Thalidomide Litigation — Grünenthal Intimidation — Landmark Settlement

1967-1968: Grünenthal executives were put on trial in Aachen, Germany
The indictment charged the company with intent to commit bodily harm and involuntary manslaughter.  The central defendant was Dr. Heinrich Mückter, an indicted Nazi war criminal, who was the company’s chief scientist and head of research. Mückter was credited with the development of thalidomide and was put in charge of marketing and promotion of thalidomide. He received a bonus of 22 times his annual executive salary for his highly successful marketing strategy. The drug’s sales made him an instant millionaire in one year. Of course the Wirtz family owners made much greater fortune from this drug. At the trial, Mückter claimed that all the company’s records were destroyed—or had disappeared in 1959. (Overell, 1993)

A riveting account of the trial is to be found in the book, Dark Remedy: The Impact of Thalidomide And its Revival As a Vital Medicine (2009) by Tent Stephens and Rock Brynner. The indictment was 972 pages long, based on 500,000 pages of documentation, many of which had been seized in police raids on Grünenthal’s headquarters. Sixty plaintiffs represented victims of peripheral neuritis. A causal effect was evident in a graph of Contergan sales which matched exactly – almost spookily—with the recorded births of deformed babies.” However, the company’s defense strategy was a war of attrition.

“Their arguments and tactics were so heinous it is hard to believe they had the gall to put them forward. First, they insisted, through a long column of witnesses, that there was absolutely no evidence connecting their drug to either nerve damage or fetal malformation. After everything the world had experienced and all the changes produced by the intervention of this compound, seven years later Chemie Grünenthal actually found scientists who insisted the drug was not to blame.

Second, they declared that, even if such proof existed, the unborn baby – unless the victim of a criminal abortion – had no legal rights; ergo, it was not against the law for a company to cause such damage to a fetus, unless it could be proved that a criminal abortion was intended.

Third, a variety of other factors might be responsible, including food additives, detergents, nuclear fallout, and even television rays. They noted that no mechanism of action whatsoever had been offered by the prosecution to explain how thalidomide could cause birth defects.”

The most grotesque argument put forth by Grünenthal and its paid expert scientific witnesses was that “all the babies’ deformities were the fault of the mothers from botched attempts at abortions.” Grünenthal’s expert, Professor Kloos from Berlin testified that:

“thalidomide did not cause the fetal malformation; he explained that thalidomide had actually salvaged the lives of deformed fetuses that otherwise would have naturally miscarried. He argued that the victims were “living abortions who had been saved by the drug.”

The first medical expert for the plaintiffs was Dr. Widukind Lenz who had spent much of his professional career personally examining children in Germany, Belgium, England, Japan, and Sweden compiling information about thalidomide caused birth defects. By the mid 1960s he had visited no less than 2,400 children who had been deformed by thalidomide. He testified on behalf of damaged children. The defense lawyers cross-examined him eighteen times, viciously attacking his credibility, hurling insults at his methods which, they claimed, were “useless.” A reporter noted that throughout the ordeal he never faltered or lost his calm, even-handed demeanor.

His response to the defense’s suggestion that it was possible that an unidentified virus was to blame: Dr. Lenze responded, “a virus would not stop at the Berlin Wall.” As noted above, the East German regulators did not approve the drug, so there were no babies born deformed from thalidomide in East Berlin.

Despite the viciousness of the defense attorneys, they won a victory in having Dr. Lenz’s testimony expunged from the record. This was a terrible blow to the prosecution. It led one of West Germany’s best-known journalists, Walter Dirks to write in the Frankfurter Hefte:

“We are currently witnessing a moral scandal…The scandal consists in the way the defense plays around with experts, the public prosecutor, the co-plaintiffs, and the court…Doesn’t the company realize that it has lost face by its behavior during this period?”

The second blow to the prosecution was FDA’s refusal to allow Dr. Frances Kelsey to testify in a foreign trial. The criminal charges were dropped and Grünenthal agreed to pay German thalidomide victims $31 million, with the German government contributing an additional amount. Thereafter, a series of local laws, some specially enacted to protect Grünenthal, bars German thalidomide victims from suing the company. (Read Thalidomide Litigation)

Grünenthal Intimidation tactics:

“At each Grünenthal site, guards watch for certain cars and people, especially thalidomiders, easy to spot because they mostly have shortened arms and deformed hands. Employees do not talk to thalidomiders — it is “verboten.” (Andrew Rule. The Last German War Secret, Herald Sun, June 2011)

Monika Eisenberg, a 49 year old thalidomide victim in Germany — one of about 2,700 surviving German thalidomiders, known as “Contergan kinder,” remembers that soon after her father was killed in a rock-climbing accident, when she was a teenager, her mother refused to sign an agreement to accept the tiny compensation offer from Grünenthal. “Two men visited, urging her mother to sign. When she refused, Monika recalls, one said to her mother: Mrs Eisenberg, you have a nice house and nice children. Your husband just died. We hope nothing else happens in future.Monika never forgot that veiled threat – and the sense of being watched. 

“Mrs Eisenberg, you have a nice house and nice children. Your husband just died. We hope nothing else happens in future.”

In 1980 a Grünenthal technician called Christian Wagemann wore an anti-fascist badge to work. He was sacked – and effectively blacklisted in the German pharma industry. He is now a school cook. Wagemann’s dismissal letter was signed by Otto Ambros, chairman of the firm’s advisory board and until his death in 1990 a respected figure in the global pharmaceutical business. Ambros also happened to be Hitler’s chief chemical weapons expert and a convicted war criminal. (The Last German War Secret, 2011)

In Germany, of the 5,000 to 7,000 thalidomide babies born, 2,700 are survivors aged 50. In the UK there are 468 survivors; in the U.S., 49; and 1,000 in Europe, and others in Japan, Asia, and Latin America.

Four thalidomide survivors – Nick Dobrik, a London jewelry dealer, Guy Tweedy, a Yorkshire businessman, Mikey Argy, a Melbourne-born office manager, and Monika Eisenberg, a German teacher – Dr. Martin Johnson, a former Royal Air Force officer who runs Britain’s Thalidomide Trust, who is writing a book, The Last Nazi War Crime. Despite the passage of more than 50 years, they have collected a thick dossier of documents for use in litigation seeking compensation for the thalidomide victims. With the help of a multi-lingual computer wizard, they have unearthed documents linking Thalidomide to Nazi experiments on concentration camp prisoners.

Thalidomide VictimsJoining their cause, retired Australian lawyer, Peter Gordon, who had successfully taken on powerful opponents; he had represented victims of asbestos, tobacco, silicone breast implants and sexual abuse in the Catholic Church, is litigating on their behalf pro bono.

2012: Fifty years of denial comes to a halt during litigation
A class-action lawsuit was filed in Australia on behalf of 100 thalidomide victims in Australia and New Zealand filed by Peter Gordon and Michael Magazanik. The legal case is the latest in a long-running global legal battle between thalidomide survivors and Grunenthal and its U.K and Australian marketer, Diageo. Plaintiff attorney’s affidavits proved that: “by May 1961, Grünenthal knew that its own medically trained staff had ‘a very real fear of side effects’ and were refusing to use thalidomide within their own families.” (Read, Australia Thalidomide Lawsuit Documents; Distillers Affidavit Part 1 and Part 2)

For nearly half a century, the privately owned company was silent and secretive about the epic tragedy it created by profiteering from a drug it knew to be defective. On August 31, 2012, Grunenthal’s new CEO, Harald Stock, who was not connected to the company when thalidomide was marketed, issued an “apology” for the first time in 50 years:

“We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you from human being to human being…We ask that you regard our long silence as a sign of the shock that your fate caused in us. We wish that the thalidomide tragedy had never happened.” Craig Mackenzie. German Firm ApologizesDaily Mail, Sept 1, 2012

But, as Harold Evans, former editor of the Sunday Times who had been closely involved with thalidomide investigations noted, that Stock made forgiveness impossible because it was followed with a complete lie: “Grünenthal acted in accordance with the state of scientific knowledge and all industry standards for testing new drugs that were relevant and acknowledged in the 1950s and 1960s.”

“Our survey of the scientific literature, consultations with reputable pharmaceutical companies and independent specialist advice swiftly found that reproductive studies were routinely done in the 1950s, because it was widely recognized that a drug could indeed reach the fetus. The tranquilizers in direct competition with thalidomide were all tested for teratogenic effects and the results published.

If reproductive tests had been done on thalidomide, they would not necessarily have shown precisely what deformities would be produced, dependent on the time of ingestion in relation to the development of the fetus, but they would certainly have shown that drugs could endanger unborn children in some way…Reproductive testing had been routine since 1944…Grünenthal did no single animal test for effects on reproduction.” (Thalidomide’s Big Lie Overshadows Corporate Apology, Reuters, Sept. 2012)

Thalidomiders called the apology an insult to thousands of people suffering disabilities from the drug.  Berrisford Boothe, 51, one of 26 known American survivors of thalidomide, who is an associate professor of art at Lehigh University in Pennsylvania, told the New York Times that he had been born with severe disabilities in both hands and one arm, and described his life as a “long and isolated journey.”  He said Grünenthal has been shaken from a half century of denial by the class-action lawsuit in Australia. And Wendy Rowe whose daughter, Lynette Rowe was the lead plaintiff in a lawsuit in Australia against the company, told ABC News:

They’ve been making billions of dollars over the last 50 years while we struggled and our parents committed suicide. And now, they’re apologizing for not saying anything. How dare they do that and think it’s going to be enough?” 

Shock is having your precious child born without arms and legs. We had to get up and face each day, every day, and cope with the incredible damage that Grünenthal did.”

Thalidomide-Frederick Dove

              Frederick Dove

Frederick Dove Born in Hamburg, West Germany, in June 1961; Thalidomide-affected hands and hips; Five hip operations as a child; Grew up in Germany, Nigeria, Netherlands, UK; Taught in Sudan 1985-89; Joined the BBC World Service in 1989; Presented Outlook from 1998-2008 and now occasionally hosts World Briefing; Former captain of England’s Disability Cricket XI. (What’s Happened to Thalidomide Babies? BBC, 2011)

As thalidomiders age, the struggle of coping with life’s daily chores has gotten more difficult:

“Every day I am in pain and every day is a struggle. We’re suffering from a physical degeneration, caused by efforts to overcome our limitations… I have no arms, so the effort of doing daily tasks has really destroyed my spine…There were some survivors who used to be able to work…They’re no longer able to. Also, some of us are no longer able to live independently. There’s all sorts of new limitations that have cropped up over time.” Mercedes Benegbi, Executive Director, Thalidomide Victims Association of Canada. Canadian Press

“If a person who has no arms and must eat and write with his feet, has pain in his hip or knee, then it’s simply impossible for him to perform these movements necessary for getting through daily life. We also use our teeth for a lot of things: For instance, I open bottles with them and raise the blinds. That’s why we need implants, but these are not covered by insurers.” Ilonka Stebritz (Deutsche Welte, 2012)

Landmark Thalidomide Settlement
In Dec. 2013, a landmark settlement was reached with Diageo for $89 Million for 100 thalidomide victims. [Diageo had bought Distillers, the distributor of thalidomide in the UK, Australia and New Zealand] Grunenthal refused to pay. The same month, a court in Spain convicted Grünenthal and ordered the company to pay compensation to 185 thalidomide victims.

Monica McGhie, one of the Australian claimants who was born without limbs after her mother took Thalidomide during pregnancy 50 years ago told BBC: “This settlement will not take the hardship away but it means I can look to the future with more confidence, knowing I can afford the support and care I need.”

In June 2014, a lawsuit was filed at the high court in the UK on behalf of eight permanently disabled people whose mothers took thalidomide for morning sickness in the late 1950s / early 1960s.

In 2015, Silent Shock by Michael Magazanik, an Australian journalist and lawyer on the legal team of the law firm Slater + Gordon, that successfully litigated on behalf of Lyn Rowe, a severely disabled thalidomider born in 1962, reveals the circumstances that led to the preventable maiming and deaths of thousands of babies: breath-taking arrogance, greed, lack of ethics and total immorality of those involved in the testing and irresponsible marketing of this highly toxic drug promoted as a harmless antidote against nausea. In their press release following publication of Silent Shock, Slater & Gordon stated:

“When apologists say that the whole thing was an unavoidable disaster – that’s rubbish. There were repeated opportunities to cut the death and injury toll short – in Germany, in Japan, in the US and in Australia. If the men at Grünenthal and Distillers hadn’t been so hell bent on profit at the expense of health and safety, things could have been very different.” (Michael Cook. Thalidomide Scandal Continues to Reverberate, BioEdge, Jun 1, 2015)

The company covered up a crime against humanity for more than 60 years.

Among the incriminating company documents uncovered during Lyn Rowe’s lawsuit, Magazanik reveals the content of an affidavit signed by Bill Poole, the former head of Distillers, the Australian distributor of thalidomide. Poole acknowledged that even after the link between the epidemic of birth defects and thalidomide had been discovered by Dr. William McBride, an Australian obstetrician whose published letter in The Lancet (1961), alerted physicians about the danger,

“Mr. Poole kept promoting a drug he knew might severely damage embryos to maternity hospitals and obstetricians. He also tried to get a government subsidy for thalidomide and steadily built up a stockpile ready to flood the Australian market: 8 million pills in a Sydney warehouse, each one of which he knew might maim and kill unborn babies. And when thalidomide was exposed, Poole lied constantly to cover up his appalling, deadly behaviour, including telling bare-faced lies to the highest levels of the Australian government.” (Lancet)

“Even before releasing the drug in October of 1957, it knew that one of its employees had given birth to a baby without ears, a red alert it ignored. From the very earliest days, it brushed aside medical complaints in increasing numbers that their wonder sedative caused peripheral neuritis, irreversible damage to the nervous systems of adults. It suppressed or delayed unfavorable reports about this from doctors by pressuring medical journals, it lied to inquiring doctors, it bribed others to write favorable reports when they had done no testing at all. For four months after an Australian obstetrician connected birth defects with thalidomide, the company continued to sell their poison to mothers, and the mothers produced more malformed babies.” (Evans. Thalidomide’s Big Lie Overshadows Corporate Apology, 2012)

Thalidomide’s Partner in Crime
In 1998, the FDA approved thalidomide for use in multiple myeloma; tests are in process for using the drug to treat other ailments. Because of the drug’s use in hard to treat diseases, multiple myeloma, a form of bone marrow cancer, AIDS, and complications of leprosy, thalidomide is still causing birth defects today – especially in Africa and South America where leprosy is still raging and where it is used to treat AIDS because other AIDS drugs are not affordable.

Thalidomide has been used nearly continuously since the drug was launched in the 50s. It has been mostly used to treat leprosy, which is still prevalent in poor countries. In Brazil thalidomide was re-licensed in 1965 as a treatment for skin lesions, one of the complications of leprosy. Leprosy is more prevalent in Brazil than in any other country except India. More than 30,000 new cases are diagnosed each year – and millions of Thalidomide pills are distributed.

“Half a century later, scientists are still not sure exactly how the drug does so much damage, which includes shortened arms and legs, ear deformities, and malformations in the digestive system.” (Gretchen Vogel, Science, 2010)

According to Deutsche Welte, a single 50 mg. pill of thalidomide contains enough ingredients to cause serious birth defects; there are now 1,000 cases of babies in Brzazil who were born with severe thalidomide type deformities since the mid-1960s. About four million Thalidomide tablets are ingested annually in Brazil. Some illiterate women misunderstood the warning symbol of a crossed out pregnant woman and thought it was an abortion drug and took it during the early stages of pregnancy –the very time it poses a threat to the developing fetus. (Jan David Walter. Children Being Born With Thalidomide Syndrome, Deutsche Welte, 2012)

Is This the Forgotten Thalidomide?”
Primodos/Duogynon, a hormone pregnancy test prescribed to 1.5 million women in the UK during the 1960s and 1970s produced another nightmare: thousands of babies were born with missing limbs, abnormalities of their internal organs and brain damage. (The Telegraph (UK) Oct. 5, 2014) Read Valerie William speech at Bayer Shareholder Meeting, April 4, 2013!

“Ideally, you should not take any medication during pregnancy unless you and your health-care provider determine that it is necessary. A small number of medications have been shown through clinical studies to be safe for use in pregnancy. The effects of many other medications on your baby are not known…there has not been much research in this area and we do not really know what effect some drugs might have.” (Canadian Society of Obstetricians and Gynaecologists)

Thalidomide References

Richard Baker, Nick McKenzie Australian women were thalidomide guinea pigs The Canberra Times,   July 27, 2012
Dhristine Chisholm. Thinking about Thalidomide in Transnational History: Canada and South Africa,   Active History, Oct 2014
Arthur Daemmrich A Tale of Two Experts: Thalidomide and Political Engagement in the United States and West Germany, Social History of Medicine, 2002
Carlos De Napoli. Hitler’s Laboratories,
Frederick Dove. What’s Happened to Thalidomide Babies? BBC News, Nov 2, 2011
Harold Evans. How Men Who Blighted Lives of Thousands Evaded Justice, The Guardian, 2014
Harold Evans. Thalidomide’s Big Lie Overshadows Corporate Apology, Reuters, 2012
Frances M.V. Hackney. How Goliath Killed David, Annals Australasia, 1995
James Linder Jones. Thalidomide – The Real Story & The First Seal Baby, Health Worldnet, 2011
Peter Kolakowski. More Help on the way for Thalidomide Victims? Deutsche Welte, 2012
Andrew Levy. Nazis Developed Thalidomide and Tested it on Concentration Camp Prisoners, Daily       Mail (UK), Feb 8, 2009
Ann Lewis. Children of Thalidomide, 2014
Craig Mackenzie. German Firm…Thalidomide  ApologizesDaily Mail, Sept 1, 2012
Michael Magazanik. Silent Shock: The Men Behind the Thalidomide Scandal and an Australian             Family’s Long Road to Justice, 2015
Nick McKenzie and Richard Baker. The 50-Year Global Cover-Up, The Sydney Morning Herald, July     26, 2012
Thalidomide’s Secret Past: The Link with Nazi Germany.
Bette Overell. Animal Research Takes Lives: Humans and Animals Both Suffer, 1993
GK Rao. Thalidomide Genocide: Saga of a ‘Wonder Drug’ The New Indian Express, Sept. 20, 2012
Tom Rowley. Thalidomide: The Fifty Year Fight, BBC Two 2014
Andrew Rule. The Last German War Secret, Herald Sun, June 27, 2011
Rosaleen Moriarty-Simmonds. Four Fingers and Thirteen Toes, 2010
RW Smithells and C. G. Newman. “Recognition of Thalidomide Defects.” Journal of Medical Genetics    (1992): posted at Thalidomide Victims Association of Canada.
Tent Stephens and Rock Brynner. Dark Remedy: The Impact of Thalidomide And its Revival As a         Vital Medicine, 2009
Judy Stone. From the Holocaust to Thalidomide: A Nazi Legacy, Scientific American, Nov., 2012
Suffer the Children: The Story of Thalidomide by Insight Team of the Sunday Times of London, 1979
Jan D Walter. Children Being Born with Thalidomide Syndrome, Deutsche Welte, 2012
Roger Williams. The Nazis and thalidomide: The Worst Drug scandal of All Time, Newsweek, Sept 12,   2012