Drug & Device News

The 100-plus plaintiffs whose cases were recently dismissed had been informed after Glynn that they must show their causes of action were substantially different from that case if they wanted to go forward with their suits. They were unable to do this, even though they offered to produce an expert witness who would attest that Merck could have done more to convince the FDA to allow the enhanced warnings.

Judge Pisano noted, however, that prior case law “provides for preemption where there is clear evidence that the FDA would have rejected a label change, and again, we know that the FDA did reject it.” In this case, Judge Pisano concluded, “any expert testimony relating to what Merck could have or should have done, and what the FDA would have done in response to the same, is purely speculation and does not rise to the level of being a genuine fact dispute.”

State's Attempt to Impose Drug Ban Is Halted

The Commonwealth of Massacusetts banned the sale of the opioid pain relief medication Zohydro ER on March 27 after lawmakers concluded that it was unsafe for use in its current form, in spite of the fact that the U.S. Food and Drug Administration has approved the drug for sale and distribution. The FDA approved the drug after its advisory committee recommended against it, and there were lingering concerns in Massachusetts that Zohydro ER's potential for abuse was too great. After Gov. Deval Patrick signed the declaration that allowed Massachusetts Department of Public Health Commissioner Cheryl Bartlett to ban distribution of the drug, its manufacturer moved for and was granted a preliminary injunction by U.S. District Judge Rya Zobel. Judge Zobel explained, “The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs ' here, opioid analgesics. If the commonwealth were able to countermand the FDA's determinations and substitute its own requirements, it would undermine the FDA's ability to make drugs available to promote and protect the public health.”

FDA Discourages Laparoscopic Power Morcellation Technique

On April 17, the FDA issued a recommendation to doctors and their patients: If there are other options available, laparoscopic power morcellation ' a technique used for removing utering fibroids or an entire uterus ' should be avoided. The method involves the use of a medical device to divide the uterine tissue into smaller pieces that can be removed through a small incision in the abdomen. The FDA release discouraging this technique states, “Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival.” The release can be accessed at http://1.usa.gov/1fR4y74.

Journal Does Not Want to Hand Over Information to Pelvic Mesh Plaintiffs

The New England Journal of Medicine has asked Woburn, MA, Superior Court Justice Diane Kottmyer to reconsider her refusal to quash subpoenas from plaintiff lawyers seeking information about an article published in the publication concerning pelvic mesh products sold by Ethicon, a subsidiary of Johnson & Johnson. Plaintiff lawyers claim the journal erroneously reported in its pages that the study of the Ethicon's pelvic mesh was conducted independently of any influence from the manufacturer, when in fact the device maker made a $750,000 payment to the study's author, had input into the parameters of the study, reviewed the article and made suggestions for changing it.

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Suits Against Merck Dismissed Due to Res Judicata

New Jersey U.S. District Judge Joel Pisano has dismissed more than 100 Fosamax lawsuits because he had already determined in a similar action that the drug's manufacturer, Merck & Co., provided doctors and consumers with the strongest warning label the FDA would approve.

In the earlier case of Glynn v. Merck , decided in June 2013, Judge Pisano dismissed a lawsuit that claimed Fosamax, a drug approved by the FDA in 1995 for use in treating osteoporosis in post-menopausal women, caused atypical femur fractures, and that Merck should have warned doctors and consumers of this risk. The reason that suit was dismissed: Merck successfully proved to Judge Pisano that it had proposed such a label change in 2008, and that the FDA declined to approve this stronger warning label.

The 100-plus plaintiffs whose cases were recently dismissed had been informed after Glynn that they must show their causes of action were substantially different from that case if they wanted to go forward with their suits. They were unable to do this, even though they offered to produce an expert witness who would attest that Merck could have done more to convince the FDA to allow the enhanced warnings.

Judge Pisano noted, however, that prior case law “provides for preemption where there is clear evidence that the FDA would have rejected a label change, and again, we know that the FDA did reject it.” In this case, Judge Pisano concluded, “any expert testimony relating to what Merck could have or should have done, and what the FDA would have done in response to the same, is purely speculation and does not rise to the level of being a genuine fact dispute.”

State's Attempt to Impose Drug Ban Is Halted

The Commonwealth of Massacusetts banned the sale of the opioid pain relief medication Zohydro ER on March 27 after lawmakers concluded that it was unsafe for use in its current form, in spite of the fact that the U.S. Food and Drug Administration has approved the drug for sale and distribution. The FDA approved the drug after its advisory committee recommended against it, and there were lingering concerns in Massachusetts that Zohydro ER's potential for abuse was too great. After Gov. Deval Patrick signed the declaration that allowed Massachusetts Department of Public Health Commissioner Cheryl Bartlett to ban distribution of the drug, its manufacturer moved for and was granted a preliminary injunction by U.S. District Judge Rya Zobel. Judge Zobel explained, “The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs ' here, opioid analgesics. If the commonwealth were able to countermand the FDA's determinations and substitute its own requirements, it would undermine the FDA's ability to make drugs available to promote and protect the public health.”

FDA Discourages Laparoscopic Power Morcellation Technique

On April 17, the FDA issued a recommendation to doctors and their patients: If there are other options available, laparoscopic power morcellation ' a technique used for removing utering fibroids or an entire uterus ' should be avoided. The method involves the use of a medical device to divide the uterine tissue into smaller pieces that can be removed through a small incision in the abdomen. The FDA release discouraging this technique states, “Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival.” The release can be accessed at http://1.usa.gov/1fR4y74.

Journal Does Not Want to Hand Over Information to Pelvic Mesh Plaintiffs

The New England Journal of Medicine has asked Woburn, MA, Superior Court Justice Diane Kottmyer to reconsider her refusal to quash subpoenas from plaintiff lawyers seeking information about an article published in the publication concerning pelvic mesh products sold by Ethicon, a subsidiary of Johnson & Johnson. Plaintiff lawyers claim the journal erroneously reported in its pages that the study of the Ethicon's pelvic mesh was conducted independently of any influence from the manufacturer, when in fact the device maker made a $750,000 payment to the study's author, had input into the parameters of the study, reviewed the article and made suggestions for changing it.

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