Court weighs rights of future children

Ruling will have serious legal, moral and public policy implications

03/01/2008 - Jaime Paxton is a miracle, both in her mother's eyes and in the sometimes-fickle world of statistics.

Under the law of averages, she shouldn't have been born.

Confident a vasectomy performed years earlier on Jaime's father was effective birth control, a Newmarket doctor put Jaime's mother on Accutane, an acne drug known to cause severe defects to fetuses.

But in an improbable turn of events, Paul Paxton's vasectomy failed soon after his wife, Dawn, began taking the drug. Unexpectedly pregnant, she hoped to beat the odds and give birth to a normal child, their fourth.

"I just felt like God was giving me a miracle and that He wasn't going to do something bad," she has explained. "I expected that when she was born ... I was going to tell all the doctors that, `Look, you guys were all wrong.'"

Jaime, now 5, was born with extreme disabilities. She's missing a right ear and portions of her face are paralyzed. Barely able to blink, she requires "artificial tears."

Through her parents, Jaime sued Dr. Shaffiq Ramji for negligence, alleging he had a duty to ensure any children born to her mother wouldn't be exposed to the drug's catastrophic risks – a duty breached when he failed to ensure Paxton used a second form of birth control, such as a condom, as the drug company recommends.

Ramji's lawyers said if the case now before the Ontario Court of Appeal succeeds, it will be the first time an appeal court in Canada has recognized a doctor has a duty of care to a child not yet conceived.

After hearing arguments over two days this week, a three-judge panel reserved its decision. Whichever way the court rules, the outcome could have profound legal, moral and public policy implications.

Facing onerous new pressures, doctors could be driven to practice"defensive medicine" to avoid liability, said Darryl Cruz and Sarit Batner, Ramji's lawyers.

This could include refusing to provide girls and women of child-bearing age – theoretically 11 to 60 – with drugs that may pose dangers to a future child, including cancer drugs, unless there's proof birth control is being used.

Or doctors could end up playing a "numbers game," weighing the risk of damage to a potential fetus against the risk of denying a prospective mother needed medicine.

This would intrude into the rights of women, etched out during the abortion debate, to have control over their own bodies, Cruz and Batner argued. In other cases, physicians anxious to avoid legal liability could end up encouraging women to have abortions, they said.

But dismissing Jaime's lawsuit would lead to an equally "stark" scenario, providing physicians blanket immunity for injuries to children not yet born or conceived, said Susan Chapman, a lawyer representing the Paxtons.

The case isn't about ethics and metaphysics – it's about ensuring the medical profession isn't shielded from the consequences of its own mistakes, she said.

But Justice Michael Moldaver, who headed the appeal panel, questioned whether it would also force doctors to "play God," having to judge, among other things, whether an unborn child would want to live with disabilities.

Moldaver also questioned how a doctor might deal, for example, with the case of a patient who promises to use two forms of birth control while taking Accutane but the doctor doesn't believe her. "What are (doctors) supposed to do? Put them on polygraphs?"

Held to such exacting standards, the medical profession "would be afraid to move," Moldaver added. "I'd be afraid to move."

For her part, Dawn Paxton, 35, told a Newmarket trial judge in 2005 that if she and her husband had been told by Ramji to use a condom as added protection against contraception, they would have done so. There's no question it would have prevented the pregnancy, her lawyers said.

She heard about Accutane in 2001 from a friend. Though her acne may have appeared mild, Paxton was sensitive about her appearance and eager to try the drug, said Justice Margaret Eberhard, the trial judge.

She found that in prescribing the drug, Ramji did owe a duty of care to the yet-to-be-conceived Jaime, but concluded his conduct met the standards of a reasonable physician and dismissed the lawsuit, prompting an appeal by both sides.

Ramji contends the judge was wrong in finding he had a legal obligation towards a child not yet conceived; the Paxtons, on behalf of their daughter, argue Eberhard erred in concluding Ramji provided proper care.

The trial judge found the drug's manufacturer, Roche, developed a "shock and awe" strategy to drive home the message to physicians and patients that Accutane and pregnancy don't mix. The company's "Pregnancy Prevention Program" requires that effective contraception be used before the drug is prescribed and recommends two reliable forms of birth control, such as the Pill along with a condom.

It also recommends doctors give patients two pregnancy tests, one before starting the two forms of birth control, followed by a second test a month later. Only then, if a woman isn't pregnant, should the drug be used.

Ramji departed from the protocol in several ways, Eberhard ruled. In addition to not recommending a condom, he prescribed the drug immediately after the first pregnancy test on Jan. 15, 2002, instead of waiting a month before allowing Paxton to take Accutane.

The evidence suggests Jaime was conceived on Feb. 14, 2002, just days before Dawn Paxton's second pregnancy test, which, in another odds-defying twist, came back with a false negative result.

What turned the case in Ramji's favor at the trial was testimony from two defense experts, both doctors, who said it was reasonable for the family practitioner to have relied on Paul Paxton's vasectomy as the only form of birth control before prescribing the drug.

As a form of sterilization, vasectomies are more effective than any two forms of contraception recommended by the drug firm, they said.

Paxton had his vasectomy 4 1/2 years before Jamie was conceived. Using a condom would have only made a marginal difference in reducing pregnancy, the experts said.

Eberhard said that while the manufacturer recommends two reliable forms of contraception, it's not a requirement and the difference in wording allows doctors to rely on their clinical judgment about what constitutes effective birth control.

But the Paxtons called their own experts at the trial who all testified that following the manufacturer's recommendations would have been the best way to ensure Dawn Paxton didn't become pregnant.

Ramji's lawyers say the issue isn't whether their client followed the "best" practices; it's whether his actions were reasonable.

The Paxtons' negligence lawsuit, they contend, is really a claim for "wrongful life," a form of civil action largely rejected by courts in Canada, Australia and England.

They argue that what Jaime, in essence, is saying is: "You shouldn't have given my mother Accutane without ensuring she would use a condom. Had you done this, I would not have been born."

Courts worldwide have found the concept of awarding such damages contrary to public policy. At the 2005 trial, Dawn Paxton testified that she doesn't regret her decision to keep Jaime.

"I love her more than anything," she said. "I am scared about her future."

If you or a loved one have been injured as a result of Accutane side effects such as Accutane birth defects, you may be entitled to compensation. Let our Accutane Attorneys evaluate your case for free today. Click here to fill out our online case evaluation form or call us toll free at: 1-800-856-6405 for your free, confidential case evaluation.