In a response to a question posed by U.S. District Court in Toledo, which is considering a federal lawsuit stemming from Johnson & Johnson’s Ortho Evra birth-control patch, the court’s majority found that the General Assembly had the authority to enact the law.

“Some may think limitations on certain damages to be unwise legislative policy-making, but it is beyond the authority of any court to write into the Constitution that which was not installed there by the framers and ratified by the people,” wrote Chief Justice Thomas Moyer.

He was joined in the majority by Justices Evelyn Lundberg Stratton, Maureen O’Connor, Judith Lanzinger, and Robert Cupp. Justices Paul Pfieifer and Terrence O’Donnell dissented.

“If a damage cap of $250,000 is constitutional – the majority opinion mentions the amount but never discusses it, apparently giving it no significance – why can’t the General Assembly limit damages for claims they do not favor to $100,000? Or $1,000? Or $10?” asked Justice Pfeifer, part of the now long-gone 4-3 majority that struck down a similar law in 1999.

“Under the court’s reasoning, there is nothing in the Ohio Constitution that restrains the General Assembly from limiting non-economic damages to $1…,” he wrote. “After today, what meaning is left in a litigant’s constitutional right to have a jury determine damages?”

Justice O’Donnell opined that the General Assembly has unconstitutionally substituted its judgment for that of a jury through Senate Bill 80, opening the door for further encroachments in the future.

Melisa Arbino, of Cincinnati, suffered a series of potentially fatal blood clots in her brain and lungs in 2005 that she maintains were the result of side effects from the hormonal patch. Ortho Evra remains on the market, but its label warns that it could lead to serious side effects.

The law does not limit damages in catastrophic cases, such as those involving paralysis or loss of limb.

It also does not limit economic damages – lost wages, medical costs, and other measurable out-of-pocket damages – in less serious cases.

The law, however, does cap harder-to-quantify non-economic damages for such things as pain, suffering, and mental anguish at $250,000, or three times the economic damages up to a maximum of $500,000 arising out of the injury, $350,000 of which could go specifically to the injured person.

The law was backed by Ohio’s business community, which cited prior decisions striking down such caps as reasons to remake the court through elections. Four justices have joined the court since the 1999 ruling.

Although not a part of this case, the ruling is likely to bolster the argument that different caps put in place under a medical malpractice tort-reform law are also constitutional.

December 27th, 2007 by JIM PROVANCE with toledoblade.com

SOURCE: Ortho Evra and Blood Clots › Ohio Supreme Court upholds law that puts cap on personal injury damages

The confidential agreement involved Alycia Brown, a resident of LaCrosse, Wisconsin, who suffered two blood clots in her lungs on May 7, 2004, after using the patch for several weeks. J&J, the world’s largest maker of health-care products, faces lawsuits by 2,400 of the 5 million women who used the patch.

Most claim they suffered strokes or clots in their legs or lungs. The company settled dozens of cases before trial without releasing financial details. The Brown agreement offers the first glimpse into how much money the company paid to resolve a case and avoid a trial that might air details of the company’s safety concerns about the drug before it came to market in 2001.

“Johnson & Johnson is finally starting to realize that the value of these cases and the toll they’ve taken on people is quite considerable,” said New York attorney Hunter Shkolnik, whose firm has filed Ortho Evra lawsuits. “They initially took the position that their conduct cannot be defended and there was low value to these cases.”

The Brown agreement, dated April 21 and entered in federal court in Ohio, was in the file of another Ortho Evra case in state court in Manhattan and made available to Bloomberg News by a court clerk. The 12-page document states that the company denied that Ortho Evra caused Brown’s death, and it acknowledged the uncertainty of litigation as a reason for settling.

Confidentiality Order

Company spokeswoman Gloria Vanderham said the company could not discuss the case because of a confidentiality order. She said the company does not discuss how many cases it settled.
“The company is defending against these claims, except where settlement is deemed appropriate,” said Vanderham, a spokeswoman for Ortho Women’s Health & Urology unit, a division of Ortho-McNeil Pharmaceutical Inc., a J&J subsidiary. “Settlement is not an admission of fault or that the company caused the event.”

The Brown agreement was in the file of a lawsuit by survivors of Zakiya Kennedy, who was 18 when she died on April 2, 2004, after using the patch. Court records show that a confidential settlement was reached in that case on Oct. 11.

Her case was scheduled for Nov. 19 and would have been the first to go to trial. The next scheduled trial involves the death of Ashley Lewis, who was 17 when she died in late 2003. It is slated for state court in St. Louis on Feb. 11.

Brown attorney Janet Abaray and Kennedy lawyer Gary Douglas declined to comment.

Warning Signs

Those suing J&J claim the company failed to heed warning signs about the patch, which delivers the hormones progestin and estrogen through the skin into the bloodstream. The plaintiffs claim the company, based in New Brunswick, New Jersey, knew that the patch, which went on the market in 2002, caused more blood clots and deaths than the birth-control pill.

The Food and Drug Administration warned in November 2005 that the patch may cause clots and expose women to 60 percent more estrogen than oral contraceptives. In February 2006, another study found a twofold increase in the risk of clots compared with women who took the pill.

Johnson & Johnson does not detail any reserves for Ortho Evra cases. It said in an Aug. 8 regulatory filing that it faces numerous product liability cases and believes any liability “will be substantially covered by existing amounts accrued in the company’s balance sheet and, where available, by third-party liability insurance.”

October 24th, 2007

SOURCE: Ortho Evra and Blood Clots › J&J pays $1.25m to settle lawuit over death of 14-year-old