Air Date: Apr 1, 2003
Reporter: Erica Johnson
Producer: Carmel Smyth
Researcher: Colman Jones

Medical Device Lawsuits

Some of the larger class-action lawsuits related to

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DALKON SHIELD
A n intrauterine contraceptive device used for about 13 years (1971–1984) worldwide; about three years (1971–1974) in the United States.

By the time the product was withdrawn from the market, A.H. Robins had distributed approximately 2.8 million Dalkon Shields in the U.S. and 1.7 million overseas. Approximately 3.6 million women worldwide actually used the Dalkon Shield. An estimated 15,000 cases were filed against A.H. Robins for reproductive and other personal injuries by the time the company filed for Chapter 11 bankruptcy protection.

The judge approved a mandatory class settlement against Aetna, Robins’s insurer, and that settlement was approved by the court of appeals. The Dalkon Shield Claimants Trust was established with the $2.475 billion proceeds of the sale of the company, and more than 300,000 individuals filed claims There seems to be a consensus that the Dalkon Shield was not adequately tested.

HEART VALVE (BJORK-SHILELY)
Some 300 deaths have been reported as a result of fractures of this heart valve, on the market from 1979 to 1986. Approximately 12,000 individuals filed claims against Pfizer, Inc. and its subsidiary, Shiley (manufacturers of heart valves) for wrongful death and personal injury in a class-action suit, alleged design and manufacturing defects; under the terms of the settlement, victims of heart valve fracture could receive somewhere between $500,000 and $2 million, depending on age, income, and family status.

It has been alleged that Pfizer/Shiley made false statements to the FDA to obtain market approval and later to keep defective Bjork-Shiley mechanical heart valves on the market. At the time of the approved settlement there were an estimated 40,000 living heart valve recipients.

“J” PACEMAKER LEADS
On the market 1988–1994; 456 individual personal injury cases, related to the tendency of these pacemaker leads to break through the polyurethane insulation of the pacemaker and penetrate the heart or blood vessels, were consolidated for a nationwide class-action lawsuit; in August 1998, the judge preliminarily approved a $57.2 million mandatory settlement, providing up to $1 million to relatives of persons who died because the or because of removal or replacement surgery patients with leads. Settlement class action/opt-out. A Canadian opt-out class action settlement provided $23.1 million to approximately 1,005 class members; 96 class members opted out.

Telectronic has recalled all unsold leads, set up a program to identify fractures as early as possible, and offered to compensate individuals with fractures. There have been 25,000 in-dividual with “J” wires implanted. The fracture rate is estimated at between 12 per cent and 20 per cent, so the number potentially harmed is expected to be between 3,000 and 5,000.

NORPLANT
Six flexible matchstick-sized, silicone-coated rods that are inserted under the skin of the upper arm and release a synthetic hormone (which has been used in birth control pills for more than 20 years) that prevents pregnancy for up to 5 years, but may be removed at any time.

The FDA approved Norplant in 1990, and according to Wyeth-Ayerst, about 1 million women in the United States have used Norplant since it was first sold there in 1991, with more than 800,000 Norplant systems prescribed and inserted during 1991–1993. Plaintiffs claim the contraceptive device causes a wide range of adverse side effects, from routine hormonal side effects, such as headache and weight gain, to more infrequently reported serious effects, such as strokes and blindness.

In 1995 the FDA investigated reports of adverse reactions and found no basis for questioning its safety and effectiveness when used as directed. In 1996 an NIH panel found Norplant safe and effective. As of Dec. 31, 1998, 3,929 Norplant cases, on behalf of more than 30,000 claimants, had been filed against American Hope Products Corp. & Wyeth-Ayerst Laboratories, a division of AHP, which manufactures Norplant systems, an implanted longterm contraceptive device. 3,399 of these cases were pending at the time. Reportedly, a total of 53,375 women have sued in federal and state courts. Approximately 70 of the cases were filed as class actions.

Some suits also name the health care providers who inserted the implant, or the Population Council, a non-profit organization that began development of Norplant in 1966 and has tested the device over the next two decades, or Dow Corning France, S.A., which makes the silicone capsules in the original Norplant system, or Leiras Oy, which fills the capsules with the active ingredient (levonorgestrel).

ORTHOPEDIC BONE SCREWS
Medical devices used to support spine after surgery; More than 100,000 Americans had bone screws implanted in the pedicles of their spines by 1994. An estimated 4,000 individual lawsuits have been filed against various manufacturers of pedicile bone screws in state and federal courts, a large number of cases consolidated in a Tennessee state court. In 1997, Judge Bechtle approved a limited fund class action settlement with Acromed Corp. for $100 million, involving claims for about 3,200 plaintiffs, from 85 district courts in 46 states. At the settlement approval hearing in 1997, plaintiffs’ counsel reported that there were more than 6,000 claimants that alleged conspiracy and other claims against all manufacturers of pedicile screws and against a number of doctors and medical societies.

Plaintiffs claim that screw have broken, causing excruciating pain and further damage to the spine. Acromed claimed that it did not approve of the use of the pedicile screws for the type of surgery involved in the litigation, that it was approved by the FDA for other purposes and was being used by surgeons without the FDA’s or Acromed’s approval, while the plaintiffs alleged that defendant marketed the screws for the surgical uses that caused the injuries. Apparently it was not tested for the uses involved.

PENILE PROSTHESES (IMPLANTS) -
On the market for about 25 years. A San Francisco newspaper article in 1994 estimated that 300,000 men have undergone penile implant surgery since 1973. It has been estimated that American Medical Systems, Inc. (AMS) has sold 120,000 products. Approximately 715 individual cases were filed against AMS in the late 1990s. Most reported cases have resulted in summary judgments for the defendants, often on statute of limitations grounds.

A class action against AMS and Pfizer, Inc., was certified in Ohio on behalf of 15,000 to 120,000 purchasers of AMS penile prostheses, but the Sixth Circuit decertified it, and four other courts denied class certification. Outside of the unsuccessful class actions, the number of individual plaintiffs appears to be in the hundreds. Mentor, Bristol-Meyers Squibb, and Dacomed have also been named as defendants in penile prostheses litigation.

After litigation class actions were denied, class counsel filed a large number of cases in Minnesota state court. There are only two reported damage awards, both of which appeared to involve questions of medical malpractice in removing allegedly defective implants. One award was for $300,000 in Los Angeles in 1993, based on severing of a nerve during surgery to remove a displaced tube, resulting in total sexual dysfunction. The other award was for $1.75 million in Philadelphia in 1995 to a man who underwent six surgeries due to infections and hematomas related to the device.

Plaintiffs have claimed that the silicone used in penile prostheses can cause systemic injuries. Defendants claim that the solid silicone elastomer used in penile prostheses is not comparable to the silicone gel used in breast implants. They assert that the FDA recognized the distinction between silicone gel and a solid silicone elastomer when it removed silicone gel breast implants from the market but permitted solid silicone elastomer prostheses —including penile prostheses and saline breast implants encapsulated in a solid silicone elastomer—to remain on the market.

Several claimants have alleged auto-immune disease and connective tissue disorders related to the exposure to silicone. Sometimes plaintiffs allege a failure to warn about dangers allegedly associated with penile prostheses. But one plaintiffs’ attorney reported that most cases do not have sufficient damages to support individual litigation and that denial of class certification nationally and in some states effectively ended the litigation. A large block of cases appear to be close to settlement, leaving a sprinkling of individual cases in the courts.

SUPER ABSORBENT TAMPONS
Available for about ten years (mid-1970s to mid-1980s), caused toxic shock syndrome (TSS) and were reported to be inadequately tested products. For example, before one product was put on the U.S. market, the following “patch test” was conducted: The material from the tampon was put on skin to see if there was any reaction. This was done to 25 female panelists and tested for 72 hours, and the testers concluded that there was no skin irritation.

Until a substantial verdict was rendered against it, one major manufacturer reportedly had conducted no studies to ascertain whether the use of a tampon was in any way related to vaginal infection. By the early 1980s, the first verdicts against tampon manufacturers apparently led to changes, including warnings and the use of more natural fibers—that drastically reduced the number of women stricken with TSS, whose symptoms include abnormally low blood pressure, fever, nausea, vomiting, reddening of skin, accelerated heartbeat, disquamation, swollen tonsils, and abnormally functioning liver and kidneys. TSS can be fatal. More than 100 individual suits were brought.

At least six tampon manufacturers in the United States and abroad were sued. One magazine was sued unsuccessfully in relation to an advertisement for tampons. In 1982, a panel denied motions filed by two groups of plaintiffs to consolidate ninety-two federal cases. Most early cases resulted in summary judgment for defendants. In 1983, a verdict for $300,000 was affirmed; in 1986, a California verdict for $100,000 in compensatory and $1 million in punitive damages was affirmed; and in 1987 a verdict for $1.5 million in compensatory and $10 million in punitive was affirmed. In 1996, 15 years after tampon use was first associated with Toxic Shock Syndrome, a putative national class action was filed to deal with the handful of pending cases, but class certification was denied.

In a case that resulted in an award of $10 million in punitive damages, the court found that the defendant had deliberately disregarded medical reports and studies linking high-absorbency tampon fibers with toxic shock syndrome while other manufacturers withdrew or modified their high-absorbency products as a result of the information.

[Source: "Individual Characteristics of Mass Torts Case Congregations", U.S. Federal Judicial Center, January 1999]