Health Canada sued for approving dangerous jaw implants

First, they sued the distributor, now Vitek implant victims are going after the government

By: Luis Millan

  The tiny implants were supposed to provide relief for a jaw disorder. Instead, hundreds of Canadians, mostly women, are now trying to cope with chronic debilitating pain and facing endless surgeries, with no relief in sight. Compounding the tragedy is the fact that the implants were never supposed to be used on anyone in Canada.
  But the victims are fighting back. After a four-year legal battle, over 300 Canadians were told they are entitled to a share of a $9.4 million class-action settlement reached in May 1999. The suit was against La Corporation Instrumentarium Inc., a Quebec company that distributed the jaw implants manufactured by Vitek Inc., an American company that declared bankruptcy in 1990.
 

The Health Protection Branch "should have known the implants were dangerous and hazardous to human life." - Lawyer John Legge

  "It was a large and pretty complicated process because the evidence was tricky and because the TMJ implant manufacturers were bankrupt," says Michael Peerless, a lawyer with Siskind, Cromerty, Ivey and Dowler of London, Ontario.
  Now, the victims are going after Health Canada's Health Protection Branch, the federal agency responsible for testing, regulating, and ensuring the safety of all medical devices imported into or used in Canada.
  Judith Logan, a 54-year old implant victim, filed a lawsuit in Toronto recently, accusing the government agency of "reckless disregard of known and reasonably apprehensible public health risks." The suit seeks general damages of $300,000, special damages of $3,000,000, plus punitive and exemplary damages of $1,000,000.
 

The implant caused five perforations in one victim's skull, leaving her brain exposed

  "The government watchdog was sound asleep," says John Legge, Logan's attorney. "It should have known the implants were dangerous and hazardous to human life. They were grossly negligent. People would not be in this predicament had they known how dangerous it was." Legge is hoping to convince the court to allow the suit to proceed as a class-action lawsuit.
  The implants were used to treat temporomandibular joint (TMJ) syndrome, a disorder that can produce excruciating jaw and facial pain, headaches, earaches, arthritis, clicking sounds in the jaw and lockjaw.
  An olive-sized structure composed of bones and a cushioning disk, the TMJ connects the lower jaw, or mandible, to the skull. The TMJ allows the mandible do things most people take for granted, from biting and chewing to smiling and kissing.
  The Vitek implants, which were made out of a porous material (Proplast/Teflon) that allowed body tissues to readily grow into its pores, proved to be a medical catastrophe. "The level of damage and pain that these people are suffering is unimaginable," says Legge. That's because the devices disintegrate into microparticles, leading to bone degeneration, giant cell reaction, and tumours - to name but a few of the long litany of ailments. On one victim the implant caused five perforations in her skull, leaving her brain exposed.
  A ruling by the courts over the certification of the class-action suit against the Health Protection Branch is expected to take place over the next four months.

Luis Millan is a Montreal-based freelance journalist who has whose work has appeared in national magazines such as Canadian Business, Equinox, Profit and Canadian Wildlife.

Get More/Do More
For more information on TMJ, visit the TMJ Association's website at www.tmj.org.

[ Front Page ]