Drug & Device News

Despite Lack of Specific Expertise, Doctors May Testify on Causation

In a 34-page opinion in Wolfe v. McNeil-PPC Inc., U.S. District Judge Jan E. DuBois held that a doctor testifying as an expert witness may opine as to causation using a “differential diagnosis” ' in other words, he or she is permitted to testify that, because other causes have been ruled out, the pharmaceutical product at issue likely caused the condition. The case involves a child who was given ibuprofen, after which she developed Stevens-Johnson Syndrome (SJS), a life-threatening condition in which the epidermis separates from the dermis. The plaintiffs assert that the warning label for Children's Motrin, which contained the ibuprofen, was inadequate. Plaintiffs are also seeking punitive damages, claiming that the drug's manufacturer withheld evidence from the FDA showing that two previous users had developed SJS. The defense objected to the plaintiffs' proffer of testimony from three doctors, none of whom is an expert in or has studied the causes of SJS. In rebuffing the objections, Judge DuBois concluded that the U.S. Supreme Court's 1991 decision in Daubert v. Merrell Dow Pharmaceuticals Inc. does not require an expert's knowledge base to be as specialized as the defense urged. Experts need not be “the best qualified” or “have the specialization that the court considers most appropriate,” wrote Justice DuBois. An expert's deficiencies in knowledge, if any, go to the questions of credibility and weight, concluded the judge, not admissibility.

Hormone Replacement Therapy Suits Move Toward Settlement

Pfizer Inc. is reportedly ready to settle about 500 of the cases against it for injuries to plaintiffs who took hormone replacement therapy (HRT) medications sold by drug manufacturer Wyeth, which Pfizer has since acquired. This represents about one third of the outstanding cases against the company currently awaiting action in the Philadelphia Court of Common Pleas. Plaintiffs in these cases claim they were not warned of an increased chance of contracting breast cancer with use of hormone replacement therapy. According to plaintiff liaison counsel Tobi Millrood of Pogust Braslow & Millrood in Conshohocken, PA, and defense liaison counsel Robert C. Heim of Dechert in Philadelphia, the cases are being settled for undisclosed amounts. But Pfizer does not plan to roll over in all the cases against it, according to Heim: “It's the company's objective to settle cases where they think they can achieve a fair result and to try the cases where they think that the other side is overreaching in terms of a fair result.”

Newly Approved Drug May Lessen Effects of Common Hospital-Acquired Infection

On May 27, the U.S. Food and Drug Administration (FDA) approved the use of Dificid (fidaxomicin) tablets for the treatment of clostridium difficile-associated diarrhea (CDAD). Clostridium difficile is one of the leading causes of hospital-borne infections, and the diarrhea and bowel inflammation it causes can sometimes be life-threatening. The bacterium is found in the stools of those infected, and can pass to others who touch contaminated items and then touch their mouths. CDAC, once it is apparently cured, can sometimes return. Vancomycin, another antibiotic treatment for CDAC that was already on the market, was tested along with Dificid. Researchers found that those patients who took Dificid as opposed to vancomycin were more likely to remain symptom-free three weeks after treatment ended.

Manufacturer Pleads Guilty to Off-Label Promotion of Epilepsy Drug

Belgian pharmaceuticals manufacturer UCB S.A. has pleaded guilty to a misdemeanor charge that it promoted its epilepsy drug Keppra for off-label uses, and it will pay $34 million to settle criminal and civil liabilities stemming from the case. The case began as two qui tam False Claims Act actions brought by whistleblowers in the courts of Washington, DC, and Oregon. The Department of Justice (DOJ) intervened. The suits alleged that the company created and disseminated posters that falsely claimed Keppra was safe and effective for the treatment of migraine headaches. The posters falsely indicated that Keppra's migraine-treating capabilities were backed by independent research, and nothing on the posters revealed that they were sponsored by UCB. In a DOJ release announcing the guilty plea, Tony West, assistant Attorney General for the Civil Division of the DOJ said, “Patients have a right to know that the drugs they are prescribed have been approved by the FDA as safe and effective for a particular use. Off-label promotion of pharmaceuticals undermines the FDA's important role in protecting the public and is a drain on taxpayers dollars.” Dwight C. Holton, U.S. Attorney for the District of Oregon, added that the settlement “demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for Medicaid and other federal health care programs.”

Despite Lack of Specific Expertise, Doctors May Testify on Causation

In a 34-page opinion in Wolfe v. McNeil-PPC Inc., U.S. District Judge Jan E. DuBois held that a doctor testifying as an expert witness may opine as to causation using a “differential diagnosis” ' in other words, he or she is permitted to testify that, because other causes have been ruled out, the pharmaceutical product at issue likely caused the condition. The case involves a child who was given ibuprofen, after which she developed Stevens-Johnson Syndrome (SJS), a life-threatening condition in which the epidermis separates from the dermis. The plaintiffs assert that the warning label for Children's Motrin, which contained the ibuprofen, was inadequate. Plaintiffs are also seeking punitive damages, claiming that the drug's manufacturer withheld evidence from the FDA showing that two previous users had developed SJS. The defense objected to the plaintiffs' proffer of testimony from three doctors, none of whom is an expert in or has studied the causes of SJS. In rebuffing the objections, Judge DuBois concluded that the U.S. Supreme Court's 1991 decision in Daubert v. Merrell Dow Pharmaceuticals Inc. does not require an expert's knowledge base to be as specialized as the defense urged. Experts need not be “the best qualified” or “have the specialization that the court considers most appropriate,” wrote Justice DuBois. An expert's deficiencies in knowledge, if any, go to the questions of credibility and weight, concluded the judge, not admissibility.

Hormone Replacement Therapy Suits Move Toward Settlement

Pfizer Inc. is reportedly ready to settle about 500 of the cases against it for injuries to plaintiffs who took hormone replacement therapy (HRT) medications sold by drug manufacturer Wyeth, which Pfizer has since acquired. This represents about one third of the outstanding cases against the company currently awaiting action in the Philadelphia Court of Common Pleas. Plaintiffs in these cases claim they were not warned of an increased chance of contracting breast cancer with use of hormone replacement therapy. According to plaintiff liaison counsel Tobi Millrood of Pogust Braslow & Millrood in Conshohocken, PA, and defense liaison counsel Robert C. Heim of Dechert in Philadelphia, the cases are being settled for undisclosed amounts. But Pfizer does not plan to roll over in all the cases against it, according to Heim: “It's the company's objective to settle cases where they think they can achieve a fair result and to try the cases where they think that the other side is overreaching in terms of a fair result.”

Newly Approved Drug May Lessen Effects of Common Hospital-Acquired Infection

On May 27, the U.S. Food and Drug Administration (FDA) approved the use of Dificid (fidaxomicin) tablets for the treatment of clostridium difficile-associated diarrhea (CDAD). Clostridium difficile is one of the leading causes of hospital-borne infections, and the diarrhea and bowel inflammation it causes can sometimes be life-threatening. The bacterium is found in the stools of those infected, and can pass to others who touch contaminated items and then touch their mouths. CDAC, once it is apparently cured, can sometimes return. Vancomycin, another antibiotic treatment for CDAC that was already on the market, was tested along with Dificid. Researchers found that those patients who took Dificid as opposed to vancomycin were more likely to remain symptom-free three weeks after treatment ended.

Manufacturer Pleads Guilty to Off-Label Promotion of Epilepsy Drug

Belgian pharmaceuticals manufacturer UCB S.A. has pleaded guilty to a misdemeanor charge that it promoted its epilepsy drug Keppra for off-label uses, and it will pay $34 million to settle criminal and civil liabilities stemming from the case. The case began as two qui tam False Claims Act actions brought by whistleblowers in the courts of Washington, DC, and Oregon. The Department of Justice (DOJ) intervened. The suits alleged that the company created and disseminated posters that falsely claimed Keppra was safe and effective for the treatment of migraine headaches. The posters falsely indicated that Keppra's migraine-treating capabilities were backed by independent research, and nothing on the posters revealed that they were sponsored by UCB. In a DOJ release announcing the guilty plea, Tony West, assistant Attorney General for the Civil Division of the DOJ said, “Patients have a right to know that the drugs they are prescribed have been approved by the FDA as safe and effective for a particular use. Off-label promotion of pharmaceuticals undermines the FDA's important role in protecting the public and is a drain on taxpayers dollars.” Dwight C. Holton, U.S. Attorney for the District of Oregon, added that the settlement “demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for Medicaid and other federal health care programs.”