The Ten Worst Drug Recalls In The History Of The FDA

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1) Fenfluramine/phentermine (Fen-Phen)

  • Wyeth-Ayerst Laboratories
  • Recalled: 1997 (after 24 years on the market)
  • Financial damage: Awards to victims close to $14 billion, making it one of the most costly products liability cases in history.

Fen-Phen’s was a hugely popular weight loss drug, its popularity peaking in the 90’s. It is estimated that as many as 6.5 million people took it to help fight obesity. After consumers began experiencing heart disease and other  pulmonary problems, the FDA set the recall in motion.  American Lawyer reported that more than 50,000 Fen-Phen victims have filed suits against Fen-Phen’s maker Wyeth, and legal expenses combined with awards may have exceeded $21 billion.  Lengthy time in the marketplace combined with the severity of both the public reaction and the significant awards granted to its victims make its impact unprecedented.


2) Diethylstilbestrol (DES)

  • Maker: Multiple manufacturers (DES was never patented as it was created with British public funds)
  • Recalled: 1975 (after 37 years on the market)
  • Financial damage: Steep, but difficult to quantify because each manufacturer paid out legal damages correlated with its respective market share (a new way of awarding damages in these cases).

DES was prescribed for more than thirty years to prevent miscarriages and other complications during pregnancy.  It was not until 1971 before it was connected to a rare tumor that kept appearing in the daughters of women who had taken it. The FDA only banned DES prescriptions to women because no such problems have been found in men. In fact, it can still be prescribed to men to treat estrogen deficiency.   Litigation over DES led to a landmark products liability award that heavily influenced how both courts and the FDA approach oversight of drugs with multiple manufacturers.


3) Cerivastatin (Baycol)

  • Maker: Bayer
  • Recalled: 2001 (after four years on the market)
  • Financial damage: Litigation-related damages totaled $1.2 billion

Baycol, prescribed to patients as a treatment for high cholesterol, is reportedly responsible for more than 100,000 deaths and about as many lawsuits.  It was connected to a severe muscle disorder known as rhabdomyolysis, which clogs the kidneys with protein from dying muscle tissue.

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4) Rofecoxib (Vioxx)

  • Maker: Merck
  • Recalled: 2004 (after five years on the market)
  • Financial damage: nearly $6 billion in litigation-related expenses alone

Vioxx is considered to be the largest drug recall in history, and one which elicited one of the greatest public outcries.  Vioxx, prescribed to more than 20 million people as a pain reliever for arthritis, was found to be responsible for increased risk of heart attack and stroke.  Both Merck and the FDA were roundly criticized for ignoring  evidence of the dangers of Vioxx before its eventual recall. The Lancet reported that as many as 140,000 people could have suffered from serious coronary heart disease from taking the drug in the US alone. Merck settled Vioxx litigation in the US for $4.8 billion, with close to $1 billion in legal expenses.

5) Valdecoxib (Bextra)

  • Maker: Pfizer
  • Recalled in 2005 after just one year on the market.
  • Financial damage: Over $2 billion in legal awards and expenses.

Bextra, like Vioxx, is a non-steroidal anti-inflammatory drug, that was prescribed to treat prescribed to treat arthritis and pain from other inflammatory disorders. It was removed from the market not long after Vioxx over similar concerns – increased risk of heart attack and stroke.  In some cases, it was also found to cause a fatal skin condition.  Although less publicized and the subject of fewer law suits, Bextra still resulted in $1.8 billion in legal awards against Pfizer and it’s subsidiary Pharamcia & UpJohn (not including expenses). The reason Bextra is on this list, however, is because it gave rise to one of the largest criminal fines ever imposed in the US.  Pharmacia & UpJohn Company was fined $1.195 billion, in addition to legal awards, after admitting to criminal wrongdoing, specifically with ‘intent to defraud or mislead’ in relation to the promotion of the drug.