Federal Court Filing Asserts That Johnson & Johnson Altered And Withheld Data About Health Risks Of Ortho Evra Birth Control Patch

As Of November 2007 J&J Faces 2400 Lawsuits Involving Strokes, Heart Attacks, And Blood Clots Allegedly Caused By Ortho Evra, With Most Cases Pending Before MDL Judge Katz

(Posted by Tom Lamb at DrugInjuryWatch.com)

In legal motions filed November 20, 2007 by lawyers representing women claiming to have been injured by their use of the Ortho Evra birth control patch, it is asserted that the drug company Johnson & Johnson (J&J) misled the FDA and doctors in the years leading up to the time that "the Patch" was approved for use by women in the U.S.

According to a November 29, 2007 Bloomberg article, "J&J Altered Birth-Control Patch Data to Hide Risks", these contentions of misconduct by J&J were presented to U.S. District Judge David Katz, of the U.S. District Court, North District of Ohio, in Toledo, who is the presiding judge for In re Ortho Evra Products Liability Litigation, Multi-district Litigation (MDL) 1742, where currently approximately 1500 federal court lawsuits from around the country have been centralized.

This November 29 Bloomberg article, by reporter David Voreacos, puts this apparent misconduct by J&J in context and provides specific instances of such from the November 20 MDL court filing:

J&J... faces lawsuits by 2,400 women who claim the patch releases high levels of estrogen that cause strokes, heart attacks, and blood clots in the legs and lungs. Internal documents and pre-trial interviews with J&J scientists show the company learned the risk in 1999 and misled the Food and Drug Administration when seeking approval in 2001 to market the device, the filings state.

The company "withheld and altered data from the clinical trials which proved that the patch delivered significantly higher levels" of estrogen than oral contraceptives, according to a motion filed by patch users Nov. 20 in federal court in Toledo, Ohio. "Obviously unaware of the withheld information, the FDA approved Ortho Evra for marketing."...

The filing details a clinical trial in 1999, known internally as PHI-014. It measured the amount of ethinyl estradiol, or EE as the estrogen component is called, released into the bloodstream every 24 hours. The company said the study proved the level was 20 micrograms.

The actual results showed the patch released 30.4 micrograms when applied to the abdomen and 38.1 micrograms when applied to the buttocks, according to the motion. A company pharmacologist, Dr. Larry Abrams, applied a ``60% correction factor'' to lower the results, the motion said....

Another study in 1999, known as PHI-017, measured the concentration of estrogen from the patch compared with three forms of the pill, the motion said. The results showed the patch delivered two times more estrogen than one pill and three times more than the other pills.

Abrams "spent an agonizing two years in delaying and obfuscating the results" before the company submitted them to the FDA in October 2001, one month before the patch was approved, the motion said.

"Over the ensuing six years and to the present date, defendants have never mentioned to the FDA the results of PHI- 017," it said.  "Clearly, defendants' omission of PHI-017 was no accident, but instead a very deliberate plan intended to deceive regulators about the high levels of EE delivered by the patch."

More recently, in February 2007, the medical journal Obstetrics and Gynecology published a study which concluded that women who used the Ortho Evra birth control patch seemed to be at double the risk of developing a dangerous blood clot in their veins as are woman who use birth control pills, or oral contraceptives.

In the past there have been some reports about J&J and its lawyers wanting to settle those lawsuits where a woman Ortho Evra was hospitalized with any of the following serious side effects: 

• stroke;
• heart attack;
• pulmonary embolism; or,
• deep vein thrombosis.

Returning to the federal court Ortho Evra MDL litigation, the lawsuits of seven so-called "bellwether" plaintiff are currently scheduled for trial, to be heard by Judge Katz, in June or July 2008. 

We will watch to see whether Johnson & Johnson and its lawyers allow those seven Ortho Evra MDL cases to go to trial, or chooses to settle -- as J&J reportedly did with a lawsuit which involved the death of a teen-aged girl named Alycia Brown.  For more on that Ortho Evra litigation update we refer you to an October 24, 2007 Bloomberg article, "J&J Pays $1.25 Million to Settle Suit Over Death of 14-Year-Old", by David Voreacos and Patricia Hurtado.