreliable, although recent independent lab tests of samples obtained from various time periods detected asbestos contamination.

In response to queries from Reuters, Johnson & Johnson’s outside litigation counsel Peter Bicks wrote: “The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc. This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.”

Source: Forbes