Fifty Years Later: A New Wave of Thalidomide Litigation

An Australian obstetrician, Dr. William McBride, had been among the first to discover that the drug could alleviate symptoms of morning sickness. He accordingly recommended this off-label use to his pregnant patients. By 1961, Dr. McBride began to associate use of Thalidomide with severe birth defects in the babies he delivered. A German newspaper soon reported that 161 babies had been adversely affected by Thalidomide, leading the manufacturers of the drug to stop distribution in Germany. Other countries followed suit, and, by March 1962, Thalidomide was banned in most countries around the world.

The scourge of birth defects from Thalidomide in the 1950s and 1960s remains one of the worst pharmaceutical disasters ever. American mothers were generally spared, due largely to the vigilance of Frances Kelsey, a Food and Drug Administration (FDA) officer who refused to approve sale of the drug in the United States. Kelsey felt that the application for Thalidomide contained incomplete and insufficient data regarding safety and effectiveness. Among her specific concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus. By July 1962, President John F. Kennedy and the American press were praising Inspector Kelsey's efforts in resisting pressure from the pharmaceutical industry to sanction sale of the drug in the United States.

Kelsey was also concerned that there were not yet any results available from U.S. clinical trials of the drug. At that time, clinical trials did not require FDA approval, nor were they subject to the massive oversight that exists today. The “clinical trials” of Thalidomide involved distributing more than 2.5 million tablets to approximately 20,000 patients across the nation, including 3,760 women of child-bearing age, at least 200 or more of whom were pregnant. More than 1,000 physicians participated in the trials, but few tracked the progress of their patients after dispensing the medication.

Despite its harmful side-effects, Thalidomide remains approved by the FDA for two uses today: the treatment of inflammation associated with Hansen's Disease (leprosy), and as a chemotherapeutic agent for patients with multiple myeloma ' purposes for which it was originally prescribed off-label.

Not Just a Thing of the Past

It is estimated that approximately 10,000 babies suffered malformations because their mothers used Thalidomide while pregnant to treat morning sickness, anxiety or insomnia. The conventional wisdom held that only about 40 of these were born in the United States, but that estimate is now being challenged.

In 10 federal lawsuits pending in Philadelphia, plaintiffs accuse a group of drug firms of concealing for more than 50 years an unknown number of Thalidomide babies born in the United States. According to the litigation, these children were born to women who, during pregnancy, were given Thalidomide distributed by companies that had cause to suspect that the drug could harm a fetus, although they knew that it had not been adequately tested. This “hidden generation” of American Thalidomide victims ' who since birth have been told that their injuries were simply congenital or an “act of God” ' could number in the hundreds or thousands, according to one of the law firms involved in the Philadelphia litigation.

The history involving Inspector Kelsey is well known, but the federal litigation points to the distribution of millions of Thalidomide pills sent to U.S. doctors through programs conducted by Smith, Kline & French, a predecessor of GlaxoSmithKline; and perhaps as well by Richardson-Merrell, a company since absorbed by Sanofi-Aventis. The exact number of patients and their identities has remained a mystery for many years. However, most recently, the United States District Court for the Eastern District of Pennsylvania ordered the parties to proceed with the discovery phase of the litigation. It further required drug firms, for the first time, to provide the plaintiffs with a list of all doctors who distributed Thalidomide to Americans. According to plaintiffs, this information will be combined with documents secured through the Freedom of Information Act and a two-year search of archives in Washington, DC, and overseas, which may (according to the plaintiffs) provide evidence of a vast cover-up by the drug firms that first introduced Thalidomide more than a half-century ago.

Through a spokesman, Glaxo-SmithKline (GSK) has stated that its predecessor “studied Thalidomide and conducted a small, short clinical trial on the drug in 1956 and 1957 that involved approximately 875 patients and a total of 67 investigators.” R. Kramer, The Inquirer, “Act of God or Drug Firms?,” http://bit.ly/1cMTlfl. GSK has further stated that the company had no knowledge of any relationship between Thalidomide and birth defects during the time it conducted the studies. Id.

A Case in Point

Perhaps one of the most remarkable stories is that of plaintiff Deborah Johnson. The Johnson litigation reached the United States Third Circuit Court of Appeals earlier this year on an issue of subject matter jurisdiction. In Johnson v. SmithKline Beecham Corporation, 724 F.3rd 337 (3rd Cir. 2013), plaintiffs challenged an order of the Eastern District of Pennsylvania that denied their motion to remand the litigation to Pennsylvania state court. The plaintiffs contended that the district court lacked subject-matter jurisdiction over their claims because the parties did not have complete diversity of citizenship. The Third Circuit, however, agreed with the district court, and held that none of the defendants was a citizen of the same state as either plaintiff (Glenda Johnson and Steven Lucier).

The substance of Johnson's suit involves injuries on both sides of her body. At birth, her thumbs were little more than fleshy wads of skin and her arms were folded up in a
manner resembling chicken wings. Surgeons fashioned usable thumbs for her from her index fingers, leaving her with four digits on each hand. One forearm is regular sized, and the other is about four inches long. According to Johnson, she heard the same explanation for decades from doctors and family: “That's how God made her.” Johnson accepted this explanation and attributed the birth defect to heredity.

As an adult, she had great concern for her own children. When her son was born, Johnson's first question was, “Are his hands and arms okay?” They were. In March 2012, her then adult son, now a medical student, told Johnson that he believed her injuries had been caused by Thalidomide. “I came home that night, and I started looking it up, and the more I read, the more I just cried,” said Johnson. According to Johnson, her mother, Delores Layssarde, had been given a drug for morning sickness early in her pregnancy. Johnson believes the drug was Thalidomide. Her lawyers now hope to prove it through the federal litigation.

In its decision on the jurisdictional matter, the Third Circuit recognized that Johnson, a Louisiana citizen, and Lucier, a Pennsylvania citizen, both suffered from birth defects allegedly caused by their mothers' ingestion of Thalidomide during pregnancy in the 1960s. The defendants consisted of drug companies and their successors-in-interest that developed, designed, manufactured and distributed Thalidomide. According to plaintiffs, “newly accessible evidence” revealed that the defendants were aware of the drug's risks even while marketing it to pregnant women, and that for 60 years they had been engaged in an elaborate, ongoing, cover-up to avoid liability for those actions.

Seeking damages for lifelong physical and emotional suffering, the plaintiffs originally filed their litigation in the Philadelphia County Court of Common Pleas, on Aug. 26, 2011 (one of the nation's well known pro-plaintiff venues). The defendants timely removed the litigation to federal court, asserting diversity jurisdiction. The plaintiffs filed a motion to remand, claiming that several of the defendants, including GSK, were Pennsylvania citizens, as was plaintiff Lucier. The district court disagreed, denied the motion, and certified the order for interlocutory appeal. The Third Circuit granted permission to appeal, and, ultimately, upheld the jurisdictional findings of the district court.

The Third Circuit's analysis focused on jurisdictional issues and not the merits of the litigation. Following remand of the case to the Eastern District of Pennsylvania, discovery orders were issued and are now in progress.

Other Countries Also Dealing with the Issue

Meanwhile, a Spanish court recently ordered a German pharmaceutical company, the Gruenenthal Group, to pay compensation to 22 Spaniards born with disabilities after their mothers used Thalidomide during pregnancy decades ago. Madrid's Prudential Court ordered the Gruenenthal Group in Spain to pay 20,000 euros ($26,300) for each percentage point of disability of the victims recognized by Spain's Ministry of Health. While the total compensation bill was not immediately made known, it appeared to be much lower than the 204 million Euros sought by the Spanish Association of Thalidomide Victims, which brought the case on behalf of some 200 alleged victims.

In a statement, Gruenenthal said that it was disappointed with the outcome and would assess the judgment in greater detail to decide on the appropriate course of action. Citing its care for those affected by Thalidomide, the company defended its conduct during the era that Thalidomide was prescribed, stating that it was consistent with “prevailing standards for the development and testing in the pharmaceutical industry at that time.”

On Dec.2, 2013 another settlement was reported in similar Thalidomide litigation. Diageo PLC has agreed to pay approximately $81 million to settle class action claims brought by Australians and New Zealanders claiming birth defects allegedly caused by the “morning sickness drug,” Thalidomide. According to a press release by plaintiff counsel, these settlements conclude two separate actions involving more than 100 claimants suffering from lifelong disabilities attributed to maternal ingestion of Thalidomide during pregnancy.

Conclusion

Overall, these developments and the intensive discovery efforts proceeding in the Philadelphia litigation have established that a tragedy many had forgotten about will once again be reported by the international press and followed by the medical-legal community. The settlements reported overseas may foretell similar results in the United States, perhaps dependent upon the potential revelations contained in decades-old documents now under review. It is entirely possible that the future course of Thalidomide litigation will become clear in 2014, with a federal court in Philadelphia at the center of the story.

Michael D. Brophy, a member of this newsletter's Board of Editors, is a partner in Goldberg Segalla LLP, practicing out of the firm's Philadelphia office.

The story begins in the post-World War II era, when literally millions of people worldwide took tranquilizers and sleeping pills on a regular basis. The demand for sedatives was higher in certain European markets, and one of the most popular drugs was Thalidomide, one of the few non-barbiturate sedatives available in 1953.

Thalidomide was also prescribed between 1953 and 1960 for treatment of morning sickness in pregnant women. Tragically, thousands of babies whose mothers used it were born worldwide with abnormally short limbs and in some cases without arms, legs or hips.

Unexpected Consequences

An Australian obstetrician, Dr. William McBride, had been among the first to discover that the drug could alleviate symptoms of morning sickness. He accordingly recommended this off-label use to his pregnant patients. By 1961, Dr. McBride began to associate use of Thalidomide with severe birth defects in the babies he delivered. A German newspaper soon reported that 161 babies had been adversely affected by Thalidomide, leading the manufacturers of the drug to stop distribution in Germany. Other countries followed suit, and, by March 1962, Thalidomide was banned in most countries around the world.

The scourge of birth defects from Thalidomide in the 1950s and 1960s remains one of the worst pharmaceutical disasters ever. American mothers were generally spared, due largely to the vigilance of Frances Kelsey, a Food and Drug Administration (FDA) officer who refused to approve sale of the drug in the United States. Kelsey felt that the application for Thalidomide contained incomplete and insufficient data regarding safety and effectiveness. Among her specific concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus. By July 1962, President John F. Kennedy and the American press were praising Inspector Kelsey's efforts in resisting pressure from the pharmaceutical industry to sanction sale of the drug in the United States.

Kelsey was also concerned that there were not yet any results available from U.S. clinical trials of the drug. At that time, clinical trials did not require FDA approval, nor were they subject to the massive oversight that exists today. The “clinical trials” of Thalidomide involved distributing more than 2.5 million tablets to approximately 20,000 patients across the nation, including 3,760 women of child-bearing age, at least 200 or more of whom were pregnant. More than 1,000 physicians participated in the trials, but few tracked the progress of their patients after dispensing the medication.

Despite its harmful side-effects, Thalidomide remains approved by the FDA for two uses today: the treatment of inflammation associated with Hansen's Disease (leprosy), and as a chemotherapeutic agent for patients with multiple myeloma ' purposes for which it was originally prescribed off-label.

Not Just a Thing of the Past

It is estimated that approximately 10,000 babies suffered malformations because their mothers used Thalidomide while pregnant to treat morning sickness, anxiety or insomnia. The conventional wisdom held that only about 40 of these were born in the United States, but that estimate is now being challenged.

In 10 federal lawsuits pending in Philadelphia, plaintiffs accuse a group of drug firms of concealing for more than 50 years an unknown number of Thalidomide babies born in the United States. According to the litigation, these children were born to women who, during pregnancy, were given Thalidomide distributed by companies that had cause to suspect that the drug could harm a fetus, although they knew that it had not been adequately tested. This “hidden generation” of American Thalidomide victims ' who since birth have been told that their injuries were simply congenital or an “act of God” ' could number in the hundreds or thousands, according to one of the law firms involved in the Philadelphia litigation.

The history involving Inspector Kelsey is well known, but the federal litigation points to the distribution of millions of Thalidomide pills sent to U.S. doctors through programs conducted by Smith, Kline & French, a predecessor of GlaxoSmithKline; and perhaps as well by Richardson-Merrell, a company since absorbed by Sanofi-Aventis. The exact number of patients and their identities has remained a mystery for many years. However, most recently, the United States District Court for the Eastern District of Pennsylvania ordered the parties to proceed with the discovery phase of the litigation. It further required drug firms, for the first time, to provide the plaintiffs with a list of all doctors who distributed Thalidomide to Americans. According to plaintiffs, this information will be combined with documents secured through the Freedom of Information Act and a two-year search of archives in Washington, DC, and overseas, which may (according to the plaintiffs) provide evidence of a vast cover-up by the drug firms that first introduced Thalidomide more than a half-century ago.

Through a spokesman, Glaxo-SmithKline (GSK) has stated that its predecessor “studied Thalidomide and conducted a small, short clinical trial on the drug in 1956 and 1957 that involved approximately 875 patients and a total of 67 investigators.” R. Kramer, The Inquirer, “Act of God or Drug Firms?,” http://bit.ly/1cMTlfl. GSK has further stated that the company had no knowledge of any relationship between Thalidomide and birth defects during the time it conducted the studies. Id.

A Case in Point

Perhaps one of the most remarkable stories is that of plaintiff Deborah Johnson. The Johnson litigation reached the United States Third Circuit Court of Appeals earlier this year on an issue of subject matter jurisdiction. In Johnson v. SmithKline Beecham Corporation , 724 F.3rd 337 (3rd Cir. 2013), plaintiffs challenged an order of the Eastern District of Pennsylvania that denied their motion to remand the litigation to Pennsylvania state court. The plaintiffs contended that the district court lacked subject-matter jurisdiction over their claims because the parties did not have complete diversity of citizenship. The Third Circuit, however, agreed with the district court, and held that none of the defendants was a citizen of the same state as either plaintiff (Glenda Johnson and Steven Lucier).

The substance of Johnson's suit involves injuries on both sides of her body. At birth, her thumbs were little more than fleshy wads of skin and her arms were folded up in a
manner resembling chicken wings. Surgeons fashioned usable thumbs for her from her index fingers, leaving her with four digits on each hand. One forearm is regular sized, and the other is about four inches long. According to Johnson, she heard the same explanation for decades from doctors and family: “That's how God made her.” Johnson accepted this explanation and attributed the birth defect to heredity.

As an adult, she had great concern for her own children. When her son was born, Johnson's first question was, “Are his hands and arms okay?” They were. In March 2012, her then adult son, now a medical student, told Johnson that he believed her injuries had been caused by Thalidomide. “I came home that night, and I started looking it up, and the more I read, the more I just cried,” said Johnson. According to Johnson, her mother, Delores Layssarde, had been given a drug for morning sickness early in her pregnancy. Johnson believes the drug was Thalidomide. Her lawyers now hope to prove it through the federal litigation.

In its decision on the jurisdictional matter, the Third Circuit recognized that Johnson, a Louisiana citizen, and Lucier, a Pennsylvania citizen, both suffered from birth defects allegedly caused by their mothers' ingestion of Thalidomide during pregnancy in the 1960s. The defendants consisted of drug companies and their successors-in-interest that developed, designed, manufactured and distributed Thalidomide. According to plaintiffs, “newly accessible evidence” revealed that the defendants were aware of the drug's risks even while marketing it to pregnant women, and that for 60 years they had been engaged in an elaborate, ongoing, cover-up to avoid liability for those actions.

Seeking damages for lifelong physical and emotional suffering, the plaintiffs originally filed their litigation in the Philadelphia County Court of Common Pleas, on Aug. 26, 2011 (one of the nation's well known pro-plaintiff venues). The defendants timely removed the litigation to federal court, asserting diversity jurisdiction. The plaintiffs filed a motion to remand, claiming that several of the defendants, including GSK, were Pennsylvania citizens, as was plaintiff Lucier. The district court disagreed, denied the motion, and certified the order for interlocutory appeal. The Third Circuit granted permission to appeal, and, ultimately, upheld the jurisdictional findings of the district court.

The Third Circuit's analysis focused on jurisdictional issues and not the merits of the litigation. Following remand of the case to the Eastern District of Pennsylvania, discovery orders were issued and are now in progress.

Other Countries Also Dealing with the Issue

Meanwhile, a Spanish court recently ordered a German pharmaceutical company, the Gruenenthal Group, to pay compensation to 22 Spaniards born with disabilities after their mothers used Thalidomide during pregnancy decades ago. Madrid's Prudential Court ordered the Gruenenthal Group in Spain to pay 20,000 euros ($26,300) for each percentage point of disability of the victims recognized by Spain's Ministry of Health. While the total compensation bill was not immediately made known, it appeared to be much lower than the 204 million Euros sought by the Spanish Association of Thalidomide Victims, which brought the case on behalf of some 200 alleged victims.

In a statement, Gruenenthal said that it was disappointed with the outcome and would assess the judgment in greater detail to decide on the appropriate course of action. Citing its care for those affected by Thalidomide, the company defended its conduct during the era that Thalidomide was prescribed, stating that it was consistent with “prevailing standards for the development and testing in the pharmaceutical industry at that time.”

On Dec.2, 2013 another settlement was reported in similar Thalidomide litigation. Diageo PLC has agreed to pay approximately $81 million to settle class action claims brought by Australians and New Zealanders claiming birth defects allegedly caused by the “morning sickness drug,” Thalidomide. According to a press release by plaintiff counsel, these settlements conclude two separate actions involving more than 100 claimants suffering from lifelong disabilities attributed to maternal ingestion of Thalidomide during pregnancy.

Conclusion

Overall, these developments and the intensive discovery efforts proceeding in the Philadelphia litigation have established that a tragedy many had forgotten about will once again be reported by the international press and followed by the medical-legal community. The settlements reported overseas may foretell similar results in the United States, perhaps dependent upon the potential revelations contained in decades-old documents now under review. It is entirely possible that the future course of Thalidomide litigation will become clear in 2014, with a federal court in Philadelphia at the center of the story.

Michael D. Brophy, a member of this newsletter's Board of Editors, is a partner in Goldberg Segalla LLP, practicing out of the firm's Philadelphia office.