Federal Court Halts Expansion of Embryonic Stem Cell Research

The New York Times reported that United States District Court Chief Judge Royce C. Lamberth issued a preliminary injunction blocking the federal funding of human embryonic stem cell research. This ruling severely impairs the progress of human embryonic stem cell research in the United States.

 

STEM CELL RESEARCH - GENERALLY

 

Presently, there are three types of stem cells used for research purposes: (1) human embryonic stem cells (“ESCs”); (2) adult stem cells (“ASCs”); and (3) induced pluripotent stem cells (“IPSCs”). Each type has unique research capabilities.

 

ESCs are pluripotent, meaning can to give rise to any of the approximately 200 types of cells in the human body, and can be used to treat diseases in two different ways - researchers can transplant ESCs into patients, or researchers may use ESCs to study disease mechanisms that cannot be studied within the human body, and to develop of the non-stem cell based therapies for these conditions. Recent studies using both methods of treatment suggest that ESCs will contribute to the development of medical knowledge in the future.

 

ASCs are found in tissues that are normally discarded after birth, such as the umbilical cord, and in the body. However, ASCs are limited because they are not pluripotent like ESCs. As such, ASCs cannot differentiate into the 200 types of cells within the human body.

 

IPSC research, the newest form of stem cell research, includes adult stem cells that have been genetically reprogrammed such that they are virtually identical to embryonic stem cells.

 

REGULATORY HISTORY REGARDING STEM CELL RESEARCH

 

The availability of federal funding for ESC research has been an issue for some time. In 1996, Congress enacted the Balanced Budget Downpayment Act, which contained a rider known as the Dickey-Wicker Amendment (“Amendment”). The Amendment prohibited the use of federal funds for (1) the creation of a human embryo or embryos for research purposes, or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under acceptable federal regulations. This amendment is passed annually by Congress in every appropriations bill for Health and Human Services since 1996.

 

Some stem cell researchers reasoned that the Amendment did not apply to ESC research because ESCs are not embryos, and research on ESCs does not result in the destruction of an embryo. Specifically, a distinction was drawn between work that leads to the destruction of embryos — which could not be financed by the federal government— and work using stem cells created through embryonic destruction, which could be funded.

 

In 2001, President Bush issued an Executive Order prohibiting federal funding for research on ESCs that were created after August 9, 2001. On March 9, 2009, President Obama issued an Executive Order removing President Bush’s limitations on ESC research. As a result, President Obama directed the National Institutes of Health (“NIH”) to review its existing stem cell research guidelines and issue new NIH guidance on research that is consistent with his Executive Order.

Accordingly, the Guidelines for Human Stem Cell Research (“Guidelines”) were drafted by the NIH to allow funding for research using human embryonic stem cells that were derived from human embryos created using in vitro fertilization for reproductive purposes and were no longer needed for that purpose.

 

SHERLEY V. SEBELIUS

 

In the present case, Chief Judge Lamberth granted the preliminary injunction effectively blocking the federal funding of ESC research. In his opinion, Chief Judge Lamberth reasoned that the NIH Guidelines violate the language of the Amendment, because the Amendment prohibits research in which a human embryo is destroyed. In order to perform ESC research, ESCs must be derived from an embryo, and the process of deriving ESCs from an embryo results in the destruction of the embryo. Specifically, he reasoned that “if one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding.”

 

Next, Chief Judge Lamberth reasoned that Plaintiffs would be irreparably injured if ESC researchers were allowed to seek federal funding for ESC research. Specifically, Plaintiffs, researchers that specialize in ASC research, asserted that obtaining NIH funding is necessary for their continued research, and the Guidelines, by allowing federal funding of ESC research, increases the competition for NIH funding. According to this opinion, competition for federal funding is enough of an injury to make a preliminary injunction a potential remedy.

 

Furthermore, Chief Judge Lamberth reasoned that it is in the public’s best interest to carry out the “will of Congress” and adhere to the Amendment. As such, federal funding of human embryonic stem cell research is presently enjoined.

 

This case is particularly interesting because although stem cell research can be a polarizing topic in our society due to the moral implications, it is the fight for funding between researchers that successfully brought this issue before a judge, and may ultimately decide whether human embryonic stem cell research may receive federal funding. It leads one to believe that no matter how moral the implications, money makes the world go around!

Tags:

Pennsylvania Court Recognizes New Cause of Action in Pharmaceutical Products Liability Case

In Lance v. Wyeth, the Pennsylvania Superior Court held that a plaintiff may properly maintain a cause of action for negligent design defect under Pennsylvania law in a pharmaceutical products liability case. In Lance, the plaintiff alleged that her daughter took Redux to treat her obesity from January 1997 through April 1997. Redux, which was manufactured by Wyeth, had been approved by FDA as safe and effective in April 1996. Wyeth ultimately withdrew the drug from the market in September 1997. More than seven years after plaintiff’s daughter had ingested Redux, she was diagnosed with primary pulmonary hypertension (PPH). One month after being diagnosed with PPH, plaintiff’s daughter was dead.

Wyeth filed a motion for summary judgment and argued that the plaintiff had failed to assert a cognizable cause of action as a matter of law. Wyeth argued that a plaintiff can only recover from a drug manufacturer by proving either a manufacturing defect or an inadequate warning. Plaintiff had not alleged either.   Instead, plaintiff had alleged that Redux was “unreasonably dangerous” and that Redux’s “risks outweighed it benefits as to all possible classes of users” of the medication.  The Court of Common Pleas granted Wyeth’s motion for summary judgment and this appeal followed.

Acknowledging that, under Pennsylvania law, a plaintiff may not state a cause of action for strict liability arising out of a design defect, so long as the drug is manufactured properly and contains adequate warnings, the court held that plaintiff properly stated a cause of action for negligent design defect. Citing Philips v. Cricket Lighters, the court stressed the difference between a cause of action for strict liability arising from design defect, which examines the product itself, and negligent design defect, which examines the conduct of the pharmaceutical manufacturer.

The court’s analysis centered around Comment k of the Restatement (Second) of Torts, § 402A, which was adopted by the Pennsylvania Supreme Court in Hahn v. Richter, and which provides:

k.            Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous . . . . The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their sue, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

The court found that nothing in comment k proscribes a plaintiff from stating a cause of action for negligent design defect. To the contrary, by its very terms, comment k expressly bars only claims for strict liability arising from design defect, insofar as they allege that a product’s design was defective and unreasonably dangerous.

Turning to the plaintiff’s claim that Wyeth acted negligently by failing to recall the product, the court refused to impose a common law duty to recall on the manufacturer, particularly where FDA has not withdrawn approval of the drug in question. 

Manufacturers should take note that the Wyeth did not argue that the plaintiff had failed to adduce sufficient evidence to withstand summary judgment, but, rather, that the plaintiff’s claim failed as a matter of law. Following Lance, manufacturers facing a negligent design defect may be more successful in attacking the plaintiff’s argument on the former grounds. Manufacturers should also take note that Lance expressly holds that negligent failure to withdraw claims are barred as a matter of law.

 

Bartlett v. Mutual Pharmaceutical Company, Inc.: Living in a Post-Wyeth v. Levine World.

Ever since the Supreme Court’s decision in Wyeth v. Levine, drug manufacturers have found themselves at increased risk from state tort claims. On July 12, 2010, the United States District Court for the District of New Hampshire issued an opinion in Bartlett v. Mutual Pharmaceutical Company, Inc., 2010 U.S. Dist. LEXIS 69825 (D.N.H. July 12, 2010).  This case arises from an incident where a plaintiff, seeking treatment for pain in her right shoulder, was prescribed a non-steroidal, anti-inflammatory drug (“NSAID”) called Clinoril. The prescription was filled with the generic version of the drug, which was manufactured by the defendant. Weeks later, the plaintiff developed Stevens-Johnson Syndrome ("SJS") progressing to toxic epidermal necrolysis ("TEN"), a potentially fatal condition. The plaintiff sued defendant and alleged, among other things, that the defendant’s drug’s safety risks outweighed its medical benefits, making it an unreasonably dangerous product and that the defendant should have strengthened the drug’s safety warning in light of a certain reports in the medical literature about the connection between the drug and SJS/TEN. Both parties moved for summary judgment on various points.

In his opinion, Judge Lapalante found the following:

 

  1. Adequacy of the Safety Warning. The court refused to grant summary judgment on whether defendant’s drug label adequately warned doctors of the risk of SJS/TEN. The court reasoned that given the severity of SJS/TEN and a study indicating that the drug had more reported cases than most NSAIDs, the decision should be left to the jury.
  1. Causation. On various issues of causation, the court found as follows:

A.                            Reliance on Warning Labels. The court granted summary judgment in favor of the defendant on the issue of whether the defendant’s alleged failure to issue a stronger warning caused plaintiff’s injuries on the basis that the plaintiff’s doctor never reviewed the label warnings.

 

B.                             Non-Label Theories. The court granted summary judgment in favor of the defendant on the issue of whether a stronger warning by the defendant could have reached the physician’s attention through some other means apart from the label and found that the plaintiff did not provide enough evidence to establish the presence of a trial-worthy issue as to whether the defendant 's alleged failure to warn caused her injuries.

 

C.                            Defective Design Claims. On the issue of design defect, the court concluded that the plaintiff presented enough evidence (in the form of expert testimony) to create a trial-worthy issue as to whether defendant’s drug is unreasonably dangerous and whether that defective condition caused her injuries.

 

  1. Fraud. The court granted summary judgment in favor of the defendant on the issue that the defendant committed fraud, because neither the plaintiff nor the plaintiff’s physicians relied on the drug’s label.
  1. Punitive Damages.  The claim for punitive damages survived summary judgment because a reasonable jury could conclude that the defendant recklessly created a risk of great harm to consumers.

 

  1. Negligence for Failure to Survey Medical Literature. Although the defendant conceded that it did not survey medical literature, the violation of an FDA regulation requiring surveillance did not amount to negligence per se and the Food Drug and Cosmetic Act did not provide private enforcement of such violations.  Thus, plaintiff’s request for summary judgment was denied.

Federal Court Rules that Generic Drug Manufacturers Cannot Hide Behind FDA Approval

The Legal Intelligencer reported that in a recent interpretation of the Wyeth v. Levine decision, a federal judge ruled that generic drug manufacturers are not immune from suit because the Federal Drug Administration (“FDA”) approved its generic drug product. In the May 26, 2010 In re Budeprion XL Marketing & Sales Litigation decision, U. S. District Court Judge Berle M. Schiller refused to dismiss a class action law suit filed by consumers who experienced side effects after switching brand-name drug Wellbutrin to generic drug Buproprion.

According to FDA regulations, to receive FDA approval for a generic drug, generic drug manufacturers must submit an Abbreviated New Drug Application (“ANDA”) providing scientific proof that the generic drug is the “bioequivalent” of a brand-name drug. This is shown by using data to prove the generic drug is comparable to the brand-name drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use. This approval process was developed in 1984 by the establishment of the Hatch-Waxman Act (the “Act”). The Act is designed to expedite the availability of less costly generic drugs by permitting the FDA to approve applications to market generic versions of brand-name drugs without costly and duplicative clinical trials.

 

In Wyeth v. Levine, the U. S. Supreme Court found that Federal law does not trump a state law imposing a duty to warn on drug manufacturers. In this case, Levine sued Wyeth for failing to adequately warn the medical staff who treated her about the risks of the anti-nausea drug Phenergan. After a clinician injected Levine with Phenergan directly into her vein, the drug entered Levine's artery, she developed gangrene, and doctors amputated her forearm. A jury determined that Levine's injury would not have occurred if Phenergan's label included an adequate warning, and it awarded damages for her pain and suffering, substantial medical expenses, and loss of her livelihood as a professional musician. Wyeth appealed the verdict all the way to the U. S. Supreme Court, asserting that Levine’s failure to warn law suit was pre-empted by Federal law because Phenergan's labeling had been approved by the FDA. The Supreme Court upheld the jury’s verdict and rejected Wyeth’s argument, stating that entrusting the FDA with drug labeling decisions does not absolve a drug manufacturer of the responsibility to comply with a state law regarding the duty to warn.

 

Judge Schiller’s decision in Budeprion expanded on the Supreme Court’s decision in Wyeth. In Budeprion, consumers brought a class action suit against Teva Pharmaceuticals (“Teva”) and Impax Laboratories (“Impax”), two manufacturers of Buproprion. The suit alleges that Teva and Impax became aware of the side effects, which stem from a difference in the method of release of the drug into the body, but failed to warn doctors or patients of the differences between the generic and brand name drug. In response to the law suit, Teva and Impax asserted that the suit should be dismissed because Federal law pre-empts claims arising from a state’s law regarding a duty to warn. Judge Schiller rejected Teva and Impax’ argument by finding that “state law causes of action do not frustrate congressional intent with respect to the regulation of generic drugs.” He opined that the Teva and Impax’ logic would remove any incentive for generic drug makers to monitor the safety of their medications and update labels accordingly after receiving FDA approval. Such an interpretation, Judge Schiller further opined, finds no support in the law.

 

This decision reminds generic drug manufacturers that while their purpose is to provide a low cost alternative to brand-name drugs, it is important to remember that the health and welfare of the consumer should always come first.