Drug & Device News

Expert Barred from Testifying About Harm from Accutane Use

In a ruling likely to impact thousands of pending cases, a New Jersey judge has barred Accutane plaintiffs from presenting expert testimony that the drug causes Crohn's disease. The testimony failed to meet the standards of scientific reliability required by New Jersey Rule of Evidence 702, Atlantic County Superior Court Judge Nelson Johnson said in a decision made public Feb. 23. It is one thing to “stand alone in the world of science by advancing a hypothesis that others do not accept,” but “quite another thing to advance a hypothesis that can only be supported by disregarding valid scientific research,” Johnson said.

There are more than 6,700 lawsuits consolidated before Johnson on a multicounty litigation docket alleging that Accutane, an acne medication made by Roche Laboratories, caused harmful side effects such as inflammatory bowel disease (IBD), ulcerative colitis, birth defects and extreme depression.

Crohn's, a type of IBD, is a chronic gastrointestinal disease, the symptoms of which include abdominal pain, severe diarrhea, fatigue, weight loss and rectal bleeding, and it can lead to colorectal cancer, bowel perforation and other life-threatening complications. The decision to exclude the expert testimony could preclude recovery on claims that Accutane caused Crohn's disease.

Roche stopped manufacturing Accutane in 2009, but the generic versions, including Amnesteen, Claravis and Absorica, remain on the market subject to restrictions on prescribing them.

Plaintiff Wins Big in Bellwether Pelvic Mesh Suit

Attorney-sponsored television ads seeking plaintiffs who have been implanted with pelvic slings are ubiquitous these days, and they're likely to get louder after the $5.7 million verdict issued in March in the first test case concerning Johnson & Johnson's Ethicon's TVT-Abbrevo, a pelvic mesh device used for treating urinary incontinence. (There have been three previous plaintiff verdicts involving other Ethicon products.) The trial, held in Superior Court in Kern County, CA, began in January and ended in March with the jury finding that the device was defectively designed and that its manufacturer failed to warn doctors of known defects. The verdict included $700,000 in compensatory damages to the plaintiff and $5 million in punitive damages. Ethicon spokesman Matthew Johnson said Johnson & Johnson plans to appeal. Johnson explained, “We have strong grounds for appeal as we believe the evidence showed that TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product.”

Changes in Marijuana- Related Crime Law Lead to Confusion

The use of marijuana is legal in Connecticut for certain medical purposes, while recreational use remains prohibited. However, in 2011, Connecticut's legislature decriminalized the possession of less than half an ounce of marijuana, making it nothing more than a civil infraction to possess such small amounts. The State's Supreme Court was recently asked to expunge the arrest and conviction record of one man, Nicholas Menditto, who had pleaded guilty to two counts of possession of a controlled substance in October, 2009. In both instances, he had been accused of possessing less than half an ounce of marijuana and was ultimately placed on probation.

Menditto was again arrested for possession of less than half an ounce of marijuana on March 25, 2011, which led to a charge of violating the terms of his probation for the earlier convictions. It was a few months after this arrest that the State's legislature decriminalized possession of small amounts of marijuana. Menditto then sought dismissal of the new charge against him and the destruction of his previous criminal records. The Superior Court Judge denied the motions after finding that the “savings clause” in the new statute ' which limited the scope of the repeal of prior statutes ' entitled the State to continue to pursue conviction for activity that, while no longer criminal, had been criminal at the time of commission. An intermediate appeals court affirmed.

The Supreme Court reversed, Justice Carmen Espinosa, writing for the unanimous court, stating, “This is not the sort of conduct to which society attaches substantial moral opprobrium, or which one takes into consideration when making important decisions such as hiring an employee, for which criminal records are often consulted.” She went on to say that, since the legislature had determined that violations involving possession of less than a half ounce of marijuana are now to be handled in the same manner as parking violations, and the State had failed to offer a plausible reason why erasure should be denied, it must be granted to Menditto.

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Expert Barred from Testifying About Harm from Accutane Use

In a ruling likely to impact thousands of pending cases, a New Jersey judge has barred Accutane plaintiffs from presenting expert testimony that the drug causes Crohn's disease. The testimony failed to meet the standards of scientific reliability required by New Jersey Rule of Evidence 702, Atlantic County Superior Court Judge Nelson Johnson said in a decision made public Feb. 23. It is one thing to “stand alone in the world of science by advancing a hypothesis that others do not accept,” but “quite another thing to advance a hypothesis that can only be supported by disregarding valid scientific research,” Johnson said.

There are more than 6,700 lawsuits consolidated before Johnson on a multicounty litigation docket alleging that Accutane, an acne medication made by Roche Laboratories, caused harmful side effects such as inflammatory bowel disease (IBD), ulcerative colitis, birth defects and extreme depression.

Crohn's, a type of IBD, is a chronic gastrointestinal disease, the symptoms of which include abdominal pain, severe diarrhea, fatigue, weight loss and rectal bleeding, and it can lead to colorectal cancer, bowel perforation and other life-threatening complications. The decision to exclude the expert testimony could preclude recovery on claims that Accutane caused Crohn's disease.

Roche stopped manufacturing Accutane in 2009, but the generic versions, including Amnesteen, Claravis and Absorica, remain on the market subject to restrictions on prescribing them.

Plaintiff Wins Big in Bellwether Pelvic Mesh Suit

Attorney-sponsored television ads seeking plaintiffs who have been implanted with pelvic slings are ubiquitous these days, and they're likely to get louder after the $5.7 million verdict issued in March in the first test case concerning Johnson & Johnson's Ethicon's TVT-Abbrevo, a pelvic mesh device used for treating urinary incontinence. (There have been three previous plaintiff verdicts involving other Ethicon products.) The trial, held in Superior Court in Kern County, CA, began in January and ended in March with the jury finding that the device was defectively designed and that its manufacturer failed to warn doctors of known defects. The verdict included $700,000 in compensatory damages to the plaintiff and $5 million in punitive damages. Ethicon spokesman Matthew Johnson said Johnson & Johnson plans to appeal. Johnson explained, “We have strong grounds for appeal as we believe the evidence showed that TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development and marketing of the product.”

Changes in Marijuana- Related Crime Law Lead to Confusion

The use of marijuana is legal in Connecticut for certain medical purposes, while recreational use remains prohibited. However, in 2011, Connecticut's legislature decriminalized the possession of less than half an ounce of marijuana, making it nothing more than a civil infraction to possess such small amounts. The State's Supreme Court was recently asked to expunge the arrest and conviction record of one man, Nicholas Menditto, who had pleaded guilty to two counts of possession of a controlled substance in October, 2009. In both instances, he had been accused of possessing less than half an ounce of marijuana and was ultimately placed on probation.

Menditto was again arrested for possession of less than half an ounce of marijuana on March 25, 2011, which led to a charge of violating the terms of his probation for the earlier convictions. It was a few months after this arrest that the State's legislature decriminalized possession of small amounts of marijuana. Menditto then sought dismissal of the new charge against him and the destruction of his previous criminal records. The Superior Court Judge denied the motions after finding that the “savings clause” in the new statute ' which limited the scope of the repeal of prior statutes ' entitled the State to continue to pursue conviction for activity that, while no longer criminal, had been criminal at the time of commission. An intermediate appeals court affirmed.

The Supreme Court reversed, Justice Carmen Espinosa, writing for the unanimous court, stating, “This is not the sort of conduct to which society attaches substantial moral opprobrium, or which one takes into consideration when making important decisions such as hiring an employee, for which criminal records are often consulted.” She went on to say that, since the legislature had determined that violations involving possession of less than a half ounce of marijuana are now to be handled in the same manner as parking violations, and the State had failed to offer a plausible reason why erasure should be denied, it must be granted to Menditto.

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