It Could Have Happened to the Queen
It was December 2011 and Lyn Rowe was about to get a demonstration of Grünenthal’s determination. Two weeks before Christmas, Grünenthal sent its legal team down to the Supreme Court building in Melbourne. Their mission was to persuade Justice David Beach to effectively throw Lyn’s claim against Grünenthal out of the Australian court system before it had even begun. Germany, according to Grünenthal, was the natural place for the claim to be heard. It was where Grünenthal’s witnesses were and also the location of up to 1.8 million pages of relevant documents, almost all of them in German. Additionally, Grünenthal argued, Rowe’s claim was oppressive and vexatious and an ‘abuse of process’. For all of those reasons, and others, Grünenthal wanted a permanent ‘stay’, or freezing of Lyn’s claim, in Australia.
Naturally Lyn’s lawyers resisted the application. If Grünenthal was successful it would mean the end of Lyn’s claim against that company. She simply could not litigate in Germany. So we filed material detailing Lyn’s personal circumstances, her total dependence on her elderly parents, the family’s precarious financial position, the difficulty for the Rowes in travelling to Germany, and even the family’s complete unfamiliarity with the German language. Obviously, we argued, the trial belonged in Melbourne, the city where Lyn lived, where her mother had taken the Grünenthal-made drug, where she was born with serious malformations, where her medical experts were, and where her lawyers practised.
Clearly if there was a choice to be made about which party should have to litigate in a foreign jurisdiction it had to be Grünenthal. It was a wealthy corporation with thousands of employees and access to the best defence lawyers anywhere in the world. Lyn Rowe was severely injured and penniless.
Grünenthal’s move seemed a desperate long shot to many of us on Lyn Rowe’s legal team. But it was evidence of the take-no-prisoners approach we had expected. Grünenthal’s Melbourne law firm, Clayton Utz, had been in these sorts of fights before, having represented corporations in tobacco, asbestos and pharmaceutical claims. So while we all considered Grünenthal’s gambit had little chance of success, it was not taken lightly.
Justice Beach gave all sides a patient hearing and then a week later produced a strongly worded judgment. Grünenthal’s attempt to have Lyn Rowe’s claim removed to Germany was scotched because ‘it cannot be said that Victoria is a clearly inappropriate forum,’ Justice Beach observed. ‘Grünenthal’s application for a stay must be dismissed.’
In court there were a few minutes of conversation after the decision, including talk about a further court date the following week. Lyn Rowe had absorbed her legal win without visible emotion but, as she listened to the ensuing conversation, she assumed she would have to return to court the next week. She started crying silently. Lyn can be stoic and emotional in quick succession. At that moment she thought that to attend court she would have to cancel an appointment to pick up a long-awaited new wheelchair. She was devastated. Lyn had been looking forward to the new wheelchair for months. As she wept, Grace Wilson, one of the legal team, wiped away her tears with a tissue and whispered that she was not needed in court and could keep the wheelchair appointment. Later more than one journalist reported—understandably but incorrectly—that Lyn had wept tears of relief at the decision to keep her trial in Melbourne. After leaving court, Ian Rowe, who had become an effective spokesman for Lyn, made a brief statement.
Now that we have the umpire’s decision that the trial should be here in Melbourne, I’d like to call on Diageo and Grünenthal to let Lyn have her day in court. Please don’t cause any more delay, just for delay’s sake. Time is not on our side. Wendy and I are getting older now, I’m almost eighty. And we really need to know that Lynette will be provided for when we can no longer do it ourselves. Every delay that Diageo and Grünenthal throw up makes it more difficult to get any security. Lyn is a brave woman—despite everything she never complains. And all she wants is the chance for a court to hear her claim. So that’s what I’m asking Grünenthal and Diageo to do—let Lyn have her day in court. Let’s get all the information on the table, and let’s get a decision.
In the days that followed Justice Beach set out a hectic schedule for pre-trial steps. This was intended to expedite the trial process and focus attention on the matters that really were in dispute. Most of our office spent the holiday period t-shirt clad, bashing away at computers—but we were relieved that Grünenthal’s attempt to sink our ship had been so categorically dismissed.
By that time there had already been a flurry of legal documents passing between the parties. In July 2011 we sent Grünenthal and Distillers Lyn’s statement of claim, the first serious salvo by the plaintiff in most legal cases. Drawing on almost eighteen months of work, it set out the history of the development of thalidomide, the licence granted by Grünenthal to Distillers to sell the drug in Australia, the warning signs that had been ignored and what we described as the negligent fashion in which the unsafe and improperly tested drug was promoted in Australia as safe and suitable for pregnancy. The statement of claim also detailed the ways in which the drug companies could have protected Lyn Rowe, and it sought damages to compensate Lyn for her losses. Finally, it also asked for additional damages—punitive or exemplary damages—to underline the gravity of the defendants’ failures.
Both Grünenthal and Distillers responded with requests for ‘further and better particulars’—lawyer-speak for more detail. Our responses ran to almost two hundred pages, providing sources for many of our allegations, citing dozens of medical journal articles, and referencing many documents from the criminal trial collection in Düsseldorf and the Sunday Times cache in London.
Grünenthal and Distillers also filed defences in which most of Lyn’s allegations were denied or not admitted. But as well as asserting that its testing had been adequate by the standards of the time, Grünenthal made some admissions. It admitted that it had received reports about thalidomide’s side effects from doctors, licensees, researchers, distributors and hospitals; that in various countries it had promoted thalidomide as safe and non-toxic and that some doctors had criticised it at the time for doing so; that it had received inquiries from doctors about whether thalidomide crossed the placenta and affected the foetus; and that it did no reproductive testing of thalidomide and had conducted no investigation into the effect of thalidomide on the foetus. Grünenthal also admitted that by the start of 1961 members of the German medical profession were concerned about the increase in birth malformations in that country.
These admissions were surprising and welcome, but we had a clear appreciation of the challenge ahead. Winning Lyn’s claim required us to succeed on every single element of the claim. Fail on any element and her claim was over. Lyn had to prove that her mother Wendy did in fact take thalidomide and that it caused Lyn’s absence of arms and legs; that Distillers and Grünenthal should have foreseen that thalidomide might damage her; that they behaved negligently by the standards of the time in exposing her to that risk; that the two companies had a duty to protect her in distant Australia; and that there was something they could have done to avoid the risk (such as withdraw the drug or put warnings on it). And then there was perhaps the biggest hurdle of all. Lyn’s time to bring her claim under the law had very probably run out—she had to persuade the judge that it was in the interests of justice to grant her permission to bring her claim after so many years.
If Lyn did win she would be awarded a lot of money. Journalists often asked how much Lyn wanted and the answer was always the same: we don’t know, but a lot. At that point we had not specified precisely what figure Lyn was seeking. We knew, and so did Grünenthal and Distillers, that it would be a very large sum: in the millions of dollars. If she succeeded, she was entitled to several categories of damages.
The first was for ‘pain and suffering’—properly known as general damages. The maximum payable in this category had been capped by law at just under $500,000. We felt certain that if Lyn succeeded at trial, her fifty years without limbs would entitle her to the maximum award.
Lyn was also entitled to lost earnings—past and future. This calculation would be unavoidably speculative. Lyn was not an injured worker with a career history and a predictable course of future employment. Lyn had never had the chance to have a career, and her moderate brain damage (the indirect result of thalidomide, and which particularly damaged her ability to concentrate) further complicated the picture. Lyn told us she would have wanted to be a nurse or doctor in other circumstances. But whatever hypothetical past and future employment a judge imagined for Lyn, her lost earnings over an entire working life would amount to a very large sum.
That left the biggest damages category of all: the cost of providing Lyn with proper and secure care. This had two components. First was care in the future, until her death; and second was reimbursement for past care. This second category in effect amounted to valuing Wendy’s unpaid care over fifty years. Providing proper care for a limbless woman is an expensive business. Because Lyn could do almost nothing for herself she needed a carer present at all times. We would seek the cost of professional care on a full-time, twenty-four-hours-a-day basis for the rest of Lyn’s life. On top of that would be things like wheelchairs, hoists and technological aids such as voice recognition software to make her life easier. The bill for all of this would be very high.
During the months after Grünenthal tried—and failed—to force Lyn to litigate in Germany, we continued to take statements from various members of Lyn’s family.
One of them was Bronwen Shannon, Lyn’s cousin on Wendy’s side. In 1976, when she was nineteen years old, Bronwen moved from Canberra to Melbourne to study, and got to know the Rowes. Bronwen vividly remembers the first time she fully appreciated the depth and complexity of Lyn’s disability. She had visited Lyn, who was in the Royal Children’s Hospital recovering from having a rod inserted into her back to correct her spine curvature and was feeling suicidal. ‘She was in pain, scared and vulnerable,’ Bronwen said. Lyn hated being in hospital, hated being away from her family, and was looking at six months on her back and then another six months in a brace. Lyn told Bronwen that if she were able, she would have gone to the top of the hospital building and wheeled herself off the edge. ‘Having led a fairly sheltered existence, this was really traumatic,’ Bronwen recalled.
The visit was topped off when a doctor brought a group of medical students into the room. Without a word of introduction, Bronwen said, the doctor ‘pulled back the bedclothes to show the students Lyn’s body, poked and prodded her and generally ignored Lyn as a human. He talked to the students about Lyn as though she were a medical specimen on display. He never even spoke to her’. Bronwen was horrified and too overwhelmed to say anything. She visited Lyn in hospital just that one time. ‘I was too immature to handle it then, but I’d love to go back in time and set that doctor straight. Still, the visit gave me an insight into how much humiliation and embarrassment Lyn has had to suffer.’
Later Bronwen lived with the Rowes for a few months while looking for a job, and helped out with Lyn’s care despite Wendy’s initial reluctance. ‘She didn’t want Lyn to be a burden to anyone,’ Bronwen said. ‘Luckily Lyn was eager for me to help and I learned how to help her with the toilet, dressing, going to bed and so on. It was all done physically in those days. The Rowes got a hoist later, but at that time we just physically lifted Lyn in and out of bed or her chair or the car.’
Lyn still gives her cousin a hard time about one incident during that period, when Bronwen was distracted after undoing Lyn’s seatbelt. Lyn leaned forward in her wheelchair, toppled, and fell face first onto the floor. She broke her nose, which she has done many times, but she especially loves that story and reminds Bronwen of it regularly.
Bronwen Shannon had grown up in Canberra believing that Lyn was a thalidomider, so when she mentioned it to Wendy, the response surprised her. ‘She said there was no proof about thalidomide. Wendy explained that her doctor had said it was just one of those things that happen and probably the result of a virus.’
The virus explanation was something that Wendy and Lyn had told many people over the years, and it was a central issue that Lyn’s lawyers had to deal with: Lyn had not in the past identified as a thalidomider. Obviously we had to get to the bottom of it. Our case was all about Lyn being a thalidomide survivor, not a virus survivor.
We had to understand the basis for the virus story, in order to dispense with it as a possible cause of Lyn’s malformations. We also had to gather all the available evidence that Dr Indian had in fact given Wendy thalidomide. We knew that Wendy’s medical records from the period had been destroyed, and that the empty pill containers had long since disappeared. There would be no hard physical proof that Wendy had been given the pills. There was no test we could give Lyn that would prove scientifically and with certainty that thalidomide was the cause of her limblessness. We would have to build the evidence of thalidomide consumption incrementally, piecing it together as best we could, largely from witness evidence. However, we did not need absolute proof, just a probability that Wendy had taken the drug and that it had caused Lyn’s injuries.
To make our case we had to go back to the start, and Wendy Rowe held many of the answers. When Lyn was born in March 1962, Wendy had never heard of thalidomide. Just three months earlier, in late November 1961, the drug had been connected to birth damage and withdrawn from sale. However when we went to the newspaper archives, we found that the story had made barely a splash at the time. Most coverage was confined to the medical press, and initially it was thought there had been very few Australian victims. Distillers, in fact, had done its absolute best to discourage local coverage. If such a disaster happened today there would be blanket media attention with extensive coverage of the victims and dire warnings issued. The drug would be ruthlessly hunted down. But in late 1961 and early 1962, when thalidomide’s danger was first revealed, the story sank. It was not until more than six months later, in the middle of 1962, that newspapers started paying close attention.
So it’s not particularly surprising that in the immediate aftermath of Lyn’s birth in March 1962, none of the doctors mentioned thalidomide to Wendy. Maybe they also didn’t know about the drug. Or maybe they didn’t want to distress Wendy any further. Dr Indian told her it was all just bad luck. ‘It could have happened to the Queen, it’s a chance in a million,’ is what Wendy remembered him saying shortly after Lyn’s birth.
But when Lyn was a few months old, Wendy’s father Ted Tudor sent her a newspaper clipping about thalidomide, and told her that Lyn looked like a victim of the drug. Tudor followed up with further clippings and a handwritten note, which Wendy was able to find fifty years later, with contact details for the Society for the Aid of Thalidomide Children in England. (Ted Tudor’s concern for his granddaughter ran deep. He was convinced that technology would ultimately make Lyn’s life much easier and spent much of his spare time designing aids for her, including the rotating spoon device Lyn eats from to this day.)
Alerted by her father, Wendy Rowe raised the thalidomide question with Dr Indian at his surgery. Wendy and I spent a lot of time talking about this discussion as it seemed a critical event. Of course there was always something exceedingly optimistic about my questions: the conversation had happened more than fifty years earlier. Many of us have trouble recalling detail after just a few months or even weeks. But despite the passage of time, Wendy’s memories were remarkably clear. Wendy knew Dr Indian had given her Distaval, and by then she knew it was the brand name for thalidomide. But Dr Indian ‘seemed defensive and uncomfortable with my question. He said it was impossible that pills could cause the sort of injuries that Lyn had, and that Lyn’s injuries must have been caused by a virus’.
It seems a strange response. Nobody was blaming doctors for the disaster; certainly Dr Indian was blameless. Perhaps he had heard only of thalidomide causing the more common shortened arms and legs; maybe he thought the complete absence of limbs was not something thalidomide could have done. Perhaps he felt such guilt or regret that he could not face the truth. Perhaps he thought that it would be better for Wendy to think the tragedy had been an act of God—something, as he’d already remarked, that could equally have happened to the Queen.
Wendy’s own response to Indian might also be thought odd at this distant remove. She did not argue or confront Indian with what she knew about thalidomide. She more or less accepted his explanation without comment. Sitting at her kitchen table in 2011, reflecting on events, Wendy explained the context.
I wasn’t assertive or confident in those days. I was twenty-six years old and struggling to cope with the shock of what had happened, with the demands that Lyn’s arrival had created, with the needs of the other two children in the wake of Lyn’s arrival and with Ian’s fragile mental state. I knew Dr Indian must be feeling bad about what happened, no matter what the cause. I didn’t want to be impolite and I liked and respected him. He had delivered my first two daughters. Also, he was a doctor. If he said it was a virus then he was probably right.
And then there is this: would it really have mattered to Wendy what had caused her daughter’s malformations? Decades on, we lawyers wanted Wendy to have fought back and forced some kind of confession from Indian. But how realistic was that? ‘It wasn’t something I spent time thinking about. There was no cure for Lyn, nothing was going to bring her limbs back,’ Wendy said. ‘We weren’t thinking about legal action, it’s not something we knew anything about.’
Others were suspicious. In 1962 the Victorian health authorities wondered whether Lyn was the victim of thalidomide and investigated Wendy’s medical records. They discovered that Indian had kept no record of any medication Wendy had taken during the pregnancy. This finding was relayed to Wendy, convincing her that further investigation was pointless.
It would be another twenty years before Wendy Rowe had a second conversation with Dr Indian about the cause of Lyn’s malformations. And as time passed she felt less and less certain about what had happened. Indian had been so certain about the virus and there was no proof about thalidomide anyway. Wendy tried to think about it as little as possible. She tried to cut conversations about the issue short. When people asked whether Lyn was a thalidomide baby, she always said, ‘No, the doctor said it was a virus.’
In the early 1980s, Wendy heard about some court cases concerning birth malformations said to have been caused by Debendox, the morning-sickness drug Dr Indian had prescribed after the Distaval did not work. She decided to investigate whether she might be able to bring a Debendox claim for Lyn. So Wendy visited the pharmacist where she had filled the prescriptions more than twenty years earlier and obtained a note confirming she had indeed taken Debendox. Then she went to see Dr Indian.
I asked him whether he was aware of the claims about Debendox and whether he thought that Debendox might have caused Lyn’s injuries. Dr Indian told me I was wasting my time. He told me Debendox was perfectly safe and that he had given it to his own daughters during their pregnancies and that their babies had been fine. He said I would be wasting my time if I thought I could get any compensation for Lyn as a result of taking Debendox.
Dr Indian’s advice about Debendox was sound. Despite the flurry of (largely unsuccessful) legal action in the 1980s, and the subsequent withdrawal from sale of Debendox (marketed as Bendectin in the US), the drug is not considered to be dangerous to the unborn child. In fact in 2013 the US FDA approved its reintroduction. But Wendy Rowe’s Debendox query was an opportunity for Dr Indian to correct his advice of twenty years earlier, and tell Wendy that if she was thinking about legal action, she should be focused on thalidomide. Again, we could only speculate why he did not. Dr Indian was, by everyone’s account, a careful and compassionate doctor. He passed away long before the legal action began and was never able to give us his side of the story.
Nonetheless our evidence that Wendy Rowe had taken thalidomide was coming together. We had her detailed, consistent evidence that Dr Indian had given her Distaval samples. We also had a cogent explanation for why she had used the virus story for so many years. We had medical evidence that the likelihood of a virus alone causing complete absence of limbs was close to zero.
But Wendy’s evidence needed support. There was no doubt that her recollection of thalidomide would be disputed and challenged at trial. How can you remember what you took fifty years earlier? she’d be asked. We needed backup. Further information, no matter how scant, would help. So we took a detailed statement from Dr Indian’s former medical partner, Dr Dickinson, the doctor who delivered Lyn Rowe. He confirmed that there had been Distaval samples at the surgery at the relevant time. Dickinson recalled that sales reps from Distillers and other pharmaceutical companies visited the surgery frequently and often left free samples which he and the other doctors kept in their desk drawers and gave to patients when appropriate. Dr Dickinson recalled that Distaval was a popular drug at the time: ‘Safe and non-toxic and an improvement on the barbiturates.’
Then Wendy put me in touch with her sister-in-law Margaret Tudor in the hope more than the expectation that she might have helpful memories. Margaret, seventy-nine years old when I met her in 2011, had married Wendy’s oldest brother Ted, a lawyer, and the couple and their four children had settled in Canberra. My first few telephone conversations with Margaret were so encouraging that we flew her down from Canberra so we could talk in person.
The minor cost of the flight paid off in spades. Margaret remembered a trip to Melbourne in mid-1961—she was able to pinpoint the timing almost exactly by reference to her own children’s birthdays—when Wendy Rowe had just fallen pregnant with Lyn. Margaret remembered that Wendy ‘was not entirely delighted to be pregnant’ and at a family lunch the conversation turned to Wendy’s morning sickness.
She said that the doctor had given her a new medication which he said would help. I was interested in such things because I had wanted to be a nurse before training as a teacher. I was also a mother and by that time had four children…I asked Wendy what the name of the medication was. She said it was called Distaval. I hadn’t heard of Distaval before. But because of the context and my interest in these things—and most importantly because of what happened afterwards—the name Distaval stuck in my memory.
This was an important piece of the jigsaw: corroboration that Wendy had been given Distaval. We were also assisted by Wendy’s youngest sister, Liz Trennery, who was eighteen years old and staying in Canada with their brother Graham in 1962 when Lyn was born. She vividly recalled receiving the news about Lyn’s condition.
Graham came into my room obviously upset and read me a letter. Our father had written to us with the news that Lynette had been born without arms or legs. He wrote that Wendy had been given thalidomide pills during her pregnancy. I remember all of this very clearly. This was shocking news. I could only imagine the shock and sorrow that Wendy and Ian and their daughters and my whole family were feeling in Melbourne.
Later, while pregnant with her two children in the 1970s, Liz Trennery refused all medication despite suffering severe migraines.
Margaret and Liz, both impressive and confident women, had armed us with significant supporting evidence that Wendy had taken thalidomide. Taken as a whole, the evidence was looking highly persuasive.
We had one further lead to pursue. We consulted a leading Melbourne geneticist, Ravi Savarirayan, who suggested testing Lyn for a couple of genetic conditions that have caused limblessness in an incredibly tiny number of people. We needed to be sure Lyn did not have either condition. None of us believed she did, but we held our breath anyway until, reassuringly, the test results came back negative.
We now felt confident of proving—on the balance of probabilities, and to the satisfaction of a judge—that Wendy Rowe had indeed consumed thalidomide. But that was just one hurdle. Many others loomed, including getting to grips with Distillers’ track record with the drug.
The small town of Turriff in northern Scotland is an unlikely setting for a piece of thalidomide history. Turriff boasts a population of only about five thousand and is probably best known for its annual agricultural show. But it was in Turriff in 1960 that a thirty-three-year-old Scottish GP wrote to the British Medical Journal suggesting that thalidomide might be the cause of nerve damage in four of his patients. In doing so, Dr Leslie Florence became the first doctor to publish on the connection between thalidomide and nerve damage.
Florence’s letter was brief—just three paragraphs. It was headed, memorably: ‘Is Thalidomide to Blame?’ He recorded the symptoms of nerve damage in his patients (tingling and coldness in the feet and hands and occasional unsteadiness), noted the common consumption of Distaval and the slow recovery after the drug was withdrawn, and wondered whether other doctors had a similar experience with the drug, which by then had been on sale for almost three years in the UK. ‘It would appear that these symptoms could possibly be a toxic effect of thalidomide,’ he concluded. A flood of correspondence followed—other doctors had indeed had the same negative experience and thanks to Florence were now connecting it with thalidomide. And, as if to seal Florence’s place in history, a few months later in Washington DC the FDA’s Dr Frances Kelsey read Florence’s letter and wondered what thalidomide might do to the foetus—a concern which helped block the sale of thalidomide in the US and saved many lives.
So Florence’s letter became one of the pivotal moments in the thalidomide story—but the man himself receded into the shadows. One published account even referred to Leslie Florence as a woman named Florence Leslie. In 2011, when I read the famous letter, I wondered whether Florence was still alive. Out of curiosity rather than any conviction it might help Lyn Rowe’s case, I did some internet searches. Before long I had found a retired doctor of that name living in Paraparaumu on the North Island of New Zealand. Within a few seconds of telephoning I knew I had the right number. A thick Scottish accent had given the game away.
Florence proved a fascinating man, keen to talk at length about thalidomide, and somewhat aggrieved he had not been accorded a more exalted place in history. He felt the FDA’s Kelsey had piggybacked on his work to achieve global fame: ‘I didn’t even get a thank you from her,’ he complained more than once. When I gently suggested that Kelsey and he had both made important contributions, he slapped me down good-naturedly. ‘What would you know, you’re a lawyer. The important thing is, I was first.’ While voluble about his rightful status, he was also a little suspicious and slightly concerned that if he helped us, Distillers might somehow exact revenge.
I told him Distillers was now part of a hugely successful multinational company (Diageo) and there was little chance thugs would be sent across the world to threaten a retired octogenarian. But Florence’s doubts were hard to assuage, including those he held about me. On one occasion, I was telephoned by a Paraparaumu policewoman whom Florence had asked to check that I was not some imposter with an elaborate ruse to scam him. The next day I telephoned Florence to apologise if I had worried him with my questions. ‘Don’t worry laddie,’ he interrupted. ‘Can’t be too careful, that’s all.’
When, soon afterwards, I suggested I visit so we could speak in person, he was enthusiastic, even inviting me to stay with him. (I declined for fear of further police checks.)
So in February 2012 I visited Florence’s townhouse in the seaside New Zealand town. He was well prepared, with his vast collection of thalidomide documents arrayed on his dining table. I quickly received a detailed tour of the (insufficient) praise and credit he had won for his letter. That was followed by the now-familiar litany of complaints: a book that was to feature him was never published because of the author’s premature death; other doctors including Widukind Lenz had hogged the limelight for publicly connecting thalidomide with malformations; and, most galling of all, the FDA’s Frances Kelsey would not have shot to global fame for blocking thalidomide sales in the US but for his letter which had got her thinking along the right track. And yet there was Kelsey, a feted hero still receiving accolades in the United States, and here he was, an obscure retired GP living on a pension in suburban New Zealand.
If this all sounds bitter, it was only marginally so. Most of Florence’s complaining was done with good grace, and he was charming company. While he continually inquired about his hourly rate (and joked that all Scots were obsessed by money), he never actually asked to be paid and was relishing the thought of belated recognition late in life, if only as a by-product of giving evidence at Lyn’s trial.
Florence’s account was important for the contemporary perspective it gave us on Distillers and its unhappy thalidomide history. As we’ve seen, Distillers was a drinks company that branched into pharmaceuticals during World War II. In June 1956, Distillers’ German-speaking medical adviser, Dr Walter Kennedy, visited Grünenthal, then a minor German drug firm. Kennedy examined a number of drugs but the one that interested him most was still in development—thalidomide. He was assured it was spectacularly effective and non-toxic and, on return to England, Kennedy gushed about it to his superiors. Completely smitten, he experimented with thalidomide on his own asthma and declared it ‘undoubtedly of help’.
Distillers management jumped to attention and so began a serious courting of Grünenthal. At this stage thalidomide had never been sold anywhere, Distillers knew little about the drug, Grünenthal’s animal work was lacking, and the so-called clinical trials in Germany were more testimonial than science. Nonetheless by late 1956 a draft licence agreement was on the table and the final version was signed in July 1957. The stringent terms of the contract illustrated Distillers’ desperation: it had just nine months to get the drug to market, and it would have to buy raw thalidomide from Grünenthal until it was selling enough of the drug for its German partner to trust it with the recipe.
To get the ball rolling, Distillers obtained a supply of pills from Grünenthal and sent them out to friendly doctors in the UK. Thus, in September 1957, seven months before launch date, Distillers’ Dr Kennedy advised Grünenthal he had ‘spread’ the drug among a ‘large number’ of doctors. This scattergun approach would reduce the clinical value of the work and not satisfy ‘medical purists’, Dr Kennedy admitted, but such ‘pilot scale trials’ were easier to arrange and they ‘arouse interest’ in the drug. Distillers was thinking of publicity and marketing more than valid science. Clearly in a rush, Distillers had been lulled by Grünenthal’s glowing assurances and appeared to believe that the safety of the drug had already been established. Its pharmacologist George Somers later admitted Distillers had erred in relying on Grünenthal’s unsatisfactory animal tests. ‘I did not have the time to carry out my own long-term research on [thalidomide] before it was launched here. It was early days in the establishment of [Distillers] as a drugs company, I had little assistance, and I was working on three other drugs at the time in very cramped conditions.’
So Distillers limited itself to some routine animal testing, and did not consider checking for a possible effect in pregnancy. Distillers later defended this omission as ‘the accepted pattern’ in the UK. This was sleight of hand. A number of sensible drug companies in the UK and overseas did perform reproductive checks at that time (as is detailed in chapter 11).
Subsequent events suggest that if Distillers scientists had done the tests they would have turned up warning signs: within weeks of withdrawing the drug from sale in late 1961, Distillers found reduced litter sizes in rats dosed with thalidomide and, soon after, malformations in rabbits.
Nor did the company check the effect of the drug in the sensitive early period of human pregnancy by following up on the babies of pregnant women who had taken it—not during the testing period and not while thalidomide was on sale.
In April 1958, with all the fanfare it could muster, Distillers launched Distaval and Distaval Forte, the first drugs in the thalidomide range, and by far the best sellers. Advertising declared the drug a major advance and salesmen were dispatched far and wide, armed with the familiar ‘super-safe, super-effective’ sales pitch. ‘The whole of our promotion is based on the extreme safety of Distaval,’ a Distillers executive later stated.
A few months after the launch one Distillers salesman found his way to remote Turriff in Scotland, where the young Dr Leslie Florence was the senior GP. At the very time Distillers had been looking for new drugs, Florence had been looking for a new job. Having studied medicine at the University of Aberdeen (where he won two university prizes), he had worked in a succession of medical jobs until in 1954 he saw an advertisement for a GP vacancy in Turriff. Florence beat eighty other applicants and he and his wife Dora moved to the town, where Florence and a junior doctor attended to about seven thousand people in Turriff and the surrounding area.
From an early age Florence had suffered with severe eczema, and the associated itchiness often led to very disturbed sleep. He frequently experimented with sleeping medications, and found they left him groggy if he had to wake to make house calls during the night. So Florence was very interested when the Distillers salesman who came to his surgery in 1958 told him about a sensational new sleeping pill, Distaval. The salesman gave him some samples. ‘Some weeks afterwards I decided to try it myself. I also gave a lower dose to my three-year-old son, who also suffered from eczema.’
Florence was impressed. ‘It allowed both of us to get a much improved sleep. I found I was wide awake and alert immediately on waking, and could drive safely.’ Soon Florence was trying the medication on his older patients who were having trouble sleeping.
On 17 February 1959 Florence wrote to Distillers, complimenting Distaval and asking for further samples. He also requested a list of thalidomide’s side effects. A week later he received a reply from Dr Denis Burley, Distillers’ medical director. Burley admitted his knowledge of ‘the absorption and metabolism of Distaval is very scanty’ but that ‘it is impossible to give a toxic overdose’. At home in New Zealand in 2011, Florence still had these letters, which he regarded as treasures.
Burley’s glowing testimonial to Florence about thalidomide was emblematic of Distillers’ delight with its new drug. A year on from the launch, sales were steadily improving and there were plans to add further thalidomide medications to the range. Eventually Distillers would sell about 100 million thalidomide tablets. The only slight early annoyance for Distillers was that reports of nerve damage following the use of thalidomide started to trickle in. One such report—indeed the most influential report—was from Leslie Florence.
Florence had spent much of 1959 liberally dispensing Distaval to family and patients, reassured by the Distillers claim that it was impossible to give a toxic overdose. But then, towards the end of 1959, he and three of his patients developed symptoms of peripheral neuritis.
First it was tingling in my feet and then in my hands, an occasional lack of steadiness on my feet, and cramping at night.
I thought it curious that all four of us should develop the same symptoms at about the same time. I studied the records and realised that we had all been taking Distaval for an extended period. I wondered whether the symptoms might be linked to Distaval. I knew that Distaval was a relatively new drug and I considered it possible that this was a side effect of the drug that had not yet been publicised.
So in February 1960, Florence contacted Distillers again to ask whether it could confirm the nerve-damage side effect. He remembered the response. ‘No such symptoms had been reported as a result of Distaval use, thalidomide was non-toxic,’ Florence summarised. ‘Distillers suggested that I re-examine my patients and consider other possibilities.’
That advice caused Florence to doubt his thesis and he continued to use thalidomide. But later that year the symptoms worsened, and Florence stopped using the drug to see if the symptoms improved. Florence also drove thirty-five miles to the University of Aberdeen to consult with Professor Alastair Macgregor, a highly regarded professor of therapeutics. ‘I showed him my case files and my letters to and from Distillers.’ Macgregor backed Florence’s theory.
Further reinforcing Florence’s suspicion was the fact that his symptoms, and those of his patients, were slowly lessening now that the drug had been withdrawn. With Professor Macgregor’s encouragement, he decided to write his famous letter to the British Medical Journal, and it was published on 31 December 1960. In the very next edition of the journal, 14 January 1961, Distillers’ Dr Denis Burley responded to Florence, admitting that ‘isolated’ reports of nerve damage had been sent to him since early 1960, and that nerve damage could indeed be caused by thalidomide.
Burley’s admission irritated Florence. He felt the company should have told him earlier, especially as he had carried on using thalidomide during 1960 after being told by Distillers that it was safe. The eminent Professor Macgregor agreed. On 30 January 1961 he wrote to Florence generously congratulating him on his letter. ‘I think it is quite disgraceful that after you had raised the matter with the Distillers Company that they did not inform you officially of the fact that they had reports suggesting peripheral neuritis.’
Macgregor and Florence were not the only parties aggravated by Distillers. In late January 1961, a Grünenthal delegation arrived at Distillers’ offices in London. The Grünenthal men specifically complained that Burley’s nerve-damage admission (prompted by Florence) had appeared in the pages of the British Medical Journal without any attempt to discuss the matter first with Grünenthal. This was ‘definitely not in our interest’ because of the ‘worldwide importance of thalidomide’, is how a German note recorded the discussion. ‘Furthermore we pointed out the possible implications for the registration in the US.’
Grünenthal’s concern was clear. It expected US Food and Drug Administration approval for sale in the US at any moment. US sales would send a flood of profits towards Grünenthal. So far, its US licence partner, Merrell, did not know about nerve damage and neither did the FDA. Grünenthal was worried that letting the cat out of the bag might delay FDA approval—a concern which proved well placed. The Florence–Burley exchange alerted both the FDA and Merrell to the nerve-damage issue and Merrell started asking questions of Grünenthal. This sent the German company into full propaganda mode. Grünenthal told the Americans, inaccurately, that nerve damage was rare, only followed long-term thalidomide use, appeared in predisposed people, and usually disappeared rapidly when the medication was withdrawn. It suggested that there had only been about fifty reported nerve-damage cases in total, though the German prosecutor later counted more than four hundred nerve-damage cases reported to Grünenthal by the end of February 1961. By this time some German doctors had rejected the drug completely.
While Leslie Florence’s substantive involvement in the thalidomide affair ended in early 1961, he suffered from nerve damage for years, an ongoing reminder that he should never have believed Distillers’ guarantee of non-toxicity. In 1966 he migrated with his wife and children to New Zealand, practising for decades as a GP in a suburb of the capital, Wellington.
Occasionally over the years references to Florence’s 1960 letter appeared in the medical literature, cheering him no end. In 1982, the British Medical Journal ran an article headed ‘Florence’. The author, Dr E. Saphier, described reading Florence’s letter on New Year’s Day 1961. ‘I too had had a similar patient [with nerve damage]. The letter clicked. I felt sure he was right. I never used thalidomide again. I told other people. They in turn told others. I remember a psychiatrist friend telling me how several of them had stopped using the drug.’ Dr Saphier noted that in the wake of the drug’s withdrawal, Florence seemed to have been forgotten. ‘In all the name calling that ensued I do not remember [Florence’s] name being mentioned, and so far as I am aware, no tribute was ever paid him. Yet he must have saved a lot of suffering.’
Leslie Florence’s health deteriorated in 2013 and in 2014 he entered a nursing home suffering dementia. Had there been a trial, rather than a settlement, he would have been an important witness. And had his health been better I have no doubt his most trenchant—and good-humoured—complaint about this book would have been the absence of several more chapters devoted to him.
Throughout 1961, Distillers had to deal with ongoing reports of thalidomide nerve damage and a debate about the condition in the pages of the UK medical journals. It was not the torrent of cases that Grünenthal was receiving (and concealing), but a steady stream nonetheless. Distillers’ own count was 417 cases by December 1961, a fraction of the real damage, but still a substantial figure.
Yet despite the nerve-damage toll, Distillers continued to advertise the drug as safe, drawing bitter complaints from doctors. In October 1961, Distillers’ safety assurances cranked up another notch. ‘It is with absolute safety that “Distaval” can be administered to pregnant or breastfeeding women without any adverse effects on the mother or the child,’ read one brochure. There was no basis for this broad assurance. Distillers had not tested the drug in early pregnancy, nor followed up pregnant women who had been given the drug.
Another safety-focused Distaval advertisement in the British Medical Journal on 4 November 1961 attracted yet more doctor criticism. By this time thalidomide sales had slumped because of the nerve-damage controversy and the company was under pressure to withdraw the drug. But like Grünenthal, though without the ruthless determination, Distillers was holding firm.
However events in Australia and Germany had overtaken the nerve-damage debate. On 17 November 1961, Woody Woodhouse, a Distillers employee in Sydney, Australia, wrote a letter to his colleagues in London detailing a visit to a local obstetrician, William McBride. McBride had told Woodhouse of malformations in six babies whose mothers had taken thalidomide. Woodhouse’s letter was received by Distillers in London on 21 November 1961, just six days after Widukind Lenz, the German paediatrician, had first telephoned Grünenthal with his conviction that thalidomide was maiming and killing babies.
The next day, 22 November 1961, Distillers wrote to Grünenthal. ‘We have had a rather disturbing report, from a Consultant Obstetrician, of deformities in children which could be associated with the taking of thalidomide by the mothers early in pregnancy, for morning sickness.’ The report described the malformations, and the deaths of all six children.
There is no history of infection and the administration of Distaval seemed to be the only common factor in these cases. I should be grateful if you could let me know whether you have heard of any similar reports. We believe that the cause of the abnormalities in these cases was much more likely to be due to undetected virus infection, but nevertheless we feel that the report must be investigated as fully as possible.
Five days later, on Monday 27 November 1961, Grünenthal responded with a telephone call alerting Distillers to the German malformation cases and its decision to withdraw the drug. Distillers quickly followed suit. Grünenthal also alerted its US licensee, Merrell, which had been trying for more than a year, increasingly desperately, to obtain approval from the US Food and Drug Administration (FDA) to sell the drug in the United States. It had a huge stockpile of the medication ready to go, and a massive sales force already schooled in the myriad wonders of thalidomide. Merrell believed thalidomide would make it a fortune. The only obstacle was a persistently stubborn FDA doctor who simply would not accept that thalidomide was fit for sale.