It they haven’t already started, pharmaceutical manufacturers should be re-assessing their compliance with all aspects of FDA “current Good Manufacturing Practices” (“GMPs”), given the agency’s focus on manufacturing and the spurt of recent warning letters and product recalls. Companies that fail to appear vigilant in ensuring that their products are GMP-compliant are inviting current and former employees to join the ranks of whistleblowers who have become wealthy relators through qui tam lawsuits. [Read more...]
False Claims Act Cases Based on GMP Violations . . . Watch Out For Whistleblowers
June 13, 2013 By Leave a Comment
Form Over Substance: Bausch + Lomb’s ISTA Pharmaceuticals Unit Settles with U.S
June 6, 2013 By Leave a Comment
ISTA Pharmaceuticals, Inc. (“ISTA”), a unit of eye care giant Bausch + Lomb (“B&L”), recently agreed to a $33.5 million Government settlement involving civil and criminal charges. The conduct underlying the settlement pre-dated B&L’s acquisition of ISTA in June, 2012 and underscores once again that when it comes to these kinds of settlements, it’s better for companies to play ball and let the Feds have their press release. [Read more...]
Bard To Pay $51 Million To Settle Old Whistleblower Claim
May 30, 2013 By Leave a Comment
C.R. Bard, Inc. (“Bard”) will pay just shy of $51 million to the Government and a former employee-turned whistleblower over allegations that the New Jersey medical device giant overbilled Medicare from January 1, 2004 through August 31, 2005 for radioactive seeds implanted into the prostate as part of a brachytherapy process. According to the Department of Justice, Bard’s scheme to push higher sales began in 1998 and involved multiple schemes to inflate medical pricing for radioactive seeds used in the treatment of prostate cancer. What the settlement really shows is that when it comes to Government enforcement actions, Bard and other companies remain at risk for behavior that occurred years ago. [Read more...]
Government One-Two Punches Novartis and Exposes Dangers of Speaker Programs
May 9, 2013 By Leave a Comment
Late last month, the Government stung Novartis with separate False Claims Act (FCA) suits only days apart. On April 23rd, the Government charged that Novartis paid kickbacks to numerous pharmacies in the form of discounts and rebates in order to induce the pharmacies to switch kidney transplant patients to Novartis’ Myfortic® from rival branded and generic drugs. And while that case presents a good blog topic in its own right, it is the Government’s second case that should really make everyone stand up and take notice. In the April 26th FCA Complaint, the Government reveals that Novartis spent $65 million on 38,000 speaker programs from 2002 through 2011 in support of sales for the hypertension drugs Lotrel® and Valturna®, and the diabetes drug Starlix® and has charged that the Company’s Speaker Programs were essentially nothing but kickbacks, providing little or no educational value. The problem is that much of what happened at Novartis has happened (and may well continue to happen) elsewhere. [Read more...]
Amphastar’s Qui Tam Suit Against Aventis Shows Importance of Patents
May 3, 2013 By Leave a Comment
In a recent ground-breaking qui tam ruling, a California federal court denied Aventis Pharma’s (a division of Sanofi-Aventis) efforts to dismiss costly and embarrassing False Claims Act (FCA) allegations brought by “whistleblower” and generic rival Amphastar Pharmaceuticals. In its qui tam suit, Amphastar alleged that Aventis overcharged the Government by inflating prices of enoxaparin, more commonly known as Lovenox®, based on an “inequitable conduct” patent ruling from several years ago. Although Amphastar’s suit may have been motivated by financial gain, vindictiveness or both, its theory that FCA liability can be predicated on branded drug sales where the drug’s underlying patent(s) have been invalidated is worrisome and could signal a new line of attack for a relator’s bar hungry for new avenues into big pharma’s deep pockets. [Read more...]
First Circuit Slams Pfizer in Three Neurontin RICO Suits; Affirms $142 Million Verdict
April 18, 2013 By Leave a Comment
Pfizer, Inc., must pay a $142 million jury verdict to Kaiser Foundation Health Plan, Inc. (“Kaiser”) for “damages” related to the off-label promotion of Neurontin®, the First Circuit ruled last week. Unfortunately, for Pfizer and other companies that have pleaded guilty to misbranding violations based on off-label promotion, the First Circuit’s ruling could spell even more trouble ahead. [Read more...]
Navigating FDA Guidance on Facebook and Social Media
March 18, 2013 By Leave a Comment
The FDA recently warned AMARC Enterprises, Inc., a California-based dietary supplement company, that its Facebook page (https://www.facebook.com/poly.mva) was not in compliance with FDA guidelines. Poly MVA, the AMARC brand name used on Facebook, inappropriately “liked” a consumer testimonial, the FDA’s December, 2012 warning letter noted. The consumer post read, in part, “Poly MVA … enabled me to keep cancer at bay without the use of chemo and radiation.” The agency further criticized a May, 2010 Facebook posting that offered information on how supplement ingredients, “… can nutritionally support the body during cancer and cancer therapy.” Criticism of Poly MVA’s use of social media comes at the end of a long list of other FDA violations, all revolving around failure to comply with various aspects of the Federal Food, Drug, and Cosmetic Act (FDCA). [Read more...]
Sanofi Braces for Another DOJ Investigation
March 14, 2013 By Leave a Comment
Only a few months after agreeing to fork over $109 million in civil penalties related to charges that the Company had provided free samples of the knee injection drug, Hylagan, to physicians as kickbacks for prescription business, Sanofi-Aventis has admitted in SEC filings that it is once again under DOJ Investigation. Although the details are sketchy, Sanofi’s disclosures to the FDA about the variability in patient responses to Plavix — the blood-thinning, anti-clotting drug that had been a blockbuster for Sanofi and its marketing partner, Bristol-Myers Squibb (BMS), prior to losing patent protection in 2012 – is at the heart of the investigation. [Read more...]
Public Disclosure Bar Still Kicking!
March 6, 2013 By Leave a Comment
In a recent federal district court case, U.S. District Judge Rya W. Zobel ruled in U.S. ex rel. Constance A. Conrad v. Abbott Laboratories, et. al., No. 02-11738, that because the plaintiff relator’s qui tam complaint could have been pieced together from public sources, the court lacked subject matter jurisdiction over the matter. As a result, the court granted the defendants’ motion to dismiss the complaint, breathing some life back into the public disclosure defense as a jurisdictional hurdle for would-be whistleblowers — a defense that the Affordable Care Act of 2010 (“ACA”) seemed to seriously restrict. [Read more...]
Government Takes A “Pass” on the First Amendment
January 31, 2013 By Leave a Comment
Last week it was reported across the internet that the FDA would not seek to appeal the Second Circuit’s majority decision in U.S. v. Caronia to the Supreme Court. Admitedly, in the wake of Caronia, I and other commentators were hopeful that the Government would seek a rehearing en banc — the Government even asked for an extension on the deadline to file the petition — and ultimately oral argument before the Supreme Court on the limits of its ability to regulate manufacturer speech. However, that collective hope waned once the Government passed on an en banc rehearing. Indeed, it soon became obvious that the ”best” course for the Government would be to avoid the risk of further adverse rulings, renew its campaign against weak-kneed manufacturers in off-label investigations outside the boundaries of the Second Circuit and focus its Supreme Court lawyering in other high-stakes areas, like “reverse payments” in patent Hatch-Waxman settlements. If the Government follows through on its reported January 22nd “statement” – no official statement was ever published to this writer’s knowledge – and fails to appeal Caronia to the Supreme Court by the March 4, 2013 deadline, the answer to the question ”what now?” becomes dicey for manufacturers. [Read more...]
