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Thalidomide victims claim drug cos. engaged in 50-year cover-up

10/27/2011 COMMENTS (19)

When Philip Yeatts was born in Brownfield, Texas, in September 1962, he had no right leg or foot. His right arm ended in a stump above his elbow, and he had a cleft palate and deformed tongue. Annette Manning, born in Green Bay in 1960, had only buds of fingers and an arm that ended in a stump -- just like Mary Hurson, born the same year in New York City, and Tammy Jackson, a 1962 baby in Ranger, Texas. In a heartbreaking new complaint against GlaxoSmithKline, Sanofi-Aventis, Avantor, and Grunenthal, these four plaintiffs, along with eight others (in three parts here, here, and here) claim that their birth defects resulted from their mothers' use of the now-notorious anti-nausea drug Thalidomide -- and that the drug companies engaged in a 50-year scheme to cover up how widely Thalidomide was prescribed in the U.S., and how varied were the birth defects that could result from the drug.

"The question is going to be, 'Why now?'" said Steve Berman of Hagens Berman. "The answer is that medical science has advanced. We now understand the mechanism by which Thalidomide works. There's been a complete change in the knowledge of how it caused birth defects."

Thalidomide was widely prescribed as a treatment for morning sickness in Europe in the late 1950s and early 1960s, until evidence emerged that the drug resulted in grave birth defects. Some countries, including England and Germany, established compensation systems for Thalidomide victims. There was no such plan in the U.S., where drug companies said Thalidomide had only been prescribed in a very restricted controlled study. According to Berman, after the awful consequences of Thalidomide came to light in the 1960s, fewer than a dozen American families sued and reached settlement with the drug companies that made and marketed the drug.

Decades later, an Australian lawyer Berman knows was contacted by Australians who believed their birth defects were caused by Thalidomide -- which has resurfaced as a potent treatment for a form of cancer. Berman's friend, Peter Gordon, ultimately reached a settlement on behalf of Australian Thalidomide victims. News of that deal, Berman said, brought Gordon inquiries from Americans who suspected Thalidomide was responsible for their injuries. Gordon brought in Berman.

Berman's better known as a securities and antitrust plaintiff's lawyer, but he told me there was no chance he wouldn't take this case once he heard victims' stories. "It's so compelling," he said. "We all felt we had to do this." Most of the clients Hagens Berman represents in the Thalidomide case, Berman said, "have been searching their whole adult lives to find out what caused this."

Berman said his team dug into the archived records of, among other things, a 1962 Congressional investigation of the drug, which was never approved in the U.S. They found that contrary to what drug companies told the public, Thalidomide was prescribed to about 20,000 patients in the U.S., under the supervision of about 1,200 doctors. They also found evidence that the drug companies were aware of Thalidomide's potentially tragic side effects long before the drug was pulled off the market in the Europe.

And many of those doctors didn't keep careful records of patients who received the drug. As the Hagens Berman complaint makes clear, each alleged Thalidomide victim has a unique story. Some have medical records showing their mothers took Thalidomide during their pregnancies. Some have mothers who recall taking the drug; others have family members who will attest their mothers used Thalidomide. For some plaintiffs, Berman said, the nature of their birth defects is the only link they'll be able to show to Thalidomide.

But recent research on the drug's properties as a cancer treatment, he said, has made it clear that Thalidomide can cause the unilateral deformations some of his clients suffer, and not just the bilateral birth defects that have been traditionally associated with the drug. "It used to be that if you had the bilateral defect, known as flippers, you were called a Thalidomide baby," Berman said. "Most of the others, doctors would just say, 'This stuff happens.'"

Berman told me there are probably many more people born in the U.S. in the late 1950s and early 1960s whose birth defects were caused by Thalidomide, which, according to him, affected the children of almost every pregnant woman who took the drug.

I left a message for Glaxo lawyer Michael Scott, who removed the Thalidomide case from the Philadelphia Court of Common Pleas to U.S. District Court for the Eastern District of Pennsylvania. He didn't return my call.

(Reporting by Alison Frankel)

(A previous version of this story referred to Aventor Performance Materials. The correct spelling is Avantor, not Aventor.)

Follow Alison on Twitter: @AlisonFrankel 

Follow us on Twitter: @ReutersLegal 


Comments (19)

11/3/2011 2:54:20 AM by IvoCerckel

Still standing.on the BBC : IvoCerckel - 4 Hours ago - Nazi link to be final nail in coffin of EU welfare states, Thalidomide was launched in 1957, year EU was created. European law has become corner stone of national legislations concerning consumers. Bergé & RobinOlivier Intro drt europ PUF 2008 s 377. In order to conceal that thalidomide was necessary to achieve this, EU waited until 25 July 1985 to adopt Product-Liability Directive 85/374 EEC http://www.bbc.co.uk/news/magazine-15536544

11/3/2011 2:49:34 AM by IvoCerckel

Also removed by the BBC: Still waiting for my first franc, er euro since I fled Belgium 11 years ago for the third world where survival is cheaper, of compensation. Ecraser les etats! Long live the euro without the eurozone welfare-states! Good luck for the NHS! Or do you need that link also? Viva l’Anarchia! Do I still need compensation? Good question! No, I need to be released of daily (welfare) state indoctrination? http://www.bbc.co.uk/dna/newscommentsmodule/F22350858?thread=8293037&post=110764235#p110764235

11/2/2011 11:41:14 PM by IvoCerckel

URL of content (now removed): http://www.bbc.co.uk/dna/newscommentsmodule/F22350858?thread=8293037&post=110764266#p110764266 Subject: What's happened to Thalidomide babies? Posting: On the other side of the Atlantic, there is a shyster lawyer who IMPLICITLY seems to be arguing that the fact that thalidomide was developed by the Nazis does not blame but EXONERATES the guv’mints of liability and transfers this liability to Chemie Grünenthal GmbH http://newsandinsight.thomsonreuters.com/Legal/News/ViewNews.aspx?id=31179

10/30/2011 11:17:56 PM by IvoCerckel

Civil conspiracy says Part III? What about the public conspiracy? Thalidomide was first marketed in 1957, the same year that the European Economic Community (EEC – now European Union, EU)-Treaty was signed at Rome, Italy. QUOTE European law has become the central element (“la pièce maîtresse”) of national legislations concerning consumers. (Jean-Sylvestre Bergé and Sophie Robin-Olivier, “Introduction au droit européen”, Presses Universitaires de France, 2008, section 377) UNQUOTE In order not to make it too obvious that thalidomide was necessary to achieve this, the then-EEC waited until 25 July 1985 to adopt its Product-Liability Directive 85/374 EEC. http://bphouse.com/honest_money/2011/04/24/thalidomide-kills-cancer-%E2%80%93-and-babies-in-2011/

10/30/2011 10:24:54 PM by IvoCerckel

This is surreal. Section 285 of Part II of the complaint mentions the Düsseldorf April 30 - May 01, 1960 congress of neurology where neurologist Dr Ralf Voss warned about the nerve damage which thalidomide causes [in the mother] according to his observations (30. April/1. Mai 1960:- Auf einem Neurologen-Kongress in Düsseldorf berichtet der Neurologe Ralf Voss über die Nervenschädigungen, die seinen Beobachtungen zufolge durch Thalidomid verursacht werden .http://www1.wdr.de/themen/archiv/sp_contergan/contergan176.html ) but this can according to the complaint only give rise to liability of the (manufacturer and) distributor to withdraw thalidomide from the market. The regulator who had allowed thalidomide [in Germany] in the first place did not have to withdraw her marketing permit. If the regulator does not react, why should the manufacturer/distributor? In my native Belgium, the permit was only withdrawn in 1969, and as I said earlier in broken English, the existing stocks of thalidomide continued to sold even after Grünenthal stopped supplying (not: "delivering or furnishing" as my broken English said) the Belgian market. The youngest thalidomide monster recognised by the Belgian government – which doesn’t recognise me – was born in October 1963. http://www.dhnet.be/infos/faits-divers/article/284615/softenon-une-asbl-contre-l-oubli.html

10/30/2011 9:15:47 PM by IvoCerckel

I finally could download PART I of the complaint. SECTION 15 p. 6; Plaintiff Ed Andre was born in Wheeling, West Virginia, on February 2, 1957 - SECTION 16 p. 6; the doctor never told his mother thalidomide was experimental http://newsandinsight.thomsonreuters.com/uploadedFiles/Reuters_Content/2011/10_-_October/thalidomidecomplaint.pdf Thalidomide was only marketed (and obtainable without prescription) in Germany from October 01, 1957 onwards. From then on – Kelsey still not at the FDA - it was exported to more than 40 countries - 1. Oktober 1957: Grünenthal bringt bundesweit Contergan und Contergan forte in den Handel. Das Beruhigungs- und Schlafmittel ist in Apotheken rezeptfrei erhältlich. Thalidomid wird in mehr als 40 Länder exportiert. http://www1.wdr.de/themen/archiv/sp_contergan/contergan176.html

10/30/2011 8:28:43 PM by IvoCerckel

I still have problems downloading the complaint. But look, the Financial Times says that the complaint says that thalidomide was used BEFORE regulatory rejection (somewhere) in 1960. Somewhere in 1960 plus nine months equals somewhere in 1960 or 1961. How come the thalidomide monsters featured at the outset of the article above about were born in 1962 – that’s more than nine months after the regulatory rejection? Here’s the FT: The company [SmithKlineFrench, a precursor company to GSK]’s decision to abandon the drug permitted Richardson-Merrell, now part of Sanofi, in turn to proceed with “investigational trials” with thalidomide in thousands of patients without surveillance for a year and a half before unsuccessfully seeking US regulatory approval in 1960.(Pharmaceutical groups sued over thalidomide October 30, 2011 7:46 pm By Andrew Jack in London http://www.ft.com/intl/cms/s/0/0ff64ea4-0312-11e1-899a-00144feabdc0.html

10/30/2011 10:31:42 AM by IvoCerckel

The seven men and six women suing drugmakers and distributors on Oct. 25 in state court in Philadelphia were born with birth defects from 1957 to 1962. http://www.bloomberg.com/news/2011-10-26/drug-companies-hid-extent-of-thalidomide-birth-defect-suit-says.html Kelsey was only appointed to the FDA in 1960. http://en.wikipedia.org/wiki/Frances_Oldham_Kelsey Yes, I know, I should double-check (with) the complaint. I’ll try to do that tomorrow Monday GMT+8.

10/30/2011 8:41:59 AM by IvoCerckel

Let me get this clear (and then I go to bed). Steve Berman, the counsel of the plaintiffs, says on his website that: The complaint claims that the defendants are either guilty of or liable for a civil conspiracy, failing to report [to Frances Oldham Kelsey??? – before she was appointed to the FDA???] and covering up evidence [in the US of A] that thalidomide was harmful, especially when taken during the early stages of pregnancy. The lawsuit also says that the defendants were negligent in continuing to manufacture, test [continuing to test - sic] and distribute the drug. http://www.hbsslaw.com/thalidomide

10/29/2011 9:50:33 PM by IvoCerckel

"a heartbreaking new complaint", says Alison in the article above. It’s hallucinations such as those by Steve Berman (and Peter Gordon) which continue to break the lives of thalidomide MONSTERS like me on a daily basis. SCREW YOU ALL!


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