Jury Awards Plaintiff $21 Million in Bartlett v. Mutual Pharmaceutical Co., Inc.

Last month we posted an article regarding Bartlett v. Mutual Pharmaceutical Co., Inc., a suit brought in the United States District Court for the District of New Hampshire by a plaintiff who claimed that her use of Sulindac, a generic version of the non-steroidal anti-inflammatory drug ("NSAID") Clinoril, caused her to develop Stevens-Johnson Syndrome ("SJS").  Ruling on motions for summary judgment, the Court refused to grant summary judgment on the plaintiff's strict liability design defect and negligent design defect claims.   At that time, the court concluded that the plaintiff had presented enough evidence to create a trial-worthy issue as to whether the NSAID was unreasonably dangerous and whether that defective condition caused her injuries.

On September 8, 2010, the jury in Bartlett awarded the plaintiff $21 million, finding that the manufacturer should have known that the NSAID was unreasonably dangerous and that the NSAID caused plaintiff's injuries, which included blindness.  The plaintiff demonstrated at trial that Sulindac had been linked with other incidents of SJS and that the rate of SJS occurence among those prescribed Sulindac was higher than those prescribed other anti-inflammatory medications.

REMINDER: Feedback and Comments on 510(k) Preliminary Reports Due By October 4

Several weeks ago, we issued a blog post and an industry alert advising members of the medical device industry of the opportunity to participate in an informational podcast being held by CDRH.  In that post, we also advised you that the preliminary reports on changes to the 510(k) process had been opened for comment by FDA.  FDA relies heavily on industry discussion and comment before finalizing its procedures and reports, but it can't do that if you as an industry participant do not stand up and make your voice heard.

FDA will be accepting comments on "Center for Devices and Radiological Health Preliminary Internal Evaluations" until October 4, 2010, which is only a few short weeks away.  You can submit your comments by writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or online through http://www.regulations.gov.

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!

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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.