Litigation

The author wishes to thank Andrew M. Hodgson for his assistance in preparing this post. Andrew is an Associate in the Firm’s Chattanooga office. 

As I approach the quarter century mark of my practice as a tort, healthcare and commercial litigator, predominately on the defense side, I reflect on some of the land mines that face the defense bar. These land mines include missing an affirmative defense, failing to join a necessary party, failing to enlist the services of all the expert witnesses needed to combat the plaintiff’s claims, and the list goes on. Even so, I would argue that none of these potential pitfalls can hold a candle to the specter of statutes of limitations and pre-suit requirements facing the plaintiff’s bar. In Tennessee, as in many states, those hurdles are magnified by pre-suit notices and other filings required of the plaintiff in making a healthcare liability claim. In November, the Supreme Court of Tennessee highlighted the importance of “crossing all your t’s and dotting all your i’s” when making such a claim in the case of Stevens v. Hickman Community Healthcare Services, Inc., No. M2012-00582-SC-S09-CV (Tenn. filed Nov. 25, 2013). Importantly, the Stevens court also made instructive rulings as to HIPAA preemption and a defendant’s right to receive records in healthcare liability actions.

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims for damages suffered due to Pfizer’s fraudulent marketing of off-label uses for the prescription drug Neurontin, an anti-convulsive approved for the treatment of epilepsy.  At the heart of the dispute is causation—the causal chain that runs from a drug manufacturer, such as Pfizer, to third-party payors of prescription drug benefits, such as HMOs, insurers and other health plans.

The First Circuit’s lead opinion—laying the common predicate necessary to understand each of the companion cases—came in the action brought against Pfizer by Kaiser, in which the court affirmed a $142 million jury award to the HMO.

The Development and Marketing of Neurontin

Neurontin was developed during the 1980s and early 1990s as an anti-epileptic drug.  In 1993, the Food and Drug Administration approved Neurontin for treatment of partial seizures in adults with epilepsy.  A campaign to market Neurontin for off-label conditions—conditions not included on the official label approved by the FDA—began in 1995.  These off-label conditions included neuropathic pain (pain from nerve damage), migraine headaches, and bipolar disorder.  Neurontin was marketed for treatment of these off-label conditions by way of, among other things:  (1) direct marketing to doctors, which misrepresented Neurontin’s effectiveness for off-label indications; (2) misleading information supplements and continuing medical education programs; and (3) articles published in medical journals that touted Neurontin’s off-label effectiveness but suppressed negative information about the drug. 

On August 20, the Fifth Circuit Court of Appeals rejected a whistleblower claim by a former employee of Cardinal Health, Inc., affirming dismissal of the former employee’s complaint, which alleged that Cardinal Health sold hospitals run by the U.S. Department of Veterans Affairs defective medical equipment, in violation of the False Claims Act (FCA).

Before her termination from Cardinal Health, the plaintiff marketed Cardinal Health’s “Signature pump”—an electronic device that regulates the rate at which intravenous fluids flow into patients—to various hospitals, including hospitals run by the VA.  The plaintiff alleged that the Signature pump had a dangerous defect, causing air bubbles to accumulate and be released into a patient’s intravenous fluids flow, potentially resulting in serious injury or death.

The plaintiff claimed that she became aware of the defect in late 2000 and discussed it with a Cardinal Health area manager in early 2001.  In mid-2001, Cardinal Health suspended shipment of the Signature pump for three months and undertook a review of the possible defect.  Cardinal Health terminated the plaintiff at the end of the three-month review period.  Cardinal Health suspended production and sale of the Signature pump for independent reasons in 2006.

“Implied False Certification” Theory of FCA Product Liability

The crux of the plaintiff’s FCA claim was that Cardinal Health falsely certified to the VA that the Signature pump was in compliance with the warranty of merchantability in the parties’ contract each time it requested payment from the VA for the pumps—a so-called “implied false certification” theory.

Are human genes patentable?

Late last week, the U.S. Supreme Court held that isolated segments of naturally occurring DNA are not patent eligible, while synthetically created DNA, such as complementary DNA (cDNA), is patent eligible. In the wake of this decision, patent portfolios should be reviewed to determine whether patents having claims to isolated DNA…

In recent months, two federal courts have dismissed lawsuits alleging that branded drug manufacturers’ discounted subsidies—coverage of co-payments—for branded drugs violate federal racketeering and commercial bribery laws.  The two cases are among a number of similar pending suits, largely coordinated by the healthcare consumer advocacy group Community Catalyst, which concern approximately 20 different branded drugs.  Both cases are significant victories for branded drug manufacturers, who face claims that they have defrauded health plans by offering discounted subsidies directly to consumers—nudging those consumers away from cheaper, generic options preferred by the health plans—in order to preserve market share for branded drugs.

The first action, brought by union health plans against the manufacturer Merck & Co. in the United States District Court for the District of New Jersey, was dismissed on April 29, 2013.  Judge Michael A. Schipp dismissed the action on grounds that the health plans lacked standing—that the health plans failed to allege that Merck’s discounted subsidies caused the health plans’ members to be prescribed or to purchase drugs that they would not have been prescribed or have purchased otherwise.

A second action against the manufacturer Bristol-Myers Squibb, also brought by union health plans under similar legal theories, was dismissed on substantive grounds by Judge J. Paul Oetken of the United States District Court for the Southern District of New York on June 6, 2013.

As Judge Oetken summarized the crux of the dispute between health plans and branded drug manufacturers:  “Insurers are keen to control drug costs, while manufacturers are determined to maintain market share while competing with generics and therapeutic alternatives.  In recent years, manufacturers have launched programs through which they offer to cover the cost of co-payment obligations for their branded drugs.  Insurers, which create tiered co-pay obligations to encourage plan members to select cheaper drugs, oppose these programs and argue that they increase overall drug costs.”

In other words, health plans use tiered co-payment plans to incentivize consumers to purchase less expensive, generic equivalents of branded drugs.  And, against these payment arrangements, branded drug manufacturers endeavor to preserve their market share by countering plan incentives with discounted subsidies.

A recent report by the Office of Inspector General for the Department of Health and Human Services (OIG) concluded that in Fiscal Year 2010, 61% of Medicare providers that appealed CMS payment decisions were fully successful in their respective appeal.  In other words, these providers persuaded the Administrative Law Judge (ALJ) handling the appeal to completely overturn previous adverse payment decisions made by CMS and its contractors.  Notably, of the 61% of providers that were successful, those appealing Part A and B claims had the most success, 67% and 59% respectively.

The Medicare overpayment appeal process consists of four levels.  At the first level of appeal, which is available after an initial overpayment determination, the individual or entity (appellant) appeals the overpayment decision to CMS’s Medicare Administrative Contractor.  If the appellant is unsuccessful, the next appeal is administered by CMS’s Qualified Independent Contractor (QIC).  The third level of appeal is administered by the ALJ, and the fourth level is administered by the Medicare Appeals Council.  OIG’s report contrasted the high success rate at the ALJ level to the low 20% success rate at the QIC level.  While there are many reasons for the difference, OIG’s report found that the main reason is that ALJs tend to view Medicare’s reimbursement and coverage policies less strictly than CMS’s contractors.  OIG also found that CMS participated in only 10% of all ALJ appeals, which resulted in the ALJ overturning CMS’s decision in 60% of these cases.

The California Supreme Court has agreed to hear a case to decide this issue (Fahlen v. Sutter Central Valley Hospitals, 208 Cal. App. 4th 557 (2012)).  The case pits the sometimes adverse interests of physicians against the interests of hospitals when employment and practice privilege issues collide.  Physicians who allege their privileges have been terminated in retaliation for blowing the whistle do not want to wait to file a whistleblower case until all administrative and judicial remedies concerning their clinical privileges are exhausted.  On the flip side, hospitals do not want to fight physicians on two fronts: in court and in the hospital’s own peer review process with the potential for judicial review.

The hospital in the case, Sutter Central Valley Hospitals, declined to renew the physician’s privileges after peer review proceedings, and that determination was upheld by the hospital’s board.  While the physician, Dr. Fahlen, might have been able to challenge that decision in court, he chose to file a lawsuit against the hospital with a number of claims, including claims under California’s whistleblower protection law (Cal. Health & Safety Code Section 1278.5, subd. (a)).  Dr. Fahlen claims that he lost his privileges as retaliation for blowing the whistle on dangerous nurses.

The Sixth Circuit recently made some interesting findings related to the knowledge standard in the False Claims Act (“FCA”) and whether maximizing profits is evidence of fraud.

The knowledge standard in the FCA may create a disincentive for defendants to litigate cases brought by the government, especially considering the standard for liability can be met by the government demonstrating that the defendant acted with reckless disregard or in deliberate ignorance of the truth or falsity of the claim.   See 31 U.S.C. § 3729.  In light of this fairly low standard, it is no secret that some defendants decide it is less costly to settle a case, rather than engaging in protracted litigation with the government.  However, in one recent case the defendant, Renal Care Group, Inc. and its wholly-owned subsidiary, decided to fight back against allegations it defrauded the government of millions of dollars while providing dialysis treatments to Medicare beneficiaries suffering from end-stage renal disease.  Renal Care lost the first battle when the district court granted summary judgment in favor of the United States and awarded the government $82.6 million in damages and penalties.  On appeal, however, Renal Care secured a major victory when the court of appeals reversed the district court’s judgments on grounds that Renal Care did not act in reckless disregard under the FCA.

Without going into the specific facts alleged by the government, there are two important findings from this Sixth Circuit decision worth noting.  First, the Sixth Circuit determined that Renal Care did not act recklessly.  Per the Sixth Circuit, a defendant can be held liable under the FCA by showing that it acted with actual knowledge or constructive knowledge.  United States v. Renal Care Group, et al., No. 11-5779, slip op. at 17 (6th Cir. Oct. 5, 2012).  Constructive knowledge can be proven by demonstrating that the defendant acted in deliberate ignorance of, or with reckless disregard to, the truth or falsity.  One of the facts relied on by the court in reaching its decision on the knowledge requirement is that Renal Care sought legal counsel, who in turn sought clarification from CMS on what appears to be fairly ambiguous regulations.  The court focused on this fact, in addition to some others, in reaching its conclusion that Renal Care did not act recklessly. 

Recently, the United States Court of Appeals for the Second Circuit heard arguments on whether lawyers are allowed to bring whistleblower lawsuits against their employer and client (U.S. ex rel. Fair Laboratory Practices Associates vs. Quest Diagnostics Inc. et al.).  A U.S. District Court threw out the case in April of 2011, ruling that…