Mary Holloway, 47, of Branchburg, NJ, pleaded guilty to violating the Food, Drug, and Cosmetic Act while she worked as a regional manager for Pfizer, according to a Department of Justice release.
As a regional manager from approximately November 2001 through April 2005, Holloway was responsible for sales of the company’s COX-II inhibitor, Bextra. The FDA approved Bextra for use in treating osteoarthritis, adult rheumatoid arthritis, and primary dysmennorhea, but denied the company’s request to approve it for acute pain.
Holloway allegedly instructed her sales force to promote Bextra to:
- Treat acute pain, a use the FDA refused to approve
- Reduce the risk of deep vein thrombosis, even though she knew there were no studies showing that Bextra was safe and effective for this use
Holloway also encouraged her 100-member sales force to make false safety claims about Bextra in order to sell the drug, and to promote use of Bextra at a higher dosage than approved.
Pfizer voluntarily withdrew Bextra in 2005. In October 2008, Pfizer agreed to pay $894 million to settle all personal injury cases, consumer fraud cases, and state attorneys general’s claims related to Bextra and Celebrex. The company disclosed in January that it set aside $2.3 billion to resolve allegations regarding past off-label promotion of Bextra and other open litigation.
A federal judge cited the February 2008 Supreme Court ruling in favor of preemption for medical device makers in his decision to grant a summary judgment for Allergan in Dorsey v. Allergan.
Judge Robert Echols of the U.S. District Court for the Middle District of Tennessee dismissed a lawsuit filed by Susan Dorsey. Dorsey received Allergan’s Style 20 breast implants in November 2005 as part of a clinical trial and claimed she began experiencing pain and fatigue almost immediately after surgery. A surgeon removed the implants in September 2006. Two months later, the FDA approved the Style 20 implants.
Dorsey sued Allergan for strict liability, claiming the implants were unreasonably dangerous. Allergan moved to dismiss, citing among other things the Supreme Court’s decision in Riegel v.Medtronic. In that case, the Court said medical device makers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review.
In his ruling, Echols said the FDA found the implants safe and effective and granted pre-market approval. To win the case under Tennessee law, Dorsey had to prove the implants were unsafe for normal use. Echols said the Supreme Court’s decision in Riegel v Medtronic specifies that such claims are pre-empted under the MDA where a specific device has received pre-market approval.
GlaxoSmithKline (GSK) will disclose payments to US healthcare professionals and their institutions to conduct clinical trials beginning in 2010, according to the company’s 2008 Corporate Responsibility Report.
In the future, GSK plans to disclose payments for other types of research and to healthcare professionals and institutions outside the U.S. The company also plans to expand publication of clinical trials on its Clinical Study Register to include all meta-analyses, observational studies, and studies of terminated compounds.
GSK will publish all clinical research as manuscripts in peer reviewed journals “whenever possible,” it says. For unpublished studies, the company will provide context and interpretation via the GSK Clinical Study Register.
Disclosure plans are nothing new for GSK. In August 2008, the company unveiled plans to post its educational and charitable grants quarterly. The company also plans to publish a report of speaking and consulting fees paid to US healthcare professionals.
An increased focus on transparency means an end to pharmaceutical industry support for American Psychiatric Association (APA) symposia.
The APA Board of Trustees voted to stop accepting industry funding for continuing medical education symposia and to eliminate industry funded meals from its annual meeting, according to an APA release.
The move puts the APA at the forefront of the trend to increase transparency and reduce potential financial conflicts of interest, according to the release.
Individual universities are also limiting how much support they allow pharmaceutical companies to provide for educational programs. Stanford University and the universities of Massachusetts, Pittsburgh, Colorado, Kansas, and California Davis require companies to contribute to a pool of money for CME funding. Memorial Sloan-Kettering Cancer Center stopped accepting industry funding for CME completely.
Senator Charles Grassley (R-IA) has led the call for increased transparency and disclosure of financial ties between the pharmaceutical industry and healthcare professionals. Grassley and Senator Herb Kohl (D-WI) introduced the Physician Payments Sunshine Act of 2009 in January. The bill would require pharmaceutical, biologics, and medical device companies to report payments they give to physicians over $100 every year.
The senators introduced the bill originally in 2007, but Congress failed to act on it. However, the bill, along with individual state disclosure laws, helped prompt pharmaceutical companies to increase their voluntary disclosure efforts. Pfizer, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, and AstraZeneca are among the companies that have already announced plans to disclose some or all payments to physicians.
Several health systems and universities, including the Cleveland Clinic and Penn Medicine, have announced plans to disclose funding their healthcare professionals receive from the pharmaceutical industry.
AdvaMed and 10 other healthcare organizations are working together to create national standards for clinical healthcare industry representative (HCIR) credentialing, according to an AdvaMed release.
Clinical HCIRs include industry professionals who provide technical support related to procedures ranging from knee replacements to programming cardiac pacemakers.
Currently, individual hospitals and healthcare facilities determine their own credentialing requirements. The new proposal would end the duplicative and sometimes conflicting regulations set up by each healthcare facility, according to AdvaMed.
The recommendation includes five basic criteria:
- Updated vaccinations
- Product or general liability insurance
- Hospital unit orientation
- Policy and procedures and training documentation
In addition to AdvaMed, the following organizations also signed the recommendation:
- American Association of Critical Care Nurses
- Association for Healthcare Resource & Materials Management
- Association of Peri-Operative Registered Nurses
- Health Industry Distributors Association
- Health Industry Representatives Association
- Healthcare Manufacturers Management Council
- Independent Medical Manufacturer Distributors Association
- Industry Partners for Patient Safety
- Innovative Healthcare Access Coalition
- Medical Device Manufacturers Association
Merck updates grand jury investigation, announces denial of class action status for Vioxx suit
March 24, 2009
A grand jury is investigating Merck’s research, marketing, and selling activities for its withdrawn painkiller Vioxx, the company announced.
Merck had previously disclosed the government’s investigation, which began in 2004, but received a letter from the U.S. Attorney’s Office for the District of Massachusetts advising it of the probe March 23.
Merck did receive some good news relating to Vioxx. New Jersey Superior Court Judge Carol E. Higbee denied a request to certify plaintiffs suing Merck for economic loss over its withdrawn painkiller as a class, according to a company release.
A class action suit would not have resulted in a fair trial because each plaintiff’s circumstances were different and the information available to physicians changed over time, according to Merck’s statement. The decision only affects consumer claims for economic loss.
In 2007, Merck reached a proposed $4.85 billion settlement to resolve patients’ claims of personal injury due to Vioxx. More than 99% of those eligible signed up for the settlement by the November 9, 2007, deadline, according to Merck. In addition, the company agreed in May 2008 to pay $58 million to settle claims by 29 states and the District of Columbia that it downplayed the risks of Vioxx in advertising.
Higbee’s ruling to deny class action status follows an earlier ruling in New Jersey. In 2007, the New Jersey Supreme Court ruled that certification of a nationwide class of insurers who paid for Vioxx was not appropriate because common questions of fact did not predominate.
Merck stopped selling Vioxx in September 2004 after a clinical trial showed that it increased the risk of strokes and heart attacks in some patients.
The Iowa Senate is following Massachusetts’ example by passing strict legislation regulating interactions between pharmaceutical companies and healthcare professionals.
The Senate passed File 389 by a vote of 30-18 on March 19. The bill must still pass the House of Representatives and be signed by the governor.
Under the bill, manufacturers, wholesalers, and their agents would be prohibited from providing or offering gifts to healthcare professionals.
Companies could provide:
- Funding for an educational, scientific, or policy-making conference or seminar, if the payment is not made directly to a healthcare professional
- Reasonable honoraria and payment of reasonable expenses for healthcare professionals who serve as faculty for educational or scientific meetings
- Compensation for the substantial professional or consulting services related to bona fide clinical trials
The bill would require companies to disclose annually the value, nature, purpose, and recipient of any gift. The bill also bans data mining of healthcare professionals’ prescribing habits.
In addition, the bill would:
- Establish an insurance exchange
- Expand public health insurance for children
- Establish an evidence-based drug education program
- Establish an office of healthcare reform
Seven states and the District of Columbia currently regulate interactions between healthcare professionals and pharmaceutical manufacturers.
Boston Scientific will take a $50 million pre-tax charge to its earnings to settle all outstanding lawsuits with Bruce N. Saffran, MD, PhD, according to a March 16 regulatory filing with the SEC.
Saffran sued Boston Scientific in 2005, alleging some of some of the company’s coronary stent systems infringed on his patent. A jury in the District Court for the Eastern District of Texas found in February 2008 that two of Boston Scientific’s Taxus stent products infringed on Saffran’s patent and awarded him $431 million, plus an addition $69 million in prejudgment interest.
Boston Scientific appealed the ruling to the Federal Circuit Court of Appeals in Washington D.C. A hearing was held before the appeals court March 2. Boston Scientific and Saffran filed a joint motion to dismiss the appeal March 17.
A second lawsuit Saffran filed in February 2008, seeking damages for the continued sale of Taxus stents, will also be dismissed as a result of the settlement.
Welch Allyn’s AED 10 and MRL JumpStart external defibrillators may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference, prompting the company to issue a worldwide recall.
U.S. customers may
- Exchange their Welch Allyn AED 10 for a like device at no cost,
- Purchase a new AED 10 directly from Welch Allyn, with a standard five-year warranty, at a significantly reduced cost
Because the chance of malfunction is low, the company recommends patients continue to use the device until they receive a replacement. The company also said a low energy shock may still be clinically effective, and a full energy shock can follow a low energy shock.
A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human bone growth products, the company revealed in a regulatory filing.
The grand jury is reviewing allegations Stryker Biotech:
- Illegally promoted its OP-1 products and Calstrux
- Sold misbranded medical devices
- Submitted false reports to the FDA regarding the number of patients treated with OP-1 under one of the company’s Humanitarian Device Exemptions (HDE)
The company previously revealed that the United States Attorney’s Office for the District of Massachusetts requested documents regarding false institutional review board approvals.
Stryker also revealed it is aware of guilty pleas entered by two former employees. Former territory manager Jason Demming pleaded guilty February to felony misbranding. In November 2008, former sales representative Darnell Martin pleaded guilty to making a false statement and felony misbranding. Both cases centered on medical devices designed to promote bone growth that the FDA approved only pursuant to an HDE.