Dolin v. Smithkline Beecham Corp.

• Decision Date: 28 February 2014
• Docket Number: No. 12 C 6403,12 C 6403
• Parties: Wendy Dolin, Individually and as Independent Executor of the Estate of Stewart Dolin, deceased, Plaintiff, v. SmithKline Beecham Corporation d/b/a GlaxoSmithKline, a Pennsylvania Corporation; and Mylan Inc., a Pennsylvania Corporation, Defendants.
• Court: U.S. District Court — Northern District of Illinois

62 F.Supp.3d 705

Wendy Dolin, Individually and as Independent Executor of the Estate of Stewart Dolin, deceased, Plaintiff

v.SmithKline Beecham Corporation d/b/a GlaxoSmithKline, a Pennsylvania Corporation; and Mylan Inc., a Pennsylvania Corporation, Defendants.

No. 12 C 6403

United States District Court, N.D. Illinois, Eastern Division.

Signed February 28, 2014

Bijan Esfandiari, Frances M. Phares, Michael L. Baum, R. Brent Wisner, Baum Hedlund Aristei & Goldman, P.C., Los Angeles, CA, Joshua Lawrence Weisberg, Lindsey Alaine Epstein, Rapoport Law Offices, PC, Chicago, IL, for Plaintiff.

Alan Scott Gilbert, Melissa Angelica Economy, Dentons US LLP, Robert E. Haley, Swanson, Martin & Bell, LLP, Chicago, IL, Andrew T. Bayman, Todd P. Davis, Heather M. Howard, King & Spalding, David F. Norden, Greenberg Traurig, LLP, Atlanta, GA, Christopher R. Benson, Austin, TX, Clement C. Trischler, Jr., Jason M. Reefer, Pietragallo Gordon Alfano Bosick & Raspanti, LLP, Pittsburgh, PA, for Defendants.

MEMORANDUM OPINION AND ORDER

JAMES B. ZAGEL, United States District Judge

Plaintiff Wendy B. Dolin has brought this wrongful death action for damages and injunctive relief against defendants SmithKline Beecham Corporation, d/b/a GlaxoSmithKline (“GSK”) and Mylan, Inc. GSK now moves for summary judgment pursuant to Fed. R. Civ. P. 56(c), and Mylan moves to dismiss pursuant to Fed. R. Civ. P. 12(b)(6). For the following reasons, GSK's motion for summary judgment is granted in part and denied in part. Mylan's motion to dismiss is granted.

BACKGROUND

Plaintiff Wendy Dolin was married to Stewart Dolin for 35 years. According to the complaint, the Dolins were financially secure, owned their home outright, and had no pressing debts.

In June 2010, Mr. Dolin's family doctor wrote him a prescription for Paxil to treat work-related anxiety and depression. Paxil is the name-brand version of the drug paroxetine hydrochloride (“paroxetine ”) and is owned and manufactured by GSK. The drug was first approved for use in the United States in 1992 for treatment of depression in adults.

Mr. Dolin's prescription, however, was ultimately filled with a generic version of paroxetine. Mylan obtained approval to market generic paroxetine in 2007. It is undisputed that the paroxetine Mr. Dolin ultimately ingested was manufactured by Mylan.

On July 15, 2010, six days after beginning to take paroxetine, Mr. Dolin left his office shortly after having returned from lunch with a business associate. He walked to a nearby Chicago Transit Authority Blue Line station at Washington and Dearborn in downtown Chicago. As a northbound train approached the station, Mr. Dolin leaped in front of it to his death. Blood tests taken with Mr. Dolin's autopsy were positive for paroxetine.

The complaint asserts that paroxetine and other similar serotonergic antidepressants called selective serotonin reuptake inhibitors (“SSRIs”) can cause an adverse reaction called akathisia, a neurobiological phenomenon marked by profound inner restlessness and agitation. Patients experiencing such a reaction will often exhibit an inability to sit still, pacing and hand-wringing. The complaint asserts that akathisia has long been associated with suicidal behavior.

According to the complaint, Mr. Dolin exhibited classic symptoms of akathisia immediately before his death. A nurse alleged to have been on the platform at the same time as Mr. Dolin noticed that Mr. Dolin was “very agitated, pacing back and forth and looking down the tracks.”

The paroxetine label in existence at the time of Mr. Dolin's death, however, did not warn of the drug's association with increased risk of suicidal behavior in adults. Indeed, the label stated that the suicidality risk did not extend beyond the age of 24. Plaintiff asserts that GSK nevertheless had knowledge that paroxetine use carried a 6.7 times greater risk of suicidal behavior in adults compared to a placebo. Plaintiff asserts that GSK has been aware of paroxetine's association with this increased risk for over 20 years. Plaintiff asserts that GSK concealed the risk, however, and promoted its version of paroxetine, Paxil, as safe and effective.

Plaintiff also alleges that GSK was at least negligent in its manipulation of adverse event data such that the true risk associated with taking paroxetine was obscured. According to the complaint, in GSK's presentation of data on suicidal behavior in patients taking either paroxetine, a placebo, or a comparator drug, GSK included suicide attempts by placebo patients that had taken place before the clinical trial had actually begun. Including these attempts, Plaintiff asserts, yielded a misleading ratio of suicide attempts by paroxetine patients to suicide attempts by placebo patients. The implication is that the connection between paroxetine and suicide attempts was stronger than GSK made it appear.

As to Mylan, Plaintiff asserts that it was aware, or should have been aware, of this undisclosed connection between paroxetine and suicidal behavior, and the misrepresentation of the data supporting it. Nonetheless, Mylan continued manufacturing and selling generic paroxetine without notifying the medical community of the risk associated with its product.

Plaintiff has brought common law negligence and negligent misrepresentation claims as well as product liability claims under theories of both negligence and strict liability against both defendants. In its motion for summary judgment, GSK relies primarily on the argument that, because GSK did not manufacture the pill that Mr. Dolin actually ingested, it is entitled to judgment as a matter of law. Mylan, for its part, argues that Plaintiff's claims as to Mylan are preempted by federal law and must be dismissed.

DISCUSSION

I. GSK's MOTION FOR SUMMARY JUDGMENT

A. Summary Judgment Standard

Summary judgment should be granted when “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed. R. Civ. P. 56(c). A genuine issue of triable fact exists only if “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Pugh v. City O f Attica, Ind., 259 F.3d 619, 625 (7th Cir.2001) (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ).

B. The Hatch–Waxman Act

The tension between the unique federal regulatory scheme governing prescription drugs on the one hand, and Illinois state tort law on the other, is at the heart of the matter currently before the Court. Federal law requires approval from the U.S. Food and Drug Administration (“FDA”) before bringing any new drug to market. Approval may be obtained only by filing a New–Drug Application (“NDA”) with the FDA. The NDA process is both lengthy and expensive.

In 1984, in an effort to make generic versions of name-brand drugs more widely, safely, and inexpensively available, Congress passed the Drug Price Competition and Patent Term Restoration Act, also commonly known as the Hatch–Waxman Act (“the Act”). The Act provides for an expedited, less costly approval process for generic versions of drugs whose name-brand predecessors have already obtained FDA approval. Once the name-brand manufacturer's patent expires, generic manufacturers are able to enter the market with the benefit of a far more streamlined approval process. This generic drug application process is referred to as the Abbreviated New Drug Application (“ANDA”).

One caveat of this approach, however, is that the generic drug's design and warning label must identically match that of the name-brand version of the drug in all material respects. As the Supreme Court recently summarized:

First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart. 21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be “bioequivalent” to an approved brand-name drug. § 355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. § 355(j)(8)(B). Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” § 355(j)(2)(A)(v).

Mutual Pharmaceutical Co., Inc. v. Bartlett , ––– U.S. ––––, 133 S.Ct. 2466, 2471, 186 L.Ed.2d 607 (2013).

Once an NDA or ANDA has been approved, the manufacturer is prohibited from making any material changes to the drug's design. 21 C.F.R. § 314.70(b). Further, generic manufacturers (though, significantly, not name-brand manufacturers) are also prohibited from making unilateral changes to the drug's warning label. See § 314.150(b)(10).

Notably, in an effort to ensure that these reduced barriers to competitors' entry into the marketplace did not stymie innovation, the Act also allows for the extension of the patent protection period to afford name-brand manufacturers a longer period of time to recoup their investment in successful drugs.

The tension between this regulatory scheme and state tort law came to a head in PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). The plaintiffs in Mensing were prescribed Reglan, the name-brand iteration of metoclopramide, a drug commonly used to treat digestive tract problems. Id. at 2572–73. The plaintiffs asserted that their long-term use of the drug caused them to develop tardive dyskinesia, a severe neurological disorder, and they alleged that the warning labels in connection with the drug inadequate. Id. at 2573.

Although the plaintiffs were prescribed Reglan, their respective pharmacists filled the prescriptions with the generic equivalent, consistent with their respective states' drug-substitution laws.¹ This...